Yourlawyer.com (Heparin News)

Heparin Less Potent, FDA Warns

Fri, 02 Oct 2009 00:00:00 -0700

Heparin, which has been reformulated following last year's contamination scandal, is not as potent as it once was. The U.S. Food & Drug Administration (FDA) is warning doctors that some patients may now require more of the drug.

In 2008, Baxter International recalled prefilled heparin vials after they were linked to serious, and sometimes fatal, allergy-type reactions in some patients. There were similar recalls by other manufacturers in Denmark, Italy, France, Germany, and Japan. In total, tainted heparin was identified in 12 countries. It was eventually determined that a counterfeit ingredient in Chinese-sourced heparin was to blame for the problems.

According to a notice on the FDA's Web site, in response to the contamination problems, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, has adopted new manufacturing controls for heparin to ensure the quality and to guard against potential contamination. These changes include a modification of the reference standard for the drug’s unit dose, the FDA said. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

The change in heparin potency may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important, the FDA said. In such situations, the agency said healthcare providers should consider the change in potency of heparin when making decisions about what dose to administer. The change in heparin potency is expected to be less clinically significant when it is administered subcutaneously due to the low and highly variable bioavailability of heparin when administered by this route. Healthcare providers should also be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.

While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked manufacturers that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, the agency said. It has also asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags.

Baxter Says Heparin Not to Blame for Delaware Reactions, Deaths

Fri, 15 May 2009 00:00:00 -0700

Baxter International says the quality of its heparin was not to blame for serious complications in three patients at a Delaware medical center last week. According to Baxter, product testing has cleared its blood thinner.

The incidents - which involved two fatalities - had re-ignited fears about potentially tainted heparin. In 2008, Baxter recalled prefilled heparin vials after they were linked to serious, and sometimes fatal, allergy-type reactions in some patients. There were similar recalls by other manufacturers in Denmark, Italy, France, Germany, and Japan. In total, tainted heparin was identified in 12 countries.

It was eventually determined that a counterfeit ingredient in Chinese-sourced heparin was to blame for the problems. The Centers for Disease Control (CDC) ultimately identified 152 adverse reactions associated with heparin in 113 patients from November 19, 2007 through January 31, 2008. What’s more, the agency said heparin manufactured by Baxter “was the factor most strongly associated with reactions.”

Baxter hasn't made heparin vials since the 2008 recall. The patients involved in the incidents at Delaware's Beebe Medical Center received heparin from pre-mixed IV bags. According to the Associated Press, unlike the heparin involved in the recall, the active ingredient for the heparin the Beebe patients received was supplied by Pfizer. The pre-mixed bags were finished at Baxter's plant in Puerto Rico.

The three patients at Beebe suffered intracranial bleeding. They all had to be airlifted to nearby medical centers, and two died. The Food & Drug Administration (FDA) and officials from Baxter had been at Beebe investigating the incidents.

Today, Baxter released a statement that said intracranial bleeding the patients suffered “was related to underlying medical conditions and risk factors.” The letter said the heparin "performed exactly as intended, and … the events were not related to a quality product issued."

According the Associated Press, the FDA is expected to release a statement on the Beebe heparin investigation soon.

Heparin Linked to Two Fatalities

Tue, 12 May 2009 00:00:00 -0700

Two of five patients sickened after being treated with heparin at Beebe Medical Center in Delaware have died, prompting the Food & Drug Administration to launch an investigation. According to the Chicago Tribune, the heparin IV bags all five patients received were supplied by Baxter International.

The incident has once again raised concerns over the safety of heparin, which caused hundreds of serious reactions and some deaths in late 2007 and 2008. Baxter heparin, some of which was tainted with a counterfeit ingredient, was subject to a massive recall at the time.

The Baxter IV heparin bags used in the Delaware incidents are a diluted form of the drug that are supplied in pre-mixed bags and used for a number of “blood-thinning purposes,” said the Tribune. Use of the drug has been suspended at Beebe Medical Center following the reports of adverse reactions in five patients, which included internal bleeding in the brain. Three of the patients had to be airlifted to other medial centers—one to Christiana Care Health System, and two to the University of Maryland Hospital. Two other patients did recover after being monitored at Bebe.

Two of the patients died, according to The Wall Street Journal. One patient was 71-year-old man and, the other, a 64-year-old woman. A spokesman for Beebe Medical Center confirmed the deaths.

According to Erin Gardiner, a Baxter spokeswoman, the side effects in the current cases involved intracranial bleeding and not low blood pressure (hypotension), reported the Journal. Low blood pressure was one of the hallmark reactions to the tainted heparin in 2007- 2008.

In early 2008, Baxter issued a massive recall of heparin products after patients treated with the drug suffered serious and, in some cases, fatal side effects. There were similar recalls by other manufacturers in Denmark, Italy, France, Germany, and Japan with tainted heparin identified in 12 countries. In the US, the FDA ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

Baxter and the other heparin manufacturers obtained raw ingredients for heparin from processors in China. In March 2008, the FDA confirmed that it had found over-sulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and Chinese producers may have used it in an attempt to cut costs.

It was eventually confirmed by the Centers for Disease Control (CDC) that the chondroitin sulfate was to blame for the heparin side effects. The CDC ultimately identified 152 adverse reactions associated with heparin in 113 patients from November 19, 2007 through January 31, 2008. What’s more, the agency said heparin manufactured by Baxter “was the factor most strongly associated with reactions.”

For now, officials at Beebe Medical Center are not saying that the heparin involved in the sickened patients was tainted, only that the outcomes are “unusual.” Baxter said that the heparin involved with the two patient deaths originated form a North American-derived bulk material supplied by Pfizer Inc., reported the Journal.

"We are not pointing fingers at Baxter," said Beebe Medical Center spokesman Wallace Hudson. "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves," quoted the Journal.

As we reported over the weekend, an independent lab is testing the Baxter heparin used at Beebe, though it is not known when those tests will be complete.

Tainted Heparin Shipped to U.S. by Two Chinese Firms, FDA Charges

Mon, 20 Apr 2009 00:00:00 -0700

The Food & Drug Administration (FDA) has cited two Chinese manufacturers for shipping tainted heparin to the U.S. According to The Wall Street Journal, one of the firms has also been charged with lying to the FDA about its role in the contaminated heparin scandal.

In January 2008, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, after being administered the products. There were similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

In March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

According to The Wall Street Journal, the FDA has now charged that Qingdao Jiulong Biopharmaceuticals Co. and Shanghai No. 1 Biochemical & Pharmaceutical Co. were involved in making and sending 19 lots of tainted heparin sodium to the U.S., which the agency discovered in April 2008. The tainted drug didn't reach any patients because the FDA stopped all the shipments at the border, the Journal said. The FDA said the heparin had been contaminated with oversulfated chondroitin sulfate.

The charges were included in letters the FDA sent to the firms following inspections conducted in July and August 2008. In its letter to Shanghai No. 1, the FDA also said it "uncovered untrue statements and information by your firm to the agency" relating to the actual maker of heparin.

The FDA letters said the firms have in the past supplied heparin to California-based Amphastar Pharmaceuticals Inc., and its subsidiary International Medication Systems Ltd. According to The Wall Street Journal, Amphastar makes pre-filled syringes and other products.

This is the first time the FDA has disclosed that Qingdao Jiulong and Shanghai No. 1 had been implicated in the tainted heparin scandal, the Journal said. At a Congressional hearing last March, the FDA would only identify Changzhou SPL, even though it had said at least 12 Chinese companies had been implicated.

Dennis Quaid Settles Heparin Overdose Lawsuit

Wed, 17 Dec 2008 00:00:00 -0800

Dennis and Kimberly Quaid have settled their highly publicized Heparin lawsuit with Cedars-Sinai Medical Center. According to the Los Angeles Times, the Quaid’s settled for $750,000 over a serious—potentially deadly—Heparin dosing error last year, citing court papers filed earlier this week in Los Angeles County Superior Court. Last year, the newborn twins—Thomas Boone and Zoe Grace—were dosed with 1,000 times the recommended does of the blood thinner, noted the LA Times, which added that a suit against drug maker Baxter Healthcare Corporation continues. The Wall Street Journal notes that a lawsuit was not brought against Cedars-Sinai and that Quaid had said earlier this year that while he was not looking to sue the hospital, he hoped it would implement measures to improve patient safety.

Heparin is a blood thinner, and the vital drug is used in surgery, dialysis, and to prevent blood clots in the bedridden. Other drugs thin blood, but do not work as quickly as Heparin, and their effects are not as easily reversed. Baxter International manufactures about half of the multi-dose Heparin vials used in the US.

The dosing error made by nurses at Cedars-Sinai landed the babies in critical condition and with the potential to bleed out, said the LA Times, which also said that although the hospital was not sued, it was described in legal paperwork as “potential defendant." According to the LA Times piece, Cedars-Sinai hospital “officials have cited at least three safety lapses that led to the overdoses”; the Wall Street Journal also stated that an internal inquiry at the Cedars-Sinai revealed the incident involved three separate safety lapses.

The Quaid’s suit against Baxter alleges that it was the drug’s labeling and design which led to what the LA Times described as a “massive overdose,” noting that—in the suit—Baxter knew other babies had died from similar dosing errors but did not recall the “high-concentration vials.” The Wall Street Journal added that while Baxter redesigned its Heparin packaging, it should have, but did not, recall the unused, higher dosage vials. Baxter claims, said the Wall Street Journal, that the hospital is at fault.

In response to the medical error, the Quaid’s have launched a Website, entitled The Quaid Foundation, devoted to reducing such preventable medical errors: http://thequaidfoundation.org/. The Foundation’s site notes that the error that caused the babies’ illness was a result of a variety of “human errors” that involved the drug manufacturer, the hospital pharmacy, the pediatric ward, and the administering nurse. The Quaid’s noted that the nurse gave two, separate and massive heparin doses to the infants over an eight-hour period. The Quaid’s also noted the heparin debacle that was linked to the death of three infants in Indianapolis.

In February 2007, the Food & Drug Administration (FDA) and Baxter International issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors did not occur. The 2007 alert was issued after three infants died in Indiana when they were mistakenly given adult doses. In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of Heparin since 2001.

Tainted Baxter Heparin Behind Allergic Reactions, CDC Says

Fri, 12 Dec 2008 00:00:00 -0800

The Centers for Disease Control (CDC) has confirmed that heparin tainted with a counterfeit ingredient was behind a surge of allergic reactions and deaths late last year. What's more, heparin manufactured by Baxter Healthcare “was the factor most strongly associated with reactions", the agency said.

This past January, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. The FDA eventually identified 93 deaths and hundreds of adverse reactions following heparin administration were reported between January 1, 2008 and March 31, 2008, although cause of death was uncertain in 45 of these deaths.

There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA initiated 13 recalls of multiple contaminated medical products containing heparin from several companies

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

According to the new CDC study, the agency has identified 152 adverse reactions associated with heparin in 113 patients from Nov. 19, 2007 through Jan. 31, 2008. The CDC said that Baxter heparin was present in 100.0% of case facilities versus 4.3% of control facilities.

“Of 130 reactions for which information on the heparin lot was available, 128 (98.5%) occurred in a facility that had OSCS-contaminated heparin on the premises. Of 54 reactions for which the lot number of administered heparin was known, 52 (96.3%) occurred after the administration of OSCS-contaminated heparin,” the study said.

The CDC investigation included testing unopened heparin vials from 21 dialysis facilities that reported reactions and 23 facilities that reported no reactions.

Lawmaker Seeks GAO Probe of Heparin Scandal

Thu, 20 Nov 2008 00:00:00 -0800

The scandal over tainted heparin has prompted one lawmaker to seek a wider investigation into the matter. Rep. Joe Barton, R-Texas, has written to the Governmental Accountability Office (GAO) requesting a thorough investigation into the Food & Drug Administration's (FDA) handling of the heparin issue.

Heparin was the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. Last January, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products.

There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

In his letter to the GAO, Barton, the ranking Republican on the House Energy and Commerce Committee, expressed concern about conflicting statements the FDA made to the public and Congress about the number of deaths tied to contaminated batches of heparin. In particular, Barton said he had concern about the FDA’s classification of the deaths of three patients. The letter cites a Chicago Tribune article where it was reported that the FDA “conclusively linked” the deaths of those patients to a foreign substance found in specific lots of Baxter heparin.

However, in his letter, Barton maintains that in a response to his questions about those deaths, the "FDA classified the cause of death from heparin as only ‘possible’ in two of those cases, and ‘unassessable’ in the third case.”

Barton’s letter to the GAO also questions whether the FDA used all of the tools available to conduct comprehensive surveillance of the heparin deaths. “FDA confirmed to the committee’s Republican staff that the agency did not follow up to interview clinical staff or Baxter for further details about each of these cases,” the letter says. “In addition, FDA told staff the agency did not access other databases, even though FDA has testified that such databases enhance FDA’s ability to evaluate drug safety problems.”

Group Says Drug Injury, Death Reports Up Sharply

Mon, 03 Nov 2008 00:00:00 -0800

Reports of drug adverse events, including deaths, increased sharply in the first quarter of the 2008, a new report says. According to the Institute for Safe Medication Practices, the non-profit research group which compiled the report, much of the increase was due to side effects from the anti-smoking drug Chantix, as well as tainted heparin. However, the narcotic pain reliever Oxycodone, the anti-anxiety medication Alprazolam (sold under the brand names Xanax, Reclam and Niravam) and Acetaminophen had the highest number of death reports in the same time period.

The Institute compiled its quarterly report from an analysis of new adverse drug event reports submitted to the Food & Drug Administration (FDA) Adverse Event Reporting System. However, this reporting is voluntary, and only a small fraction of adverse drug events that occur are ever reported to FDA, or to drug manufacturers which then investigate and forward reports to the agency. The Institute's statement on its report also cautioned that, while the sum of adverse event reports normally provides an overall adverse event profile for a drug, the individual reports themselves do not prove that the drug caused the event described.

According to the Institute's latest quarterly report, adverse drug reactions and deaths hit record numbers in the first quarter of 2008. According to the report, there were:

20,745 new cases of serious injuries were reported, which is 38% higher than the average for the previous four quarters, and the highest for any quarter yet reported in a calendar quarter since 2006.
4,824 drug-related deaths were reported, a 2.6-fold increase from the previous quarter and the highest number of deaths yet reported since 2006. Fatal cases also accounted for a larger share of all serious cases: 23% of those in the first quarter of 2008 compared to a historical average of 16%.
1,464 (7.1%) of all cases of serious injuries were attributed to identifiable medication errors.

For the second straight quarter, Chantix accounted for more reported serious injuries than any other prescription drug, with a total of 1,001 new cases including 50 deaths. That number included numerous cases that involved vehicular or other accidents, or syncope with a high potential to cause accidents, the Institute says. Chantix has also been the subject of an FDA safety review involving psychiatric side effects, including suicidal behavior.

Ranked second in reported serious injuries was heparin, the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. In the first quarter of 2008, the FDA received 779 reports of serious injury in which heparin was the principal suspect drug, including 102 deaths.

Most strikingly, the Institute found that 10 different drugs this quarter could be linked to 100 or more deaths while in the previous 2 years, only 1-3 drugs accounted for 100 or more deaths. The risks of many of these drugs, like Oxycodone, Alprazolam and others, have been the subject of previous safety warnings from the FDA and the Institute.

Two drugs linked to 100 or more deaths, acetaminophen (160 reported deaths) and ibuprofen (114 reported deaths), are among the most widely used drugs in the nation. While both acetaminophen and ibuprofen have well-characterized safety profiles, the Institutes press release pointed out that an overdose of acetaminophen can result in irreversible injury to the liver and death. Ibuprofen carries warnings that sustained use can result in serious gastrointestinal side effects, and some may increase the risk of heart attack

Finally, the Institute also said it had investigated a surge in reported deaths associated with Fiorcet, a generic drug combination product containing acetaminophen, butalbital, and caffeine that is used to treat tension headaches. But the Institute determined that these reports did not indicate a safety problem, and instead were attributable to questionable coding of a published statistical report summarizing cases reported to the country’s poison control centers in 2006.

Serious Drug Reaction Reports Reach A Record High Due to Heparin and Chantix

Thu, 23 Oct 2008 00:00:00 -0700

The Associated Press (AP) is saying that the number of adverse effects, including deaths, linked to medications reported to the government has set a record in the first three months of this year; this according to a health industry watchdog group. It seems, according to the AP, that the U.S. Food and Drug Administration (FDA) “received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths.” The FDA data was derived from an analysis of federal data by the nonprofit Institute for Safe Medication Practices (ISMP), which reviewed data as far back as the 1990s.

Two drugs accounted for what the AP termed a “disproportionately large share of the latest reports.” One drug was heparin, the tainted blood thinner from China that caused an international safety scandal that, according to the ISMP study, accounted for 779 reports of serious problems, including 102 deaths. The FDA, which relies on data spanning a longer time frame, reports 238 deaths possibly linked to heparin.

The other drug was Chantix, a new anti-smoking drug from Pfizer that has been blamed for a number of unusual and dangerous reactions and works in the brain to both ease withdrawal symptoms and block the pleasurable effects of nicotine when a smoker attempts to light up. Chantix received the most reports of any medication. The FDA should forcefully warn patients taking Chantix that they might suffer blackouts and other problems that could lead to accidents, the report said. The report found 15 cases of traffic accidents, and 52 additional cases involving blackouts or loss of consciousness in Chantix patients; the FDA received 1,001 reports of serious injuries, possibly linked to Chantix, represnting more than for the ten best-selling brand name drugs combined.

Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. Meanwhile, we have long been reporting on the bizarre reactions Chantix users have been experiencing and, earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Although the government has banned Chantix for pilots, Pfizer said yesterday "We stand by the efficacy and safety profile of Chantix."

The FDA had no immediate response to the report, but defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy; its monitoring system relies on voluntary reports from doctors. Many believe the system only captures a small percentage of actual cases.

The report also stated that the 20,745 cases reported from January-March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, said the AP. Twenty-three percent—4,824—ended in death, a nearly three percent increase from the last calendar quarter of 2007. Previous ISMP research revealed that serious drug safety problems reported to the FDA increased significantly from 1998-2005.

“FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation,” reported the AP. For instance, if “the FDA were a police agency, the reports would indicate ‘probable cause,’ but not necessarily ‘guilt beyond a reasonable doubt,’” the AP pointed out. As far as Chantix is concerned, many feel that reasonable doubt has been met.

FDA To Open China Office, Others to Follow. But Will it Help?

Mon, 20 Oct 2008 00:00:00 -0700

The Food & Drug Administration (FDA) should be opening its new China office later this year, the Associated Press reports. The agency hopes a greater presence in China will prevent unsafe imports - such as tainted heparin and melamine-laced foods - from gaining entry to the US. Eventually, the FDA will open similar offices in other countries, but even officials at the agency concede that there still won't be enough inspectors to oversee every foreign facility that produces food and drugs for sale in the US.

In the past year and a half, imports from China have been at the center of safety worries in the US and other countries. Earlier this year, heparin contaminated with a counterfeit ingredient was implicated in dozens of deaths in the US, and hundreds of serious reactions both here and abroad. In the past month, the FDA has issued recalls of several foods imported from China that may have been tainted with the industrial chemical melamine. Melamine tainted dairy products have hospitalized thousands of children in that country.

Critic have long argued that the FDA does not have the funding or manpower to police the massive amounts of food and drugs imported from overseas. A recent report from the Government Accountability Office (GAO) found that, on average, foreign drug plants are inspected only once every 13 years.

The opening of a Beijing, China office later this year is just the first step in the FDA's plan to expand its presence overseas. According to the Associated Press, staff posted at the China office will inspect facilities, provide guidance on U.S. quality standards, and eventually train local experts to conduct inspections on behalf of the FDA. The FDA will eventually open offices in the Chinese cities of Shanghai and Guangzhou.

China has not been the only country sending questionable imports to the US This year, peppers from Mexico were implicated in one of the largest salmonella outbreaks in US history, and the FDA recently banned Indian generic drug maker Ranbaxy from importing drugs.

Over the next year, the agency plans to place 60 food and drug regulators in offices worldwide, focusing on India, Latin America and the Middle East. According to the Associated Press, the plan would cost about $30 million in its first year, primarily to set up the offices and hire new staffers, including foreign nationals who would report to the agency.

But even FDA Commissioner Andrew von Eschenbach and Health and Human Services Secretary Mike Leavitt, whose department oversees the FDA, acknowledge the agency will still have too few inspectors to adequately police every foreign manufacturer that sends products to the U.S. According to the Associated Press, they are hoping to solve that problem by allowing a voluntary inspection, where manufacturers would pay third-party inspectors to verify that their plants meet FDA standards.

Beside the obvious conflict-of-interest problems posed by manufacturers paying a for-profit service for their own inspections, many doubt that the FDA will convince overseas companies to participate. Similar attempts at a voluntary inspections system haven't been well received in the past by overseas manufacturers. To counter that problem, the FDA says it would offer those manufacturers that do agree to such a program expedited entry for their products at US ports.

But such a program would require the approval of Congress, and many members have expressed skepticism that it would work. Democrats in the House of Representatives, for example, have a proposed a program that would require companies to pay mandatory user fees to help finance additional FDA inspections.

Regulator Issues Safety Alert for Stronger Heparin Rules

Tue, 30 Sep 2008 00:00:00 -0700

According to a recent Associated Press (AP) report, the Joint Commission issued a safety alert to hospitals this week to adopt strict measures to prevent errors that involve blood thinners, such as heparin. The AP says that mistakes “have been made nearly 60,000 times and led to dozens of deaths in recent years.”

Measures could include, for example, bar-coding technology for medicines or computerized drug orders. The Commission also advised hospitals to more closely monitor patients on these drugs and ensure adult-strength heparin is stored nowhere near children's heparin units. The alert also mentioned that “28 deaths are among 32 reports of drug errors involving blood thinners that it received between 1997 and last year,” the AP said. "We know that there are many more (deaths) and ... that's the reason for issuing this alert," said Dr. Mark Chassin, president of the Commission. The commission is a private group that sets hospital standards and accredits most of the nation's hospitals. “Accreditation brings prestige and federal dollars,” the AP explained.

Heparin is the drug involved in Dennis Quaid's twins’ overdose this past autumn at Cedars-Sinai Hospital in Los Angeles, California. In July, 14 babies received accidental heparin overdoses at a hospital in Corpus Christi, Texas. In February 2007, the Food and Drug Administration (FDA) and Baxter International, issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of heparin. The memo advised hospitals to double-check inventory to ensure dispensing errors did not occur and was issued after three infants died in Indiana when they were mistakenly given adult doses.

According to US Pharmecopia, during the prior 18 months, there were roughly 250 medical errors nationwide involving heparin and children a year or younger. This year, tainted heparin has been implicated in 149 deaths and hundreds of allergy-type reactions. The firm, which sets drug standards, stated in the alert that a total of 59,316 medication errors involving blood thinners were reported between 2001 and 2006 to its database. Nearly three percent, or about 1,700 of the errors resulted in patient harm or death. In March, the FDA confirmed it found oversulfated chondroitin sulfate in samples of the active ingredient used in heparin linked to the scandal involving China-manufactured heparin for Baxter International.

As part of its measures, Commission investigators will make unannounced visits to ensure hospitals are adopting strict procedures to prevent blood thinner-related errors. Those who fail to make such changes could have their accreditation revoked, Chassin said. Chassin explained that the challenge with blood thinners is that too much can cause hard-to-control bleeding internally and from every body opening, while not enough can cause life-threatening blood clots. Heparin is usually given intravenously. Warfarin, another blood thinner cited in the alert, is available in pills patients can take at home, but Warfarin can cause negative reactions when mixed with other medicines.

The AP piece also mentioned that James Conway, senior vice president of the nonprofit Institute for Healthcare Improvement in Cambridge, Massachusetts felt that the recommendations "absolutely" will make a difference and hospitals will pay attention. Time will tell.

Contaminant-Free Synthetic Heparin Under Development

Tue, 19 Aug 2008 00:00:00 -0700

Following over 80 American deaths and hundreds of illnesses attributed to contaminated heparin derived from pig intestines processed in China, chemist Robert J. Linhardt is making the blood-thinner heparin without using animal tissue.

Conventional heparin is often made in small workshops in China, which contributes to contamination, according to Linhardt, who is a professor of chemistry, biology, and chemical engineering at Rensselaer Polytechnic Institute in Troy, New York. "Our group has been working on understanding heparin biosynthesis for almost 30 years," he said. "We are working on what might be the next generation of heparin production, with no animal source." Pig intestines are the traditional manufacturing source for heparin.

Although synthetic heparin has been made in the recent past, it was only manufactured in microscopically small amounts. Linhardt is scheduled to speak Sunday at the American Chemical Society annual meeting, in Philadelphia and described a new method of heparin biosynthesis that has produced amounts measured in milligrams. Linhardt hopes that production can be dramatically increased. The process starts with a polysaccharide, a chain of carbohydrate units, extracted from the bacterium E. coli. "We treat it to reduce the molecular size, then subject it to enzymatic steps to convert it to heparin," he explained. "We use recombinant enzymes that are part of the natural pathway for heparin synthesis." The challenge is in "scaling up the process so it is commercially viable," Linhardt said. "We are now working with one liter amounts. There are million-liter fermenters. We have to scale up three orders of magnitude, which is pretty daunting but not impossible."

Heparin is administered via injection and is used to prevent blood clotting during heart surgery, kidney dialysis, and other procedures. With a fully synthetic form of heparin, the sort of contamination seen this past year would be a thing of the past, Linhardt said. Linhardt’s group received funding from the U.S. National Institutes of Health (NIH). "It's too early to approach a pharmaceutical company," he said. "We have talked to a number of them. They all are interested in the approach but want to wait."

Linhardt said he is aware that there are several drugs designed to replace not only heparin, but also the widely used clot-preventing medication Coumadin. Such medications are in clinical trials in Europe, with some already approved for medical use. "I won't deny there's competition," Linhard said. "But those drugs are a thousand times more expensive than heparin. Also, they are not as good as heparin. It has multiple activities, many of which benefit patients. Those drugs are very specific. They work well only for a small number of applications." Synthetic heparin could cost no more than the animal-derived product, Linhardt said. "We believe that the heparin market is here to stay," he said.

Meanwhile, in March, the Food and Drug Administration (FDA) confirmed it found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter-supplied heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties and was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories.

Hearing Today in Infants' Heparin Overdose Case

Thu, 14 Aug 2008 00:00:00 -0700

On July 6, 17 premature babies being treated in the Neonatal Intensive Care Unit at Christus Spohn Hospital South in Corpus Christi, Texas were overdosed with the blood thinner, Heparin. The deaths of twin babies—Keith and Kaylynn Garcia—are believed linked to the hospital error and, now, lawyers for the Garcia family and others are preparing for today’s hearing. Heparin is an anti-clotting drug used to flush IV—intravenous—lines.

On July 8, the hospital announced an investigation to determine the cause of the "preventable medication error." Also on July 8, Keith Garcia died; Kaylynn died the next day. Hospital officials claim they have not discovered anything to indicate the Garcia twins died as a result of the Heparin overdose. But, Keith and Kaylynn’s parents, in collaboration with parents of other affected babies, have hired attorneys to investigate if the overdose caused injuries to their babies and resulted in the twins’ deaths.

One of the attorneys representing several families in the Heparin cases, said he has already had several Heparin samples collected from the hospital and that the purpose for today’s hearing is for the judge to decide what evidence he wants preserved, in case lawsuits seeking damages are filed. Twenty samples of the same Heparin believed to have been accidentally given to the babies was collected from Christus Sphon South last week. The attorney feels the Heparin samples and other medical evidence will enable them to determine if the babies were injured because of the overdose and will clarify how much Heparin the babies were given. The Garcia family attorney also had samples collected from the hospital and said the Garcia’s may be called to testify today.

Heparin is the drug involved in Dennis Quaid's twins’ overdose this past autumn at Cedars-Sinai Hospital in Los Angeles, California. In that case, the Heparin was made by Baxter Healthcare. Christus Spohn Hospital South said its Heparin was not made by Baxter, but would not say who manufactured it because the mistake was a mixing error.

In February 2007, the Food and Drug Administration (FDA) and Baxter International, issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check inventory to ensure dispensing errors did not occur and was issued after three infants died in Indiana when they were mistakenly given adult doses. According to US Pharmecopia, during the past 18 months, there have been roughly 250 medical errors nationwide involving Heparin and children a year or younger.

This year, tainted Heparin has been implicated in149 deaths and hundreds of allergy-type reactions. In March, the FDA confirmed it found oversulfated chondroitin sulfate in samples of the active ingredient used in Heparin supplied by Baxter. The FDA said the chondroitin sulfate was molecularly changed to mimic Heparin’s blood-clotting properties and was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in Heparin and may have been substituted to cut costs.

Hearing Today in Infants' Heparin Overdose Case

Wed, 13 Aug 2008 00:00:00 -0700

Baxter Under Fire Again, This Time for False Advertising

Thu, 07 Aug 2008 00:00:00 -0700

U.S. regulators are criticizing Baxter International Inc.'s promotion for the bleeding treatment FEIBA VH. The U.S. Food and Drug Administration (FDA) says the promotion misleads doctors about the drug's safety and effectiveness.

A "clinical thank you email" submitted for review by Baxter to the FDA, violates FDA policies by saying FEIBA VH works better and causes fewer side effects than has been proven in studies; this, according to a letter to the company posted on the FDA's Web site. FEIBA VH contains sterile, freeze-dried human protein that controls spontaneous or surgery-related bleeding in patients with hemophilia. "By promoting misleading safety and efficacy claims, you are potentially encouraging the unsafe use of FEIBA VH," the FDA said in July 7 letter. The FDA ordered Baxter to cease using the email and any promotions that exaggerate FEIBA VH’s safety and effectiveness.

According to Baxter spokeswoman Deborah Spak, Baxter is working with the FDA to revise its promotional statements and add context to support them. Baxter is the world's largest maker of blood-disease treatments.

Most recently, tainted Heparin manufactured by Baxter International has been directly linked to the deaths of three people, according to the FDA. Earlier this year, the FDA received over 90 reports of deaths and more than 1,000 adverse events associated with patients in the U.S. who had one or more allergic reactions to heparin products, including those sold by Baxter since January 1, 2007. This January, Baxter recalled nearly all its Heparin injections in the US after some patients experienced extreme, sometimes fatal, allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. Baxter came under FDA scrutiny in January after recalling supplies of the blood-thinner Heparin linked to allergic reactions and deaths. The FDA found the drug to be contaminated with a cheaper ingredient from China. Chinese officials disputed the cause of the reactions. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France, Germany, and Japan. In total, the FDA said tainted heparin was identified in 12 countries. In the US, other heparin suppliers issued precautionary recalls, and some medical devices makers recalled Heparin-coated products.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter Heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic Heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in Heparin, and producers may have used it in an attempt to cut costs. In April, a research team, led by scientists at MIT, found chondroitin sulfate activates two inflammatory pathways: One that initiates blood clotting and dilation of the blood vessels, and one that produces anaphylactic toxins. The first leads to a dangerous decrease in blood pressure, the second, to a serious allergic reaction.

Tainted Baxter Heparin Definitively Linked to Three Deaths

Wed, 30 Jul 2008 00:00:00 -0700

Tainted heparin manufactured by Baxter International has been directly linked to the deaths of three people, according to the Food & Drug Administration (FDA). Earlier this year, the FDA had received more than 90 reports of deaths and more than 1,000 adverse events associated with patients in the U.S. who had one or more allergic reactions to heparin products, including those sold by Baxter since Jan. 1, 2007.

In January, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

In April, a research team, led by scientists at MIT, found that the chondroitin sulfate activates two inflammatory pathways: one that initiates blood clotting and dilation of the blood vessels, and one that produces anaphylactic toxins. The first leads to a dangerous decrease in blood pressure, the second a serious allergic reaction. In blinded laboratory tests, the contaminated heparin activated the biological pathways, while normal heparin did not. In the study, pigs treated with tainted heparin exhibited side effects similar to those seen in humans.

According to an article in The Chicago Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, when reports of heparin adverse reactions peaked. Of 10 reports of death from severe anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths, so the FDA could not determine if those patients received tainted heparin.

Of the remaining 83 reports, the FDA described 13 as "potential complications of heparin use" such as bleeding; 25 cases were due to causes unrelated to heparin use such as pneumonia, sepsis and kidney failure. The FDA said that there was insufficient information available about the remaining 45 fatalities to conclusively cite a cause of death.

Dennis Quaid Tours Dallas Hospital, Looks at Heparin Tracking System

Wed, 23 Jul 2008 00:00:00 -0700

Actor Dennis Quaid toured a Dallas hospital on Tuesday to learn about a system to prevent the types of errors his family experienced when his newborn twins were accidentally given a massive overdose of the blood thinner Heparin. According to an Associated Press (AP) report, officials at Children's Medical Center Dallas showed Quaid and his wife, Kimberly, its bar-coding medication system that enables electronic drug tracking from dispensing to administration. "This system here at Children's Medical Center, I'm really amazed ... it's beyond cutting edge," Quaid said at a news conference after the tour. "I was so encouraged here to see this being implemented…. Human error is going to happen."

Quaid's twins, born November 8, recovered from a Heparin overdose this autumn at Cedars-Sinai Hospital in Los Angeles, California. Quaid said his twins fell ill with staph infections, suffering the overdose November 18. The babies were administered 1,000 times the correct dose. Heparin concentrates are bottled with similar labels and size, an issue long debated. Quaid said that when rotated slightly, the light blue 10-unit bottle and the dark blue10,000-unit bottle are difficult to distinguish from each other.

Quaid called the incident "a nightmare to live through…. At the beginning there was a lot of anger, shock, and fear." Quaid has turned his anger into “a desire to raise awareness about medical errors in medications and formed The Quaid Foundation, according to the AP. "We certainly don't blame the nurse, but everybody makes mistakes," he said. "It was just a breakdown." According to the AP, a January report from the California Department of Public Health said Cedars-Sinai did not adequately educate staff about safe use of Heparin and nurses sometimes failed to adequately read labels on Heparin vials.

Meanwhile, 14 babies were recently overdosed at Christus Spohn Hospital South after pharmacy workers made what the hospital called a Heparin "mixing error." Two of the babies—born one month premature—died; however, the hospital claims its physicians have found no direct links to the overdose. Autopsies are being underway.

In February 2007, the Food and Drug Administration (FDA) and Baxter International, issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check inventory to ensure dispensing errors did not occur and was issued after three infants died in Indiana when they were mistakenly given adult doses. According to US Pharmecopia, during the past 18 months, there have been roughly 250 medical errors nationwide involving Heparin and children a year or younger. This year, tainted Heparin has been implicated in 149 deaths and hundreds of reactions. In March, the FDA confirmed it found oversulfated chondroitin sulfate in samples of the active ingredient used in Heparin supplied by Baxter International; the ingredient was molecularly changed to mimic heparin’s blood-clotting properties. The ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Second Baby Dies in Heparin Overdose Tragedy

Fri, 11 Jul 2008 00:00:00 -0700

Over a dozen premature babies were overdosed with the blood thinner, Heparin, at Christus Spohn Hospital South in Corpus Christi, Texas. We recently reported on the tragic death of twin, Keith; now Kay Lynn Garcia, his sister, has died, according to an attorney for the Garcia family.

Heparin, an anticoagulant used to clean intravenous tubes and prevent blood from clotting in the lines, is the drug involved in Dennis Quaid's twins’ overdose this past autumn at Cedars-Sinai Hospital in Los Angeles, California. In that case, the Heparin was made by Baxter Healthcare. Christus Spohn Hospital South said the Heparin used in its case was not made by Baxter, but would not say who manufactured it because the mistake was a mixing error, not a confusion of bottle labels.

Spokeswoman Sherry Carr-Deer confirmed 14 babies received a more concentrated dose of Heparin than prescribed saying, "We know for sure, we know absolutely for sure, that there were 14 babies who got the concentrated heparin," Carr-Deer said. She said three other babies were in the unit when the higher doses were given, but could not confirm if those babies were overdosed. The other babies who received a higher-than-prescribed dose of Heparin remain in critical but stable condition at the hospital, Carr-Deer said. According to standard procedure, nurses were supposed to clean the infants' IV lines with Hep-Lock, a drug containing a very small dose—10 units—of Heparin. Instead, the twins received 10,000 units, or 1,000 times the prescribed amount.

A judge approved the Garcia family’s attorney’s request for a temporary restraining order directing the hospital to save medication, documents, lab results, and vials involved in the babies' care. "We haven't filed a lawsuit seeking damages, just trying to find out what happened," the attorney said. He said he plans to ask the court to let him take depositions from hospital personnel. "The babies were roughly four weeks' premature and should not have been at high risk. The doctor assured the parents the newborns' lungs were fully developed, he added.

In February 2007, the Food and Drug Administration (FDA) and Baxter International, issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check inventory to ensure dispensing errors did not occur and was issued after three infants died in Indiana when they were mistakenly given adult doses. According to US Pharmecopia, during the past 18 months, there have been roughly 250 medical errors nationwide involving Heparin and children a year or younger. Also, this year tainted Heparin has been implicated in 149 deaths and hundreds of allergy-type reactions. In March, the FDA confirmed it found oversulfated chondroitin sulfate in samples of the active ingredient used in Heparin supplied by Baxter International. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Heparin Overdoses at Texas Hospital Under Investigation

Wed, 09 Jul 2008 00:00:00 -0700

Heparin overdoses were accidently administered to 17 premature babies at a Texas hospital, possibly playing a role in the death of one of them. The overdoses, which occurred at the Christus Spohn Hospital South in Corpus Christi, were discovered Sunday. While 16 of the babies are recovering now, an autopsy has been scheduled to determine if the heparin overdose caused the one death.

Heparin is a blood thinner that is routinely used in the hospital neonatal intensive care units to flush intravenous lines and prevent blood clots from forming. Unfortunately, heparin overdoses are a common medical mistake. In February 2007, the Food & Drug Administration (FDA) and Baxter International, once a major supplier of Heparin, issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors did not occur. The 2007 alert was issued after three infants died in Indiana when they were mistakenly given adult doses. According US Pharmecopia, during the past 18 months, there have been roughly 250 medical errors nationwide involving heparin and children a year or younger.

According to the Houston Chronicle, the Heparin first was administered in the Corpus Christi hospital's neonatal intensive care unit Friday. A nurse discovered the overdose on Sunday, during routine blood testing. The use of Heparin in the unit was discontinued, and the infants were given medication to counteract the Heparin's effects. One infant remains in critical condition in the unit, and was in that condition for several days before the heparin dosages, the Chronicle said. Three infants have been discharged and 12 are stable and remain in intensive care.

Two members of the Christus Spohn Hospital South's pharmacy staff have taken voluntary leave, pending an investigation that could take as long as two weeks. The hospital has also notified the Texas Department of Health Services and the FDA of the incident.

Recently, Heparin has sparked concerns for reasons other than accidental overdoses. This year, tainted Heparin has been implicated in 149 deaths and hundreds of allergy-type reactions. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in heparin supplied by Baxter International. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Drug Makers Decry FDA Safety Push

Tue, 01 Jul 2008 00:00:00 -0700

Drug makers are complaining that the Food & Drug Administration (FDA) is too focused on, of all things, safety. The pharmaceutical industry says the FDA' s tougher stance is slowing the arrival of new drugs to the market, but consumer advocates - citing recent scandals involving defective drugs - say a stronger focus on safety is long overdue.

According to the Wall Street Journal, the FDA approved just 19 new medicines last year, the fewest in 24 years, and announced about 75 new or revised "black-box" warnings about potential side effects -- the agency's strongest -- twice the number in 2004. The number of so-called approvable letters, which typically postpone FDA approval decisions pending more data, increased by 40% last year.

Drug makers are less-than-enthusiastic about the FDA's new approach. Schering-Plough Corp. Chief Executive Fred Hassan told The Wall Street Journal that the new safety focus means that drug companies must now spend significantly more time and money to get a drug approved - and even then, approval is not guaranteed. "What will it take to get new drugs approved?" Hassan said. "The point is, we don't know."

The FDA's new caution can be traced to the Vioxx debacle. Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The FDA ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Shortly after Vioxx was pulled from the market, it was revealed the FDA had tried to silence the drug expert who headed that analysis. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

Following the Vioxx mess, several other drug safety scandals intensified pressure on the agency. For instance, after a study was published last May detailing heart risks with the diabetes drug Avandia, it was revealed that in 2005 GlaxoSmithKline had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.

And just this year, it was learned that the makers of Vytorin withheld a study that found the expensive cholesterol medication was no more effective than cheaper statins for two years. Poor FDA oversight of foreign drug plants allowed tainted heparin to kill at least 149 people this year, and the agency has been slow to take strong action against the stop-smoking drug Chantix, which has been linked to suicides.

These and other scandals have strained the credibility of both the FDA and the pharmaceutical industry. The FDA has apparently heard the criticism. In addition to being tougher on new drug approvals, the agency is adding warnings about cancer risk to arthritis drugs for children, and warnings about suicide risk to epilepsy drugs. The FDA is also considering instituting tougher approval criteria for diabetes drugs.

None of this sets well with the pharmaceutical industry, which relies on new drug approvals to stay in the black. But considering the industry's recent history of manipulating clinical data, concealing dangerous side effects and aggressively promoting risky products, drug makers have only themselves to blame.

Despite Lackluster Performance, FDA Hands Out Big Bonuses

Fri, 27 Jun 2008 00:00:00 -0700

The US Food and Drug Administration (FDA) just announced that it has increased employee bonuses by a whopping 29 percent in the past year, despite earlier objections from lawmakers, its ongoing complaints over inadequate funding, and a number of embarrassing and widely publicized blunders, including one that allowed tainted heparin into the country.

For year ending April 12, the FDA paid out $35 million in staff incentives, a figure that is a significant increase from the $27.1 million it paid the prior year, according to records posted on the House Energy and Commerce Committee’s Website. Just last year, lawmakers complained that the FDA was issuing too many bonuses, especially to high-ranking officials. This recent increase, which was shown in the latest records provided by the FDA, has prompted renewed objections by Representative Bart Stupack—Democrat-Michigan—chairman of the panel's investigative subcommittee. "It is outrageous that bonuses for top officials at FDA increased by nearly 30 percent over the past year despite the agency's poor management," Stupak said "These bonuses are not going to the men and women in the field who FDA struggles to retain. They're going to top agency officials in Washington who have presided over the agency while an unprecedented number of Americans have been sickened by contaminated food and drugs."

Stupak and other lawmakers faulted the FDA's handling of food and drug safety after consumers became ill from tainted spinach in 2006, peanut butter in 2007, and the blood thinner heparin this year. In the Heparin debacle, the FDA reported that since the end of 2007, it received over 700 reports of adverse reactions associated with Baxter's multiple-dose injectable Heparin; 40 percent of these reports were deemed serious. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock and, in 21 cases, led to death.

The investigation revealed problems over inadequate FDA inspections of oversees drug and drug component manufacturers and ingredients obtained from shoddy, unregulated factories. The inadequacies highlighted some critical problems at the FDA and led to government investigations and hearings over FDA practices. But, FDA spokeswoman, Heidi Rebello, argues that bonus payments help attract and retain employees. "The agency employs a very knowledgeable, experienced, and highly educated staff and has to compete with the private sector to attract individuals of the highest caliber to meet the growing demands on its scientific and regulatory mission both here and abroad," she said.

Some question why bonuses were paid given the caliber of work. For instance, current requirements state each foreign plant must be inspected every two years. As it stands, it would take the FDA over 13 years to inspect all foreign plants exporting prescription drugs to the US and 27 years to inspect all foreign plants exporting medical devices. Of 3,250 non-US plants subject to FDA inspections last year, only 1,445 foreign inspections occurred—in the last five years, according to a Government Accountability Office study. It’s worse in China where the FDA averaged just 15 inspections in China in each of the last five years, despite that there are 714 plants shipping drug products to the US.

Heparin-Related Deaths Surged Since 2006, FDA Says

Fri, 20 Jun 2008 00:00:00 -0700

Deaths following administration of heparin increased significantly this year, according to the Food & Drug Administration (FDA). While it is not known if heparin played a role in all of the deaths, a good number of them occurred after patients experienced allergy-type reactions associated with contaminated lots of the drug. Unfortunately, in many of those cases, the FDA has been unable to determine if the heparin used was adulterated.

According to the FDA, it has now received reports of 248 deaths among people who had taken heparin since January 1, 2007. Of those, 238 were reported to the FDA on or after January 1, 2008. Among the fatalities, 149 involved patients who suffered allergic reactions known to be associated with tainted heparin. In most deaths, the FDA said it didn’t have enough evidence to determine if heparin was to blame. The number of reported deaths spiked in January at 50 and declined to five last month.

Whatever the cause, the 248 deaths since January 2007 indicate a significant increase in heparin-related fatalities compared with the prior year. Between January 1, 2006 and December 31, 2006, there were only 55 reported deaths following the administration of heparin - about 4 or 5 per month. Most of the patients in these reports were suffering from a variety of underlying medical conditions, on in only 3 cases did deaths occur following an allergy-type reactions.

The spike in allergic-type reactions - including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening - following administration of heparin prompted Baxter International to recall nearly all of its heparin injections in the US earlier this year. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

In April, a research team, led by scientists at MIT, found that the chondroitin sulfate activates two inflammatory pathways: one that initiates blood clotting and dilation of the blood vessels, and one that produces anaphylactic toxins. The first leads to a dangerous decrease in blood pressure, the second a serious allergic reaction. In blinded laboratory tests, the contaminated heparin activated the biological pathways, while normal heparin did not. In the study, pigs treated with tainted heparin exhibited side effects similar to those seen in humans.

Heparin Deaths Now Number 149

Tue, 17 Jun 2008 00:00:00 -0700

Tainted heparin may be linked to 149 deaths, up from the 81 fatalities federal regulators reported in April. While all of the deaths involved patients who experienced allergic reactions following the administration of heparin, the Food & Drug Administration (FDA) said that it could not say for sure if contaminated heparin was responsible for all o the deaths.

Earlier this year, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Earlier this month, the FDA said that medical devices made with heparin had been implicated in 11 additional deaths, and 86 more adverse reactions. Most of the cases involved heparin used to clean intravenous lines. The heparin associated with two of the 11 deaths wasn’t contaminated and the FDA is unable to conclusively say how many of the deaths and side effects involved the tainted heparin. The FDA also did not identify which companies’ products were associated with the adverse reactions and deaths.

According to the FDA, it has now received reports of 248 deaths among people who had taken heparin since Jan. 1, 2007. Of those, 149 were people who suffered allergic reactions. In most deaths, the FDA said it didn't have enough evidence to determine if heparin was to blame. The number of reported deaths spiked in January at 50 and declined to five last month. The FDA said yesterday that all supplies of heparin currently sold in the United States are safe.

FDA May Outsource Overseas Drug Maker Inspections

Fri, 13 Jun 2008 00:00:00 -0700

The Food & Drug Administration (FDA) is said to be considering a plan that would outsource the inspection of overseas drug makers to private entities. The FDA outsourcing proposal is drawing criticism, however, because a similar program for foreign medical device makers has been a failure.

The FDA has been under a lot of scrutiny lately, especially for its oversight of imported food and drugs. Since late last year, tainted heparin sourced from China has been blamed for at least 81 deaths and hundreds of adverse reactions in the U.S. It was eventually learned that the FDA had never inspected the Chinese plant where raw heparin ingredients were made.

Unfortunately, the heparin case is not an isolated incident. A recent report from the Government Accountability Office (GAO) found that, on average, foreign drug plants are inspected only once every 13 years. Critic have long argued that the FDA does not have the funding or manpower to police the massive amounts of food and drugs imported from overseas.

In May, the heparin debacle prompted FDA Commissioner Andrew von Eschenbach wrote a letter to Sen. Specter recommending an additional $275 million for funding food and drug safety. On Monday, the Bush Administration finally got around to asking Congress for those funds. Some of that money would be used to allow quicker entry for imports certified by private parties.

The FDA says it just does not have the manpower to inspect every foreign drugmaker that imports to the U.S. "It's very difficult to see how we could actually cover the entire globe," Janet Woodcock, head of the agency's Center for Drug Evaluation and Research, told Reuters. "If you consider many of these other plants aren't really inspected at all, putting in some type of program would be better than not covering them."

However, a similar program for foreign medical device makers has not been very efficient. Under the medical device program, it took the FDA two years to approve the first private inspectors that companies can hire to check their facilities. But the overseas medical device manufacturers have shown little enthusiasm for the program. Since then, only 12 third-party inspections have been conducted. Another 158 have jointly been conducted with the FDA.

One of the reasons that medical device makers have resisted private inspections is the cost. With relatively few FDA-approved private inspectors, they are able to charge exorbitant fees. It is simply more cost-effective for manufacturers to allow the FDA to inspect their plants - for free.

Many consumer advocates argue that the FDA is better suited to the inspections. They argue that private companies will have a financial incentive to keep drugmakers happy, and may downplay poor inspections.

That may have already happened with private food inspection companies. Yesterday, a Congressional committee subpoenaed nine private food inspection companies. The committee is investigating charges that private food labs may have been encouraged by importing companies to withhold tainted food samples in order to enable foods to reach U.S. consumers. The committee had already asked 50 multinational food companies for a variety of recall- and food-import records dating as far back as 2000.

Heparin Lawsuits Sent to Federal Court in Toledo

Wed, 11 Jun 2008 00:00:00 -0700

Dozens of lawsuits stemming from tainted Baxter Heparin will all be transferred to U.S. District Court in Toledo before Judge James G. Carr. There are at least 30 lawsuits pending against Baxter International for the tainted heparin that led to scores of deaths and serious reaction across the country, and many more could still be filed as victims and their families are still learning that contaminated heparin made them sick.

Earlier this year, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. Ultimately, tainted heparin injections have been blamed for more than 80 deaths and more than 700 adverse reactions in the U.S.

There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

In March, the Food & Drug Administration (FDA) confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It cost-*s a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Last week, the FDA said that medical devices made with heparin had been implicated in 11 additional deaths, and 86 more adverse reactions. Most of the cases involved heparin used to clean intravenous lines. The heparin associated with two of the 11 deaths wasn’t contaminated and the FDA is unable to conclusively say how many of the deaths and side effects involved the tainted heparin. The FDA also did not identify which companies’ products were associated with the adverse reactions and deaths.

The Judicial Panel on Multidistrict Litigation - a seven-member panel of federal judges - ruled that all of the Baxter Heparin lawsuits nationwide would be moved to Toledo. In the ruling, Judge G. Heyburn II, of the U.S. Western District of Kentucky and chairman of the panel, wrote: "Seven of the 23 known actions are pending in this [Northern District of Ohio], mostly before Judge James G. Carr, who has the time to devote to this docket,"

In addition to Baxter, many of the heparin lawsuits scheduled to be heard in Toledo also name Scientific Protein Laboratories as a defendant.

Tainted Heparin Still a Danger

Tue, 10 Jun 2008 00:00:00 -0700

Tainted heparin might still be in circulation, the Food & Drug Administration (FDA) has warned after finding the recalled drug in medical facilities in one state. The agency is also warning that medical devices made with tainted heparin may pose a danger to patients as well.

In January, Baxter International began recalling heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC.

Tainted heparin injections have been linked to more than 80 deaths and hundreds of adverse reactions in the U.S. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

Last week, the FDA said that medical devices made with heparin had been implicated in 11 additional deaths, and 86 adverse reactions. Most of the cases involved heparin used to clean intravenous lines. The heparin associated with two of the 11 deaths wasn’t contaminated and the FDA is unable to conclusively say how many of the deaths and side effects involved the tainted heparin. The FDA also did not identify which companies’ products were associated with the adverse reactions and deaths.

The FDA has advised health professionals and facilities to review and examine all drug/device storage areas — including emergency kits, dialysis units and automated drug storage cabinets — to ensure that all of the recalled heparin products have been removed and are no longer available for patient use.

Former Metabolife Executive Gets 6 Months for Lying to FDA

Tue, 10 Jun 2008 00:00:00 -0700

The former chief of Metabolife has been sentenced to six months in jail for misleading federal regulators. Michael J. Ellis, 55, pleaded guilty in November to one count of making false statements to the Food & Drug Administration (FDA) in 1999 regarding Metabolife 356. In addition to prison time, Ellis has been ordered to pay a $20,000 fine.

Metabolife 356 was a controversial dietary supplement that was used to control appetite and facilitate weight loss. Metabolife contained the stimulant Ephedra, which has been linked to serious side effects including seizures, heart attacks, and death. In 2004, the FDA banned the use of Ephedra in dietary supplements.

Ellis committed his crime when the FDA was considering subjecting Metabolife to stricter federal regulation. According to prosecutors, Ellis and the company sent letters to the FDA saying they had “never received a notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.” Metabolife's own documents showed that it had received many reports from consumers of seizures, heart attacks, strokes, loss of consciousness and other serious illnesses, said the U.S. Attorney's Office.

On August 15, 2002, the Justice Department announced that it started a criminal investigation into whether Metabolife lied about the safety of the controversial dietary supplement. A few hours after news of the federal investigation on Metabolife was made public, Metabolife announced it would finally give the FDA the 13,000 complaints it received since 1997. Of those complaints, 80 of them involved deaths, seizures, heart attacks, or other serious events.

Ellis is expected to start serving his sentence at a federal prison in two months. Metabolife, which faced more than 360 Ephedra lawsuits, filed for bankruptcy in 2005. That year, Ideasphere, a New York-based maker of nutritional supplements, acquired the company’s assets for $12 million.

Tainted Heparin Used in Medical Devices Linked to 11 Deaths

Fri, 06 Jun 2008 00:00:00 -0700

Tainted Heparin made by Baxter International has been linked to more than 80 deaths and hundreds of adverse reactions in the US, resulting in a massive recall of Baxter Heparin earlier this year. Internationally, several other heparin makers have issued their own recalls of tainted heparin, and dozens of similar reactions - though no deaths - were reported in Germany. Eventually, it was discovered that the main ingredient in some Heparin, which is made in China and derived from pig intestines, turned out to be contaminated. Now, it appears that additional fatalities may have been caused by medical devices made with tainted Heparin.

At least 11 deaths and 86 cases of harmful side effects reported this year in the US have been linked to the use of medical devices containing the blood thinner Heparin. Most of the cases involved Heparin used to clean intravenous lines, said Karen Riley, a Food and Drug Administration (FDA) spokeswoman. According to Riley, the Heparin associated with two of the 11 deaths wasn't contaminated and the FDA is unable to conclusively say how most of the other deaths and side effects involved the tainted Heparin. Riley also said that she was unable to identify which companies' products were associated with the adverse reactions and deaths.

Heparin is a blood thinner administered in surgery and other critical care areas to prevent clots, is crucial in dialysis and heart surgery, and is used for the bedridden. Heparin, which has been manufactured since 1930, is administered to millions of patients yearly and Baxter manufactures about half of all multiple-dose heparin vials sold in the US. The FDA has reported that, since the end of 2007, it received over 700 reports of adverse reactions associated with Baxter's multiple-dose injectable Heparin; 40 percent of these reports were deemed serious. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock and, in 21 cases, led to death.

The ensuing investigation revealed problems regarding inadequate FDA inspections of overseas drug and drug component manufacturers and ingredients obtained from shoddy, unregulated factories. These inadequacies served to highlight some of the critical problems going on at the FDA and have led to government investigations and hearings over FDA practices.

In addition to Baxter, companies including the device make Medtronic Inc. have voluntarily recalled products that may contain contaminated Heparin. Side effects and deaths linked to medical devices occurred between January 1 and May 14, according to the FDA's Website. Since January 2007, 81 people have died after allergic reactions, the FDA said on April 21. Riley said the 11 deaths involving devices are “probably in addition'' to the 81, though some of the reports to the FDA are “very sketchy'' and there could be “some minor overlap.''

The FDA also said contamination could lead to inaccurate test results from diagnostic devices that monitor Heparin or use it as part of the device itself.

Baxter has said the main ingredient for its heparin probably was contaminated before reaching its supplier in China.

The European Medicines Agency said today in a statement that one of its committees concluded a type of Heparin, enoxaparin, can still be used, provided that measures are taken to reduce risks. Enoxaparin was found to include a low level of contamination. Sanofi-Aventis SA's Lovenox contains enoxaparin.

MIT Study Proves Heparin Deaths, Reactions Result of Fake Ingredient

Thu, 05 Jun 2008 00:00:00 -0700

A group of scientists, led by researchers at the Massachusetts Institute of Technology (MIT), have shown that a counterfeit chemical found in batches of tainted heparin was responsible for hundreds of adverse reactions and 81deaths among patients in the US. The study, published in the current issue of the New England Journal of Medicine, also reports that a new test to detect contaminated heparin has been developed.

In January, Baxter International began recalling heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the Food & Drug Administration (FDA) confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC.

The FDA has not determined when the chondroitin sulfate entered the heparin supply chain, but suspicion rests on China. Changzhou used two consolidators to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops. In April, FDA Commissioner Andrew von Eschenbach has said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” The reason for the counterfeiting may have been economic. According to The New York Times, oversulfated chondroitin sulfate costs $9 a pound compared with $900 a pound for heparin.

While the Chinese have not disputed that the chemical made its way into the heparin at some point along its manufacturing supply chain, regulators there have insisted that the chondroitin sulfate could not have caused the adverse reactions. But the MIT study is strong evidence that such a theory is without merit.

Using lab animals - in this case pigs - the scientists found that chondroitin sulfate activates two inflammatory pathways: one that initiates blood clotting and dilation of the blood vessels, and one that produces anaphylactic toxins. The first leads to a dangerous decrease in blood pressure, the second a serious allergic reaction. In blinded laboratory tests, the contaminated heparin activated the biological pathways, while normal heparin did not.

The experiments also helped scientists come up with a test for detecting the chemical in heparin. Heparin consists of a long, complex chain of repeating sugar molecules. Oversulfated chondroitin sulfate, which is derived from animal cartilage, has a structure very similar to that of heparin and thus cannot be identified with the tests normally used to inspect batches of heparin. Traditional heparin safety screens test only for contaminants such as protein, lipids or DNA, and thus would not detect the presence of sugar chains that do not belong. The MIT research team played a key role in developing new technologies for analyzing complex sugars. Using the new technology, the research team was able to detect the presence of the faulty sugars.

Dennis Quaid Tells Congress Victims of Defective Drugs Must be Able to Sue

Fri, 16 May 2008 00:00:00 -0700

On Wednesday, actor Dennis Quaid urged the U.S. Congress to preserve patients' rights to sue manufacturers for injuries from defective drugs as he related how his newborn twins nearly died from an accidental Heparin overdose. In late 2007, the babies were given a massive, accidental overdose of the blood thinner, Heparin, at California’s Cedar-Sinai hospital and were dosed with vials of Heparin 1,000 times stronger than what should have been prescribed.

Dennis Quaid has sued Baxter International Inc., maker of Heparin, for negligence in packaging different doses in similar vials—which contributed to the overdose—and not issuing a recall after three other infants died from a similar mix-up wherein six newborns were mistakenly overdosed.

Quaid said his twins were two weeks old when they were twice given 1,000 times the recommended dose of Baxter's Heparin while being treated for an infection. Their blood "basically turned to the consistency of water," causing massive bleeding, he said. About 40 hours later, clotting started returning to normal and they recovered, although long-term effects are unknown, Quaid said.

Quaid said victims of harm from medicines should be able to seek damages from manufacturers in state court. Drug and medical-device makers argue that U.S. Food and Drug Administration (FDA) approval should preempt state liability suits in many instances; the Supreme Court backed that view in a recent device case. "I believe if preemption of lawsuits is allowed to prevail, it will basically make all of us, the public, uninformed and uncompensated lab rats," Quaid said as he urged Congress to pass legislation to protect patients' ability to sue drugmakers if the Supreme Court further restricts the suits.

Pharmacy technicians stock Heparin for use in preventing clots and for flushing IVs. Hospital protocol is to keep the different units separated, but a technician accidentally put the 10,000 unit vials in the drawer where the 10 unit vials were stored. Baxter said the overdose resulted from human error at the hospital and was "unrelated to the safety and efficacy of Baxter's product." Baxter had revised Heparin labels before the Quaid twins were treated, but did not recall older bottles because that "may have disrupted the supply of a safe and critical medication." Baxter cited preemption in its motion to dismiss Quaid's lawsuit.

Under the current administration, the FDA advocates preemption. "FDA believes that the important decisions it makes about the safety, efficacy, and labeling of medical products should not be second-guessed by state courts," said FDA Deputy Commissioner Randall Lutter. Patients still could sue if companies sold devices that failed to meet FDA conditions of approval, he added.

Representative Henry Waxman—Democrat-California and House Oversight and Government Reform Committee chair—called the FDA's view a "radical legal doctrine" that was not in keeping with previous FDA positions and would be harmful if allowed. "One of the most powerful incentives for safety—the threat of liability—would vanish," added Waxman who said he will back legislation to reverse the Supreme Court's February ruling, which involved a New York man who was injured when a doctor inflated a Medtronic Inc. balloon catheter during an artery-clearing procedure. A similar case involving drugmaker Wyeth is expected to be heard by the high court in October.

In Wake of Baxter Heparin Recall, Overdose Fears Grow

Thu, 15 May 2008 00:00:00 -0700

The recent heparin safety problems have spawned even more concerns about the drug. Baxter International's decision to suspend heparin manufacturing earlier this year had already stoked fears of a heparin shortage. But as other manufacturers have stepped in to fill the void left by Baxter, medical facilities are receiving shipments of different quantities and strengths than what most practitioners are used to. Heparin is one of the top five drugs associated with medication errors, and pharmacists and others worry that the confusion now surrounding the drug might cause patients to receive improper doses.

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the Food & Drug Administration (FDA) confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-thinning properties. Baxter, which supplied roughly 50 percent of the heparin injections used in US, temporarily suspended heparin manufacturing, and is said to be considering getting out of the business all together.

Other drug manufacturers have stepped up their production of heparin, and the FDA says a shortage of the vital blood thinner has been avoided. Unlike the single-dose products typically distributed by Baxter, many of the vials now contain larger or more potent quantities. Pharmacists and others are reportedly worried that doctors and nurses may be unfamiliar with new packaging for heparin, and could easily give a patient a more potent dose than intended. The concern is so great, according to an article in Newsday, that the Institute for Safe Medication Practices near Philadelphia is planning to warn about the higher risk of medication error in the next newsletter it sends to the country's 6,000 hospitals.

Even before the recent problems, heparin overdose was a cause for concern. In February 2007, the FDA and Baxter International issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors did not occur. The 2007 alert was issued after three infants died in Indiana when they were mistakenly given adult doses. In December 2007, actor Dennis Quaid and his wife named Baxter in a lawsuit after their newborn twins were mistakenly given potentially fatal overdoses of heparin. In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of Heparin since 2001.

Politics Take Precedent in Heparin Probe

Wed, 14 May 2008 00:00:00 -0700

Tainted heparin has killed at least 81 people in the US, and sickened scores more here and in Germany. Yet, the heparin investigation is being bogged down by politics, and as a result, US regulators are no closer to finding out how heparin became contaminated with a counterfeit ingredient than they were months ago.

It first became apparent in January that something was wrong with heparin supply when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the Food & Drug Administration (FDA) confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties.

That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Recently, researchers in the US were able to show that the chondroitin sulfate could produce reactions like those seen in patients in lab animals. Last month, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

While China is the main suspect in the heparin contamination, the FDA has no idea where the chondroitin sulfate entered the supply chain. What is known is that Changzhou obtained the pig-derived raw ingredients for heparin from two unregulated workshops. While the FDA has been allowed to inspect Changzhou - something the agency had never done prior to the heparin problems - the Chinese won't give the agency access to any of the workshops that make raw heparin ingredients. The Chinese also won't let the FDA look at records pertaining to heparin manufacturing and the procurement of ingredients, and the agency has also been barred from interviewing workers in heparin manufacturing.

For their part, the Chinese are denying that the chondroitin sulfate had anything to do with the reactions and deaths seen in US patients. The Chinese assert that since contaminated heparin has been found in 12 countries, and reactions have only been seen in the US and Germany, the chemical is not to blame. They claim the reactions have also been reported in people who received untainted heparin.

So what is the FDA doing to address China's uncooperative attitude? It appears, not much. The agency seems more interested in placating the Chinese than getting to the bottom of the heparin mystery. For instance, the FDA has denied Congressional investigators access to a list of firms in China that supply heparin ingredients that was requested almost ten days ago. The FDA is citing privacy agreements as its reason for the refusal.

The FDA is also going along with China's refusal to open up the entire heparin supply chain for inspection. While it has barred Changzhou from importing products to the US, other manufacturers are still sending heparin ingredients to the US. That has some lawmakers upset. Earlier this week, Rep. Bart Stupak (D-Mich.) told The Wall Street Journal that the FDA needs to be tougher on China. “If I was the FDA director, I’d shut down every drug coming in from China” until they were deemed safe, he said.

Instead, Health & Human Services Secretary Michael Leavitt is insisting that heparin sourced from China is now safe. He made that statement earlier this week, while he was visiting China. That Leavitt even made such assurances at a time when the Chinese have blocked the FDA's heparin investigation is truly astonishing.

HHS Head Insists Chinese Heparin is Safe

Tue, 13 May 2008 00:00:00 -0700

Heparin imported from China is now safe - at least that is what Health and Human Services Secretary Michael Leavitt is claiming. Heparin sourced from China has been linked to at least 81 deaths, and investigators believe that a contaminant that somehow made its way into the Chinese supply chain is responsible for the deaths and reactions linked to the drug. But Leavitt insisted yesterday that tighter testing and controls will insure that no more tainted heparin makes its way into the US.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in heparin recalled by Baxter Intenational heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. Last month, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

The FDA, which falls under Leavitt's authority, has been rightly criticized for its role in the heparin debacle. Shortly after the first heparin recall was issued, it was learned that the FDA had never inspected the Changzhou plant. Apparently, an error in the agency's compute database had made it appear as though inspectors had checked out the facility. Once the FDA did finally inspect Changzhou, it found a host of problems which it detailed in a warning letter. The FDA also banned the plant from importing to the US until corrections are made.

Leavitt told the Associated Press yesterday that the FDA has implemented tougher testing and other controls to insure the quality of the heparin supply. "We have put in place processes that we believe can ensure the safety of the heparin supply within the United States," he said.

Leavitt also said that he believed the US and China would soon resolve a dispute over the FDA's investigation. The Chinese so far have refused to acknowledge that chondroitin sulfate had anything to do with the heparin reactions, despite scientific studies done in the US that demonstrated the chemical could do so. The Chinese have also not allowed the FDA access to the entire heparin supply chain. Though it inspected the Changzhou facility in March, the FDA has been barred from having complete access to some Chinese workshops that supplied Changzhou with raw heparin ingredients, as well as records and workers.

Atrium Recalls Heparin-Coated Hydraglide Catheters Amid Contamination Concerns

Mon, 12 May 2008 00:00:00 -0700

Another medical device maker is recalling a heparin-coated product amid fears that the drug could be contaminated. Earlier today, Atrium Medical Corporation announced that it was initiating a voluntary and precautionary recall of selected lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. The recalled catheters are used for autotransfusion during cardiopulmonary bypass surgery.

Tainted heparin has been of concern since January, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in 11 other countries, including Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were associated with contaminated batches of heparin.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Since then, researchers have been able to show that chondroitin sulfate can cause reactions like those seen among patients treated with tainted heparin.

In speaking with reporters after a Senate hearing last month, FDA Commissioner Andrew von Eschenbach said that while the agency has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

According to an Atrium press release, its heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Atrium said in the release that the patient risk associated with the presence of the contaminant in heparin-coated medical devices is not known at this time. Customers with affected lots are advised to immediately discontinue use of these devices and obtain replacement catheters from Atrium. So far, Atrium has not received reports of any heparin-related injuries arising from any use of the Hydraglide Thoracic Catheters

The Atrium Hydraglide recall follows last week's medical device recall by Medtronic. That recall involved a variety of disposable medical devices, used during cardiac bypass surgery, that are made with Medtronic’s Carmeda BioActive surface, which includes heparin. Both recalls were initiated because of an April 8 recommendation by the FDA that medical devices made be subjected to a new method of testing to insure that the drug was not contaminated with chondroitin sulfate.

FDA Issues Another Heparin Warning, Faces More Backlash in Congress

Mon, 12 May 2008 00:00:00 -0700

Some medical facilities still have recalled heparin in their inventories, prompting the Food & Drug Administration (FDA) to issue yet another warning about the defective drug. Meanwhile, the FDA is facing more criticism for not cooperating with a congressional investigation into the heparin debacle, with some lawmakers voicing frustration over the FDA's refusal to turn over a list of Chinese heparin suppliers to investigators. Others are disturbed by the agency's inability to convince the Chinese to allow US inspectors access to all aspects of the country's heparin manufacturing system.

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. Last month, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

Despite the publicity over tainted heparin, it appears some medical facilities haven't gotten the message and are still stocking recalled heparin. Last week, the FDA issued an updated heparin warning in an attempt to make sure all medical providers are aware of the heparin recalls. "Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement," the notice read. "Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used," it said.

The FDA's reminder was prompted by reports from California Department of Health, the FDA's own recall monitoring, and from Baxter International Inc., the largest supplier of heparin, showing problems in the recall response. An FDA spokesperson told The Wall Street Journal that California authorities had sent a letter out on May 2 about gaps in the recall response. Inspectors checked various facilities and found recalled heparin on crash carts, in catheter labs, and even on hospital pharmacy shelves.

Meanwhile, members of Congress have become increasingly impatient about the FDA's response to a congressional heparin investigation. At this time, the FDA is refusing to give lawmakers access to the names of Chinese companies that supply heparin ingredients. The FDA has said that doing so would violate privacy agreements concerning proprietary information.

Congress is also less than pleased with what appears to be Chinese attempts to block some facets of the heparin investigation. Though it inspected the Changzhou facility in March, the FDA has been barred from having complete access to some Chinese workshops that supplied Changzhou with raw heparin ingredients, as well as records and workers. The FDA was already under fire because, due to a compute error, it had never inspected Changzhou until the heparin contamination became an issue. Since the March inspection, the agency has issued the factory a warning letter and barred it from importing products to the US.

But despite the Chinese reluctance to open up the entire heparin supply chain to FDA inspection, the agency is allowing heparin imports from that country's other manufacturers. The FDA didn't issue a blanket "import alert" legally holding up all Chinese heparin pending successful testing, because it doesn't have the legal authority to do so, FDA officials have said.

Rep. Bart Stupak (D-Mich), the lawmaker leading the congressional investigation, told The Wall Street Journal the FDA should take a tougher stance with China. If I was the FDA director, I'd shut down every drug coming in from China" until they were deemed safe, he said.

Medical Devices Made with Tainted Heparin Recalled by Medtronic

Thu, 08 May 2008 00:00:00 -0700

Medtronic Inc. is recalling some medical devices because they may be coated with tainted heparin, a drug linked to 81 deaths in the US. The disposable medical devices, used during cardiac bypass surgery, are made with Medtronic's Carmeda BioActive surface, which includes heparin. No injuries have been reported in relation to the Medtronic devices, but the recall underscores the enormous scope of the problems involving contaminated heparin.

Tainted heparin first garnered attention earlier this year, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in 11 other countries, including Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were associated with contaminated batches of heparin.

In March, the FDA confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Since then, researchers have been able to show that chondroitin sulfate can cause reactions like those seen among patients treated with tainted heparin.

In speaking with reporters after a Senate hearing last month, FDA Commissioner Andrew von Eschenbach said that while the agency has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Medtronic says the Carmeda BioActive surface is used on blood oxygenators, reservoirs, pumps and other disposable products that are used during the bypass surgery. According to Reuters, Medtronic initiated the recall because of an April 8 recommendation by the FDA that medical devices employing heparin be checked with newly-developed tests to make sure the heparin is not tainted. Chondroitin sulfate cannot be identified with the tests normally used to inspect batches of heparin.

A separate Medtronic line of disposable bypass-surgery products covered with a different biosurface called Trillium will remain on the market because they incorporate far smaller amounts of heparin.

Chinese Still Deny Role in Heparin Problems, Say Baxter is Blocking Investigation

Tue, 06 May 2008 00:00:00 -0700

The Chinese State Food and Drug Administration has alleged that Baxter International has refused to cooperate with its investigation into tainted heparin. The Chinese are also insisting that a counterfeit chemical found in batches of a heparin ingredient sourced from China had nothing to do with the hundreds of adverse reactions and scores of deaths linked to heparin in the US. However, last week a US research team published a study that showed how that fake chemical - oversulfated chondroitin sulfate - could cause the very type of reactions seen here.

The US Food & Drug Administration (FDA) has linked tainted heparin with 81 deaths in the US, and hundreds of adverse reactions. Baxter International recalled nearly all its heparin injections in the U.S. after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Last month, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

In a written statement, China's State Food and Drug Administration insisted that the chondroitin sulfate had nothing to do with the adverse heparin reactions. The Chinese assert that since contaminated heparin has been found in 12 countries, and reactions have only been seen in the US and Germany, the chemical is not to blame. The statement also claims reactions have also been reported in people who received untainted heparin.

The statement also claimed that "Baxter failed to provide necessary cooperation in the process of the investigation, which is not conducive to further identifying the reasons for the adverse reactions to heparin." Baxter is denying these allegations, and says it is cooperating with all parties in the heparin investigation. Last month, Chinese regulators were even given access to Baxter's New Jersey plant where it finishes processing raw heparin.

The Chinese assertion that chondroitin sulfate was not behind the heparin reactions is questionable. Late last month, a research team, led by scientists at MIT, found that the chondroitin sulfate activates two inflammatory pathways: one that initiates blood clotting and dilation of the blood vessels, and one that produces anaphylactic toxins. The first leads to a dangerous decrease in blood pressure, the second a serious allergic reaction. In blinded laboratory tests, the contaminated heparin activated the biological pathways, while normal heparin did not. In the study, pigs treated with tainted heparin exhibited side effects similar to those seen in humans.

FDA Planning Hiring Blitz

Thu, 01 May 2008 00:00:00 -0700

The beleaguered Food & Drug Administration (FDA) is planning on filling over 1,300 positions by the end of September, triple the amount hired by the FDA over the past two years. The FDA will add 600 new jobs—including chemists, biologists, and statisticians—and will fill over 700 currently open posts. Most of the new positions will be in the department charged with reviewing new drugs; 150 will be in field offices that inspect manufacturing plants and food centers. The FDA currently has 10,000 employees.

Approximately 500 of the new positions will be funded by user fees paid to the FDA by drug makers filing applications to market new products, according to Christopher Kelly, FDA spokesman. These fees were appropriated from Congress as part of legislation passed in September that renewed and increased fees paid to the FDA by makers of drugs and medical devices, Kelly said. The FDA will hold recruitment fairs and conferences to fill the positions and most of the jobs will be at the FDA’s new headquarters in White Oak, Maryland.

The FDA has recently been under intense Congressional scrutiny due to the tragedies linked to the contaminated blood thinner heparin, tainted pet food, and the recall of Merck & Co.'s painkiller Vioxx. Earlier this year, Representative Bart Stupak said that if Americans "knew how little the FDA did to assure the food and drug supply, if the truth ever came out...people would be marching in the street." Stupak—an eight-term Democratic congressman and chairman of the Subcommittee on Oversight and Investigations of the House's powerful Energy and Commerce panel, which has jurisdiction over the FDA—is at the center of an aggressive effort by congressional Democrats to spotlight what they say are problems with the Bush administration's position on consumer-safety issues. Stupak called for the resignation of von Eschenbach and other top officials.

Representative John D. Dingell, Democrat-Michigan and chairman of the House Energy and Commerce Committee, has long been unhappy with the U.S. Food and Drug Administration (FDA) and its commissioner, Andrew von Eschenbach. Dingell recently accused von Eschenbach of not doing his job and has repeatedly asked the FDA chief how much it would cost to do more inspections. The commissioner still has not provided specifics.

Dingell and other lawmakers said the FDA must conduct more inspections of companies sending drugs to the U.S. to ensure they are safe. “You cannot do your job, you are not doing your job,'' Dingell told von Eschenbach, who was a witness at the hearing before the energy and commerce panel's investigations subcommittee. “You simply are absolutely incapable of addressing your responsibilities.''

Heparin Contaminated on Purpose, Congress Told

Wed, 30 Apr 2008 00:00:00 -0700

Tainted heparin that has killed 81 people in the U.S. may have been intentionally contaminated, witnesses appearing before a congressional committee said yesterday.   In written testimony, a Food & Drug Administration (FDA) official told lawmakers that it "does strain one’s credulity" to think that the heparin contamination was accidental. The head of Baxter International, the company that issued a massive recall of heparin earlier this year, said that he was also of the belief that the heparin contamination was deliberate.

In March, the FDA confirmed that it had found a counterfeit ingredient, oversulfated chondroitin sulfate, in samples of the active ingredient used in Baxter heparin. The chemical had been molecularly changed to mimic heparin's blood thinning properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Since then, companies in several other countries have issued heparin recalls, and a cluster of heparin reactions has been reported in Germany. In the US, some other manufacturers have issued precautionary recalls.

Due to a computer error, the FDA never inspected the Changzhou plant as is required by law. When heparin problems finally prompted the agency to conduct an inspection, it found a multitude of problems. The FDA has since issued Changzhou a warning letter, and it has been barred from exporting to the US until corrections are made.

The FDA has not determined when the chondroitin sulfate entered the heparin supply chain, but suspicion rests on China. Changzhou used two consolidators to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops.   Earlier this month FDA Commissioner Andrew von Eschenbach has said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” The reason for the counterfeiting may have been economic. According to The New York Times, a Congressional investigator said oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.

Yesterday, Dr. Janet Woodcock, director of the FDA’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony that a third of the ingredient found in some batches of heparin contained contaminant. She said the agency was working on the hypothesis that the contamination was intentional, although that has yet to be proven.

Robert L. Parkinson, Baxter’s chairman and chief executive, concurred with Dr. Woodcock. He told the committee, “We’re alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate a life-saving medication.”

Lawmakers also heard from the family members of patients who died after being administered tainted heparin. LeRoy Hubley of Toledo, Ohio, described how both his 65-year-old wife and his 47-year-old son died within a few weeks of each other. Both suffered from a genetic kidney disease that required constant dialysis, for which heparin is routinely used. “As Christmas music softly played in the background, we each said our goodbyes,” Hubley said, breaking down in tears. “Then my wife and love of 48 years drifted away.” Hubley said it was weeks before he found out that either death was due to contaminated heparin.

Last week, the FDA said it had evidence that the chondroitin sulfate did, in fact, cause the reactions and deaths. However, the Chinese are disputing this, and say the heparin problems could have originated in the US.   David G. Strunce, chief executive of Scientific Protein Laboratories, said that his company tried to find the original source of the contamination but was stopped by the Chinese authorities.

Heparin Hearing to Feature Baxter CEO

Mon, 28 Apr 2008 00:00:00 -0700

A congressional hearing into tainted heparin that begins tomorrow will feature testimony from the Chief Executive Officer of Baxter International. Baxter International supplied about 50 percent of the heparin used in the US, and recalled most of its heparin products in February following reports of adverse deaths and reactions linked to the blood thinner. At least 81 deaths among US patients have been linked to heparin contaminated with a counterfeit ingredient, although not all of the deaths have been blamed on Baxter heparin.

In March, the Food & Drug Administration (FDA) confirmed that it had found a counterfeit ingredient, oversulfated chondroitin sulfate, in samples of the active ingredient used in Baxter heparin. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Since then, companies in several other countries have issued heparin recalls, and a cluster of heparin reactions has been reported in Germany. In the US, some other manufacturers have issued precautionary recalls.

The FDA has not determined when the chondroitin sulfate entered the heparin supply chain, but suspicion rests on China. Changzhou used two consolidators to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops. FDA Commissioner Andrew von Eschenbach has said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

Last week, the FDA said it had evidence that the chondroitin sulfate did, in fact, cause the reactions and deaths. However, the Chinese are disputing this, and say the heparin problems could have originated in the US. But an FDA inspection of Changzhou uncovered a number of problems, and earlier this month, the FDA issued the plant a warning letter, calling the facility "unsuitable". The FDA has also blocked Changzhou from importing anything to the US until the agency can confirm it has made appropriate corrections.

Starting tomorrow, a US House of Representatives Subcommittee on Oversight and Investigations will hold a hearing called "The Heparin Disaster: Chinese Counterfeits and American Failures," the latest congressional proceeding to address shortcomings in the US inspection process. Baxter CEO Robert Parkinson will testify, along with FDA drug unit chief Janet Woodcock. Also slated to testify is the CEO of Scientific Protein Labs.

Meanwhile, some media reports have suggested that Baxter is considering giving up the heparin business altogether. Earlier this month, Wall Street analysts asked Parkinson whether it was worth the legal risks and liability to remain in the business given that heparin accounts for only $30 million of Baxter's more than $11 billion in annual sales. Parkinson said that the company had not yet decided if it would reenter the heparin market.

In Wake of Heparin Scandal, US Trade Official Blasts China on Drug Safety

Fri, 25 Apr 2008 00:00:00 -0700

Christopher Padilla, the under secretary of commerce for international trade, told a group of businessmen that the United States was concerned that Chinese regulators did not have the authority to monitor both pharmaceuticals and bulk chemicals and that China did not have the ability or will to regulate its economy properly, allowing the export of a chemical that tainted the blood-thinning agent heparin which is linked to the deaths of dozens and the illnesses of hundreds. The Chinese manufacturer of heparin did not register with that country's State Food & Drug Administration (SFDA) as a maker of active pharmaceutical products.

"This is a loophole that must be closed," Padilla said, adding that the Chinese SFDA does not have the authority to simultaneously regulate pharmaceutical makers of active pharmaceutical ingredients and makers of bulk chemicals which may be used in pharmaceuticals but not considered of medicinal use. "The rapid growth of China's economy has clearly outstripped the ability and the will of the government to effectively police that economy," Padilla said. Padilla, who is leading a group of healthcare executives to China, also said effective monitoring was a part of larger healthcare reforms that mainland authorities were handling.

This week, U.S. researchers from the Massachusetts Institute of Technology (MIT) identified a chemical contaminating the blood-thinner heparin from China, revealing how it could cause a sometimes-fatal allergic reaction. The tainted heparin was used by at least 81 U.S. patients who later died, forcing heparin maker Baxter International to recall the drug and causing diplomatic strain between the U.S. and China.

Healthcare services and products are one of the United States' fastest growing exports to China; reforms could include anything from basic state-funded health insurance to enhancements in how it provides healthcare and primary care and regulates hospitals, according to Padilla. "I have a new-found respect for the enormity of the challenge that China faces in the healthcare reform effort," he said.

Disputes between patients and hospitals are common in China, where market reforms of the 1980s ended lifelong healthcare and inadequate monitoring has lead to overcharging, bogus treatments, and corruption. For instance, earlier this year, one of China’s largest state-owned pharmaceutical company’s—exporter to dozens of countries, including the U.S.—was at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or harmed by contaminated leukemia drugs. Chinese drug regulators accused the manufacturer—Shanghai Hualian—of a cover-up and closed the factory that produced them. In December, China’s Food and Drug Administration said that Shanghai police began a criminal investigation. And, in China's harshest action, thus far, the country's former top drug regulator was executed for accepting millions of dollars in bribes to approve substandard medicines, including an antibiotic that killed at least 10 people.

China could unveil its health service plan this year. It is expected that the plan will institute universal medical coverage paid for by insurance rather than general taxation. "It won't happen this year," said Rachel Lee, a principal for The Boston Consulting Group based in Shanghai. "Foreign investors are very interested in China, but the problems are also very large," she said.

Scientists Show Chemical in Tainted Heparin Caused Illnesses

Thu, 24 Apr 2008 00:00:00 -0700

Scientist now know why contaminated heparin caused serious and sometimes fatal reactions in hundreds of patients. In a study published in the "New England Journal of Medicine", researchers say that pigs treated with tainted heparin have exhibited side effects similar to those seen in humans. The scientists also wrote that a test has been developed that can determine if heparin has been contaminated with the chemical causing the side effects.

The Food & Drug Administration (FDA) has linked tainted heparin with 81 deaths in the US, and hundreds of illnesses. Baxter International recalled nearly all its heparin injections in the U.S. after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Last week, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

The New England Journal of Medicine study, led by researchers at MIT, offers the first potential link between the contaminant and the adverse reactions. The researchers found that the chondroitin sulfate activates two inflammatory pathways: one that initiates blood clotting and dilation of the blood vessels, and one that produces anaphylactic toxins. The first leads to a dangerous decrease in blood pressure, the second a serious allergic reaction. In blinded laboratory tests, the contaminated heparin activated the biological pathways, while normal heparin did not.

The researchers also said that regulators now have a test to detect contaminated heparin. Heparin consists of a long, complex chain of repeating sugar molecules. Oversulfated chondroitin sulfate, which is derived from animal cartilage, has a structure very similar to that of heparin and thus cannot be identified with the tests normally used to inspect batches of heparin. Traditional heparin safety screens test only for contaminants such as protein, lipids or DNA, and thus would not detect the presence of sugar chains that do not belong. The MIT research team played a key role in developing new technologies for analyzing complex sugars. Using the new technology, the research team was able to detect the presence of the faulty sugars.

According to The New York Times, the FDA has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. The FDA has not determined the original source of all the contamination or the points in the supply chain at which it was added. The Times also said officials have discovered tainted heparin lots that were manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February.

FDA Issues Chinese Heparin Supplier Warning Letter After Finding Conditions Unsuitable

Thu, 24 Apr 2008 00:00:00 -0700

An inspection by U.S. regulators of the Chinese factory that supplied tainted heparin ingredients to Baxter International revealed significant deviations from U.S. Current Good Manufacturing Practice standards. As a result, the Food & Drug Administration (FDA) informed the plant in a warning letter that all future shipments from the Changzhou SPL facility will be refused entry to the U.S. until the factory makes required corrections and the FDA is able to confirm that it is in compliance with Current Good Manufacturing Practice standards.

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the FDA confirmed that it had found a counterfeit ingredient, oversulfated chondroitin sulfate, in samples of the active ingredient used in Baxter heparin. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. So far, 81 deaths in the U.S. have been linked to the tainted heparin, and earlier this week, the FDA said it had evidence that the chondroitin sulfate did, in fact, cause the reactions and deaths.

The FDA conducted an inspection of Changzhou SPL in March. According to the strongly-worded warning letter to the factory dated April 21, conditions there were deemed "unsuitable" by the FDA. The agency said that the Changzhou provided no assurance that processing steps used to manufacture heparin ingredients were capable of effectively removing impurities. The letter also stated that Changzhou had acknowledged to the FDA that it received and used heparin crude materials from a workshop that Changzhou itself had deemed as "unacceptable" in a "pre-audit". Even though that workshop was ultimately not approved to be a supplier to the facility, Changzhou used crude material from this workshop in the production of heparin ingredients that were shipped to the U.S.

In addition, the FDA warning letter to Changzhou SPL said that the testing methods employed by the facility were not " verified to ensure suitability under actual conditions of use," and that equipment used at the factory to make heparin ingredients was "unsuitable for its intended use".

The FDA has given Changzhou SPL 30 days to respond to the charges in the letter. Until the FDA is able to confirm that Changzhou has corrected violations at the factory, and certify that it now meets Current Good Manufacturing Practice standards, all products made there will be denied entry to the U.S.

Chinese Complete Inspection of Baxter Heparin Plant

Wed, 23 Apr 2008 00:00:00 -0700

Chinese inspectors have visited the Baxter International plant in New Jersey where the final processing of tainted heparin took place. The Food & Drug Administration (FDA) has said that the heparin from that plant was contaminated with a counterfeit ingredient from China. But the Chinese insist there is no evidence that the hundreds of adverse reactions and scores of deaths seen in US patients administered heparin are linked to the fake ingredient, and claim the problems could have originated in the US.

The FDA has linked tainted heparin with 81 deaths in the US, and hundreds of adverse reactions. Baxter International recalled nearly all its heparin injections in the U.S. after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Last week, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

But at a news conference earlier this week, a Chinese official disputed that the heparin problems occurred in that country. Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products, said that Chinese investigators tested batches of heparin used by patients who reported health problems, and only some contained chondroitin sulfate. He also said that heparin with the contaminant has been found in many nations, but that none has reported a similar spike in harmful reactions as in the United States. Shaohong also said Chinese officials are focusing on the whole product, and speculated that other contaminants, problems with the device used to inject the heparin, or health factors with the patients who used the drug could also be causing the reactions.

But the FDA countered, saying a cluster of adverse reactions to heparin has been reported in Germany. Evidence is also growing that implicates the chondroitin sulfate in the US reactions. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said that Chinese officials had tested batches of heparin with methods less sensitive than those used in the US and elsewhere and had missed the presence of the contaminant. She said FDA scientists now believe the adverse reactions were most pronounced when large doses of the drug were administered quickly, and the contaminant acted as a "mediator" that caused a response similar to an allergic reaction.

According to The New York Times, the FDA has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. The FDA has not determined the original source of all the contamination or the points in the supply chain at which it was added. The Times also said officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February.

The Chinese inspectors finished their tour of Baxter's plant yesterday. So far, neither the Chinese nor Baxter will comment on the inspection.

Heparin Mess Leads to US, China Dispute

Tue, 22 Apr 2008 00:00:00 -0700

Tainted heparin has officials from the U.S. and China at odds, with each blaming the other country's manufacturing for problems with the drug. U.S. regulators say they have now found a direct link between a contaminant found in heparin from China and severe, allergy-type reactions seen in some patients. The announcement by the Food & Drug Administration (FDA) contradicts assertions made by a Chinese official yesterday that adverse reactions to tainted heparin were not tied to a counterfeit ingredient found in some batches of the drug, and were not the fault of the Chinese manufacturer that supplied raw ingredients for heparin.

The FDA has linked tainted heparin with 81 deaths in the US, and hundreds of adverse reactions. Baxter International recalled nearly all its heparin injections in the U.S. after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Last week, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

According to The New York Times, the FDA has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. The FDA has not determined the original source of all the contamination or the points in the supply chain at which it was added. The Times also said officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February.

Meanwhile, Baxter International confirmed that tests had shown that the chondroitin sulfate could cause illness, but disputed the FDA assertion that tainted heparin was associated with 81 deaths. Baxter's own numbers indicate only 5 deaths linked with heparin, and the company insists that the tainted drug may have only "contributed" to, rather than caused, the fatalities.

Yesterday, Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products, insisted that problems with heparin sold by Baxter originated in the U.S. He also insisted that there was no proof the chondroitin sulfate was responsible for the problems. Shaohong told reporters at a news conference that the Chinese were planning to send inspectors to Baxter's New Jersey plant to see if the problems started there.

Another Chinese official, Ning Chen, second secretary at the Chinese Embassy, told The Times that, “We don’t have a strong evidence to show that it is heparin or its contaminant that caused the problem." Chen insisted that heparin reactions had only been seen in the US, indicating that neither the chondroitin sulfate or Chinese manufacturing was at fault.

But Dr. Janet Woodcock, director of the FDA's drug center, disputed Chen, pointing out that a cluster of heparin reactions had been reported in Germany, and that China had conceded that the drug involved in those reactions was contaminated. She also said the FDA was "fairly confident" that the chondroitin sulfate was capable of causing the adverse heparin reactions seen in the past year.

FDA Slams Conditions at Chinese Plant Implicated in Heparin Debacle

Tue, 22 Apr 2008 00:00:00 -0700

Conditions at the Chinese plant that produced a raw ingredient for tainted heparin have been deemed "unsuitable" by the US Food & Drug Administration (FDA), prompting the agency to send a strongly-worded warning letter to the factory. Raw ingredients supplied by the Changzhou, China plant were contaminated with a counterfeit ingredient, and have been implicated in 81 deaths in the US, as well as hundreds of adverse reactions.

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. Last week, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

Due to computer error, the FDA never inspected the Chinese plant where raw ingredients for Baxter heparin were made. When heparin problems finally prompted the agency to conduct an inspection, it found a multitude of problems, including:

Incomplete manufacturing instructions
Lack of critical processing steps or annual test results
Lack of an impurity profile for Heparin
Incomplete manufacturing instructions for Heparin Sodium USP
Investigations into failed lots were approved as complete, but no cause was listed
Inadequate control of material flow in the processing area

Yesterday, a warning letter from the FDA to the Chinese factory was released. In the letter, the FDA said its inspection of the Chinese facility two months ago revealed "significant deviations" from US good manufacturing practices. In addition, the FDA said the plant's processing steps used to manufacturing heparin's active ingredient provided "no assurance" any impurities could have been effectively removed.

Scientific Protein Laboratories responded to the letter by claiming it does reflect Changzhou SPL's "actual state of compliance". The company also said the contaminant was introduced earlier in a supply chain. Changzhou buys its crude heparin from two companies, called consolidators, that gather it from workshops that make it from pig intestines. Many Chinese workshops that make crude heparin are unregulated family operations. Those workshop were apparently never inspected by the FDA either.

FDA Inspections of Foreign Drug Makers Still Lacking, GAO Audit Says

Tue, 22 Apr 2008 00:00:00 -0700

The Food & Drug Administration (FDA) is inspecting more foreign drug makers than it once did, but is still only conducting a fraction of the reviews necessary to keep consumers safe from defective drugs, a new audit has found. Concerns about the FDA's oversight have intensified in recent months, following the discovery that heparin ingredients made in China may have been responsible for dozens of deaths and hundreds of illnesses in the US. Investigations into the heparin debacle revealed that, due to a computer error, the Chinese plant that made the active ingredient for Baxter International's recalled heparin had never been inspected by the FDA.

The results of this new audit are similar to a report filed by the Government Accountability Office (GAO) in November, which found the FDA doesn’t know how many foreign firms are actually subject to inspection. The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. The agency also could not confirm how many foreign firms have never been inspected. In those rare cases where the FDA actually did visit foreign plants, officials provided advance warning and rely on translators supplied by the companies being inspected, clearly a conflict of interest that compromises the integrity of the inspections. The report was alarming, considering the fact that about 40 percent of pharmaceuticals and 80 percent of the chemical ingredients in drugs are imported, and a growing share come from countries like China, that are still working on implementing a product safety infrastructure.

Now, the GAO has released a new audit of the FDA's overseas policing efforts. According to the audit, the FDA increased inspections of foreign manufacturing sites to about 11 percent last year and took other steps in recent months, but made limited progress overall. The GAO estimated it would cost between $67 million and $71 million to inspect all 3,200 foreign sites every two years. The FDA has only proposed spending about $11 million on foreign inspections in fiscal 2008, the GAO said.

The consequences of the FDA's failure to keep tabs on foreign drug suppliers were made all too apparent by this year's heparin problems. Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries. The FDA has said tainted heparin has been implicated in 82 US deaths.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Scientific Protein Laboratories. The Chinese facility had never been inspected by the FDA because of a computer glitch that led agency personnel to believe it had been reviewed. Once the heparin problems became apparent, the FDA did send inspectors to the plant who reported that conditions there did not meet US good manufacturing practice standards.

A House of Representatives subcommittee is set to question FDA Commissioner Andrew von Eschenbach about foreign drug inspections at a hearing today where representatives from the GAO will appear also to discuss the recent audit.

Heparin Problems Not Our Fault, Chinese Official Says

Mon, 21 Apr 2008 00:00:00 -0700

A counterfeit ingredient found in batches of recalled heparin is not to blame for the deaths and reactions seen in U.S. patients treated with the drug, a Chinese government official claimed today. Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products, insisted that problems with heparin sold by Baxter International originated in the U.S. and said regulators from China will soon arrive here to inspect the New Jersey plant that finishes processing Baxter heparin.

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 62 to be exact - were associated with contaminated batches of heparin.

In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. Last week, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

However, the Chinese are disputing that the chondroitin sulfate has anything to do with the heparin injuries seen in the US. Shaohong said that Chinese investigators tested batches of heparin used by patients who reported health problems, and only some contained chondroitin sulfate. "The oversulfated chondroitin can therefore not be the suspected root cause of heparin ADE (adverse events)," he told reporters at a news conference this morning.

Shaohong also said Chinese officials are focusing on the whole product and planned to visit Baxter's plant in New Jersey later on Monday. "They will cooperate with us, no problem," he told reporters. Shaohong speculated that other contaminants, problems with the device used to inject the heparin, or health factors with the patients who used the drug could also be causing the reactions.

Despite Shaohong's insistence that Chinese manufacturing is blameless in the heparin debacle, counterfeit ingredients have caused problems with Chinese imports in the past. The news of heparin contamination came almost one year after some pets in the US died as the result of a pet food ingredient shipped from China that contained toxic levels of melamine, which was added to make it appear higher in protein. In Panama around the same time, 120 people died because an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine imported to that country. Diethylene glycol contamination also resulted in a recall of Chinese-made toothpaste in the US over the summer.

China has also made efforts to crack down on heparin producers since it became apparent that something had gone wrong with the drug. According to a report in The Wall Street Journal, the Chinese State Food and Drug Administration issued an order in a notice seen on its Web site that requires heparin producers to obtain the raw chemicals used to make the drug from registered suppliers. Raw heparin suppliers, meanwhile, are required to improve their management and tests on their products, it said. This was a reversal of the Chinese government’s earlier position, as the agency had earlier insisted that ensuring the quality of exported chemicals like heparin was the responsibility of importers and importing countries.

FDA China Office Slated to Open in October

Tue, 15 Apr 2008 00:00:00 -0700

A month from now, the US Food & Drug Administration (FDA) could have full-time personnel on the ground in China, provided the Chinese government gives final approval to the plan. The assignment of FDA personnel to China comes on the heels of several scandals involving defective drugs and contaminated food ingredients made in that country, most recently tainted heparin that has been linked to dozens of deaths in the US. The move also marks a significant change in the way the FDA polices drug imports, as previously the agency relied on inspections at points of entry to detect defective drugs. If all goes as planned, the FDA will open a permanent office in China next October.

In the past year, imports of Chinese drugs and foods have been at the center of several safety scandals. Most recently, heparin sourced from that country was found to be contaminated with chondroitin sulfate which had been molecularly altered to mimic the drug's blood clotting properties. Hundreds of people have been sickened in the US because of reactions to tainted heparin, and according to the FDA, as many as 62 people may have died as a result. Baxter International recalled nearly all its heparin products in the US earlier this year, and other companies, including B. Braun and Covidien, Ltd., have issued recalls of heparin products as a precaution. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan.

The news of heparin contamination came almost one year after some pets in the US died as the result of a pet food ingredient shipped from China that contained toxic levels of melamine, which was added to make it appear higher in protein. In Panama around the same time, 120 people died because an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine imported to that country. Diethylene glycol contamination also resulted in a recall of Chinese-made toothpaste in the US over the summer.

Shortly after Baxter recalled its heparin, it was discovered that the FDA had never inspected the Chinese plant that supplied Baxter with the raw ingredient used in heparin. Apparently, a computer error led the agency to believe it had been inspected. Recent reports have also found that the FDA is ill-equipped to police foreign drug makers. In November, the Government Accountability Office found the FDA doesn’t know how many foreign firms are actually subject to inspection. The agency also could not confirm how many foreign firms have never been inspected. In those rare cases where the FDA actually does visit foreign plants, officials provide advance warning and rely on translators supplied by the companies being inspected, clearly a conflict of interest that compromises the integrity of the inspections.

Last month, the FDA said it would be seeking a more permanent presence in China, and said it planned to establish eight permanent FDA positions at US diplomatic posts in China. The FDA also said it would hire five Chinese employees in Beijing, Shanghai and Guangzhou. The FDA is still awaiting final approval from the Chinese government on the opening of the its office there, but that the agency expected to begin work in May before the official opening of the office in October. According to The Wall Street Journal, the FDA's China office will be headed by Christopher Hickey, currently director of the Asia and the Pacific office at the U.S. Department of Health and Human Services.

Government statistics indicate that about 40% of pharmaceuticals and 80% of the chemical ingredients in drugs are imported. While a large amount comes from China, India and Mexico are emerging as big drug and chemical importers. The US plans on eventually expanding its presence in those countries as well, and is currently in talks with the Indian government to do so.

FDA Commissioner Says Heparin Contamination Probably "Fraud"

Tue, 15 Apr 2008 00:00:00 -0700

A heparin ingredient sourced from China was likely intentionally replaced with a counterfeit ingredient, the head of the Food & Drug Administration (FDA) said today. There is no way that chondroitin sulfate, the chemical found in batches of recalled heparin, could have made its way into the drug naturally, FDA Commissioner Andrew von Eschenbach told a Senate hearing, leading him to characterize the contamination as "economic fraud".

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the FDA. Of those, the vast majority - 62 to be exact - were associated with contaminated batches of heparin.

In March, the FDA confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. In speaking with reporters after a Senate hearing, von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, "the concern is that it had to be by design."

If so, it would not be the fist time Chinese products were the subject of fraudulent ingredient substitutions. In fact, the news of heparin contamination came almost one year after some pets in the US died as the result of a pet food ingredient shipped from China that contained toxic levels of melamine, which was added to make it appear higher in protein. In Panama around the same time, 120 people died because an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine imported to that country. Diethylene glycol contamination also resulted in a recall of Chinese-made toothpaste in the US over the summer.

Heparin Lawyer Recall Allergy Side Effects Allergic Reaction Attorney Injury Lawsuit

Tue, 15 Apr 2008 00:00:00 -0700

Baxter Heparin Recall and Injuries.

Keywords: Heparin | Lawyer | Recall | Allergy | Allergic Reaction | Side Effects | Attorney | Injury | Lawsuit

Information on Adverse Event Reports and Heparin 6/19/08

Department of Health & Human Services Warning Letter 4/21/08

Click Here For Breaking News About Heparin!

The Heparin recall and injury lawyers at our firm are currently evaluating potential lawsuits on behalf of people injured by Baxter Heparin. As of March 2008, Baxter Heparin had been linked to hundreds of serious and sometimes life-threatening reactions, including at least four deaths. Our Baxter Heparin injury lawyers are offering free consultations to victims of the tainted drug and their families. The Baxter Heparin injury lawyers at our firm will work hard to make sure people injured by this defective drug receive the compensation they deserve.

Call 800-LAW-INFO For Free Consultation with a Experienced Heparin Recall / Side Effects Lawyer

Heparin is a blood thinner, and the vital drug is used in surgery, dialysis, and to prevent blood clots in the bedridden. Other drugs thin blood, but they do not work as quickly as Heparin, and their effects are not as easily reversed. Baxter International manufactures about half of the multi-dose Heparin vials used in the US.

Baxter Heparin Recall

In January 2008, Baxter International recalled 9 lots of its 1000/unit mL multi-dose Heparin vials. The Baxter Heparin recall was initiated after the company received 100 reports of serious allergy-type reactions in patients who had been administered Baxter Heparin. Following the recall, Baxter said that it was suspending the manufacture of Heparin until the reason behind the reactions could be determined.

In mid-February 2008, the Food & Drug Administration (FDA) issued a Public Health Advisory warning doctors and other health practitioners not to use Baxter Heparin products. According to the FDA, since the beginning of 2008, it has received 350 reports of side effects linked to Baxter Heparin. The FDA also said that four patients had died after being administered the drug. The FDA said nearly all the reported reactions to Baxter Heparin had been in dialysis patients who received high doses of Heparin over a short time. The FDA cautioned that doctors who continued to use Baxter Heparin should use the lowest doses possible and administer it slowly.

Finally, on February 29, the FDA announced that Baxter would be recalling all of its remaining Heparin products. By this time, Baxter Heparin had been implicated in more than 400 life-threatening reactions and could have been responsible for as many as 21 deaths. Baxter claimed that it had waited to issue the full-scale Heparin recall because the company wanted to avoid causing a Heparin shortage. The Baxter Heparin injury lawyers at our firm contend that the company and the FDA erred in allowing this tainted drug to remain in circulation for so long, and we intend to hold Baxter accountable for its negligence.

Heparin's Side Effects

Heparin's side effects involved a variety of symptoms including abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. Our Heparin injury lawyers have determined that the drug involved in these reactions was defective, and that Baxter's failure to adequately regulate its suppliers contributed to the Heparin's defects.

Baxter Heparin Supplier Never Inspected by FDA

On February 14, 2008, it was revealed that a Chinese factory that supplied the active ingredient for Baxter Heparin had never been inspected by the FDA. That ingredient is made by the Chinese facility, as well as a US plant, both owned by Wisconsin-based Scientific Protein Laboratories LLC. At the time, the FDA said it did not know why the Chinese manufacturer had not been subject to an inspection. Eventually, the FDA determined that the name of the Chinese plant had been mixed-up in the agency's database with another Chinese company, causing the FDA to overlook the required inspection.

At the same time, Baxter claimed it had inspected the facility during the previous six months and planned another inspection in the near future. Following the revelations about the lack of FDA inspections, Baxter International CEO Robert Parkinson said that the company did not know much about its Chinese supplier. Parkinson tried to shift blame for the Heparin debacle to Scientific Protein Laboratories. Our Baxter Heparin injury lawyers believe the response of Baxter's CEO is indicative of the negligent attitude the company took towards this drug, and we believe both Baxter International and Scientific Protein Laboratories are liable for injuries caused by the tainted Heparin.

When the FDA finally did conduct an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a letter to the Chinese company. The FDA cited the manufacturer for a number of violations, including:

· Incomplete manufacturing instructions

· Lack of critical processing steps or annual test results

· Lack of an impurity profile for Heparin

· Incomplete manufacturing instructions for Heparin Sodium USP

· Investigations into failed lots were approved as complete, but no cause was listed

· Inadequate control of material flow in the processing area

Baxter Heparin Found to be Contaminated

On March 5, 2008, both Baxter and the FDA announced that their respective investigations had found a contaminant in the active ingredient used in Baxter Heparin. The FDA said its investigators found a contaminant in some batches of the active ingredient used in recalled Baxter Heparin. FDA Deputy Commissioner Janet Woodcock told reporters that the agency had not yet determined if the contaminant was responsible for the Heparin reactions.

Independently, Baxter also said its investigators had found chemical differences in the active pharmaceutical ingredient used in lots of Heparin associated with the adverse reactions. The company said its findings "suggest that the root cause may be associated with the crude Heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter". Our Baxter Heparin injury lawyers believe that Baxter International's failure to insure that its Chinese supplier had been appropriately inspected by the FDA played a large role in the deplorable conditions that existed at that facility and allowed this contamination to occur. This lack of inspection was also one of the main factors contributing to the Baxter Heparin reactions that seriously injured so many patients.

Other Baxter Heparin Problems

Our Baxter Heparin lawyers are also offering free consultations to victims of other Heparin injuries, including accidental overdoses. In February 2007, the FDA and Baxter International issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors did not occur. The 2007 alert was issued after three infants died in Indiana when they were mistakenly given adult doses. In December 2007, actor Dennis Quaid and his wife named Baxter in a lawsuit after their newborn twins were mistakenly given potentially fatal overdoses of Heparin. In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of Heparin since 2001.

Other Heparin Side Effects

Our heparin injury lawyers are also offering free case evaluations to people injured by other heparin side effects. Heparin can have serious side effects, so it is important that people being treated with heparin be carefully monitored. Heparin should not be used to treat people with low numbers of blood cells called platelets in their blood, or who have previously developed a reduced platelet count due to treatment with heparin. Patients who are actively bleeding, or those who are more prone to bleeding than normal, (for example, due to the blood clotting disorder hemophilia) should also not be given heparin. Patients with severe high blood pressure, peptic ulcer or bacterial infections of the heart valves or lining around the heart must also not be given heparin. Heparin also cannot be used in patients who have had recent injury or surgery to the brain, spinal cord or eyes, or are due to have lumbar puncture or epidural anesthesia, or who have severe liver disease.

People being treated with heparin need to have regular blood tests, usually on a daily basis, to check the length of time it takes their blood to clot. This is so that the dose can be adjusted to ensure that the lowest effective dose is used at all times, thus reducing the risk of bleeding. Heparin can sometimes cause the number of platelets in the blood to fall - a condition known as thrombocytopenia. If this happens, the heparin will need to be stopped and alternative treatment used. Heparin can also cause elevated levels of potassium in the blood. This is called hyperkalaemia. Some people may be at a greater risk of this, for example those with diabetes or kidney problems, or people taking other medicines that can cause potassium to be retained in the body.

Legal Help for Baxter Heparin Victims

If you or a loved one suffered a serious injury after being administered Baxter Heparin, you have valuable legal rights. Please fill out our online form or call us at 1-800 LAW INFO (1-800-529-4636) to discuss your case with an experienced Baxter Heparin injury lawyer / Attorney.