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Heart Device Patients Often Unaware of Recalls

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

It seems that many patients who have been implanted with heart devices are not aware of recent recalls and do not understand the dangers they might face, this according to two new surveys. Although the surveys are small, they do indicate a lack of understanding among doctors and patients about heart disease and the devices used to treat it, said Dr. Bruce Wilkoff, director of cardiac and tachyarrhythmia devices at Cleveland Clinic Wilkoff, who is familiar with the surveys. "There are fundamental problems with even the physician's understanding of the situation and an appropriate focus on accurate information," Wilkoff added. One of the new surveys found that nearly one in five heart patients didn't know about recent recalls of their devices.

Meanwhile, recent recalls of implanted defibrillators have forced some patients to have them removed. Spefically, defibrillator lead wires—especially those in the Medtronic Sprint Fidelis and St. Jude Riata devices—have fractured, perforated patient heart walls, or caused device failure. In some, these malfunctions led to additional cardiac procedures or complications and even death. Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator. When a defibrillator wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall.

The findings are planned to be released at the Heart Rhythm Society's annual meeting in San Francisco and involved 61 randomly selected patients at the University of Maryland and the Baltimore VA Medical Center who were asked about recalls between October 2006 and April 2007. Eighteen percent didn't know about any pacemaker or defibrillator recall, about half learned about recalls through the media, 24 percent heard through their doctor, and over half said they'd be very worried if their device was recalled.

"We need to do a little better of a job and find better means of talking to our patients," said survey lead author Dr. Timm-Michael Dickfeld, director of electrophysiology at the Baltimore VA Medical Center. "They seem to like to have the physicians talk to them more, and explain these things more, and not leave it up to the media or the TV to inform them."

A second survey, conducted by doctors at the University of Oklahoma, asked 165 patients with a variety of heart devices whether they'd want them removed if there was a recall or safety advisory. Five percent reported they'd want the device removed immediately if there was a "recall" and 2.5 percent said they'd want it taken out if there was a "safety advisory."

CPSC Head Voices Opposition to Tougher Lead Standards

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

Nancy Nord, head of the Consumer Product Safety Commission (CPSC), said a new federal standard limiting lead in toys and other children's products "might prove to be overly broad." Nord, an appointee of President Bush and former lobbyist for corporate interests, has long been criticized for seeming to be disinterested in ensuring the CPSC fulfills its mission of protecting the public.

The limit on lead is part of a product safety bill currently under Congressional consideration and would require the CPSC to set a standard limiting lead in children's products to trace amounts of 100 parts per million for the content and 90 parts per million for paint or coatings.

Americans need a strict federal standard on lead in children's products and many consider lead poisoning to be one of the most important chronic environmental illnesses affecting children today. Exposure to lead in children and unborn children can cause brain and nervous system damage, behavioral and learning problems, slowed growth, hearing problems, headaches, mental and physical retardation, and behavioral and other health problems. Lead is also known to cause cancer and reproductive harm and, in adults, lead can damage the nervous system. Despite efforts to control lead and the success in decreasing lead poisoning, serious cases still occur. Once poisoned, no organ system is immune. Of particular concern is the developing brain because negative influences can have long-lasting effects and can continue well into puberty and beyond. Lead can be inhaled or ingested once it settles out of the air and once in the body, is rapidly absorbed into the bloodstream.

Recently, American consumers have been facing ongoing, huge problems with lead-contaminated products. In 2007, the CPSC announced 106 recalls of lead-contaminated children's products totaling 17,126,810 individual items representing a 500 percent increase from 2006.

Considering the life-threatening gravity of this situation, it was generally believed that Nord would be seeking strong federal action. This does not seem to be the case. Also, many are wondering what happened to the CPSC Reform Bill, which does include the lead standard as well as other important provisions. The House bill (H.R. 4040) passed in December and the Senate bill (S. 2663) passed in early March. Democratic leaders were hoping to finalize the bill before last Christmas; however, concerns are mounting that the bill will not be finalized by year-end, 2008. Meanwhile, CPSC recalls of lead-contaminated children's products continue and show no signs of diminishing.

Earlier this year, some toymakers decided to take it upon themselves to tackle lead and other standards in toys being sold to American children by enforcing voluntary standards that are more stringent than the mandatory federal standard currently in place.

President Bush has been criticized for continually blocking the CPSC from doing its job; therefore, Congressional action is needed to help increase safety to consumers, especially children. Also, one of CPSC's three commissioners resigned in 2006 and under the Consumer Product Safety Act, the CPSC can continue to conduct formal business with two commissioners for six months. That quorum expired and has been extended, but President Bush has refused to nominate a candidate to serve as CPSC's third commissioner, despite growing concern over toy safety.

Paxil Birth Defect - Club Foot

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

Paxil and Club Foot

Keywords: Lawyer Paxil Club Foot Lawsuit Birth Defect

The lawyers and attorneys at our firm are currently offering free case evaluations to families with children who were born with Club Foot because their mothers took Paxil during pregnancy. Club Foot is a birth defect that, if not treated, will lead to significant discomfort and disability by the teenage years. Studies have indicated that babies are far more likely to develop Club Foot if they are exposed to Paxil in the womb. These babies face years of treatment, possibly involving surgery. Our Paxil birth defect lawyers are dedicated to making sure the families of these babies are compensated for the medical bills they incur, as well as the pain and suffering they endure.

The causes of Club Foot are not completely known, although genetics is thought to play some role. Environmental factors could also cause the disorder. A recent study conducted by the Institute of Reproductive Toxicology at the University of Ulm, Germany, noted that some women who took selective serotonin reuptake inhibitor antidepressants (SSRIs), such as Paxil, during pregnancy had infants born with Club Foot. A July 2007 article in the New England Journal of Medicine also found that women who took Paxil during pregnancy were at a 5.8 percent increase of having a child born with this defect.

Club Foot and its Treatment

Club Foot occurs when a newborn infant's foot is turned to the side and it may even appear that the top of the foot is where the bottom should be. The involved foot, calf, and leg are smaller and shorter than the normal side. The bones, joints, muscles, and blood vessels of the limb are also abnormal. A Club Foot occurs in approximately one in every 1,000 births, with boys slightly outnumbering girls. One or both feet may be affected.

Club Foot is treated with both non-surgical and surgical therapies, and most doctors will try to avoid surgery if possible. One non-surgical therapy for treating Club Foot is called the Ponseti method. It involves stretching, casting and bracing the limb to correct the Club Foot. With this method, the doctor changes the cast every week for several weeks, always stretching the foot toward the correct position. Once the foot has been corrected, the infant must wear a brace at night for two years to maintain the correction. While very effective, this treatment can be uncomfortable for an infant. It also has a risk of complications. While the child is in a cast, parents must watch for changes in skin color or temperature that may indicate problems with circulation.

Sometimes, surgery may be needed to adjust the tendons, ligaments and joints in the foot/ankle of a child with Club Foot. Usually done at 9 to12 months of age, surgery corrects all of a baby's Club Foot deformities at the same time. After surgery, a cast holds the Club Foot still while it heals. It's still possible for the muscles in a child's foot to try to return to the Club Foot position, and special shoes or braces will likely be used for up to a year or more after surgery. Unfortunately, surgery is not a complete cure, and will likely result in a stiffer foot than non-surgical treatment, particularly as the years pass by.

No matter what treatment is used, however, a corrected Club Foot will still not be perfect. The Club Foot will likely stay 1 to 1 1/2 sizes smaller and somewhat less mobile than the normal foot. The calf muscles in a child's Club Foot leg will also stay smaller. The treatment for a Club Foot - especially if it involves surgery - can be painful and traumatic for both the child and parents. The Paxil birth defect lawyers at our firm believe that GlaxoSmithKline should be held liable for this pain and suffering when Club Foot is the result of Paxil.

Paxil and Birth Defects

Paxil is one of the most popular antidepressants on the market, and by 2006, more than 19 million prescriptions had been written for the GlaxoSmithKline drug. Paxil was approved to treat symptoms of depression, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, generalized anxiety disorder, social phobia/social anxiety disorder, and premenstrual dysphoric disorder. Paxil was the first antidepressant formally approved in the US for the treatment of social anxiety disorder.

Major depression in women is most common during the childbearing years, and about 10% of pregnant women have the condition, which is often treated with an SSRI like Paxil. Some studies suggest that babies born to mothers who took SSRIs while pregnant may have temporary withdrawal symptoms. And in 2005, preliminary data from two studies suggested that babies born to mothers who took Paxil in early pregnancy are 1½ to 2 times more likely to be born with a heart defect than babies in the general population. The Paxil birth defect lawyers at our firm believe that GlaxoSmithKline has engaged in a concerted effort to downplay Paxil's risks, an we intend to hold the drug maker accountable for this.

Legal Help for Victims of Paxil-Related Club Foot

Children born with Club Foot as a result of Paxil and their families have valuable legal rights. If you or someone you know have suffered because of this injury, 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 Paxil birth defect lawyer.

Jackets Sold at TJ Maxx Recalled for Drawstring Hazard

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

Today, the U.S. Consumer Product Safety Commission (CPSC), in cooperation with Maran Inc., of North Bergen, New Jersey, announced a voluntary recall of about 6,000 Squeeze Kids Girl’s Corduroy Jackets due to a strangulation hazard.

Maran’s Squeeze Kids Girl’s Corduroy Jackets were manufactured in China and sold exclusively at TJ Maxx retail stores nationwide during January 2007. The jackets retailed for about $13. The Squeeze Kids Girl’s Corduroy Jackets have a drawstring that runs through the hood, which poses a strangulation hazard to children. The recalled jackets are made of brown corduroy with a pink hood and pink sequins on the front pockets. The words “Squeeze Kids” and style number 4JZ642FK are printed on the care label sewn into the back collar area. Recalled sweatshirts were sold in girls’ sizes small (7/8), medium (10), large (12/14) and x-large (16).

Consumers are advised to immediately remove the drawstrings from the sweatshirts to eliminate the hazard or to return the garments to the place where purchased or to Maran Inc. for a refund. Maran Inc. can be contacted toll-free at (866) 431-5698 between 9:00 a.m. and 5:00 p.m. ET Monday through Friday or at its Website at www.Sqz.com

Meanwhile, several firms that sold children’s clothing with drawstrings that posed a strangulation hazard have agreed to pay a total of $320,000 in fines. These firms failed to report to the CPSC—as required by federal law—that their children’s hooded sweatshirts or jackets were sold with drawstrings at the hood and neck. Since April 1, 2007, there have been 17 recalls of over 190,000 units of children’s clothing because of drawstrings in the hood or neck. This, despite the existence of an 11-year old voluntary industry standard that instructs manufacturers not to use drawstrings in the neck area of children’s outerwear and to ensure drawstrings at the waist are of a certain length, have no toggles or knots, and are sewn in the back so they can’t move. The CPSC has similar guidelines on the books and both New York and Wisconsin have made the standard mandatory.

Still, the guidelines are routinely ignored by the clothing industry and that attitude has had deadly consequences. From January 1985 through January 1999, the CPSC received reports of 22 deaths and 48 non-fatal entanglement incidents involving drawstrings on children’s clothing.

The CPSC can take action if it sees voluntary standards being flouted, which includes levying fines, which it did in the case of eight firms--Life is Good Inc., True Religion Apparel Inc., The Cayre Group Ltd., DollarDays International, LLC, Kohl’s Department Stores Inc., Seena International Inc., Gildan Activewear SRL, and Neiman Marcus Group Inc—that did not report hazardous drawstring clothing to the agency. Federal law requires manufacturers, distributors, and retailers report dangerous products to the CPSC within 24 hours after learning that a product contains a defect which could create a substantial risk of injury to the public, presents an unreasonable risk of serious injury or death, or violates a federal safety standards.

Most recently, in April, Brents-Riordan Inc. LLC, of Shreveport, Louisiana, recalled 7,400 hooded youth sweatshirts and jackets due to similar strangulation hazards.

Dry Dog Food Blamed for 70 Cases of Salmonella

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

Salmonella poisoning in 70 people around the country has been linked to dry dog food. According to the Centers for Disease Control (CDC), it is the first time a Salmonella outbreak has been linked to dry dog food.

Last August, Mars Petcare US, Inc. recalled its Red Flannel Large Breed Adult Formula and Krasdale Gravy Dry Dog Food because of Salmonella contamination. The Salmonella was traced back to the company's Pennsylvania factory.

Now the CDC is blaming the dry dog food for 70 cases of Salmonella, most of which occurred in Pennsylvania, New York and Ohio. There were also reported cases in Alabama, California, Illinois, Indiana, Iowa, Kentucky, Michigan, Minnesota, North Dakota, South Carolina and Virginia. About 40 percent of those infections involved infants, according to a report published in the May 16 issue of the CDC's Morbidity and Mortality Weekly Report. Of the 38 people for whom clinical information was available, 15 (39 percent) had bloody diarrhea. For the 45 persons whose hospitalization status was known, 11 (24 percent) had to be hospitalized. No deaths were reported, according to the report.

The CDC said that although no pets became ill, Salmonella was identified in feces samples from dogs that ate the dry food. In addition, Salmonella was found in open bags of the pet food fed to the dogs and in unopened bags of dog food made in the Pennsylvania plant.

While this is the first Salmonella outbreak ever associated with dry dog food, some experts believe that food born illnesses from pet foods are more common, but are under-reported. To avoid contracting food poisoning from pet food, it is important to avoid cross-contamination, anyone handling pet food should wash their hands with hot, soapy water when they are done. Likewise, pet food bowls, dishes and scooping utensils should also be washed after use. Dry food should be stored in a cool (under 80-degrees) dry place in its original bag or a container with a lid. Unused wet food should be refrigerated, and the thermostat should be no higher than 40-degrees. Any stale or spoiled food should be thrown away. Pet food also should not be stored or handled anywhere human food is stored or prepared. Pet food should also be kept away from young children, who might be tempted to give it a taste.

Salmonella is a potentially deadly type of food poisoning, symptoms of which include fever, abdominal pain, nausea, gas and bloody diarrhea. Symptoms appear within 36 hours of exposure, and usually last four to seven days. In very severe cases, Salmonella can lead to kidney failure and other complications. Salmonella can be particularly dangerous for children, the elderly and people with weakened immune systems. Some victims of Salmonella will develop a disease called Reiter’s Syndrome, a difficult- to- treat condition that causes severe joint pain, irritation of the eyes, and painful urination. Reiter’s Syndrome can plague its victims for months or years, and can lead to chronic arthritis.

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.

Possible Listeria Contamination in Sweetwater Valley Farm Aged Black Pepper Cheese

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

Effective immediately, the Sweetwater Valley Farm, Inc. of Philadelphia, Tennessee is recalling its Tennessee Aged Black Pepper Cheese due to a potential Listeria monocytogenes contamination. The food product is listed as Tennessee Aged Black Pepper Cheese, Lot Number 616-361 and was distributed in five-, seven-, and 10-ounce ounce bars through Sweetwater Valley Farm’s retail store in Philadelphia, Tennessee as well as through a winery in Portland, Tennessee.

No more than 100 pounds of the possibly tainted Tennessee Aged Black Pepper Cheese were distributed between December 27, 2007 and May 12, 2008. Although no illnesses have been reported, to date, the recall followed a routine sampling program by the Tennessee Department of Agriculture which revealed that the finished product contained the Listeria moncytogenes bacteria. Sweetwater Valley Farm has halted distribution of the affected lot and continues its investigation into what caused the Listeria contamination.

Consumers who have purchased lot number 616-361 of Tennessee Aged Black Pepper Cheese are urged bring it to Sweetwater Valley Farm for replacement or refund. Consumers can also ship the product back to Sweetwater Valley Farm for replacement or refund. Consumers can contact the Sweetwater Valley Farm’s consumer affairs department at 1-877-862-4332 for more information.

Listeriosis is a type of food poisoning generated by the Listeria monocytogenes bacteria and is dangerous to the elderly, pregnant women, newborns, those with chronic medical conditions, people with HIV, or those who are undergoing chemotherapy. Most experience only mild flu like symptoms—fever, muscle aches, nausea, or diarrhea. In serious cases, the disease spreads to the nervous system, causing headaches, stiff neck, and convulsions. In pregnant women, Listeriosis can result in miscarriage or stillbirth. Listeria lives in soil, stream water, sewage, plants, and food and can easily contaminate dairy and beef products; listeria thrives in cold environments.

This year, listeria has been the focus of a number of outbreaks, including three cases in North Carolina linked to soft cheeses and an outbreak at Massachusetts’ Whittier Farms dairy where four people died and more were sickened. In Washington, the Ca Rem #1 Ice Cream, SeaTac recalled popsicles for contamination; the Minnesota Department of Agriculture (MDA) alerted the public to avoid consuming smoked pork and beef bratwurst produced by J&B Meats; Meijer Inc. of Grand Rapids, Michigan, pulled 2,184 pounds of frozen entrees; and Stop and Shop recalled four types of prepared chicken. Raw milk from Piney Ridge dairy farm and Clark and Elaine Duncan's farm was contaminated with Listeria monocytogenes in Pennsylvania. Recently, the Rhode Island Department of Health issued a warning about soy sprouts infected with listeria sold under the Chang Farms label. The Gourmet Boutique of Queens, New York recalled about 286,000 pounds of fresh and frozen beef, pork, and poultry products that may be contaminated.

And, just this week, the Georgia Department of Agriculture food scientists discovered Listeria monocytogenes in a sample of Bright Water Smoked Salmon & Cheese Spread and in another unrelated contamination, R&R Alsatian Sausage and Products recalled some of its beef jerky products due to possible contamination with Listeria monocytogenes, according to the Department of State Health Services in Texas.

Migraine Meds Linked to Potentially Fatal Serotonin Syndrome

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

Triptans, a class of medications used to treat migraines that includes Imitrex, Zomig and others, can cause serotonin syndrome. Serotonin syndrome is a rare, but potentially life-threatening adverse drug reaction that results from intentional self-poisoning, therapeutic drug use, inadvertent interactions between drugs, or the recreational use of certain drugs. The disorder occurs when excess serotonin activity produces a specific spectrum of symptoms including mental status changes, overactive reflexes, muscle spasms, fever, uncoordinated movements, heavy sweating and nausea or vomiting.

Triptans, a family of drugs introduced in the 1990s, are used to relieve the symptoms of migraines and cluster headaches. Triptans relieve pain by narrowing blood vessels in the brain and relieve swelling. Evidence is accumulating that these drugs are effective because they act on serotonin receptors in nerve endings as well as the blood vessels.

It has long been known that triptans, when taken along with selective serotonin reuptake inhibitors (SSRIs) such as Paxil and Zoloft, could cause serotonin syndrome. SSRIs are a class of antidepressants used in the treatment of depression, anxiety disorders, and some personality disorders. They are also sometimes used to prevent migraines. SSRIs increase serotonin level.

But this is the first time that triptans alone have been linked to the disorder. Reporting in the May 15 issue of the New England Journal of Medicine, researchers from Georgetown University and the Food and Drug Administration (FDA) detail 11 cases of serotonin syndrome associated with the use of triptans alone that were reported to the FDA's Adverse Event Reporting System (AERS).

The average age for someone experiencing serotonin syndrome associated only with triptan therapy was 39.9 years, and the most common symptoms included tremor, stiffness, palpitations, high blood pressure and agitation, according to the study. Five people required hospitalization, and two cases were classified as "life-threatening." Four of the 11 cases cleared up within an hour of treatment

The researchers recommended that people using triptans consult with their doctors if they experience any symptoms of serotonin syndrome.

Lifeway Foods Shutdown by FDA Over Manufacturing Violations

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

Today, the U.S. Food and Drug Administration (FDA) announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., of Skokie, Illinois. The shutdown will remain in effect until both companies are found compliant with food safety laws. A consent decree of permanent injunction—which was signed by both corporations and two of their top executives, defendants Julie and Edward Smolyansky—stops all cream cheese and seafood processing in facilities in Skokie, Illinois and Philadelphia, Pennsylvania. According to the FDA, conditions at the facilities made it more likely that products would become contaminated with bacteria that causes food poisoning.

The action follows an extensive an ongoing history of violations of the Federal Food, Drug, and Cosmetic Act that date back to at least 2004. The complaint was filed by the U.S. Department of Justice and—according to an FDA release—alleges that the Julie and Edward Smolyansky:

“Labeled and distributed cream cheese products with inadequate labels, including labels that did not disclose major food allergens, trans fat levels, and complete ingredient lists;
“Processed and distributed products with seafood, including whitefish salad, ground nova salmon, and lox cream cheese and lox cream cheese spreads, without adequate Hazard Analysis and Critical Control Point (HACCP) plans to ensure the safe and sanitary processing of seafood containing products; and
“Failed to document that they monitored sanitation conditions to keep food contact surfaces clean, to prevent cross-contamination from unsanitary objects, and to maintain hand washing, hand sanitizing, and toilet facilities.”

"We simply can’t allow companies to put the public's health at risk by not having adequate procedures and plans to produce safe food and proper labeling," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "We will work to take action against companies and their executives that violate the law."

Under the decree, the FDA will only allow operations to resume when the FDA agrees that they are in full compliance with all food safety. As part of the decree, the defendants must hire seafood-processing expert to prepare an HACCP plan and to submit that plan to the FDA.

Without adequate controls and when HACCP violations occur, a serious public health hazard can take place. For instance, Lifeway Foods and LFI Enterprises’ seafood products could foster dangerous—often deadly—bacteria, such as Vibrio species, Salmonella, Escherichia coli, Campylobacter jejuni, Staphylococcus aureus, and Listereria monocytogenes. Food these pathogens can cause serious illnesses—sometimes death—for those who eat them. Also, foods sold with labels that do not disclose major food allergens and complete ingredient lists can cause severe and deadly allergic reactions in those allergic to the undisclosed allergens.

Meanwhile, according to a recent government report, despite efforts in the U.S. to contain food borne illness, there has been no reduction in the number of infections, as a matter-of-fact, food borne illness reports remained stable last year following a prior period of decline. The report issued by government researchers found no change in the rate of infections caused by Listeria, Salmonella, Shigella, E.coli O157, and several other bacteria in 2007 compared with the previous three years and showed an increase in Cryptosporidium—a parasite which causes diarrhea—levels in recent years.

Paxil and ASD / VSD (Heart Birth Defects)

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

Paxil Heart Birth Defects (ASD / VSD)

Keywords: Paxil ASD Lawyer VSD Heart Lawsuit Birth Defects

The lawyers and attorneys at our firm are currently offering free case evaluations to families whose children were born with heart defects, specifically Atrial Septal Defects (ASD) and Ventricular Septal Defects (VSD), due to their mother's use of Paxil while pregnant. While several studies have linked the antidepressant Paxil to a number of birth defects, by far the most common problems associated with Paxil use during pregnancy are ASD and VSD. These heart defects, which involve holes between the heart's pumping chambers, can be devastating, and often babies with these problems must undergo painful surgeries to correct them. Our Paxil heart defect lawyers will make sure that infants and families coping with ASD or VSD are compensated for these injuries.

Ventricular Septal Defects

A ventricular septal defect (VSD) is a hole between the right and left pumping chambers of the heart. VSD is among the most common congenital heart defects, occurring in 0.1 to 0.4 percent of all live births and making up about 20 to 30 percent of congenital heart lesions. VSD is probably one of the most common reasons for referral of an infant to a cardiologist.

Although babies with large VSDs may do very well in the first weeks of life, such defects eventually become dangerous. In these cases, VSD will gradually lead to symptoms of congestive heart failure and must be treated. Medium or moderate VSD is more challenging to predict. Sometimes babies born with moderate VSD will have problems with congestive heart failure like babies with large VSD. Others will have no problems at all and just need to be watched.

VSD has can have a very characteristic heart murmur, however, a murmur is often not heard at birth, especially in a large VSD. It is only when there is excessive flow across the hole into the lungs that a murmur can be appreciated. Babies who do have moderate or large VSD with excessive blood flow to the lungs will have signs of congestive heart failure. The most important sign will be the baby's growth. In older children, lower energy levels compared to other children the same age may be a symptom of VSD.

Babies who have shown some signs of congestive heart failure from VSD will typically be placed on medication, usually a diuretic to help get rid of extra fluid in the lungs. A medication like digoxin might be used to stabilize heart rhythm. In babies who are failing to thrive because it is too difficult for them to eat, a high calorie formula or fortified breast milk will be added to help the baby grow. A nasogastric feeding tube may be necessary to deliver the food if a baby is too weak. The point of such treatments is to control the symptoms of heart failure, and help the baby achieve normal growth.

Hopefully, the VSD will close and no other treatment will be needed. When the symptoms of VSD are hard to control with medicines or there is persistent evidence that the heart is doing extra work, surgical closure of the defect is often recommended.

In September 2005, the Food & Drug Administration (FDA) and GlaxoSmithKline, the maker of Paxil, alerted doctors about a new study on major birth defects seen in babies born to women who took the antidepressant during the first trimester of pregnancy. In the study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants. Most of these defects were heart related, and the most common heart problem seen in the study was VSD. At that time, the label of Paxil was modified to include information on this study.

The Paxil birth defect lawyers at our firm know that VSD can take an enormous toll on babies and their families. The medications and treatments used to stave off heart failure are expensive, and often carry other dangerous side effects. Surgery is always a painful and traumatic experience for infants. Our Paxil birth defect lawyers will do everything they can to make sure families victimized by this drug get their lives back on track.

Atrial Septal Defects

An atrial septal defect (ASD) is a hole in the wall between the two upper chambers of the heart. In some cases, the hole may close on its own, but often infants with ASD must undergo surgery to correct the problem. While ASD is sometimes diagnosed at birth, it is not unusual for the defect to be discovered later in life. An adult who has had an undetected atrial septal defect for decades may have a shortened life span from heart failure or high blood pressure in the lungs.

In December 2005, the FDA again announced that it was requiring GlaxoSmithKline to add additional warnings about Paxil birth defects to the drug's prescribing information. The FDA took the action because the early results of two more studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. In addition to VSD, the studies indicated that Paxil use during the early months of pregnancy put infants at risk of ASD. In addition to the label change, the FDA also moved Paxil to another pregnancy category. The FDA had previously classified the Paxil birth defect risk as Category C (Risk of Fetal Harm Cannot be Ruled Out). The new Paxil labeling now classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

Infants with large atrial septal defects may have a poor appetite, and they often do not grow at a normal rate. In some cases, they may also exhibit signs of heart failure or arrhythmias. But very often, symptoms do not appear for years - when a person is in their 20s, 30s, or 40s - after ASD has done significant damage to the heart and lungs. Paxil was first approved in 1992, and thousands of pregnant women have taken the drug since then. Because the symptoms of ASD often take time to appear, our Paxil heart defect lawyers expect many cases of Paxil-related ASD will be diagnosed in adults in the coming years.

The symptoms of long-standing ASD include shortness of breath, fatigue, swelling of legs, feet or abdomen, and heat palpitations. Large ASDs can cause a range of life-threatening problems if they are not treated. These include right-sided heart failure, a higher risk of heart attack and stroke, and heart rhythm abnormalities.

In a child, doctors may observe the atrial septal defect for a period of time to see if it closes on its own. If a hole hasn't closed early in childhood, it usually will never close on its own and requires surgery to correct. For adults and children, surgery involves plugging or patching the abnormal opening between the atria. Doctors can do this through two methods: open heart surgery or cardiac catheterization. For children, both procedures involve a great deal of trauma and pain. Our Paxil injury lawyers want to make sure that GlaxoSmithKline is held accountable for the pain and suffering inflicted on Paxil birth defect victims.

Legal Help for Victims of Paxil-related ASD or VSD

If you or someone you know used Paxil during pregnancy and gave birth to a child with ASD, VSD or other heart defects, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) to discuss your case with an experienced Paxil birth defect lawyer.

FDA Head Faces Reality, Asks Congress for More Funding

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

Beleaguered Food and Drug Commissioner (FDA) Dr. Andrew C. von Eschenbach has finally written Congress saying the FDA needs an immediate $275 million to ensure the safety of imported foods, drugs, and medical devices. The May 5 request was sent to Senator Arlen Specter—Republican-Pennsylvania—and provides a detailed spending plan: $125MM to finance food safety activities, $100MM for medical product and drug safety activities, $40MM for modernizing the FDA’s science and work force, and $10MM to upgrade agency facilities and laboratories.

Presidential appointees do not generally deviate from the president’s spending plans and, if so, not in writing. von Eschenbach’s move surprised many and was seen as a sign of the president’s fading authority in the closing months of his presidency. “In 30 years at the agency, I never saw anything like this happen before,” said William Hubbard, a former deputy FDA commissioner.

On May 1, Specter wrote von Eschenbach asking for how much the FDA needed “to protect the public’s health.” In a handwritten note in the margin, Specter wrote, “Andy, I know the situation is extreme. I want to get you financial help now.” von Eschenbach wrote that he was providing his budget “without regard to the competing priorities that the agency, the president, and their advisors must consider as budget submissions to the Congress are developed.”

Bush asked Congress to provide an allocated budget for fiscal year 2009 of $1.77 billion, an increase of $50.7 million over 2006, which was seen as insufficient to cover increased FDA salary expenses. von Eschenbach has suffered unrelenting criticism from the House and Senate Democrats following repeated scandals and on Capitol Hill, there is a bipartisan consensus the FDA must conduct increased inspections of foreign drug plants and imported food.

In April, at a House Energy and Commerce Subcommittee on Investigations, Representative John D. Dingell—Democrat-Michigan and chairman of the commerce committee—repeatedly asked von Eschenbach for a figure that would enable the FDA to conduct adequate inspections saying, “You cannot do your job, you are not doing your job, how much money do you need to do it?” von Eschenbach did not give an amount. A week earlier, Senator Robert F. Bennett—Republican-Utah—looked for a figure from von Eschenbach who only said that the FDA could not efficiently absorb a $375 million increase in its budget next year. In this week’s letter, von Eschenbach said the FDA could absorb an additional $275 million in the next few months.

Last week, Senator Herb Kohl—Democrat-Wisconsin and Senate appropriations subcommittee Chairman—sponsored a measure to give the FDA an additional $275 million this year as part of an emergency supplemental appropriations bill largely intended to finance the war in Iraq. The subcommittee has jurisdiction over the FDA and this may be the only way to provide additional FDA funding as appropriations bills are expected to be delayed. The bill echoes von Eschenbach’s financial breakdown.

When told of von Eschenbach’s letter to Specter, Dingell said he wondered “why the commissioner is beginning to finally recognize what has been painfully obvious to everyone else.”

Lawmakers Want More FDA Oversight of Imported Medical Devices and Cosmetics

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

Democratic lawmakers say the US Food and Drug Administration (FDA) has insufficient funding and power to maintain appropriate oversight and regulation of imported products, especially medical devices and cosmetics. "While the market for these products becomes increasingly global, the FDA has no requirement to inspect foreign establishments manufacturing medical devices," said Representative Frank Pallone (New Jersey-Democrat) who led a US House of Representatives Energy and Commerce panel Wednesday.

Lawmakers continue to work toward legislation that would require drug and device makers, food manufacturers, and cosmetic companies to register with the FDA and pay for mandatory inspections of foreign factories. The proposed bill follows a flood of tainted goods imported from China, including poisonous pet food, tainted toothpaste, and contaminated medications, such as the blood thinner heparin. Currently, the FDA inspects foreign makers of heart defibrillators and other high-risk devices about once every six years; makers of hearing aids and less risky devices once every 27 years; and US device facilities once every three to five years, according to the Government Accountability Office (GAO).

Some Republicans feel industry fees are like an added tax that would burden manufacturers. Representative Joe Barton—Texas-Republican—said imported devices did not pose the same risks as other products. "We've had major problems with food imports from China, we've had major problems with drug imports from China, but I'm not aware that we've had major problems with medical device imports from China," he said.

Device makers also argue that increased inspections for low-risk products, like contact lenses and glucose meters, would delay those products from reaching patients. "Requiring FDA to conduct pre-approval inspections ... would bring the approval process to a grinding halt," said Steven Ubl, head of the Advanced Medical Technology Association, in testimony to Wednesday’s panel. Also, industry groups questioned more inspection fees for device companies, which already pay the FDA to review products for approval. FDA officials said they are working to increase inspections and create agency offices in other countries.

Stephen Sundlof, head of the FDA's Center for Food Safety and Applied Nutrition, which oversees cosmetics, urged lawmakers to focus on risky products and better use of private inspections. Democrats said the FDA has even less power over cosmetic products, which have gone largely unregulated for decades—the industry is overseen by rules enacted 70 years ago and the FDA has only reviewed 11 percent of related ingredients and banned or restricted 10 types that posed safety risks. About $62 billion in personal products are sold in the US annually and the number of imported products has tripled since 2000 and is expected to grow, said Sundlof who also acknowledged that regulating cosmetics has become a challenge as more products "straddle the line between cosmetics and drugs."

"I think improving oversight authority of cosmetics is long overdue," said Representative Jan Schakowsky (Illinois-Democrat). Sundlof acknowledged only one-third of all US cosmetic makers are registered with the FDA and said companies are responsible for ensuring safety before marketing products. Unlike drugs or devices, cosmetics are not approved by the FDA prior to being placed on the market.

FDA Defends BPA in Baby Bottles

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

The federal agencies that regulate use of the estrogen-mimicking chemical BPA are agreeing with the chemical industry in defending its safety. Despite overwhelming evidence to the contrary, the U.S. Food and Drug Administration (FDA) just announced it sees no reason to advise consumers to stop using products made with the controversial chemical, which is found in many plastic items. Norris Alderson, the FDA's associate commissioner for science said although the FDA is reviewing concerns about bisphenol A, or BPA, "a large body of available evidence" indicates products such as liquid or food containers made with BPA are safe. In testimony before a Senate subcommittee, Alderson defended the FDA's reliance on two industry-funded studies in making this determination. Critics have accused the FDA of failing to act on BPA concerns and have accused them of acquiescing to industry.

Meanwhile, in a number of studies not funded by industry, a variety of health problems have occurred in laboratory animals exposed to low BPA levels, which have been found to cause changes in behavior; in the brain, prostate gland, and mammary gland; and the age at which girls enter puberty. In the lab, BPA is linked to sex-hormone-imbalances, including breast and prostate cancer, early puberty, miscarriage, low sperm count, and immune-system changes. The National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction found BPA risk and exposure causes neural and behavioral effects in children, becoming the first federal agency to accept such fears. A group of scientists from the Centers for Disease Control (CDC), the FDA, and the Institutes of Health (NIH) warned that very low doses of BPA cause profound effects on laboratory animals, particularly during pregnancy and infancy and that BPA can permanently rewire genetic programming before birth. The federal National Toxicology Program said experiments on rats found precancerous tumors, urinary tract problems, and early puberty when animals were fed or injected with low BPA doses.

And, despite the FDA’s statements to the contrary and industry’s defense of BPA, legislation has been proposed in several states to limit or ban BPA use. Toys 'R' Us, Wal-Mart, Playtex, and CVS have all announced that they are phasing out bottles and other baby feeding products containing BPA and Nalgene said it would stop using BPA.

Some senators also faulted the FDA and the Consumer Product Safety Commission (CPSC) for also failing to protect consumers from phthalates, another class of controversial chemicals that is used to improve flexibility in plastics. This March, the Senate passed legislation to impose a nationwide ban on phthalates in children's toys and products. "The FDA could hardly be doing less," Democratic Senator John Kerry of Massachusetts said. Senator Charles Schumer, a New York Democrat, said the FDA was "looking the other way" on safety concerns about BPA. "Parents always err on the side of caution when it comes to their kids' health. We think that the law should do the same," he added. In April, Schumer, Kerry, and other Democratic senators introduced a bill to ban BPA in children's products and direct the CDC to study BPA health effects in humans.

28 Positive for Salmonella at Princeton University

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

The number of confirmed Salmonella victims at Princeton University has risen to 28, and the number could go higher as officials say more than 70 people have reported symptoms typical of Salmonella. The university is still awaiting lab tests that will confirm whether or not those illnesses are, in fact, Salmonella.

According to the Centers for Disease Control (CDC), Salmonella bacteria sicken 40,000 people every year. Although the true number could be much higher, because it is estimated that for every case of Salmonella poisoning reported, two others are unreported. Salmonella causes fever, abdominal pain, nausea, gas and bloody diarrhea. Symptoms appear within 36 hours of exposure, and usually last four to seven days. In very severe cases, Salmonella can lead to kidney failure and other complications. Salmonella can be particularly dangerous for children, the elderly and people with weakened immune systems. In rare cases, Salmonella can cause a disease called Reiter’s Syndrome, a difficult- to- treat condition that causes severe joint pain, irritation of the eyes, and painful urination.

Over the last year and half, hundreds of people were sickened by Salmonella-tainted Peter Pan Peanut Butter and Banquet Pot Pies sold by ConAgra foods. In the past couple of months, Malt-O-Meal Cereal has been blamed for 23 cases of Salmonella, while Honduran cantaloupe was recalled after in was linked to more than 50 cases of the disease. Smaller outbreaks of Salmonella are reported on a regular basis throughout the country.

The first case of Salmonella at Princeton was confirmed on April 29 through lab tests. So far, Salmonella has been confirmed in 20 students and eight staff members. According to The Princeton Packet, the New Jersey Department of Health and Senior Services had completed more than 85 “control interviews”. The control interviews consisted of health officials talking both to people on campus who fell ill and also those who didn’t to see if there were commonalties between the food case histories of the two groups.

The origin of the Princeton Salmonella outbreak has yet to be determined. Last week, a spokesperson for the University said that its food services department has sent 20 categories of food served on campus to labs for testing. At the same time, the University also closed some of its food stations at the Frist Campus Center, suspended services of a range of food that might be linked to Salmonella and changed some food vendors. This week, a salad bar and a Mexican food station at the center remain closed as a precaution.

Ford Recalls Trucks for Faulty Brake Hose

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

Ford Motor Company is recalling more than 650,000 vehicles because of a defective power brake assist hose. According to Ford, the hoses on some of its F-150 and Mark LT trucks has a defect that may making braking difficult. There have been reports of 11 minor accidents caused by the brake hose issue, but no injuries.

The Ford recall covers 2005 and 2006 F-150 and Mark LT trucks equipped with the 5.4-liter three-valve engine, according to the National Highway Traffic Safety Administration (NHTSA) website. The brake hose may swell over time causing the hose to become detached from the intake manifold, NHTSA reported. As a result the agency warned, applying the brakes could require increased pressure on the brake pedal. More than 600,000 of the recalled trucks are in the U.S. and roughly 50,000 are in Canada. Another 1,500 pickups are in other countries.

Ford plans to begin notifying F-150 and Mark LT owners of the recall in early July. At that point, dealers will replace the hose at no charge to customers. The official start of the recall is being delayed because parts are currently not available to complete the required repairs.

Meanwhile, Ford is trying to declare an end to a much larger recall involving faulty cruise control switches. Over the past ten years, Ford has issued six recalls of cars and trucks with control switches that can develop a short circuit and spark a raging fire, usually when the car is parked and unattended. About 12 million Ford vehicles have been recalled since 1999, including 1993-2004 Ford F150 trucks, 1994-2002 F250 through F550 Super Duty trucks with gasoline engines, and 1998-2001 Ford Explorer and Mercury Mountaineer SUVs, all of which were among the best-selling vehicles in the nation during those years. A complete list is available at http://www.nhtsa.dot.gov/.

A variety of problems have plagued and delayed the Ford cruise control switch recalls. In February, Ford recalled about 225,000 vehicles that had already been repaired because some wiring harnesses appeared to be defective. A shortage of parts also delayed repairs of the defective switches.

Ford is now preparing to send “final repair notices” to 3.5 million Ford vehicle owners next month. According to Consumer Affairs.com, the final repair notice is theoretically the last time the automaker will attempt to warn owners of the affected models. The automaker says it will send multiple final notices to customers who do not take their vehicles in for the repair.

Ford reported to the NHTSA earlier this year that just more than 4 million of the recalled vehicles have been repaired to date. Ford also reported 834,000 of the recalled vehicles were not delivered, exported, stolen or scrapped. That leaves more than 7 million Ford cars and trucks in the U.S. that could potentially catch fire - significantly more vehicles than the company plans to include in its final repair notices.

Cypher Stent Ad Criticized

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

A 60-second television ad for the Cypher drug coated stent—made by the Cordis subsidiary of Johnson & Johnson—is under fire. It seems the ad failed to fully warn consumers about the potential dangers of receiving a stent, according to an article published by The New England Journal of Medicine. The Journal says the ad promotes the Cypher stent’s potential benefits but minimizes its risks and this may be deceptive and should be reviewed by federal regulators.

The ad uses the tag line “life wide open,” a play on words. Stents are an important element in heart-disease treatment. Tiny wire-mesh tubes, stents prop open arteries once doctors clear them of blockages. Stents are implanted to maintain arterial blood flow and there is long, ongoing debate over drug-coated versus bare metal stent use.

“We believe that the Food & Drug Administration (FDA) should perform a critical post-release review of the ‘Life Wide Open’ campaign to assess whether it meets the basic regulatory requirements for non-deceptive advertising,” the Journal’s article said. The article also questioned the validity of advertising such high-risk procedures directly to the public.

Cordis defended the ad, saying its content and message had been reviewed by the FDA prior to the ad’s release last Thanksgiving Day, during a popular NFL game broadcast. “The goal of the ‘Life Wide Open’ campaign is to foster an informed, balanced conversation between patients and physicians about treatment options for coronary artery disease, which kills millions of Americans each year,” Cordis said. Cordis spokesman Christopher Allman, said the ad was no longer running nationally but was being broadcast in Baltimore.

The article comes as pressure mounts on the FDA to limit consumer medical advertising or at least increase its oversight. The US is one of the few industrialized countries that permit such advertising. Tomorrow, an FDA advisory committee plans to discuss whether TV ads for prescription drugs should include a statement encouraging consumers to report negative side effects to a toll-free number operated by the FDA, a requirement currently in effect for print ads. There is no such requirement for medical devices ads, which are not as closely monitored.

During a Congressional hearing last week on drug advertising, the chairman of the House Energy and Commerce Committee, John D. Dingell (Democrat-Michigan), pressed several drug company representatives on whether they would support the proposed ads. “They said they couldn’t tell us, so we’re communicating with the CEOs of the companies,” said Dingell who also said he supported the requirement, “But understand one thing, it might not be enough.” Dingell said the committee found systemic violations of advertising requirements by drug companies. “Some ads appear to be misleading and others appear to be downright deceptive,” Mr. Dingell said.

The chairman of the House subcommittee investigating drug advertising, Representative Bart Stupak, said that Congress should consider banning drug ads aimed directly at consumers.

Although the FDA currently does not scrutinize advertising for medical devices as closely as for prescription drugs, it does regulate ads for so-called high-risk medical devices, including stents.

Nursing Home Problems Missed in Inspections, GAO Says

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

In a report scheduled for release today, the Congressional Government Accountability Office (GAO) reveals a widespread “understatement of deficiencies,” that include malnutrition, severe bedsores, overuse of prescription medications, and nursing home resident abuse in the nation’s nursing home inspection reports. The report states that nursing home inspectors routinely ignore or minimize problems that pose serious, immediate patient threats.

Facilities are generally inspected once yearly by state employees who work under contract with the federal government. Federal officials attempt to validate state inspector work by joining them on visits or conducting follow-ups. It was in a follow-up that the GAO discovered the state missed at least one serious deficiency in 15 percent of all inspections. Worse, in nine states—Alabama, Arizona, Missouri, New Mexico, Oklahoma, South Carolina, South Dakota, Tennessee, and Wyoming—inspectors missed serious problems in over 25 percent from 2002 to 2007.

There are 16,400 nursing homes with over 1.5 million residents nationwide; approximately one-fifth of the homes were cited for serious deficiencies last year. “Poor quality of care—worsening pressure sores or untreated weight loss—in a small, but unacceptably high number of nursing homes, continues to harm residents or place them in immediate jeopardy, that is, at risk of death or serious injury,” the report said. Taxpayers spend about $72.5 billion annually to subsidize nursing home care and facilities must meet federal standards to participate in Medicaid and Medicare, which cover over two-thirds of their residents, at a cost of more than $75 billion a year.

Senators Charles E. Grassley (Republican—Iowa) and Herb Kohl (Democrat—Wisconsin and Senate Special Committee on Aging Chairman), requested the study and introduced a bill to upgrade nursing home care and increase penalties for federal standards violations. The maximum fine, now about $10,000, would be increased to $25,000 for a serious deficiency and $100,000 for deficiency resulting in patient death. The senators are pushing their bill for inclusion in a package of Medicare changes Congress is expected to pass in June.

The American Health Care Association, a nursing home trade group, opposes the bill. “We should not be increasing fines, adding auditors, and encouraging a ‘gotcha’ mentality. We should be testing new, less punitive ways to measure and improve the quality of care,” said Bruce A. Yarwood, association’s president. But, David P. Sloane, senior vice president of AARP, the lobby for older Americans, said it was “one of the most significant nursing home reform initiatives” in two decades. Under the bill, nursing homes must provide consumers and the government with more information about their owners and “affiliated or related parties,” including any individual or company with a role in managing operations. Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services, said he has been frustrated in identifying nursing home owners for facilities providing substandard care. “We have found nursing home residents who were grossly dehydrated or malnourished. We’ve found patients with maggot infestations in wounds and dead flesh. We’ve found residents with broken bones that went unmended,” he said. After discovering such problems, the federal government now requires some companies to sign compliance agreements, which are monitored by outside experts.

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.

Trasylol Gone for Good

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

Trasylol is being removed from the market for good. Bayer AG had suspended marketing of Trasylol, a drug used to prevent bleeding during heart surgery, in November, after a clinical trial found patients treated with Trasylol were dying at higher rates than others. Now, the results of that trial are in, and the death risk has been confirmed. Yesterday, Bayer notified the Food & Drug Administration (FDA) that it was removing the remaining Trasylol stock from the market.

Trasylol was approved in 1993 and has been used in a third of all heart surgery patients in the US. However, Trasylol has been the subject of concern for years, and its safety has been reviewed several times. Last November, the Canadian Data Safety Monitoring Board had stopped a Trasylol trial - known as the BART clinical study - after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.

Now, an analysis of that Canadian trial is set to be published next week. According to media repots, the study found Trasylol increased chances of death by 54 percent, compared to two much-cheaper drugs. Six percent of the Trasylol patients died within 30 days of surgery, compared with 4 percent who got either Amicar or Cyklokapron, despite a slightly lower percentage of the Trasylol patients suffering from massive bleeding or needing transfusions. The researchers found those who died in the Trasylol group had a much higher proportion of heart complications after surgery, including heart attacks.

The Canadian study is just one of several that have illustrated the deadly consequences of Trasylol, and many health advocates believe it should have been removed from the market years ago. In September 2006, Dr. Dennis Mangano presented a study he authored to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death. Ealier this year, Mangano told “60 Minutes” the he believes Trasylol should have been taken off the market when he published his study in 2006. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month.”

Even Bayer had evidence of Trasylol's death risk, but withheld it for a time. Bayer executives attended Mangano’s presentation in order to defend Trasylol. What they did not tell the FDA was that their own Trasylol study, known as the I3 drug report, confirmed Mangano’s findings. That study, which analyzed a database of hospital patients treated with the drug, suggested that Trasylol could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. Bayer claims that this was an oversight, as the company’s management was not informed of the report until after the safety review.

In December 2006, the FDA updated the Trasylol label to include a black box warning - the agency’s strictest safety notice - stating that the drug placed patients at a high risk of kidney failure. Then in September 2007, even while agreeing with the assessment that Trasylol had a high risk of causing fatal side-effects, an FDA advisory panel voted that Trasylol should stay on the market.

Bayer faces nearly 80 lawsuits over Trasylol. As late as February, the company had maintained that it would eventually return Trasylol to the market. Yesterday, Bayer changed its tune, and said it was removing Trasylol supplies from all countries where it remained in the supply chain, except where local authorities wanted to keep it in the market for special access programs.

Senate Guts Bill to Regulate Industry Gifts to Doctors

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

A Senate bill under revision would require drug makers and medical device makers to publicly report gifts over $500 annually to doctors; the previous bill was more stringent and required all gifts valued over $25 be reported. Penalties for drug and device makers were reduced to fines of between $1,000 and $50,000 per violation, a change from the earlier proposal released last year with higher penalties from $10,000 to $100,000 per violation. The new version pushes back when the bill would go into effect, from 2008 to 2011 and also includes several changes sought by industry, including having the federal law preempt state laws requiring gift disclosure.

The bill would require drug and device makers to submit an annual report to the federal government, which would post it on the Internet. It is unclear if similar legislation would be introduced in the House.

Extravagant gifts given to doctors by industry, such as golf vacations and expensive dinners, have long been criticized as influencing doctors' prescribing habits. Industry says such gestures are part physician education; however, critics say these practices sully independent decision-making. "Transparency brings about accountability and benefits everyone, consumers most of all," said Senator Chuck Grassley, an Iowa Republican. Grassley is sponsoring the bill with Democrat Senator Herb Kohl of Wisconsin.

Some consumer groups disagree. “It is absolutely unacceptable. The whole idea of the registry is it provides a gift-by-gift annotation," said Peter Lurie, deputy director of Public Citizen's health research unit, who testified at an earlier hearing on the topic. "Penalties need to be significant otherwise these companies will treat it as a cost of doing business," Lurie said.

The Pharmaceutical Research and Manufacturers of America, a trade group for big drugmakers, had not taken a position when the first bill was announced, but now says it hopes any legislation not "inadvertently imply that these transactions are inappropriate" and is concerned about the burden placed on doctors and companies to report.

Last year, five medical device makers settled a U.S. Justice Department investigation over gifts and payment practices. Four of them—Zimmer Holdings Inc,, Johnson & Johnson's DuPuy Orthopedics, Smith & Nephew, and Biomet Inc.—agreed to pay a combined $311 million as part of the settlement. The fifth company, Stryker Corporation agreed to change its practices and was not fined.

Meanwhile, there is a growing movement underway among healthcare facilities to ban gifts to doctors by drug companies in an attempt to remove conflicts of interest during the prescription-writing process. SMDC Health System, the Duluth-based operator of four hospitals and 17 clinics across northeastern Minnesota and northwestern Wisconsin purged its facilities of all promotional trinkets with logos from drug companies. It took 20 shopping carts to remove all the products and SMDC plans on shipping the 18,718 items to the West African nation of Cameroon to the health system of the Evangelical Lutheran Church of Cameroon, which has three hospitals and several rural health centers where the advertised drugs are not available. Also, Kaiser Permanente, the country’s largest HMO, Veterans Affairs hospitals, and medical centers at several universities have recently adopted strict conflict-of-interest policies, such as gift bans.

Thousands Injured in Escalator, Elevator Accidents

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

Elevators and escalators offer a convenient way to travel from one building floor to another. But escalators and elevators are not without serious risks.

According to the U.S. Consumer Product Safety Commission (CPSC) approximately 90 billion people ride an escalator annually, from which, approximately 11,000 related injuries occurred in 2007. The CPSC reports that most of these accident injuries are the result of falls; however, 10 percent occur when hands, feet, or shoes are trapped in escalators, with the most common entrapment being to the foot. From 1992 to 2001 the CPSC reported 20 non-work related deaths of escalator passengers and 39 non-work related deaths of elevator passengers.

Soft-sided shoes are the most likely to get stuck and pose the possibility of injury on escalators. The CPSC has reports of 77 entrapment incidents since January 2006; half resulted in injury and all but two involved popular soft-sided flexible clogs and slides.

One of the most serious escalator risks, accounting for 20 percent of the injuries according to CPSC, is being caught in or between the bottom or top of an escalator, or between a moving stair and escalator sidewall. Young children are at particular risk of getting their hands, shoes, dangling shoelaces, or clothing caught in the escalator; adults' clothing can get trapped, as well. When an item gets caught in the moving elevator, it quickly gets sucked in with incredible force. There are numerous reports each year of children losing toes or fingers because of this risk.

Malfunctions in escalators and elevators also result in injury such as when an escalator malfunctioned and quickly sped up or reversed its direction of movement. Falling into an elevator shaft when an elevator call button is pushed and the doors open, but no elevator appears are common as are fall injuries on elevators from tripping when an elevator doesn't stop flush with the floor on which the door is opening.

And then there are the germs. Elevators and escalators are among the most germ-riddled public places. Elevator buttons, and particularly the popular first-floor button, are loaded with germs. According to Charles Gerba, Ph.D., professor of microbiology at the University of Arizona, "If you can, let someone else push it so you don't have to touch it." So are escalator handrails; Gerba advises to avoiding touching them as well, if possible. Holding onto the handrail reduces the risk of tripping on an escalator, so use a hand wipe, when possible.

To prevent escalator and elevator injuries, the CPSC suggests:

When stepping onto an escalator, ensure the step is flat and fully extended.
Do not ride an escalator with untied shoes.
On escalators, always face forward, hold the handrail, stand in the center of the step, do not lean on the side, and step off at the end of the ride.
Always hold children's hands on escalators; do not permit children to sit or play on the steps.
Do not bring children onto escalators in strollers, walkers, or carts.
Avoid the sides of escalator steps where entrapment can occur.
Know where the emergency escalator shutoff buttons are.
Before entering an elevator, ensure it's there and flush with the floor.

"Disease Mongering" Behind Blockbuster Requip Sales

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

Restless Legs Syndrome (RLS) is a relatively new term that has become somewhat ubiquitous following a multi-million dollar ad campaign spearheaded by drug maker GlaxoSmithKline. Given that the US Food and Drug Administration (FDA) has approved generic versions of Requip, RLS may have run its course, according to experts.

In 2005, the FDA approved the first drug for RLS—a twitching condition affecting the legs—launching a new household term, a new designer disorder, and a multi-million-dollar consumer ad campaign. Television ads hyping ropinirole hydrochloride, a drug originally used to treat Parkinson’s disease, sent patients to doctors demanding brand name, Requip. In under a year, Requip sales doubled from $165 million in 2005 to nearly $330 million in 2006. By last year, 4.4 million prescriptions were written, with sales of nearly $491 million, according to IMS health, an industry information agency.

Some call the RLS phenomenon an example of “disease mongering” in which promoters, such as drug companies, deliberately enlarge the market by promoting advertisement and convincing people they’re sick and need treatment. “You may have something that’s a normal condition,” said Dr. Lisa M. Schwartz, associate professor of medicine and community and family medicine at Dartmouth Medical School in Hanover, New Hampshire. “It makes you wonder whether there’s a disease to be treated.” Schwartz and her husband, Dr. Steven Woloshin, also at Dartmouth, say that drug company promotions, combined with uncritical media reporting, exaggerated the prevalence of RLS, leading to over-diagnosis and -treatment with powerful brain-altering drugs.

At least one sleep disorder specialist expects the focus on RLS to fade as rapidly as the Requip television commercials, which have been pulled. “Restless legs syndrome is a great example of a suddenly out-of-the-blue disease,” said Dr. Christopher J. Earley, an associate professor of neurology at Johns Hopkins University in Baltimore who treats RLS. Advertising created an overheated demand for diagnosis among consumers, while samples gave and easy answer for busy doctors, he said. "I would anticipate there would be something of a fall-off," Earley said.

That prediction alarms patient advocates who welcomed public attention—and all that drug industry funding; however, the generic switch leads to fewer ads, that should decrease patient demand for diagnosis and treatment, leaving only the most serious sufferers to weigh the benefits against potentially severe side effects. Doctors may not be inclined to prescribe the drug if the supply of brand-name samples disappears; generics won’t come with samples.

Ad decline depends largely on the makers of Mirapex, the second-leading drug approved to treat RLS, said Schwartz. “If it ends up that they pull back, the market might go down,” Schwartz said. “It’s usually a pretty sharp drop,” said Glaxo spokeswoman Mary Anne Rhyne.

Though drugmakers portrayed their products as a sure-fire cure for symptoms, the reality isn’t so certain. The range varied considerably in the trials, none of which lasted more than 12 weeks.

And, side effects can be considerable. The biggest problems included debilitating nausea, dizziness, and falling asleep during daily activities and studies link the drugs to compulsions such as gambling or sexual promiscuity. Even when the drugs do work, patients face problems of increased tolerance, which can cause augmentation, in which the drug increases RLS symptoms.

Immucor Gets FDA Warning Letter

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

Immucor, a maker of blood-testing supplies, has received a warning letter from the Food & Drug Administration (FDA) because of problems with its manufacturing procedures. The letter, dated May 2, said Immucor had 15 working days to make corrections. Should it fail, the FDA warned Immucor it could face license suspension and/or revocation, seizure and/or injunction.

The warning letter stems from an FDA inspection of Immucor in Norcross, Georgia, between January 8 and January 17, 2008. The FDA warning letter says the company allowed products into its inventory that had previously tested positive for microbial growth and were put on hold by the FDA. The blood reagent products were allegedly allowed back into Immucor's inventory before the FDA could complete its investigation. The FDA also claims Immucor "failed to establish and maintain procedures for implementing corrective and preventive action, including requirements for investigating the cause of nonconforming product and identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems."

The FDA acknowledged that it received written responses from Immucor that address the violations found during the January inspection. However, the agency said those responses did not provide sufficient detail to fully assess the adequacy of your corrective actions. For example, the FDA said the responses failed to discuss implementation of adequate quality assurance oversight to ensure prompt identification, correction, and follow up to problems associated with the manufacture of Immucor products.

Immucor Chief Executive Officer Gioaccino De Chirico said in a press release that the company was working to make sure it was in compliance with the FDA. "We take our regulatory responsibilities very seriously and are working diligently to respond to the FDA as soon as possible," De Chirico said. The press release also noted that the FDA had not recalled any Immucor products, or placed any limitations on the manufacture or distribution of any of our products.

Report Detailed Thimerosal Cover-up

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

In 2005, Robert F. Kennedy, Jr. published a lengthy examination of the history of Eli Lilly´s deadly mercury compound, thimerosal, in vaccines and its decades-long history of suppressed data about dangers to those receiving it, especially via injection. Following is some excerpted information from that paper. In the coming days, we will provide more information from this important paper on this dangerous health issue.

In June 2000, a group of government scientists and health officials met for a secret, highly-secluded meeting convened by the Centers for Disease Control and Prevention (CDC) to discuss issues over the safety of a variety of ubiquitous childhood vaccines routinely given to infants and young children. The CDC issued no public announcement of the session; 52 private invitations were sent to attendees including high-level CDC and Food and Drug Administration (FDA) officials, the top vaccine specialist from the World Health Organization (WHO) in Geneva, and representatives from every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth, and Aventis Pasteur. Meeting information was strictly "embargoed"; there would be no copying or removing documents.

According to CDC epidemiologist, Tom Verstraeten, who analyzed the CDC’s enormous cache of medical records of 100,000 children, thimerosal pointed to a dramatic increase in autism rates as well as many other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told the group, citing the staggering number of earlier studies indicating a link between thimerosal and speech delays, attention-deficit disorder (ADD), hyperactivity, and autism. Since 1991, when the CDC and the FDA recommended three additional vaccines laced with thimerosal be administered to extremely young infants—one within hour of birth—the estimated number of autism cases increased 15-fold, from one in every 2,500 children to one in 166 children.

Instead of alerting the public and removing thimerosal from the vaccine supply, the group worked on a cover up. According to transcripts obtained under the Freedom of Information Act, many attendees expressed concerned over how this would affect the vaccine industry’s. "We are in a bad position from the standpoint of defending any lawsuits," said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for Children in Delaware. "This will be a resource to our very busy plaintiff attorneys in this country." Dr. Bob Chen, head of vaccine safety for the CDC, expressed relief that "given the sensitivity of the information, we have been able to keep it out of the hands of, let’s say, less responsible hands." Dr. John Clements, vaccines advisor at the WHO, said, "perhaps this study should not have been done at all," adding "the research results have to be handled," and warning that the study "will be taken by others and will be used in other ways beyond the control of this group."

"You can play with this all you want," Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results "are statistically significant." Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado—whose grandson was born on the meeting’s first day—said, "My gut feeling? Forgive this personal comment: I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on.

Definity, Optison Black Box Warning Revised

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

The Food & Drug Administration (FDA) is watering down its warning about the possible risks of Definity and Optison, micro-bubble contrast agents used during ultrasounds of the heart to enhance images during a procedure called echocardiography. Though the labels of the contrast agents will continue to bear a black box warning about the risk of serious, and sometimes fatal cardiopulmonary reactions, the FDA has dropped a ban on giving the agents to acutely ill patients, such as those with congestive heart failure. The FDA also changed monitoring requirements for the drugs. The warning had called for monitoring all patients for 30 minutes after they receive the agents, but the new warning says only patients with pulmonary hypertension or unstable cardiopulmonary conditions need to be monitored.

Definity, marketed by Bristol Myers Squibb, and Optison, distributed by General Electric, consist of microscopic gas-filled spheres that sharpen ultrasound pictures. According to the FDA, there have been more than 200 reports of serious cardiac reactions involving the use of Definity and Optison. In October 2007, the FDA said that it knew of at least 11 deaths associated with the administration of either Definity or Optison. Four of those fatalities occurred either during infusion or within 30 minutes following the administration of the contrast agent. The FDA said that most of the serious but non-fatal reactions also occurred in the same time frame.

As a result of these reports, the FDA requested that the labeling on Definity and Optison be modified to include a black box warning about the cardiac problems associated with these agents. A black box warning is the FDA’s strictest type of warning. But many cardiologists questioned the restrictions the FDA placed on Definity and Optison. At least one prominent cardiologist said that the black box warning was added to the ultrasound contrast agents without a formal examination of the risks and benefits of using them.

The FDA's decision to drop the ban on micro-bubble contrast agents for acute patients came after a study was published that indicated the risk from the dyes might not be as serious as first thought. That study, which was presented at the April meeting of the American College of Cardiology, examined the clinical outcomes of nearly 18,000 patients who received ultrasound contrast agents during an echocardiogram and compared their results to those from a group of approximately 6,000 patients who did not need to receive contrast agents.

To test the safety of contrast agents, the researchers looked at the short-term (within 30 minutes of the infusion) and long-term (within 24 hours) outcomes and noted any serious adverse events or deaths. Of the nearly 18,000 individuals to receive the contrast agents, not one experienced an adverse event within 30 minutes. One death and three non-fatal heart attacks occurred within 24 hours; however these could not be attributed to the contrast agents.

According to The Wall Street Journal, cardiologists are applauding the FDA's move. The previous restrictions meant physicians had to used other diagnostic methods — including angiograms and an ultrasound technique that involves going in through the patient’s throat — that come with their own risks.

Beta Blockers Increase Surgery Risk

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

A new study on the effects of beta blockers and surgical procedures reveals that patients given a beta blocker—beta blockers are a type of blood pressure drug—to reduce heart risks prior to surgery, were one-third more likely to die within a month and also had double the risk of stroke compared with those who received a placebo, or a dummy pill. The Canadian study appears in the journal, Lancet. The study is the largest, most rigorous to date that reviews the effects of beta blockers in reducing surgery-related risks; other, smaller studies provided mixed results. “There is a real potential that beta blockers are causing serious harm in the surgical setting,” said Dr. P.J. Devereaux of McMaster University in Ontario, who conducted the study. “If my mother was undergoing surgery and given a beta blocker, I would be extremely upset based on this evidence,” Devereaux added.

It has been long believed that taking a beta blocker prior to major surgery protects the patient from heart risks related to the surgery’s stress. These new findings challenge that theory. Surgery often raises levels of a stress hormone known as catecholamine. Catecholamine increases pressure and heart rates. “Beta blockers block the effects of increased catecholamines, so the physiological rationale would say they would be beneficial to people,” Devereaux said.
Devereaux and colleagues tested this idea, studying over 8,000 patients in 23 countries at 190 hospitals who were undergoing major surgery unrelated to the heart. Those studied had or were at risk for clogged arteries. Half were given the beta blocker metoprolol—sold by AstraZeneca as Toprol XL—two to four hours before and 30 days following surgery. The other half received a placebo.

The doctors were looking for heart complications such as heart-related death, non-fatal heart attacks, or a heart-stopping event known as cardiac arrest in which the person survived. The study revealed that those who took the drug had fewer heart attacks and abnormal heart rhythms; however, they were more likely to die or have a stroke. For every 1,000 people with similar risks undergoing non-cardiac surgery, the drug could prevent 15 people from experiencing heart attack, three from requiring a shock to restore a normal heartbeat, and seven from developing a type of heart rhythm known as atrial fibrillation.

That said, eight more people would die, five would have a stroke, 53 percent would have abnormally low blood pressure, and 42 percent would have an abnormally slow heart beat. “This is an important study because, although the beta blocker reduced the number of heart attacks that occurred following surgery, it caused more strokes, thus—on balance—causing more harm than good,” Peter Weissberg, medical director of the British Heart Foundation, said. “This is why it is so important to undertake large clinical trials rather than assuming drugs will only do what is expected of them,” Weissberg added.

Devereaux, initially presented his findings at the November American Heart Association meeting and expects this study to create debate over the wisdom around patients taking beta blockers prior to a major surgery. “It is telling us something we didn’t realize in the past,” he said.

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.