Yourlawyer.com (Enbrel News)

FDA Releases More Humira, Enbrel, Remicade Info

Tue, 01 Sep 2009 00:00:00 -0700

Federal regulators have released more information regarding cancers associated with drugs like Humira, Enbrel, and Remicade. Last month, the Food & Drug Administration (FDA) had mandated that the Black Box Warnings on these drugs - known as TNF blockers - highlight their possible association with lymphoma and other cancers in children and teens.

In a supplementary "Question and Answer" document released yesterday, the FDA provided more information on the types of cancers seen in children and teens treated with TNF blockers. According to the document, the following types of pediatric malignancies were reported between 2001 and 2008:

Hepatosplenic T-cell lymphoma, 10 cases
Non-Hodgkin’s lymphoma, 7 cases
Hodgkin's lymphoma, 6 cases
Leukemia, 6 cases
Malignant Melanoma, 3 cases
Thyroid cancer, 3 cases
Basal cell carcinoma, 1 case
Lymphoma and AML, 1 case
Leiomyosarcoma, 1 case
Nephroblastoma, 1 case
Renal cell carcinoma, 1 case
Metastatic hepatocellular cancer, 1 case
Malignant mastocytosis, 1 case
Neuroblastoma, 1 case
Colorectal cancer, 1 case
Yolk sac tumor, 1 case
Myelodysplasia, 1 case
Bladder cancer, 1 case

These 48 cases of pediatric cancers included both U.S. (32) and non-U.S. (16) cases. According to the document, 31 cases of malignancy were reported in children taking Remicade, including 10 cases of hepatosplenic T-cell lymphoma in patients with inflammatory bowel disorder; 15 cases of malignancy in children receiving Enbrel were reported; and two cases of malignancy in children receiving Humira were reported. The FDA also said that the 48 cases of pediatric cancers did not confirm a dose association with malignancy.

Last month, the FDA had said that there were 11 deaths among the 48 cases of cancer. The causes of death included hepatosplenic T-cell lymphoma (9 cases) and T-cell lymphoma (1 case). In the remaining case, the patient died from sepsis after achieving remission of the lymphoma.

In children, TNF blockers are used to treat rheumatoid arthritis, inflammatory bowel disorder and Crohn’s disease. They are also approved to treat a variety of chronic, inflammatory and autoimmune system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF blockers work by neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue.

The FDA had been studying the link between the pediatric uses of TNF blockers and cancer since 2008.

Group Calls For Study Of Arthritis Drugs

Wed, 01 Jul 2009 00:00:00 -0700

Arthritis and other autoimmune medications have made recent headlines over a variety of issues including links to serious opportunistic fungal infections and cancer. Now, as part of President Barack Obama’s health care overhaul, a review of arthritis medications manufactured by Wyeth, Abbott Laboratories, and Johnson & Johnson (J&J) might warrant some additional scrutiny, reports Bloomberg.com.

Recently, we reported that federal regulators ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The U.S. Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of its Amendments Act of 2007.

Drugs used to treat autoimmune disorders were also under investigation by federal regulators amid concerns they might be linked to cancer in children and young people. The drugs are known as tumor necrosis factor (TNF) blockers, and are used to treat various forms of arthritis including juvenile idiopathic arthritis and Crohn’s disease. Enbrel, marketed by Wyeth and Amgen and Remicade sold by Schering-Plougshare among these drugs which are TNF blockers and which impede the action of a substance made by the body’s immune system called TNF. People with an autoimmune disease, such as rheumatoid arthritis, have too much TNF in their bodies.

Arthritis drugs generated nearly $17 billion in 2008 for drug giants Amgen, Wyeth, Abbott, and J&J, noted Bloomberg. Advisors external to the Department of Health and Human Services (HHS) said studies should compare drug efficacy for Remicade (J&J) and Enbrel (Wyeth and Amgen), specifically, said Bloomberg.

As part of the health system overhaul, President Obama has slated a little over $1 billion under the U.S. economic-stimulus plan to study medical treatment efficacy, said Bloomberg. According to a report just issued by the Institute of Medicine—an arm of the National Academy of Sciences—it recommends how approximately $400 million of the allocation to HHS should be used, according to Bloomberg. Last year, the U.S. spent $2.4 trillion on health care, which is greater than any other industrialized nation, said Bloomberg, noting that the U.S. also has the highest rates of both chronic disease and infant mortality, citing the report.

It has long been known that people taking TNF blockers run a risk of developing opportunistic infections, and the prescribing information for the drugs has included this information. But the FDA says that current warnings are inadequate. The labeling order came after the FDA reviewed 240 reports of histoplasmosis; an infection caused by the fungus Histoplasma capsulatum, in patients treated with Enbrel, Humira, or Remicade. In at least 21 cases, health care professionals did not initially recognize histoplasmosis, antifungal treatment was delayed, and 12 patients died.

The FDA also reviewed TNF blockers over a possible link to cancer. Last June, the agency said it was investigating about 30 reports of leukemia, lymphoma, and other cancers in children and young adults. Approximately half of the reports were lymphomas, cancer of the immune system cells, which were both Hodgkin’s and non-Hodgkin’s based. In April, the FDA had Amgen and Wyeth include a new black box warning on the Enbrel label stating that the drug has been associated with serious infections, including tuberculosis (TB) in some patients. The Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, in which TB was observed in about 200 people.

Simponi Carries Risk of Possibly Fatal Fungal Infections

Fri, 29 May 2009 00:00:00 -0700

Simponi, a new rheumatoid arthritis drug, can cause severe and potentially fatal fungal infections, according to a new warning released yesterday by the Food & Drug Administration (FDA). Because of this risk, the agency said that when making a decision to use Simponi, doctors must balance the potential benefits with the potential risks of therapy based upon a patient’s individual need.

Simponi is one of a class of drugs known as TNF-alpha blockers. Such medications work by suppressing the immune system. Other drugs in this class include Humira, Cimzia, Enbrel, and Remicade. Simponi was only approved in April as a treatment of adult patients with: moderate to severe rheumatoid arthritis in combination with methotrexate, psoriatic arthritis (either alone or in combination with methotrexate), and ankylosing spondylitis.

It has long been known that people taking TNF-alpha blockers run a risk of developing opportunistic infections, including histoplasmosis, an infection caused by the fungus Histoplasma capsulatum. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF-alpha blockers. Last fall the FDA ordered the makers of TNF-alpha blockers to strengthen the existing warnings about opportunistic fungal infections linked to the drugs.

A "Dear Healthcare Professional" letter issued by Centocor Ortho Biotech, Inc. advises doctors to carefully review Simponi's prescribing information, which includes important information about the risk of serious infections including TB and invasive fungal infections, such as histoplasmosis, in a Boxed Warning.

The letter also warns that invasive fungal infections are not consistently recognized in patients taking TNF-alpha blockers. This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death. For patients who reside or travel in regions where mycoses are endemic (eg, Ohio and Mississippi River valleys and southwestern United States), invasive fungal infection should be suspected if they develop a serious systemic illness, the letter warns.

The letter also advises that patients be encouraged to report signs of infection and be closely monitored during and after treatment with Simponi and other TNF-alpha blockers for the development of invasive fungal infection. Signs and symptoms of such disorders include fever, malaise, weight loss, sweats, cough and dyspnea, pulmonary infiltrates on X-ray or serious systemic illness. TNF-alpha blockers should be discontinued in patients who develop such symptoms, and they should undergo a complete diagnostic workup. Once the infection has cleared, use of Simponi and other TNF-alpha blockers may be restarted based on a reevaluation of risks and benefits.

Humira, Cimzia, Enbrel and Remicade to Bear Stronger Infection Warnings

Thu, 04 Sep 2008 00:00:00 -0700

Federal regulators have ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of the Food and Drug Administration Amendments Act of 2007.

Humira, Cimzia, Enbrel and Remicade are known as tumor necrosis factor (TNF) blockers. They are used to treat rheumatoid arthritis, Crohn's disease and other conditions. The drugs work by suppressing the immune system. It has long been known that people taking TNF blockers run a risk of developing opportunistic infections, and the prescribing information for the drugs has included this information. But now the FDA says that current warnings are inadequate.

The FDA's order came after the agency reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.

The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.

The agency has given the makers of Humira, Cimzia, Enbrel and Remicade 30 days to submit the required safety labeling changes, including strengthened warnings and revisions to the Medication Guides, or to provide a reason why they do not believe labeling changes are necessary. If they do not submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.

The FDA is also reviewing TNF blockers over a possible link to cancer. In June, the agency said it was investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin’s and non-Hodgkin’s based.

In April, the FDA had Amgen and Wyeth include a new black box warning on the Enbrel label stating that the drug has been associated with serious infections, including tuberculosis in some patients. The Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

Despite Enbrel Risks, FDA Panel Recommends it for Psoriasis in Children

Thu, 19 Jun 2008 00:00:00 -0700

A Food & Drug Administration (FDA) advisory panel has recommended that the agency approve Enbrel to treat moderate-to-severe psoriasis in children, despite concerns that the drug has been linked to cancer and serious infections, including tuberculosis. Enbrel is already approved to treat psoriasis and rheumatoid arthritis in adults and juvenile arthritis in children.

Enbrel is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body’s immune system called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. The FDA first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include psoriasis and other conditions.

In April, the FDA requested a new black box warning for the Enbrel label stating that the drug has been associated with serious infections, including tuberculosis in some patients. The new Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

Earlier this week, the FDA said it would seek a stronger label on the drug to include warnings that its use could lead to children's deaths as well as moderate-to-severe infections. Reports submitted to the agency linked Enbrel to infections that sometimes led to hospitalization and death. Of the 14 deaths recorded by the FDA, more than half were in children taking Enbrel for arthritis, while the others were among children taking the drug for unapproved uses. The FDA scientists also recommended that stronger warnings about the possibly-fatal infections be added to Enbrel’s label.

The FDA is also reviewing Enbrel and other TNF blockers over a possible link to cancer. The FDA is investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin’s and non-Hodgkin’s based.

Ultimately, the FDA advisory panel voted 7-5 with one abstention to recommend expanding Enbrel's approval. The panel of outside medical experts said that Enbrel appears effective in treating psoriasis in children, but it expressed concern about whether the medicine will increase risks of malignancy and serious infections such as tuberculosis. Some panel members expressed concern about giving a drug with unknown side effects to children with only moderate psoriasis. However, they did not recommend that Enbrel be approved only to treat severe psoriasis, saying that might limit whether insurance companies will cover the drug's costs.

The FDA is not bound to follow the recommendations of advisory panels, but the agency usually does so.

Enbrel Infection Risk Cited

Mon, 16 Jun 2008 00:00:00 -0700

Enbrel has been linked to sometimes deadly infections when administered to children, casting doubts that the Food & Drug Administration (FDA) will approve the Amgen and Wyeth drug to treat severe psoriasis in children. Enbrel is already approved to treat psoriasis and rheumatoid arthritis in adults and juvenile arthritis in children.

Enbrel is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body’s immune system called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. The FDA first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include psoriasis and other conditions.

In April, the FDA had Amgen and Wyeth include a new black box warning on the Enbrel label stating that the drug has been associated with serious infections, including tuberculosis in some patients. The new Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

Today, FDA scientists expressed concern about broadening the drug's approval, citing reports of dangerous side effects in children who have already taken the drug. Reports submitted to the agency linked to infections that sometimes led to hospitalization and death. Of the 14 deaths recorded by the FDA, more than half were in children taking Enbrel for arthritis, while the others were among children taking the drug for unapproved uses. The FDA scientists also recommended that stronger warnings about the possibly-fatal infections be added to Enbrel's label.

On Wednesday, an FDA advisory panel will vote on whether Enbrel should be cleared for the new use. The FDA is not required to follow the panel's advice, though it usually does.

The FDA is also reviewing Enbrel and other TNF blockers over a possible link to cancer. The FDA is investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin’s and non-Hodgkin’s based.

Humira, Enbrel, Remicade Being Investigated for Cancer Link

Wed, 04 Jun 2008 00:00:00 -0700

Humira and other drugs used to treat autoimmune disorders are being investigated by federal regulators amid concern that they might be linked to cancer in children and young people. The drugs are known as tumor necrosis factor (TNF) blockers, and are used to treat various forms of arthritis including juvenile idiopathic arthritis and Crohn's disease.

In addition to Humira, which is made by Abbott Laboratories, four other TNF blockers are currently on the market in the US. They are Enbrel, marketed by Wyeth and Amgen; Remicade sold by Schering-Plough; and Cimizia, made by UCB of Belgium. TNF blockers impede the action of a substance made by the body’s immune system called TNF. People with an autoimmune disease, such as rheumatoid arthritis, have too much TNF in their bodies.

The FDA said its review will focus on Humira, Enbrel and Remicade. Remicade is approved for use in children with Crohn's disease. Enbrel and Humira are approved to treat children with juvenile rheumatoid arthritis, according to the FDA. The FDA is requiring the maker of Cimzia to conduct a study to assess long-term risks of the product, including lymphoma and other cancers. This study will begin in 2009 and take about 10 years to complete. All of the labels for the drugs currently address the possible risk of cancer when taking the drug.

The FDA is investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin's and non-Hodgkin's based.

The FDA has requested that makers of TNF blockers approved for use in children and young adults supply information about all reported cases of cancer among patients in these age groups taking the drugs. The FDA has also asked health-care professionals to weigh the possible risks against the benefits when prescribing TNF blockers.

In addition to the possible cancer risk, TNF blockers have been associated with an increased risk of some infections. In May, Enbrel had its label modified to include a black box warning - the FDA's strictest safety alert - about its association with serious infections, including tuberculosis. The warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

Enbrel Black Box Warns of Tuberculosis Risk

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

Enbrel, a drug used to treat psoriasis that has been associated with serious infections, including tuberculosis in some patients. Enbrel's labeling will now carry the Food & Drug Administration's (FDA) strictest safety notice, a black box warning.

Enbrel, manufactured by Amgen and Wyeth, is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body’s immune system called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. The FDA first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include psoriasis and other conditions.

The new Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people. Approximately 14,000 Americans were diagnosed with tuberculosis last year. Tuberculosis is a bacterial lung infection, and according to the federal Centers for Disease Control and Prevention (CDC), people with weakened immune systems are more likely to contract the disease. Enbrel and other medicines in the same class work by blocking a type of immune system protein.

The new Enbrel label says that patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to starting and during treatment with Enbrel. In cases of latent tuberculosis infection, treatment should be initiated prior to therapy with Enbrel. The Enbrel black box warning also says some patients who tested negative for latent tuberculosis prior to receiving Enbrel have developed active tuberculosis. The black box warns physicians to monitor patients receiving Enbrel for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection.

The Enbrel Patient Package Insert is also being converted to a Medication Guide. The Medication Guide is designed to provide important patient safety information and increase the awareness about the proper use of Enbrel. The companies said that the Medication Guide will be distributed when a prescription for Enbrel is dispensed in the US.

More Trouble for Amgen, as Enbrel Gets Stronger Infection Warnings

Tue, 18 Mar 2008 00:00:00 -0700

Enbrel, a popular treatment for rheumatoid arthritis and psoriasis, is getting stronger warnings about serious infections associated with its use. Yesterday, Amgen and Wyeth added the strongest U.S. Food and Drug Administration (FDA) warning—the “black box”—to the prescribing information Enbrel. The warning will highlight the risk of infections, including tuberculosis. The information, which is currently in boldface, must now be highlighted inside a boxed border Amgen and Wyeth said.

In global studies of over 20,000 patients taking Enbrel, tuberculosis was observed in about 200 people. Approximately 14,000 Americans were diagnosed with tuberculosis last year. Tuberculosis is a bacterial lung infection, and according to the federal Centers for Disease Control and Prevention (CDC), people with weakened immune systems are more likely to contract the disease. Enbrel and other medicines in the same class work by blocking a type of immune system protein. The prescribing information warns about new cases and reactivated latent infections, the companies said.

In addition, Moody’s Investors Service placed Amgen’s long-term and short- term debt ratings under review for a possible downgrade. The rating action follows last week’s recommendation by an FDA advisory panel for additional restrictions on the use of Amgen’s anemia drugs, including its top-seller Aranesp, in cancer patients, Moody’s said yesterday. Interim results from a recent, independent study involving breast cancer patients found Aranesp did not enhance the effect of chemotherapy prior to surgery. The study involved over 700 patients and evaluated whether Aranesp prevented anemia and augmented the therapeutic effects of chemotherapy regimens.

Amgen also reported that participants who received Aranesp had numerically more deaths and reports of tumor growth than control group patients. Preliminary, long-term, follow-up data revealed more deaths in the group receiving Aranesp, with more tumor progression events versus the control group. The entire drug class has been under a microscope as debates rage over whether anemia drugs increase the risk of heart attack and stroke, and whether they may play a role in fueling the growth of cancer. Aranesp labels were updated to include revised dosage guidelines and information on the drugs’ cardiovascular side effects following the FDA’s ordering of a black box warning about cardiovascular problems and other safety.

About $11.2 billion of Amgen’s A2 long-term and Prime-1 short-term rated debt will be affected, the rating agency said. Aranesp sales fell at least 50 percent last year after the medicines were tied to greater risks of heart attacks, stroke, and death at high doses. Reduced demand caused Amgen to lose $29 billion in market value last year. “Amgen’s key credit ratios may not have sufficient cushion to absorb any further decline in Aranesp sales at the current rating level,” Moody’s said in the statement. Enbrel was the world’s fifth-best-selling drug last year, with $5.28 billion in revenue. Wyeth and Amgen’s drug competes with Johnson & Johnson’s Remicade, which generated $5.21 billion.

Enbrel, an injection, is designed to work by soaking up an excess inflammatory protein called TNF. The protein can attack the skin and lead to psoriasis, or it can attack joints, causing rheumatoid arthritis, researchers say.

Enbrel Marketing Focus of New Jersey Amgen Probe

Fri, 18 Jan 2008 00:00:00 -0800

The marketing of Enbrel is the now the subject of an investigation by the New Jersey Attorney General’s Office.   The Enbrel probe will look into allegations that Amgen, the maker of the psoriasis drug, instructed Enbrel sales representatives to violate patient confidentiality rules and engage in the illegal promotion of off-label uses of the drug in an effort to increase sales. According to a press release from the New Jersey Attorney General, a subpoena was issued to Amgen for “a comprehensive array of documents and information” related to the sale, marketing and prescribing of Enbrel.

The New Jersey Attorney General’s office began its Enbrel probe after two former Amgen employees charged that the drug maker engaged in illegal marketing practices.   Elena Ferrante of Montvale, New Jersey, who was terminated by Amgen in 2005, and Mark Engelman of Laguna Niguel, California, who resigned from the company last year, is suing Amgen for lost wages and other compensation after refusing to participate in improper promotion of Enbrel. Enbrel is approved only for treating moderate to severe psoriasis, but the former employees say they were expected to engage in promotion efforts that sometimes included patients with less severe disease. Enbrel has not been approved for patients with less severe psoriasis.

Ferrante and Niguel claim that Amgen sales reps were instructed to go into dermatologists’ offices and get permission to go through files to identify patients with psoriasis based on the diagnostic coding system insurers use for reimbursement. The representatives were told to then call insurers covering patients with mild psoriasis to seek approval for reimbursement of Enbrel, which costs $20,000 to $50,000 per year, depending on the severity of the sometimes-painful skin condition. When calling the insurance companies, they were instructed not to identify themselves as Amgen sales reps. Rather, they allege that they were told to say that they were “calling on behalf of Dr. So-and-So”.

The Health Insurance Portability and Accountability Act (HIPAA) contains very tough sanctions for disclosing someone’s health information — up to 10 years in jail and a $250,000 fine if the information was transferred or used for commercial advantage. Promoting Enbrel to treat less severe psoriasis could also land Amgen in hot water. Although doctors are free to prescribe approved drugs in any manner they see fit, it is illegal for drug companies to actively promote such off label uses.

Enbrel blocks the action of a substance made by the body’s immune system called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies.   The Food & Drug Administration first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include severe psoriasis and other conditions.

Enbrel Marketing Scheme Violated HIPAA, Former Amgen Employees Claim

Fri, 11 Jan 2008 00:00:00 -0800

Two former Amgen employees are charging that the drug maker engaged in illegal marketing practices in an attempt to increase sales of the drug Enbrel. The former Amgen salespeople claim that they were encouraged by the company to illegally access patient records to induce insurance carriers to pay for Enbrel, an extremely pricey drug.

According to the drug’s website, Enbrel is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body's immune system called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. The Food & Drug Administration (FDA) first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include psoriasis and other conditions.

Elena Ferrante of Montvale, New Jersey, who was terminated by Amgen in 2005, and Mark Engelman of Laguna Niguel, California, who resigned from the company last year, is suing Amgen for lost wages and other compensation after refusing to participate in improper promotion of Enbrel. Enbrel is approved only for treating moderate to severe psoriasis, but the former employees say they were expected to engage in promotion efforts that sometimes included patients with less severe disease.

Ferrante and Niguel claim that Amgen sales reps were instructed to go into dermatologists' offices and get permission to go through files to identify patients with psoriasis based on the diagnostic coding system insurers use for reimbursement. The representatives were told to then call insurers covering patients with mild psoriasis to seek approval for reimbursement of Enbrel, which costs $20,000 to $50,000 per year, depending on the severity of the sometimes-painful skin condition. When calling the insurance companies, they were instructed not to identify themselves as Amgen sales reps. Rather, they allege that they were told to say that they weres “calling on behalf of Dr. So-and-so.”

The representatives also allege that the Amgen sales force was told to write letters on behalf of doctors, seeking advance approval so doctors could write prescriptions for Enbrel. Doctors writing prescriptions would benefit from frequent patient visits to have the drug injected.

If proved, the allegations could cause Amgen serious trouble. The Health Insurance Portability and Accountability Act (HIPAA) contains very tough sanctions for disclosing someone's health information — up to 10 years in jail and a $250,000 fine if the information was transferred or used for commercial advantage. Physicians who agreed to participate in the alleged Enbrel marketing scheme could also be in trouble.

An attorney for the two former Amgen employees told the Associated Press that the New Jersey attorney general's office is investigating and has interviewed Ferrante. According to the Associated Press, that office would not confirm or deny any investigation of Amgen or Enbrel. However, last fall, the New Jersey attorney general convened a task force to investigate how the doctor-patient relationship is affected by the widespread practice of drug and medical device makers giving physicians gifts and fees for researching, consulting and speaking about their products.

Arthritis Drug Enbrel Linked to Serious Side-effects

Tue, 17 Oct 2000 00:00:00 -0700

Enbrel, (etanercept) used by more than 70,000 rheumatoid arthritis patients in the United States, may be responsible for serious blood reactions and stimulate nervous system disorders. Reports of ten occurrences, half of which were fatal, have led the drug’s manufacturer, Immunex Corp., to issue a cautionary statement about Enbrel’s use.

The company warned that a few patients using Enbrel have been diagnosed with neurological and hematological disorders. In a letter to healthcare professionals, the company said, “Rare cases of central nervous system disorders such as multiple sclerosis, myelitis and optic neuritis have been reported in patients with rheumatoid arthritis who have received Enbrel therapy.” Furthermore, the letter noted some “rare reports of pancytopenia, including aplastic anemia.” Both are significant hematological events.

However, the Food and Drug Administration was quick to point out that there is no proof that Enbrel actually causes or worsens symptoms of demylelinating, or nervous system, diseases such as Multiple Sclerosis, (MS) nor does it cause dangerous anemia.

Specifically, the reports note 11 cases of nervous system disorders and 10 cases of blood-cell shortages that significantly increases the risk of fatal infections. These problems are rare in comparison to the number of people who are safely using Enbrel for the effective treatment of rheumatoid arthritis pain, and to slow the progression of this joint disease.

In a public statement the company commented that: “In the majority of these cases, there was a close temporal relationship between the start of treatment with etanercept (Enbrel) and the occurrence of hematological disorders (range two weeks to five months). Since the clinical experience with etanercept is still limited as this product has only recently been marketed, onset after this period cannot be ruled out.”

In Europe, where the drug has been available since February 2000, the European Medicines Evaluation Agency also urged doctors to exercise caution when prescribing the medication. They stressed the need to inform patients about the possible signs and symptoms of blood disorders and infections. The drug company’s representative in the U.K., also noted that “Other medications can induce this type of complication.”

However, the statement advised that if patients “develop signs and symptoms suggestive of blood dyscrasias or infection (e.g. persistent fever, bruising, bleeding, pallor,) while on Enbrel, they should seek immediate medical attention.”

The Dark Side of an Arthritis Breakthrough

Wed, 30 Aug 2000 00:00:00 -0700

With her quick laugh and endless charm, it's easy to forget just how lousy Caryn Goldstein can feel. At 33, she suffers from both rheumatoid arthritis and Crohn's disease, two inflammatory conditions that leave her achy and exhausted.

"I've tried just about every drug," she says, adding that nothing has given her much relief.

She had high hopes that Remicade (generic name infliximab) would be different. The new drug, which blocks a pain-causing nuisance known as tumor necrosis factor (TNF), has proven beneficial for both Crohn's and rheumatoid arthritis. A perfect fit. But for Goldstein, the drug backfired.

The series of shots left her disoriented, and for a week afterward she felt like she had a terrible case of the flu. Then at a hospital last October in Kentucky, she looked up from the needle in her arm to see her nurse's eyes turn "as wide as saucers."

A bright rash had spread almost instantly across Goldstein's face. Fearing that Remicade could put her at risk for deadly anaphylactic shock, she and her doctor decided that was enough.

"Remicade was a disaster for me," says Goldstein.

Many patients have experienced quite the opposite. Indeed, Remicade and other drugs that interfere with TNF are some of the most impressive pain-relief missionaries to come around in years, often providing help to those who have exhausted all other options.

"These drugs are the miracle drugs of the decade," says John Cush, MD, an arthritis specialist at Presbyterian Hospital in Dallas. "The effects can be just dramatic."

But doctors are noticing a dark side as well. Although problems are rare, anti-TNF drugs are increasingly linked to unusual and distressing side effects. On August 17th, the Food and Drug Administration (FDA) will meet with their arthritis advisory board to discuss the latest concerns.

"I have no idea how this will shake out," says one former FDA board member.

Adverse events reports filed with the FDA put these drugs in the vicinity of a number of serious and potentially deadly side effects. The reports, which were made available to Medscape Health through a Freedom of Information Act request, are hopelessly incomplete. They do not, for example, place blame on a specific drug: Rather, they simply show that a drug was taken around the time of a severe reaction.

Nevertheless, the FDA relies on these documents to issue new warnings, or worse--to determine if a drug is dangerous enough to be withdrawn. Some adverse events found over a 2-month period:

From September 1 to December 31st of 2000, 22 patients died while taking Enbrel (etanercept) and 18 needed emergency care at a hospital. Remicade, which has greater sales overall, was listed in 48 deaths and nearly 100 life-saving interventions to prevent "permanent damage." Many patients were taking various drugs in addition to anti-TNF ones. But the only treatment listed for one 9-year-old girl who needed to be hospitalized was Enbrel. The drug is approved for use in juvenile rheumatoid arthritis.

At least five patients developed lupus after taking Remicade, including one 43-year-old man. Although there is no conclusive evidence that these drugs cause lupus, experts say that laboratory experiments suggest a possible link. At a recent medical conference in the Czech Republic, French researchers announced that two of their patients developed lupus soon after starting Enbrel.

Warnings that the FDA issued earlier on anti-TNF drugs continue to show up in the latest reports, including nervous system disorders and deadly infections like sepsis. Disturbing new cases of tuberculosis show up as well. Officials say that as many as 60 patients worldwide have developed tuberculosis while taking Remicade, and nearly a dozen while taking Enbrel.

Experts familiar with these reports say that it nearly impossible to tell how dangerous Enbrel and Remicade might be. Arthritis patents are sick to begin with, and they are likely to take various immune-suppressing treatments, which could be the real trouble.

"A lot of times when you get these reports, it just has very incomplete data," says Leslie Garrison, senior vice president of clinical research for Immunex, the company that markets Enbrel. "We've been doing our homework and it appears that all these rare events are not outside the expected rates."

Long-term clinical trials show that TNF agents are overwhelmingly safe for the 5 years they have been looked at. But experts say that such studies may give an incomplete picture as well.

"You only use the most healthy patients for a study," says one researcher who took part in a TNF drug trial and asked not to be named. Stacking the deck may make it hard to tell how others will do, especially if they are elderly or suffer from other conditions besides arthritis. It's left to random adverse event reports to fill in the blanks.

"Any death is a concern," the researcher says.

And there is reason to suspect that there may be more problems than what is recorded.

"Most doctors don't report this stuff," says Cush. "It's a pain in the ass."

He estimates that the real number of adverse events related to these drugs could be ten times as high as the FDA suggests. Caryn Goldstein, for one, says authorities were not told about her bad reaction to Remicade.

"I didn't know you could do this in cases like mine," she says.

Should Enbrel and Remicade be withdrawn? Hopefully not, experts say. All drugs come with an inherent risk, and rheumatologists have toiled for years with dodgy treatments because they had little else. Anti-TNF agents offer a more precise way to attack arthritis and they show a startling potential to turn the disease around.

"These drugs are having profound effects on the joints," say Jack Klipple, the scientific advisor for the Arthritis Foundation.

Unless TNF agents are more dangerous than expected, experts urge doctors and patients to keep an open mind.

"It's really an individual decision," say Cush. "Are they willing to accept the known and unknown risks for a better quality of life?"

Enbrel Multiple Sclerosis Side Effects Injury Attorney

Wed, 30 Aug 2000 00:00:00 -0700

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Injured By Enbrel?

The FDA approved Enbrel (Generic: Etanercept), which is used to treat Rheumatoid Arthritis, on June 6, 2000. Enbrel is a popular drug used by over 70,000 Rheumatoid Arthritis patients in the United States. On October 17, 2000, Immunex Corp. the manufacturer of Enbrel stated that the drug might cause serious blood reactions and stimulate nervous system disorders. Reports of 10 such incidences, half of which were fatal, prompted this action by Immunex.

The central nervous system disorders that Enbrel patients encountered include Multiple Sclerosis, Myelitis and Optic Neuritis, Pancytopeni and Aplastic Anemia. In a public statement in October 2000, Immunex commented that, "In the majority of these cases, there was a close temporal relationship between the start of treatment with Enbrel and the occurrence of hematological disorders (range two weeks to five months). Since the clinical experience with Etanercept is still limited as this product has only recently been marketed, onset after this period cannot be ruled out."

In Europe, where the drug has been available since February 2000, the European Medicines Evaluation Agency also urged doctors to exercise caution when prescribing the medication. They stressed the need to inform patients about the possible signs and symptoms of blood disorders and infections.

On February 15, 2002 researchers in Chicago reported that four (4) women with Rheumatoid Arthritis developed symptoms of the autoimmune disease Systemic Lupus Erythematosus (SLE) after taking the Enbrel. The patients developed symptoms including face reddening and body rash while taking the drug, but the symptoms disappeared when the drug was halted, according to a research letter in the February 16, 2000 issue of The Lancet.

If you or a loved one took Enbrel and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.