Disability Law

The American Association for Justice has issued this news release:

Study indicates many biological medicines trigger safety warnings after coming on the market.

USA Today (10/22, Rubin) reports that about "one in four recently approved products in a relatively new class of medicines needed some type of regulatory action because of safety issues that arose after they came on the market," according to a study published in the Oct. 22/29 issue of the Journal of the American Medical Association. Thijs Giezen, Pharm.D., of the University of Utrecht in the Netherlands, and colleagues, arrived at this conclusion after focusing "on 174 medicines called biologicals that were approved in" the U.S. and/or the EU "between January 1995 and June 2007."

In the Los Angeles Times (10/21) Booster Shots blog, Shari Roan explained that "biological products are made from natural sources, such as human or animal tissues or microorganisms," and "include enzymes, antibodies, growth factors, hormones, and vaccines." Biological products "represented 24 percent of the new drug approvals in the U.S." between 2003 and 2006. Because of that, it is important to understand their risks and benefits.

"Many biotech drugs affect the immune system, raising a risk that the drug may alter its function in unintended ways," Bloomberg News (10/22, Cortez) points out. "The alerts...stemmed mostly from injection site reactions, infections, immune system disorders, and cancers." Specifically, "infections triggered safety alerts for the arthritis medicines Enbrel (etanercept), sold by Amgen Inc.; Johnson & Johnson's Remicade (infliximab); and Abbott Laboratories' Humira (adalimumab)." In addition, ImClone System Inc.'s Erbitux (cetuximab) "got a warning for its ties to cardiopulmonary arrest, while Genentech Inc.'s Herceptin (trastuzumab) was linked to infusion-site reactions and lung toxicity." Meanwhile, "Rituxan (rituximab), which Genentech sells with Biogen-Idec Inc. for lymphoma, caused rare cases of...progressive multifocal leukoencephalopathy (PML)," a condition that "is also tied to Biogen's multiple sclerosis drug Tysabri (natalizumab)."
        According to the AP (10/22, Tanner), other "drugs under examination are Genentech Inc.'s psoriasis drug Raptiva (efalizumab), which just last week the Food and Drug Administration (FDA) warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks," which "Pfizer Inc. stopped selling...last year."
        HealthDay (10/21, Gardner) noted that, "between January 1995 and June 2008, 82 safety-related regulatory actions were issued for 41 of the medications, or almost 24 percent of the total." Of these "actions, 63 were advisory letters to healthcare professionals in the" U.S. and Europe, and the rest "were black box warnings. None of the drugs were withdrawn from the market." The majority "of the actions (70.7 percent) were taken within the first five years after approval, with 3.7 years being the average time until a regulatory action was issued." By comparison, "a 2002 paper in JAMA showed that, of 548 new non-biologic drugs approved over a 25-year span, 1975-2000, 10 percent had new black-box warnings or were withdrawn from the market, and about half of those warnings or withdrawals occurred within two years after the product had been on the market."
        In accompanying editorial, JAMA argues against preemption. In the Wall Street Journal (10/21) Health Blog, Jacob Goldstein wrote, "The Journal of the American Medical Association (JAMA) has come out against the drug industry in Wyeth v. Levine, a case whose outcome could have a big effect on drugmakers' exposure to patient lawsuits." In an editorial accompanying the biological drug study, Catherine DeAngelis, M.D., and Phil Fontanarosa, M.D., editor-in-chief and executive deputy editor, respectively, of JAMA, argued that "the right to sue drugmakers in state court is an important protection for patients." They asserted that if the Supreme Court endorses preemption by ruling in favor of Wyeth, "patients will lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by FDA."
        According to Drs. DeAngelis and Fontanarosa, the study's "findings confirm that clinical trials don't identify the 'full risks and complete safety profile' of new drugs," MedPage Today (10/21, Smith) reported. The physicians "argued that because approval and post-marketing surveillance are flawed and incomplete, 'some patients inevitably will continue to experience harm from the use of newly marketed products.'" They asserted that, "until the system of approving drugs and monitoring their safety improves markedly...patients will need legal recourse against" pharmaceutical makers.
        In the Pharmalot (10/21) blog, Ed Silverman noted that "the court's decision...is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the" FDA.
       PhRMA VP responds to JAMA study, editorial. WebMD (10/21, Hitti) provided reaction from Alan Goldhammer, Ph.D., vice president for scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA), in response to both the study and the editorial. He told "WebMD that it 'isn't surprising' that safety issues sometimes come up once a drug goes on the market." According to Goldhammer, "clinical trials never capture all of the safety -- or, for that matter, efficacy value -- of a given drug." He pointed out that, because "biological drugs work on complicated pathways in the body...safety issues can occur if the drug 'doesn't adequately control the pathway, or does something that wasn't noticed in the clinical trials.'" Still, "that doesn't mean that biological drugs are riskier than nonbiological drugs," Goldhammer argued.