By Jeff Stier, Esq.
Posted: Friday, November 21, 2008

EDITORIAL
Publication Date: November 21, 2008

This article first appeared on November 21, 2008 on MedicalProgressToday.com:

Fred Baron, the Texas trial lawyer and Democratic fundraiser who lobbied on behalf of the plaintiffs bar, died of bone cancer on October 30. My sympathies go out to Mr. Baron's friends and family. There is no politics or ideology in the battle against cancer, and we all wish that he had beaten this terrible ailment. However, last ditch efforts to save his life by gaining special access to a drug with well-publicized side effects tells a sadly ironic tale of how lawsuits have demonized a life-saving industry and made it harder for patients and their physicians to make personalized decisions about their own health.

Trial lawyers like Mr. Baron have famously waged war against pharmaceutical companies, accusing them of foisting unsafe drugs on consumers and attacking the FDA for being too lax in its regulation of industry. As a result, he contributed to an environment where drug companies remove potentially life-saving drugs from the market out of fear of litigation and the FDA has become increasingly risk-averse in its review and management of new medicines.

There are risks associated with all drugs, some serious; in 2005, Biogen removed Tysabri from the market for almost two years because of concerns surrounding a very rare but potentially fatal side effect -- and probably to avoid litigation.

But many MS patients concluded that the drug's unique ability to alleviate the crippling effects of the disease outweighed the small risk of a devastating adverse effect. After Biogen and the FDA pulled the drug, some MS sufferers rebelled and even asked their physicians for contraband samples. Thanks in part to their protests the drug later returned to market with a FDA-approved risk management program that limited off-label use of the drug.

Later, preliminary tests suggested that Tysabri might be effective against bone cancer.

Desperate, like many cancer patients who've run out of options, Mr. Baron wanted to try it off-label. But, unlike many cancer patients who seek access to experimental therapies, Mr. Baron was able to enlist the help of high-powered advocates to convince the company Biogen to give him access to the drug.

In mid-October, after a massive lobbying campaign which included phone calls to Biogen's CEO from Representative Henry Waxman, Senator Ted Kennedy, Bill and Hillary Clinton, and even FDA Commissioner Andrew Von Eschenbach, Mr. Baron eventually gained access to the drug even though his case did not fit clinical trial criteria. Details of the deal have not been reported.

This is not to say that Mr. Baron did anything wrong. Mr. Baron’s struggles, however, illustrate the complex and personal nature of patients’ drug safety decisions, and the foolishness of treating pharmaceutical companies (who make life-saving products) like tobacco companies.

Some self-proclaimed "consumer groups" and their allies in the plaintiff's bar see the issues differently. They advocate for FDA withdrawal of "dangerous drugs" (denying access even to patients who would willingly accept the risk of side effects) and much more onerous regulation of the industry and its products.

For instance, just last month Public Citizen, an ally of the plaintiff’s bar, petitioned the FDA to remove the diabetes drug Avandia from the market because the risk of death from liver failure and other risks "far outweigh[ed] its benefits," according to the group's director, Dr. Sidney Wolfe.

The problem is that is impossible for Dr. Wolfe to make that judgment. Each patient faces unique circumstances that might tip the risk v. benefit equation for a particular drug in a different direction. Even if Avandia isn't the best choice for all diabetes patients, the final decision should be left to physicians and their patients -- armed with an informative drug label supplied by the FDA and the drug's manufacturer.

Plaintiff's firms also portray the pharmaceutical industry in the most negative light possible. Baron's former firm, Baron and Budd, P.C., has an entire section of its webpage dedicated to "unsafe drugs" which they suggest are more dangerous than illicit drugs. They even offer an 800 number to call if you think you've been harmed by drugs in your medicine cabinet.

The blanket condemnation of drugs issued by activists like Public Citizen and plaintiff's attorneys isn't in the best interest of patients -- that is to say, everyone. Whether it is cancer, Alzheimer's, or diabetes, we will all be in Mr. Baron's shoes someday, turning to the much maligned drug companies for salvation, hoping that they will have a cure for us, and that regulators and lawyers won't have barred the door to those therapies in a vain quest to protect us from "risks."

I only hope that the legal and regulatory communities learn an important lesson from Mr. Baron's untimely death: Without "Big Pharma" and its medicines, it is true, there would be no drug risks. But there would also be no medical progress, and no hope for patients struggling with life-threatening diseases.


Jeff Stier, J.D., is the Associate Director of the American Council on Science and Health (ACSH).

See also: ACSH's publication Weighing Benefits and Risks in Pharmaceutical Use.