Thursday, March 4, 2010

NOTE TO READERS: On March, 4 2010, The Washington Times ran an oped by Dr. Gilbert Ross, medical director of the American Council on Science and Health, entitled “When senators play doctor.” Dr. Ross has written for USA Today, The Wall Street Journal, The Los Angeles Times and The Washington Times previously. Dr. Ross did not disclose to the Times that he had been convicted of Medicaid fraud and, for a period of years, lost his license to practice medicine. Had the Times known these facts, we would not have run the article.

In a rare display of bipartisanship, two leading senators have come together - to attack the Food and Drug Administration (FDA) and gut its authority to regulate drugs.

Sens. Charles E. Grassley and Max Baucus’ recently released a 300-plus-page analysis of Glaxo-SmithKline’s (GSK) diabetes drug Avandia is a bizarre distortion of both science and the regulatory process. The senators’ attack on the drug giant GSK and the FDA claims that Avandia caused more heart problems than a competitor drug and that the drug company hid that fact from the public and from regulators.

The senators pored over several years’ worth of studies of Avandia, and what they think they found made them very unhappy - so unhappy, in fact, that they couldn’t even wait for their own press conference, leaking the report’s finding to the New York Times several days in advance.

The revelations contained in the report were abetted by the unsolicited opinions of the FDA’s own in-house anti-pharma gadfly, Dr. David J. Graham. In short, the report concluded that GSK had hidden the extent of Avandia’s heart effects and the FDA had been negligent in not calling the company on it and pulling the drug off the market. Using Dr. Graham’s own method of evaluating comparative effectiveness, the report asserted that thousands of cardiac events over the past few years have been linked to Avandia.

As befits politicians posing as scientists, their assessment - of both Avandia’s risk-benefit profile and of the FDA’s evaluation methods - was simply wrong when it wasn’t misleading. The adverse-event estimates are egregiously flawed, based as they are on a completely unjustified comparison of the adverse effects of Avandia and a similar (but ostensibly safer) drug, Actos. But comparing outcomes between two or several unrelated trials, with different study populations and controls, is comparing apples and oranges: It is scientifically invalid. The only way to compare two drugs is with a head-to-head comparison study - which is under way now.

The charges in this compendium undoubtedly will launch a torrent of litigation against GSK, to the delight of trial lawyers, despite the fact that the senators’ assertions are unsupported by the data. When the FDA did a thorough re-evaluation of Avandia in 2007, their concerns about possible heart risk resulted in a “boxed warning” advising doctors about the risk in heart patients. And when a large new study was completed last year - the RECORD trial - the FDA announced that it would undertake yet another evaluation of Avandia to include these latest data and issue a revised recommendation this June. The FDA also demanded (in 2007) a comparison study between Actos and Avandia, and that trial - called the TIDE study - is under way (even though the aforementioned Dr. Graham, acting as judge and jury based on his own skewed assessment, declared it “unethical” even to continue the research).

Seemingly isolated from the news about these existing studies, the Senate report demands that the FDA re-evaluate Avandia and include a head-to-head comparison trial to get the truth about the relative risks (and benefits) of Avandia and Actos. Perhaps someone should tell Mr. Grassley and Mr. Baucus that their demands are already being met.

The bureaucratic agenda behind this gratuitous and unscientific attack is spelled out in the report: The authors want to create an independent drug-safety division within - but separate from - the FDA. Even though our drug regulators are the world’s most demanding, the senators and Dr. Graham want even more stringency. They have long been advocates for an even more cautious, risk-averse FDA, elevating safety above all other concerns - even at the cost of sacrificing innovative, lifesaving new drugs.

FDA’s already risk-averse stance has led to historic lows in the number of new drugs available to sick patients. The “safety first” advocates don’t seem to realize that all drugs have risks. Every prescription written by a physician demands an individualized discussion of possible benefits and risks with the patient. The trumped-up Avandia “scandal” provides them and their acolytes with a media megaphone, sounding the alarm to warn us about rampant Big Pharma greed and FDA negligence. Their solution: get all “risky” drugs off the market - leaving us with only the older, tried-and-true drugs, generics if possible.

However, studies have shown that newer drugs tend to work better, preventing more illness and death and saving health care dollars in the long run. If the senators have their way, decisions about which drugs are available will be made by the government or self-appointed “consumer advocates” who know what’s best for you and your doctor. Those are the ones who tell us to stop the new Avandia trial, who tell us the debate is settled: Avandia must go.

But there is a place for a drug like Avandia - some patients will do better on it than on the alternatives. That choice - that decision - should not be ceded to politicians who think they know what’s best for you, better than you and your own doctor.

Dr. Gilbert Ross is medical director of the American Council on Science and Health.

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