The Drug Jungle

Two Doctors Challenge the FDA Over the Public's Misunderstanding of What FDA-Approved Means

by Bill Sardi

Recently by Bill Sardi: The Federal Government Wants a Million More Hearts To Keep Beating To Gain Votes, Not Save Lives

Two doctors are challenging the Food & Drug Administration to improve consumer information about prescription drugs following an online survey of nearly 3000 Americans showing many Americans mistakenly believe "FDA approved" means drugs are extremely effective and without serious side effects, and that newer drugs are superior to older ones.

Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS, affiliated with the Veterans Administration Outcomes Group, White River Junction VA Medical Center, White River Junction, Vermont, and Dartmouth Institute for Health Policy and Clinical Practice, Hanover, New Hampshire, say the FDA "needs to do a better job of routinely communicating what it knows – and does not know – about how well drugs work."

Drs. Schwartz and Woloshin say "Many Americans misunderstand what FDA drug approval means. A substantial proportion mistakenly believes that the FDA only approves – and only permits advertising of – drugs that are extremely effective and without serious side effects. Furthermore, many also fail to recognize fundamental uncertainties about the benefits and harms of newer drugs."

Almost half of those surveyed chose a drug that was shown only to reduce cholesterol levels over a drug known to actually reduce heart attacks, and almost two-thirds chose a newly approved drug over an equally effective one approved 8 years earlier. Their survey was recently published in a recent edition of the Archives of Internal Medicine.

Drs. Schwartz and Woloshin say: "Ironically, trust in the FDA and the prevalent misconceptions about what FDA approval means may undermine efforts to promote skepticism about markers of disease and new drugs."

Drs. Schwartz and Woloshin were prompted to conduct the survey in the wake of the Vioxx scandal where the FDA approved a drug on limited evidence provided by the drug manufacturer and then allowed Vioxx to be widely advertised on television as if it were a breakthrough. It ended up being a killer of thousands.

What consumers are in the dark about is that the imprimatur of the FDA misleads many to falsely believe drugs are safe. In fact, the safety profile of new drugs is not known possibly for years from the date of their approval.

Drs. Schwartz and Woloshin criticize the FDA for approval markers of disease rather than disease itself. The best example is cholesterol-lower drugs which lower circulating levels of cholesterol (a marker) but do not significantly reduce the risk of death for coronary heart disease. Actually, statin cholesterol-lowering drugs that were first approved (example: Mevacor) did not significantly reduce cholesterol, but the FDA continued to allow the drugs to be marketed under the guise they saved lives. Later on more powerful statin drugs were approved but to be effective they have to interfere with the natural production of cholesterol in the liver, thus making them liver toxins.

There is a call for FDA to place a new drug warning on labels and the FDA did implement such a warning for Vioxx six years after the drug was on the market, but Drs. Schwartz and Woloshin point out that "there are no FDA requirements to do so for other new drugs."

The Institute of Medicine called for a new drug warning in 2006, something that the Great Britain has already adopted. A black triangle is added next to the name of all drugs for at least the first 2 years they are on the market.

Drs. Schwartz and Woloshin go on to say that: "the US FOOD AND DRUG Administration approves drugs when it believes that benefits outweigh harms. But approval does not mean that the FDA believes benefits are large (or important) or that all serious side effects are known. The typically small size (a few hundred to a few thousand participants), short duration (less than a year), and limited end points of pre-approval studies ensure that important uncertainties remain. Uncertainties are greatest in the first few years after approval and for drugs approved solely on the basis of a surrogate (marker of disease) outcome."

Drs. Schwartz and Woloshin continue: "Despite uncertainties about benefits and harms, many new drugs are aggressively promoted to the US public in no uncertain terms. For example, direct-to consumer (DTC) advertising for Zetia and Vytorin (approved only on the basis of improving lipid profiles) reached $200 million (sales reached $1.8 billion) in 2007, the year before a randomized trial reported in the New England Journal of Medicine failed to detect any clinical benefit. Advertisements only included a statement acknowledging that the clinical benefit was unknown after publication of this trial."

Their report in the Archives of Internal Medicine says: "In 2000, a year after it was approved by the FDA, direct-to-consumer advertising for Vioxx surpassed all other drugs, reaching $500million (sales reached $2.4 billion) by 2003, the year before it was withdrawn from the market because it caused myocardial infarction and strokes. The FDA has never required advertisements to acknowledge uncertainties inherent in all new drugs."

While precautionary statements printed on labels do help consumers better understand risks, the improvement is modest. A 23-word explanation resulted in 12% more people correctly choosing a drug that reduced heart attacks over one only known to improve cholesterol levels. A 37-word explanation resulted in 19% more people correctly choosing the drug with a longer track record. This assumes consumers actually read drug labels. Many don't. And even with the inclusion of these precautionary statements, one-third of participants still chose a drug with an unproven benefit.

The Best of Bill Sardi