- BIOETHICS FORUM ESSAY
Classic Drugs under Attack
The pharmaceutical industry has made many arguments against generic drugs, but the newest entry almost qualifies as farce. A recent New York Times op-ed accuses the government of “ an inherent conflict of interest” for testing new drugs against tried-and-true drugs. The Center for Comparative Effectiveness, the agency under attack, doesn’t even exist yet; it would be created by a provision of the proposed State Childrens’ Health Insurance Program. The preemptive strike in the Times is written by Peter Pitts, who heads the Center for Medicine in the Public Interest (CMPI), a pharma front group. By day, Pitts is senior vice president for Manning, Selvage and Lee, a PR firm that represents pharmaceutical companies.
The purported “conflict of interest” refers to the fact that Medicare might refuse to pay for expensive drugs that work no better than inexpensive drugs. It would be hard to rile most folks over consumer-funded comparative research, but it makes sense that industry fears independent comparisons of newer drugs with proven, cheaper treatments. After all, a new drug need only be better than placebo to be approved by the Food and Drug Administration. Proven drugs are more formidable opponents. Large, definitive, government-funded, randomized controlled trials have routinely found classic drugs superior to or equivalent to glamorous newcomers. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), for example, compared the effectiveness of several antihypertensive drugs and declared an older, dirt-cheap diuretic the winner. Older drugs for schizophrenia were just as effective as newer drugs in the federally funded Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE). No doubt coincidentally, CMPI recently released a report criticizing ALLHAT and CATIE. The report is actually a transcript of a panel discussion – now that’s what I call evidence!
Sure, some drugs out there are true medical advances, but most “new drugs” are reformulations, combinations, or minor variations of older drugs. Large, taxpayer-funded, randomized controlled trials, designed by people with no financial interest in the outcome, are the closest to solid gold evidence we will ever get. Comparative effectiveness trials may cause Medicare and other insurers to refuse to cover new drugs that have no proven advantages over classic drugs. But that’s good public health practice, and not just for reasons of cost. Novel drugs may have adverse effects that surface only after a drug is in wide use. Most safety problems are identified after a drug is marketed. In fact, half of drug withdrawals or black-box warnings (the FDA’s most severe warning) take place in the first two years after drug enters the market, and half of all withdrawals take place within seven years of approval.1
Physicians and consumers should trust the results of taxpayer-funded trials over studies funded by companies that profit most from promoting the newest, most expensive drugs to as many people as possible, as fast as possible. Trust the science, not the spin.