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  • 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.

1. K.E. Lasser et al., “Timing of New Black Box Warnings and Withdrawals for Prescription Medications,” Journal of the American Medical Association 287 (2002): 2215-20.

 

Readers respond

Just read this, although it was apparently published in October of last year. The essay’s conclusions are incredibly accurate, as I am a seasoned and ex big pharma sales rep. In addition to a new drug that amazingly is allowed to be approved if it is proven more effective than a placebo, many studies can and often have to be done on that same drug with great repetition during this approval time, and will continue to be generated until the two studies required for approval are produced. Related to this, and more concerning, is the questionable quality of clinical trials themselves, as novice doctors are now allowed to conduct such studies thanks to the advent of contract research organizations, all of which are for profit, along with their institutional review boards. So considering such factors involved with meds allowed to be prescribed to patients, this quite possibly could be rather harmful and/or useless. It’s frightening, as well as corrupts science in general.

You mentioned the ALLHAT trial along with another one. I was selling very expensive blood pressure drugs when the ALLHAT study was released, which greatly vexed my employer once we became aware of its existence, yet the study itself, as you pointed out, was more authentic and valid than the studies utilized by big pharma so often, which are consistently misleading and biased, along with all the statistical gymnastics included in these studies, such as speaking and illustrating these false results in relative instead of absolute terms. It’s not true evidence, but deception with the motive of profit instead of patient benefit.

The pharma industry is the largest purchaser of journal reprints, and this agreement occurs before the publication of such a reprint is released to assure the fabricated positive results will be clearly noted in these reprints, that are likely ghostwritten, which further supports their uselessness.

Geeezzz. No one takes a stand anymore these days.

Thanks for writing this essay,

– Dan Abshear

Published on: October 26, 2007
Published in: Clinical Trials and Human Subjects Research, Conflicts of Interest in Research

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