CT Blue

Check out this article at the New York Review of Books (Drug Companies and Doctors: A Story of Corruption). It’s a review of three books about the way that drug companies market their product, and of the corrupt relationships between doctors and drug companies. It’s difficult to summarize. Read it now, since I think you can only read current articles on the site. The review (written by a former Editor of the New England Journal of Medicine) documents the following points, among many others:

• Doctors, particularly prestigious doctors, have been paid for advocating the use of prescription drugs for conditions (such as childhood bi-polar, a growth disease) for which the drugs have not been approved. They can do this because once a drug is approved for any use, doctors are free to prescribe it for any condition, though the drug companies cannot market it for any but the approved purpose. However, they can pay huge consulting fees to doctors who advocate for those uses.
• Drug companies have created new diseases to fit the drugs they create (Shyness, for example, is now “social anxiety disorder”, for which you should be medicated.
• The doctors who perform clinical tests are conflicted, and the tests are designed to achieve favorable results.

I’ve really only scratched the surface. Here’s an illustrative paragraph that interested me, since I have so many clients who take the medications mentioned.

Many drugs that are assumed to be effective are probably little better than placebos, but there is no way to know because negative results are hidden. One clue was provided six years ago by four researchers who, using the Freedom of Information Act, obtained FDA reviews of every placebo-controlled clinical trial submitted for initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. They found that on average, placebos were 80 percent as effective as the drugs. The difference between drug and placebo was so small that it was unlikely to be of any clinical significance. The results were much the same for all six drugs: all were equally ineffective. But because favorable results were published and unfavorable results buried (in this case, within the FDA), the public and the medical profession believed these drugs were potent antidepressants.

The review puts most of the blame on the doctors, on the theory that the corporate corrupters are just being corporations, and calls on doctors to reform themselves, because otherwise the government “will step in and impose regulations. No one in medicine wants that.”.

Maybe no one in medicine want that, but the rest of us should. Just as the capitalists are just being capitalists, so the doctors and researchers are just being human. Most, if not all of these abuses could be easily remedied with a little judicious governing. For example, it would have been a lot harder for GlaxoSmithKline to market its drug, Paxil, as a cure for a made up disease (Social anxiety disorder), if it hadn’t been legal for it to advertise (The article discusses a giant ad campaign designed to boost “awareness” of social anxiety disorder and Paxil). Remember the good old days when drug makers couldn’t advertise to the general public? I’ve seen ads telling people to ask their doctors about certain drugs without even telling the viewer what the drugs were for. If such ads were banned, like cigarette ads, then one giant abuse would be ended. Unscientific studies, at least in the approval process, could be stopped by requiring all such studies to be carried out by government labs or researchers with whom the government contracts directly. The companies could be required to fund the research, but not pick the researchers. Any outside study could not be considered in the approval process. Don’t want drug companies making payments to doctors? Ban it, or at least remove the tax deduction for any such payments. In fact, most of the problems appear to be rather easy to address on a theoretical level. Political will is another matter.

Parenthetically, there’s indirect evidence here that doctors don’t spend as much time worrying about lawsuits as they claim. I’m referring to the practice of prescribing drugs for conditions for which the drugs have not been approved or proven effective.

Consider the clinical trials by which drugs are tested in human subjects. Before a new drug can enter the market, its manufacturer must sponsor clinical trials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill. The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive—that is, they show effectiveness without serious risk—the drug is usually approved, even if all the other trials are negative. Drugs are approved only for a specified use—for example, to treat lung cancer—and it is illegal for companies to promote them for any other use.

But physicians may prescribe approved drugs “off label”—i.e., without regard to the specified use—and perhaps as many as half of all prescriptions are written for off-label purposes. After drugs are on the market, companies continue to sponsor clinical trials, sometimes to get FDA approval for additional uses, sometimes to demonstrate an advantage over competitors, and often just as an excuse to get physicians to prescribe such drugs for patients. (Such trials are aptly called “seeding” studies.)

It’s hard to believe doctors would prescribe in that fashion if they were constantly worried about lawsuits.

Update: Today a sort of inverse proof that judicious government can solve these problems, as injudicious government has just attempted to exacerbate them. (Via Majikthise from Reuters)

U.S. health officials finalized guidelines that allow pharmaceutical companies to tell doctors about unapproved uses of their medicines, a practice opposed by critics of industry marketing.

The Food and Drug Administration (FDA) guidelines allow manufacturers such as Pfizer Inc (PFE.N) and Merck & Co (MRK.N) to distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.

The move, announced a week before Republican President George W. Bush leaves office, puts in place a policy that drew objections from congressional Democrats and drug-industry critics when it was proposed last year. Opponents say it will allow promotion of uses without adequate testing.