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A Depressing Story You Need to Read

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If President Obama's health reform, the Affordable Care Act, backfires politically, one reason will be the staggering political power of the drug industry. If, for example, the health reform had used the bargaining power of the federal government to lower the cost of prescription drugs bought by Medicare and Medicaid, instead of the current system in which the government pays sticker price, there would have been far less need to find savings in Medicare and far less political backlash among voters.

But there would have been a huge political backlash on the part of the drug industry, whose benign neutrality the administration sought and got. So bulk purchase of drugs at negotiated prices was a non-starter politically.

The drug industry has also very substantially captured the Food and Drug Administration, which is far too quick to approve new, "me-too" drugs of dubious clinical value and far too slow to remove dangerous or ineffective drugs from the market or at least condition them with clear limitations and warnings. The Obama FDA is only marginally better on this front than George W. Bush's.

If you want to get a sense of just how damaging the drug industry is, you need to read Dr. Marcia Angell's blockbuster two-part article in the June 23 and July 14 New York Review of Books. Here is the punch line of part one, "The Epidemic of Mental Illness: Why?" The current generation of anti-depressant drugs, which change the way the brain absorbs a neurotransmitter called serotonin, are probably no more effective than placebos.

Yet these widely prescribed and hugely profitable drugs produce major changes in brain chemistry, are often difficult to kick, and patients can find themselves on a whole cocktail of drugs to counteract each other's effects. As Angell writes: in positing that depression was caused by too little serotonin, "instead of a developing a drug to treat an abnormality, an abnormality was postulated to fit a drug." As she adds, "Or similarly, one could argue that fevers are caused by too little aspirin."

Angell draws on three books, most notably, The Emperor's New Drugs, by Irving Kirsch. As Angell explains the system, a drug company may submit any number of clinical trials to the FDA in seeking approval for a new drug. No matter how many trials prove duds, as long the drug maker can produce two trials that show some clinically significant difference between the drug and the placebo, it generally gets the drug approved. This is rather like a student doing over exams until the right answer pops up.

Studies that show benefit are of course published and publicized. Studies that show no benefit are kept quiet. But the duds remain on file with the FDA. So Kirsch used a freedom of information request to review all of the trials that drug makers had submitted. He found that the vast majority of 42 clinical trials submitted to the FDA between 1987 and 1999 for such best selling selective serotonin reuptake inhibitor drugs as Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor, showed no improvement compare to placebos. And if you averaged all the studies, the improvement was marginal.

But then Kirsch adds another twist. Since anti-depressant drugs generally have side effects, patients often guess correctly whether they are receiving the placebo or the drug because of the presence or absence of side-effects. That, of course, ruins the "double blind" nature of the clinical trial, in which no subject is supposed to know whether they are getting the drug or a placebo.

But in some trials, according to Kirsch, scientists use "active" placebos that include a harmless drug that produces a side effect such as a dry mouth. That way, both the group receiving the drug and the group receiving the placebo believe that they are getting the drug. Guess what? In trials using an active placebo, with "side effects," there was no difference between the patient response to the drug and to the placebo.

Angell argues that much of the huge increase in reported mental illness is the result of the development and marketing of drugs.

In part two of her piece, citing another recent book, Unhinged, by Daniel Carlat, Angell observes that psychiatrists consistently take more money from the drug industry than any other medical specialty. Psychiatry, working in tandem with the drug industry, keeps inventing new diagnoses for which new drugs are needed. Or perhaps it's vice versa. In the research work for DSM-V, Angell reports, fully 56 percent of the members of working groups disclosed significant industry interests.

My friend Dean Baker has long argued that if all pharmaceutical research were publicly financed and placed in the public domain, conflicts of interest would be wiped out, research would be guided by medical need rather than profit, and taxpayers could actually save money because more than half of all drugs are now purchased (at patent-protected prices) by Medicare, Medicaid, the VA, or some state agency.

Under that system, scientists could then go back to doing science, rather than trying to cash in as handmaidens of the drug industry.

Dr Jonas Salk, who created the polio vaccine, was asked in a TV interview whether he planned to patent his discovery. He responded, "The people own the patent on this vaccine. There is no patent. Could you patent the sun?"

Today, industry is patenting, if not the sun, applications of solar energy, and the drug industry is patenting folk medicines long used by indigenous peoples. Corrosion of the public spirit of scientists and the distortion of scientific inquiry is one of the many costs of this pervasive commercialization. Not to mention the creation of bogus illnesses that require bogus drugs with little medical benefit but real side effects.

That's truly depressing.

Robert Kuttner is co-editor of The American Prospect and a senior fellow at Demos. His latest book is A Presidency in Peril.