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Nexus Between Psychiatrists and Drug Firms Dangerous, Say Critics

by Medindia Content Team on May 11 2007 11:34 AM

Some might squirm at the thought that doctors could be on the payrolls of drug manufacturers.

Such stories are rampant in many developing countries. But things are no difference in the West too.

Recently a study showed repeated visits by representatives of pharmaceutical firms resulted in prescription of untested medicines to patients.

Last month the venerable New York Times wrote, doctors who have close relationships with drug makers tend to prescribe more, newer and pricier drugs — whether or not they are in the best interests of patients.

It wrote about a pharmaceutical company Amgen, which makes the most expensive drugs used in the treatment of kidney disease and which underwrote more than $1.9 million worth of research and education programs led by a Dr. Allan Collins.

He is a most influential kidney specialist and president of the National Kidney Foundation and director of a government-financed research center on kidney disease.

In 2005, Amgen paid Dr. Collins at least $25,800, mostly in consulting and speaking fees, the records show.

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Doctors receive money typically in return for delivering lectures about drugs to other doctors. Some of the doctors receiving the most money sit on committees that prepare guidelines instructing doctors nationwide about when to use medicines.

In dozens of interviews, most doctors said that these payments had no effect on their care of patients.

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Dr. Collins said his sole focus was the health and well-being of patients. “Just because I might do consulting work doesn’t mean I don’t press the agenda of the public health,” he said.

And now the same newspaper has come out with yet another devastating expose.

Drug maker payments to Minnesota psychiatrists rose more than sixfold, to $1.6 million. During those same years, prescriptions of antipsychotics for children in Minnesota's Medicaid program rose more than ninefold.

Also called atypicals, they have become popular because they can settle almost any extreme behavior, often in minutes, and doctors have few other answers for desperate families.

Their growing use in children is closely tied to the increasingly common and controversial diagnosis of pediatric bipolar disorder, a mood problem marked by aggravation, euphoria, depression and, in some cases, violent outbursts. The drugs, sometimes called major tranquilizers, act by numbing brain cells to surges of dopamine, a chemical that has been linked to euphoria and psychotic delusions. The sudden popularity of pediatric bipolar diagnosis has coincided with a shift from antidepressants like Prozac to the far more expensive atypicals.

The drugs, which can cost $1,000 to $8,000 for a year's supply, are huge sellers worldwide. In 2006, Zyprexa, made by Eli Lilly, had $4.36 billion in sales, Risperdal $4.18 billion and Seroquel, made by AstraZeneca, $3.42 billion.

Yet childhood bipolar disorder is an increasingly controversial diagnosis. Even doctors who believe it is common disagree about its telltale symptoms. Others suspect it is a fad. And the scientific evidence that atypicals improve these children's lives is scarce.

Some psychiatrists who advocate use of atypicals in children acknowledge that the evidence supporting this use is thin. But they say children should not go untreated simply because scientists have failed to confirm what clinicians already know.

Many Minnesota doctors, including the president of the Minnesota Psychiatric Society, said drug makers and their intermediaries are now paying them almost exclusively to talk about bipolar disorder. Atypicals have side effects that are not easy to predict in any one patient. These include rapid weight gain and blood sugar problems, both risk factors for diabetes; disfiguring tics, dystonia and in rare cases heart attacks and sudden death in the elderly.

A girl, on an atypical regimen, regained her appetite and put on weight, but it also heavily sedated her. Over a period of time she also developed a disabling knot in her back, the result of a nerve condition called dystonia. The girl has since recovered, but after discontinuing the atypical and opting for counseling.

In 2006, the Food and Drug Administration received reports of at least 29 children dying and at least 165 more suffering serious side effects in which an antipsychotic was listed as the "primary suspect." That was a substantial jump from 2000, when there were at least 10 deaths and 85 serious side effects among children linked to the drugs. Since reporting of bad drug effects is mostly voluntary, these numbers likely represent a fraction of the toll.

The analysis of Minnesota records shows that from 1997 through 2005, more than a third of Minnesota's licensed psychiatrists took money from drug makers, including the last eight presidents of the Minnesota Psychiatric Society.

The psychiatrist receiving the most from drug companies was Dr. Annette M. Smick, who lives outside Rochester, Minn., and was paid more than $689,000 by drug makers from 1998 to 2004. At one point Dr. Smick was doing so many sponsored talks that "it was hard for me to find time to see patients in my clinical practice," she said.

"I was providing an educational benefit, and I like teaching," Dr. Smick said.

Dr. Steven S. Sharfstein, immediate past president of the American Psychiatric Association, said psychiatrists have become too cozy with drug makers. One example of this, he said, involves Lexapro, made by Forest Laboratories, which is now the most widely used antidepressant in the country even though there are cheaper alternatives, including generic versions of Prozac.

"Prozac is just as good if not better, and yet we are migrating to the expensive drug instead of the generics," Dr. Sharfstein said. "I think it's the marketing."

It is illegal for drug makers to pay doctors directly to prescribe specific products. Federal rules also bar manufacturers from promoting unapproved, or off-label, uses for drugs.

But doctors are free to prescribe as they see fit, and drug companies can sidestep marketing prohibitions by paying doctors to give lectures in which, if asked, they may discuss unapproved uses.

The drug industry and many doctors say that these promotional lectures provide the field with invaluable education. Critics say the payments and lectures, often at expensive restaurants, are disguised kickbacks that encourage potentially dangerous drug uses. The issue is particularly important in psychiatry, because mental problems are not well understood, treatment often involves trial and error, and off-label prescribing is common.

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