Psychotropic Drugs and Children, Buyer Beware

When Ana Bailey was diagnosed with anxeroia at the age of 12, her psychiatrist prescribed an antipsychotic medication which had weight gain as a side effort. Three years later, Risperdal a drug used to treat schizophrenia, has caused another side effect; dystonia, a painful nerve condition in Ana’s back which requires her to awkwardly twist her neck for relief.

Risperdal is not approved for the treatment of eating disorders.

A doctor can prescribe any drug for any condition. This practice is called using a drug “off-label”. The Federal Drug Administration takes a lassiez faire approach; the regulatory agency neither approves nor promotes “off label” use.

The government requires a pharmaceutical company to get approval for the drug’s initial purpose but after that its buyer beware. Drug companies seldom seek approval of a drug’s new “off label” use because of the time and expense.

So a psychiatrist can prescribe a drug for a child even though it’s only approved for adults.

The post Harvard Professors Flunk Appearance of Propriety documents the pervasive influence of drug company money upon the psychiatric promotion and prescription practices. In the end, corporate marketing influences the type of care a patient receives.

Nevertheless, the profession maintains that it’s independent even though they accept payments from drug companies. When questioned about the appearance of impropriety, psychiatrist Dr Susan Albrecht offered this tone deaf response to the NYT “If someone takes the point of view that your doctor can be bought, why would you go to an E.R. with a sick child and say ‘Can you help me.’”

Because your desperate and there’s no alternative?

Dr. Sharfstein, past president of the American Psychiatric Association, comments in the same article about how patent-protected expensive Lexapro is the top selling antidepressant in the country over the generic Prozac,

“Prozac is just as good if not better, and yet we are migrating to the expensive drugs instead of the generics. I think it’s the marketing.”

Marketing by pharmaceuticals and psychiatrists also seems to have had a huge influence on the increased diagnosis of bipolar disorder in children and the rise of “off-label” prescriptions of antipsychotics and antidepressants to them.

The number of kids diagnosed with bipolar has increased 40 times in a 9 year period and evidence is scarce that the antipsychotics and antidepressants even work.

The story of Ana’s anxeroia, lexapro over prozac and the treatment of children for bipolar are like canaries in a coal mine; all suggest that something is terribly wrong with the drug companies, academics, researchers and psychiatrists that makeup the pharama medical complex.

If Ana’s mother can’t trust her daughter’s doctor for the full story, she is forced to do a lot of homework and make decisions about a complex topic for which she has neither the training nor the experience. There has to be a better way.

Bristol Myers Squib Gets 5YR Probation For Illegal Drug Sales

Bristol Myers Squib Chairman & CEO James M. Cornelius

His company (BMS) just paid out one of the biggest settlements ever for drug dealing. It sold the antipsychotic drug Abilify without FDA approval to children and the elderly. There were the usual consulting fees and luxury resort trips paid to doctors and health care providers to grease the skids.

In order to push product to little ones, BMS had a sales force visit “child psychiatrists and pediatric specialists”. For the elderly who had dementia, this pharmaceutical multinational created a “special long-term care sales force”

The icing on the cake was when the company tried to spin the fact they got 5 years probation with Inspector General’s Office by calling it a “corporate integrity agreement.” Where are mandatory jail sentences when you really need them.

Street dealers are more authentic than these guys.

Facts Courtesy of the Boston Globe

See also Harvard Psychiatrists Flunk Appearance of Propriety about peddling antidepressants to children.

Harvard Psychiatrists Flunk Appearance of Propriety

Three Psychiatrists who perform research at Harvard University have a lot of explaining to do. In fact there are practices throughout the entire profession that give one pause.

Senator Chuck Grassley, Republican from Iowa, has been a bulldog in examining how money from pharmaceutical companies influences the practice of psychiatry. As a result of the Senator’s tenacity, the following has come to light.

• Dr. Joseph Biederman of Harvard Medical School’s Psychiatric Department belatedly reported $1.6 million in consulting fees to his university. To protect the integrity of academic research, disclosure of anything more than $10, 000 in money from drug companies is required by the National Health Institute.
• His colleagues Dr. Timothy E. Wilens and Dr. Thomas Spencer belatedly disclosed $1.6 million and $1.0 respectively.
• Dr. Melissa P. Debello of the University of Cinncinnati reported $100,00 in consulting fees. While the drug company Astrazenca, maker of the antipsychotic Seroquel, paid her $238,000.

Dr. Bierderman has championed the controversial practice of prescribing unapproved psychiatric drugs to very young children for bipolar disorder. According to NYT article Researchers Fail to Reveal Full Drug Pay, the number of children diagnosed as bipolar has increased 40 times in a 9 year period. The benefits of prescribing these psychiatric drugs remains unclear.

In 2006 The American Psychiatric Association received 30% of its financing, $63.5 million from the pharmaceutical industry. As quoted in the article Psychiatric Group Faces Scrutiny Over Drug Industry Ties, Senator Grassley’s reaction, “I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions.”

In the states of Vermont and Minnesota, the pharmaceutical industry pays more to psychiatrists than does any other medical specialty. National studies of industry practice have shown that when psychiatrists are on the company payroll, they report more favorable drug findings to the manufacturer than psychiatrists who are not compensated by the company.

It will be important to watch what changes, if any, are made to prevent the appearance of impropriety. I think that the IRS might also be interested in the ability of these learned professors to properly disclose their consulting fees.