The drug industry-physician nexus has once again seen a mind-boggling leap in the number of those treated for bipolar disorder. While the diagnosis is itself dubious, the efficacy of the drugs is even more so, say critics.
Not too long ago, a child who was irritable, moody, and distractible and who at times sounded grandiose or acted without regard for consequences was considered a "handful." In the U.S. by the 1980s, that child was labeled with a "behavioral disorder" and today that child is being diagnosed as "bipolar" and "psychotic" -- and prescribed expensive antipsychotic drugs.
On September 4, 2007, the New York Times reported, "The number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003 ... Drug makers and company-sponsored psychiatrists have been encouraging doctors to look for the disorder."
The same day Bloomberg News reported, "The expanded use of bipolar as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion U.S. market for antipsychotic drugs."
With the advent of Eli Lilly's serotonin-enhancer Prozac at the end of 1987, the general public and doctors began receiving a multi-billion dollar marketing blitz proclaiming that depression is caused by a deficiency of serotonin, and that this deficiency could be corrected by Prozac (and, later, other serotonin-enhancer antidepressants such as Zoloft, Paxil, Celexa, Lexapro, and Luvox). Between 1987 and 1997, the percentage of Americans in outpatient treatment for depression more than tripled. Of those in treatment, the percentage prescribed medication almost doubled. In 1985 the total annual sales for all antidepressants in the U.S. was approximately $240 million, while today it is approximately $12 billion. In 2006, the American Journal of Psychiatry reported that the percentage of American adults with major depression in 1991 was 3.33 percent, but by 2001, the percentage had more than doubled to 7.06 percent.
The serotonin-deficiency theory of depression was so successfully marketed that it was news to many Americans when Newsweek's February 26, 2007 cover story, "Men and Depression," mentioned that scientists now reject the theory that depression is caused by low levels of neurotransmitters such as serotonin. Thomas Insel, director of the National Institute of Mental Health, told Newsweek that "a depressed brain is not necessarily underproducing something."
The demise of the serotonin-deficiency theory of depression should not be considered news in 2007 because in 1998 The American Medical Association Essential Guide to Depression was already stating: "The link between low levels of serotonin and depressive illness is unclear, as some depressed people have too much serotonin." That same year Elliot Valenstein, professor emeritus of psychology and neuroscience at the University of Michigan, in his book Blaming the Brain pointed out, "Furthermore, there is no convincing evidence that depressed people have a serotonin or norepinephrine deficiency." (Antidepressants that increase the neurotransmitter norepinephrine as well as serotonin include Effexor and Cymbalta). In 2002 the New York Times reported: "Researchers knew that antidepressants seemed to raise the brain's levels of messenger chemicals called neurotransmitters, so they theorized that depression must result from a deficiency of these chemicals. Yet a multitude of studies failed to prove this precept." Unfortunately, that fact was buried under more than fifty preceding paragraphs, notes acidly Bruce E. Levine, a clinical psychologist and author.
Similar to the Bush administration, which knew it is was far easier to sell a war when Americans believed they were threatened by weapons of mass destruction, antidepressant manufacturers know it is much easier to sell serotonin-enhancer drugs when people believe depression is caused by a deficiency of serotonin. The Bush Administration and the mental health establishment (including the National Institute of Mental Health) have retreated from their respective theories, but neither has spent a great deal of time or energy getting the word out. Since each officialdom's earlier claims were so loudly trumpeted and their later retractions so quietly whispered, many Americans continue to believe in mistaken rationales for policies and treatments that continue to affect millions of lives.
The reality is that when patients report Prozac, Paxil, or Zoloft as "working," it is not because these drugs are correcting any kind of chemical imbalance. These drugs can temporarily "take the edge off" -- as is the case with many psychotropic drugs, legal or illegal. But for a significant number of people, these drugs produce extremely unpleasant side effects, while for many others, these drugs have little or no effect. So, overall, the difference in effectiveness between antidepressants and a sugar-pill placebo is "clinically negligible." This was the conclusion of University of Connecticut professor of psychology Irving Kirsch, who used the Freedom of Information Act to gain access to 47 antidepressant studies sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone that had been submitted to the U.S. Food and Drug Administration (but many of which had not been published). Kirsch discovered that in the majority of the trials, the antidepressant failed to outperform a sugar-pill placebo.
Besides, much of Big Pharma's antipsychotic boon is attributable to generous U.S. government agencies, especially Medicaid. The Medicaid gravy train has been fueled by Big Pharma corruption so over-the-top that it has been the subject of recent media exposures.
The Associated Press, on August 21, 2007, reported, "A groundbreaking Minnesota law is shining a rare light into the big money that drug companies spend on members of state advisory panels who help select which drugs are used in Medicaid programs for the poor and disabled." Those advisory panels -- dominated by physicians -- have great influence over the $28 billion spent by Medicaid on drugs, but only Minnesota, Vermont, and Maine require drug companies to report monies paid to physicians.
Anyway why now are we hearing more from the corporate media about the demise of the serotonin-deficiency theory of depression, wonders Levine. Perhaps it is because the blockbuster serontin-enhancer drugs have either lost their patent protection or are soon to lose it and drug companies are preparing us for the next wave of patent-protected drugs and biochemical justifications for them. The Newsweek article on "Men and Depression" went on to state, "Instead of focusing on boosting neurotransmitters (the function of the antidepressants in the popular SSRI category such as Prozac and Zoloft), scientists are developing medications that block the production of excess stress chemicals."
In 2000 an article in USA Today, "FDA Advisors Tied to Industry," reported that in 55 percent of the FDA advisory meetings on drug approvals, half or more of the FDA advisers had financial connections to the interested drug company; and in 92 percent of these advisory meetings, at least one FDA adviser had a financial conflict of interest. Joseph Glenmullen, in Prozac Backlash, notes that Paul Leber, director of the FDA's division of neuropharmacological drug products, left the FDA in the late 1990s to direct a consulting firm that specializes in advising pharmaceutical companies attempting to gain FDA approval for new psychiatric drugs.
Drug companies have also been successful hijacking university psychiatry departments too. In 2005 the Boston Globe reported that Harvard Medical School's psychiatry department at Massachusetts General Hospital received $6.5 million from four drug companies. Marcia Angell, physician and former editor-in-chief of the New England Journal of Medicine and author of The Truth About the Drug Companies, reported that the head of the psychiatry department at Brown University Medical School made over $500,000 in one year consulting for drug companies that make antidepressants. Angell remarked, "When the New England Journal of Medicine, under my editorship, published a study by him and his colleagues of an antidepressant agent, there wasn't enough room to print all the authors' conflict-of-interest disclosures. The full list had to be put on the website."
Drug companies also provide major funding for so-called "mental health consumer organizations," the most well-known of which is the National Alliance for the Mentally Ill (NAMI). NAMI received $11.72 million from drug companies between 1996 and mid-1999, according to Mother Jones in 1999, which also reported that Eli Lilly was NAMI's leading drug company funder and that "in the case of Lilly, at least, 'funding' takes more than one form. Jerry Radke, a Lilly executive, is 'on loan' to NAMI, working out of the organization's headquarters."
Exposés of Big Pharma methods of influencing NAMI have not stopped the practice. In the first quarter of 2007, Eli Lilly's "Grant Office 2007" posted that Lilly provided NAMI with a grant of $450,000 for NAMI's "Campaign for the Mind of America 2007."
In the end the campaign might take a heavy toll of the American mind in many ways, it is feared.