A recent story on NPR accused the drug manufacturer Merck of inventing a disease, osteopenia, in order to sell its drug Fosamax. It showed how the definition of what constitutes a disease evolves, and the role that drug companies can play in that evolution.
Tuesday, March 16, 2010
As mental illness has become profitable, we are seeing more of it
Date Published: 2007-11-01 05:00
Author: Bruce E. Levine, PhD
The U.S. Psycho-Pharmaceutical-Industrial Complex
In Eugene Jarecki's documentary film Why We Fight, about the U.S. military-industrial complex, U.S. foreign policy critic Chalmers Johnson states: "I guarantee you when war becomes that profitable, you are going to see more of it." Similarly, as mental illness has become extremely profitable, we are seeing more of it. 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" ("Bipolar Illness Soars as a Diagnosis for the Young"). 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. Bloomberg News, also on September 4, 2007, 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." Psychopathologizing young people is not the only reason for the dramatic rise in sales of such antipsychotics as Eli Lilly's Zyprexa and Johnson & Johnson's's Risperdal (each, in recent years, grossing annually from $3 to $4 billion). 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. The AP article focused on John E. Simon, a psychiatrist on the Minnesota advisory panel since 2004, who received $489,000 from Eli Lilly between 1998 and 2006. The top drugs paid for by Minnesota Medicaid, according to the AP article, have been antipsychotic drugs, especially Eli Lilly's Zyprexa.
Serotonin Deficiency and WMDs
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.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 (Prevention & Treatment, "The Emperor's New Drugs," 2002).Why now are we hearing more from the corporate media about the demise of the serotonin-deficiency theory of depression? 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."
Big Pharma, FDA, NIMH, and Congress
There are other parallels between the military-industrial complex and the psychopharmaceutical-industrial complex. Vital to the profits of both are supportive U.S. government regulatory, research, and purchasing agencies. There is nothing more important for a drug manufacturer than FDA approval and so it is common sense that a pharmaceutical company will spend whatever it takes to ensure FDA approval. 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 (2000), 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.The revolving door of employment is also used by Big Pharma to maintain influence over the National Institute of Mental Health. In Talking Back to Prozac (1994), Peter and Ginger Breggin report that in 1993 Steven Paul, scientific director of NIMH, resigned to become vice president of Eli Lilly (maker of Prozac and Zyprexa). In 2001 Roche Pharmaceutical (manufacturer of Valium, Klonopin, and other psychiatric drugs) proudly announced that Lewis Judd, a former NIMH director, had joined its scientific advisory board. To the delight of Big Pharma, NIMH uses taxpayer monies to fund researchers who are financially connected to pharmaceutical companies. One important example is the "Sequential Treatment Alternatives to Relieve Depression (STAR*D)," a $35 million U.S. taxpayer-funded study that proclaimed the effectiveness of antidepressant treatment. The results of STAR*D were widely reported by the corporate media. Unfortunately, the NIMH press release about STAR*D excluded the fact that STAR*D researchers received consulting and speaker fees from the pharmaceutical companies that manufacture the antidepressants studied in STAR*D--and this fact went unreported by the corporate media. Also not in the press release and unreported is the fact that STAR*D researchers failed to include a placebo control and failed to incorporate relapse rates in the overall results. So in reality, STAR*D antidepressant results were no better than the customary placebo results or the results of no treatment at all--this also unreported by the corporate media. The corruption by Big Pharma of the FDA and NIMH is not difficult when these agencies' overseer, the U.S. Congress, has also been corrupted by Big Pharma. Billy Tauzin, a former Republican congressperson from Louisiana, is one example. Tauzin, as chairman of the House Energy and Commerce Committee, helped shepherd passage of the Medicare prescription drug law --a bonanza for Big Pharma. Soon after this favor to Big Pharma, Tauzin became head of Pharmaceutical Research and Manufacturers of America (PhRMA), Big Pharma's trade organization. Tauzin's annual salary as head of PhRMA (as reported on April 1, 2007 by "60 Minutes") is $2 million.
Robert Whitaker, in his book Mad in America (2001), summarized the beginnings of Big Pharma's corruption of America's psychiatrists and their professional organization, the American Psychiatric Association (APA): By the early 1970s, all of psychiatry was in the process of being transformed by the influence of drug money. Pill-oriented shrinks could earn much more than those who relied primarily on psychotherapy (prescribing a pill takes a lot less time than talk therapy); drug-company sales representatives who came to their offices often plied them with little gifts (dinners, tickets to entertainment, and the like); and their trade organization, the APA, had become ever more fiscally dependent on drug companies. 30 percent of the APA's annual budget came from drug advertisements to its journals."Whitaker also reported that the APA relied on drug company grants to fund its "educational" programs. Such grants have continued and in the first quarter of 2007, Eli Lilly reported providing grants of over $412,000 for two APA programs: "Improving Depression Treatments" and "Understanding the Complexity of Bipolar Mixed Episodes."Drug companies have also been successful hijacking university psychiatry departments. 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 (2004), 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." For those troubled by the success of the psycho-pharmaceutical-industrial complex at manufacturing consent in the United States, the title "Campaign for the Mind of America 2007" is a chilling one.
ZBruce E. Levine, Ph.D., is a clinical psychologist and author of Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Chelsea Green, 2007). www.brucelevine.net