Most Americans would agree that the drug problem is serious enough with substances like LSD, crack and methamphetamine available to our children. So how and why do dangerous drugs continue to find their way onto the market and into our streets?
While individual doctors and others abuse the system, and are certainly a factor, the more fundamental problem is the continuous inbreeding between the FDA and the drug makers it is mandated to oversee. Instead of one monitoring the other, the two have become bedfellows. Conflicts of interest in the agencys drug-approval process foster a regulatory approach toward major manufacturers which is, at best, weak-kneed and ineffectual.
Freedom revealed in its November/December 1993 issue1 that at least five of the 10 members of the FDAs Psychopharmacologic Drugs Advisory Committee had conflicts of interest based on business dealings or other ongoing relations with manufacturers of antidepressant drugs totaling a minimum of $1.1 million at the very time these members voted against relabeling an antidepressant to give proper warning of its dangers.
Even after exposure of such instances, reform seemed to have been the furthest thing from the mind of David Kessler, who announced his retirement as FDA commissioner in late 1996, shortly after controversy surfaced in regard to personal misuse of government expense accounts. Under Kesslers tenure, which began in 1990 and ended on February 28, 1997, the sea of dangerous drugs on the market continually rose.
Looking again at antidepressants, their quantities grow despite bountiful evidence of hazards which range from increasing risk of sexual dysfunction to suicide.
A look beneath the surface reveals much more. Kessler solicited funds from the major pharmaceutical makers, persuading them that their drugs could be approved much more rapidly if they would pay the FDA to do so. Thus user fees came into being payments to the FDA which enable it to hire staff who will then be able to expedite reviews, primarily reviews of the manufacturers application. In effect, the drug maker pays the salaries of the people who have the power to approve its drug.
User fees amount to hundreds of millions of dollars and comprise a major portion of the FDAs budget. It is hardly a mystery how FDA officials became so eager to follow the bidding of the drug companies.
Generic drugs and medical devices have, to date, been excluded from the Kessler plan, with the result that their products have been handled far more slowly. In effect, the more money the FDA receives from the drug manufacturers, the more compliant it is to their wishes.
It is because the FDA serves private interests, not the American people, that unsafe drugs cascade onto the market in vast quantities and into the homes of the Don Simpsons and millions of others.
|Hundreds of millions of dollars in pharmaceutical advertising are now making their way to broadcast and cable television networks thanks to a federal policy announced in August 1997 which allows companies to plug their drugs directly to the public without having to detail their side effects while print ads routinely tout prescription drugs in magazines and newspapers.|
Sanctioning Advertising Hype
To bolster the flow, according to FDA Deputy Commissioner Mary Pendergast, manufacturers spend more than $10 billion each year to hawk their wares.
This ready source of money lends itself to abuse. As Greg Critser noted, Our media and medical establishments are drunk on it from the editorial pages of The New York Times, which regularly rents out space to Lilly et al., to the American Medical Association and the American Psychiatric Association, whose members suck up free promo money and research funds.
Much of the money is spent on advertising. A 1992 article in the Annals of Internal Medicine, the journal of the American College of Physicians, described a study of more than 100 advertisements in the 10 leading American medical magazines. The doctors who authored the piece concluded that many of the ads were misleading and sharply contrast with the general perception of accuracy of the articles in the journals.
Marriages of Convenience
Because the scientific evidence shows that psychotropic drugs in particular are both dangerous and ineffective, one may ask how they became the treatment for almost anything that ails Americans. The answer, according to Dr. John Sommers-Flanagan of the University of Montana, is that they are propelled by a tremendous marketing and promotional campaign.
Deceptive ads fill the pages of medical and psychiatric journals. If you look at the pictures that go along with the advertising, Sommers-Flanagan said, you will see that they are often very young-looking people. Although if you look at the fine print under the Prozac ad, it would say safety and efficacy for children has not been established.
Exploiting visual images of young people to promote that a drug be used by youth even though not approved for them compares to replacing the Marlboro man with a junior high school student. But as reprehensible as this may be, it ranks among the least of the unethical practices used to convince America it should be a nation of pill poppers or, in the case of mint-flavored liquid Prozac already approved by the FDA and available for prescription by doctors to children drug drinkers.
And America has become just that, thanks to the marriages of convenience in which the American Psychiatric Association (APA), the National Institute of Mental Health (NIMH), the FDA and pharmaceutical companies enjoy power, prestige and profits at the expense of the American people.
A New Illness
The study that gained FDA approval of the tranquilizer Xanax is an example. In 1980, psychiatrists invented a new illness called panic disorder, and listed it in the APAs bible, the Diagnostic and Statistical Manual.
To ensure the FDA would approve Xanax for treatment of panic disorder, its manufacturer, Upjohn, hired a psychiatrist, Gerald Klerman, to organize and promote the studies required by the agency.
As the man responsible for the earlier but seriously flawed NIMH studies that duped the health care industry and public into believing that neuroleptic2 drugs were safe and effective, Klerman came well qualified for the job.
Undoubtedly his contacts from his days as NIMH director from 1971 to 1975 and his supervision of the National Institute of Drug Abuse and the Alcohol, Drug Abuse and Mental Health Administration from 1977 to 1980 were added benefits.
Advertisements promoting the Xanax study stated evaluations were made at weeks one, two, three, four and eight of the study. The conclusion that Xanax was safe and effective, however, was based on the findings of week four.
Small print at the bottom explained that week four was considered the end of the study because of the high rate of placebo dropouts. This in itself is highly unusual and a red herring as dropouts occur far more frequently from side effects of the drug being tested than from the non-results of a placebo or from the mild side effects that may arise from another drug administered.
An examination of the study, published in the Archives of General Psychiatry, revealed why it actually ended at week four. At week eight, the Xanax patients were doing no better than the placebo patients and, when the taper-off period began, the Xanax patients proved to be in far worse shape. Xanax patients were tortured by intense withdrawal symptoms and a 350 percent increase in the number of panic attacks.
Yet how did the studys summary describe it? As an unqualified success. And that was all the FDA needed.
Further clouding the truth, Klerman wrote a lengthy introduction in which he claimed Upjohn had gone to great lengths to ensure scientific objectivity and quality.
What Klerman didnt say was certainly misleading. The reader assumed he was reading an independent review from the former director of NIMH not essentially a paid endorsement. No mention was made that Klerman had been a paid consultant to Upjohn since 1983.
Upjohn money also may have ensured that the Archives of General Psychiatry would not subject the study or its introduction to a critical eye. Its editor in chief, psychiatrist Daniel X. Freedman, became a paid consultant to the Upjohn Company the year the study was published.
|Exploiting images of youth to promote drug use by children even though not approved for them compares to replacing the Marlboro man with a junior high school student. The practice has been soundly criticized by Professor John Sommers-Flanagan (above), among others.|
Drug company money is the lifeblood of the American Psychiatric Association. When the APA held a conference in 1987 on how it could procure more cash, patients and influence, the gathering was financed by several drug companies. One drug maker produced an elaborate slide show on how psychiatrists could gain referrals from medical doctors.
The APAs Public Affairs Division designed a calendar with the theme, Psychiatry in medicine/Medicine in psychiatry. Also aimed at gaining referrals from medical doctors, the calendar was produced and distributed by Upjohn.
The APA showed its appreciation for this financial support by promoting Xanax in the January 4, 1991, issue of its house organ, Psychiatric News. Its endorsement failed to mention that the successful four-week study actually lasted eight weeks and was hardly a success.
The APA receives funding from virtually all pharmaceutical companies. Its own Task Force to Study the Impact of the Potential Loss of Pharmaceutical Support concluded in the 1970s that the APA would perish without these funds. This is because, despite the highly inflated claims regarding the mentally ill population in America, psychiatrists have a great deal of trouble keeping their couches filled.
Likewise, pharmaceutical companies need someone to push their drugs. Thus, the two industries melded a relationship that proved to be so lucrative the APA voted to encourage even more support from drug companies in 1980.
Drug company money funds the APAs Political Action Committee, an entity with special departments that cajole Congress, state legislators, the media and the public to support the mental health industry. Their Federal Legislative Institute has seen to it that new legislation is introduced each year to obtain increased government spending on psychiatric programs or to require insurance companies to provide increased or unlimited reimbursement for drug-based psychiatric treatments.