Drug Companies Turn ‘Informed Consent’ into a Sham

When will physicians, HMOs and elected officials take the following pledge? “I pledge to accept no money, gifts or hospitality from the pharmaceutical industry; to seek unbiased sources and not rely on information disseminated by drug companies, and to avoid conflict of interest in my practice, teaching and/or research.”

by Kathie Zatkin

Revelations about the “wonders” of hormone replacement therapy have finally begun to raise suspicions about other drugs. Although the alleged benefits of all drugs should be subjected to heightened scrutiny, the practice of deliberate deception, misleading reports, and conducting research with a knowing disregard for the subjects of that research, is starkest regarding psychotropic medication and research on persons labeled “mentally ill.”

Lying to research subjects and the public about the dangers and results of drug research, the risks of participating in drug trials, and failing to reveal conflicts of interest between “independent researchers” and their funders — all that is only part of the pattern.

The risks associated with psychotropic medications continue to be minimized, while drug companies support a deliberate campaign to convince the public that persons who resist taking psychotropic medication do so, not because of the effects of the medication, but because the person lacks insight. Family members of persons diagnosed with “mental illness,” many of whom are the strongest supporters of forced drugging laws, are an important part of this “campaign.”

I fear that eventually the media will be forced to report quotations like the following: “I feel duped.” “I was just a pawn of a multi-billion dollar industry. By trying to make life better for my child, I undoubtedly contributed to his physical and mental deterioration.” “The drug companies knew we would do anything to help our son. Now it looks as though we signed away his body and his mind” (by allowing him to participate in drug company research while he was an outpatient and we were his conservators).

Despite mounting evidence of faulty research and biased reporting of research findings, the drug companies can assert that public pronouncements about the benefits of pharmaceuticals are free speech protected by the First Amendment. Pharmaceutical companies, which spend more on direct lobbying, front groups, and political advertising than any other industry (the industry has more than one lobbyist for every elected representative in Washington), are seldom questioned.

Regarding alleged conflicts of interest between funder and researcher, and in some cases guardians of research subjects, the drug companies maintain that these relationships are sacred and any governmental interference would severely infringe on the doctor-patient relationship.

Drug company spokespersons frequently expound this message: “The FDA already requires numerous safeguards to protect the public, particularly research subjects. This is the primary reason research is so costly (the FDA regulations); the public just doesn’t understand.”

Robert Whitaker’s book, Mad in America, reveals harsh truths about the extent of corruption in the field of psychiatric drug research [see “Mad in America,” June 2003, Street Spirit]. After chronicling the historical course of (mis)treatment of the mentally ill, including the history of what qualified as “research,” Whitaker reminds us that this is not only history, it is very recent practice.

The antipsychotic drugs (“atypicals”) that came to market amid fanfare and acclaim in the early 1990s had been  “tested” under new protocols. The modicum of independent testing that previously existed was replaced in the late 1980s by for-profit clinical trials. Academic research had been replaced by for-profit research. Drug companies got more and more control over the study design and therefore the results; clinical researchers and their research “institutions” got more and more money.

Whitaker describes an outrageous case involving the drug risperidone. Richard Borison and Bruce Diamond, faculty members at Georgia Medical College, hired only attractive female coordinators to literally solicit schizophrenic males to participate in their “study.” After Borison and Diamond set up their own “research mill” named Clinical Therapeutics, these attractive study coordinators who lacked medical training were given broad decision-making powers as well as huge bonuses for enrolling participants. They  “churned some patients through study after study,” adjusted drug dosages and fudged eligibility criteria.

Although Borison and Diamond’s clinical interest in the research appears minimal, their financial interest was significant. Whitaker describes the lavish lifestyle Borison and Diamond enjoyed and cites more than $5 million in cash and securities they stashed in various banks. Bribes to keep whistle-blowers quiet were also paid. Borison and Diamond eventually went to prison, but not for research fraud; their crime was stealing from the college.

Borison published “Recent Advances in the Pharmacotherapy of Schizophrenia” at about the same time he was indicted. Prior to receiving over 160 contracts from drug firms in the course of a decade and his eventual prison sentence, Borison had already received a significant 1984 public rebuke from the FDA for fabricating results about the supposed dangers of using generics in place of Thorazine.

As for the patients involved in the tests of these new atypicals, Whitaker reports that the FDA protocols approve of a testing technique which makes patients actively psychotic. “Washout” requires patients to be abruptly withdrawn from their current medications with the expectation that hallucinations and delusions will quickly return. Patients are then given a placebo, a standard/older drug, or the experimental/new one. Not surprisingly, research subjects were not informed about the “washout” effect. The overall suicide rate for patients involved in the trials, on a time-adjusted basis, was two to four times the norm for schizophrenics. [See Mad in America by Robert Whitaker, Perseus Publishing, pp. 261-270.]

Of course, drug companies continue to “stand by their research.” Pharmaceutical corporations are actively engaged in marketing psychotropic medication, not only to the public via television and other mainstream media, but to all potential constituencies, including obstetricians, pediatricians, and genetic counselors, alleging that infants as young as six months could benefit from psychotropic medications.

Despite a few tiny bits of negative publicity, drug companies continue to profit. Drug companies even manipulate and expand the definitions of illness to their advantage. Under the headline, “Help for depression lacking, studies find,” an article in the June 18, 2003, San Francisco Chronicle reported on a study that used “new clinical definitions to measure depression” and purportedly found far greater levels of depression than ever before reported. The Chronicle reported: “The study, whose lead authors are doctors at the AdvancePCS Center for Work and Health in Maryland, received funding from Eli Lilly & Co.”

 

The advertising dollars of giant pharmaceutical corporations push a barrage of mind-damaging substances on the public.  Graphic courtesy of Leonard Roy Frank and Madness Network News Reader

The advertising dollars of giant pharmaceutical corporations push a barrage of mind-damaging substances on the public. Graphic courtesy of Leonard Roy Frank and Madness Network News Reader

 

Eli Lilly is the manufacturer of the antidepressant drug Prozac.

Only two days later, the Chronicle published an article entitled: “Warning on prescribing Paxil for kids.” According to this report, “No one under age 18 should be prescribed the drug Paxil for major depression because the adult anti-depressant may increase a child’s risk of suicide, the government said Thursday.” The article concluded that despite these warnings, “The company (GlaxoSmithKline) is seeking FDA approval to sell Paxil to treat another illness, obsessive-compulsive disorder, in children.”

Tremendous weight gain, coupled with the significant increase in diabetes associated with the new anti-psychotic drugs would probably be unacceptable to the FDA if the target population for the drugs were not persons labeled mentally ill. Warnings would at least be more prominent and risks more emphatically reported. Patients who declined such “treatment” would not have their capacity to decline the “treatment” questioned.

Even if a “treating professional” does feel some concern about the risks associated with these drugs, polypharmacy has a handy remedy to assuage these feelings: Just add another drug or, if diabetes develops, just use a different anti-psychotic drug and continue the diabetes treatment. More and more drugs and related paraphernalia are marketed for diabetes; and once again, the definitions are changing so that greater numbers of persons are considered diabetic or “at risk” if “untreated.”

Pharmaceutical companies know that doctors rely on drug company reports to make prescribing decisions. Patients are supposed to trust their health care provider to provide informed consent. How can a patient assess the risks and benefits of a proposed treatment when the prescribing provider receives continuing education credit from clinical faculty with drug company ties and drug information from drug company representatives?

Pharmaceutical companies have willing believers in their marketing claims and schemes. Federal and state governments have been active partners for years, touting drugs as a cheaper, better alternative to doctor visits. In the 1960s, the government also wanted to save money. Psychotropics were seen as an easy way to empty the state hospitals and provide a more “humane” type of (“community”) care. Later on, medication, particularly psychotropics, became the standard when managed care came into the picture.

Today, politicians feel pressured to save money, protect the public, end homelessness and still be viewed as compassionate. Families are concerned about “disturbing behavior” and individuals are indeed suffering. No wonder the evidence that even those drugs marketed as ‘second generation atypicals’ (psychotropic drugs with supposedly fewer side effects) can be just as harmful as the older medications is barely whispered or kept under seal.

More and more media rely on pharmaceutical corporate sponsors. Drug companies even benefit from competitors’ drugs being marketed for the same purpose as their own. The drug companies correctly believe that such competition is good for the industry because the idea is to get the doctors to prescribe. Psychiatrists watch television and read trade magazines too.

Why aren’t the so-called investigative reporters and TV shows exposing the drug companies? Could the reason be that almost every investigative news show is sponsored by one or more pharmaceutical companies? Look at your morning paper, Sunday inserts, and magazines. Do you see advertisements for drugs? Remember when tobacco advertising filled the airwaves and print media?

The use of medication to “treat” mental illness is regarded as a sacred cow. When will we realize that this “treatment” may really be more like the golden calf or perhaps the Trojan horse?

There is clearly a missionary zeal to embrace the belief that pharmaceuticals are safe and that research methodologies and reports are unbiased. It’s much more palatable to believe that emotional “dis-ease” and/or homelessness are the products of a broken brain, and that the proper remedy is medication, than to actually reflect upon the myriad causes of “dis-ease” and the risks associated with this “treatment.”

Drug companies have deep pockets, but federal and state governments and those acting in a fiduciary capacity should also be liable for any harms caused by the drugs that persons are coerced to accept. We are all on notice. We must ensure that all persons have the right to fully informed consent and that others, even those who claim to be using the latest scientific methods, do not determine the amount of risk that is acceptable to another.

When will physicians, HMOs, elected officials, and those employed in public, private or public/private partnerships take the following pledge?

“I pledge to accept no money, gifts or hospitality from the pharmaceutical industry; to seek unbiased sources and not rely on information disseminated by drug companies, and to avoid conflict of interest in my practice, teaching and/or research.”  — from the physicians’ No Free Lunch Pledge, published in Hadassah Magazine, June/July 2002.

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