Duty to Warn

new logokohlsBy Gary G. Kohls, MD

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The pharmaceutical companies are an amoral bunch. They’re not a benevolent association. So they are highly unlikely to donate large amounts of money without strings attached. Once one is dancing with the devil, you don’t always get to call the steps of the dance.”—A psychiatrist, quoted in the Boston Globe, 2002.

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The New England Journal of Medicine, under the editorship of Marcia Angell, MD, published a study in the May 18, 2000 issue whose principle author was the chief of Brown University’s Department of Psychiatry. The academic psychiatrist had reportedly made $500,000 in one year doing consultancy “work” for various psycho-pharmaceutical companies that marketed antidepressant drugs. In editing the article, Dr Angell discovered that there wasn’t enough room to print all the various co-author’s conflict of interest disclosures. Because of space limitations, Angell put the full list on the website rather than in the hard copy issue.

In a foot note to the article, she wrote: “Our policy requires authors of Original Articles to disclose all financial ties with companies that make the products under study… In this case, the large number of authors and their varied and extensive financial associations with relevant companies make a detailed listing here impractical. Readers should know, however, that all but one of the twelve principal authors have had financial associations with Bristol-Myers Squibb – which also sponsored the study – and, in most cases, with many other companies producing psychoactive pharmaceutical agents. The associations include consultancies, receipt of research grants and honorariums, and participation on advisory boards.

Angell then proceeded to write an editorial in the same issue. It was titled, “Is Academic Medicine for Sale?” In it she expressed her concern about the merging of commercial and academic interests.

“Q: Is academic medicine for sale?

  A: No. The current owner is very happy with it.”

In response to Angell’s editorial, a reader sent a letter to the editor asking rhetorically, “Is academic medicine for sale? No. The current owner is very happy with it.”

After two decades of exemplary work at the once prestigious NEJM, Dr Angell was shamefully and arbitrarily fired for stating the obvious. The courageous whistle-blower then proceeded to write her first book, The Truth About the Drug Companies: How They Deceive us and What to do About It (2004).

Having heard about the sinister machinations of the hundreds of multinational pharmaceutical companies (that make the chemical pharmaceuticals that cause almost as many deaths in America as heart disease or cancer), I decided to put together sort of a timeline of the process of psychiatric drug development. There are many authors that back up what is printed below, including books, articles and lectures by Angell, Dr Peter Breggin (see http://www.breggin.com), Robert Whitaker (see MadinAmerica), Dr David Healy  and Dr Peter Gotzsche, among others.

Here is my approximation of how a new, potentially lethal brain-altering psych drug gets developed and then marketed by Big Pharma:

How the Drug Industry’s Amoral Psychopharmacology Units Create the Next Hoped-for Blockbuster Drug

1) Assign to your organic chemists (who decided to go to work for Big Pharma rather than teach and do research at lower pay at some university) the job of exploiting an innovative, un-patented small molecule that is likely to be able to cross the blood-brain barrier into the cerebrospinal fluid. (Knowing that most such molecules have been discovered and partially developed by tax-supported public institutions, like university research/teaching hospitals, you will still later imply that your research and development unit did all the work and incurred all the expense.)

2) Test the new chemical on hundreds or thousands of laboratory animals (mice, rats, guinea pigs, monkeys) until you find the lowest dose that kills 100% of the animals. (That will be the LD 100 [lethal dose 100]).

3) Then experiment with the dose until you find the one that kills 50% of the animals (that is the LD 50). Do forensic evaluations on the killed and surviving animals, focusing on the organs that might be of interest later in the marketing of the drug to humans.

4) Find the dose that doesn’t kill any animals and observe the effects of the drug in a number of experiments, comparing those results with those animals that were given a placebo. In order to save time and money, have these experiments done in the shortest possible time period. (Ex: one day, 5 days or 21 days [which is considered a “long-term” animal lab trial].)

5) Have the lab animal observations looked at by upper management, seeking their recommendations as to what the observed effects might point to the potential usefulness in treating an as yet to be determined (or invented) human disorder (perhaps for some future new psychiatric diagnosis or possibly a substitute for one of your drugs that will soon be losing its patent protection. (For example, slowed behaviors in the treated animal might indicate the new drug might be useful for anxiety, insomnia, seizures or hypertension, whereas agitated or manic drug-related behaviors might indicate that the new drug might be useful for somnolence, fatigue, depression or so-called ADHD.)

6). Establish a safe dose for humans. Then make a deal with one of the hundreds of reliable (ie, in getting positive results), “independent”, for-profit contract research organizations (CROs) that are in the business of doing human trials at less cost that your corporation. Insist on complete control of the design of the clinical trial, who will author it and the publication of the results.

7) Pay millions of dollars to dozens of groups of psychiatrists who have lots of drugged-up and therefore compliant patients who might be willing – depending on the cash incentives – to sign a release of liability form and go off their old drugs in order to start taking the new experimental one. As an extra incentive consider paying a bonus payment to the doctor if he can get more than 5 patients to sign up.

8) Have the CRO ignore the fact that most of the psychiatric patients will have had dozens of previous psychiatric labels, a host of unknown psych drug-induced psycho-toxicities, neuro-toxicities, psych drug addictions or withdrawal syndromes in the past or present.

9) Be assured that it will go without saying that the CRO will throw certain patients out of the clinical study during the pre-study “wash-out” phase of the experiment. Experience has shown that previously drugged-up patients who suddenly quit their old dependency-inducing drugs will commonly have immediate, unwanted withdrawal effects (such as death) which would adversely affect the study results. (If not “washed out” before the study officially begins, those patients would mess up the anticipated favorable – and orchestrated – publishable results). Be assured also that the patients who seem to tolerate stopping the old drugs (perhaps because they were being poisoned by them?) will further favorably skew the results to convince future prescribers of the benefits of the new blockbuster. (“I feel so much better on this new pill, doc.”)

10) If obtaining patients from the developed world is too difficult, have an offshore multinational research company that has a presence in some impoverished third world country do the human trials, even if the results from those malnourished, chronically ill, desperate (and therefore cheaper) patients will have little or no relevance to better-nourished American patients. (Many third world countries have corrupt, easily bribed governments that will allow unethical and potentially dangerous experimentation on its unaware, desperate or easily bribed citizens.)

11) When the human trials are complete (in the case of antidepressants, lasting only an average of 4 – 6 weeks in length, despite the fact that most patients will be taking the drug for years), bury the unfavorable trial results, and refuse to show them to anybody, unless and until a court subpoenas them for the inevitable lawsuits for corporate malfeasance or physician, clinic or hospital malpractice.

12) Massage the numbers of the two best-looking trials so the results that go to the FDA can be claimed to be “statistically significant” (even if the results are not “clinically significant”) even though the trial was only designed to be found “better” than a placebo. (American drug trials are only done in comparison with placebos and never a rival drug!)

13) Present the two (of many) clinical trials to one of the FDA screening committees that have been found to be made up of mainly of psychiatrists with major financial or professional conflicts of interest (usually financial entanglements with Big Pharma or professional loyalty entanglements with the American Psychiatric Association [APA]). Don’t show them the failed trials (Ex: several failed SSRI drug trials – hidden from scrutiny by Big Pharma – clearly showed how dangerous they were for children. If those trials had been published, many pediatricians would not have prescribed them to their otherwise doomed innocent patients.

14) If you perceive that there is a good chance that the FDA will approve your new drug for a specific disorder (invented or otherwise), have your marketing department develop television “public interest” commercials about the existence (and seriousness!) of the disorder for which the drug is to be marketed.

15) Simultaneously, have your Washington, DC lobbyists alert the (APA) academic psychiatrists who are the “thought leaders” (and who are somewhere on your payroll) to invent a new Diagnostic and Statistical Manuel-approved psych label that will then be promoted by that small, obscure insider committee of corporate-connected psychiatrists who vote on such things. (Ed note: The Diagnostic and Statistical Manuel (DSM) is the billing manual for psychiatrists, whose patient-contact code numbers must be used or else no insurance payment will be forthcoming. Incidentally, the DSM has no statistics in it!)

16) Create cunning TV commercials that show unhappy, tired confused actors posing as patients being transformed into happy and confident humans after they take your new drug. Have the disclaimers about the serious, sometimes lethal, drug effects appear in small print or recited by a speed reader.

17) Issue cunning video commercials disguised as a news release about the new disorder or drug to mainstream television outlets, knowing that such free videos will be welcomed by lazy TV news desks as fillers or “news releases”, thus getting cheap advertising.

18) Bribe physicians with junkets, vacations, clinic meals, trinkets, cheap continuing education courses, extravagant meals and “consulting fees” that will reliably influence them to prescribe your drug to as many patients as possible.

19) Have your lobbyists (more Big Pharma lobbyists are in DC than there are legislators in Congress.) bribe, with campaign “contributions” and many of the inducements in # 18 above) as many politicians as it will take to block regulatory legislation, inducements for alternatives to Big Medicine and the sobering truths about corporations such as yours.

20) Sit back and rake in the dough while America goes broke paying for all those toxic, addictive drugs and your toxic vaccines; and when the lawsuits roll in (at least those that your raft of shyster lawyers couldn’t derail) from the families of dead or damaged patients, humbly accept the wrist slap admonition to “don’t to that again” and use a small portion of your windfall profits to settle out of court, admitting no guilt, and demanding that the judge apply a gag order to the plaintiffs so that nobody will ever find out how much was the settlement was for or other details of the lawsuit – typical tactics for psychopaths. And then go ahead and do it again.

21) Utilizing the propaganda methods listed above, your psycho-pharmaceutical monopoly should still be around well every aquifer and every drinking water supply will be so contaminated with your metabolically-stable, toxic and unfilterable drugs (that can’t be adequately metabolized by the liver but are excreted in the urine) that every non-patient – and not just the drugged-up patients – will be struggling to survive on this poisoned planet.

And you Big Pharma CEOs will soon be in the same boat as the rest of us because NASA apparently isn’t finding enough uncontaminated water (or oxygen) on Earth’s closest planet, as you had hoped. Perhaps you should say your Mea Culpas, tell the truth about your toxic products for a change, sell off your Big Pharma shares, stop the poisoning and join the human race.

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Dr Kohls is a retired physician who practiced holistic mental health care for the last decade of his career. He writes a weekly column for the Reader Weekly, an alternative newsweekly published in Duluth, Minnesota, USA. Many of Dr Kohls’ columns are archived at http://duluthreader.com/articles/categories/200_Duty_to_Warn.

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