Bogus Clinical Trials

Bogus clinical trials are used to push brain poison on the masses!

Inventing Bogus Mental Illnesses and Drugs for Profit —
The Pharmaceutical Industry and the Self-Interested Physicians Who Help It Lie

In addition to distorting scientific data about the inefficacy of many drugs, the medical industry is now inventing mental illnesses and quack cures for them.

Not only are we plagued with diseases that don’t exist, we are reverse-blessed with drugs that do not effectively treat (a) the real diseases they were initially claimed to manage or (b) the fabricated disease the industry invented to disguise its clinical failures.

Inventing unreal diseases for profit

Dr. Marcia Angell (former editor-in-chief of the New England Journal of Medicine) wrote a book review regarding three medical authors’ attempts to warn us about what is going on in medicine.

Citations (for the books Angell reviewed)
Irving Kirsch, The Emperor’s New Drugs: Exploding the Antidepressant Myth (Basic Books, 2010) (Amazon Kindle)

Robert Whitaker, Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America (Crown, 2010) (Amazon Kindle, Barnes & Noble Nook)

Daniel Carlat, Unhinged: The Trouble With Psychiatry—A Doctor’s Revelations About a Profession in Crisis (Free Press, 2010) (Amazon Kindle, Barnes & Noble Nook)

Angell begins her review by saying:
It seems that Americans are in the midst of a raging epidemic of mental illness, at least as judged by the increase in the numbers treated for it.

The tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007—from one in 184 Americans to one in seventy-six.

For children, the rise is even more startling—a thirty-five-fold increase in the same two decades.
© 2011 Marcia Angell, The Epidemic of Mental Illness: Why?, New York Review of Books (23 June 2011) (paragraph split)

Really?
From a statistical perspective, it is highly unlikely that these numbers accurately reflect any semblance of scientific (or even semantic) reality.

Think about it.
During your lifetime, did 2.5 more adults suddenly deviate so far from the norm that you would call them mentally ill?

Did 35 times (3500 percent) more children suddenly go off the deep end of the “normality” spectrum?

Is this alleged phenomenon genetically or environmentally plausible?
The short answer is “no.”
The 3 experts agree that deliberately distorted data is most probably responsible for this “phenomenon”

Angell, whose former job required expertise in reviewing medical science claims, wrote that the three authors agree that the drug companies define:
(1) what comprises mental illness,
(2) the diagnostic process,
(3) proper treatment.

Convenient for the industry, no? — Especially when one recognizes that medical clinicians and researchers (not purely profit-seeking corporations) are presumably the people our culture has assigned to perform all three of these functions.

The authors agree that the pharmaceutical industry engages in illegal marketing and near-bribery to get its bogus mental illnesses recognized and treated.  And they refute the chemically-imbalanced neurotransmitter model that the companies invented to justify their claims.

Do we smell manipulative corporate greed in the wings?

Problems with scientific methodology and logic are often attributable to avarice

When I was in school, I quickly noticed how much of medicine and medical research is fundamentally unscientific.

Although I was willing to accept biological causation for at least some mental illness, I thought that the deficient (or excess) neurotransmitter model was a shot in the dark.  Even if partially true, it was too simplistic to be useful in engineering competent drugs.

For example, if an imbalance in neurotransmitters makes one “ill” in one aspect of the brain’s many functions, why does that imbalance not have negative effects among all its other functions in the brain and body?  This question is especially on-target, given the brain-body’s tendency to equilibrate its number of chemical receptors, according to the amount of the substance (to which they are specifically sensitive) that is “floating” around.

Angell, and the authors she is reviewed, wondered much the same thing:

When it was found that psychoactive drugs affect neurotransmitter levels in the brain, as evidenced mainly by the levels of their breakdown products in the spinal fluid, the theory arose that the cause of mental illness is an abnormality in the brain’s concentration of these chemicals that is specifically countered by the appropriate drug.

Thus, instead of developing a drug to treat an abnormality, an abnormality was postulated to fit a drug.

That was a great leap in logic, as all three authors point out.

It was entirely possible that drugs that affected neurotransmitter levels could relieve symptoms even if neurotransmitters had nothing to do with the illness in the first place (and even possible that they relieved symptoms through some other mode of action entirely).

As [Daniel] Carlat puts it, “By this same logic one could argue that the cause of all pain conditions is a deficiency of opiates, since narcotic pain medications activate opiate receptors in the brain.” Or similarly, one could argue that fevers are caused by too little aspirin.

But the main problem with the theory is that after decades of trying to prove it, researchers have still come up empty-handed.

© 2011 Marcia Angell, The Epidemic of Mental Illness: Why?, New York Review of Books (23 June 2011) (paragraph split)

Oops.

“But do the drugs work?”

If anti-depressant drugs do have a favorable effect on ill health, it appears to be predominantly as an effect of the placebo response.  That makes the drug companies’ pretenses regarding chemical causation problematic.

According to Angell, psychologist Irving Kirsch used the Freedom of Information Act to obtain clinical trials data from the Food and Drug Administration.  His haul included clinical studies of antidepressants that the manufacturers had tried to hide.

(The companies obviously publish only what suits their money-making purposes.)

The FDA assists the pharmaceutical industry in these distortions and repressions of fact by keeping what it terms “proprietary” information private.

Note

In ultimately scientific endeavors — especially those that directly affect health — it is rationally difficult to justify laws and regulations which permit (or require) a federal agency to assist private enterprise with the obviously intentional distortion of scientific findings.

Angell continues:

Kirsch and his colleagues used the Freedom of Information Act to obtain FDA reviews of all placebo-controlled clinical trials, whether positive or negative, submitted for the initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor.

Altogether, there were forty-two trials of the six drugs. Most of them were negative.

Overall, placebos were 82 percent as effective as the drugs, as measured by the Hamilton Depression Scale (HAM-D), a widely used score of symptoms of depression.

The average difference between drug and placebo was only 1.8 points on the HAM-D, a difference that, while statistically significant, was clinically meaningless. The results were much the same for all six drugs: they were all equally unimpressive.

Yet because the positive studies were extensively publicized, while the negative ones were hidden, the public and the medical profession came to believe that these drugs were highly effective antidepressants.

© 2011 Marcia Angell, The Epidemic of Mental Illness: Why?, New York Review of Books (23 June 2011) (paragraph split)

Deliberately-sown delusion is evil — and it should probably be considered quasi-criminal

Angell’s last statement (above) is the key one.

The pharmaceutical industry deliberately and grossly distorts the practicing medical profession’s view of the efficacy of its drugs.  That concealment action is equivalent to the intentional cultivation of delusion among the public and the professionals it depends upon for truth-based healing.

Even as a secularist in matters of this kind, it difficult to consider the intentional creation of un-truth as being anything but evil.  There is a very dark side to pure capitalism.  We do ourselves a practical and moral disservice by pretending that there is not.

The only difference between the fraud involved in someone selling medical snake-oil and the pharmaceutical industry’s repeated distortions of scientific truth in regard to its own bogus creations is that the industry has a moneyed hold on government.

Government protects these dissembling pharmaceutical companies from what should (in a more rational society) be a public unmasking and quasi-criminal prosecution.

Consider author Kirsch’s analysis — effective drugs don’t act the way these tested anti-depressants did

One of the hallmarks of genuine scientific thinking is an ability to consider alternative explanations for findings.  Angell highlights Kirsch’s apparently capable analysis of the astonishingly bad anti-depressant performance as compared to the placebo effect.

First, Kirsch reasoned that double-blinded studies are not a protection against patients detecting side-effects from the drug being tested.

If patients recognize that a reportedly psychoactive substance might have side effects (and an inert placebo would not), they might respond favorably to a drug with side effects just because it seems to be working in some manner— even though the pharmaceutical compound itself might not really be working to counter their depression.

Kirsch’s analytical clincher came next:

To further investigate whether side effects bias responses, Kirsch looked at some trials that employed “active” placebos instead of inert ones.

An active placebo is one that itself produces side effects, such as atropine—a drug that selectively blocks the action of certain types of nerve fibers. Although not an antidepressant, atropine causes, among other things, a noticeably dry mouth.

In trials using atropine as the placebo, there was no difference between the antidepressant and the active placebo. Everyone had side effects of one type or another, and everyone reported the same level of improvement.

© 2011 Marcia Angell, The Epidemic of Mental Illness: Why?, New York Review of Books (23 June 2011) (paragraph split)

Kirsch also found no dose response

Kirsch found no dose response among the tested anti-depressants.

That result is so physiologically odd as to be unbelievable, at least insofar as effective pharmaceuticals would be concerned.  Therapeutically-effective drugs do have dose responses.  Pharmacology, as a discipline of study, is intensely aware of the need to research dose response curves, even down to tailoring dosages appropriately for individual patients.

Kirsch concluded that there was no drug-related anti-depressant effect

According to Dr. Angell, Irving Kirsch concluded that the clinical trials’ anti-depressants only looked a tiny bit effective when compared to inert (no side-effect) placebos.

When compared to a placebo that did have side-effects, the drugs’ teeny anti-depressant effect vanished.

In other words, the patients’ allegedly favorable responses to treatment were almost certainly made purely upon the side-effects they detected during the trials, rather than on the tested drugs’ behavioral efficacy.  The active placebo performed just as well as the drugs being tested.

In effect (from my undiplomatically-stated perspective) these many clinical trials constituted deliberately bad science, sloppily interpreted.

It should not take a motivated outsider (like Kirsch) to step in and expose the disingenuously-marketed self-seeking of the companies in question.  That should be the FDA’s job.

Sadly, we live in a culture that values profit above health and truth.

Medicine has been exceedingly slow to wake up to the debilitating influence that greed wreaks on its professional honor

It has taken medicine’s more self-aware spokespersons quite a while to wake up to the insidious way in the industry is increasingly founded upon profit-motivated deception and deliberately sloppy research.

The Greed Disease — well camouflaged by our human ability to self-justify — has spread to a substantial proportion of medical companies, investigators and clinicians.

The many clinicians and medical scientists who continue to serve patients honorably and selflessly are increasingly caught in a system that debases their well-intended patient-serving efforts.

It is difficult to practice sound medicine, when the corporate powers-that-be deliberately debase the science upon which medical interventions are founded.

Clinicians and scientists are generally not in a position to evaluate the quality of the allegedly scientific data upon which they depend.  Worse, the medical system’s corporate infrastructure deliberately seduces practicing professionals into supporting the industry’s money-making deceptions.

The word “profession” no longer means what it used to

The medical culture’s overall descent into pure money-grubbing means that it has lost the mantle of universally-presumed honor that the word “profession” was meant to convey.

Professional codes were developed to assure clients that practitioners would put self-interest aside in order to serve in a trustworthy manner.  Instead, we live in an age in which the reverse seems to be the case.

The ethical case against medical lying

Institutionalized lie-telling on this scale demeans our humanity, even when that word is connotatively taken to mean that we are susceptible to spiritually base impulses.  Most spiritual traditions interpret our “humanity” to mean that we are called to noble purpose in spite of our flaws.

Instead of elevating behavior, professional codes have become a concealing hypocrisy that too many practitioners hide behind in order to lure the naive and helpless into being manipulated for profit.

Corporate-influenced medicine today is arguably less often an honest calling to those who would heal, than it is an invitation to profit from deception and excuses for moral inaction.

This is not a good situation.

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