clinical trials


While I was training in psychiatry 30 years ago, the field was changing around me.  The older psychoanalysts were forced — reluctantly — to add prescription of psychotropics to their practices or else patients would never make it to their door. Of course, they had little to no training in pharmacology and less interest so they didn’t usually know what they were doing. While I was ascending in the ranks of psychiatric trainees, the best and the brightest of us were ushered into special training in pharmacology research.  I was (and probably still am) about as idealist and apolitical an up-and-coming psychiatrist that anyone could have invented. Read more on The Politics of Drug Development…


I’ve got my outrage in motion and I’m blowing the whistle on one of the dirtiest tricks the big pharmaceutical companies play on us.

They have a technique called “Seeding Trials” that masquerade as drug testing (clinical trials) but are really nothing more than marketing surveys they can use to get around government regulations about promoting their drugs for alternative uses (also know as “off-label” uses).

But I’m printing this news in my private newsletter — not in my public blog.

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Take care and be happy!

Dr. G


Topic:  Research Fraud

For someone who has been a part of many clinical trials, I will be the first to admit that I have very little training in research design or statistics.  Oh, the hours I’ve spent surreptitiously curled up on the sofa of a doctors’ lounge or my own apartment, thinking that somebody paid somebody a lot of money to write “science” so I could figure out how and why I would know things.  It pretty much worked. There were a few mentions of statistics at my delightfully thorough prep school, but there was not so much as a word at medical school.  The research types were always hanging around medical school settings — their brains rented and services bought by the medical side of things — as they did not make much money.  We did receive some wonderful instruction from clinicians as to how to evaluate research literature and decide how to apply it to our practices.

I have a vivid memory of an endearing shy and spindly instructor during a course required for incipient biologists at Boston University.  He had Jewish afro hair, coke bottle bottom glasses, and a more than passing resemblance to a young Woody Allen.  Oh, how he despaired that we were mostly going to be money-chain doctors as opposed to truth-chasing scientists. I remember that once, and only once, did he reach fiery intensity in that class. “Nothing will be published unless the probability that it actually shows what it is supposed to show is greater than 19 out of 20, that means p>.05.  But nobody wants to admit what that really means.” Oh, how silent we were, on the edge of our chairs. Read more on Research Fraud Isn’t Reported To The Public…

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Seventh grade science class at my prep school featured some basic knowledge and definitions that had to be memorized.  I aced it, of course, but I don’t think anyone else even liked it.

Eco-friendly Chemical UsageOver the course of my education (many, many years) I had a lot of science classes.  And after I went to medical school, I was all scienced-up.  Some of the classes were simply a waste of time – things required by law but not taken seriously by the school.  Others were fascinating and formed my blossom love of science that led me to study medicine.

But I did get a lot of basics in that seventh grade class.  Things like definitions.  Words like “solute” and “solvent” held no mysteries for me.  Water was, of course, the greatest solvent ever invented, but there were others.  Like when we sent clothes to the dry cleaners, we had to remember the rhyme “Your best bet is carbon tet” a reference to carbon tetrachloride (CCl4).  Funny little doggerel, I know, but it was even on the final test.

Carbon tetrachloride was not part of the chemistry of living things, so it is not terribly much of a surprise that I haven’t heard much about it until today.  I also recognize the names of its close cousins; trichloroethylene and perchloroethylene.

Sure sounds as if carbon tet and some related solvents in paints and adhesives are related to Parkinson’s Disease.

Read more on Dry-Cleaning Solvents Causing Parkinson’s…

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This is one of those stories that I find very difficult to write. My anger is great and clouds my mind. Yet if I do not, there may be some kind of eruption – tears, shouts, or pounding on the wall.

The headline in the Philadelphia Inquirer read, “4 ex-pharma execs face possible jail time.”

“Possible” jail time? This is murder.

Operating TableIn brief:

Synthes received FDA approval bone cement for use only to fill bony voids or defects in some parts of the body, but not in the spine.

In 2003 and 2004, the company is accused of having its representative train surgeons to use this cement for the very thing they were forbidden by the government to do.

For those who don’t know, many surgeries are performed by people who aren’t technically allowed to practice medicine.  A lot of times, people who didn’t complete medical school or people who have had their medical licenses taken away for various disciplinary reasons can get employment with a manufacturer of pharmaceuticals or medical appliances (like replacement hip joints) and will train doctors on how to utilize these new products.

This isn’t widely discussed and is shady, at best. It’s probably criminal, but that’s another column.

Synthes executives are charged with conducting illegal clinical trials in which 200 patients were treated for ways not approved by the FDA.

Of those 200, three died.

Read more on Getting Away With Murder — Cheaply…

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Life is fragile at best.  At worst it is undervalued.  Prolonging it and maintaining its quality is something most doctors have at least thought about.

Me — I was brought up by family values as well as institutional values to venerate the academic system as a seeker of truth, guardian of highest ethics.

I thought that the institutions that regulated clinical research, whether they were academic or not, were at least trying to be ethical in the face of mounting economic pressures from those who develop substances to be used for the human body, to prolong and maintain life. Some people still believe in this.

Some people, even some I can call “friend,” consider me a failed academic, someone who could have contributed more to society had she written more papers that somebody thought were good enough to publish in medical journals.

All of the above is unadulterated lies and total BS that has kept many competent minds devoting their lives to ideals that are later sold to the highest bidder.

I don’t think I have any lingering doubts that my running from academics, yelling and screaming, was the best decision I ever made.

blood transfusion

The story of Polyheme – developed as a synthetic substitute for human blood — is perhaps the worst example of human rights having been sold down the river for development of something of serious danger (if you believe the publically published academic results) and at best, unproven help (are they really keeping this kind of secrets from us so the company developing this junk can make money?) to either prolonging or maintaining life.

The story is complicated, but basically, here it is.

Read more on Substitute Blood — A Failure Of Clinical Ethics…

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Here is a letter signed by prominent Irish psychiatrists saying that there is no evidence whatsoever that antidepressants cause homicide.

The “PLOS” or “Public Library of Science” is supposed to be an easier and gentler place to get science published, although the esteemed (foreign) colleagues who have done research with me on natural substances have informed me it is not so easy a door to enter.

Nevertheless, here is a very scholarly angle.  There is evidence that the prescription of antidepressants may engender aggression, violence, or homicide.

There is also an article cited by Dr. Peter Breggin in the Journal of Safety and Risk in medicine, to which I cannot seem to link anyone directly but a download is available through the wonderful people at this Irish foundation.  These folks are trying to bring forth the truth and the light.

Black Box Warning

Black Box Warning

I am now of the opinion that the academic ideal I once pursued does not exist, and is, if it exists, a pack of lies at best.

There are FDA black box warnings about antidepressants promoting aggression, but I am unaware of such warnings having ever stopped a colleague from prescribing any antidepressant.

Read more on Seeking Truth In Drug Research — And Getting Frustrated!…

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