Seeking Truth In Drug Research — And Getting Frustrated!

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.

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.

All “magazines” are driven by advertising and all medical journals have beautiful color advertisements for medications.  There is a lot of data about the problems of psychiatric medications.  Some of it I believe to have been frankly repressed by the drug companies.  Some of it is just published in places nobody has the time to read or even the pluck to be able to find, like the things above.

So I am stuck, really stuck, in a “learned” profession where nobody knows what is going on.  A profession where I have no respect for the “authorities.”  I am doing, I think, the only thing a reasonable and intelligent woman can do.

I am now an authority.

Once upon a time I wrote articles with my preceptors for publication.

I was an academic, then.  People told me how lucky I was to be an academic.  This was the last bastion of “pure thought” or “freedom of thought.”

I was young, but not a child.  I could not see clearly then what I see now.  Sometimes I want to get angry at myself for not seeing, but that would be wasted anger.  I see medical colleagues who may have never seen and never care.

To be an academic physician is no freedom.  To be a physician in private practice is only freedom if you decline personal funds from drug companies, as I have.

Take an average — or perhaps above average — medical school psychiatry department, such as the University of California at San Diego.  I cannot find a single listing of how many clinical trials are going on.  But I do know they have a page to get people into clinical trials, of all departments.

A clinical trial is the attempt to use a medication and to collect data about it before it is approved by our beloved Food and Drug Administration (FDA) and can be sold to the public and reimbursed by drug companies.

Drug companies pay a lot of money to people who are subjects and whose data is collected.  Long before the internet, a respected colleague told me that it took about two semi-trucks full of paper data about a new drug that had to be backed up to and unloaded at the FDA building in Washington before a drug could be reviewed.

In the early phase of the “trial,” they give the drug to an animal.

Supposedly regulated for being humane, we never seem to hear much about that one because rodents can’t exactly defend themselves.  I suppose all is well because in America at least, we seem to be far more vocal about protecting animal rights than about protecting those of humans.

The first human experiments are generally on a healthy person who is confined and collect their bodily fluids and do measurements and such.

The money is generally paid to the institution who collects the data.  A small honorarium may be paid to the recruiting and/or treating physician.  Both of these honoraria are generally pretty darn insignificant, however, compared to the amount of money that the drug company will make on the drug.

Flash forward to a friend of mine who had a pretty nasty abscess on her back, probably from a bra that did not fit.  She is a retired United States of America federal government employee, and has some of the world’s greatest insurance benefits.

She told me with excitement she was on a brand new antibiotic that nobody else could get yet.  She said the healing of her abscess was taking longer than expected, but she seemed to have enough confidence in her treating physicians to stick with it.

I was angry and could have clobbered her physicians.  I explained to her what I am explaining to you now.

1. All clinical trials offer “free treatment” for some condition.  In her case, so did her insurance, so there was no advantage to her to be in a “free treatment” program.  She was going to get herself treated free no matter what.
2. All clinical trials offer an “unproven” treatment, since the collection of the data from your treatment is proving the efficacy of the treatment.
3. When you are enlisted as a patient in a clinical trial, a lot of people are making money off you.  Your doctor is almost certainly getting more money than the standard insurance payment.  If you are sent to another doctor especially for the trial, there is often (although admittedly, not always) a referral fee involved.  All clinical trials pay your “expenses.”  Many pay for your time, transportation, and trouble.  Kick up a fuss and see how much money you can get if you really want to be involved in something like this.
4. By not only federal but also international law, EVERY medication or other procedure that is given to a patient requires what is known as an “informed consent.”  (This is where my friend, a fairly intelligent woman, was raked over the coals and played for stupid.

She trusted the people who put the papers in her hands enough to sign them, without reading them verbatim.)

I cannot ever replace the sleepless nights I spent deciding who should be in clinical trials — when it was good for them, and when it was good for the clinical trial.  But the bottom line is this:

Every human who is in a clinical trial has a result to know about the “proven” treatments that are being declined in favor of the treatment being studied.

She was never told, did not know that these existed.

She was seen in a large, heavily advertised local hospital.  They broke federal and international law with their inadequate explanation, which treated her like an idiot.  Nobody but me seems to both know and care that they did this.

I offered to help my friend file a complaint if she wished, but she did not want to.  Her abscess was already getting better.  I certainly respected her intention.  I have not seen her lately, but when last I did, her abscess seemed better.  I think it could have gotten better and faster with a “proven” antibiotic treatment, but certainly nobody will ever know.

This example comes from antibiotics and infections.  As disagreeable as “pus,” the breakdown products of white blood cells and other detritus, seems to be, it is identifiable.  You know when you got it and you know when you don’t.

Imagine what all this is like for psychiatric illness.  No pus, no bleeding, no discharge.  Just the wails and moans that might be the product of an angry spouse of a broken hotplate on the stove that precluded any kind of an adequate preparation of breakfast.  No easy brain biopsies, no easy blood tests to support the pseudo-scientific explanations for the descriptive rubbish that ends up in the DSM-IV.

Now, go back to the data at the beginning of this essay.  When I was an academic studying new prescription psychiatric drugs, I believed that psychiatric drugs could not possibly cause aggression or homicide.  I read (and even memorized) the articles that drug company representatives handed me most dutifully.  I believed, and I have said many times that belief is the most powerful entity known to human kind.

Since then I have fallen back to collecting data.  There is piteously little data collected and/or released by drug companies that might put them into danger.  And when serious questions are raised, the way that this question about the connection between antidepressants and violence has been raised with Prozac, these questions are, in these United States, deferred to the judicial system.  I do not know who puts pressure on who, but I do know that the judicial system has acquitted Prozac — and possibly other drugs — of inducing suicide or homicide, and that the “vaccination” courts are still out on the link between autism and thimorosal (mercury) in vaccines

Judges are, I suspect, hardworking folks, but they are not pharmacologists.

Something is happening on the political level that ought to be resolved on the pharmacological level.

I remember when I was finishing my training in psychiatry, and the research preceptor, who had accepted me as a scholar who needed to advance in research, asked me why.

I told him I was making clinical decisions on partial and fragile knowledge and had just came to the frightening realization that I knew all the knowledge available and nobody knew anything more than I did, so research was crucial and biased.

Now, one step further, I have realized that research and data collection are more biased than I could have imagined.  They are biased by forces such as corporations and the judiciary, of which I know little.  Forces such as brain biochemistry and making patients well, of which I know quite a bit, do not seem to be significant.

The only positive of this is the availability of data on the internet beyond the wildest dreams of an idealistic pharmacology research fellow.

I have not given anyone an antidepressant (conventional, prescription) in my private practice for a very long time.  In public clinics, I review black boxes.  If a package insert is not available, the physician’s desk reference is simply a compendium of package inserts.

I will seek the truth.  This is a path of more public risk than I ever could have imagined.