BECOMING FAMOUS

About 1949 Dr. Schwartz established a cardiac clinic in the OPD with about six of us. A surgeon had a patient with Lareich Syndrome, a saddle thrombosis of the aortic bifurcation which was a rare condition. I co-authored a paper for the Medical Society of NJ Journal. We thought so little about it that we did not bother to have reprints for distribution although for about a year we were receiving requests from all over the world.

Shortly thereafter, I received from Ciba a supply of a purified form of Rauwolfia an Indian plant which was used to treat hypertension for clinical pre FDA approval. I treated a total of six patients and thought that the results were promising enough to write a letter (report) to Ciba. This was not a controlled study. Ciba used that letter as part of their approval application for Reserpine, the first drug anti-hypertensive. I found this out latter when a pharmacy detail man from another company was selling a similar drug and referred to my letter in its sales promotion.

About a year later Ciba wanted me to do clinical trials on a drug that they thought would be competitive with Smith-Kline-French’s blockbuster Dexedrine diet drugs. I tried Ritalin on a few patients and concluded that it was worthless. After my negative report, Ciba never again asked to do a clinical trial on one of their drugs. Ritalin would surface every few years for another use, until years later it found a home in the treatment of hyperactive children.

I was not surprised when years later the government cracked down on the use of poorly supervised pre-approval field trials. The drug companies did not want negative reports and condoned false data. In fact there have been incidents in the past where serious complications even death had occurred and the Pharmaceutical company had hidden those reports.

Unfortunately our society demands the release of new drugs before they can be adequately determined. Premature publicity by the media puts pressure on the regulatory agencies. When bad results happen after the medication has been on the market there is always finger pointing , and a swing to extreme conservatism before the government allows the sale of good new drugs. Ultimately political pressure again results in relaxing the safeguards.

The drug companies now do extensive pre-patient and human trial studies before FDA approval. Most trials are without bias and the results published and studied before we can use the medication. Unfortunately there is always pressure by institutions (medical schools) and large hospitals for the grant monies that are involved in these studies. Fortunately it is not often that the individuals doing the study bend their criteria to remain in the good graces of the company.

Part of the tragedy for both the physician and the patient is the autocratic restrictions on therapy. Indications for a drug are listed on the information insert along with contra-indications and real and potential adverse reactions. That list is usually so broad and all consuming that the manufacture has completely CHA. If anything goes wrong irrespectively of administration the doctor is exposed to malpractice suit-a trial lawyer's nirvana- or even loss of license. Unfortunate outcomes are treated as malpractice.

I did not have a problem in the early years of practicing of using a drug or a dosage for an illness that was not listed as indicated. The caveat was that there was reasonable evidence that the therapy would be effective and not harmful. I am not condoning irrational treatment or ignorance. It is also a given, that the doctor should explain to the patient that although the treatment being prescribed had not received FDA approval there was sufficient evidence in the literature that it worked and should be given if "he" wished a watched trial. now a days that would have to be a written release for a degree of legal protection. Oh the lawyers rule the world.

By the 80s things had become so codified that any deviation from the "book" if reported would result in disciplinary action from the Board of Medical Examiners. The "cookbook" took precedent over the best individualized treatment for the patient. The insurance companies slavishly followed industry generated standards to authorize tests, treatments and punish any doctor who exhibited ingenuity.