Wednesday, August 5, 2009

Insanity is Expecting Different Results from the Same Behavior

In 1966, a long time ago, I began working for a major pharmaceutical company selling the company’s products to physicians and hospitals in the Detroit area. I really didn’t sell drugs to physicians, but rather attempted to sway their thinking about prescribing my company’s products for their patients. What triggers this trip down memory lane is a lead article in today’s New York Times which describes how this company has used ghost writers in the past ten years to write articles about the value of it’s major line of products, estrogen products, for the treatment of nearly every ailment suffered by the post-menopausal woman. As an aside, ghost writing involves the writing of an article by an unknown person, then getting some prominent physician to sign off on it so that the company can use the prominence of the physician. What has been revealed in the latest venture is that this line of drugs causes cancer in women. In and of itself, this would be a terrible tragedy, but it is far worse than that. It is not new news that these drugs cause cancer. It is old news and the company keeps getting away with the same conduct over and over again.

A little bit of history is in order. Estrogens, either naturally occurring (isolated from pregnant mares’ urine), or synthetic (chemically produced from coal tar) have been used and promoted extensively for women since the FDA approved their use in 1941. Prior to that time, a wide variety of animal species had been tested for the possibility that these substances may produce cancer. In fact, the lead synthetic estrogenic agent, DES, was developed specifically as a cancer-producing agent to study cancer. By 1941, there were literally hundred of scientific papers published which revealed that cancer had been produced in organ systems of every species that had been tested; i.e., rats, mice, dog, monkey, to name but a few. Michael Shimkin, M.D. a leading Harvard researcher and physician stated in 1945, “It is to be hoped that given the results of animal experiments that the widespread use of estrogens in women will not produce a catastrophe of calamitous proportions.” [Disclosure; Dr. Shimkin was a friend of mine and an expert witness in the many cases I handled involving DES producing cancer in the daughters of pregnant women administered the drug during the 1950s.]

By the time I started working for the company in 1966, 13 million women a day were taking Premarin, a pill to offset the “curse” of post menopause. The company had designed a promotional pitch to deal with “cancerophobes” as part of a massive promotional effort which pitched the promise of “Feminine Forever” to women who took the product for the rest of their lives. The cancerophobe title was given to physicians who were concerned that the drug could cause cancer if given in the manner suggested by the company. We (the sales staff) were given an elegant brochure which featured the scientific report of a Dr. Karl Karnaky of Houston, Texas. Dr. Karnaky’s summary of his research was “there is no proof that estrogen causes cancer. Instead, there is proof that it, indeed, prevents cancer.” Impressive stuff indeed. By 1970, this sales pitch was successful in nearly doubling the use of Premarin in America. Unfortunately, there were tragic consequences for the users of this product. By the mid 1970s, there were two elegant epidemiologic studies published which revealed quite clearly that estrogen administered via the drug route caused cancer of the uterus in the user when taken for longer than two years. At the time of the publication of these articles I was in a quandary. I had left the drug company and had begun practicing law in Detroit. One of my initial responsibilities was the preparation of the DES-daughter cases. Once, the news that Premarin was causing a lot of cancer in a lot of women hit the headlines, I was inundated with potential new cases of women who had taken Premarin for years and had developed intrauterine cancers. My quandary was “Could I bite the hand that once fed me?” In conducting my own research, I happened to come by the so-called scientific article written by Dr. Karnaky in support of my former company’s promotion. Dr. Karnaky’s research, as described in his own article, was that he gave the drug to ten women. Only one of these women developed cancer, whereas in his opinion, two women would be expected to develop cancer if left untreated. No control group was used. In the area of science, this is referred to as an anecdotal observation and is totally without any scientific merit. I can remember my outrage when I read this piece of trash (which was not provided to the sales staff). Those bastards were willing to compromise the lives and safety of millions of women to produce a profit that even today is in the billions of dollars annually. I had no problem resolving my quandary in favor of the women who had been harmed and represented over the next four years several hundred women with Premarin-caused cancers. [All were settled for sums not to be disclosed per agreement, a common occurrence in the pharmaceutical industry which often buys its way out of its misdeeds by offering hush money.]

Now, today, this article in the Times tells us that cancer in users of this drug were identified in 2002! Wow, what a revelation. This is insane. It is often said that insanity is expecting different results from the same behavior. This company with its dubious claims for a billion dollar a year profit making drug has been permitted by the FDA to strew the path of the American populace with the lives and bodies of hundreds of thousands of women whose only sin is the belief in the knowledge of their own physicians that he/she would do nothing to harm them.

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