Ghostwriting Mysteries of the Medical Device Industry

Pharmaceutical and medical device manufacturers sell their wares for a profit. Nothing wrong with that. If I sold widgets, I would certainly want to generate a profit. If my widgets carried with them the potential to cause severe injury and death though, I would have the absolute responsibility to not place my profits above safety. I would have the absolute duty to alert the public of any potential dangers from the use of my widgets. If I produced a bad widget or if I discovered that use of my widgets inherently caused injury, I would be absolutely duty-bound to alert the consumer. In other words, I am not permitted to generate profit on the backs of injured consumers.

In the pharmaceutical and medical device industry, manufacturers can profit and lose as a result of scientific studies reporting the efficacy and dangers of their products. This is a good thing, though, right? Well, you would think so. The scientists study medical products and are in a position to alert manufacturers to potential dangers—that is a good thing. Well, it’s a good thing if you are not a CEO, waist deep in substantial investments and needing to generate a profit for shareholders. It’s bad if you are a CEO who discovers (or the scientists illustrate what you already knew) that your profitable product is hurting or killing people.

We have suspected for some time that some scientists and medical experts might be “spinning” their conclusions in medical literature so as to down play the problems with various drugs and devices. We now discover what was published in the New York Times about Wyeth and their hormone replacement therapy products (written by Natasha Singer):

“Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.”

“The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.”

What happens here is a ghostwriter authors a paper that is favorable to the particular drug or medical device and a “recognized expert” is paid to put his or her name on the article in order to lend real credence to it. Win – win, right? Not surprisingly, the articles are often written in a way to obscure or outright dispute problems that the manufacturer knows about or should know about before the product hits the market.

So, if this is happening; if scientific opinions are manufactured by the drug and medical device industry as a part of their marketing plan, would they go the extra distance? Would the medical device industry pay to prevent articles critical of their product from being published? Would this industry pay medical experts to write articles that raise serious doubt over the valid scientific basis for criticism already leveled at a particular product? How would this help a particular manufacturer?
The answer is “Daubert”. Drug and device manufacturers are always looking at the potential of lawsuits from a bad product. The old bean counter approach:

• how long can we market this bad product;
• how much income can we generate in the time we market this product;
• what will the lawsuits cost us;
• how much profit can we generate factoring in the lawsuits?

Daubert is a legal theory that is supposed to prevent the use of “junk science” in the courtroom. It permits judges to deny the plaintiff the right to have a jury hear their case and it prohibits defendants from using unique scientific defenses. Some argue that what it really does is place a legal expert (think the Judge here) in the position of having to decide science. This is much the same as having a scientist decide legal precedent. Neither scenario is absent potential problems and serious error.

Could defendants be preparing for Daubert defenses when they first produce a product or when they first realize their product is hurting people?

Perhaps the easiest way for a defendant to “create” a Daubert defense in some cases is simply to “provide” the medical community with literature that criticizes conclusions critical of the product, reached by legitimate scientists, conducting real investigative analysis. Suppose a series of manufacturers with the same product (and, so the same problems) got together and “suggested” or drafted medical articles, which claim that the particular medical device or drug cannot be blamed for the injuries or death simply because insufficient reliable evidence exists to be able to determine just what is causing the injuries and deaths. These “friends” of the manufacturers simply suggest that it is merely coincidence that patients who all used the same drug or device all suffer the same or similar injuries. These “experts” suggest that there are so many other potential causes that no one can determine the real cause; that it is mere happenstance, a statistical anomaly, a mystery.

Could it be that after the drug and medical device industry began using “ghost writers” that they also developed the idea of using “mystery writers” to create doubt over the harm caused by their products? Is it beyond reasonable thinking that these manufacturers believed they could convince non-scientists (think judges here) to allow them to take advantage of a legal theory like “Daubert”? Could some drug and medical device CEO’s be that ghostly, mysterious, or greedy?