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February 09, 2008

New York Times accusations against financial ties and medical device companies

Maybe I am naive because I have represented physicians and hospitals and medical device companies for years.  Almost without exception, the goal of every person that I have met - and medical device companies are made up of people - has been to create as safe and as effective a product as possible, and for patients to be able to receive the very best care as possible.  Of course, medical device companies are run for profit.  Evidence of the particular genius of our economic system is that for-profit companies are able to develop the life saving and enhancing products that they do.

It is very easy to demagogue the fact that device companies can be very profitable, and throw up the mantra of Michael Moore and his ilk, and my colleagues in the plaintiff's bar - that profits are put over safety.

Comes now the New York Times, and not for the first time, in an article on January 30, 2008 (read here) in which financial ties of clinical trial investigators to the devices that they investigate are criticized.    Where is the evidence in the article by this Times' reporter that results were affected by financial ties?   

The Drug  And Device Law blog by Beck/Hermann has an extensive, and excellent, post on this topic (read here).  Mssrs. Beck and Hermann make many of the points that I would have, and in a more colorful way.  Thus, I will not belabor their post as it is so good.

However, there are two points that I will not let pass.

The cynical part of me looks to the glaring and obvious issue that confidential documents were leaked to the reporter and form the basis of the article.  Obviously, the device company and its attorneys did not leak the materials.  Who does that leave?  Hmmmmmm?  What is the redress for companies that are put in the position that the manufacturer here was? 

The article, like a good plaintiff's attorney would, raises a lot of innuendo about financial ties but provides no proof whatsoever that they results of the studies were altered as a result of those ties.  My opinion?  The surgeons involved will not as a group risk their professional lives to promote a product that does not work.  Why?  First, there is my belief that they, like the device companies, want to do good.  Second, if they are using products that do not work, then their results, and their reputations, and eventually their practices will suffer.  For those of you that think that all behavior is governed by profits, when their practices suffer, their profits will suffer.  They will no longer be perceived as the premier surgeons that they are, and their opportunities to participate in clinical trials will suffer.  They will make less money.

Maybe there are surgeons who will behave in the manner that the reporter seems to think - but all of them in a clinical study of this sort?  That is incredibly difficult to believe.  Of course, there are bad apples in every walk of life.  But, to accuse the surgeons of the motives and behaviors that the Times does in the article, without proof, and based only on the words of the paid expert for the attorney for a plaintiff is irresponsible. 

It does make for good press though, I suppose.

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Comments

It is difficult to get into the mind of physicians who are affiliated with medical manufacturers. On some occasions, the physician can be naively caught in concerted schemes by mfr to cover up and minimize a known problem. I think as a rule, physicians don't believe their partnering mfr would stoop to such schemes and bring harm to patients. And in other instances, physicians take the view that these patient's quality of life is otherwise not good, and not much harm is done.

I regret I had to bring an FDA complaint last year, where again, the mfr failed to report and where most physicians were unaware. Such developments are troubling for U.S. health care. Perhaps the most striking distinction between physicians and business and scientific employees of a medical mfr, is the later did not take an "oath" to uphold patient care. Rather, an oath to stockholders' financial interests. By bringing stockholder sentiments into this equation, advocates, litigators and others may be better able to influence higher standards.

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