Pharmaceutical Fraud– A Serious Problem

Joachim Boldt, MD is an anaethesiologist with a multitude of peer-reviewed publications on colloids, a type of drug used during surgery for blood volume replacement. But, up to 90 of his publications are fraudulent. It has recently been reported that Dr. Boldt conducted drug trials without approval from patients or the hospital authorities, fabricated results, and forged co-author signatures–all to make colloid treatment appear more beneficial to patients than it is. The source of his funding? The companies that make the colloids, including Baxter, B. Braun, and Fresenius Kabi.

Before this scandal hit the news, millions of people in England were treated with colloids, even though other research showed they increase the risk of death after surgery by preventing blood clotting and contributing to kidney and heart failure. These pharmaceutical agents are still used in the USA. According to the above-linked article, Thoralf Sundt III, MD, Chief of Cardiac Surgery at Massachusetts General Hospital said, ”We use colloids all of the time in heart surgery — routinely… I would say that this is very important … if true, this has placed real people at risk of death and complications.”

Comment from AITSE Consortium member Bernard Brandstater MD:

Thanks for sharing this with me. I think that the report is not only correct, it is also balanced and fair.

The colloid solutions that are discussed in Boldt’s writings belong to a class that has been marketed for many years in the US; I have administered them myself with no observed untoward effects. I must say, however, that I have not seen it [this class of drugs] pushed strongly in the marketplace, which may suggest that the supplying company was not confident about it.  Some of the same questions have been raised concerning another category of colloid, the dextrans. These affect capillary perfusion and blood coagulation, but lost popularity because of occasional allergic reactions.

I am reminded of the case of Scott Reuben, whose name has become notorious in anesthesiology circles in the last two or three years.  He published a series of articles in reputable journals, touting the benefits of multimodal analgesia, a way of controlling post-surgical pain by using a combination of drugs given intravenously, others given by mouth, and reinforced by peripheral nerve blocks using local anesthetics. Dr. Reuben reported impressive benefits in pain relief and his data seemed to reflect carefully designed studies, including rigorous statistical control. (His studies also benefited Pfizer and Merck to the tune of billions of dollars.) But somebody blew the whistle on Dr. Reuben, and 21 articles, published over a 12 year period, have been withdrawn.

I had one sad experience myself many years ago, consisting of fabricated data produced by a well credentialed research scientist whom I had recruited to do work in the department over which I was then the chair.  When I discovered the truth, I fired him the next day in an interview that was one of the most distasteful encounters in my life.

It’s clear: dishonesty can crop up in the least expected places, and there is no sure-fire protection.  It is a regrettable by-product of a scientific community in which a life career can depend on a person’s publications. I suspect that the publish-or-perish mindset is bringing into print a tsunami of irrelevant or trivial articles. And this dilution of quality is troubling me in anesthesiology. I can see the trend at work amongst the ambitious young trainees that I work with even now. The science community has accomplished great things in the modern world, but it is populated by human beings who can make errors of judgment, and whose opinions must always be open to question.

That is the purpose of AITSE: to encourage good science, based on impartial evaluation of data, not the personal or financial benefit of the scientist, physician, or corporate entity. This is an important goal, worthy of support–partner with us now and make a difference!