Let’s face it: the pharmaceutical industry has a credibility gap. In a recent article, Mayo Clinic Proceedings, they even admit that the credibility of industry-funded research has suffered greatly in recent years. The article’s authors outline 10 recommendations to repair the reputation of industry-funded research.
Transparency is the clear focus of the recommendations. The general theme is to empower physicians and other scientists with enough information that they can critique the study results themselves. Does this help close the credibility gap? The short answer is no.
First, here are the 10 recommendations, which, upon first glance, seem like a good start:
1. Ensure clinical studies and publications address clinically important questions
2. Make public all results, including negative or unfavorable ones, in a timely fashion, while avoiding redundancy
3. Improve understanding and disclosure of authors’ potential conflicts of interest
4. Educate authors on how to develop quality manuscripts and meet journal expectations
5. Improve disclosure of authorship contributions and writing assistance and continue education on best publication practices to end ghostwriting and guest authorship
6. Report adverse event data more transparently and in a more clinically meaningful manner
7. Provide access to more complete protocol information
8. Transparently report statistical methods used in analysis
9. Ensure authors can access complete study data, know how to do so, and can attest to this
10. Support the sharing of prior reviews from other journals
However, upon closer inspection, the 10 recommendations are ambiguous and do not go far enough.
This is because the recommendations are ill defined and only address industry funded clinical research. The National Institutes of Health defines clinical research as:
Research that is that either directly involves a particular person or group of people or uses materials from humans, such as their behavior or samples of their tissue, that can be linked to a particular living person. (The process of clinical research, however, protects personal data.)
Given this definition, one would have to wonder if this includes studies influenced by industry friendly investigators. For example, a recent article in the Journal of Clinical Hypertension addresses whether or not restricting visits by pharmaceutical representatives influence what doctors prescribe or therapies they employ (see that article here). One of the most significant results of the study was that doctors are less likely to stop prescribing drugs that receive black-box warnings.
Sounds like a clinically important question, right?
The study’s main author, George A. Chressanthis, Ph.D, is a long time pharmaceutical industry insider and former AstraZenca executive. He is a Professor of Healthcare Management and Marketing at Temple University. He is also an advisor to a SZF Associates, a market research and consulting firm serving the pharmaceutical and biotech industry. It is not surprising to me that someone with his background would author studies with pro-industry results. And a brief look into Dr. Chressanthis’ other published peer-reviewed article supports my theory.
Dr. Chressanthis’ other peer-reviewed article suggests that physicians should not prescribe generic drugs in certain patient populations (see that article here). As we all know, generic drugs are cheaper and can be produced by more than one pharmaceutical company. This is another article with pro-industry findings that supports big pharma’s bottom-line.
It took some research to come up with all of this information about Dr. Chressanthis. Do you think a physician in a busy practice would do such research? I doubt it.
Do you think these recommendations go far enough?