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Did Biogen Bribe Doctors or Play it Fairly?
(Thursday, November 4, 2021) Companies developing new drugs often hire outside subject matter experts (SMEs) to advise on the development strategies, build scientific consensus, and advocate for the product to others. And the SMEs are compensated for their time. But does getting paid for their time compromise the integrity of the SMEs? A news item floating in the media this week accused the physicians supporting Biogen’s new Alzheimer’s drug, Aduhelm, of basically taking bribes from Biogen to support the drug. The headlines read, “The loudest physician proponents of Aduhelm have all taken money from Biogen”. Such accusations are serious, if true. But a balanced review of the practice of hiring SMEs shows that the truth is far from the accusation, in almost all cases. SMEs hired by companies are well established academics, physicians, and other experts who have a wealth of relevant experience that could be invaluable for companies developing products. Almost all SMEs consulting with companies, do these consultations part-time, outside of their full-time jobs. In many cases, the companies may provide grants to their labs for research, include these SMEs as investigators on their clinical trials, use their expertise to publish data, and have these SMEs share their experiences and opinions with their peers, public and regulators. Since all these activities require time and effort, it is a standard practice to compensate the SMEs for their time. It is legal and fair for anyone working for you to be paid for their time. For transparency, every time the SMEs publish, present, or participate in discussion, they are required to disclose their financial relationship with the company. All regulatory submissions require financial disclosure certifications, lying about which is illegal. This practice is at the core of the ability of any company being able to hire talent to supplement internal resources for developing new innovative products. The article about Biogen casts a false shadow on this practice. The article points out that four of most vocal proponents for Aduhelm were together paid about $117,000 by Biogen since 2014. This means that each of these SMEs averaged about $4178 per year over the last 7 years. If this number seems low, it is. At the fair-market-rate for consultation fees, this accounts for less than 10 hours of consultation per year. The activities that they are being accused of improperly doing would take a lot longer than 10 hours per year. These SMEs may have also been paid for participating as investigators on clinical trials, provided grants for basic research, and/or paid for other services, all of which would be perfectly legal, and disclosed to all relevant bodies. But the article instigates nefariousness of the practice without evidence. Aduhelm is based on controversial science where there are strong opinions on both sides of the aisle. To accuse one side’s integrity with anecdotes and incomplete information is a cheap shot. It is unfair to the SMEs and Biogen. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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