segunda-feira, 30 de maio de 2011

Resposta da Society of Hospital Medicine

Copio e colo na íntegra abaixo a resposta da SHM sobre a postagem Sanofi acusada de pagar Society of Hospital Medicine para fazer lobby na FDA contra genéricos. O destaque em amarelo é feito por mim.
In recent days SHM has been in the media concerning our relationships with sanofi-aventis and a letter I wrote to the FDA. I want to speak directly to the SHM membership about this issue.

For several years SHM has worked on projects to prevent venous thromboembolism with funding support from sanofi-aventis. During the course of that relationship, representatives from sanofi-aventis approached SHM about the issue of bioavailability of generic low-molecular-weight heparins, and asked if SHM would consider writing a letter to the FDA asking that consideration be given to requiring additional clinical trial evidence on the efficacy of of generic low-molecular-weight heparins prior to approving these medications. While SHM does not routinely send letters to the FDA, it often makes comments and writes letters to many other government organizations and individuals, including CMS and members of Congress.

In doing our due diligence on gathering the scientific facts on this matter, I met with academic experts on the subject and reviewed the scientific literature. I decided there was enough scientific basis to write a letter on behalf of SHM to the FDA indicating that, while SHM generally supports the use of generic drugs, it might make sense in the class of low-molecular-weight heparins to perform additional testing to assure that generic substitutes would provide full pharmaceutical effect for our patients during their treatment.

Though SHM had an ongoing relationship with sanofi-aventis in which they were funding SHM quality improvement projects, I neglected to disclose this relationship in my letter to the FDA. SHM did publicly disclose its relationships with industry on our web site and in other public reports, but looking back now I clearly see how the FDA would have been better served to have had the full details of this relationship presented in our letter along with our scientific comments, so that they could have considered my comments letter in this context. I regret that omission and its impact on SHM’s reputation for being straightforward and transparent.

I cannot rewind the past. What I can do, and what we have done in the past year, is commit to implementing the strong policies for disclosure and transparency that the SHM Board put in place in 2010, which are available at

As explained in SHM Past President Jeff Wiese’s October 2010 article in The Hospitalist titled, To Err is Human, these policies outline that SHM will not comment on any drug or device unless the communication is first fully reviewed and approved by its Board of Directors. Further, all communications from SHM now contain a standard footer on the Society's printed and electronic letterhead that directs the recipient to an SHM conflicts of interest webpage, which outlines all of SHM’s relationship with industry.

I sincerely regret that my actions in this instance have drawn attention away from the exceptional work that hospitalists are doing every day and the work that SHM continues to do to support those efforts. I regret any negative impact this situation has had on the Society of Hospital Medicine.

I welcome your input and questions on this important issue and ongoing dialogue. Please feel free to contact me at

I am committed to providing the future leadership that you, SHM and our specialty deserve and that you have come to expect from me.

Larry Wellikson, MD, SFHM
Chief Executive Officer
Society of Hospital Medicine

Nenhum comentário:

Postar um comentário

Related Posts Plugin for WordPress, Blogger...