Saturday, July 2, 2011

Kudos To CEO Ken Frazier -- New Merck's Study Transparency Measures

Even though this item was dumped into "the memory hole" (released late on a holiday Friday), this news deserves mention -- and significant praise. It is progress. Incremental progress, but progress just the same.

Merck will now make the various statistical analysis packages from all studies available to all -- not just to those people who write in to request 'em (and then, as under prior practice, only to those Merck deemed worthy). Every little bit helps, right?

Right -- here it is

. . . .Today Merck said the company is strengthening its publications policy as part of its continuing, voluntary commitment to increase transparency about how it conducts business.

Effective July 1, when Merck submits a manuscript on a study of an investigational or an approved medicine or vaccine to a biomedical journal, Merck will include the protocol and statistical analysis plan as part of the submission package. Merck previously supplied this material only upon request. Upon a journal’s acceptance of the manuscript for publication, Merck will provide the journal with the opportunity to post on its web site, at journal's discretion, the key sections of the protocol, including the objectives and hypotheses, patient inclusion and exclusion criteria, study design and procedures, efficacy and safety measures, the statistical analysis plan, and any amendments relating to those sections.

To ensure that information proprietary to the company is not made available publicly, Merck will require that certain sections, including the “background” and “rationale” sections of the study protocol be redacted prior to posting. The company will, however, always provide the full, non-redacted protocol to journal editors.

It’s our responsibility to make available important information about our products and the science on which they are based, and do so in an objective, accurate and balanced way," said Michael Rosenblatt, M.D., Merck executive vice president and chief medical officer. "Proactively sharing our study protocols will enhance the exchange of ideas within the scientific and medical community, and ultimately lead to a better understanding of the benefits and risks of our products among health care professionals and patients. . . ."

Quite so -- and good show, Whitehouse Station.


marilynmann said...

What Merck is proposing here is fine, but they need to go further. They need to commit to having the data collected and controlled by an academic steering committee and have the data analyzed by an independent academic statistician.

See Catherine DeAngelis, Phil Fontanarosa. Ensuring Integrity in Industry-Sponsored Research: Primum Non Nocere, Revisited. JAMA. 2010;303(12):1196-1198.

Condor said...

Agreed -- great link, BTW. It is incremental progress with most of big pharma, unless someone has the juice to get it legislated/regulated. Doesn't seem likely near-term.

Happy 4th!


Anonymous said...

I'm sure you saw this:

I wonder how many of the pipeline up for sale are from the Merck vs the S/P development candidates?

For the record, Dr. Chatterjee is a legacy S/P employee so, I think it gives 'more' to your position that this was about a S/P bust up.

Anonymous said...

on top of all this, another round of layoffs:

Ah, Fast Freddie-gotta love what he and his crew has accomplished