January 30,2008

Senator Grassley’s floor statement regarding manipulating science and Avandia


As if read into the record

Statement of Senator Charles E. Grassley Before the United States Senate

Manipulating Science

January 30, 2008

SPEECH ON DRUG SAFETY

Mr. GRASSLEY: Mr. President, last May, Senator Baucus and Ibegan investigating GlaxoSmithKline regarding theirdiabetes drug, Avandia.

We began this investigation when Dr. Steve Nissen at theCleveland Clinic published a study in the New EnglandJournal of Medicine.

That study found a link between Avandia and heart attacks.Shortly after we began our investigation, Dr. ScottGottlieb, a former deputy commissioner at the Food and DrugAdministration, wrote an op-ed in the Wall Street Journal.In that article, he insinuated that congressionalinvestigators had obtained a copy of the Nissen studybefore it was published.

Dr. Gottlieb suggested that this action called intoquestion the integrity of both congressional investigatorsand Dr. Nissen.

Well, congressional investigators did NOT get a copy of theNissen study until it became public. But you can imaginemy surprise when I learned that one of GlaxoSmithKline’sown consultants leaked a copy of the study toGlaxoSmithKline weeks before it was published.

The man who did this is Dr. Steven Haffner. He confirmedto my investigators that he faxed a draft of the study toGlaxoSmithKline weeks before it was published.

The New England Journal of Medicine picked Dr. Haffner topeer review the study submitted by Dr. Nissen. That meansthat Dr. Haffner was supposed to check the study forquality.

He was not supposed to pass it back to GlaxoSmithKline.

Not only did Dr. Haffner breach his agreement with the NewEngland Journal of Medicine to properly peer review theNissen study, but he violated practically every tenet ofindependence and integrity held sacred by the major medicaljournals.

Dr. Haffner told my investigators that GlaxoSmithKline didnot ask for an early copy of the Avandia study.But the question still remains about what the company didonce they had the study. Maybe GlaxoSmithKline’sexecutives returned the study to Dr. Haffner.

Or maybe they contacted the New England Journal of Medicineto report this violation of publishing ethics.

I don’t know, but I have sent GlaxoSmithKline a letterasking how they behaved after Dr. Haffner leaked the studyto them.

But the most troubling aspect of this situation is that theintegrity of another aspect of the scientific process iscalled into question – scientific peer review.

This process ensures that other scientists will judge astudy’s quality before it is made public and becomes usedas a marketing tool.

It is only good quality science that separates modernpharmaceuticals from old fashioned snake oil.

Over the last few years, my investigations have found thatthe Food and Drug Administration has a very cozyrelationship with drug companies.

I have also discovered that drug companies spend big bucksto influence which drugs doctors prescribe.

Finally, I have shown that some drug companies intimidatescientists who speak up about bad drugs. Now it appearsthat even peer reviewed science is not completely withoutits own problems.

Before I close, I would like to ask unanimous consent toenter into the record my letter to GlaxoSmithKline.