May 30,2008

Grassley statement about the commentary titled “Grassley's War on Cancer Patients” printed in the 5/29/08 Wall Street Journal

Statement of U.S. Senator Chuck Grassley of Iowa
regarding the guest commentary titled "Grassley's War on Cancer Patients"
printed in The Wall Street Journal on Thursday, May 29, 2008

The vicious attack by Dr. Mark Thornton on the May 29 editorial page of the Wall StreetJournal against my oversight of the Food and Drug Administration exploits cancer patients forgreater drug company profits, and it would result in less information for all patients.

Readers should also know that those in charge of the Wall Street Journal editorial pagedid not require the author to disclose that he is the Senior Vice President of ProductDevelopment at GenVec, Inc., a company that stands to make a lot of money depending on FDAapproval of therapies the company is developing for pancreatic cancer, rectal cancer, head andneck cancer, and melanoma.

In his Wall Street Journal piece, Dr. Thornton mischaracterizes and protests my askingthe Government Accountability Office to determine if the FDA is carrying out its own policy ofrequiring follow-up studies on pharmaceutical drugs that have been approved based on surrogateend points. This means that the FDA may approve a drug if the drug achieves somethingspecific like slower tumor growth, controlled glucose levels or lower cholesterol, separate fromwhether the drug will help a patient live a longer or healthier life. Surrogate end points are avalid way for the FDA to approve drugs. The FDA's policy to follow up on such approvals isdesigned to provide additional information about a drug's performance for anyone who is usingor considering a particular drug.

In recent years, many leaders in the field of medicine, including the Institute of Medicine,the New England Journal of Medicine, and the Journal of the American Medical Association,have concluded that the FDA's post-market surveillance of pharmaceuticals is inadequate andneeds reform. My own scrutiny found the same in many cases. The diabetes drug Avandialowers blood sugar levels but has also been found to increases the risk of a heart attack. Thedrug Vytorin lowers cholesterol but does not improve a person's cardiovascular health. Myrecent request for an independent review of the FDA's performance with follow-up studies onsurrogate end point approvals is not part of a conspiracy to slow the approval of cancer drugs, assuggested by a drug company doctor. It is an effort to strengthen post-market surveillance by theFDA, to make the relationship between the FDA and drug makers less cozy as there's been toomuch collaboration in addressing post-market concerns, and to see the FDA be moreforthcoming with information about drug safety and risks after drugs are on the market and morebecomes known about them than can ever be learned from clinical trials or smaller-scale testing.

For cancer patients and others, follow-up studies on drugs approved through thesurrogate end point method would give them more information about the drugs they're taking.What's wrong with that? A cancer patient deserves to know if his therapy slows tumor growthbut doesn't extend life expectancy. A diabetic deserves to know if his prescription controlsglucose levels but increases his risk for a heart attack. A heart patient deserves to know if hismedicine lowers cholesterol but doesn't change his cardiovascular condition. The decision totake a particular drug is personal, and people have the right to the whole picture.

Drug makers and drug developers violate the public interest when they work to muzzlethe scientific process and fight disclosure of newly emerging information about variouspharmaceuticals in order to drive up their sales and profits. Everyone wants new life-enhancingand life-saving therapies. Cancer patients and others deserve to have information in order toweigh the risks, benefits and unknowns for themselves. The FDA is responsible for developingthis information and making it available. Congress is responsible for overseeing the FDA'seffectiveness, and that work has to continue despite attacks on editorial pages, even those attacksthat are discredited by conflicts of interest.