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Possible Changes at the FDA

Posted 1/4/2016

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  There has been news recently about possible changes in the traditional approval processes at the FDA. An article in the New York Times suggested that the Director, Dr. Richard Pazdur, has modified his views after his wife's death this fall from ovarian cancer. The question is whether it is becoming easier for some drugs to achieve FDA approval and, therefore, be more quickly available to patients.

   I am certainly not an expert about the FDA nor about the clinical trials process, but this feels important. The lengthy process, one might even say arcane, that a potential drug and its manufacturer must follow has developed over years of experience. Yes, it is surely important to bring helpful medications to the market as quickly as possible, but it is just as important to prevent harm and be sure that new drugs are not dangerous. It is tough to balance the competing interests, especially when the voices of desperately ill individuals and their families are heard.

  Remember the disastrous experience of stem cell transplants (often incorrectly referred to as bone marrow transplants) for women with metastatic breast cancer. In the 1990s, there were clinical trials going on internationally to test the value of this aggressive treatment. Since the initial results were promising, women began to clamor for immediate availability, and all sorts of hospitals/institutions began to deliver transplants. The whole thing unraveled in 2000 when a highly cited positive study from South Africa was shown to be fabricated. See https://en.wikipedia.org/wiki/High-dose_chemotherapy_and_bone_marrow_transplant for more information.

  When reading the Times article or thinking about all of this, keep in mind the reasons for our current program. When thinking about any one sick patient, including Mrs. Pazdur, remember the limits of even good drugs for people with Stage IV cancers. Nothing is going to cure a woman with Stage IV ovarian cancer; the best hope is buying time, good time, and some experimental drugs achieve approval because they demonstrate an increase in survival of only a month or two.

  Here is the start of the article: 

F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval
By GARDINER HARRIS JAN. 2, 2016
BETHESDA, Md. — Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.
So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.
He was also Mary’s husband.
In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.
Others worry that the emotions of a loving husband have short-circuited vital safeguards.
“Rick Pazdur is the most important person in the cancer world,” said Ellen Sigal, the founder and chairwoman Friends of Cancer Research, an advocacy group. Now that he has watched his wife die of the disease, she said, “you can’t go through something like this and not be changed by it.”
Certainly there has been a change at the powerful agency. Since Ms. Pazdur learned she had ovarian cancer in 2012, approvals for drugs have been faster than at any time in the F.D.A.’s modern history. Although companies go through a years long discovery and testing process with new drugs before filing a formal application with the F.D.A., the average decision time on drugs by Dr. Pazdur’s oncology group has come down to five months from six months. That is a major acceleration in a pharmaceutical industry where every month’s delay can mean thousands of lives lost and sometimes of millions of dollars in sales that, given limited patent times, can never be recovered.

Read more: http://www.nytimes.com/2016/01/03/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-approval.html

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