F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug - NYTimes.com

F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug - NYTimes.com:
Dr. Hamburg’s decision, outlined in a 69-page memorandum, agrees with the unanimous recommendation made by an F.D.A. advisory committee in June, at the end of a two-day hearing at which some women taking the drug pleaded for its continued approval.
 "An initial clinical trial that was the basis for the provisional approval showed that Avastin, combined with the drug paclitaxel, which is also known by the brand name Taxol, delayed the progression of disease by about five and a half months, compared to use of paclitaxel alone.

But in subsequent studies, in which Avastin was combined with different chemotherapy drugs, tumor growth was delayed by one to three months. Avastin did not prolong lives at all, nor did it improve quality of life.

Many breast cancer specialists say that Avastin does appear to work very well for some patients, and some advocates have said the drug should be left on the market for the sake of those patients. But Dr. Hamburg said there was no way to determine in advance who those patients were, so many women would use the drug. “The evidence does not justify broad exposure to the risks of this drug,” she wrote."

'via Blog this'

Advisers Suggest F.D.A. Limit Menthol Cigarettes - NYTimes.com

Cigarette companies have successfully targeted black smokers

New York times

BUSINESS DAY

Advisers Suggest F.D.A. Review Use of Menthol in Cigarettes

By DUFF WILSON

Published: March 18, 2011

The scientific panel’s findings could provide a legal basis for the F.D.A. to try to limit, phase out or even possibly ban menthol in cigarettes.

80% of Black smoker smoke menthol cigarettes, which have long been the subject of misleading claims by manufacturers who suggest that they are "cool", less dangerous than other cigarettes.

Faulty DePuy Artificial Hip Points to Broken Implant System - NYTimes.com

As I am wont to say about drugs - post-approval is Phase IV: the mass, poorly controlled, human experiment stage, so with devices like hip implants which, if they are "substantially equivalent" to devices already on the market, or make only minor changes, are subject to minimal FDA review.  Followed, of course, by maximum marketing.
“You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr. Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic.
Faulty DePuy Artificial Hip Points to Broken Implant System - NYTimes.com

Graphic warnings: the FDA's proposed new labels on cigarette packs

HERE are the new graphic warnings.  Ey-catching.  But are they effective?  Adequate?  Compared ot other countries?  Look HERE.

Until 2009 when President Obama signed the Family Smoking Prevention and Tobacco Control Act of 2009 that enabled some FDA regulation the only permitted warnings on cigarettes and in cigarette advertising were those prescribed by statute.  The original warning  was set in the Public Health Cigarette Smoking Act of 1969,  15 U. S. C. §§ 1331-134 which provided: 

WARNING: THE SURGEON GENERAL HAS DETERMINED THAT CIGARETTE SMOKING IS DANGEROUS TO YOUR HEALTH

The 1969 Act of Congress also provided

"No requirement or prohibition based on smoking and health shall be imposed under State law with respect  to the advertising or promotion of any cigarettes the packages of which are [lawfully] labeled."

In 1992 in Cippollone v. Liggett The Supreme Court held that  state product liability could not permit a jury to find that warning inadequate because such a verdict would be a  "requirement" beyond what Congress specified.  Thus all tobacco claims - except for those based on fraud - were preempted by federal law.  No "failure to warn" claims were permitted.

If state tort suits had been permitted for "failure to warn" what obstacles would plaintiffs have faced?

When Drugs Cause Problems They Are Supposed to Prevent - NYTimes.com

When new drugs are approved by the FDA they are compared to placebo: i.e. do they do any good? and does the good they appear to do outweigh the toxic side effects? These approvals are all based on quite small samples, and short time frames. Phase IV follows approval. I call it mass marketing: the poorly controlled mass human experiment stage. That may be too kind. Most of the time there is no systematic study of the actual conditions of use, as I discuss in my 2007 article Punctuated Equilibrium, in which I call for recognition of a duty of product stewardship. 


For new drugs - and for old drugs that have been little monitored - that means recognizing their  experimental nature - even after FDA has approved it as "safe and effective".  Their experimental nature  should lead courts to recognize a corresponding duty of product stewardship - a duty of ongoing active study and product development; a duty of the manufacturer to conduct systematic  active post-approval surveillance of the actual use of the product.


The need for such surveillance is highlighted by our experience with drugs like the diabetes drug Avandia - now virtually banned because it increases the risk of heart attack - the principal killer of diabetics.   FDA now permits its use only if every other drug has failed.  The drug's deleterious effects became known not through company study, nor through FDA surveillance, but rather because a prominent cardiologist Steven Nissen in 2007 raised the hue and cry in the pages of the New England Journal of Medicine.

Similar was the Vioxx experience - an anti-arthritic drug competitive with Aleve that caused heart attacks and lasted only 5 years before it was withdrawn.  The lessons of that experience and the additional powers given the FDA in 2007 are explored here by Margaraet Gilhooley, a former Associate General Counsel at the FDA. 


Since 2007 the FDA has had the power to require post-approval studies - but it still has been  employed only rarely.  The problem of drug safety is particularly acute when drugs  - like Avandia - have been mass marketed and the problems which they cause or exacerbate are the very conditions they are meant to treat, or those from which their intended target is particularly likely to suffer - even without the drug. 


As the article by Gina Kolata in today's  New York Times points out drugs which are used long-term for chronic conditions present particularly difficult problems because the mass use of the drug makes active surveillance an expensive proposition. And only recently approved drugs are even subject to the review power that the FDA gained in 2007.

News Analysis - When Avandia and Other Drugs Cause Problems They Are Supposed to Prevent - NYTimes.com