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Not Brazil. Their main concern was related to the definition of counterfeits because of its intellectual property rights (IPR) implications. One of Brazil’s hang-ups centered on the potential inclusion of "substandard" medicines” in the overall definition of “counterfeits” -- which Brazil sees as a code word for unauthorized generics and similares.
And not India. According to Gopa Kumar, research officer at the Centre for Trade and Development, “Counterfeiting is an issue of trademark violation and has no bearing on public health.”
Yep – that’s a direct quote, Check it out here:
http://www.livemint.com/2008/05/23004023/India-fears-generic-drugs-may.html
The only thing this absurd rhetoric from Brazil and India puts into context is the pretzel logic gyrations of Jamie Love and his Sci-Fi obsession over the “definition” of counterfeits.
For more on this, see “Putting Lipstick on a Blister Pack” here:
http://www.drugwonks.com/blog/putting_lipstick_on_a_blister_pack/
This time the clock was on the side of Brazil and India because there was insufficient time to convene a drafting group to resolve the resolution. But the resolution (proposed by Nigeria and others), to aggressively address the problem – and define counterfeiting for what it is – criminal international health care terrorism, is on the table for discussion at the Executive Board meeting in January. That’s concrete progress.
And remember the words of Hubert Humphrey:
“Things are not only what they are. They are, in very important respects, what they seem to be.”
www.stats.org/stories/2008/prozac_wars_may12_08.html
The blogs that have allowed these posting -- unfiltered -- know better and bear a responsibility for allowing the attacks and vitriol to become so unhinged and personal. We recommend that you review some of the post as www.pharmalot.com
or www.pharmagiles.com that in particular mocks my use of medications and that of my daughter's to see what we happily deal with....
These are sad, hateful people. The problem is they often reflect and influence the thinking of people like Brownlee and Lenzer who are considered mainstream.
We at CMPI are simply trying to insure that people get the right medicine at the right time. No more, no less.
I know the difference of course. And as far as progression free survival not being helpful or not being a quality of life measure..many cancer patients and physicians would beg to differ. If the commenter regards as a low bar standard then he can apply to himself, his loved ones and his friends. But don't impose it on me and my family. Improved survival overall in a disease that is as genetically diverse in origin and progression as cancer is total nonsense, a dodge for denying access and it is the ultimate low bar standard. It is death sentence for sure.
From Idea to Commercialization”
An Executive Program for Biotechnology and Medical Device Entrepreneurs and Managers.
The Faculty of Management of Tel-Aviv University, the Israel Life Science Industry Organization (ILSI), The Center for Medicine in the Public Interest and International Institute for Biotechnology Entrepreneurship (a non-profit global contribution by Burrill & Company) are now holding the second program “Health Care Technological Innovation - From Idea to Commercialization.”
This program focuses on the critical elements in the formation, launch, and strategic and operational management of health-related technologies, with a particular focus on companies working in medicinal biotechnology, enabling technologies for life-science research, and medical devices used in human diagnosis and treatment.
We have had many excellent presentations focusing the value-driven reimbursement, personalized medicine as a platform for comparative effectiveness and the role of the Critical Path as a framework for demonstrating risks and benefits of products over the life of a product.
At the same time, Peter Pitts is featured in The Journal of Biolaw and Business Special Commemorative Edition published in honor of Israel's 60th anniversary. His article: "FDA and the Critical Path to 21st Century Medicine" is based on his presentation at the first CMPI sponsored seminar for Israeli life science startups in November 2007.
For the abstract and more info on The Journal go to www.biolawbusiness.com
PS I am also in Israel to see my son receive his beret after completing basic training in the IDF.
Here's the photo.
Everyone, it seems (including my hero, Will Shortz) wants to talk about safety.
And nobody more so (or more appropriately so) than the FDA. Remember -- it was Milton Friedman who said that the FDA was "obsessed with safety." And while Professor Friedman didn't mean it as a badge of honor -- it was taken as such by the 10,000 dedicated public servants at the agency.
But, unfortunately, safety seems only to "sell" when there's a tabloid quality to it. Ask yourself this: What do Vioxx and Avandia and Heparin all have in common? Answer: Page One coverage.
In today's New York Times, reporting on the FDA's new "Sentinel" program appears on Page A18 -- on a slow news day.
It's just another example of tabloid journalism trumping solid reporting. And, for the record, the article in the New York Times by Gardiner Harris is a solid piece of reporting. Have a look :
www.nytimes.com/2008/05/23/washington/23fda.html
Tabloid is easy. Quality is hard.
Tim, as you may already know, has announced his retirement from Eli Lilly & Co. where he served for 22 years (most recently as Vice President for Global Regulatory Affairs).
Tim is a scientist -- and a believer in the art of the possible. Tim-Possible.
When I served at the FDA, Tim offered sage advice and pointed criticism. Both were served with the best interests of the public health in mind -- and his inevitable impish smile.
His one note, high-pitched "HA!" is a trademark.
One of the architects of PDUFA, Tim was also one one of the first people the FDA recruited to discuss the nascent concept of the Critical Path. He loved the idea but also helped to identify some of the problems.
Tim is a guy who, as the old Jewish joke goes, "knows where the rocks are."
His regulatory knowledge is nonpareil and his optimism is contagious.
We wish him well in all of his new endeavors.
Yesterday Jamie Love e-mailed Bruce Sterling (the science fiction) and asked him to help come up with a new term for counterfeiting because, “There are significant problems with overusing the term.” Science Fiction? Give me a break.
In any event, it's a moot point because there is already a word that accurately describes international prescription drug counterfeiting – that word is “crime.” And it translates accurately into most languages.
(As far as Jamie's "significant problems" are concerned, that's another issue for another time.)
Personalized medicine for quicker cures
As we listen to presidential candidates and Congress debate how to control health care and drug costs and raise drug safety standards, most solutions lead to increased government regulation. That is underlined when debate turns to cancer care with high-cost drugs and low returns in quality of life and survival.
But more government regulation on reimbursement rates and overly burdensome drug development requirements will result in less medical innovation and rationing of medical care. What's missing from the debate is the public policy encouragement to produce more "smart" medicine.
One of the hardest parts about being an oncologist is telling patients they have cancer. Even harder, though, is knowing that the drugs prescribed don't work well in most patients and/or will cause severe side effects in others.
That is changing. Scientists working at biotechnology companies are using the knowledge of the human genome to develop drugs targeted to help individual patients. That concept -- known as personalized medicine -- holds the promise of improving care for patients and quickening the pace of drug development so we can "hurt the cancer more than the patient."
The human genome has shown us how our genes affect our health -- including whether we are at risk of disease. Recent advances in DNA research also have taught us how to examine what happens to a cancer tumor's gene or set of genes when they are turned on or off in the presence of a drug.
At my company, Cell Therapeutics Inc., one of our subsidiaries, Systems Medicine, is examining the function of genes in a tumor through a process called genetic profiling. SM examines about 30,000 relevant genes from tumor cells and tests them to determine which gene or genes make the tumor susceptible to the effects of different cancer drugs. Using that technique, we can identify which cancers are sensitive to which drugs. It is a fundamental shift in approaching the dilemma of which is the right drug for the right patient while exposing the least number of patients to a drug's severe side effects.
The power of this technology is enormous. Rather than imposing new regulations on manufacturers or physicians, the most effective way to ensure safety is to use scientific advances to better understand why some patients react badly to some drugs, and encourage development of new diagnostics and therapies that take that into account.
Adoption of personalized medicine will mean that patients will get quicker access to the newest cancer therapies. The current time and cost of drug development is about 16 years and $1.7 billion. Cancer drug development is actually the least-efficient in all of medicine. Genetic profiling could shorten clinical development time and costs because only those patients likely to benefit will be enrolled in clinical trials, making it easier for regulators to make safety and efficacy decisions more quickly.
But, federal regulators need to understand the value personalized medicine can bring and develop policies that encourage development of these new drugs and diagnostics, while doctors need to understand the power of genetic profiling so they can make good prescribing decisions. Some day, instead of physicians diagnosing lung cancer or colon cancer based on where the tissue is from and the way a tissue looks under the microscope, we may be referring to a genetic profile of a tumor in your lung or colon tissue recognizing that the genes that make each of us unique also makes our cancers unique.
The product is Ivory Soap -- and it's only 99 and 44/100th% pure. Should it be taken off the market?
Silly? Not when you consider that the current debate over drug safety is being hijacked by the Panjandrums of the Precautionary Principle. What we need is a debate on smart safety.
Have a look at this new op-ed in The Journal of Life Sciences, "A Balancing Act:."
Here's the link:
www.tjols.com/article-662.html
And here's a taste:
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
