|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 08-23-2005
FDA Reviews of New Drugs May Signal Tougher Scrutiny
This weekís edition contains several articles focusing on the concept of medical innovation and risk: both why it is important to reward risk-taking through free markets, and how innovation can be deterred when Americaís civil justice system inflicts damage awards on corporations that are capricious and arbitrary.
Repercussions from the Vioxx withdrawal may be felt for yearsóboth through the ensuing avalanche of litigation against Merck and through an FDA that feels like its every move is being second-guessed by the media and Congress. The FDA may weather the storm and continue its push to utilize cutting edge science to accelerate drug development and improve drug safety, or it could retreat under political pressure and delay reforms until the smoke clears.
It is too early to tell what path the agency will ultimately take, but as this article notes, FDA advisory committee meetings slated for the next few weeks will give the public and industry a preview of how the agency sees its role in the post-Vioxx era:
In the first two weeks of September, FDA advisory committees will review a series of potential blockbuster drugs, including an inhaled insulin called Exubera, to be marketed by Pfizer Inc.; Bristol-Myers Squibb Co.'s Pargluva for adult-onset diabetes; and another Bristol-Myers medicine, Orencia, aimed at treating rheumatoid arthritis. Analysts predict each drug could have annual sales of more than $1 billion if they pass the FDA approval process.
The industry will view the votes as a signal of how deeply a sense of caution on drug approvals has taken hold, particularly in the wake of last week's $253 million court verdict against Merck & Co. over its painkiller Vioxx, which was voluntarily pulled from the market because of concerns about its safety.
"This is really a critical period," said Tom Garvey, a former FDA official who now consults for the drug industry. "It will be very important to see where they set that balance point between benefit and risk."
Diabetes and arthritis are serious conditions that afflict millions of Americans, and new drugs for these diseases are vitally needed. These drugs, however, may be taken long-term by millions of patients and therefore raise the specter of unpredictable side effects that could haunt the agency years after the drugs are first approved.
Rather than delaying new treatments for years in a vain attempt to eliminate all risks, the FDAóand industryóneed to remind the American public that medical innovation is always fraught with risks, but the riskiest course of all is to abandon the quest for new cures.
Panel wants state to waive stem cell product royalties: Experts say profit interest may discourage private investment
And this is all about advancing the public health, right?
US retirees still wary of Medicare drug plan-study
Itís amazing what a little proactive communications can achieve. While searching for stories on the new prescription drug benefit, I found mostly positive stories Ė and itís about time. (Although I should also mention that these were not the stories being pushed to Page One by The New York Times or the Washington Post.)
Patents versus Patients? Antiretroviral Therapy in India
Itís access not price, stupid.
Drug database canít take doctorís place
Itís not how much information youíve got, itís what you can do with it.
Health Agency Tightens Rules Governing Federal Scientists
Quite a quandary. How do you recruit and retain the best and the brightes and, maintain integrity while, at the same time, treating your professional staff like, well, professionals?
Metabolic syndrome doesn't exist, diabetes groups claim
Itís time that we all begin to look at new solutions to our nationís obesity epidemic. ADA is, surprisingly, not being helpful and one wonders why?
Prescription Drugs: Cigna Launches Web Site To Help Customers Compare Prescription Drug Prices
When asked how consumers can save money on their prescriptions (other than caveat emptor importation), I always point out that comparison-shopping between pharmacies can have a huge impact. So kudos to Cigna for their new web site that shows drug prices for 52,000 pharmacies nationwide (both brick-and-mortar and Internet).
The Lobbying-Industrial Complex
If you build it, they will come.
Stung by Public Distrust, Drug Makers Seek to Heal Image
Breaking news - Pharma industry has image problem. Enough about the problem, how about a thoughtful, long-term solution. (Note to Pharma execs: this means changing what "long-term" means from the end of the quarter to the end of the quarter century.)
Cheap medicine proves a gold mine for Mexican pharmacist in politics
This just scares the bejesus out of me. I hope that Senators Dorgan, Vitter and Grassley have their pesos at the ready.
Drug prices under fire: Pharmacists pocket higher Medi-Cal reimbursements
It is just astounding what politicians will do to advance their careers. Last week Mr. Lockyer was attacking tunafish. As a resident of California, he should be reminded of the Japanese proverb, "Donít fix the blame. Fix the problem."
Whose Vioxx is gored?
And a surprisingly welcome voice is that of Michael Kinsley.
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