Latest Drugwonks' Blog
Interesting article by Anna Mathews in today’s edition of the Wall Street Journal on how the FDA approaches the regulation of prescription drug product names.
Here’s a sample …
“The FDA’s scrutiny, an odd corner of the federal bureaucracy where language meets safety, is a growing problem for drug companies. They spend as much as $1 million per product making up, checking and registering words like Lipitor, Prozac and Zyprexa. In the 2004 fiscal year, the agency’s name-safety reviewers turned down 123, or 36%, of the proposed names they received. That was up from 90, or 29%, the year before, and 86, or 31%, in 2002. The rejection rate now may be even higher. The FDA recently toughened its procedure by requiring that possible names be checked against overseas brands because of concerns about U.S. drugs that have names identical to some used abroad, but very different uses.”
“To find out whether a drug works, a manufacturer runs studies, with the guidance of the FDA. The agency then decides whether the product merits approval. With a proposed name, the agency does its own internal tests to see whether the name is likely to be confused with that of an existing drug. The tests involve writing the names on mock prescriptions to check how they would look in real-world conditions, conducting Web searches and using a proprietary software program that the agency has never released.”
The full story (and it is worth reading) can be found at: http://online.wsj.com/article/SB114255589999700763.html
Here’s a link the the FDA’s Critical Path Opportunities Report.
Yesterday I spent a lot of time talking to reporters about why I believe Andy von Eschenbach will make a terrific FDA Commissioner. Today all the news is about Plan B. And while that’s certainly relevant, what about some background on AvE? Isn’t that important information for the public to know? Doesn’t the media have a responsibility to report it?
Guess not. Too bad. We will.
It’s official. President Bush nominates Andy.
It’s news today — even though DrugWonks reported it last week.
But whatever — it’s the right choice.
Bob Goldberg calls it like he sees it …
Last week, according to Fox News, South Carolina Senator Lindsay Graham urged GOP activists to make sure the party returns to its roots before Election Day. “We’re not going to win by being Democrats,” he said “Conservatism sells.”
Does being a conservative include voting to place the pharmaceutical and biotechnology industry under the the same government controls that exist in Canada and the United Kingdom? The same controls that have destroyed innovation and delayed access to new medicines in Germany? How does Graham’s flirtation with command and control health care square with his desire to ensure the party returns to its roots? Or does he mean pushing conservative principles six feet under?
Bob Goldberg has his mind in the toilet as well …
The last time I checked Costco did not control 60 percent of the toilet paper market and therefore did not, as a matter of course tell people to use the Kirkland (that’s the Costco house brand for you outsiders) before stepping up to the Charmin two-ply plush. And by the way, if you don’t like Costco’s limited selection of items for each type of good, you can go to Walmart or Target or Kohl’s or any number of department stores, etc.
This is not about price. This is all about choice and value. And the fact is there is not one example, not one, of a government system “negotiating” drug prices where access to medicines are not delayed or denied and where the total cost of treating disease does not balloon as a result and where people do not die waiting for important drugs. THEY are the ones making this about saving money. Let’s make this a battle about saving lives now and in the future.
According to a story running on the AP wire today, “Spending on brand advertising is flat while disease awareness campaigns are flourishing. The look of the ads are more straightforward; doctors bluntly describing products is becoming de rigueur.”
Read that out loud. That’s the sound of voluntary guidelines working.
The AP continues, “The possibility of more government regulation looms. Late last year, the Food and Drug Administration held two days of public hearings on drug advertising and is now reviewing comments on the subject. The FDA said it is too early to say whether any new rules will be instituted, but some say it is likely.”
Well, I was there (in fact, I testified) and the message from the senior management of the FDA who sat on the panel was NOT that new rules would be instituted, but rather that the agency and industry need to work together to make direct-to-consumer communications better.
And that’s a good thing.
For the growing chorus of politicians who think that Medicare Part D should look more like the benefits offered by the VA, consider the following …
(1) A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA National Formulary’s drugs are more than 8 years old, with just 19% of its prescription drugs approved since 2000 and 38% of prescription drugs approved between 1990-2000.
(2) The VA imposes an automatic one-year hold on most new medicines while it “studies” the effects.” For many important medicines such as Gleevec for stomach cancer or drugs for mental illness, patients must “fail first” on a cheaper drug before they get a breakthrough.
(3) Lichtenberg found that veterans’ life expectancy increased significantly before the National Formulary was introduced (between 1991-1997)) but did not increase and may have declined after the National Formulary was introduced (between 1997-2002). Yet, the life expectancy of all U.S. males increased both before and after 1997.
Remember the character-assasination job that Alicia Munday did awhile back in the Seattle Times? Well here’s what one of their own editorial writers had to say about it. And all I can add is “well done!”
Our Man at the F.D.A.
The Times’ page one story on Scott Gottlieb, the Wall Street analyst hired by the Food and Drug Administration is an editorializing story — a story with a message. We can tell the story straight — and our reporter, Alicia Mundy, tells it pretty straight, but the premise of it, the definition of it as a story, carries a message of the fox guarding the henhouse or “regulatory capture,” meaning an industry influencing its regulator.
Our reporter has put in a resume of Mr. Gottlieb, and so we can have a rough measure of his attachments to Wall Street. He ran a Forbes investment newsletter for about half a year, also participating as a policy guy at the American Enterprise Institute, a right-of-center policy shop. He has previously worked for the FDA in medical policy under the Bush administration. He has worked for George Gilder, who writes about investments and policy from a pro-technology view. He has been a medical internist at a hospital. In the Clinton years he wrote for the Journal of the American Medical Association and worked in the investment firm Alex. Brown. His degree is in economics.
My question is: For a policy job, would it have been preferable to hire a person who had been in the bureaucracy for an entire career? Certainly there are people like that, and probably lots at the FDA. Probably the lifetime regulators are more pro-regulation than Mr. Gottlieb will be. The unspoken assumption of this story is that that’s what the public should want.
It’s not what I want. I want innovation, I want information, and I want choice. I want new drugs to be tested and reviewed, but I don’t want the system to be so safety-conscious that I can’t get the drugs I need. The fact is, people are suffering and dying now. New medicines may be able to help them. If you insist on a drug-approval system of near-zero risk, you delay the new medicines and more people suffer and die. You can die from taking a drug that should have been studied longer and you can die from not getting a drug that should have been approved earlier.
There is also the question of whether people who are sick should be allowed to make these choices themselves. If you have cancer, and it’s going to take five years to review a new drug to a zero-risk standard, maybe you don’t want to wait five years. Maybe you want the drug now. I think the system should allow that — and (judging from one newspaper article) Mr. Gottlieb is more likely to consider that point of view than someone who has been a regulator all his adult life.
Bruce Ramsey, Editorial Writer, The Seattle Times
I’ll be speaking in Brussels on how Europe can begin to embrace and then help to educate the empowered 21st century health care consumer. Here’s more information …
The Amigo Society invites you to discuss:
“Consumers and Health Information: Is knowledge really power?”
Featuring:
Peter J. Pitts
Former Associate Commissioner
Food and Drug Administration (USA)
Commentators:
James Copping,
European Commission
(High Level Pharmaceutical Forum)
Colin Webb
Vice-President, European Patients’ Forum
A recent consumer survey in Europe asked people in eight old and new EU member countries what reforms would most likely increase their quality of care. In every nation, by a large margin, “giving patients more information about their illness” was the preferred solution.
Health care education is the consumer’s Rosetta Stone. Public policy institutes, pharmaceutical companies, health care professionals and patient advocates, along with government must be allied in the drive to deliver information to patients, for it is, ultimately, about saving lives and saving our health care systems. Moreover, increasing information to patients will improve disease awareness and aid in defeating patient non-compliance estimated to cost billions of euros a year in increased emergency room visits, unnecessary surgeries, expensive hospital stays, and lost productivity.
To debate and discuss the value of these arguments, please join us on:
Tuesday 21 March 2006
7-8:30 pm (cocktails to follow)
Hotel Amigo, Rue de l’Amigo 1-3, Brussels
To RSVP visit
http://www.stockholm-network.org/conferences/events/signup.php
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.
