Latest Drugwonks' Blog

Ten years ago, few people predicted the impact of the Internet or the cell phone. Today the digital revolution has transformed the way we work, live and learn. Information is being turned into knowledge literally at the speed of light. Today, we are on the verge of another revolution that will dramatically change the way we live and how well we live.

So why aren’t people paying attention?

Over the next decade, researchers will use genomics to develop many more disease-specific drugs and diagnostics to predict who will respond best and who needs a medicine most than ever before. And medical information will be used to discover the best way to care for people based upon their unique genetic and individual circumstances.

So why doesn’t the media write about it more (or more enthusiastically)?

Drug, biotech and diagnostic firms are already gathering genetic information on patients taking part in clinical trials. New technological tools are currently available or under development that will help achieve this vision. The real concern, for industry and society alike, is not that technology will not advance, but that the technology itself will not be fully used.

So why isn’t government doing something to help FDA facilitate and advance the public health?

Last week the FDA announced the next phase of the Critical Path project — and in great detail. Unfortunately the announcement was largely ignored by the media, assorted thought-leaders, and our elected representatives.

We here at drugwonks.com will do our best to fill in the blanks, but we’d certainly appreciate some assistance from the MSM

Well, not really. But I did enjoy my 12 minute live segment on last night’s NewsHour with Jim Lehrer. Ray Suarez interviewed me and Dr. Alistair Wood on the future of the FDA. We talked about Andy von Eschenbach and Critical Path, and personalized medicine, and the fact that if we want the FDA to do more we need to make sure the agency is properly funded. And, yes, we also touched on Plan B.

Here’s a link to the audio archive: http://www.pbs.org/newshour/newshour_index.html

And here’s the video clip (“FDA Under Fire”): http://www.pbs.org/newshour/video/

The Name Game

  • 03.17.2006

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.

Download file

Andy who?

  • 03.16.2006

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.

Graham Crackers

  • 03.15.2006

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.

VA is not the way

  • 03.13.2006

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.

CMPI

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.

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