Sachs Appeal

• 11.19.2008

Sorry for the late evening post, but I've been at 24th IFPMA Assembly in Washington, DC. all day.

Some highlights:

The luncheon keynoter was Jeffrey Sachs, Quetelet Professor of Sustainable Development and Professor of Health Policy and Management at Columbia University -- but he's probably better known you drugwonks out there as the Director of the Earth Institute and author of "Common Wealth" and "The End of Poverty." Most of his talk was of the usual garden-variety "more government, please" variety -- but he did say one thing worth mentioning, that although he has some serious issues with pharmaceutical patents, "lifesaving innovation would be impossible without them." Yes -- "impossible." I wonder what Jamie Love will have to say about that?

The best panel of the day featured the health ministers from Kenya and Uganda (Peter Anyang' Nyong'o and Richard Nduhuura respectively), who spoke of their nations' need for enhanced healthcare infrastructure -- and then Alessandro Banchi (Chairman, Boehringer Ingelheim) laid it it out in black and white, "The elephant in the room is the fragility of healthcare systems -- not the price of drugs." Neither of the two ministers objected.

Zhang Weibo (Director, Pharmaceutical & Biological Review, People's Republic of China), spoke on the issue of IP and TCM (Traditional Chinese Medicine) -- an issue that deserves further discussion -- and will certainly get it. (Note to Congress: Better open the fortune cookie and start thinking about DSHEA reform.)

Swati Piramal (Director of Strategic Alliances, Piramal Healthcare, Ltd, India) spoke about India's emergence as a nation of pharmacetical innovation. She said her firm has a few drugs in the pipeline that can be brought to market for under $100,000,000. That got people's attention.

More from the IFPMA Assembly tomorrow.

Return Policy

• 11.18.2008

Return Policy:

If you wish to return your donation, please contact us at (212) 417-9169. Please give us your order #,  the amount you'd like us to return, and the reason. We will call you, generally within 5 business days, to arrange the necessary refunds.

Any donations made cannot be returned after 30 days.

Pharma's Margin Call

• 11.17.2008

PS/ The faucet leaks

• 11.17.2008

In what he referred to as a “note on the desk” to the next Secretary of Health and Human Services, Mike Leavitt, the current inhabitant of that seat released “The Personalized Health Care Initiative.”  Personalized health care should be an "explicit goal of health care reform,'' Leavitt said.

According to the HHS website, “The Personalized Health Care Initiative will improve the safety, quality and effectiveness of healthcare for every patient in the US.  By using “genomics”, or the identification of genes and how they relate to drug treatment, personalized health care will enable medicine to be tailored to each person’s needs. Healthcare that is proactive, instead of reactive, gives the patient the opportunity to become more involved in their own wellness.”

HHS seeks to advance this Initiative through two guiding principles:

(1) Provide federal leadership supporting research addressing individual aspects of disease and disease prevention with the ultimate goal of shaping preventive and diagnostic care to match each person’s unique genetic characteristics.

(2) Create a “network of networks” to aggregate anonymous health care data to help researchers establish patterns and identify genetic “definitions” to existing diseases.

Oh well, better late than never. (The complete report can be found here.)

Hopefully there is a longer memo (perhaps with the keys to the backdoor and the security code to the secretarial washroom) on the urgent need to fund the Reagan/Udall Foundation.

Lewis Black: Equal Opportunity Offender

• 11.14.2008

The great Lewis Black expounds on why politics is a renewable resource for comedians...

NICE Birthday Wishes to Prince Charles

• 11.14.2008

Yesterday I had an op-ed in the Washington Examiner, “Obama, Congress Should Learn from Britain’s Healthcare Failings,” where I make the point that “NICE’s failings indicate that government is liable to misuse drug approval power, and they should arouse suspicion about the merits of additional government intervention in the healthcare market. The British government is finally giving patients and physicians the freedom they need to best combat disease. American lawmakers should follow their lead.”

But what I’d like to share with you is a comment that was posted in response to my discussion of NICE and its implications for US healthcare reform.

Here it is:

“Pitts cannot hope to cover all of the NHS's sins in a short piece. They also instruct doctors to lie to patients, informing them that life-saving treatments do not exist, when the NHS has merely decided the procedures are too pricey. It is better, in the view of the NHS, that people die rather than complain. Also, thousands die in their hospitals each year because staff cannot be bothered to wash their filthy hands. A trip to the NHS is often a death sentence, pure and simple."

And to that all I can add is, “Happy 60th Birthday, Prince Charles.”

Health Policy Shocker: Commonwealth Survey Finds US Healthcare Worst in World Yet Again

• 11.13.2008

Pearls from the Tevi Fountain

• 11.13.2008

Congratulations.  You’ve survived the “valley of death,” emerged from the “tar pit of safety," successfully forged the Critical Path and received FDA approval.  Mazel tov.  Now you’ve earned the privilege of fighting with CMS and a potential AHRQ comparative effectiveness review.

And it’s been ambiguity all the way down the line.

So here’s some welcome news: Tevi Troy, the HHS DepSec will host a series of conferences over the next two months to discuss how different HHS agencies can help improve the process.  And is there anyone out there who feels improvement is not required?

The first conference takes place this Friday, November 14th at HHS HQ (aka the Hubert Humphrey Building) in Washington, DC. December forums are being scheduled for the west coast and Midwest.

At this first meeting, senior officials from NIH, FDA, CMS, and AHRQ will discuss (and likely have to defend) their agencies’ roles in facilitating the development of innovative medical technologies. 

Topics include:
          
* The role of basic and clinical research conducted and supported by the NIH in the development of new products;

* FDA's efforts to use state-of-the-art science in support of medical product development, as well as to promote consistency and efficiency in medical product review;

* CMS’ perspective on the challenges innovators face in current reimbursement and coverage processes and how innovators can better navigate the system and;

* AHRQ’s role in promoting quality research and value exchanges and how these benefit innovators.

For more details, contact the HHS press office at (202) 690-6343.

And tell them Drugwonks sent you.

A Baucus Caucus

• 11.13.2008

Senator Baucus, in his white paper, "A Call to Action," says that "his door is open."  That's good news -- because when it comes to something as crucial and complicated as healthcare reform, a welcome mat beats a baseball bat.  To view the Senator's document, click here.  There's not a lot of detail -- more of a conceptual blueprint.  And that's the right way to begin.

A Ray of Hope

• 11.12.2008

My candidate for FDA commissioner, Ray Woosley, (I said that to ensure he stays right where he is!) once again demonstrates that productive public-private partnerships are critical to promoting a new era of personalized medicine. Ray's leadership and dedication has sustained the Critical Path Intiative and supported the vision of Mark McClellan, Janet Woodcock and others at th FDA who launched it nearly 4 years ago.

 

C-Path Expands Partnerships to Speed Development of Critical New Drug Therapies

 

Dear Friend of C-Path:

Thanks to Arizona supporters, C-Path was created in Tucson four short years ago and we have been very successful in bringing drastic improvements to the methods used to evaluate new drugs and diagnostic tests; changes that are advancing personalized medicine. In addition, Arizona’s Governor, The Honorable Janet Napolitano, along with our state and federal legislators, have been very supportive of our work and our mission.

One of the state’s truly innovative new programs is Science Foundation Arizona (SFAz) which provides highly competitive grants to support meritorious collaborations between scientists and businesses in Arizona. Last year we were fortunate to receive one of the first of these highly competitive awards.

And again, I am extremely pleased to tell you that we have just been awarded a four year SFAz grant for $9 million. With this award, we will be able to expand our work and form additional industry-FDA consortia. These new consortia will improve our understanding of major diseases such as Alzheimer’s and Parkinson’s so that, when effective treatments are discovered, they can be developed in less than three years and with a 95% chance of success; not the current situation, 15 years and a 5% chance of success.

Thank you for your friendship and interest in C-Path.

Best wishes,

 

Ray Woosley