Tuesday Will be a Busy Hearings day — NIH Reform to be Subject of House Energy & Commerce Hearing

Tuesday, September 9, 2008

NIH Reform Act of 2006:
Progress, Challenges, and Next Steps

Subcommittee on Health Hearing

10:00 a.m. in Room 2123
Rayburn House Office Building

Full Committee Chairman
John J.Dingell’s Statement (in full-text)

Subcommittee Chairman
Frank Pallone’s Statement (PDF File)

WITNESS LIST:

Elias A. Zerhouni, M.D.,
Director,
National Institutes of Health
9000 Rockville Pike
Bethesda, MD

LIVE VIDEO LINK, here, on Tuesday.

If time permits, I’ll blog both. That is all.

Today’s New York Times Editorial — on Vytorin and Zetia. . . .

I debated about holding this until the end-of-day, Friday — or, posting on it, over the weekend — inasmuch as it breaks no real “new” ground on the Vytorin/Zetia v. other therapies questions. . . . but on the chance you haven’t already seen it, do go read this editorial, in full. ‘Tis very sober, balanced and still very troubling — here’s a snippet:

. . . .The risks and benefits of a best-selling anti-cholesterol drug remain thoroughly muddled despite a new analysis that purports to exonerate it from the worst safety concerns. For now, patients and doctors are best advised to use Vytorin only as a last resort when other treatments have failed. . . .

A huge marketing effort propelled Vytorin and Zetia to blockbuster status. Then the bad news started coming in. A small clinical trial indicated that while Vytorin reduced cholesterol levels, it failed to slow the growth of fatty plaques in the arteries. A second trial showed that Vytorin did not help people with heart-valve disease avoid further heart problems. Worse yet, that trial suggested that Vytorin increased the risk of developing and dying from cancer. . . .

The F.D.A. will conduct its own analysis of the cancer risks. The agency also needs to evaluate whether it should demand larger and more definitive clinical trials before approving certain drugs. Meanwhile, millions of people are still taking Vytorin and Zetia without knowing whether they are safe and clinically effective. . . .

By the way — here’s the Times‘ most-recent actual reportage on Vytorin/Zetia — from Monday, of this week — as a reference point.

Expect these sorts of articles and editorials to come into play at the Senate Health Care Reform Hearings, starting next Tuesday morning. We’ll cover ‘em — wall to wall. Bank on it.

Today’s New York Times Editorial — on Vytorin and Zetia. . . .

I debated about holding this until the end-of-day, Friday — or, posting on it, over the weekend — inasmuch as it breaks no real “new” ground on the Vytorin/Zetia v. other therapies questions. . . . but on the chance you haven’t already seen it, do go read this editorial, in full. ‘Tis very sober, balanced and still very troubling — here’s a snippet:

. . . .The risks and benefits of a best-selling anti-cholesterol drug remain thoroughly muddled despite a new analysis that purports to exonerate it from the worst safety concerns. For now, patients and doctors are best advised to use Vytorin only as a last resort when other treatments have failed. . . .

A huge marketing effort propelled Vytorin and Zetia to blockbuster status. Then the bad news started coming in. A small clinical trial indicated that while Vytorin reduced cholesterol levels, it failed to slow the growth of fatty plaques in the arteries. A second trial showed that Vytorin did not help people with heart-valve disease avoid further heart problems. Worse yet, that trial suggested that Vytorin increased the risk of developing and dying from cancer. . . .

The F.D.A. will conduct its own analysis of the cancer risks. The agency also needs to evaluate whether it should demand larger and more definitive clinical trials before approving certain drugs. Meanwhile, millions of people are still taking Vytorin and Zetia without knowing whether they are safe and clinically effective. . . .

By the way — here’s the Times‘ most-recent actual reportage on Vytorin/Zetia — from Monday, of this week — as a reference point.

Expect these sorts of articles and editorials to come into play at the Senate Health Care Reform Hearings, starting next Tuesday morning. We’ll cover ‘em — wall to wall. Bank on it.

Middle-School’s Back in Session — and, So is Congress: More Health Care Reform Hearings!

That light — in the distance — is most-definitely not the end of the tunnel — it is the oncoming train’s headlights. Confidential Note to Big Pharma: It is time. to. get. off. the. tracks.

This is the first of three hearings, due to be held in quick succession, before the November elections. . . . Expect much to be made of “profiteering” by pharma — as well as much rhetoric on “commerce coming before science” — again, in pharma. Here’s the run-down on the three scheduled hearings:

September 9 -– Improving health care quality –- examining the importance of measuring and improving the quality of care provided to patients in all settings and learning more about quality improvement initiatives in the private sector.

September 16 –- Delivery system reform –- creating a patient-centered model of care, understanding the importance of primary care and developing new approaches to shore up its role in the health system. [Potentially the most damaging -- to Big Pharma's "business as usual" models.]

September 23 –- Insurance market reform -– exploring ways to improve access to coverage through pooling arrangements, or through the creation of a health insurance exchange or “connector” -– connecting individuals, small businesses and those eligible for premium subsidies to available health insurance plans.

The Full Witness Line-up — for the first Senate hearing:

UNITED STATES SENATE
COMMITTEE HEARING NOTICE

“Improving Health Care Quality:
An Integral Step Toward Health Reform“

September 9, 2008, at 10:00 a.m.,
in 215 Dirksen Senate Office Building

Member Statements:

Senator Max Baucus, MT

Senator Charles Grassley, IA
[On Hearing day, you'll be able to click on each name, above, for full-text, easy-view versions of the Opening Statements.]

Witness Statements [On Hearing day, you'll be able to click on the names of the witnesses to see PDF files of their statements]:

Peter V. Lee, J.D., Executive Director, National Health Policy, Pacific Business Group on Health, San Francisco, CA

Samuel Nussbaum, M.D., Executive Vice President for Clinical Health Policy and Chief Medical Officer, WellPoint, Inc., Indianapolis, IN

Gregory Schoen, M.D., Regional Medical Director, Fairview Northland Health Services, Princeton, MN

Kevin B. Weiss, M.D., President and CEO, American Board of Medical Specialties, Evanston, IL

William L. Roper, M.D., M.P.H., Dean, School of Medicine, University of North Carolina and Vice Chancellor for Medical Affairs and CEO, UNC Health Care System, Chapel Hill, NC

By Order of the Chairman:

Max Baucus (D, MT),
United States Senator,
and Chairman, Senate
Committee on Finance

And By:

Charles S. Grassley (R, IA)
United States Senator
and Ranking Member,
Committee on Finance

We’ll have LIVE video, and when the below-light is “ON” — live-blogging underway — so do join us!

PM — at Gooznews — On SEAS, NEJM and Peto

This is very solid, serious stuff — do go read it.

“Quelle für die Bilder” — How cool is THAT?!

~~~~~~~~~~~~~~~
UPDATED — 09.05.08 @ 4 PM EDT
~~~~~~~~~~~~~~~

The author of the below blog liked my calling that joint “The Big Sneeze“.

That is all.

~~~~~~~~~~~~~~~

I think this may be the first non-English-language site to use my graphics, and link to this site (though some might argue that a fair chunk of what I write isn’t really in the native English tongue, either, afterall!) — Cool, nonetheless!

The name of the blog is pretty darn clever, as well: gesundheit.blogger.de

Of course — this is exactly what I intended to have happen, in deciding to make all my content public domain (or “copy-left“, if you will) — that it would be spread across the wide web, from Germany to Malta, from Beijing to Nome, from Texas to Rome. . . .

Quoting the Big Sneeze(!), now:

. . . .Inegy® und Krebs: Statistik für FortgeschritteneDie Argumentation des unabhängigen und weltbesten Statistikers Richard Peto, der im Auftrag der Hersteller von Inegy® (in den USA: Vytorin®) dem Verdacht auf ein durch das Medikament erhöhtes Krebsrisiko nachgegangen ist, lässt sich kurz zusammenfassen.

In der SEAS-Studie entwickelte sich die Anzahl der Krebstodesfälle in der Tat beunruhigend und war um fast 70 Prozent erhöht. . . .

 

 

 

The (rather inartful) babble-fish translation, into English version reads thus — but you’ll catch the main idea, right away “. . . .The argument of the independent and world Statistikers Richard Peto, on behalf of producers of Inegy ® (in the U.S.: Vytorin ®) to a suspected by the drug increased risk of cancer is pursued, can be summarized briefly. In the SEAS study developed the number of cancer deaths indeed worrying and was almost 70 percent. . . .”

How do you say “Ouch” — in German?

PM — at Gooznews — On SEAS, NEJM and Peto

This is very solid, serious stuff — do go read it.

"Quelle für die Bilder" — How cool is THAT?!

~~~~~~~~~~~~~~~
UPDATED — 09.05.08 @ 4 PM EDT
~~~~~~~~~~~~~~~

The author of the below blog liked my calling that joint “The Big Sneeze“.

That is all.

~~~~~~~~~~~~~~~

I think this may be the first non-English-language site to use my graphics, and link to this site (though some might argue that a fair chunk of what I write isn’t really in the native English tongue, either, afterall!) — Cool, nonetheless!

The name of the blog is pretty darn clever, as well: gesundheit.blogger.de

Of course — this is exactly what I intended to have happen, in deciding to make all my content public domain (or “copy-left“, if you will) — that it would be spread across the wide web, from Germany to Malta, from Beijing to Nome, from Texas to Rome. . . .

Quoting the Big Sneeze(!), now:

. . . .Inegy® und Krebs: Statistik für Fortgeschrittene

Die Argumentation des unabhängigen und weltbesten Statistikers Richard Peto, der im Auftrag der Hersteller von Inegy® (in den USA: Vytorin®) dem Verdacht auf ein durch das Medikament erhöhtes Krebsrisiko nachgegangen ist, lässt sich kurz zusammenfassen.

In der SEAS-Studie entwickelte sich die Anzahl der Krebstodesfälle in der Tat beunruhigend und war um fast 70 Prozent erhöht. . . .

The (rather inartful) babble-fish translation, into English version reads thus — but you’ll catch the main idea, right away “. . . .The argument of the independent and world Statistikers Richard Peto, on behalf of producers of Inegy ® (in the U.S.: Vytorin ®) to a suspected by the drug increased risk of cancer is pursued, can be summarized briefly. In the SEAS study developed the number of cancer deaths indeed worrying and was almost 70 percent. . . .”

How do you say “Ouch” — in German?