Medical Students On the Take From Tort Lawyers

• 06.12.2008

Nailing Nissen

• 06.12.2008

Max Senate

• 06.12.2008

Here's a safe prediction about our next President -- He'll be a Senator.

To that end, we thought it would be interesting and important to see what some of the elite 100 think on the topic of American healthcare reform.

So we asked.

Have a look at two new video podcasts with Senator Richard Burr (R, NC) and Senator Bob Corker (R, TN).

Here are the direct links:

Senator Burr: www.vimeio.com/1148600

Senator Corker: www.vimeo.com/1155911

Other newsmaker podcasts can be found at www.cmpi.org

Patients are a Virtue

• 06.12.2008

New York State Assemblyman Richard Gottfried has introduced a bill that would place severe restrictions on those who sell prescription drugs.

The goal, no doubt, is to appear tough with drug companies. Given the rising cost of health care, this is politically understandable. Unfortunately, the proposed bill would only make doctors' jobs harder -- depriving them of vital information and undermining their ability to make the best clinical decisions possible. Ultimately, patients will pay the price.

Read the full op-ed from today’s edition of the Albany Times-Union

This back-handed attempt to prohibit off-label prescribing is nothing more than yet another inappropriate government intervention into the doctor's office. Gottfried's bill may make for good political theater, but the grandstanding ignores a fundamental truth: Doctors, not bureaucrats, know their patients' medical needs best.

Now Pitching for the Yankees....

• 06.11.2008

Pfizer Connects the Dots

• 06.11.2008

Pfizer will directly fund basic research in an open-ended collaboration with Univ of Calif San Francisco..I hope this gives the connect dots crowd angina (that drugs developed through this deal with Satan can treat) so that they in turn can refuse them based on the Pharmalot principles:

1. Any drug developed by a collaboration with BIG PHARMA is by definition less effective and more dangerous than literature and FDA documents state and is more dangerous and less effective than bloggers, trial lawyers and unbalanced patients proclaim.

2. Any older drug is safer and more effective than any newer drug even though every older drug was developed in the same fashion as newer drugs.

3. Newer drugs are more dangerous and less effective older drugs because older drugs are made by generic companies who don't market products and newer drugs are approved by an FDA run by a Bush administration appointee.

4. Any research produced by anyone who has ever consulted with or conducted research for a biotech or pharmaceutical firm is tainted and the results, though reproduced and validated by scientific methods, are false.

5. Except Steve Nissen.


6. Or Curt Furberg

www.sfgate.com/cgi-bin/article.cgi

The Wearin' o’ the Vermillion

• 06.11.2008

The Wall Street Journal reports that, “The criminal-investigations wing of the Food and Drug Administration is in hot water with Democrats and Republicans in both the Senate and the House.”

That would be the he Office of Criminal Investigations, the OCI. It seems that many of the usual suspect FDA-bashers (Senator Grassley, Mr. Stupack, Mr. Barton) are “concerned” that the OCI is being pressured to pursue some cases (like the abuse of scheduled medicines such as Oxycontin or ingredients for methamphetamine) while ignoring others (like the brouhaha over Ketek clinical trial oversight).

Why would the OCI focus on the former rather than the latter? Hint: Much larger public health issues. Why would some politicians want the OCI to reverse its priorities? Could it be … politics? After all, bashing Big Pharma (or, if you prefer, Big Pinata) is much sexier, garnering much bigger headlines.

It's also important to mention the OCI's central role in fighting counterfeit drugs (aka: international healthcare terrorism). But saying "thank you" isn't in the current Congressional lexicon. Too bad. OCI's earned it many times over.

According to the Journal, “Mr. Grassley has already cut into OCI's autonomy. For nearly a decade, OCI worked under a little-known memorandum of agreement that gave OCI precedence over the Inspector General's office at Health and Human Services Department in conducting internal-affairs cases. That authority was withdrawn at the end of 2007 after Mr. Grassley complained that OCI selectively investigated FDA whistleblowers.”

There’s a difference between whistleblowers and felons. Note: Releasing internal FDA documents to the media is a felony.

As if the slight to the very hard working and dedicated OCI staff wasn’t bad enough – the WSJ article singles out the OCI’s director, Terry Vermillion, for particular abuse.

“Mr. Vermillion hasn't been made available for interviews. He came under fire from Democrats and Republicans last year when news reports revealed that large bonuses pushed his take-home pay for 2006 to $198,000, more than that of a member of Congress or a Supreme Court justice."

Note to Alicia Mundy: What about all those Congressional perks? They sure add up --and quite nicely. FDA perks are restricted to parking spaces at HQ. Sloppy reporting. (I assume the Supremes must have pretty nifty perks too.)

Terry is a tough mother you-know-what. Precisely the kind of guy you want running the FDA’s Office of Criminal Investigations. And I say that from personal, first-hand knowledge and experience.

And he’s got a BS tolerance about the size of a pea. Anybody who would be foolish enough to tell him to selectively do his job would be in for a very unwelcome and brutal surprise.

Another shameful show trial? Yes. But what’s worse is that it continues to erode FDA morale and dampen esprit de corps -- just at a time when the agency (and the country) needs it more than ever.

Tabloid Medicine: The Prequel

• 06.10.2008

Prescription for Paperwork

• 06.10.2008

As Albany considers healthcare reform, CMPI Chairman, Dr. Michael Weber warms that the unintended consequences may very well be a prescription for paperwork trumping public health.

Here are the first two paragraphs from his op-ed in today’s edition of the New York Post:

“FEW relationships are more personal - and private - than the one between patient and doctor. Unfortunately, this fact appears to be lost on New York's politicians.

Gov. Paterson is now backing legislation designed to limit the influence drug companies wield over doctors. The goal may sound reasonable - but the bill itself would bring a massive and unnecessary government intrusion into individual medical decisions.”

Click here for the complete article

To see Dr. Weber discuss this and similar issues on a recent CMPI video podcast, click here:

http://www.vimeo.com/1045899

As Dr. Weber writes, “Gov. Paterson means well in promoting these "reforms" - but he's wrong. The bill would only drive up medical costs by producing reams of added paperwork for doctors, patients and administrators alike.”

Money talks. Healthcare walks.

• 06.10.2008

Last week I attended a conference of European pharmaceutical executives, legislators, and regulatory officials.  The theme was “Economics and Ethics.”

 
While the “universal” consensus was that ethics are primary – economics came in a very close second.  One robustly debated theme was the idea of “an ethical standard based on resources.”

In other words, reality.

 We live in the real world where increasing drug development costs and shrinking resources for reimbursement (government-paid in the case of the Europeans) cannot be ignored when it comes to either green-lighting a development program or making an access decision based on healthcare technology assessment (HTA).

One leading consultant suggested that pharmaceutical development program should not proceed beyond Phase II until the company met with reimbursement agencies to gauge the likelihood of a positive coverage decision based on clinical endpoints.

Frightening that such a highly paid consultant could so completely miss the point – that government healthcare systems exist to serve their citizens, not to act as actuarial bean counters.  Financial prudence?  Cetainly.  But not at the expense of the right medicine for the right patient at the right time.  That’s a medical decision. That’s ethics.

Many present pointed out that what we really need are better tools to allow smarter development programs that don’t fail in late Phase III (as over 50% do today).  In the US that means the Critical Path.  In Europe it’s the Innovative Medicines Initiative.  Both are predicated on patient-centric care.

But when a healthcare system is a government-pay model, the cost-based versus patient-centric momentum seems unstoppable.

Consider the remarks last week of Thomas Lonngren, executive director of the European Medicines Agency (EMEA),

 "It could come to a situation where we are approving a product based on efficacy, safety and quality ... but the patient can't get it because the health technology institute says it is not cost-effective."

 Note to Tom – already happening.

Consider Britain's National Institute for Health and Clinical Excellence (NICE) and the series of high-profile disputes in which new drugs for conditions such as cancer and rheumatoid arthritis have been turned down for use on the state health service.

And what’s worse than a bad decision in one country?  Correct – a cavalcade of uncoordinated, voodoo cost-based decisions -- with one even less patient-centric than the last. Or, as Lonngren commented,

 "… a different decision in each member state (of the European Union) because this is not harmonized.”

Other countries, including Germany, have recently set up their own versions of NICE and Lonngren said the emergence of such health technology institutes posed a challenge for drug manufacturers since these bodies often required additional research, and he suggested there might be scope for cooperation with the EMEA in designing drug approval programs in future.

Is that a good idea, EU harmonization of HTA? Or is it the camel getting its nose under the tent?

That, ladies and gentlemen, is the distinction between “universal” healthcare and “government” healthcare.  In short –no difference at all.