The Eyes of Texas

A Reuters’ story tells about John Kopchinski, a Gulf War veteran from Texas who later became a disgruntled sales representative for Pfizer. John found Pfizer’s sales tactics hard to swallow. As he explains it:

"In the Army I was expected to protect people at all costs....At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives.”

Unable to live down to Pfizer’s ethics, he blew the whistle on ‘em.

Click link for full story.

PFIZER DENIES USE OF INTIMIDATION

Accusations of Witness Intimidation in the Neurontin Trial

According to the American Laywer (law.com), Pfizer has been accused of using a private detectice and former CIA agent to intimidate Dr. David Franklin, well known as the whistleblower who initiated the Neurontin qui tam suit that, for many years, was the largest criminal and civil bust for off-label promotion (until Pfizer's marketing of Bextra and Lilly's of Zyprexa broke the Neurontin record).

See the story at:

http://www.law.com/jsp/article.jsp?id=1202432898903

Once again, this is the sort of behavior, if it occurred, which is entirely outside the scope of FDA jurisdiction but relevant in civil suits. And thus another reason why even a utopian FDA would not cover delinquencies covered by civil liability, and thus why FDA preemption remains a bankrupt doctrine.

NOT YOUR FATHER'S FDA

Sweeping Changes in Store

It happens in small steps, but every day we learn another bit about the changes the Hamburg/Sharfstein team are bringing to an FDA saddled in dysfunction, corruption, and incapacity. Most recently, they have announced a program that would bring much more transparency to decisons on NDAs and applications for new indications that could unearth material on drugs and devices that are normally not surfaced except in litigation. Read about it in the New York Times:

http://www.nytimes.com/2009/06/02/health/policy/02fda.html?emc=tnt&tntemail1=y

After years of having to put up with an FDA leadership that wanted mostly to hide under rocks or their jockey shorts of their benefactors, it is almost difficult to believe we are seeing this much change. I still wonder how many dead-enders there are who will offer pockets of resistance--and maybe more--as reform goes on. Old and corrupt regimes die hard, as the last eight years have taught us, even at their most grotesque.

One interesting tidbit I didn't know. After the scam around the CLASS study was uncovered, and JAMA learned that it had been given the only part of the data set, the journal explicitly disowned the article. Neverthless, detailers continued to use it to sell Celebrex. I never get tired of quoting what Bob Temple said at the time: That the hype from the JAMA article will always have greater impact than our labeling does.

MY TIME TO GAG

Chantix Kicking Butt in Wisconsin

With multiple hat tips and bows to our inspirational leader, we learn that Pfizer has sponsored a continuing education online course through the University of Wisconsin which promotes Chantix. The "course" ignores both other first-line treatments and the variety of problems associated with the drug. More than two-thirds of those who have taken the "course" are MDs.

In the Milwaukee article cited, the following is noted about a recent JAMA report: "In the first quarter of 2008, Chantix accounted for more serious injuries (1001) than the top ten best-selling drugs combined (837).

Here is a link to the relevant article:

http://www.jsonline.com/news/43837682.html

You've come a long way, baby.

It Ain’t Necessarily So…

The Boston Globe has reported that an anesthesiologist at Baystate Medical Center in Springfield, Mass. allegedly fabricated studies on post-surgery pain management.

“The investigation uncovered 21 published papers over 13 years…”

Dr. Steven Shafer, editor of the journal Anesthesia and Analgesia, stated that, if the allegations are proven to be true, the case will be “the largest research fraud in anesthesia.”

Some of the drugs involved, Celebrex, Lyrica, and Neurontin, are made by Pfizer and it was learned that the company had given the doctor five research grants, and he was also one of their registered speakers. However, a Pfizer spokesperson stated that the company is, “not involved in the conduct of any of these independent studies or in the interpretation or publication of the study results.”

The doctor is currently on leave.

To read the full story, copy and paste the link below.

www.boston.com/news/health/articles/2009/03/11/doctor_accused_of_faking_studies/ - Liz Kowalczyk, Globe Staff / March 11, 2009

ANOTHER OFF-LABEL BUST

POff-Label Promotion and "Closet Deregulation"

The NYT reports two guilty pleaas by former Stryker sales reps for off-label promotion.

http://www.nytimes.com/2009/02/20/business/20bone.html?emc=tnt&tntemail1=y

Without getting into the particulars of this case, it does seem that off-label prosecution is coming thick and fast. The record verdicts agaist Lilly/Zyprexa a few weeks ago, the even larger verdict against Pfizer/Bextra (announced on the day of the Wyeth buy), and now this smaller case.

As many of you know, the same folks who fight for FDA preemption are generally also fighting for looser (or non-existent) off-label promotion guidelines. The irony is not subtle. On the one side, we must always defer to FDA's "scientific expertise." Except in those instances when it we opt to ignore it.

This recent case seems especially egregious in that the off-label use was not only unapproved but, allegedly, dangerous in the application for which it was being promoted.

In any event, preemption used to be called "closet tort reform." We can now be clear that it is "closet deregulation" as well -- and neither aspect is in much of a closet.

PFIZER V. GRASSLEY

Disclosing Gifts to Docs

The WSJ Health blog has an interesting commentary on the difference between some of the plans for disclosure of gifts to docs put forward by companies and the plan advocated by Chuck Grassley.

http://blogs.wsj.com/health/2009/02/10/how-pfizers-doctor-payment-disclosure-compares-to-grassley-plan/

Some of the commenters point out that none of this would impact patients; they would not change docs or question a particular prescription.

I wonder if that is true. I'm not talking about the small sums, but if you knew your doc was receiving very significant moolah from this or that company, would it impact the way you viewed that practice and impact your experience and even choices as a patient?