The tortious ties of the Prescription Project

• 03.27.2007

As we noted The Prescription Project is " an initiative of the Boston-based nonprofit healthcare advocacy group Community Catalyst, which made headlines a little over a year ago when it sued Pfizer over its marketing claims for Lipitor. The Prescription Project is being conducted in partnership with the Institute on Medicine as a Profession (IMAP) and is funded by a USD 6 million, two-year grant from The Pew Charitable Trusts and money from George Soros.

In addition, the group has assembled a prestigious advisory committee whose members include Cathy DeAngelis, the editor-in-chief of JAMA; Steven Nissen, the president of the American College of Cardiology; and Philip A Pizzo, the dean of the Stanford School of Medicine."

Part of this campaign includes class action lawsuits initiated by the Prescription Action Litigation Project which in turn is comprised of Trial Lawyers Inc (large trial firms that seek huge monetary damages by suing corporations) and their public advocacy front, Public Citizen and various state organizations.

For instance, one mainstay of the PALP is the law firm Hagens Berman Sobol Shapiro (HBSS) which has been going after Pfizer for what is alleges are "false marketing claims by pharmaceutical giant, Pfizer. We are investigating claims made for its cardiovascular disease drug Lipitor, that encouraged doctors to prescribe the drug for patients when it was not necessary or healthy to do so." The firm is claiming that Pfizer encouraged doctors to prescribe the cholesterol drug for hypertension, chronic kidney disease, and many other unapproved illnesses besides the prevention of cardiovascular disease. ...

Hagens, Berman is famous for suing Starbucks for unbridled competition and being slapped with a $10 million penalty for violating their ".. duty of loyalty to three small water bottlers that in 2003 were close to settling a claim with Nestle Waters North America, the owner of Poland Spring Water Co." "Seattle law firm told to pay $10.8 million", Seattle Post-Intelligencer, Mar.24; Lattman, Mar. 24).

Public Citizen and the U.S. Public Interest Research Group (PIRG) works closely with Hagens Berman and other tort firms through Community Catalyst and TPP and other conduits to attack off label prescribing via fishing expeditions, testimony and now legislation at the state level to force doctors to either disclose or disgorge any money obtained from drug or biotech firms for any purpose.

This is not an effort to 'clean up' medicine. This is a witch hunt, a Stalinist effort to purge medicine of any relationship between academia, private industry and clinicians. And it is an effort to presume that off-label prescribing is both hurtful and possibly criminal behavior. Let's be clear: the goal is to create another opportunity for shaking down the drug industry and physicians. All you need are RiskMaps that prohibits and limits off-label prescribing and you have a whole new source of revenue for tort lawyers.....

Sort of like shorting currencies and buying them up. No wonder Soros is involved.

Pauline Chen - humanistic doctors

• 03.27.2007

my book review in NY Post Opinion books on Sunday speaks to the need to retain the patient contact, caring, and deep involvement with patients that is at the heart of good medicine.
This essential quality will be the first thing to be further jeopardized if government mandates for expanded coverage don't take "quality of care" into account. Dr. Chen directs these issues to the essential need to care for dying patients, but it is a universal concern for all health care.

http://www.nypost.com/seven/03252007/postopinion/postopbooks/dying_for_compassion_postopbooks_marc_k__siegel.htm

Just in from the Beeb …

• 03.27.2007

Drugs watchdog faces legal review

The NHS drugs watchdog is to face a judicial review in court for the first time over the guidance it offers.

Two firms have been granted the review over the way the National Institute for Health and Clinical Excellence reached its conclusion on Alzheimer's drugs.

NICE ruled NHS patients with newly diagnosed, mild Alzheimer's disease should not be prescribed the drugs.

Eisai and Pfizer said the process was unfair, but NICE said the claims were without foundation.

NICE guidance in 2001 recommended donepezil, rivastigmine and galantamine - which can make it easier to carry out everyday tasks - should be used as standard.

But in November the watchdog announced people with newly diagnosed, mild Alzheimer's were exempt.

Campaigners have repeatedly argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.

Neil Hunt, chief executive of the Alzheimer's Society, which will give evidence in the case, said: "Denying people in the early stages of this debilitating disease access to drug treatments is cruel and unethical.

Why should we care about how the Brits choose care for Alzheimer’s patients Over There? Because their “evidence-based” model is being touted by many Over Here as the right path.

Consider what’s happening Down Under where a similar (although by no means identical) system is also used to limit available treatment for Australians who suffer from Alzheimer’s Disease. The particulars are different – but the message is the same: when government acts to limit therapeutic choices, patients suffer the consequences.

Australia limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.” In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.”

Restrictive formularies (yes, like the VA system) and health care systems (such as in the United Kingdom, Australia, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.

Comparative Effectiveness Anyone?

• 03.27.2007

Please join CMPI and Old Dominion University for a robust conversation with Carolyn Clancy, Gail Wilensky, Scott Gottlieb, Stephen Spielberg (no, the one from Dartmouth), Dr. Bob (Goldberg) and distinguished others for a half-day seminar on the role of comparative effectiveness research.

Yes, Senator Baucus was invited.

It's on March 29, from 9am to 2pm at the National Press Club. Full program details can be found at http://www.cmpi.org

To RSVP, please contact Connie Davis, csdavis@odu.com

Hope you can attend.

Anna Nicole-Smith Drug Importation Access Act...

• 03.27.2007

Re-reading the Dorgan-Snowe drug importation legislation in the wake of the laundry list of drugs found in Anna Nicole's blood at time of death leads me to this interesting clause in the bill which takes the definition of the doctor-patient relationship with respect to internet prescribing to Hollywood levels:

(3) QUALIFYING MEDICAL RELATIONSHIP-

`(A) IN GENERAL- With respect to issuing a prescription for a drug for a patient, a practitioner has a qualifying medical relationship with the patient for purposes of this section if--

`(i) at least one in-person medical evaluation of the patient has been conducted by the practitioner; or

`(ii) the practitioner conducts a medical evaluation of the patient as a covering practitioner.

`(B) IN-PERSON MEDICAL EVALUATION- A medical evaluation by a practitioner is an in-person medical evaluation for purposes of this section if the practitioner is in the physical presence of the patient as part of conducting the evaluation, without regard to whether portions of the evaluation are conducted by other health professionals.

`(C) COVERING PRACTITIONER- With respect to a patient, a practitioner is a covering practitioner for purposes of this section if the practitioner conducts a medical evaluation of the patient at the request of a practitioner who has conducted at least one in-person medical evaluation of the patient and is temporarily unavailable to conduct the evaluation of the patient. A practitioner is a covering practitioner without regard to whether the practitioner has conducted any in-person medical evaluation of the patient involved.

And the loophole that will make it easy for any criminal, kiddie-porn site operator or terrorist to set up shop in Canada and source drugs from anywhere:

"An agreement by the exporter to comply with applicable provisions of Canadian law, or the law of the permitted country designated under subsection (a)(4)(D)(i)(II) in which the exporter is located, that protect the privacy of personal information with respect to each individual importing a prescription drug from the exporter under subsection (a)(2)(B)."

Please note that Canada does not vouch for what happens in the scores of export houses up north that import commercial quantities of drugs from Pakistan, Iran, Turkey, etc under a personal use exemption. So all you have to do to comply with the Anna Nicole import bill is be a Rx chop shop in Canada.

The Battle for A Breakthrough

• 03.26.2007

The next time someone who knows nothing about drug development or medicine blathers on about why drug companies don't just focus on breakthrough drugs should read the article in the NEJM about the quest to find a drug that actually reverses atherosclerosis. The statin focused pathway makes a lot of sense and it not dead despite what you will hear because of the complexity that has been discovered in large part because of the huge wager Pfizer made on the torcetrapib molecule.

The "failure" has, as Dr. Nissen and colleagues, article demonstrates, advanced our understanding. I have been a severe critic of Nissen with respect to his pronouncements on the safety of ADHD drugs, but as this article suggests, his handling of the torcetrapib issue has been thoughtful, responsible and in some respects visionary.

http://content.nejm.org/cgi/content/full/NEJMoa070635v1

More needs to be written about this unfolding saga -- as well as other struggles to understand the intimate connection between disease, body, molecule, genetics. It might promote the growth of something lack among those eager to issue pronouncements about how companies should run their businesses: humility. As Derek Lowe of www.corante.com has noted, on a good day scientists walk into a lab not knowing what to expect, The NEJM shows that real money is invested on this proposition every.

These boots were made for walking

• 03.26.2007

I keep getting free pedometer offers from AARP. Now I know why. Their usual harangue about rising drug prices has gotten stale. No one is buying it.

AARP launches ad campaign urging drug-price negotiations

Here's the link to the story in USA Today:

http://www.usatoday.com/news/washington/2007-03-25-aarp_N.htm?csp=34

And keep the pedometer!

There's a caveat to cheaper drugs

• 03.26.2007

Okay -- who's in favor of cheaper drugs?

http://www.santacruzsentinel.com/archive/2007/March/25/edit/stories/05edit.htm

Also -- please see Scott Gottlieb's excellent op-ed in today's WSJ:

http://online.wsj.com/article/SB117486373440048427.html?mod=opinion_main_commentaries

Enjoy.

The $50,000 Question

• 03.26.2007

An excellent commentary from today's edition of the Wall Street Journal ...

Drug Crazy
By RICHARD A. EPSTEIN

In an industry advisory last week, the U.S. Food and Drug Administration announced tough new conflict-of-interest rules against doctors who sit on its advisory committees, which recommend whether the FDA should allow pharmaceutical companies to market their new products. The agency's rationale is that greater transparency is necessary to remove any taint that might undermine the public's confidence in the approval process.

The new rules categorically bar any individual from sitting on any committee to evaluate a drug up for approval when that individual has a financial interest exceeding $50,000. The $50,000 figure includes stock ownership, related research and consulting arrangements. Unfortunately, this measure sweeps too widely by lumping together experts who do clinical trials with those who have a direct economic stake in the success of a drug. The precise measurement of that stake mysteriously turns on the extent that the drug has a "potential for gain or loss" to the committee members or their families. Persons whose financial stakes are less than $50,000 may be allowed to meet with these committees, but not to vote.

The main justification for this new regime is the widespread perception that drug and device makers have "hijacked" the FDA process, allowing dangerous drugs to slip into the market. The most conspicuous illustration involves the various COX-2 inhibitors such as Vioxx and Bextra, when at least 10 members of the FDA advisory panel who voted to leave these drugs on the market had some ties to their respective manufacturers, Merck and Pfizer.

It is here that the difficulties begin. The common perception is that the FDA acted too late in removing these drugs from the marketplace, and indeed should never have approved them at all. That perception rests on a crucial tradeoff: how much of an increased risk of heart attack should people be allowed to run in order to mitigate the ravages of arthritis and other degenerative diseases. One common, but cavalier, notion is that people should learn to cope with pain to stave off the greater potential harm of a heart attack. The evidence on the ground suggests another story.

"Suffering boomers want to fill Vioxx void" is a headline in last Friday's Chicago Tribune. The gist of the story: Baby boomers and others have returned to Pfizer's Celebrex, which reported an 18% increase in sales notwithstanding the FDA's stringent black box warning. Similarly, many individuals stashed away their Vioxx for a rainy day after it was recalled by Merck. These individuals understand the risk they're running, but trust their physicians to minimize its impact.

This evidence should put the FDA's zeal in a new light. Just how do these advisory committees "protect" informed product users by limiting their choices for dealing with crippling chronic conditions?

The FDA's major problem is not laxity, but zealotry. Its current get-tough view on conflict of interest only aggravates the fundamental flaw in its institutional design. Transfixed on the harms drugs can cause, the FDA remains largely oblivious to the harms they can prevent. Any delay in the use of a successful drug is costly: The delay matters little to the FDA, but a great deal to the thousands who plea for compassionate exemptions to try a drug that has not met with FDA approval. Nor is the FDA sensitive, as individual physicians surely are, to the simple fact that a drug which cannot be tolerated by one person works wonders in another.

The current get-tough policy on conflicts of interest only magnifies these costly FDA biases. The agency rules cut out the persons who know most about the drugs, and who could well counter unsound objections by critical committee members. But keeping these experts off the committees also skews the deliberative process in a more subtle and powerful way.

Anyone who consults for drug companies is likely to come with the presumption that new drugs may well fill important therapeutic voids. Once these individuals, as a class, are kept off advisory committees, the remaining drug experts are more likely to have the populist views held by the likes of a Marcia Angell or Sidney Wolfe, who suspiciously view most new drugs as insignificant advances over prior treatments. I tremble at the thought that these "untainted" experts will markedly slow down the FDA approval process. This would be bad news for the tens of millions who suffer from arthritis, and the countless individuals who suffer from other conditions. Nor would a the change go unnoticed by drug manufacturers or venture capitalists.

Right now, we all have a simple expedient to protect ourselves against dangerous drugs that make it to the market: Don't take them. But we have no protection at all when the FDA denies us that choice in the first place. Right now the pace of drug approval is too slow. We don't need the FDA to slow it up still further.

Kultur Kamp

• 03.24.2007

John Kamp weighs in on the Markey/Waxman bill:

Although I have considerable respect for Congressman Markey, I most of the marketing "improvements," in the new Markey Waxman bill are simply marketing restraints. What an irony that two of the most articulate speakers in the U. S. House of Representatives would use censorship to as a way to help patients learn about the safety aspects of medicine.

Take a careful look at a couple of the restrictions.

1. Clearly an across the board ban on DTC the first three years after a drug's approval would be a violation of the First Amendment. The Supreme Court has never approved censorship as a way to promote an informed population. Even more important, it would be a mistake. What if we have a new drug for bird flu about the time of an outbreak? Wouldn't we want the public to know in every possible way? Similarly, don't we want the public to know about any HPV virus drug that could save the life of hundreds of women? Ignorance is never preferable to education.

2. Mandatory review of the all DTC ads before airing is clearly the kind of "prior restraint" government censorship long banned by English common law and recognized by the Supreme Court as a violation of the First Amendment.

The Coalition for Healthcare Communication salutes companies for taking great care in their ads and following the PhRMA self-regulatory principles. We don't salute Congressmen who would make censorship FDA law. Congress should never force Congressman Markey submit his often pithy remarks to a censor before he is allowed to utter them, nor should Congress silence drug companies until some censor can pass judgment.

It's one thing for a speaker to hold his tongue, it's another for the government to tie it in knots.