Yet when the public contracts cancer or Alzheimer’s or Crohn’s or Parkinson’s, they will be demanding the pharmaceutical cures from their physicians. And the public will continue to smoke and overeat and sit on its 1-19-19 watching TV, content in the knowledge that it can take a pill to lower its cholesterol, blood pressure and hypertension, and suck on an inhaler to help with the COPD. Maybe the public should look in the mirror.

http://www.controlled-trials.com/news/Good_Publication_Practice_for_pharmaceutical_companies_2355-Article.pdf

The authors of the JAMA article selectively referred to articles, many of which were written prior to the guidelines’ (to which Merck and other leading companies contributed) publication in 2003. As they surely know leadtime from submission to publication in many journals can exceed 12 months, and so many of the cited articles pre-dated the voluntary and endorsed guidelines referred to here.

It is easy to adopt a position and find data to support it especially with agenda as obvious as this. Unfortunately the public - including the NY Times - too easily seizes on yet another pharma industry horror story coming from an apparently unbiased source.

I could go on: I don’t have time; but I am angered by the relentless, political onslaught led by these self-appointed vigilantes of the ‘truth’.

http://www.beforeyoutakethatpill.com/blog.html

With the Vioxx studies there was a quote from a pharma exec to the effect of him asking marketing why they did this post approval study that exposed them to the risk of finding out about a new adverse side effect.

The tortious ties of the Prescription Project

Robert Goldberg
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.

Anyone up to challenge the claims of the dermatologist on breakthrough Alzheimer’s disease treatment. Etanercept hypothesis presentation at:
Best Practices in the Continuum of Care: Advances in Alzheimer’s Disease Management. April 16, 2008 Double Tree Hotel, Little Rock, Arksansas
2:15-3:00pm CT presentation
Perispinal Etanercept for Alzheimer’s Disease
Edward Tobinick, MD

Where are the ethics of rehashing totally one-sided plaintiff lawyer stuff? Plaintiffs did not get the zillions of dollars they thought they’d made with Vioxx and now are just rehashing things for public embarrassment.

I got an idea. Let’s have: Grassley, JAMA, the plaintiff’s bar and a few other naysayers manage all medical innovation, clinical studies, publications, drug development and medical education. They ought to do a fine job.

If I sound tired of all this, it’s because I am. Let’s move on to talk about bigger issues like how are we going to ensure at least a minimum amount of healthcare for most americans, or how we are going to put our forces together to cure cancer.

Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with advanced or poorly controlled diabetes. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you closely for signs and symptoms of TB.

Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).

In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.

INDICATIONS
Moderate to Severe Rheumatoid Arthritis (RA)
ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.

In medical studies, ENBREL was shown to be effective in about 2 out of 3 adults with RA who used it, and has been shown to begin working in as few as 2 weeks, with most patients receiving benefit within 3 months. In an RA medical study, 55% of patients had no progression of joint damage. The claims of instant improvement in this off-label use of Etanercept in Alzheimer’s disease is clearly at odds with the two week period before any improvement in approved indication such as RA.

Common side effects in adult clinical trials were injection site reaction, infection and headache.
The unique injected patented site which the inventor calls a Perispinal injection is part of this procedure. This in the neck area, then tilt the head back to encourage the flow of Etanercept toward the area of the brain. The FDA site guidelines for administration are; thigh, abdomen but not near navel and top shoulder. TNF has its role to play as part of defense of our immune system. Etanercept lowers the immune system. Should Alzheimer’s disease patients be exposed to an off-label drug which exposes them to serious infections and possible adverse events associated with Etanercept, an immune lowering drug. This is all based on a hypothesis that is full of extraordinary claims without the standard pre-clinical into clinical trials or availability of basic research papers. If somebody claims a breakthrough in the treatment of Alzheimer’s disease as these claims do in the use of Etanercept by perispinal administration, this in the field of neuroscience which is full of claims without merit. We all want to aid better treatments, but that does not mean having to accept extraordinary claims of improvementin an off-label use, yet the science tells us of the associated severe risks with this drug from the clinical trials, which did not include the effects of this drug on Alzheimer’s patients. I want the Alzheimer’s disease patient to get the best treatment, but I cannot agree that a hypothesis from a dermatologist should go unchallenged just because of it’s extraordinary claims and its anticedents