Pfizer hedging its bets? UPDATE

Today Pfizer agrees to pay out $894 million to settle lawsuits over Celebrex and Bextra. Other NSAIDS still show a link to heart disease but this is one of the most readily preventable health conditions we know of and other posts on this blog give you some of that data. For pain and inflammation there are many excellent natural remedies as well as one of the natural products I use from time to time that has been tested at Dana Farber.

$894 million deal ends pain of Pfizer's lawsuitsBy Linda A. Johnson, Ap Business Writer
17 October, 2008
TRENTON, N.J. – Drug giant Pfizer Inc. has reached an $894 million deal to end most of the lawsuits over its two prescription pain relievers, the popular Celebrex and a similar drug, Bextra, no longer on the market.

The world's biggest drugmaker said Friday it has agreements in principle to end more than 90 percent of personal injury lawsuits brought by people claiming the pills caused heart attacks, strokes or other harm.

The settlement includes roughly 7,000 personal injury cases, mainly plaintiffs who took since-withdrawn Bextra, said plaintiff attorney Perry Weitz. He represents nearly 2,000 claimants, about 10 percent of them relatives of people who died.

"It gives Pfizer closure and the claimants their money sooner, rather than later or never at all," Weitz said.

Pfizer hopes to finalize claims covered by the settlement, which now includes up to 92 percent of plaintiffs, by year's end. It also hopes to include many of the remaining claimants in the settlement and will fight any remaining personal injury suits with court motions or at trial, General Counsel Amy Schulman told The Associated Press.

"I don't think either side has an interest in protracting this," Schulman said in an interview.

Weitz said plaintiff lawyers will "have issues" with Pfizer "if their claimants aren't paid before the end of the year."

In early trading, Pfizer shares were down 47 cents, or 2.8 percent, at $16.50.

Schulman said the deal comes after two important court rulings — one by a New York state judge overseeing many of the state-level personal injury cases and the other by a federal judge in San Francisco coordinating pretrial steps in federal lawsuits over the drugs.

"We teed up some pretrial motions for a court ruling on whether there was significantly reliable evidence that would allow an expert to testify as to whether there was an increased risk of heart attack and stroke at the most common dose," 200 milligrams, Schulman said. Both judges ruled that was not the case, she said.

The proposed deal also would end suits by insurers and patients seeking to recover what they spent on Bextra and Celebrex, as well as claims by 33 states and the District of Columbia that Pfizer improperly promoted Bextra.

Out of the total settlement, $745 million will go to settle personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs. Two additional states, Louisiana and Mississippi, still have pending cases regarding Pfizer's promotion of the drugs.

New York-based Pfizer withdrew Bextra from the market in 2005, a year after Merck & Co. withdrew its Vioxx, a similar drug.

The Vioxx withdrawal, which triggered an avalanche of lawsuits against Merck, also raised concerns about the safety of other medicines in the same class, called Cox-2 inhibitors. They were heavily touted by their makers as superior to traditional nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen, because they block an enzyme involved in promoting inflammation but — unlike NSAIDs — don't block an enzyme that protects the stomach from bleeding and other side effects.

Other NSAIDs, such as ibuprofen and naproxen, have also been linked to increased heart risks.

Celebrex is the only Cox-2 inhibitor that the Food and Drug Administration has allowed to remain on the U.S. market.

Attorney Christopher Seeger, a member of the plaintiffs steering committee, said he'll "have no problem recommending" the settlement to the roughly 400 clients he represents.

"We're very satisfied with the deal," Seeger said.

Schulman said the company's negotiations with opposing lawyers had been under way for some time but picked up in the late summer.

"Litigation can be distracting, and putting these matters behind us helps our shareholders and, most importantly, patients and doctors," Schulman said.

Weitz noted that it took four or five years to get through trials for less than 20 cases in the massive Vioxx litigation, because the court system can only handle a limited number of cases at a time.

Pfizer will take a pretax charge of $894 million to its third-quarter earnings, which it is scheduled to report on Tuesday.

Merck, based in Whitehouse Station, N.J., has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming Vioxx cause heart attacks, ischemic strokes or death. It still faces other litigation over the former blockbuster arthritis treatment.

Copyright © 2008 The Associated Press.

Pfizer to Drop Development of Certain Drugs
by Shelley Wood, Heartwire 2008. © 2008 Medscape

October 3, 2008 (New York, NY) — Pfizer is getting out of the cholesterol-lowering game to focus on what it perceives to be more lucrative diseases, according to an internal memo obtained by Forbes [1]. And for the most part, the chosen "disease areas" don't include the heart.

In the memo, Martin Mackay, president of Pfizer Global Research & Development (R&D), informed his staff that the company plans to "exit" the fields of atherosclerosis/hyperlipidemia, heart failure, obesity, and peripheral arterial disease.

Instead, the company, whose cholesterol-lowering drug atorvastatin (Lipitor) is the world's top-selling drug, says it is turning its attention and R&D dollars to cancer, diabetes, Alzheimer's, pain remedies, and mental health as its "higher-priority areas."

The news comes in the wake of the flop of Pfizer's hoped-for new flagship, torcetrapib, a CETP inhibitor that was widely predicted to be the company's next blockbuster drug. While CV drugs have been the major moneymakers for Pfizer in recent years, those days are drawing to a close. In addition to Lipitor, which will lose patent protection in 2011, Pfizer's other major player in the CV drug arena is Norvasc (amlodipine), which came off patent in 2007.

Among the lower-priority "disease areas" where the company says it will continue working are thrombosis and transplant, the memo notes.

Contacted by heartwire, a handful of leaders for some of the major Pfizer-sponsored trials in cardiovascular disease over the past decade declined to comment on the company's announcement or speculate on what it might mean to the field of CV drug development--with one exception. Dr John Kastelein (Academic Medical Center, Amsterdam, the Netherlands), who was an investigator in the Pfizer-sponsored ASAP, TNT, and IDEAL trials, called Pfizer "a real powerhouse" in the CV drug arena.

"I kind of knew this was coming, but when you see it in print, it still hits hard," he told heartwire. "I think this is very, very significant both for the company itself and for the whole field of CV drug development. Pfizer had truly excellent people in the development arm of their company for CV and metabolic drugs, and they've contributed to this whole notion that you need more robust LDL lowering and that that's better than mild LDL lowering, which has become one of the axioms of CV prevention. And if they're stepping out now, that not only signifies their own problems, but it also signifies the problems in CV drug development, and how incredibly difficult and costly it has become to bring new drugs forward. And that's not good for patients."

Kastelein predicts that drug companies, having "lost faith" somewhat in HDL-raising therapies, will need to look more closely at anti-inflammatory drugs in the setting of coronary artery disease. "But there, the problem is, if you have no biomarkers whatsoever to do even dose-finding studies, you need to move from relatively small phase 2 trials to incredibly large, hard-outcome studies, which is taking quite a risk," he said. And that, at least for Pfizer, is too much risk.

"Everyone, not just Pfizer, is realizing that the days of the really big blockbuster drugs are over. And what is going to replace that are drugs in a class that are 10 times or 100 times more difficult to develop, so the risks are much higher. And these days, after Avandia and ezetimibe, everything is about safety. This means the FDA is forced, by public and colleague pressure, to demand even larger databases before drugs are going to market, which is of course making it more expensive. It's a cycle that's very hard to break."

Calls to Pfizer were not returned before this story was published.

Herper M. The Pfizer memo. Forbes, September 30, 2008. Available at: http://www.forbes.com/business/2008/09/30/pfizer-drug-agenda-biz-bizhealth-cx_mh_0930pfizermemo.html.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

Reducing Breast Cancer, Naturally

NSAIDS have risks as mentioned by Dr. Sarah Rawlings who participated in this study.

Aspirin has its own set of side effects that can lead to silent bleeding from the gastrointestinal tract or other locations in the body. Eventually this can impact the integrity of the cell wall membrane. Aspirin also can raise the risk of allergy in some people and it can cause poisoning along with damage to the eighth cranial nerve that relates to your ability to hear.

Ibuprofen is known to cause serious kidney problems and also can effect the liver. Liver health is closely associated with hormone recycling and also interacts with your immune system to boost immunity.

Anti-inflammatory herbs and supplements may be more helpful because they are not burdened by the toxic side effect issues of pharmaceutical products. Contact us to learn of and purchase our wide variety of effective professional formulae, herbs and supplements to reduce inflammation.

A secondary warning might be heeded if you have been prescribed an anti-depressant as part of your medical treatment, for cancer or other ill-health conditions, as studies report that SSRIs in combination with NSAIDS can create a lethal combination.

An article written by an ND colleague of mine for many years concludes that "Combining SSRIs with NSAIDs, aspirin or corticosteroids is the equivalent of playing a game of gastrointestinal Russian roulette. For anyone taking SSRIs, a combination of natural pain relievers that includes DL-phenylalanine, turmeric, Boswellia serrata, and nattokinase can prove to be a safe alternative. Furthermore, using a supplement that contains glutamine, deglycyrrhizinated licorice (DGL), N-acetyl glucosamine, marshmallow, berberine, cabbage, slippery elm, phosphatidylcholine, and gamma oryzanol is an effective way to strengthen the GI tract for individuals who continue with SSRI treatment. Individuals planning to stop SSRI treatment should always discuss their plans with their physician before doing so."
Read more here-

Painkillers 'cut breast cancer'
By Emma Wilkinson, Health reporter, BBC News

Regular use of common painkillers such as aspirin and ibuprofen reduces the risk of breast cancer, according to an international study.

The research, which looked at information from 2.7 million women, was published in the Journal of the National Cancer Institute.

Aspirin cut the risk by 13%, while ibuprofen lowered it by a fifth.

However, experts warned long-term use of painkillers can have serious side-effects.

"Anti-inflammatory drugs can have potentially very serious side-effects when taken over a long period."
Dr Sarah Rawlings, Breakthrough Breast Cancer

There have been many studies looking at the role of painkillers in breast cancer, and the latest is a review of 38 of these, combining their results to give a more reliable picture.

Both aspirin and ibuprofen are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and it is their ability to interfere with inflammation in the human body which appears to be key.

Two body chemicals which help produce inflammation, COX1 and 2, are thought to play roles in the development of cancer by influencing how cells divide and die, the production of new blood vessels that can "feed" tumours, and influence the body's immune responses.

It appears NSAIDS inhibit these chemicals.

Women taking either aspirin or ibuprofen regularly had a 12% lower chance of developing breast cancer compared to those who did not use them at all, while regular ibuprofen use appeared to have the biggest effect.

Drug warning

Dr Mahyar Etminan, from the University of British Columbia, who led the research, said the results were "encouraging", and could help scientists trying to understand the complex origins of breast cancer.

However, he warned against women adopting painkillers as part of a cancer prevention lifestyle.

"We don't recommend the routine use of NSAIDs for breast cancer prevention until large randomised trials confirm these findings." He said results from a trial of this type would be available next year.

The regular use of painkillers is problematic because, in some people, they can cause serious side-effects, including stomach ulcers, increased risk of stroke, asthma and heart, liver and kidney problems.

The potential benefits of reducing breast cancer risk would have to be balanced against these.

This advice was echoed by Breakthrough Breast Cancer, which urged women worried about breast cancer risk to talk to their GP rather than simply take painkillers.

Head of policy Sarah Rawlings said: "The potential of anti-inflammatory drugs, such as aspirin, to lower the chances of developing breast cancer is very interesting, but as the researchers say, large scale trials are needed to confirm these findings.

"Anti-inflammatory drugs can have potentially very serious side-effects when taken over a long period."

Story from BBC NEWS:http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7658472.stm
Published: 2008/10/08 09:09:35 GMT
© BBC MMVIII