Intestinal Anti-inflammation Drug CAUSES It

I work with Alice from time to time as several of my articles are found at healthiertalk.com, where she is the editor.

I find it supportive to see that other health sites are proactively education you about drug risks, especially when dangerous side effects can be the outcome.

By Alice Wessendorf

Another drug produced by Big Pharma that causes, and even worsens, the exact problem it is supposed to treat? It’s almost like this isn’t news anymore.

Turns out that the Caspase–1-inhibiting drugs, designed to quell the inflammation in the colon associated with colitis, are triggering intense inflammatory reactions that lead to severe flare ups of colitis.

A research team out of McGill University has proven that inhibiting or eliminating the protein Capsase-1—the very one targeted by these drugs—can cause the inflammation process to go out of control. Even worse, suppressing this important protein could eventually lead to certain cancers developing.

Every day your gut is bombarded with bacteria and the result is a controlled inflammatory response by your body. Occasionally, in some people, that inflammatory response flares out of control and this can lead to inflammatory bowel disease and make them susceptible to developing cancer like cancer of the colon.

Drug makers suspected that the protein Caspase-1 was involved in this inflammation process. So in all their wisdom, and rush to get a new product to market, they designed drugs to suppress it. Problem is they failed to take into account that the protein was an integral part of the entire regulated inflammation process.

So, the drugs leave your gut essentially defenseless when it comes into contact with bacteria. No Caspase-1 means no barrier. Bacteria are left free to invade deeper into tissues and cause much more severe inflammations, which can lead to cancer.

This is yet one more example of drugs doing more harm than good. In this case, Big Pharma’s half-cocked profits-before-people run to market could kill you.

This class of drug has also been tried with ALS or Lou Gehrig's Disease.

Need some practical, non-drug approaches to dealing with an inflamed bowel?
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Posted in: Cancer,IBS,inflammation,intestinal health,Marshmallow root

Inflammation and Chronic Disease: An old idea and diabetes

The issue of inflammation is one reason why vitamin C is so helpful to people with diabetes.  The suggested dose is approximatwely 10, 000 mg in divided doses each day.

Does Inflammation Trigger Insulin Resistance and Diabetes?

Nearly 21 million Americans suffer from type 2 diabetes, and every year 800,000 more are diagnosed. Considering the growing numbers, scientists are trying to fit together the disease’s disparate puzzle pieces. People who acquire it are typically obese, suffer from chronic inflammation and are resistant to insulin, the hormone that removes sugar from the blood and stores it as energy. For years no one has known exactly how the three characteristics are related, if at all. But a handful of recent studies suggest that they are inextricably linked through the actions of specific inflammatory immune cells and a master genetic switch—and the hope is that an understanding of the relations could open the door to new therapeutic opportunities.



Complete article: http://www.scientificamerican.com/article.cfm?id=inflammatory-clues

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Posted in: diabetes,inflammation

PUFAS Lead to Increased Inflammation

"A high intake of polyunsaturated fat in the diet, ... may lead to inflammatory ... disease, ..."

Dating back to 2007 there have been a dozen posts here on problems with the plant sterol products glutting the market. The most common of these products is the margarine with the claim of reducing heart disease.

Some other data exists showing that these products lead to asthma. Asthma, heart disease and inflammatory bowel disease are all symptoms of reactive inflammation.

I don't count plant sterols or the products made from them as healthy, nor do I consider that the PUFAS (polyunsaturated fatty acids) to be health promoting, except when an actual imbalance exists.

Additionally, the fact that many of these oils are from genetically engineered sources raise even more health concerns.

As the story goes, when making margarine just cooking the oils a little longer gives you the tub...

Learn more from the Campaign for Healthier Eating

And read Smith's comments on Obama's new food czar here.

I'll stick with my long used, made at home organic unsalted butter and olive oil blend recipe!

Healthy fat link to bowel disease
A high intake of polyunsaturated fat in the diet, while good for the heart, may lead to inflammatory bowel disease, say researchers.

Experts believe a high intake of linoleic acid, found in foods like "healthy" margarines, may be implicated in a third of ulcerative colitis cases.

The researchers base their findings, due to be published in Gut, on food diaries from more than 200,000 people.

If the link proves to be causal, some people might want to modify their diet.

“ There is good biological plausibility of why linoleic acid can cause inflamation, and certainly Western diets are often excessive in this kind of fat ”
Dr Anton Emmanual Core

The researchers also found that a diet rich in another type of fat, omega 3 fatty acid found in oily fish such as salmon and herring, reduced the likelihood of developing ulcerative colitis by 77%.

Linoleic acid is a naturally occurring essential fatty acid, present in a variety of foods, including the oils of seeds and nuts, such as sunflower, safflower, soya, corn seeds or walnut oils.

The multinational team working on the EPIC (European Prospective Investigation into Cancer and Nutrition) study say there is a plausible biological mechanism that could explain why linoleic acid is linked with this bowel condition.

Cell membranes

Once in the body, linoleic acid is converted to arachidonic acid, which is a component of the cell membranes in the bowel.

Arachidonic acid can then be converted into various inflammatory chemicals, high levels of which have been found in the bowel tissue of patients with ulcerative colitis.

In all, 126 of the people in the study developed ulcerative colitis after an average period of four years.

After adjusting for other factors likely to influence the results, including smoking, age, total energy intake, and use of aspirin, those whose diets included the most linoleic acid were more than twice as likely to develop the condition as those whose diets contained the least.

Lead researcher Dr Andrew Hart of the University of East Anglia, Norwich, said: "There are no dietary modifications of benefit in patients with ulcerative colitis, although, based on this study's findings, a diet low in linoleic acid may merit investigation."

In the UK, people consume on average about 10g per day of linoleic acid, found in around nine level teaspoons of polyunsaturated margarine or three teaspoons of sunflower oil.

In the study, the people who consumed the most linoleic acid had a daily intake three times this or more.

Biologically plausible

Dr Anton Emmanual, medical director of the digestive disorders charity Core, stressed that the study did not prove that linoleic acid caused bowel disorders, and warned that dietary diaries could be unreliable.

However, he said: "Nevertheless there is good biological plausibility of why linoleic acid can cause inflamation, and certainly Western diets are often excessive in this kind of fat.

"The omega 3 fish oils counteract the harmful effects of lineloic acid it would be helpful to see whether diets high in fish oils reduce colitis.

"Lineloic acid may have small part to play in some patients, but factors such as smoking, bacteria and stress are likely to be at least as important."

Professor Jon Rhodes, of the British Society of Gastroenterology, said the study was interesting, but also stressed it did not prove cause and effect - further tightly controlled studies would be needed to do that.

Dr Elisabeth Weichselbaum, of the British Nutrition Foundation, said the study was interesting.

But added: "The results need to be interpreted with caution.

"People who have very high intakes of omega-6 fats are likely to have a generally different diet from those with low intakes. Therefore, it may as well be possible that there are other factors that could have an effect."

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/8161616.stm
Published: 2009/07/24 00:00:44 GMT © BBC MMIX

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Posted in: IBS,inflammation,natural health news,plant sterols,PUFAS

Correcting One of Those Cholesterol Myths

I notice from time to time that people are searching for information about keeping arteries clean and healthy. This may be associated with the rash of anti-cholesterol drug-dosing-on-a-rampage panic, or earnest queries.

Order lecithin granules through simply4health.org to help us continue this work.

I am not a fan of soy. It might be said that if I suggest a soy based supplement that I am ignoring my own best advice. My greatest concern about soy today are the facts that it is generally a GMO crop and it does have many negative health effects.

On the up side, a long used supplement, especially for those who have been convinced that eggs are evil, you might find some salvation in lecithin.

Lecithin is good for you in that it contains phosphatidyl choline, phosphatidyl inositol and essential fatty acids as linoleic acid in a tablespoon of granules. It also contains fish-oil-like, omega-3 linolenic acid. Any one of these substances is not found in a standard daily diet.

Choline & Inositol are essential for the breakdown of fats and cholesterol. And lecithin helps prevent arterial congestion, helps distribute body weight, increases immunity to viral infections, cleans the liver and purifies the kidneys.

Dr. Michael Sharon suggests that it "improves the condition of patients with neurological disorders such as tardive dyskinesia (a side effect of anti-psychotic drugs), Parkinson's disease and Alzheimer's disease or pre-senile dementia."

It may help with improving attention span which would certainly benefit ADD/ADHD issues.

Lecithin helps in maintaining the surface tension of cell wall membranes. Without enough lecithin, the cell wall hardens. This condition contributes to premature aging of the cells. The surface tension of the cell, maintained by lecithin is also responsible for transmitting nerve impulses and messages through or from the cell.

Udo Erasmus, PhD shares some lecithin function facts -

"Lecithin helps keep cholesterol soluble. In a food like eggs, which contain a large amount of cholesterol, it is especially important that lecithin be of high quality.

"Lecithin keeps cholesterol isolated from arterial linings, protects it from oxidation, and helps prevent and dissolve gall and kidney stones by its emulsifying action on fatty substances.

"Lecithin is necessary in our liver's detoxification functions, which keep us from slowly being poisoned by breakdown products of metabolic processes that take place in our body. Poor liver function is a common forerunner of cancer. According to some healers, cancer always involves the liver. Deficiency of either Choline or EFAs can induce cancer in experimental animals, and is likely involved in causing some human cancers.

"Lecithin increases resistance to disease by its role in our thymus gland. Here, EFAs are precursors of several prostaglandins, as well as being vital as part of the ammunition made by our immune cells to kill bacteria (fatty acid peroxides are used to produce bacteriocidal hydrogen peroxide).

"Lecithin is a phospholipid that makes up 22% of both the high density (HDL) and low density lipoprotein (LDL) cholesterol-carrying vehicles in our blood. These vehicles keep cholesterol and triglyceride fats in solution in our bloodstream and carry them to and from all parts of our body.

"Lecithin is an important part of membrane phospholipids that are involved in electric phenomena, membrane fluidity, and other functions for which EFAs are responsible.

"Finally, lecithin is an important component of bile. Its function in digestion is to break food fats into small droplets (emulsify them), to increase their surface area, speeding up the digestion of fats by enzymes."

Other helpful information about lecithin is that each serving (1 tbsp.) contains:
Choline 275 mg, Inositol 168 mg, Potassium 108 mg, Linoleic Acid (omega 6 EFA) 2,025 mg, Phosphatidylcholine 1,760 mg, Phosphatidylethanolamine 1,530 mg, Phosphatidylinositol 1,070 mg, Linolenic Acid (omega 3 EFA) 260 mg.

and Lecithin

Breaks up fats and cholesterol, Excellent for a healthy heart
Contains the Highest Phosphatide concentration available (98% or more!)
Is a Rich source of GLA (Gamma Linoleic Acid)
Helps the body utilize Vitamins A,D,E and K
Is Excellent for memory, concentration and recall
Cleanses liver and kidneys
Helps the body absorb nutrients

Lessen Chronic Inflammation
People whose diets supplied the highest average intake of choline (found in egg yolk and soybeans), and its metabolite betaine (found naturally in vegetables such as beets and spinach), have levels of inflammatory markers at least 20% lower than subjects with the lowest average intakes, report Greek researchers in the American Journal of Clinical Nutrition (Detopoulou P, Panagiotakos DB, et al.)

Compared to those whose diets contained <250 mg/day of choline, subjects whose diets supplied >310 mg of choline daily had, on average:

* 22% lower concentrations of C-reactive protein
* 26% lower concentrations of interleukin-6
* 6% lower concentrations of tumor necrosis factor alpha

Compared to those consuming <260 mg/day of betaine, subjects whose diets provided >360 mg per day of betaine had, on average:

* 10% lower concentrations of homocysteine
* 19% lower concentrations of C-reactive protein
* 12% lower concentrations of tumor necrosis factor alpha

Each of these markers of chronic inflammation has been linked to a wide range of conditions including heart disease, osteoporosis, cognitive decline and Alzheimer's, and type-2 diabetes.

In an accompanying editorial in the American Journal of Clinical Nutrition entitled, "Is there a new component of the Mediterranean diet that reduces inflammation?," Steven Zeisel from the University of North Carolina at Chapel Hill noted that choline and betaine work together in the cellular process of methylation, which is not only responsible for the removal of homocysteine, but is involved in turning off the promoter regions of genes involved in inflammation.

"Exposure to oxidative stress is a potent trigger for inflammation. Betaine is formed from choline within the mitochondria , and this oxidation contributes to mitochondrial redox status ," Zeisel continued.

"If the association between choline and betaine and inflammation can be confirmed in studies of other populations, an interesting new dietary approach may be available for reducing chronic diseases associated with inflammation," he concluded.

Recommended daily intakes of choline were set in 1998 at 550 milligrams per day for men and 425 milligrams a day for women. No RDI has been set for betaine, which, since it is a metabolite of choline, is not considered an essential nutrient.

Practical Tip: Egg yolks are the richest source of choline, followed by soybeans. Spinach, beets and whole wheat products are primary sources of betaine. (Olthof MR, van Vliet T, et al. J Nutr)

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Posted in: arteries,cholesterol,cleansing,eggs,health,health education,health news,inflammation,lecithin,natural health news,natural news,neurological problems,tardive dyskinesia,weight loss

Vitamin C Effective in Reducing Inflammation

Inflammation is involved in numerous health issues from allergy to post-op surgical reactions. Life Extension provides this chart -

Allergy: Inflammatory cytokines induce autoimmune reactions

Alzheimer's: Chronic inflammation destroys brain cells

Anemia: Inflammatory cytokines attack erythropoietin production

Aortic valve stenosis: Chronic inflammation damages heart valves

Arthritis: Inflammatory cytokines destroy joint cartilage and synovial fluid

Cancer: Chronic inflammation causes many cancers

Congestive heart failure: Chronic inflammation contributes to heart muscle wasting

Fibromyalgia: Inflammatory cytokines are elevated

Fibrosis: Inflammatory cytokines attack traumatized tissue

Heart attack: Chronic inflammation contributes to coronary atherosclerosis

Kidney failure: Inflammatory cytokines restrict circulation and damage nephrons

Lupus: Inflammatory cytokines induce an autoimmune attack

Pancreatitis: Inflammatory cytokines induce pancreatic cell injury

Psoriasis: Inflammatory cytokines induce dermatitis

Stroke: Chronic inflammation promoted thromboembolic events

Surgical complications: Inflammatory cytokines prevent healing

The more vitamin C you take the less inflammation you will experience.

The important information about anti-oxidant vitamins is certainly something you aren't reading in the mainstream press or hearing on TV or radio.

Certainly vitamin C is much less expensive than a statin drug and isn't replete with serious side effects or death. The important concern is to purchase a mineral bound ascorbate form of the vitamin, or those with food based formulas. The vitamin C blend we have been offering our our clients for the last decade or more contains both food and mineral-ascorbate sources and is organic as well(C5 or C5+).

The USDA-RDA dose of sixty milligrams of vitamin C daily will prevent scurvy but it is not therapeutic enough to prevent or reverse health problems.

Outside the issue of CRP, adequate vitamin C intake daily is one of the best preventive measures against macular degeneration you can use.

Of course the choice is yours, but there is quite enough information I've posted about CRP and related issues here on Natural Health News to get your brain cells itching for relief of inquiring mind syndrome.

An article scheduled to appear in the January 1, 2009 issue of Free Radical Biology and Medicine reports the finding of researchers at the University of California, Berkeley that supplementing with vitamin C reduces C-reactive protein (CRP), a marker of inflammation linked with an increased risk of cardiovascular disease and diabetes.

Berkeley professor emeritus of epidemiology and public health nutrition Gladys Block and her associates randomized 396 nonsmokers to receive 1000 milligrams vitamin C, 800 international units vitamin E, or a placebo for two months. Serum C-reactive protein levels were measured before and after the treatment period.

Although no effects for vitamin E were observable, and no effect for vitamin C was noted among those with desirable CRP levels, for participants with elevated C-reactive protein (defined as 1 milligram per liter or higher), vitamin C lowered CRP by 0.25 milligrams per liter compared to the placebo, a reduction similar to that associated with statin drug treatment.

"This is an important distinction; treatment with vitamin C is ineffective in persons whose levels of CRP are less than 1 milligram per liter, but very effective for those with higher levels," stated Dr Block. "Grouping people with elevated CRP levels with those who have lower levels can mask the effects of vitamin C. Common sense suggests, and our study confirms, that biomarkers are only likely to be reduced if they are not already low."

Dr Block noted that a trial reported earlier this week in the Journal of the American Medical Association, which found no association between supplementation with vitamins C and E and the risk of stroke or heart attack, failed to screen participants for CRP elevation, which is important in the determination of who might benefit from vitamin C.

In another recently reported study ( the Jupiter trial), Harvard Medical School researchers showed that statin drugs reduced cardiovascular disease and cardiovascular mortality in individuals with normal lipids and elevated CRP. The trial found a 37 percent reduction in CRP associated with statins compared to treatment with a placebo. "One of the strengths of the Jupiter trial is that only persons with CRP levels greater than 2 milligrams per liter were enrolled," Dr Block remarked. "Researchers found very important effects of lowering CRP in people who had high levels to begin with."

"Major studies have found that the level of CRP in the body predicts future risk of cardiovascular disease, including myocardial infarction, stroke and peripheral artery disease, as well as diabetes," Dr Block stated. "Some believe CRP to be as important a predictor of future heart problems as high levels of LDL and low levels of HDL cholesterol."

"This is clearly a line of research worth pursuing," she added. "It has recently been suggested by some researchers that people with elevated CRP should be put on statins as a preventive measure. For people who have elevated CRP but not elevated LDL cholesterol, our data suggest that vitamin C should be investigated as an alternative to statins, or as something to be used to delay the time when statin use becomes necessary."

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Posted in: cardiovascular disease,CRP,health news,heart,inflammation,natural health news,natural news,vitamin C

Low Cholesterol Risks

Professionals only supplements resources that I rely on in my clinical work usually publish reports on studies of natural supplements that help health concerns.

While most hear about how high cholesterol is so bad and how many risky drugs you need, often you don't hear that low cholesterol can impair your immune function or defer review of other more risky markers. Triglycerides included.

I've educated on triglyceride issues for so long it seems funny to me that its just hitting headlines. Still its not prominent in the media to equal the risk to your health.

The real warning should be that yes, high triglycerides will kill you.

The Deadly Truth about Low Cholesterol
It’s a common misconception with fatal consequences: Many people still believe that low total cholesterol levels mean you’re not at risk for stroke, heart attack, or any of the other deadly risks that come with cardiovascular disease.

But in reality, nothing could be further from the truth—and unless you’re paying close attention to one particular group of fats called triglycerides, your heart could be a ticking time bomb, no matter how healthy your cholesterol might look.

Triglycerides are naturally manufactured and stored by both your liver and fat cells. At normal levels, they’re a crucial source of energy for your body—but start producing more than you can store, and those excess triglycerides will be dumped into your bloodstream, where they can wreak havoc on your arteries, heart, pancreas, and liver.1

Studies have shown that abnormally high triglyceride levels raise your risk of heart attack threefold—and when accompanied by low levels of high-density lipoproteins (HDL, or “good” cholesterol), your risk jumps a staggering 16 times higher. In fact, this ratio is one of the single strongest predictors of heart attack risk, even more accurate than the better-known LDL (low-density lipoprotein, or “bad” cholesterol) to HDL ratio.2 And it isn’t just your heart that suffers. Studies show that risk of stroke, obesity, diabetes, and liver disease are all linked to these dangerous fats.3-5

Keeping triglycerides in check is absolutely critical to your health—and a simple combination of omega-3 fatty acids, niacin and a supplement blend™ can make all the difference. One recent trial showed that supplementing with fish oil daily slashed triglyceride levels by 46 percent in as little as eight weeks.6 And niacin boasts nearly five decades of research demonstrating that it not only reduces triglycerides and LDL cholesterol, but also increases HDL levels by up to 29 percent.7-8

Finally, be wary of your blood sugar: Numerous clinical trials have shown that refined carbs and sugar can actually double triglyceride production.9-10 Tossing sugary sodas and boosting protein intake can help.11 So can supplementing with natural blood sugar managing agents like bitter melon, goat’s rue and quercetin.12-13A comprehensive formulas like some we use in our work contain these ingredients along with several others, including cinnamon. Clinical trials reveal that this popular spice can reduce triglycerides by 23 to 30 percent.14

References:

1. Webster’s New World Medical Dictionary, 3rd edition, William Schiel, Jr, MD, Author, 2008, Webster publishing.

2. Gaziano, JM., Hennekens, CH. Fasting triglycerides, high-density lipoprotein, and the risk of myocardial infarction. Circulation. 1997 Oct 21; 96(8):2520-5.

3. Grundy, SM., Cleeman, JI., Merz, CN., Brewer, HB, Jr., Clark, LT., Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004 Jul 13; 110(2):227-39. Review. Erratum in: Circulation. 2004 Aug 10; 110 6):763.

4. Tanne, D., Koren-Morag, N., Graff, E. Blood lipids and first-ever ischemic stroke/transient ischemic attack in the Bezafibrate Infarction Prevention (BIP) Registry: high triglycerides constitute an independent risk factor. Circulation. 2001 Dec 11; 104(24):2892-7.

5. Kadikoylu G, Yavasoglu I, Bolaman Z. Plasma exchange in severe hypertriglyceridemia, a clinical study. Transfus Apher Sci. 2006 Jun; (3):253-7.

6. Vega GL, Chandalia M, Szczepaniak LS, Grundy SM. Effects of N-3 fatty acids on hepatic triglyceride content in humans. J Investig Med. 2008 Jun; 56(5):780-5.

7. Crouse, JR. 3rd. new developments in the use of niacin for treatment of hyperlipidemia: new considerations for use of an old drug. Coron Artery Dis. 1996 Apr; 7 (4):321-6.

8. Drexel H. Nicotinic acid in the treatment of hyperlipidaemia. Fundam Clin Pharmacol. 2007 Nov;21 Suppl 2:5-6.

9. Teff, KL., Elliott, SS., Tschop, M., Dietary fructose reduces circulating insulin and leptin, attenuates postprandial suppression of ghrelin, and increases in triglycerides in women. J Clin Endocrinol Metab. 2004 Jun;89(6):2963-72.

10. Furtado, JD., Campos, H., Appel, LJ., Miler, ER. Effects of protein, unsaturated fat, and carbohydrate intakes on plasma apolipoprotein B and VLDL and LDL containing apolipoprotein C-III: results from the OmniHeart Trial. Am J Clin Nutr. 2008 Jun;87 (6): 1623-30.

11. Parks, EJ., Skokan, LE. , Timlin., Dingfelder, CS. Dietary sugars stimulate fatty acid synthesis in adults. J. Nutr. 2008 Jun: 138 (6): 1039-46.

12. Sridhar MG, Vinayagamoorthi R, Arul Suyambunathan V, Bobby Z, Selvaraj N. Bitter gourd (Momordica charantia) improves insulin sensitivity by increasing skeletal muscle insulin-stimulated IRS-1 tyrosine phosphorylation in high-fat-fed rats. Br J Nutr. 2008 Apr;99(4):806-12.

13. Rivera L, Morón R, Sánchez M, Zarzuelo A, Galisteo M. Quercetin ameliorates metabolic syndrome and improves the inflammatory status in obese zucker rats. Obesity (Silver Spring). 2008 Sep;16(9):2081-7.

14. Anderson RA. Chromium and polyphenols from cinnamon improve insulin sensitivity. Proc Nutr Soc. 2008 Feb;67(1):48-53.

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Posted in: cholesterol,health news,inflammation,LDL,natural health news,natural news,triglycerides

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.

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