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Heart Pill to Be Sold by Itself (New drug to increase HDL, Pfizer had wanted to sell with Lipitor)
NY Times' Terrorist Tip Sheet ^ | July 26, 2006 | ALEX BERENSON

Posted on 07/26/2006 2:25:15 PM PDT by neverdem

Reversing a strategy that had drawn criticism from doctors, Pfizer says that it will apply for approval to sell a promising new heart treatment as a standalone pill — rather than only in combination with Lipitor, Pfizer’s best-selling cholesterol treatment.

The new drug, torcetrapib, is still being tested in clinical trials and is at least 18 months from federal approval.

But cardiologists say it has the potential to become a significant new treatment for heart disease.

Clinical trials show that torcetrapib substantially raises the levels of so-called good cholesterol, a novel approach to preventing heart attacks and strokes.

Wall Street analysts predict that it could become a blockbuster medicine, with sales of several billion dollars annually.

Previously, Pfizer had said it would sell torcetrapib only in combination with Lipitor, one of several medicines called statins that lower levels of LDL, or bad cholesterol. Cholesterol-reducing medicines are the largest prescription drug category, with worldwide sales of $32 billion last year.

By offering torcetrapib only in a combination pill, Pfizer would have forced patients taking other statins — like Zocor, from Merck — to switch to Lipitor if they wanted torcetrapib’s benefits.

In an interview last year, Dr. John L. LaMattina, Pfizer’s top scientist, defended the company’s plans, saying that the costs of testing torcetrapib alongside every statin would be prohibitive. Already, Pfizer says it is spending $800 million to develop torcetrapib. Pfizer is the world’s largest drug maker, with sales of $51 billion and a profit of $8 billion last year.

But Pfizer’s plan angered cardiologists, who said the company appeared to be putting its profits ahead of patients’ health. Not all patients can easily switch from one statin to another, and some patients cannot take statins at all. In June 2005, an article in The New England Journal of Medicine...

(Excerpt) Read more at nytimes.com ...


TOPICS: Business/Economy; Culture/Society; Extended News; Government; News/Current Events; US: District of Columbia; US: Maryland
KEYWORDS: cholesterol; drugs; hdl; hdlcholesterol; health; healthmedicine; heart; pfizer; pharmaceuticals

1 posted on 07/26/2006 2:25:21 PM PDT by neverdem
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To: neverdem
"In an interview last year, Dr. John L. LaMattina, Pfizer’s top scientist, defended the company’s plans, saying that the costs of testing torcetrapib alongside every statin would be prohibitive."

And why, precisely, would Pfizer have to pay for those studies?? Seems to me that the manufacturers of those "other statins" would be the ones verifying the performance of THEIR statins vis-a-vis the new HDL-raising drug.

2 posted on 07/26/2006 2:31:34 PM PDT by Wonder Warthog (The Hog of Steel-NRA)
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To: neverdem

Nothing the Pharmaceutical Industry does in regard to marketing surprises me anymore. I would like to see the outcomes data on this drug (not just the cholesterol levels and 'decreasing plaque' size but a decrease in heart attacks, strokes or deaths) before adding this to an already numerically large and expensive medication regimen that cardiac patients are prescribed...
For Example: Beta Blockers, ACE Inhibitors, Aspirin, a Statin, maybe nitroglycerin, plavix, and other medications for their other non-cardica health problems...


3 posted on 07/26/2006 2:38:45 PM PDT by flixxx
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To: Wonder Warthog

The other medications/statins have NO incentive to pay for those studies...they already have a market share and what if their drug had similar outcomes (or worse, faired poorly) against the new drug)...it is very difficult to get head to head studies performed against 'established' medications...


4 posted on 07/26/2006 2:40:46 PM PDT by flixxx
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To: flixxx
"The other medications/statins have NO incentive to pay for those studies...they already have a market share and what if their drug had similar outcomes (or worse, faired poorly) against the new drug)."

But the point is that the HDL drug would probably always be taken IN ADDITION TO a statin drug. If they don't test their statin in combinatin use with the HDL drug, then they will lose market share vs. Lipitor. Seems to me that if they want to retain market share, they'd do the testing.

5 posted on 07/26/2006 2:55:59 PM PDT by Wonder Warthog (The Hog of Steel-NRA)
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To: neverdem

Blah, blah, blah!

When they do a study and put these "wonder drugs" up against NIACIN I might change my mind.

Niacin bested them in in The Coronary Drug Project 20 years ago and would do it again today.

More smoke and mirrors to keep the patents current./flame suit on

1: J Am Coll Cardiol. 1986 Dec;8(6):1245-55.

Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin.

Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W.

The Coronary Drug Project was conducted between 1966 and 1975 to assess the long-term efficacy and safety of five lipid-influencing drugs in 8,341 men aged 30 to 64 years with electrocardiogram-documented previous myocardial infarction. The two estrogen regimens and dextrothyroxine were discontinued early because of adverse effects. No evidence of efficacy was found for the clofibrate treatment. Niacin treatment showed modest benefit in decreasing definite nonfatal recurrent myocardial infarction but did not decrease total mortality. With a mean follow-up of 15 years, nearly 9 years after termination of the trial, mortality from all causes in each of the drug groups, except for niacin, was similar to that in the placebo group. Mortality in the niacin group was 11% lower than in the placebo group (52.0 versus 58.2%; p = 0.0004). This late benefit of niacin, occurring after discontinuation of the drug, may be a result of a translation into a mortality benefit over subsequent years of the early favorable effect of niacin in decreasing nonfatal reinfarction or a result of the cholesterol-lowering effect of niacin, or both.

PMID: 3782631 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=3782631&query_hl=9&itool=pubmed_docsum


6 posted on 07/26/2006 2:57:38 PM PDT by oxcart (Journalism [Sic])
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To: oxcart

Thanks for the link.


7 posted on 07/26/2006 3:22:16 PM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem
This cholesterol scam is the biggest in the history of the world. Good Dr. Atkins pointed out that it means squat. People with low cholesterols and skiny died of heart attacks about the same rate as people with high cholesterol. People with higher cholesterol are smarter - brain "grease". Take that cholesterol lowering medication and you screw your liver - read the fine print, ble, bla, bla...
As seen on TV: "tell your doctor to prescribe you ......more crap from money hungry pharmaceuticals. "
8 posted on 07/26/2006 3:53:51 PM PDT by Leo Carpathian (ffffFReeeePeee!)
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To: neverdem
I've turned on policosanol (bee wax extract) by Dr. Rosenfeld of FoxNews. Pharmaceutical companies don't like this much. The reason, they can't pattern it because it's comes natural...

From National Institute of Health Policosanol. You can buy off the web for dirt cheap. A typical 20mg 60 pills go for less than $20 that lasts for 2 months.

.

Disclaimer: I got no connection to the site...

Also search policosanol articles on the same site, you'll find a lot of good info. The only thing I do, changed my diet (no longer stuff 'til you drop :), walked and exercised regulary, and I have been on it for 4 years, my total down from 270s to 170s. I can't speak enough good of this stuff. I recommend if anyone interested, talk and discuss with your physician.


Effects of policosanol 20 versus 40 mg/day in the treatment of patients with type II hypercholesterolemia: a 6-month double-blind study.

Castano G, Mas R, Fernandez L, Illnait J, Gamez R, Alvarez E.

Medical Surgical Research Center, National Center for Scientific Research, Havana City, Cuba.

Policosanol is a well defined mixture of higher aliphatic primary alcohols isolated from sugar cane wax with cholesterol-lowering effects proven for a dose range from 5-20 mg/day in patients with type II hypercholesterolemia and dyslipidemia associated with noninsulin dependent diabetes mellitus. This randomized, double-blind study investigated the cholesterol-lowering efficacy and tolerability of policosanol 20 mg/day compared with 40 mg/day. Changes in low-density lipoprotein (LDL)-cholesterol levels were predefined as the primary efficacy endpoint. Patients with type II hypercholesterolemia were enrolled in the study and instructed to continue a step I cholesterol-lowering diet for 6 weeks and those eligible to be included (89) were randomly allocated to receive under double-blind conditions placebo (n = 30), policosanol 20 mg/day (n = 29) or 40 mg/day (n = 30). After 24 weeks, policosanol at 20 and 40 mg/day significantly (p < 0.00001) lowered LDL-cholesterol by 27.4% and 28.1%, total cholesterol (p < 0.00001) by 15.6% and 17.3%, and the LDL-cholesterol/high-density lipoprotein (HDL)-cholesterol ratio by 37.2% and 36.5%, respectively The ratio of total cholesterol/HDL-cholesterol was lowered by 27.1% and 27.5%, while HDL-cholesterol levels increased (p < 0.001) by 17.6% and 17.0%, respectively. Compared with baseline, policosanol 20 mg/day lowered triglycerides (p < 0.05) by 12.7%, while they were lowered (p < 0.01) by 15.6% at a dose of policosanol 40 mg/day All the above-mentioned significant differences were also different from placebo and no significant changes occurred in any lipid profile parameters in the placebo group. Based on the mean values of LDL-cholesterol levels at study completion, the mean percent reductions from baseline were 27.4% and 28.1% for the 20 and 40 mg/day groups, respectively. Thus, the effects of both policosanol doses on the main efficacy variable were practically identical. Consistent with the data obtained for LDL-cholesterol, both doses were similarly effective in changing all the other lipid profile parameters. No unexpected adverse effects were observed and there were no significant between-group differences regarding safety indicator values or reported adverse effects. In conclusion, although the tolerability profile remains excellent, according to the present results policosanol at a dose of 40 mg/day does not offer significant additional cholesterol-lowering efficacy over the 20 mg/day dose.

Publication Types:
PMID: 11708574 [PubMed - indexed for MEDLINE]
9 posted on 07/26/2006 4:01:48 PM PDT by Toidylop
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To: Leo Carpathian

Not quite. Read my post #9. Policosanol is natural like "alcohol" and it doesn't hurt your liver like any other prescribed drugs. I agreed that the phamarceutical companies are not very truthful about "cholesterol" control.


10 posted on 07/26/2006 4:05:50 PM PDT by Toidylop
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To: Toidylop
The reason, they can't pattern it because it's comes natural...

Gee... bad grammar.

11 posted on 07/26/2006 4:17:04 PM PDT by Toidylop
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To: Toidylop

See post #6


12 posted on 07/26/2006 5:34:59 PM PDT by oxcart (Journalism [Sic])
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To: El Gato; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; Dianna; ...
Glaxo has bird flu 'breakthrough' ~ a vaccine for the H5N1 bird flu

To heal a wound, turn up the voltage

Diabetes study finds children at higher risk - Study strengthens warning obesity could shorten life

FReepmail me if you want on or off my health and science ping list.

13 posted on 07/26/2006 10:25:08 PM PDT by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem; oxcart

thanks for the links...

oxcart, what is your recommended dose per day?


14 posted on 07/26/2006 10:42:16 PM PDT by bitt (NY Times to New York: Drop Dead!)
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To: Toidylop
and it doesn't hurt your liver like any other prescribed drugs.

Lipitor is some of the NASTIEST stuff around. I took it for 3 months and one of my ankles and foot started swelling and HURTING. I've been off the stuff a year and it looks like the swelling is permanent.

15 posted on 07/26/2006 10:55:20 PM PDT by DJ MacWoW (If you think you know what's coming next....You don't know Jack.)
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To: Wonder Warthog
Seems to me that if they want to retain market share, they'd do the testing.

Not if they can use political influence to force Pfizer to pay for it.

16 posted on 07/27/2006 6:18:40 AM PDT by Doctor Stochastic (Vegetabilisch = chaotisch ist der Charakter der Modernen. - Friedrich Schlegel)
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To: neverdem

Five months later:

http://www.freerepublic.com/focus/f-news/1747738/posts

Pfizer Ends Studies on Drug for Treating Heart Disease
NY Times ^ | December 3, 2006 | ALEX BERENSON

Posted on 12/03/2006 12:46:25 AM PST by neverdem

Pfizer announced last night that it had discontinued research on its most important experimental drug, a treatment for heart disease. The decision is a stunning development that is likely to seriously damage the company’s prospects through the next decades.

Preliminary research found that the drug, torcetrapib, appeared to be linked with deaths and heart problems in the patients who were taking it.

For people with heart disease, Pfizer’s decision to stop the trial represents the failure of a drug that many cardiologists had viewed as a potentially major advance in efforts to reduce heart attacks and strokes.

Torcetrapib is designed to raise levels of so-called good cholesterol. It was to be used in combination with older drugs called statins, like Lipitor and Zocor, which reduce so-called bad cholesterol.

As recently as Thursday [11/31/06--note this article was dated 12/3/06], Pfizer executives had hailed the drug at a meeting with investors and analysts at the company’s research center in Groton, Conn.


17 posted on 12/04/2006 4:57:55 PM PST by Auntie Mame (Fear not tomorrow. God is already there.)
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