Posted on 11/03/2007 10:09:54 AM PDT by 21stCenturyFreeThinker
It is shaping up to be the biggest shift yet to a generic drug, potentially saving the nation $2 billion a year or more in prescription costs.
And scientists and doctors say that for most of the 16 million people in America who take drugs to reduce cholesterol, the low-priced alternative will work as well as the name-brand medicine — Lipitor, which is made by Pfizer and is the nation’s most widely prescribed drug.
While Lipitor itself is not available as a generic, a very similar drug made by Merck, Zocor, lost its patent protection last year. The generic version of Zocor, simvastatin, is now much cheaper than Lipitor, leading insurers to press doctors and patients to switch.But Pfizer is not letting its flagship drug go down without a fight.
The company has mounted a campaign that includes advertisements, lobbying efforts and a paid speaking tour by a former secretary of the federal Department of Health and Human Services. Pfizer is also promoting a study — whose findings many experts are questioning — that concluded that British patients who switched to simvastatin had more heart attacks and deaths than those who remained on Lipitor.
The Lipitor battle has become a test of the pharmaceutical industry’s ability to defend name brands, even as insurers, patients and doctors seek to whittle the nation’s $270 billion annual prescription drug bill by using generic alternatives whenever possible.
(Excerpt) Read more at nytimes.com ...
The company has mounted a campaign that includes advertisements, lobbying efforts and a paid speaking tour by a former secretary of the federal Department of Health and Human Services.Expensive advertising, intense lobbying, and a former HHS secretary. Ever wonder why health care reform is on the table? Push too far and you get a backlash.
Lipitor needs to be taken off the market. When 3 doctors gang up on your father and tells him he needs to sue them, something is definitely wrong. My Dad has extreme pain in his legs because of lipitor. They pay doctors $200 per prescription. Dad told his first doctor that something was happening to his legs but the doctor kept prescribing anyway. He wanted that money. His new doctor and 2 specialists told him that they are tired of the problems they are getting because of this. His pain specialist said that 50% of his clients are there because of lipitor. Unfortunately, the lawyer filed 3 days too late.
I take 20 mg Lipitor a day. Costs me about $4.50 a tablet. Wouldn’t mind seeing the price go down, but I know generics don’t always work as well as the original.
Zocor along with a respectable effort at reducing overall fat and esp transfat intake keeps my LDL at 30 - 40. I’m a happy camper, but damn, I’d love to eat a real old-time pizza, in fact the whole extra large, LOL
Death Rate: Source: Archives of Internal Medicine Vol. 153 No. 9, May 10, 1993 Total serum cholesterol levels and mortality risk as a function of age. A report based on the Framingham data http://archinte.ama-assn.org/cgi/content/abstract/153/9/1065
The relationship between total cholesterol level and all-cause mortality was positive (ie, higher cholesterol level associated with higher mortality) at age 40 years, negative at age 80 years, and negligible at ages 50 to 70 years. The relationship with CHD mortality was significantly positive at ages 40, 50, and 60 years but attenuated with age until the relationship was positive, but not significant, at age 70 years and negative, but not significant, at age 80 years. Results for the relationship between low-density lipoprotein cholesterol and high-density lipoprotein cholesterol and mortality help explain these findings. Non-CHD mortality was significantly negatively related to cholesterol level for ages 50 years and above. [Ed: - low cholesterol = higher non-chd mortality; high cholesterol = lower; CHD = Coronary Heart Disease]
Before Lipitor I tried Zocor, but it was not nearly as effective for me.
My cholesterol is now around 120 vs 260 to 300 before medication.
I take 20 mg Lipitor a day. Costs me about $4.50 a tablet. Wouldn’t mind seeing the price go down, but I know generics don’t always work as well as the original.It depends on the medicine. A lot of that perception is created with their very effective advertisements that frequently include smoke and mirrors.
Some older generics have more side effects than the newer medicines which make it worth the money to use the newer drug. But Zocor just went off patent and really is one of the newer drugs itself.
This is just a matter of one drug company trying to smear the others products. I doubt our health is the central concern.
Last time in, prompted by a letter from my insurance company and my own curiosity, I asked my doctor about switching from Lipitor. He told me that the other drugs were not the same and I should stay on it.
Intellectual property is the issue here. I believe the Lipitor patent extends thru 2011. Any generics will be made in India (Ranbaxy or Dr Reddy). Hell, they are already making generics in violation of patent law and shipping to Canada.
Sharply Lower Cholesterol Levels Cut Heart Attack, Stroke Risk
Tuesday, March 8, 2005
HealthDay News
More study is needed before guidelines should be changed, researchers say
By Amanda Gardner
HealthDay Reporter
TUESDAY, March 8 (HealthDay News) — Reducing “bad” cholesterol levels to new lows resulted in fewer problems, including heart attacks and strokes, in people with established coronary disease, a new study finds.
However, there was no commensurate decline in death rates.
The study appears in the April 7 issue of the New England Journal of Medicine, but was released Tuesday to coincide with a presentation at the American College of Cardiology’s scientific sessions in Orlando, Fla.
Participants in the study took a high dose (80 milligrams) of atorvastatin, better known by its brand name Lipitor, a drug made by Pfizer, which also funded the study.
The results are not enough to warrant an all-out change of current cholesterol recommendations at this time, the study authors said.
“I don’t think we ought to make a flat-footed recommendation based on one study,” cautioned Dr. John LaRosa, lead author of the study and president of SUNY (State University of New York) Downstate Medical Center in New York City.
“It was good, but they didn’t reduce total mortality, so we need to be a little cautious,” agreed Dr. Bertram Pitt, author of an accompanying editorial in the journal and a professor of medicine at the University of Michigan Medical School.
While current guidelines recommend LDL levels of less than 100 mg per deciliter of blood for people with stable coronary heart disease, more recent data have suggested that levels less than 70 mg per deciliter might be better, the study authors said.
That previous research was not definitive, however. So the authors of the new study undertook a review involving 10,001 people with coronary heart disease who had LDL levels of less than 130 mg per deciliter.
The participants in the study were randomly assigned to receive either 10 milligrams or 80 milligrams of Lipitor a day and were followed for about five years.
Those who were treated with the higher level of Lipitor had mean LDL cholesterol levels of 77 mg per deciliter. Those treated with the lower dosage had mean levels of 101.
In the 80 milligram group, 434 patients (8.7 percent) had a heart attack, stroke or other event, compared with 548 patients (10.9 percent) in the low-dose group. That means there was an absolute reduction in the rate of major cardiovascular events of 2.2 percent and a relative reduction of 22 percent, the study authors said.
Although there were no differences in overall mortality, there was a slight increase in deaths not related to cardiovascular causes in the high-dose group, which is of potential concern, the study authors said.
Nevertheless, LaRosa felt the results were striking: Even if there was no reduction in mortality rates, there were other significant benefits, such as living without the disability of stroke.
“The most common cause of death in this study in both groups was not coronary disease,” LaRosa said. “A few years ago, if you told me you had a treatment that would lower the death rate of coronary disease so that it was no longer the most common cause of death in people that had it, nobody would have believed it.”
But it is the deaths not related to cardiovascular causes that has Pitt worried. “There are benefits, but is there any risk? That’s a little uncertain,” he said. “It’s not clear-cut. People will have to look at it and decide.”
It’s also not clear if the lower cholesterol levels were related to Lipitor or would be seen with other statins as well. Other studies are ongoing, LaRosa said, and “within a year we’ll at least be able to say that it applies to two statins or it doesn’t.”
“I don’t even think it’s a question of statins,” he added. “I think it’s probably a function of how low you can get the LDL, however you do that.”
As for whether overall cholesterol policy should be changed, LaRosa noted that two other large studies addressing essentially the same question would be complete in about one year and may provide some answers.
“When you are going to make official national guidelines, you want to make sure you are standing on absolutely solid ground,” LaRosa said.
All but one of the study authors acknowledged having received funds from Pfizer for research or being employed by the company. And all but one of the authors also acknowledged receiving fees and/or grants from numerous other pharmaceutical companies, including makers of other statin drugs.
SOURCES: John C. LaRosa, M.D., president, SUNY (State University of New York) Downstate Medical Center, New York City; Bertram Pitt, M.D., professor, medicine, University of Michigan Medical School, Ann Arbor; March 8, 2005, presentation, American College of Cardiology scientific sessions, Orlando, Fla.; April 7, 2005, New England Journal of Medicine
When the patent on Lipitor does expire they will have “Lipitor II” ready for market:
“Pfizer also announced the results of separate studies combining Lipitor with an experimental drug, torcetrapib, showing that the combination effectively raised HDL, or “good” cholesterol, and reduced LDL, or “bad” cholesterol.
The phase 2 studies, which are conducted prior to phase 3, or late-stage clinical trials, showed that the Lipitor-torcetrapib increased HDL cholesterol by 44 to 66 percent, and reduced LDL by 41 to 60 percent, the company said.
“We think this is going to be the first breakthrough in lipid therapy in 20 years,” said Dr. Chuck Shear, Pfizer’s vice president of cardiovascular metabolic development. “It’s going to provide very significant risk reduction.”
Pfizer is currently conducting phase 3 studies on the combination. Shear would not say when the late-stage studies are expected to be completed. If phase 3 is successful, the next step would be filing with the FDA.
Michael Krensavage, analyst for Raymond James, recently estimated that, under the best case scenario, annual sales of a Lipitor-torcetrapib combination could reach $25 billion.”
From money.cnn.com
Death Rate: Source: Archives of Internal Medicine Vol. 153 No. 9, May 10, 1993 Total serum cholesterol levels and mortality risk as a function of age. A report based on the Framingham dataGreat article. Statins are known to do wonders at reducing cholesterol. It is definitely important and I take lipitor myself.
The issues are 1) how long should the patents last?, and 2) should drug companies be smearing each other's products in advertising.
The drug companies create breathtakingly effective new medicines. But the business side lacks a lot. Much of the research for these medicines was done with public money as well.
Has your Dad started taking in CoQ 10? Sounds like he needs it....
“I don’t even think it’s a question of statins,” he added. “I think it’s probably a function of how low you can get the LDL, however you do that.”
There is the truth. LDL levels <30 with much higher HDL actually causes arterial plaque size reductions......Plaque is the obstruction that kills heart muscle or cerebral tissue.
Terms like CHD, etc, deliberately overlook this. Wanna reduce your obstructions? Get your LDL level into the basemant with HDL double or triple the LDL.
Sharply Lower Cholesterol Levels Cut Heart Attack, Stroke Risk Tuesday, March 8, 2005I have a lot more faith in peer reviewed science research than in what the advertising department conjures up.
I hope this new drug comes through. I will gladly pay the price if it's that effective. I'd rather not pay for advertising and pseudo study wars.
I take 20 mg lipitor, and have done so now for several years. No noticeable bad effects. I have a really first-rate GP, and I trust his judgment (which is not true of every doctor).
If there were a generic version of lipitor, fine, I’d take it. But this is the generic version of another drug said to be similar to lipitor. Maybe so, maybe not. I’ll ask my doctor. Meantime, my health insurance covers most of it, and it costs me about $120 a year.
Indian law grants/recognises patents to processes, not end molecules. This is what the generic manufacturers are exploiting. IIRC, there is a lot of pressure to get the law amended to include end-product molecules as well, and that will shut down the Indian generic makers (Cipla, Ranbaxy, Dr. Reddy’s, Wockhardt and Sun Pharma).
> My Dad has extreme pain in his legs because of lipitor.
Lipitor is insidious.
My doctor prescribes the damn stuff and I have been unsuccessful in getting him to switch me to something else. I think the Lipitor manufacturer has brainwashed all the physicians.
One thing I have noticed is that if I get injured or cut or sick from a cold or whatever, it takes months to heal. By months, I mean that if I get a cut while doing home maintenance, it can take 3 or 4 months to heal. I did learn a trick though. If I stop taking Lipitor my injuries heal normally. A cut or sore takes 10 days instead of 10 weeks.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.