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Medical Forum / General / Cardiology / September 2005Lipitor not better than rivals. doesn't prolong life for diabetics
AP Study: Lipitor No Better Than Rivals Sunday September 4, 4:53 pm ET Cardiovascular Treatment Lipitor, World's Best-Selling Drug, No Better Than Rivals, Study Says DUESSELDORF, Germany (AP) -- Pfizer Inc.'s cardiovascular treatment Lipitor, the world's best-selling drug, is no more effective than similar drugs and in some cases has worse side effects, according to a study by an independent German institute. The results come from a survey of previous studies worldwide, rather than new clinical tests on patients. It was released Saturday by Institut fuer Qualitaet und Wirtschaftslichkeit im Gesundheitswesen. IQWiG is an independent institution that studies value-for-money in health care, set up at the instigation of the German government. The study follows a controversy in Germany about the pricing of Lipitor and other statin drugs, which aim to reduce cholesterol levels. According to IQWiG, life-prolonging results for patients suffering from chronic coronary heart disease was seen with Merck & Co.'s Zocor and Bristol-Myers Squibb Co.'s Pravastin -- but not with Lipitor. Jonathan Jones at Pfizer U.K.'s Cardio-Vascular Group said he couldn't comment directly without studying IQWiG's analysis. However he noted that the side effects of the rival medicines differed, and that any study could yield different answers depending on the weight given to them. Representatives based at Pfizer's New York headquarters did not return calls Sunday. In acute diseases, there weren't enough data to prove that any of the group -- Lipitor, Zocor or Pravastin -- was better than the other. With diabetes mellitus, only Merck's Zocor was shown to prolong life. After Germany's health insurers introduced a fixed price for Lipitor by the end of 2004, Pfizer asked its patients to pay the difference between the price of Lipitor and the sum that would be paid by health insurers. Other pharmaceutical companies lowered the price for drugs after the move of the health insurers. Pfizer then started an advertisement campaign in newspapers, stating that Lipitor is better than other statins, notably that is has fewer side effects at high dosages. As a result, IQWiG's study on statins focused on Lipitor. IQWiG the study contested Pfizer's claim that Lipitor is better than other statins. It noted that some studies on Lipitor had to be stopped because it had more side effects compared with Zocor. According to consulting firm IMS Health, Lipitor $12 billion worth of Lipitor last year. Zocor, the world's second-best-selling drug, posted sales of $5.9 billion. http://biz.yahoo.com/ap/050904/germany_lipitor_study.html?.v=1 Note in particular: "Lipitor, the world's best-selling drug, is no more effective than similar drugs and in some cases has WORSE SIDE EFFECTS, according to a study by an independent German institute." "It noted that some studies on Lipitor HAD TO BE STOPPED because it had MORE SIDE EFFECTS compared with Zocor." > AP > Study: Lipitor No Better Than Rivals [quoted text clipped - 60 lines] > > http://biz.yahoo.com/ap/050904/germany_lipitor_study.html?.v=1 > Note in particular: > [quoted text clipped - 29 lines] > > chronic coronary heart disease was seen with Merck & Co.'s Zocor and > > Bristol-Myers Squibb Co.'s Pravastin -- but not with Lipitor. > > In acute diseases, there weren't enough data to prove that any of the > > group -- Lipitor, Zocor or Pravastin -- was better than the other. > > > > With diabetes mellitus, only Merck's Zocor was shown to prolong life. COMMENT: Please note my many notes to this group on why I only prescribe the three oldest statins: mevastatin/Mevacor, simvastain/Zocor, and pravastatin/Pravachol. They are the ones with the giant trials. They deserve your patronage and respect for funding them. We don't know enough about the newer ones, and we were running the risk of getting another Baycol, or just such results as you see above. The problem is insurance companies and HMOs have been pushing Lipitor because it gives more LDL lowering per buck (and they sometimes also offer Mevacor). So the two statins we know most about, Zocor and Pravachol (in that order), get short shrift because people think they're being ripped off, and don't realize (or don't care) that they're paying for information as well as the drug (which has a very low marginal cost). The old problem: people are information-socialists. They think information should be FREE! They rebel if charged for it, and think they're being ripped off. And then, when they inevitably suffer the consequences of acting on poor information because they were too cheap to obtain it, they believe themselves victims of an evil plot. Well, the evil plot was that they got what they paid for, instead of what they thought was due them free, out of the goodness and kindness of the universe (or the government). You've heard me say "wait" on Lipitor. You've heard me denigrate Crestor. As Wilde said, "the plain and simple truth" is rarely plain and never simple. In this case, statins are not good, and statins are not bad. Rather the universe is complex, and some statins are better than others. Also, there is rarely such a thing as a bad drug. But there are certainly BAD combinations of PARICULAR PEOPLE AND PARICULAR DRUGS. But now we generalize: that's true of all drugs. Even the ones the Narcs like to jail people for using. Fundamentalist minds, which are simply incapable of seeing anything (drug or human) in any other terms than black and white, cannot come to grips with the grayness of reality. Hopefully, by means discussions such as these, some of the rest of us can do a little better. SBH > > Note in particular: > > [quoted text clipped - 79 lines] > > SBH "Also, there is rarely such a thing as a bad drug. But there are certainly BAD combinations of PAR{T}ICULAR PEOPLE AND PAR{T}ICULAR DRUGS. But now we generalize: that's true of all drugs. Even the ones the Narcs like to jail people for using." Kudos. Spoken like the pure chemist I suspect you are. Zee > "Also, there is rarely such a thing as a bad drug. But > there are certainly BAD combinations of PAR{T}ICULAR PEOPLE AND [quoted text clipped - 6 lines] > > Zee COMMENT: Though I have a degree in chemistry and am presently slaving over a chemical patent, what I spend most time doing is experimental physiology. My next paper (manuscript just arrived and undergoing final editing now) will treat successful use of a new preparation of general anesthetic in horses (veterinary medicine and pharmacology). My previous paper and abstracts covered the topic of induced hypothermia in dogs, as a model of post-resuscitation encephalopathy prevention (resuscitation physiology). Coming up next is a case report of a radical and successful treatment of sinonasal/brain cancer in 2 humans, using proton radiation and intra-arterial chemo (RADPLAT+protons). I'm the first to have done that, back in 2000 (nobody's done it since-- it's horrendously complicated and only a few places have medical synchrotrons). That's experimental medicine: oncology. Somewhere I have to write up 11 trials of absorption performance of coenzyme Q10 preparations in humans, done over the last year--- more of a nutritional topic. So I'm not a "pure" anything. I am proud to be a scientist. In any case, the divisions within science are artificial. SBH > > "Also, there is rarely such a thing as a bad drug. But > > there are certainly BAD combinations of PAR{T}ICULAR PEOPLE AND [quoted text clipped - 30 lines] > > SBH Message to all Lipitor users: I am currently on 80 mg Lipitor (1 per day), currently have no adverse liver functions based on recent blood tests, no muscle pain, I think my memory is fine, and now have a total cholesterol level of 130 down from 245. However, I have read that Lipitor, dosage was not stated, does reduce testerone levels in men. My experience/evidence of this side effect is parallel with considerable erectile disfunction combined with a much lower libido. Erectile disfunction is not artery or vein blockage related because I still have the 4:00 AM erection every morning. Does anyone else have the same symptoms? Please comment. LW The full Statin Adverse Effects FAQ can be viewed at: http://www.freewebs.com/stopped_our_statins/StatinFAQ_031305wTOCv4.pdf Below, please find extracted the section on ED: Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS To my physician, I believe that my symptoms may be due to the adverse effects a_ssociated with cholesterol-lowering statin drugs. I need your help to understand the cause of my symptoms, treatment options, and the prognosis for my recovery. Please review the references below, published medical studies that show similar problems a_ssociated with statin drugs. These are made available via the National Institutes of Health (NIH, http://www.ncbi.nlm.nih.gov/Entrez/) library of biomedical journal citations and other major repositories of medical research. Also, I am respectfully requesting that you file an adverse effects report with the FDA (http://www.fda.gov/medwatch/how.htm), and that you please send a copy of the report to the to the NIH-funded Statin Study, attention: Dr. Beatrice Golomb, Principal Investigator. Statin Study website: http://medicine.ucsd.edu/statin/ Statin Study contact info: http://medicine.ucsd.edu/statin/contactinfo.html UCSD STATIN STUDY E-MAIL ADDRESS: statinstudy@ucsd.edu MAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995 PHONE NUMBER: (858) 558-4950 Thank you ERECTILE DYSFUNCTION (ED) AND STATINS References (updated as of January 7, 2005): Do lipid-lowering drugs cause erectile dysfunction? A systematic review. Rizvi K, Hampson JP, Harvey JN. University of Wales College of Medicine, Wrexham Academic Unit, Wrexham, UK. Fam Pract. 2002 Feb;19(1):95-8. PMID: 11818357 BACKGROUND: Erectile dysfunction (ED) is common although under-reported by patients. Along with the better known causes of ED, drug-induced impotence needs to be considered as a cause of this symptom. Lipid-lowering drugs have been prescribed increasingly. Their relationship to ED is controversial. OBJECTIVES: Our aim was to clarify the relationship between lipid-lowering therapy and ED. A secondary aim was to a_ssess the value of the systematic review procedure in the area of adverse drug reactions. METHODS: A systematic review was carried out using computerized biomedical databases and Internet sources. Terms denoting ED were linked with terms referring to lipid-lowering drugs. Information was also sought from regulatory agencies. RESULTS: A significant literature was identified, much from obscure sources, which included case reports, review articles, and information from clinical trials and from regulatory agencies. Information from all of these sources identified fibrates as a source of ED. A substantial number of cases of ED a_ssociated with statin usage have been reported to regulatory agencies. Case reports and clinical trial evidence supported the suggestion that statins can also cause ED. Some information on possible mechanisms was obtained, but the mechanism remains uncertain. CONCLUSIONS: The systematic review procedure was applied successfully to collect evidence suggesting that both statins and fibrates may cause ED. More numerous reports to regulatory agencies complemented more detailed information from case reports to provide a new perspective on a common area of prescribing. See also: http://www.spacedoc.net/libido_statins.htm http://www.spacedoc.net/sexual_side_effects_statins.htm > The full Statin Adverse Effects FAQ can be viewed at: > [quoted text clipped - 153 lines] > related because I still have the 4:00 AM erection every> morning.>> Does > anyone else have the same symptoms? Please comment.> LW> One more: http://www.theomnivore.com/Statin_impotence_Apr_2005.html >> > "Also, there is rarely such a thing as a bad drug. But >> > there are certainly BAD combinations of PAR{T}ICULAR PEOPLE AND [quoted text clipped - 45 lines] > Does anyone else have the same symptoms? Please comment. > LW |
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