Re: Over Dose: Jay Cohen on statins and marketing hype

From: Andrew Heenan (andrew3_at_heenan.net)
Date: 07/09/04

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    "Zee" <zwalanga@yahoo.com> wrote in message
    news:e5f4a9c2.0407091113.10774b2a@posting.google.com...
    > "Pharmaceutical companies are waging aggressive campaigns to change
    > prescribers' habits and to distinguish their products from competing
    > ones, even when products are virtually indistinguishable. Victory in
    > these therapeutic-class wars can mean millions [billions today] of
    > dollars for a drug company. But for patients and providers it can mean
    > misleading promotions, conflicts of interest, increased costs for
    > health care, and ultimately, inappropriate prescribing.18"
    >
    >
    > From: http://www.medicationsense.com/index.html
    >
    >
    > THE TRUTH ABOUT CRESTOR: IS CRESTOR DANGEROUS AND, IF SO, WHY? The
    > Intensive Marketing of This New, Super-Strong, Cholesterol-Lowering
    > Statin Drug Raises Questions and Concerns. Are Crestor Users in
    > Jeopardy? Is Crestor Especially Dangerous for Asians? Who Should Take
    > Crestor and When? A Lower, Safer Approach That Most Doctors and
    > Patients Don't Know About.
    >
    > What is Crestor and What Is the Problem?
    >
    > Crestor is the newest statin and the strongest statin yet. Statins are
    > the highly touted drugs for reducing cholesterol. Studies clearly show
    > that statins improve cholesterol numbers (by lowering LDL and raising
    > HDL) and may reduce C-reactive protein. Statins impede
    > atherosclerosis, reduce heart attacks and strokes, and cardiac death.
    > Thus, the statins Lipitor and Zocor are not only the #1 and #2
    > top-selling drugs in America, but also household names.
    >
    > Other statins include Pravachol, Mevacor, and Lescol -- and now
    > ultra-potent Crestor. Until 2001, there was another statin: Baycol. It
    > was then the newest statin and a potent statin -- until it was
    > withdrawn because of dozens of deaths. Is Crestor another Lipitor or
    > another Baycol? Although Crestor has been on the market only a year,
    > it has already been linked to numerous cases of severe muscle
    > breakdown, kidney toxicity, and deaths. Public Citizen recently
    > petitioned the FDA to ban Crestor.
    >
    > The Marketing of Super-Strong Crestor
    > Crestor's introduction in August 2003 provides a textbook example of
    > how marketing strategies can supersede medical science and common
    > sense. Taking a page from Lipitor's highly successful marketing
    > campaign in 1997, Crestor is now being aggressively marketed as the
    > strongest statin of all.
    >
    > The manufacturer's recommended initial dose of Crestor is 10 mg/day
    > (except for people with kidney problems). This dosage is so strong
    > that Crestor's advertising can boast it is stronger than equivalent
    > doses of any other statin. This is quite a claim, because Lipitor and
    > Zocor are pretty strong themselves. Indeed, their top-selling status
    > has been built on their own advertising about their power to reduce
    > cholesterol and LDL-cholesterol (LDL-C) levels.
    >
    > But more isn't necessarily better with most medications, including
    > statins. As I've written in medical journal articles and in my
    > upcoming book (What You Need To Know About Statin Drugs And Their
    > Natural Alternatives),1 the standard starting doses of Lipitor and
    > Zocor are often double or quadruple the amounts that millions of
    > people actually need, triggering many avoidable side effects. So what
    > can we say about super-strong Crestor, which is even stronger? We can
    > say that the drug company-recommended, super-strong initial 10-mg dose
    > of Crestor has already been linked to severe toxicities.1A This should
    > not surprise anyone.
    >
    > Excessive Doses = More Side Effects
    > One of my basic principles is: The best dose of any medication is the
    > least amount that works. Medical science agrees. Most people with
    > elevated cholesterol or LDL-C have mild-to-moderate elevations. For
    > many, dietary interventions are enough. For others, modest statin
    > doses are often plenty. But the recommended initial doses of Lipitor,
    > Zocor, and Pravachol are strong, yet that's what doctors prescribe to
    > most people, even to people who don't need such strong statin therapy.
    > This is the crux of the problem of statin side effects such as muscle
    > aches, joint pains, abdominal discomfort, memory and cognitive
    > impairment.2-6 Side effects are a major reason that 60%-75% of people
    > started on statins quit treatment.7,8 The average time until they
    > discontinue treatment: 8 months. Many people quit within a few months.
    >
    > Liver injury, liver toxicity, and death are also concerns with
    > statins. Like other statin side effects, these reactions are
    > dose-related: the greater the dose, the greater the risk. Dr. W.C.
    > Roberts, the editor-in-chief of the American Journal of Cardiology,
    > warns: "With each doubling of the [statin] dose, the frequency of
    > liver enzyme elevations [indicating liver irritation or injury] also
    > doubles.9"
    >
    > Nerve injuries have now been documented in people taking statins
    > long-term.10, 11 The incidence is low, perhaps 1 in 2000 to 5,000, but
    > with millions taking statins, this adverse effect will afflict
    > thousands of people each year. These injuries can be severe and
    > permanent, and even mild nerve injuries can take months to fade away.
    >
    > Doctors cannot anticipate who will develop a long-term side effect
    > with statins, but doctors should (but usually don't) anticipate that
    > they will occur in some people. The only defense: using the least
    > amount of medication you need.
    >
    > Do We Need a Stronger Statin?
    > The standard starting dose of Crestor is 10 mg, which reduces LDL-C a
    > whopping 46%-52%.12 Some people, especially those with serious
    > coronary disease, require this degree of LDL-C reduction, but most
    > people with elevated cholesterol require only 20%-30% reductions --
    > and therefore much less medication.
    >
    > Crestor's manufacturer does recommend a lower 5-mg dose for people
    > requiring "less aggressive LDL-C reductions.12" Yet, 5-mg Crestor
    > reduces LDL-C 42%, still far more than most people with elevated
    > cholesterol need.
    >
    > And remember, this 42% LDL-C reduction represents the average among
    > study subjects. Many people get even greater reductions with this
    > dosage. In one study, 5 mg of Crestor reduced LDL-C as much as 71% in
    > subjects.13 This is an impressive number, but reducing cholesterol too
    > aggressively is believed to be a trigger for cognitive, memory, and
    > mood problems with statins. And too low cholesterol levels aren't good
    > either, because cholesterol is a necessary building block in human
    > cells and a substrate of many of our hormones.
    >
    > So contrary to Crestor's marketing, we shouldn't be overly impressed
    > with which statin is strongest. You don't want the strongest statin.
    > You want the mildest statin that works for you.
    >
    > Lower, Safer Doses of Crestor Work --
    > But Your Doctor Doesn't Know About Them
    > The lowest marketed dose of Crestor is 5 mg. Yet, studies show that
    > 2.5 mg of Crestor reduces LDL-C 40%, and just 1 mg reduces LDL-C 34%,
    > on average.13, 14 These doses are still stronger than the standard
    > initial doses of Pravachol, Mevacor, Zocor, and Lescol, and they would
    > certainly be strong enough for most people with elevated cholesterol.
    > Indeed, the lead author of one Crestor study stated: "Even at 1
    > mg/day, rosuvastatin [Crestor] reduced LDL-C by 35%, the same
    > percentage reduction seen with simvastatin [Zocor] 20 and 40 mg.14"
    >
    > Yet, you won't find any information about this in the Crestor package
    > insert,12 pharmacy slips, or the Physicians' Desk Reference.2
    > Crestor's manufacturer isn't going to inform you or your doctor about
    > lower Crestor doses that aren't available, even if they are effective
    > -- and safer. This goes right to the heart of the issue of informed
    > consent. Your right of informed consent is denied if you aren't given
    > enough information to make an intelligent choice.15 You aren't alone:
    > one study showed that only 9% of office patients receive enough
    > information to fulfill their right of informed consent .16 No wonder
    > medication side effects continue to be one of the leading causes of
    > death in America.
    >
    > The Marketing of Crestor
    > Why isn't Crestor marketed at lower, safer doses? Drug companies like
    > to keep dosing simple, because simple dosing makes doctors' job
    > easier. The fact is, doctors are inadequately trained about
    > medications. Their one pharmacology course covers hundreds upon
    > hundreds of drugs, but not deeply. Doctors assume that drug companies
    > and the FDA are providing complete information with the best doses,
    > when in fact they aren't. That's why doctors rarely question
    > irrational drug company guidelines even when the guidelines tell
    > doctors to prescribe the same strong doses to young and old, big and
    > small, healthy and frail.
    >
    > I could list hundreds of quotes about problems with drug research and
    > marketing, but the following two will suffice. The first is from Dr.
    > Andrew Herxheimer, the highly respected expert at Britain's renowned
    > Cochrane Coalition:
    >
    >
    > "Drugs are often introduced at a dose that will be effective in around
    > 90% of the target population, because this helps market penetration.
    > The 25% of patients who are most sensitive to the drug get much more
    > than they need.17"
    >
    >
    > Actually, with statins, the number is probably much higher. Dr. David
    > Kessler, when he was FDA commissioner, wrote this about marketing
    > strategies vs. medical science:
    >
    >
    > "Pharmaceutical companies are waging aggressive campaigns to change
    > prescribers' habits and to distinguish their products from competing
    > ones, even when products are virtually indistinguishable. Victory in
    > these therapeutic-class wars can mean millions [billions today] of
    > dollars for a drug company. But for patients and providers it can mean
    > misleading promotions, conflicts of interest, increased costs for
    > health care, and ultimately, inappropriate prescribing.18"
    >
    >
    > My articles and books contain dozens of examples of excessively dosed
    > drugs. Crestor is another. In October 2003, Dr. Richard Horton, editor
    > of the British Medical Journal, published a scathing critique of
    > Crestor's marketing, stating that the manufacturer's tactics "raise
    > disturbing questions about how drugs enter clinical practice and what
    > measures exist to protect patients from inadequately investigated
    > medicines...." Yet, Horton added, the manufacturer will "do whatever
    > it takes to persuade doctors to prescribe rosuvastatin, including
    > launching an estimated $1 billion first-year promotional campaign.19"
    >
    > So, even though the FDA has repeatedly cautioned doctors about using
    > new drugs when older, better known drugs are available, the onslaught
    > of drug reps and intensive advertising pushing Crestor has worked. By
    > early 2004, 27% of all new prescriptions for statin drugs was for
    > Crestor. The Wall Street Journal reported:
    >
    >
    > "AstraZeneca sales force (Crestor) was making more calls to doctors
    > than any of its competitors. Beginning in late February, reflecting
    > the sales calls, new prescriptions of Crestor began to rise and
    > overtook Lipitor by the beginning of March.20"
    >
    >
    > Once again, intensive marketing trumps medical science -- and patient
    > safety. Is this how we want our health care system to run?
    >
    > Is Crestor Risky for Asians?
    > In studies, blood levels of Crestor rose twice as high in Chinese and
    > Japanese subjects as in other groups. Higher blood levels mean
    > stronger effects and greater risks of side effects. The only place in
    > the lengthy Crestor package insert that specifically describes this
    > problem is the "Clinical Pharmacology, Special Populations" section,
    > which many doctors won't notice. Yet, the all-important "Dosage and
    > Administration" section, which most doctors do read, makes no mention
    > of Asian patients. It does make a vague statement about patients "who
    > have predisposing factors" to side effects, but many doctors will miss
    > the implication and prescribe the same strong standard doses of
    > Crestor to Asian patients. If you are of Asian heritage, it is better
    > to use other statins that don't pose particular risks to Asians.
    >
    > Who Needs Crestor? Crestor vs. Lipitor, Zocor, Pravachol, Mevacor, and
    > Lescol
    > How does Crestor compare with other statins? Who should get Crestor?
    > As it is, many doctors are already prescribing overly strong doses of
    > statins to people who don't need such intensive treatment. Stories
    > abound about doctors prescribing excessively strong doses and ignoring
    > obvious, serious side effects.
    >
    > It is important to remember that in most instances, elevated
    > cholesterol is not an emergency. There's time to use caution, to use
    > the "Start Low, Go Slow" method that allows you and your doctor to
    > gauge the exact amount of medication you need. Different people get
    > widely differing responses to statins. Some people get large LDL-C
    > reductions with tiny doses. Others require stronger doses. The only
    > way to know your response is to start low and, if needed, increase
    > gradually. Of all the statins, this is least possible with Crestor.
    >
    > Who actually needs Crestor? Hardly anyone. Other statins have much
    > longer track records and should be used first. The respected Medical
    > Letter on Drugs and Therapeutics agrees, recommending Crestor only for
    > "non-Asian patients who have not responded adequately to statins with
    > a longer record.21"
    >
    > The fact is, milder statins such as Mevacor, Lescol, and Pravachol are
    > strong enough for most people. Lipitor and Zocor are strong enough for
    > almost all of the rest. There are very few people who actually require
    > super-strong Crestor. Moreover, Mevacor is now available as generic
    > lovastatin and much cheaper at pharmacies such as Costco.
    >
    > What You Should Do?
    > A favorite tactic of drug companies is to provide free samples. Drug
    > companies know that once you are started on a medication, you won't
    > want to switch. So sales reps shower doctors with samples, and doctors
    > think they are doing you a favor by giving you a free sample when
    > starting a medication. But they aren't doing you a favor at all.
    >
    > So if your doctor offers you free samples of Crestor, respectfully
    > decline. Drug companies don't provide samples because of their
    > altruism, but as hooks to boost sales of new drugs against established
    > competitors. Unless a new drug really offers something important,
    > resist the pitch.
    >
    > When Baycol was withdrawn because of dozens of deaths, Newsweek asked
    > me what I thought. My response: "I think it's frightening that 800,000
    > people were taking Baycol. Baycol was the newest and least known
    > statin, and it offered nothing superior to other statins. No one
    > should have been exposed to Baycol unless the other five statins had
    > been tried first unsuccessfully, and that is very few people.22" My
    > opinion remains exactly the same about Crestor.
    >
    > The marketing of Crestor is an outrage. The frequent prescribing of
    > super-strong Crestor by doctors is symptomatic of how dominant the
    > drug industry is in influencing the knowledge and decisions of
    > doctors. We must change this. If your doctor suggests Crestor, ask
    > why. Unless there's a very good reason, tell your doctor you would
    > prefer a statin with a longer track record. If your doctor dismisses
    > your opinion, you can quote the top drug experts at the FDA, as they
    > recently wrote in the Journal of the American Medical Association:
    >
    >
    > "Clearly, physicians and patients should be aware that recently
    > marketed drugs are at risk of being found to cause unsuspected serious
    > adverse effects.... A physician considering prescribing a new drug
    > should consider carefully the reason for the choice, particularly when
    > an equally effective alternative is available, as there is always some
    > risk of an undiscovered adverse drug reaction.23"
    >
    >
    > If you are feeling bold, ask your doctor why he/she is suggesting the
    > least-known, most-powerful statin that already has been linked to
    > multiple toxicities, rather than better known, apparently safer other
    > statins. Until we hold our own doctors accountable for their
    > thoughtless decisions, nothing will change and our children will be
    > subjected to the same drug-company controlled health care system.
    >
    > You may also want to tell your doctor that you would rather start with
    > a low-dose statin. Many people get good results with low doses. If you
    > don't, the dosage can be easily, gradually increased so that you get
    > the right amount of statin for you and not a milligram more. Remember,
    > the best dose of any medication is the lowest dose that works. If the
    > medical community applied this principle consistently, we would not
    > have a side-effect epidemic today.
    >
    > REFERENCES
    > 1. Cohen, JS. What You Need to Know about Statin Drugs and Their
    > Natural Alternatives. Square One Publishing, New York: September 2004.
    > 1A. More Crestor Safety Concern; Call for Ban Renewed. Dickinson's FDA
    > Webview, 5/17/2004.
    > 2. Physicians' Desk Reference, 57th Edition, Montvale, N.J.: Medical
    > Economics Company, 2003.
    > 3. Wierzbicki, AS, Lumb, PJ, Semra, et al. Atorvastatin compared with
    > simvastatin-based therapies in the management of severe familial
    > hyperlipidaemias. Qjm 1999;92(7):387-94.
    > 4. Nawrocki, JW, Weiss, SR, Davidson, MH, et al. Reduction of LDL
    > cholesterol by 25% to 60% in patients with primary
    > hypercholesterolemia by atorvastatin, a new HMG-CoA reductase
    > inhibitor. Arteriosclerosis, Thrombosis, and Vascular Biology
    > 1995;15(5):678-82.
    > 5. Bertolini, S, Bon, GB, Campbell, LM, et al. Efficacy and safety of
    > atorvastatin compared to pravastatin in patients with
    > hypercholesterolemia. Atherosclerosis 1997;130(1-2):191-7.
    > 6. Marz W, Wollschlager H, Klein G, et al. Safety of low-density
    > lipoprotein cholestrol reduction with atorvastatin versus simvastatin
    > in a coronary heart disease population (the TARGET TANGIBLE trial).
    > American Journal of Cardiology 1999;84(1):7-13.
    > 7. Jackevicius, CA, Mamdani, M, Tu, JV. Adherence with statin therapy
    > in elderly patients with and without acute coronary syndromes. JAMA
    > 2002;288:462-467.
    > 8. Benner, JS, Glynn, RJ, Mogun, H, et al. Long-term persistence in
    > use of statin therapy in elderly patients. JAMA 2002;288:455-461.
    > 9. Roberts, WC. The rule of 5 and the rule of 7 in lipid-lowering by
    > statin drugs. American Journal of Cardiology 1997;80:106-7.
    > 10. Gaist, D, Jeppesen, U, Andersen, M, et al. Statins and the risk of
    > polyneuropathy: a case-control study. Neurology 2002;58:1333-1337.
    > 11. Peripheral neuropathy due to statins: a rare but potentially
    > incapacitating adverse effect. Prescribe International 2000;9:115.
    > 12. Crestor Package Insert. AstrZeneca Pharmaceuticals LP, Wilmington
    > DE:2003.
    > 13. Olsson, AG, Pears, J, McKellar, J, et al. Effect of rosuvastatin
    > on low-density lipoprotein cholesterol in patients with
    > hypercholesterolemia. American Journal of Cardiology 2001;88:504-508.
    > 14. Olsson, AG. A new statin: a new standard. The American Journal of
    > Managed Care 2001;7:S152.
    > 15. American Medical Association Council on Ethical and Judicial
    > Affairs. Code of Medical Ethics, 1998-1999 Edition. American Medical
    > Association, Chicago, IL.
    > 16. Braddock, CH, Edwards, KA, Hasenberg, NM, et al. Informed Decision
    > Making in Outpatient Practice: Time to Get Back to Basics. JAMA
    > 1999;282:2313-20.
    > 17. Herxheimer, A. How much drug in the tablet? Lancet 1991;337:346-8.
    > 18. Kessler, DA, Rose, JL, Temple, RJ, Schapiro, R, Griffin, JP.
    > Therapeutic-class wars--drug promotion in a competitive marketplace.
    > New England Journal of Medicine 1994;331(20):1350-3.
    > 19. Horton, R. The statin wars: why AstraZeneca must retreat
    > [editorial]. Lancet 2003 (Oct. 25);362:1341.
    > 20. Winslow, R. Lipitor prescriptions surge in wake of big study. Wall
    > Street Journal, Mar. 18, 2004:D4.
    > 21. Rosuvastatin -- a new lipid-lowering drug. The Medical Letter on
    > Drugs and Therapeutics, Oct. 2003;45:81-83.
    > 22. Cohen, JS. Too Much of a Good Thing? Baycol: A Cholesterol Drug Is
    > Pulled after 31 People Died -- What Happened? Newsweek.MSNBC.com, Aug.
    > 10, 2001:www.msnbc.com/news/612443.asp.
    > 23. Temple, RJ, Himmel, MH. Safety of Newly Approved Drugs. JAMA, May
    > 1, 2002;287:2273-2275.
    >
    > Copyright 2004, Jay S. Cohen, M.D. All rights reserved. Readers have
    > permission to copy and disseminate all or part of these articles if it
    > is clearly identified as the work of: Jay S. Cohen, M.D., the
    > MedicationSense E-Newsletter, www.MedicationSense.com. You may not use
    > this work for commercial purposes.
    >
    > If you find this article informative, please tell your friends, family
    > members, colleagues, and doctors about www.MedicationSense.com and the
    > free MedicationSense E-Newsletter.
    >
    > NOTE TO READERS: The purpose of this E-Letter is solely informational
    > and educational. The information herein should not be considered to be
    > a substitute for the direct medical advice of your doctor, nor is it
    > meant to encourage the diagnosis or treatment of any illness, disease,
    > or other medical problem by laypersons. If you are under a physician's
    > care for any condition, he or she can advise you whether the
    > information in this E-Letter is suitable for you. Readers should not
    > make any changes in drugs, doses, or any other aspects of their
    > medical treatment unless specifically directed to do so by their own
    > doctors.
    >
    >
    >
    > --------------------------------------------------------------------------
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