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

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Date: Fri, 9 Jul 2004 23:44:21 +0100

Trollpost

Clue: crossposting all over the show
Action: DO NOT FEED the troll.

"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 withdrawn because of dozens of deaths.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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