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    Monday, August 21, 2006

    The Summer of My Disenchantment: I am ready to throw in the towel and admit defeat. The drug companies have won. They've suceeded in dominating the debate about which medicine to use for what and when. Professional judgement and experience, and scientific evidence have failed to check their promotional assaults. They've won the battle, and maybe the war.

    I've grown used to patients requesting drugs their friends have recommended. I've grown used to patients insisting that certain drugs are the best in their class, based on nothing more than television commercials. I've grown used to the cozy relationship between drug companies and medical celebrities. But, when my favorite cardiologist, a man I've known for years to be of sound judgement and character, starts telling my patients that Lipitor is the best statin, and that they should be taking medication for their "pre-hypertension," - well, I'll never get used to that.

    What happened? Did he lose his marbles? Is he too busy to read the literature? Or did he just succumb to clever marketing? Alas, I think the latter, and he is by no means alone. Although Pfizer certainly thinks Lipitor is the best statin on the market, the truth is there is no "best" statin- at least not that can be shown by the evidence. So why do so many doctors think that Lipitor is the "best"?

    For one thing, Pfizer has aggressively marketed the drug to doctors, with a well-trained sales force:

    All this reflects the company's guiding sales principle: It wants doctors to think of Pfizer sales reps as vital suppliers not only of drugs but also of new, useful medical information. "What's important is that [the reps] get access to doctors who are incredibly crunched for time," says Richard Braaten, vice president in charge of training. "We want them to be able to give standup presentations in the middle of a hallway if they have to." The approach seems to work. In a national survey of doctors by industry consultant Verispan in 2002, Pfizer's sales force ranked as "most esteemed."

    But that's only a small part of their genius. The real jewel in their PR crown is the way they've manipulated the research data to make it seem - with a quick glance at an abstract and a well placed press release - as if Lipitor is superior. They've had studies published in The Lancet, JAMA, and the New England Journal of Medicine showing that Lipitor reduces the risk of heart disease in hypertensives and diabetics. They have studies showing that it is superior to other drugs in lowering cholesterol and reducing plaque build-up in arteries, and preventing cardiovascular disease. And most recently, they've presented evidence that Lipitor reduces the risk of stroke. But take a closer look at those studies. None of them actually prove that Lipitor is "better" than any other statin.

    Lipitor reduces risks in hypertensives and diabetics? Why, yes, it does. But it was compared to placebo in both cases, not another cholesterol drug. A generic statin may do just the same. Is it better than Pravachol at reducing cholesterol plaque build-up in coronary arteries? Yes, if a high dose of Lipitor is compared with a moderate dose of Pravachol rather than a high dose. (Not surprisingly, the Pravachol users had high cholesterol levels than the high-dose Lipitor users.) Is it better than Pravachol at preventing heart disease? Again, yes, if a high dose of Lipitor (and lower cholesterol levels) is compared to a moderate dose of Pravachol (and higher cholesterol levels.) Is it better than anything else being used in the community by practicing physicians? Yes, if high dose Lipitor and a defined cholesterol level guideline is compared to a very vague category of "any treatment deemed appropriate by their regular physicians." Does it reduce the risk of stroke? Only compared to placebo.

    What's missing from all of those studies is a head to head comparison of outcomes based on the cholesterol level alone - regardless of whether it's achieved by diet, a generic statin, or Lipitor. Show me a study that proves that a Lipitor-generated LDL of less than 70 is superior to a diet-generated LDL of less than 70 or a Pravachol or lovastatin-generated LDL of less than 70, and then I'll believe it's the "best statin". If there were a Nobel Prize in marketing, whoever was in charge of designing these studies surely deserves it.

    Interestingly, a recent article on electronic records in the New York Times mentions just this topic as an illustration of the usefulness of an electronic record as a tool for third party payers to dispute the hyped-up pharmaceutical research data:

    Still, the potential for market-disrupting cost savings is illustrated by what Kaiser and the V.A. have done in their drug management programs with statins, cholesterol-lowering drugs. Statins are the largest prescription drug category in the United States, with sales of $16 billion last year, according to IMS Health, a research group; Lipitor ($8.4 billion), from Pfizer, and Zocor ($4.4 billion), from Merck, took 80 percent of the market.

    In recent years, Kaiser and the V.A. have been using generic lovastatin for many of their patients taking statins, saving millions of dollars. At Kaiser, for example, its research pharmacists and cardiologists had been looking at closely at using the generic even before Merck’s Mevacor, the brand name for lovastatin, lost its patent protection in 2001. Kaiser’s research on safety and effectiveness concluded that lovastatin could generally be used as an alternative.

    ..... But nearly 90 percent of patients, according to Kaiser’s research, can reach their cholesterol-lowering goals with lovastatin. (Zocor lost its patent protection in June, further opening the statin market to lower-priced generics.)

    The V.A. also makes extensive use of lovastatin. These kinds of programs can be carried out confidently only at places with the resources to conduct research, monitor individual patients and track outcomes across patient populations using electronic medical records. “This has to be driven by the clinical data, not merely cost savings,” said Joseph J. Canzolino, associate chief consultant for pharmacy benefits management at the V.A.


    So, has it come to this? We need to invest in expensive computer software to counteract sophisticated drug industry marketing? Jeesh.

    UPDATE: From the comments:

    ...but your statement that if patients can get to "goal" with a cheaper drug they should use the cheaper drug is not evidence based, In fact use of the "Goals" is not evidenced based. I'm not aware of any data which shows that a drug induced decrease in LDL can go too low. In fact every study I'm aware of has shown that the lower the LDL goes the lower the risk is.

    So since lipitor is the most powerful statin (most LDL lowering per mg) except for crestor (a drug with a questionable safety profile, or at least one not as proven as atovastatin) shouldn't it give the most protection andif it gives the most protection doesn't that make it the "best " statin.


    Not quite true. What the studies show is that there are slightly better outcome with an LDL cholesterol (the "bad" cholesterol) of around 70 - the average achieved with Lipitor. The studies were designed so that the competing statins would only lower LDL cholesterol to around 100, by using smaller doses the competing drugs.

    It's true that Lipitor will drop cholesterol by a greater percentage than other statins, but there's no proof that it's superior if other, cheaper statins can get you to the same goal. Or if diet does, for that matter.

    It's not necessarily true that the lower the cholesterol the better the result. Cholesterol is not a completely useless biochemical. It's an essential building block of cell membranes. There may not be any studies to confirm how low is too low, but common sense tells us that it can be too low. And there's some evidence to back this up.

    So, while Lipitor may be the right choice for some people who have their best response to it, it isn't de fact the best statin for every one.
     

    posted by sydney on 8/21/2006 11:25:00 PM 13 comments

    13 Comments:

    When Lipitor goes generic you will see it fall off the face of the Earth. The beauty of statins for the drug companies is they can show a measurable change in LDL with no life threatening side effects.

    Sadly, many doctors do believe that the drug reps are fountains of truth. Only by staying the course can doctors like you give patients like me the information we need to counter this machine that cares nothing for our health, but everything about making money.

    Steve Lucas

    By Anonymous Anonymous, at 4:36 AM  

    Interesting post. Thanks for the analysis. It mirrors what I had suspected recently with regards to the "80mg Lipitor" reduces the risk of stroke. Emphasis on the 80mg part.

    AstraZeneca did something similar with their marketing of Nexium, btw. You'll recall that Prilosec is typically prescribed as 20mg QD. Nexium is most common as 40mg QD. A drug rep (no longer with AZ) told me that they compared the two together -- only Nexium was at 40mg and Prilosec was at 20mg. Naturally that part wasn't emphasized, and a lot of doctors were snowed by it. Hence Nexium's evergreened, un-deserved, excessively-costly popularity.

    In the case of Lipitor, I think marketing will only work for so long. It's in the government's interest to conduct head-to-head studies comparing the generic statins to Lipitor because it can save them money. It's only a matter of time before this is done -- and I think the results are not going to be in Pfizer's favor, which is why I think Lipitor will largely be irrelevant by the time it loses protection in 2010.

    By Anonymous RJS, at 11:22 AM  

    http://pharmagossip.blogspot.com/2006/08/statin-wars-generic-simvastatin-makes.html

    Take some comfort from the above graph.

    Chin up - remember "nil desperandum carborundum" (Dont let the buggers grind you down)

    By Blogger insider, at 1:08 PM  

    Great rant, Sydney!
    For more on how pharma (and probably other) companies may manipulate clinical research and clinical research literature, see some posts on Health Care Renewal:
    http://hcrenewal.blogspot.com/2005/05/medical-journal-are-extension-of.html/
    http://hcrenewal.blogspot.com/2005/05/troubling-study-of-contracts-between.html/
    http://hcrenewal.blogspot.com/2005/11/muraglitazar-case-new-window-on.html/
    http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html/
    We physicians have got to start resisting this stuff!

    By Blogger Roy M. Poses MD, at 3:08 PM  

    Ask the patients that almost died from drug interactions while taking Baycol if there are no life-threatening side effects from statins. They all carry serious warnings on muscle damage. What works for one person doesn't work for another. Slavish focus on cost and not effectiveness is just as foolish as accepting uncritically sales rep pitches. If a physician is too busy to carefully consider what medication is best to treat a patient, maybe they should consider what criteria they use in any diagnosis. Drug companies do what any company does, promote its product. The sad thing is that, despite their reputation in society, too many physicians are either too lazy or too ill informed to do anything other than listen to a drug rep. And this should be blamed on the drug companies and the patients?

    By Anonymous Anonymous, at 11:05 PM  

    i've posted comments at my new blog. Briefly: better health costs more, research to support using cheaper meds is easier with EMRs, and genomic medicine is less important than close monitoring (good care). Where's your rant against genomic medicine? ;)

    By Blogger Enoch Choi, at 2:55 AM  

    Your comments do raise an important aspect of care...

    but your statement that if patients can get to "goal" with a cheaper drug they should use the cheaper drug is not evidence based, In fact use of the "Goals" is not evidenced based. I'm not aware of any data which shows that a drug induced decrease in LDL can go too low. In fact every study I'm aware of has shown that the lower the LDL goes the lower the risk is.

    So since lipitor is the most powerful statin (most LDL lowering per mg) except for crestor (a drug with a questionable safety profile, or at least one not as proven as atovastatin) shouldn't it give the most protection andif it gives the most protection doesn't that make it the "best " statin.

    By Anonymous joel topf, at 4:22 PM  

    Meanwhile, the VA has been assiduously switching patients with dementia on anything BUT Razadyne to Razadyne. Not cost driven?

    By Blogger Greg P, at 9:25 PM  

    I do the math over and over again and I keep coming up with the same result: How can doctors complain about not having enough time to bone up on the efficacy of and indications for a drug's usage, and yet find the time to lunch, dine, and other wise hob nob with pharmaceutical rep's?

    By Blogger NoAcuteDistress, at 1:19 PM  

    Syd writes:

    > So, has it come to this? We need
    > to invest in expensive computer
    > software to counteract
    > sophisticated drug industry
    > marketing? Jeesh.

    Well, Syd, no and yes.

    It is one thing to show that the evil drug company did not prove what they want you to believe they proved. For this, no expensive computer software is needed. Only cheap computer software: imagine a blog where the latest (implied) claims of the drug companies are de-bunked by "ordinary" physicians for other physicians to check in on once a month, or when the next patient comes in with the latest television commercial memorized.

    It is another thing to prove something yourself: to base medication choices on something resembling evidence -- other than evidence of lower price. For this you need expensive computer software, decent coding systems, conscientious data gathering, a documented decision-making process, and the rest.

    t

    By Blogger Tom Leith, at 1:38 PM  

    Hmmm,
    I thought the math would be really simple. If we assume Pfizer is correct that Lipitor is 43% better (using the numbers 70 and 100 and assuming a simple linear correlation to outcomes - insane I know but stay with me here...) then simple economic theory seems to suggest that

    Simvastatin (the one compared in the 100 vs 70 endpoints) 1mg = 0.7 x Atorvastatin 1mg.
    So if Lipitor costs more than 43% more than generic Simvastatin the person would not be buying the cheaper drug...

    Have I made any obvious mistakes here?

    In Oz Lipitor 40mg is about AUD$80 for 30 tablets,
    Generic Simvastatin AUD$66.67 or a 20% difference. Someone must have had a special word in the Minister for Health's ear??? or maybe the prices reflect a 20% per milligram better performance?

    So how much are they over there?

    Benedict

    By Blogger Benedict 16th, at 8:56 AM  

    Eli Lilly 3Q 10% profit rise is nearly all from psyche drugs including zyprexa.

    How have they schemed to squeeze more money from their zyprexa cash cow when pill production has actually gone down?

    ANS-Eli Lilly profiteers have jacked up the price of zyprexa to the federal govt,from the Medicare D payouts.

    Eli Lilly is a big drug company that puts profits over patients.

    They covered up findings that their Zyprexa has a TEN times greater risk of causing type 2 diabetes

    Only 9% of Americans trust big pharma,right around the same rating as tobacco companies.

    Daniel Haszard Eli Lilly zyprexa drug caused my diabetes www.zyprexa-victims.com

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