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Studies funded in part by drug companies claim that every dollar spent on drugs results in more dollars saved, but other experts aren't so sure.

While this debate rages, an expert review panel of cardiologists just dropped a nuclear weapon on a couple of heart disease drugs.  Last year alone, consumers spent $5 billion on Vytorin and Zetia, two heart disease drugs sold by Merck and Schering-Plough.  Did we get our money's worth?  

This week, an expert panel at the annual convention of the American College of Cardiology reviewed drugs for heart disease and found:  

Two widely prescribed cholesterol-lowering drugs, Vytorin and Zetia, may not work and should be used only as a last resort, a panel of four cardiologists told an audience of more than 5,000 people at a major cardiology conference on Sunday.

Instead, physicians and patients should rely more heavily on older cholesterol-lowering drugs called statins, which have proven benefits and can be cheaper, the panel said.

“The strongest recommendation we can make on this panel is to go back to statins,” said Dr. Harlan M. Krumholz, a cardiologist at Yale. “They work.”

An editorial by doctors partially funded by drug companies in the New England Journal of Medicine sounded a cautionary note, but still recommended that doctors only try the drugs in question as a last resort:

In the meantime, the thoughtful clinician may elect to adopt the following reasonably cautious strategy, which is similar to that recommended in the January 15 statement of the American College of Cardiology.  First, achieve targets for levels of LDL and HDL cholesterol (or of the ratio of total cholesterol to HDL cholesterol) with the use of statins plus drugs that have shown clinical benefits when added to statins (e.g., nicotinic acid, fibrates, and bile acid sequestrants), as tolerated. Second, use ezetimibe in patients who, despite the above-mentioned therapy, do not achieve their individual targets. And third, wait for clarifying studies.

Should we be concerned?

Vytorin and Zetia are among the top-selling drugs in the world, with combined sales of $5 billion last year. About five million people worldwide, including four million Americans, take the medicines, which have been heavily advertised to consumers in the United States.

The companies responded with predictable denials:

Merck and Schering-Plough, the companies that make Vytorin and Zetia, said on Sunday that they disagreed with the recommendations. Vytorin and Zetia have been proved to lower cholesterol and are valuable treatments for patients, said Dr. Rick Veltri, vice president of the Schering-Plough research institute.

“We feel that nothing’s changed,” Dr. Veltri said.

The reason is obvious:

On Monday, shares of Merck fell $6.77 to $37.74 while Schering fell $5.07 to $14.40 at mid-day.

The stakes of the debate are high both medically and financially. The drugs produce about 70 percent of Schering-Plough’s profit, according to analysts.

Apparently, we've spent $5 billion a year on patented pills that may be worse than generics.

It's time to reform the way we pay for drugs.  Take a look at Australia, where they pay for proven value, not marketing hype.  I'll take up the Australian system in a future diary.

UPDATE: (April 1)  The companies roll out their marketing campaign to defend their drugs:

Deepak Khanna, general manager of the Merck Schering-Plough joint venture that markets the drugs, said the companies' sales force has prepared a letter for doctors that provides the companies' view of the study presented at the conference and will provide copies of the study, called Enhance, to doctors. "Our sales force and medical-affairs group have been well prepared about what this study is and how to talk about it," Mr. Khanna said.

The companies hope to appeal to the significant number of doctors who aren't swayed by the study's findings and remain convinced their patients will benefit from Vytorin. Still, many physicians will be more comfortable operating in line with the consensus of their peers.

I'd like to see the New England Journal of Medicine compare this marketing letter with the study.

Originally posted to Eunomia on Mon Mar 31, 2008 at 06:20 PM PDT.

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Comment Preferences

  •  I'm one who has taken (1+ / 0-)
    Recommended by:
    luckylizard

    Vytorin since it hit the market.  However, I spent years taking Zocor at large doses to absolutely no effect.  The Vytorin has brought my numbers down somewhat.  Now, what that means, well, I guess according to this piece of research, we really don't know.  Guess it means I shouldn't go getting a false sense of security.

    Vytorin is a statin...its a statin plus Zetia.  A combo drug.  I did only start it after a statin alone proved ineffective.

    I'm not even supposed to have high cholesterol.  I'm not overweight, and I'm a  woman not in menopause.  I eat about 1500 calories a day with little red meat in my diet.  I drink my glass of wine almost every night.  Go figure.  It's probably genetic in my case.  My brother's went high when he was only 33.  

  •  You have written an excellent and important diary (1+ / 0-)
    Recommended by:
    luckylizard

    Thanks.

  •  Rx advertising (1+ / 0-)
    Recommended by:
    Eunomia

    is one of the most insidious things that has happened in my lifetime. I am all in favor of informed patients but what appears on TV is just legalized drug pushing.  As summer approaches I see ads for Nasonex at nearly every break.  It is made to sound not only beneficial but benign for all of us with those pesky "nasal allergies."  It is a steroid which will be absorbed into the bloodstream as rapidly as any other inhaled substance.  I wonder why the Congress is so worried about baseball players who truly know the risks of their steroid use and not about those who will pester their doctors until they prescribe this powerful drug for common allergies. There may very well be some cases when this drug is necessary but to promote it as some kind of panacea for every runny, itchy nose is just criminal.  

    -7.62, -7.28 "We told the truth. We obeyed the law. We kept the peace." - Walter Mondale

    by luckylizard on Mon Mar 31, 2008 at 07:36:22 PM PDT

    •  More money is spent (2+ / 0-)
      Recommended by:
      el dorado gal, luckylizard

      on such advertising than is on research and development...how screwed up is that?

      I have to take several prescription drugs.  I cannot imagine why every runny nose, case of heartburn, etc., needs to be treated with a long term prescription drug.

      •  I have a chronic condition (1+ / 0-)
        Recommended by:
        luckylizard

        (interstitial cystitis) which can be treated two ways: by modifying your diet and cutting out the foods and drinks that cause discomfort or by taking a pill. The pill costs $300/month retail, it helps 3 out of 10 patients, it has a raft of side effects, you don't see results for 3 to 6 months and you have to take it for life or symptoms return, worse than before. The dietary modifications show results within a week. They don't cost much. Yes, it's tougher to give up coffee, soda, tea, liquor, tomatoes and citrus than to pop a pill, but it works much better.

        Guess which one my ob-gyn immediately recommended You're right, the pill. When I said I preferred to manage my symptoms with diet, she was very disapproving. I need a new doctor.

        •  I don't have a problem (1+ / 0-)
          Recommended by:
          luckylizard

          with needing a drug.  I take a host of heart drugs.  I need them.  I can't think my heart back into rhythm.  I can, however, manage to watch what and when I eat and avoid gastric reflux.  Couldn't imagine not wanting to change the diet first.

      •  But, but (0+ / 0-)

        if they give us the drugs for the same price as other countries get them, the companies won't be able to do their fantastic R&D!  

        Their idea of R&D, by the way, is to take a competitor's drug, tinker with a molecule, and get a patent on the "new" drug.  Innovative, eh?  Bastards...

        -7.62, -7.28 "We told the truth. We obeyed the law. We kept the peace." - Walter Mondale

        by luckylizard on Mon Mar 31, 2008 at 11:47:33 PM PDT

        [ Parent ]

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