Statins for People Who Don’t Have Cholesterol Problems

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I loved the lead to a story that ran in the New York Times yesterday:

“With the government’s blessing, a drug giant is about to expand the market for its blockbuster cholesterol medication, Crestor, to a new category of customers: as a preventive measure for millions of people who do not have cholesterol problems.

“Some medical experts question whether this is a healthy move.”

It is such a rare pleasure to run into intentional understatement in the mainstream media.  Kudos to NYT reporter Duff Wilson for not only recognizing irony, but managing to incorporate it into the lead of a NYT story.

The article goes on to point out that cholesterol-lowering drugs, known as statins, “may not be as safe as doctors previously thought.”  Meanwhile, the benefits for healthy patients are . . .  well, “slim to none” is the phrase that comes to my mind.

Cost vs. Benefit

Nevertheless, the FDA gave its blessing to prescribing Crestor for men older than 50 and women older than 60 who have no diagnosis of high levels of LDL, or bad, cholesterol or coronary heart disease, but who have an elevated blood level of an inflammation marker known as C-reactive protein, or CRP, and at least one additional risk factor for heart disease, such as high blood pressure, a smoking habit or a family history of heart disease. If doctors follow these criteria  Crestor’s manufacturer, Astra Zeneca could hope for up to 6.5 million new customers. The company is already preparing its marketing campaign. (“Feeling healthy? Don’t Be Too Sure . ..)

Wilson reports that the FDA’s decision was made based on a recent study which compared patients who took Crestor to those who took a sugar pill: “The rate of heart attacks, was 0.37 percent, or 68 patients out of 8,901 who took a sugar pill. Among the Crestor patients it was 0.17 percent, or 31 patients. That  . . . difference between the two groups translates to only 0.2 percentage points in absolute terms — or 2 people out of 1,000.”

Is the pill worth what patients are paying the drug-maker? “Crestor, which had sales of $4.5 billion last year, will not be subject to generic competition until 2016 — and so the company has more years to benefit from expanded use of the product at name-brand prices,” Wilson observes. “The drug, taken as a daily pill, sells for at least $3.50 a day, compared with only pennies a day for some generic statins.”

On Health News Review, in a post titled “$638,000 to prevent one heart attack” Gary Schwitzer  underlines the bottom line in Wilson’s story : “Critics [say] the claim of cutting heart disease in half –repeated in news stories nationwide–may have misled some doctors and consumers because the patients were so healthy that they had little risk to begin with.”

Yet, maybe Crestor is worth it. After all, it’s protecting 2 people out of 1,000 against having a heart attack. Even if that’s only 0.2 percent, that’s two human lives spared—isn’t it? No, it’s not. Most of those patients survive the heart attack. The evidence that statins actually save lives is complicated in ways that the hype over low cholesteron rarely acknowledges  (I have been following the cholesterol/statin story for two years. See  my earlier posts on “The Cholesterol Con” here and here.

In the case of this seeming healthy group of patients, “Ultimately, the benefit is statistically significant but not clinically significant," Dr. Steven W. Seiden, a cardiologist in Rockville Centre, N.Y., told Duff. “The benefit is vanishingly small,” Seiden added. “It just turns a lot of healthy people into patients and commits them to a lifetime of medication.

On the other hand, even if the patients doesn’t die, having a heart attack is a terrifying experience.  This is something anyone would want to avoid. . . . Perhaps one should take statins, just as a preventive measure. Unless, of course, you’re worried about the side effects  . . .

Risks

According to the Times: “For healthy people who would take statins largely as prevention —which would be the case for the new category of Crestor patients — [some] experts suggest the benefits may not outweigh any side effects. Among the risks raising new concerns, recently published evidence indicates that statins could raise a person’s risk of developing Type 2 diabetes by 9 percent.

In addition, as I have discussed in the past, we know that statins can cause deep muscle pain and even memory loss for some patients. Women may be particularly vulnerable, and for women, the benefit of taking statins is particularly cloudy, see posts here and here.

And then there is this: “There is also debate over the blood test being used to identify the new statin candidates. Instead of looking for bad cholesterol, the test measures the degree of inflammation in the body, but there is no consensus in the medical community that inflammation is a direct cause of cardiovascular problem …”

Meanwhile, the Times reports: “The new Crestor guidelines continue a steady expansion of the number of people considered candidates for statins over the last decade. The recommendations and guidelines have been expanded by various [FDA]advisory panels — many of whose members have also done paid consulting work for the drug industry. Another of those [FDA] panels is now preparing statin guidelines due next year, which are expected to further expand the number of candidates for the drugs.”

What’s Going On at the FDA?

I had been hoping that Joshua Sharfstein, the FDA's new deputy commissioner would cast a cold eye of some of the drug industry’s efforts to medicate all of America. His reputation suggested that he would get tough on Pharma. Indeed, one of his critics expressed the fear that Sharfstein might “be reluctant to appoint experts to the FDA’s advisory committee panels if they have taken money from the manufacturer.” Because he was named “Deputy FDA Commissioner,” not Commissioner, the appointment did not require Congressional confirmation.

But now I’m wondering. In January, Merill Goozner, author of GoozNews on Health, quoted  Jim Dickinson, editor of FDAWebview, an industry newsletter that closely follows enforcement issues at the agency. 

“ ‘It has taken almost a generation, but by now, the pro-industry infiltration of FDA's culture is firmly entrenched. Not only is collaboration in product reviews officially encouraged, but good relationships across the regulatory fence hold the prospect of a possible future career in a well-paid industry job – a connection that is less likely to be publicly noticed in news media that now have to line up for information that has been filtered through agency press offices. The arm's-length relationship that formerly ruled every contact between agency and industry has become a fading memory.’ He concludes there's nothing that Margaret Hamburg, the new commissioner, and Joshua Sharfstein, her deputy, can do about it.”

Perhaps we need separate health care reform legislation addressing the corporate takeover of the FDA.

13 thoughts on “Statins for People Who Don’t Have Cholesterol Problems”

  2. I agree with the ‘turns healthy people into patients’ line of criticism here.
    How many will proceed to gain weight and not watch their diets like they should because they’re taking what looks to be an expensive(must be effective!) drug?

  3. I thought when I read this that it was an excellent April Fool’s joke…then was saddened to discover that it is true. Heck, there isn’t even that much benefit for the patients that take it that *do* have high cholesterol!

  4. I applaud your take on this issue. I have long cast a dissapointed eye on the jupiter trial. I agree that when you look at the actual numbers only a very small number of people benfit. Furthermore the treatment effect was more impressive then even for people who have know coronary disease and go on statins. This makes no sense and makes most clinicians believe that the benefits are exagerated by the jupiter trial.
    Most people forget that when it comes to coronary disease the top risk factors are still….hypertension, smoking, and diabetes. Cholesterol comes a distant fourth.

  7. Spot on! Thanks for taking this on, Maggie. It is truly remarkable to me how little effort some physicians put into understanding the studies thrust in front of them by journals and pharmaceutical companies. Another important aspect of this to remember is that when a physician sees a patient who is on a statin, if the patient does not know he is on the statin purely for preventive effect, the doctor will assume the patient has high cholesterol. This of course sends the patient down a slippery slope of more interventions. This patient has high cholesterol; therefore, his blood pressure goal is lower than that of someone without high cholesterol. So he gets put on blood pressure medications. Then someone decides to screen him for diabetes using the A1C test (now recommended by the ADA). He ends up in the borderline diabetes category, further pushing down his cholesterol and blood pressure goals. If his doctor subscribes to the concept that medications such as metformin decrease incidence of diabetes, now the patient is on metformin. So we go very quickly from a healthy person on no medications to someone on 3 or more medications. This happens all too often, especially in these days of fragmented care when few people have a real primary care physician who takes full responsibility for their care.
    Something else to delve into is the much greater benefit of exercise and lifestyle changes, at low cost and with minimal side effects. Too bad there’s no pharmaceutical company to market that; if there were, doctors would be all over it. As it is, all we can do is a lackluster 15-minute attempt at counseling. Meanwhile, multiple studies have shown that intensive, supportive lifestyle interventions significantly reduce many adverse health outcomes.

  8. Sylvia, Ginger G., Gary, Jordan, pcb, Tom, EVERYONE
    Sylvia– From what I have read, I agree. I just don’t see medicating healthy people with a drug that carries serious side effects.
    Ginger G– Yes, this is an example of turning healthy people into patients. Part of what Naomi called recently wrote about in a recent post about “the medicalization of life.”
    And the truth is that if statins protect against a non-fatal heart attack, they are protecting against a wake-up call that could tell a patient that he needs to change his diet and exercise.
    Gary G– Very true.
    Jordan– Thank you. I agree on the Jupiter trial.
    And, of course, you are right about the leading causes of heart attacks.
    But no one can make hundreds of millions of dollars by helping smokers and those suffering from hypertension–or by helping a patient manage diabetes.
    We just don’t pay doctors well for these services. But we pay a fortune for drugs of uncertain value.
    pcb-Thanks for the link. I enjoy Dr. Rich.
    Tom– Interesting. I’m not a doctor so I don’t recommend treatments.
    But I have to say that Vitamin D and Fish Oil sounds a lot safer than statins. Thanks for the link; I suspect other readers will be very interested.
    EVERYONE: I have to say that every time I have written about cholesterol and statins, I have expected to receive many messages from patients who are taking Lipitor or Crestor, and are very happy to be on the medication.
    I also have expected to hear from physicians pointing out that I am not an M.D. (which I’m not) and aruging that I have no idea what I’m talking about.
    Instead, I receive comments like these.My original cholesterol con posts were cross-posted on Alternet where I received more than 100 comments–most from people who had taken themselves off statinss because they didn’t like the side effects, and lived to tell the tale. They felt that statins were being hyped.
    This reponse suggests that there is a huge disconnect between much of what you usually read and hear about statins in the mainstream press “million of life saved” and the reality . .
    In the post, I forgot to mention: Kudos to TIME magazine which recently ran a story
    questioning the benefit of statins for women.
    The drug companies selling statins have huge marketing and advertising divisions.
    But eventually, I’m hopeful that more and more patients and doctors will realize that far too many people are on statins
    exposed to risks without
    commensurate benefits.

  9. Although I am also skeptical of widening the use of statins let me be the devil’s advocate here:
    First, $600,000 to prevent one heart attack is excessive but statins are available generically for 11 cents a day; $20,000 would be a bargain. No company, however, is going to underwrite such a study for a generic drug. Even if you don’t want to extrapolate the results to other statins, Crestor will be available generically in a few years.
    Secondly, it’s reasonable to ask whether people with elevated CRP are “healthy”. Asymptomatic, certainly,but the same thing can be said for people with high blood pressure. Hypertension in most cases is treated because it is a risk factor and, in that sense, no different than high CRP.

  10. Marc–
    The problem is that we don’t know that elevated CRP puts people at a higher risk of dying.
    At a higher risk of having a heart attack, yes . . .
    but a heart attack can be a wake-up call that causes someone to change diet and exercise.
    Ultimately, we’re all mortal so we’re all “at risk”
    The problem is that in our sociey we overdiagnose– no one is healthy, everyone is in need of treatment, medication, etc.
    This is not healthy.

  12. Jdach–
    Thanks for the link. Yes, from what I have read there is no solid evidence that statins reduce mortalities among women.
    At the very least, women should be aware that this is a controversial area, and if they are experiencing side effects, they should consider going off their statins to see if the symptoms disappear.

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