August 21, 2004

The Wrong Rx for the Overweight and Out-of-Shape

Sedentary work, sedentary leisure and a caloric intake of unhealthy foods wildly beyond most peoples’ falling energy needs. It isn't hard to identify the causes of the nation's obesity epidemic.

This devolving lifestyle costs the U.S. healthcare system billions annually to care for the overweight and out-of-shape. There’s an explosion in “late onset” diabetes with many teenagers now falling into this category. There’s a rising tide of high blood pressure and heart disease, which is already America’s number one killer.

The drug industry claims to have one answer for this epidemic. Take statins. These supposed wonder drugs – like Pfizer’s best-selling Lipitor – lower cholesterol. For people already suffering from or at high risk of heart disease (smoking, obesity and diabetes are major risk factors), clinical trials have shown that lowering cholesterol can reduce the incidence and deaths caused by heart attacks, strokes and other forms of heart disease.

But by how much? Last week’s Lancet, a leading health journal out of Great Britain, reported on the latest study on statins, this time in diabetics who had relatively normal cholesterol levels. By pushing those levels down below normal, statins reduced strokes by 48 percent, heart attacks by 36 percent and deaths by 27 percent, according to the study, which was funded largely by the British government with the pills provided by Pfizer. These relative reductions in risk were touted in the media coverage (Washington Post headline: “Statins Cut Diabetics’ Risk of Heart Attacks, Study Finds.”)

It certainly sounded impressive. But it was a misleading way of presenting the data and distracted the public from alternative ways of treating the problem. Here is the reality behind those reductions.

There were 2,800 patients in the four-year trial, half on Lipitor and half given a placebo. Total mortality from all causes in the placebo arm was 82 deaths or 5.8 percent. Total mortality in the drug arm was 61 deaths or 4.3 percent. In other words, treating 1,400 people with Lipitor for four years saved about five lives a year or less than one in 250 treated (that’s an absolute risk reduction – as opposed to the relative risk reduction reported in the paper and in the press—of 0.4 percent for each year on the drug).

The data is similarly unimpressive if one looks at individual events, whether fatal or non-fatal. There were 26 fewer heart attacks over the four years, or to put it in absolute terms, one fewer heart attack per 200 treated. Strokes were even less – one fewer stroke for each 327 treated per year.

Is there another way to get these relatively minor health benefits (although very real to the people who might not die or be saved the heartache of heart attacks and strokes)? Before I answer that question, let’s take a little detour to calculate the cost of achieving these benefits through drugs.

Lipitor in the dosages used in the trial cost about $1,000 a year in the U.S. (about $700 if you buy online from Canada). So our cost is easy to calculate. It takes somewhere between $200,000 and $250,000 per year in Lipitor sales to save a one diabetic’s life and to stop another diabetic from having either a heart attack or stroke.

Let’s extrapolate this to the larger population. If diabetics' physicians, who will undoubtedly be bombarded with ads, free samples and reprints of this study, put another one million of the U.S.’s 17 million diabetics on statins, it will cost the health care system about $1 billion per year. Hold that thought.

Are there alternatives? Harvard professor John Abramson, in his new book "Overdosed America," points out that observational studies of diabetics, half of whom lead sedentary lifestyles, have shown that improving diet and regular exercise reduces overall mortality by about four per 250 treated. That’s four times better than statins.

Moreover, I’m betting the people who dieted and exercised not only did four times better on immediate outcomes like heart attack, stroke and death, but they looked better, felt better and gained incalculable psychological benefits that can never be produced by popping a pill. Indeed, the constant need for medication is one of the major psychological drawbacks to good diabetes control and has been blamed for diabetics' above average suicide rates.

I can already hear the critics complaining. How are you going to convince people to diet and exercise? We're a pill-popping culture.

Let’s go back to the $1 billion cost per one million people treated with Lipitor. What else might a billion dollars buy?

It could fund a program that sent public health workers, physical trainers and counselors into American communities with the greatest obesity problems (yes, there is a class, geographic and ethnicity dimension to our obesity epidemic). A billion dollars would support about 20,000 such workers (that’s at $50,000 per year per worker, which would include administration and overhead).

Or, it could support 15,000 such workers and a massive fitness public relations campaign. Or, it could fund 10,000 workers, a public relations campaign, and subsidized gym memberships. Or . . . but you get the picture.

Besides being a great jobs program in communities most in need of an employment boost, the P.R. campaign would give myopic medical reporters some interesting relative risk numbers to report. I can see the headlines now: "Diet, Exercise 400 Percent Superior to Statins for Diabetics."

Posted by gooznews at August 21, 2004 01:06 PM
Comments

Hi Merrill,

I enjoyed reading your most recent column. You and I are on the same wave length. Just last week I was on a soap box here at work going on about all the patients that now take the statin drugs, like I mean every elderly person is on them, but yet we haven't heard the fantastic breaking news that life expectancy is up, heart attacks are down, etc., you get my drift. I vowed not to get my cholesterol checked and be another person obsessed with lowering my numbers. What prompted my ranting was that I have now seen several patients with the adverse side effect of muscle fatigue, caused by statins and it is very serious. What amazed me was that a lot of physicians don't immediately connect the two and I've seen one case where the MD stopped the statin for a few weeks, saw no change in the patient and restarted the drug. This side effect can take months to years to resolve. It's a serious problem caused by denervation.
Debbie

Posted by: Debbie Goozner at August 26, 2004 03:35 PM

I think the analysis is 100% correct. I am am board certfied cardiologist in Orange County, Calif.. I am concerned with the drug companies dictating medical policy and forcing doctors to adhere to their claims for fear of litigation. I see hundreds of patients per week in my practice. I practice preventive and interventional cardiology. I estimate that 20% to 30% of my patients must be taken off of statins because of side effects, not the 3% that they claim. I have been performing invasive angiograms and PTCA and Stents for 25 years. I know prevention is better than treatment of heart disease. Statins can be life-saving, but they are being over prescribed. BP meds are being over prescribed. I believe diet and exercise is the most important approach to heart disease. I have co-authored a book called the OC Heart Diet. I believe that one way to stratify risk for heart disease is to use EBCT heart scans for coronary calcium. The literature is overwhelmingly positive that the scan is the best predictor of risk for future cardiac events and will guide who should be treated with cholesterol meds.

Posted by: Larry Santora, MD at February 21, 2005 01:25 PM