Is the calorie-free sweetener erythritol safe? The FDA did not evaluate long-term use, and new research suggests it may cause blood clots in people with high blood pressure and other risk factors.
Does Every Diabetic Really Need A Cholesterol Pill?
In 2009, HMSA (Hawaii’s largest health insurance company) will start fining doctors who don’t put every last one of their diabetics over the age of 40 on a cholesterol lowering pill. No matter what your cholesterol, if you are a diabetic, your doctor will probably write you a prescription. Even if you don’t have heart disease. How can they justify this?
I asked HMSA’s medical director, an internal medicine MD. He says the practice is well supported by extensive research. But it appears he didn’t do the research himself, nor did anyone in HMSA. HMSA hired a company to outsource this decision making process. When I look at their package of supporting information, I see some very fishy writing.
Two of the articles are based on the opinions of nine doctors, eight of whom are paid drug company consultants.
One citation is a CDC web site that has disappeared.
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The only article of any merit is about a study done on about 2,000 people with diabetes, half of whom took a sugar pill and half of whom took a cholesterol pill. Almost two hundred people had to stop the cholesterol pill due to side effects. This effectively weeds out the more sickly people and so it is not surprising that in the group taking the pill there were fewer heart attacks – at least to start with. The study was stopped early, for reasons they don’t explain. What has me worried is that, when I look at the graph comparing death rates in the two groups, the first few years look pretty good for the group on the drug. But by the end of year three, people start dropping dead fast – so fast the line looks like its starting to go straight up. What is the real reason they stopped the study prematurely? Could it be that they saw where the line was heading, and decided to quit while they were ahead?
Remember, this line is the group of healthier people (b/c they could handle the side effects of the drug) and even they started to die after taking it for almost four years. HMSA wants diabetics to stay on it for life.
The research does show that some people who have had heart attacks do benefit from statins. But the research does not support what HMSA plans to pay your doctor to do now. If I don’t go along with this, I will lose money. This is not fair to me as a conscientious physician, and its not fair to HMSA’s customers who may pay a price with their lives in four years time.
Safe For Four Years? In this highly selected group of people, problems seem to increase just before the study was ended prematurely by the organizers.
A quick glance, and the graphs make the drug look pretty good. The two lines represent cumulative “endpoints” over time of (top to bottom) major heart attack, death, or other heart-related emergency room visit. And the top line represents people on placebo, the bottom represent people on the pill. The higher the line, the more people have been diagnosed with one of the endpoints, either major heart attack, death, or other heart-related emergency. But all is not as it seems, so to understand, you have to take a better look.
The middle graph is the most important because it answers the one question we really care about – does taking this pill prevent anyone from dying? So let’s look at the middle one. (Why is that the most important question? See below)
Right above the graph it says there’s a risk difference of 27%. That sounds pretty good. It sounds like more than a quarter. And if it were true that cholesterol pills could prevent one heart attack for every four people taking it, I’d be all for it. But that’s not what relative risk means. Relative risk is a handy way to exaggerate a minimal benefit of a drug. Most busy doctors fall for the trick.
If your doctor took the time to look real close, she’d see that at year one the number of people who were not taking the drug who died was 1418, versus only 1395 deaths in the group taking the drug. A minimal effect – less than one percent. Though the drug may have saved 22 lives that year, and the difference is real, certainly, to those 23 people, but it means that if you give the drug to 100 people, not even one will benefit. (So what if you take drugs that don’t help? Side effects, that’s so what- including memory problems, cancer, accidental death, and more. See my posts here and here.)
But the scary thing about the graphs, that most doctors don’t catch, is the total numbers of people who stay in the study till the end. Of the over 1400 who start, 5 years later the number dwindles to 350. Why? Did they die?
For the answer, stay tuned. There’s much more to “evidence based medicine” than meets the eye!
This Post Has 4 Comments
The group I belong to is affected by HMSA’s program that withholds pay from doctors who fail to prescribe statins to men or women who carry a diagnosis of coronary artery disease. I don’t like it one bit. But fortunately I only have one patient affected by the plan. This current arrangement is not as much of a threat to patient health or physician sanity as the plan they wanted to implement as of the summer of ’08, which would have required all patients who carry a diagnosis of diabetes to be on statins, or their physicians face penalties.
Thank you for your thoughtful comments!
It is now March 2009 and a very reliable source has recently informed me that HMSA is paying doctors bonuses if they prescribe statins to any of their patients both non-diabetic and diabetic. In addition, when doctors don’t sign up for this “bonus rewards program” and don’t prescribe statins to patients who have high cholesterol but don’t want to take drugs, HMSA still pressures them by sending them a list of patients who have high cholesterol and telling the doctors that they should be following the standard protocol. So, does following the standard protocol include coercion? or forcing doctors to force patients to take a drug with deadly side effects?
Hi Dr. Cate,
Yup, I learned from Owen of the Vitamin C Foundation that when they stop the study early it means that the results were not going in their favor. Similar to the Women’s Health Initiative where they were studying the effects of HRT and had to be stop early because either too many women were dying or coming down with cancer or heart disease. Although I am still confused about those charts, I really appreciate you pointing out that , “relative risk is a handy way to exaggerate the minimal benefit of a drug” and that “most doctors fall for the trick.” It makes me wonder how many other studies are out there for other drugs that use the “relative risk” trick in order to exaggerate their findings. I like that you also point out that if the drug were given to 100 people not one person will benefit but perhaps all will suffer from the side effects. I wonder if this is the reason why statins are mass marketed widely because the “benefit” only shows up if thousands of people are on the drug. But your last paragraph is the saddest part of all, because in the end we don’t know what happened to all those people who started out on the study and to think that HMSA is using these faulty studies to encourage wider use of a bad drug is criminal in my opinion. Shame on them. Thanks Dr. Cate for bringing awareness to this very important issue.
Mahalo for detailing how special interest funding dictates what research look at and what research ignore to obtain needed justification for actions to increase profit margins possibly at the risk to patient life. It is a stretch to claim such flawed studies “scientific research”.