FDA Officially Unconcerned that Crestor Causes Diabetes

By | December 30, 2009 at 3:36 pm | 6 comments | Heart Health | Tags: , , , ,

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Imagine a world where everyone is on powerful cholesterol-lowering drugs. Not just sick people. Everyone.

Astra Zeneca has imagined it, and now they’re going to see their dream come true. On December 16, the FDA announced their approval of Astra Zeneca’s cholesterol-lowering drug Crestor for use in people without high cholesterol despite the fact that a new study showed conclusively that the drug causes diabetes. By a vote of 12 to 4, the panel judged that even people at very low risk of heart disease should take the cholesterol medication anyway.

“I do think the diabetes problem is real, but I’m comforted by the fact that the drug works even in that patient group, so it’s very convincing,” said Michael Proschan, a statistician with the National Institutes of Health. In other words, even after Crestor gives you diabetes (or some other problem, see below), it may still cut your risk of certain types of heart disease, so why worry?

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If you’ve been reading my blog, you probably aren’t surprised by this absurd determination. As I’ve said elsewhere, the intention of the drug companies is to market their products like Wrigley’s markets chewing gum: to sell to everyone, not just sick people. And the FDA often lends them a helping hand.

The December 16, 2009 declaration was made after the FDA completed a review of a large study published in 2008, known as the JUPITER study.

In designing the JUPITER study, Astra Zenica wanted to show that Crestor might benefit people without high cholesterol in order to expand Crestor’s potential customer base by an estimated 65 million people. So Astra Zenica enrolled people with normal cholesterol but high levels of body inflammation as measured by a protein called CRP, or C-reactive protein. Then they waited to see what would happen.

The study concludes that Crestor reduced the subjects’ risk of certain kinds of heart disease by 40%. But that’s not what the study actually shows—and the FDA knows it!

The people who make money selling Crestor designed and paid for the study, so of course it would be foolish to take any of these results at face value. But that’s exactly what the FDA does, assuming enough of us will be fooled by the pretense of oversight to make this whole charade profitable.

To give JUIPITER and other studies the appearance of legitimacy, drug companies have perfected the art of stacking the deck in their favor by a variety of methods. Basically, they cheat.

How drug companies cheat…

Firstly, they tend to pick the kinds of people likely to benefit from the drug, and exclude those likely to suffer side effects from entering their studies. In the case of JUPITER (as is the case with most cholesterol drug studies), by excluding anyone with heart failure or a history of cancer from participating, they reduce the number of people who suffer from the known propensity of Crestor to damage heart muscle cells and derange the immune system. (They don’t advertise that they did this so your doctor may have no idea that the drug has not been tested on people with these two common conditions.)

Secondly, they use statistical terms that don’t mean what most people (including doctors) think they mean, which brings us to that supposed 40%. Nobody’s risk was cut by 40%, only their relative risk was cut.

Huh?

The people enrolled in JUPITER were all at low risk of suffering a stroke or heart attack, with an average probability of 2.8 percent over the 1.9 years of the study. The drug cut their risk down to 1.6 percent. You and I would read that as a reduction of 1.4%. But applying the strange math of statistics, they can actually lie and get away with it, and they do so by comparing not the ABSOLUTE risk (1.4) but the RELATIVE risk (40 percent). Where does 40% come from? Simple: 2.8 is 40% more than 1.6, so the relative risk reduction is 40%.

Statistical manipulations are frequently employed by the authors of drug company-sponsored studies to make almost every drug seem far better than it really is.

The third way drug companies cheat is by pretending they don’t understand basic physiology.

Crestor Causes Diabetes, Diabetes Causes Heart Disease, Therefore Take Crestor to Prevent Heart Disease (???)

JUPTER showed that taking Crestor will INCREASE your relative risk of developing diabetes—by a whopping 29 percent over just 1.9 years. Over a longer period of time than 1.9 years, presumably a larger proportion of people would develop diabetes. Diabetes increases your risk of heart disease. And over all that time, many of those people who have Crestor to thank for their diabetes will also develop heart disease.

By the way, every doctor understands that diabetes increases your risk of heart disease. So where is the outpouring of protest by concerned physicians?

And by the way, every academic physician who has published a paper does understand the difference between relative risk and absolute risk. So where are the John’s Hopkins and Harvard intellectuals warning people about the misrepresentations of the facts?
scratch back

This apathy on the part of many MDs is a big reason that people are loosing faith in allopathic medicine, skipping important vaccines, and putting off the purchase of health insurance until after its already too late.

Diabetes not only increases your risk of heart attacks and strokes, but also of cancer, chronic musculoskeletal pain, dementia, and more. Crestor itself, by reducing your body’s ability to make isoprene units, directly increases your risk of all these things as well.

This increase in diabetes was the reason for the FDA’s mandatory review, but I think anyone who follows the news knows that the FDA is bought and sold and the review process is nothing more than window dressing serving to do little more than offer an excuse for more interviews and more free advertising for the supposed benefits of our latest wonder drug.

So should you get your CRP tested? Sure. If it’s high, that’s a good indication that the diet you are following is likely to make you sick. (CRP is also elevated when the immune system is highly active, as it is during infections and autoimmune disorders.) But if you ask your doctor if Crestor—or any other cholesterol-lowering medication—is “right for you?” keep in mind, he or she may be inclined to simply continue going along with whatever the FDA recommends.

If you care about your health, don’t let your doctor off the hook so easily. Ask why you’d want to take a pill that’s been proven to put you at risk of diabetes.

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6 Comments

  1. Noel C. Robertson (1 year ago)

    I have been hit with both medication from a heart doctor to a hospital that give my husband the wrong medication. I nee to detoxi my body from these drug (Liptor and Crestar, )ect. I am try of truing the medical field with my life. How can I function it your body is not healthty.

  2. John Kobeck (2 years ago)

    “In every medicine there is a little poisen” ~
    But perhaps just a little too much in the Statin class. There have been several recent studies that point out that fat is not the culprit. We are now learning that its carbs, high processed carbs that are in reality causing high trigs, which also lead to small dense cholesterol particles (the kind that penetrate artery walls and cause unstable plaques).
    I know several people who have benefited form a Paleo type diet (caveman) and even though their cholesterol may have even increased, their overall health has improved.

  3. Martha Rosenberg (3 years ago)

    Certainly Dr Cate is not saying that modern drugs do not save lives.

    She is pointing out that when science takes a back seat to marketing as with the Jupiter study the public’s faith in medicine falls — as it should.

    Drugs that cause diabetes for people who aren’t even at risk? When C-reactive protein is not even a valid surrogate endpoint? And the principal investigator of the Jupiter study holds a related patent? Please!

  4. Ron Schwartz MD (3 years ago)

    to read this article,everyone is incompetent or in bed with drug companies which save our lives and give us the best standard of health since the creation of the earth, to read this article the average person would be mislead to believe that- everyone- 18,000 people were all picked so drug companies would make money and the FDA is made up of incompetence and only the author of this article is telling the truth. This articles fear mongering and makes the average person think you have a 29 percent chance of getting diabetes on Crestor, which is not the case, the author is playing with the numbers to try to make a name for themselves.
    Take your crestor, it is a good drug, minimal to no side effects and the most effective fat lowereing drug on the market. and i don’t work for the drug companies

    • Catey (3 years ago)

      Thank you for pointing out a potential misunderstanding. Crestor does not cause an absolute risk of diabetes equalling 29 percent, but rather a 29 percent additional risk over whatever your risk would be off the drug. I hope you disclose this to your patients, Dr. Schwartz. But based on your authoritarian tone I suspect you just tell them “Tak your crestor, it is a good drug, minimal to no side effects and the most effective fat lowereing [sic] drug on the market”

      By the way, you might want to read the package insert because Crestor lowers cholesterol, not “fat,” and if you tell your patients the drug will lower their “fat” you are implying Crestor helps with weight loss, which is unsubstantiated.

    • David (2 years ago)

      Anyone reading this might be tempted to assume that doctors and drug companies are responsible for the best standard of health since the creation of the earth. One would do better to thank the sewage workers and those responsible for the supply of clean water.