The results of a recent study, published in the New England Journal of Medicine, may well pave the way for almost all Americans to be taking pharmaceuticals.
In the words of one news report, The JUPITER study (“Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin”) concluded that there is “powerful evidence that seemingly healthy people having what are considered safe cholesterol levels and no apparent risk for heart disease could lower their chances of having a heart attack or stroke or dying from any cause by taking a widely prescribed cholesterol medication—Crestor.”
(Emphasis is mine.)
The JUPITER study was conducted by Paul Ridker, MD, of Harvard and Brigham and Women's Hospital in Boston. Dr. Ridker has been a longtime pioneer of the theory that elevated levels of C-Reactive Protein, a substance in the blood that signals inflammation, is an important predictor of heart disease.
Of the results of this study, Dr. Ridker noted: “The potential public health benefits are huge. It really changes the way we have to think about prevention of heart attack and stroke.” I agree. But I don’t agree with Dr. Ridker that putting more people on statins would necessarily be a good thing.
The JUPITER study, I might add, was sponsored by AstraZeneca, the manufacturer of Crestor.
The study was slated to last for five years, but was stopped “after an average follow-up of two years when an independent monitoring panel concluded that the benefit [of taking Crestor] was too great to continue withholding the real drug from the participants receiving the placebo.”
Much of the publicity -- and many of the news stories surrounding this study -- have implied that the connection between CRP and heart disease is “news.” This is not true. What IS true is that many researchers have long known that, while cholesterol is one risk factor for heart attack and stroke, fully half of heart attacks and strokes occur in people whose cholesterol is normal. And, thanks to Dr. Ridker’s work, many have known that there is reason to believe that C-Reactive Protein is another important indicator of cardiac risk. (There are several other indicators, too, which many conventional doctors don’t know about – or choose to ignore. You may read about them in The Great American Heart Hoax, a terrific new book by renowned preventive cardiologist, Dr. Michael Ozner. )
Some Nutritional Supplements Can Also Lower C-Reactive Protein Levels
However, to me, one of the most upsetting aspects of this study is what is NOT being pointed out in these news stories: that several other studies have also been conducted, which show that nutritional supplements can also lower C-Reactive Protein levels, and hence a person’s likelihood of having a heart attack. In addition, many articles and books to this effect have been written.
So, why haven’t the nutritional studies, books and articles received more publicity? Most likely, because pharmaceutical companies –- who conduct 80% of today’s clinical trials -- can’t make money from studying about and promoting the efficacy of natural treatments. (Please listen to my interview with Dr. Ronald Hoffman's interview with Honest Medicine, in which he discusses the flaws in the “testing” of nutritional supplements.)
So, while Dr. Ridker may be correct (and probably is correct) when he says that “the potential public health benefits are huge,” what he isn’t saying is obvious: that there is also a huge potential for a significant boost in AstraZeneca’s profits.
Many other things about this study are disturbing -- not the least of which is the possibility of putting almost a whole population on Crestor -– or any other statin!
News By Press Release?
Also troubling is the fact that, as Joel Lexchin, MD, wrote in a 2003 article in the British Medical Journal, studies funded by pharmaceutical companies are much more likely to have positive results than those that are not industry-funded. In addition, studies that turn out negatively for a company are often not published at all.
1) Many of the “news stories” reported “the facts” of this study almost as they appeared in AstraZeneca’s press release. (See the Reuter’s news story, “AstraZeneca's Crestor cuts deaths, heart attacks.”)
This reminds me of an article by Nutrition Reporter, Jack Challem, titled “What’s Wrong with Medical Reporting?”. Written in 1995, the message of this article rings especially true today: that, for some reason -- perhaps because health reporters find medical information so difficult to understand –- many of their “news reports” follow (sometimes almost verbatim) pharmaceutical company press releases. (This same lament was echoed on November 19, 2008, by Christine Russell in a Columbia Journalism Review piece, “Science Reporting by Press Release"; according to Ms. Russell, the problem is even worse today!
In his 2003 book, The Inflammation Syndrome: The Complete Nutritional Program to Prevent and Reverse Heart Disease, Arthritis, Diabetes, Allergies, and Asthma, Mr. Challem acknowledged Dr. Ridker’s work with CRP, citing studies conducted as far back as the late 1990s -– hardly recent.
Statins Have Risks
But Challem adds something just as important: “Although many studies have found that vitamin E and other nutrients significantly reduce CRP levels, several major pharmaceutical trials have begun positioning ‘statin’ drugs as the therapy of choice for lowering CRP levels. . . . Despite their popularity and a common perception of safety, statins pose serious risks.” (p. 55)
2) The publicity surrounding the JUPITER study definitely downplayed the risks posed by statins, including Crestor. Dr. Andrew Saul, editor of the Journal of Orthomolecular Medicine, points out in a recent article, criticizing the study -- “Why Treat Nutritional Deficiency With Drugs?” -- discusses these very serious, not-to-be-ignored side effects:
"Crestor and other statin drugs have serious side effects. The incidence of established side-effects, such as rhabdomyolysis (0.3 per 10,000 per year), myopathy (1.1 per 10,000) and peripheral neuropathy (1.2 per 10,000 per year) seems low, but may be underestimated as it takes time to establish long-term side-effects. (The depletion of coenzyme Q10 by statins is a particular concern.) The figures imply that for every ten people who avoid a cardiovascular event, at least one previously healthy person will suffer a non-trivial side effect of the statin drug.
"The doctors reported a statistically significant increase (270) in diabetes in the statin group compared to the placebo group (216). Over the course of the study, this corresponds to an increased risk of approximately 61 in 10,000 people. So, the number of people on statins reported to become diabetic was greater than the number that avoided a heart attack! These people might have shorter lives and be at greater risk of heart disease in the long term."
(Dr. Saul is also the co-author (with Steve Hickey) of the just-released book, Vitamin C: The Real Story, the Remarkable and Controversial Healing Factor, by Basic Health Publications, one of the premier publishers of some of the most reliable books on nutrition and supplements.)
3) The fact that the JUPITER/Crestor study was stopped three years early reminds me of a point made by John Abramson, MD, in his book, Overdosed America. Dr. Abramson wrote that an article published in Journal of the AMA (JAMA), reporting on the CLASS study, stated that Celebrex, “when used for 6 months. . . is associated with a lower incidence of clinical upper GI events than comparator NSAIDs (ibuprofen and diclofenac).”
However, as Dr. Abramson also points out, there was more to the story that unfortunately, was left unstated in JAMA -- in particular, that:
“the manufacturer’s original research plan, as submitted to the FDA, had defined the duration of the CLASS study that compared Celebrex with ibuprofen as 12 months, and that of the study comparing Celebrex with diclofenac as 16 months. And indeed, the combined study had run for a full 12 months. The authors, however, submitted only the first 6 months for the article in JAMA. Left unreported (and unmentioned) in the JAMA article were the data from the second 6 months of the study, during which time, as shown in the data on the FDA’s website, six of the seven serious gastrointestinal complications that occurred were in patients taking Celebrex.” (P. 29, Overdosed America)
While I am not suggesting that the Crestor study was purposely stopped early because the researchers were worried that more complications would ensue if it were continued for the full five years, I am questioning whether that would have happened. Is it possible that even more blood sugar (i.e., diabetes) problems – or other serious statin side effects -- might have shown up had the study been kept going longer?
Lowering CRP Nutritionally
But there still other troubling aspects of this study –- among them the fact that there is reason to believe that Dr. Ridker has known for years that there are nutritional solutions to elevated CRP. He himself has gone on record as saying that he knows that nutrition and diet can lower CRP levels. In 2007, commenting in heartwire (a professional news service of WebMD), he was quoted as saying: "These data add to a growing knowledge base that diet alone can have a substantive effect on lowering CRP levels. Physicians should remember that advice on diet, exercise, and smoking cessation remains crucial for our high CRP patients."
This is quite different from implying that a good part of the American population should be taking statins, isn’t it?
Dr. Ridker has been famous in alternative and integrative medicine circles because, for years, these practitioners have known that (a) elevated levels of CRP may be a risk factor for heart attacks and many other diseases; and (b) as Mr. Challem pointed out in his book, there have been studies throughout the years, performed by reputable researchers at highly regarded educational institutions, showing that certain nutritional supplements can lower a person’s CRP level, and with it, a risk of developing several conditions, either caused or exacerbated by, inflammation – including having a heart attack. Alternative and integrative physicians – and nutritionists, too – who rely less heavily on pharmaceuticals than do conventional doctors, have been advising their patients to take inflammation-lowering nutritional supplements for years.
Since nearly all of these studies on nutritional supplements capable of lowering CRP are catalogued by the National Institutes of Health (NIH) in its online database, Medline, it really is shocking to me that so few conventional doctors have bothered to read them. If they had, they would not be so impressed with (or so surprised by) this recent study.
Here are seven such studies, several of which were also cited by Dr. Saul in his article, from which I quoted earlier:
1) "C-reactive protein concentration and concentrations of blood vitamins, carotenoids, and selenium among United States adults", 2003, the European Journal of Clinical Nutrition. This study concluded that “C-reactive protein concentration . . . was inversely and significantly associated with concentrations of retinol, retinyl esters, vitamin C, alpha-carotene, beta-carotene, cryptoxanthin, lutein/zeaxanthin, lycopene, and selenium. . . . ” It also concluded that these results looked promising and that further study would be warranted.
2) "Low circulating vitamin B(6) is associated with elevation of the inflammation marker C-reactive protein independently of plasma homocysteine levels." Published in 2001 in the American Heart Association journal, Circulation.
3) "Alpha tocopherol supplementation decreases serum C-reactive protein and monocyte interleukin-6 levels in normal volunteers and type 2 diabetic patients." Published in 2000 in Free Radical Biology & Medicine
4) "Effect of supplementation with with tomato juice, vitamin E, and vitamin C on LDL oxidation and products of inflammatory activity in type 2 diabetes." Published in 2000 in Diabetes Care
5) "Effect of high-dose alpha-tocopherol supplementation on biomarkers of oxidative stress and inflammation and carotid atherosclerosis in patients with coronary artery disease." Published in American Clinical Nutrition in 2007.
6) "Vitamin C treatment reduces elevated C-reactive protein." Published in 2008 in the Free Radical Bioloogy & Medicine
7) "High-Fiber Diets, Fiber Supplements Reduce CRP Levels" March 12, 2007, Archives of Internal Medicine
I urge you to read all seven abstracts/articles online. Each and every one of them has been freely available to medical practitioners. But it seems that only alternative and integrative practitioners -- who don’t like to rely heavily on pharmaceuticals -- were interested.
In closing, I’d like to cite Dr. John Abramson’s reaction to the JUPITER study:
“We’re already struggling to provide health services for the 46 million Americans who don’t have health insurance in the United States. This is going to drain away a lot of money from the system for little or no benefit. We know that there are lifestyle interventions that are effective.”
Dr. Abramson is impressive to me –- and gives me much hope -- because, while he is highly skeptical of Big Pharma, and while his message is firmly on the side of lifestyle changes (including diet and supplements), he still manages to maintain a strong connection to academic medicine. As a clinical instructor at Harvard Medical School, Dr. Abramson is sure to influence a large group of our future doctors. Perhaps this is a signal that real change is coming –- not only to the country, but also to our country’s medical system. I certainly hope so.
Let’s also hope that very soon, there will also be a change in the way studies are conducted: without financial ties to Big Pharma; and that more than half the nation won’t be put on pharmaceuticals as a result of these “trials.”