Panaceia or Hygeia

immunize yourself against the pandemic of lifestyle diseases

Posts Tagged ‘LDL’

JUPITER is a gas giant

Posted by Colin Rose on November 21, 2008

An excellent article by André Picard in today’s Globe and Mail, the only story on JUPITER I have seen in the lay press that reveals the massive fraud behind the reporting of this “study”.

JUPITER is aptly named. It’s gigantic. Probably the largest, most expensive drug trial in history. When one looks below the surface of the publication in the NEJM, the results are about as exciting as the Jovian composition. A lot of gas. I would conservatively estimate that this “study” cost at least $500 million. But if you are AstraZeneca and stand to sell $many billions worth of Crestor because of this paper that’s small change. And junk food addicts, who comprise most of the subjects of JUPITER have one more excuse, however deceptive, to continue their self-destructive habits.

Here is my opinion posted in the NEJM blog on the paper.

nyt-jupiter-unethical

A more detailed analysis of the marketing driven deception and lack of professionalism in the paper by Sandy Szwarc.

Another perspective by John McDougall similar to mine on the big lie behind the claim that many “healthy” people need Crestor..

When all of these criticisms are considered it turns out that JUPITER is nothing more than a thinly disguised  infomercial for Crestor and should never have been published in a presumably high quality journal like the NEJM. But in being able to make this paper freely available on the web (and not wait 6 months like other papers) the NEJM must have received a large payment from AstraZeneca.

Non-blinded statin trials like JUPITER, have the potential for bias in subjective outcomes like the decision to do an angioplasty or coronary bypass, outcomes that constitute the vast majority of the combined endpoint. Also, it is quite likely that when the JUPITER subjects knew that their blood LDL was low because they were taking Crestor they had less incentive to change self-destructive lifestyles. That is probably why the group treated with Crestor had significantly more diabetes. In light of the JUPITER trial the Therapeutics Initiatives group at the University of British Columbia has updated their recommendations for use of statins in primary prevention, which would include people like those entered into the JUPITER trial, and concluded that “statins do not have a proven net health benefit in primary prevention populations and thus when used in that setting do not represent good use of scarce health care resources.

See a slide show on JUPITER and “dyslipidemia”.

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Lead “investigators” of JUPITER

Paul M Ridker, M.D., Eleanor Danielson, M.I.A., Francisco A.H. Fonseca, M.D., Jacques Genest, M.D., Antonio M. Gotto, Jr., M.D., John J.P. Kastelein, M.D., Wolfgang Koenig, M.D., Peter Libby, M.D., Alberto J. Lorenzatti, M.D., Jean G. MacFadyen, B.A., Børge G. Nordestgaard, M.D., James Shepherd, M.D., James T. Willerson, M.D., Robert J. Glynn, Sc.D., for the JUPITER Study Group

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Dominican Republic

What typical JUPITER subjects would look like. These are "apparently healthy" people? Is it not unethical to prescribe drugs to these people to "treat" the symptoms of their self-destructive lifestyles?

Nowhere in the JUPITER paper will you see it mentioned that CRP can be markedly reduced with cost-free lifestyle change alone, no statins, as shown in this paper in the Journal of Applied Physiology in 2006, results of which are summarized below. The subjects in the JAP paper were just the same as in the JUPITER study, obese people, many with metabolic syndrome but the authors did not call them “apparently healthy”. They had nothing to sell.

jap-diet-crp

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When it comes to statins, don’t believe the hype

November 20, 2008
The Globe and Mail
André Picard”Cholesterol drug causes risk of heart attack to plummet” – Fox News.

“Cholesterol-fighting drugs show wider benefit” – The New York Times.

“Cholesterol drug cuts heart risk in healthy patients” – The Wall Street Journal.

The New York Times article summarized the exciting news in a front-page story saying that “millions more people could benefit from taking the cholesterol-lowering drugs known as statins.”

That’s big medical/business news, because statins are already the bestselling drugs in the world, with sales in excess of $20-billion (U.S.).

Quoting some of the world’s top heart researchers, media reports touted the importance of a blood test for C-reactive protein. That’s because those benefiting from statins had high levels of CRP (a marker for inflammation) rather than high levels of LDL cholesterol, which is usually the criterion for statin prescription.

The news stories were based on research published last week in the prestigious New England Journal of Medicine and presented, with much fanfare, at the annual convention of the American Heart Association.

Like much reporting on medical research (and drug research in particular), however, there is more (or, more accurately, less) to these stories than meets the eye.

The principal finding in this study was that participants who took a statin pill recorded a 50-per-cent reduction in the risk of heart attack, stroke, surgery and death compared with those who took a placebo (a sugar pill).

Who wouldn’t be wowed by those numbers? Who wouldn’t want that miracle drug?

But the benefits are relative risk reductions.

When you look at the raw data in the study, they reveal that 0.9 per cent of statin users had cardiovascular problems. By comparison, 1.8 per cent of those taking a placebo had heart problems.

There were 17,802 participants in the study, yet there were only 83 cardiac events among statin users, compared with 157 in the placebo group. That’s 50 per cent fewer.

Are those really “dramatic” findings? Do statins really make heart attack risk “plummet”?

According to a cautionary editorial in the New England Journal of Medicine (which received virtually no mention in news reports), 120 people in this study needed to be treated with a statin for two years to see a benefit in one person.

That’s a lot of people taking a pricey drug ($3 Canadian a day) for no benefit – not to mention that there are risks.

While researchers (and journalists who report on studies) love to highlight benefits of drugs, they too often gloss over risks.

Like all drugs, statins have side effects. The drug used in the study, rosuvastatin (brand name Crestor), has been associated with muscle deterioration and kidney problems.

In the study, those taking statins had a higher risk of developing Type 2 diabetes – 3 per cent compared with 2.4 per cent of those taking a placebo. That’s a 25 per cent higher relative risk among people with very little heart disease to begin with.

As noted earlier, researchers (and news stories) suggested that, based on the findings, the number of patients taking statins could and should expand dramatically.

But is that really what the research tells us, even in its most optimistic interpretation?

The study involved exclusively men older than 50 and women older than 60 who did not have high cholesterol or histories of heart disease or inflammatory illness. All the people in the study needed to have low cholesterol and high CRP.

Initially, researchers recruited 90,000 people in those age groups, but more than 80 per cent of them were deemed ineligible. This is a very select population.

To say, by extrapolation, that these “dramatic” (read: modest) benefits apply to the general population is erroneous.

Similarly, while it is true that about half of all heart attacks and strokes occur in people whose cholesterol is not considered high, does that mean everyone should get a blood test to measure levels of C-reactive protein? Hardly.

Yes, there is more heart disease among people with high levels of CRP, but the jury is still out on what this means.

Some scientists believe that because CRP – secreted in response to inflammation – is present in plaque, it increases the risk that the plaque will burst, leading to blood clots that cause heart attacks. But other researchers think that CRP levels are, at best, a telltale sign of heart disease, a bit like grey hairs are a sign of aging – not its cause.

The CRP test is expensive at almost $50. And it’s worth noting that one of the principal authors of the new research holds the patent on the test and makes money every time it is used.

When you cut through all the hype and the self-interest, what we know is this: Statins reduce levels of [LDL] cholesterol. This is beneficial to people who have had a heart attack or other serious heart problems.

But for otherwise healthy people, high CRP levels or not, the potential benefits of taking statins are marginal, and the risks are not insignificant.

Hardly the stuff of dramatic newspaper headlines.

Posted in atherosclerosis, cardiology, cholesterol, coronary artery disease, death, diabetes, diabetes, Type 2, drugs, junk food, obesity, professionalism, statins, waist circumference | Tagged: , , , , , , , , , , , , , , , , , , | 2 Comments »

CALIPSO

Posted by Colin Rose on July 9, 2008

Here is a good example of a “study” of statins written by a non-medically licenced employee of a statin-peddling drug company, Merck Frosst Schering, with the names of prominent “experts”, many known to be financially associated with drug companies, shown as secondary authors.

What a nice name! Reminds one of sunny Caribbean islands. Except they had to use an “I” instead of a “y”. Guess they couldn’t find an acronym that fit easily. What was done? Doctors were paid to collect data on patients to whom they prescribed statins. Results? Horrors of horrors, many of them did not reach “target” LDL (bad blood cholesterol). Conclusion? You guessed it. Not enough people are taking enough statins. Suggestion? “Strategies should be implemented to promote achievement of lipid treatment goals…”

Who sets these “targets” anyway? Again, you guessed it, the same sort of doctors as the authors listed in CALIPSO, most paid by drug dealers in one way or another. See the evidence in the US and Canada.

More than half of the subjects had no history of cardiovascular disease, so statins were being used for primary prevention and there is no overall benefit of statins this class of patient.

Note that the first author is employed by a Merck, a big seller of statins.

No attempt was made to alter high risk lifestyles (42% had abdominal obesity and 17% smoked). That’s hard work and takes a lot of time. But, why bother? Surely, after years of medical terrorism by drug dealers, everyone knows that atherosclerosis is caused by bad blood cholesterol and there is a very profitable strategy for attaining “lipid treatment goals”; pay doctors to give statins to reach those arbitrary targets as is now happening in parts of the USA.

The Canadian Journal of Cardiololgy, at least 80% of whose revenue comes from drug companies, does not require financial disclosure by authors but we have found them from another source. In the Acknowledgements those nice people at Merck and  BioMedCom, contracted to do the “study”, are thanked.

While BioMedCom claims to do “scientifically rigorous” work, CALIPSO is not science at all. It is a highly biased sample of what doctors will do if paid to report on the patients to whom they prescibe statins. There is no proof that if the patients had reached “target” they would have benefitted at all. There is no control group who did not receive statins and there is no indication of outcome at all. This is not science, but another attempt at medical terrorism to sell more drugs and any doctor who would put his name on such a study cannot claim to be an expert in “hypercholesterolemia” nor should he or she be part of any group advising other doctors like the “Working Group” in Canada.

Why would all those “experts” in the author list need to hire BioMedCom, to do this “study”? What did these doctors do to justify putting their names on the “study”? And why is an employee of Merck first author? We leave the answers to the reader’s imagination.

 

Financial Conflicts of Interest Not Reported in CALIPSO Paper

 

Posted in atherosclerosis, cardiology, cholesterol, drugs, obesity, professionalism, statins | Tagged: , , , , , , , , , , , , , , , | Leave a Comment »

Drug Dealers Bribe Doctors to Prescribe Statins

Posted by Colin Rose on July 9, 2008

Here is a very important post from Dr. Catey Shanahan documenting direct bribes from drug dealers to clinics who can attract more doctors by paying them more as long as they pledge to get every patient’s LDL below 100. Without major dietary change, counseling for which takes a lot of unpaid time of the doctor, this can only be done by prescibing statins, already the most prescribed drugs in the world. When will the physician licensing bodies stop this corruption of the medical profession and forbid any financial connection of practicing doctors with any industry associated with medical practice?

Unlike Dr. Shanahan, I do blame the doctors. This sort of behavior is highly unprofessional. If no doctor went along with this highly unethical practice, contrary to the Hippocratic oath, it wouldn’t exist.

It seems insurance companies are so occupied with getting $zillions from drug dealers that they can’t be bothered to look at the data. Here are some from the ALLHAT-LLT study. In spite of a large reduction in LDL, bad blood cholesterol, there was no effect on mortality or morbidity in this group of very high risk people including diabetics, all of which the insurance company says should be give statins. Where a bar crosses the vertical line there is no significant effect in that sub-group.

And look at the baseline characteristics of the participants in ALLHAT-LLT: all overweight, 43% obese, 23% smoking, 35% diabetic. Is it not highly unethical to perform a drug study for lifestyle diseases in such a group with obviously atherogenic lifestyles BEFORE optimizing the lifestyles of all participants?

Legal Addictions

An ALLHAT-LLT type subject

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Many of the comments on the NYT and other articles on the new recommendations for pediatricians and family doctors to put children on brain-damaging statins are expressing outrange that drug companies are taking over the minds of doctors. Don’t blame doctors. We’re being threatened by insurance companies. If we don’t do exactly what drug companies want, we’ll be paid less. In some cases, some of us might loose our jobs. (OKay, we do deserve some blame for not standing up for ourselves!)

I went for a job interview in Portland and in a conversation with the medical director of a large group there, I was told that if I failed to get my patients LDL levels down to 100 “someone will sit down and talk with you.” This particular group was able to offer a better starting salary than average. I had assumed that the reason they could offer more was through efficiencies. During the interview, I learned there was more to it than that. They had special arrangements with drug companies called ‘incentive programs.’ The medical director told me with absolute glee “we keep asking them [meaning drug companies] for money and they keep giving it to us.” He sounded like a kid at Christmas!

This group’s policy is to get everyone’s LDL under 100, regardless of risk factors. Stratifying risk is “too complicated.” So they make it simple for their docs. How convenient for the drug companies. I suspect that because this organization has such an aggressive general policy, the drug companies reward them handsomely for taking such a progressive position. They can offer about $50,000 more per year than doctors working in their own, independent offices.

HMSA is Hawaii’s largest medical insurance company. They are paying me to prescribe statins to people who have had heart attacks. Next year, they will pay me to prescribe statins to every single one of my diabetic patients. If I don’t I may loose about $20,000 and my entire group will be penalized financially as well.

If any of this disturbs you, please write to John Berthiaume MD, HMSA Vice President/Medical Director. 818 Keeaumoku Street, Honolulu, HI 96814. Or, you can write to the medical director of your own insurance company and let them know what you think about your payments going into programs that force doctors to write bad prescriptions or loose money!

Posted in atherosclerosis, cholesterol, diabetes, professionalism, statins | Tagged: , , , , , , , , , , , , | Leave a Comment »

ILLUSTRATE illustrates the futility of measuring and treating blood “cholesterol”

Posted by Colin Rose on March 31, 2007

Intravascular ultrasound is a sensitive method for measuring the size of atherosclerotic plaques in the arterial wall. When testing a drug to see if it will have an effect on plaque volume, this technique is the gold standard.

ILLUSTRATE set out to show that adding torcetrapib, a drug that increases HDL, the “good” cholesterol, to Lipitor, that decreases, LDL, “bad” cholesterol would reverse plaque or at least stop its progression.

Here are the baseline characteristics of the subjects. Note that the average BMI was 30. Overweight is defined as a BMI over 25 and obesity over 30. So, all of them were overweight or obese. 20% were diabetic, most likely Type 2, related to obesity, and 75% were hypertensive. 18% smoked. All of those factors are risk factors for atherosclerosis related to lifestyle. Therefore, unless one intends to first completely eliminate these lifestyle risk factors, it was unethical to even conceive such a trial particularly since it is proven that atherosclerosis can be reversed by lifestyle change alone. The trialists probably rationalized that atherosclerosis, like pneumonia, must be treatable by drugs and Pfizer, who funded the trial, has a slogan, “Working for a Healthier World” it is ethical to do such a trial. Besides the money helps to keep one’s IVUS lab going and one is promoting the notion that the technique will some day lead to the cure for atherosclerosis.

 

Legal Addictions

The typical ILLUSTRATE patient

Here are the reported results. What was not mentioned in the abstract above is that plaque actually INCREASED in both the the Lipitor only group and the Lipitor plus torcetrapib group. Now, before actually starting the trial, the subjects were given enough Lipitor to adhere to the guidelines written by doctors paid by Pfizer and other statin dealers. So, following the guidelines for blood cholesterol lowering with Lipitor does not slow progression of plaque. The obsession with blood cholesterol is completely futile.

nejm-illustrate-result.jpg

The conclusions of the authors shows their blinkered view of atherosclerosis. While Dr. Nissen donates his personal drug money to charity (how much is paid to run his IVUS lab, if any, is not stated), all the other authors have major financial connections to drug dealers. Revkin, Shear and Duggan are employees of Pfizer and own stock. Naturally this group would ignore non-drug methods for reversing atherosclerosis

We have known how to reverse the atherosclerotic process very easily since the revolutionary work of Dean Ornish the final report of which was published in 1998. No drugs are necessary, only a change in lifestyle which was not seriously attempted in this study. There is even no reference to Ornish’s work in the paper, a major oversight of the reviewers. So, why don’t the IVUS groups do a study of plaque volume after significant lifestyle change? Who would fund it? If Pfizer is really “Working for a Healthier World” and not just making a profit, Pfizer should be funding an IVUS lifestyle trial.

Posted in atherosclerosis, cholesterol, coronary artery disease, professionalism, statins | Tagged: , , , , , , , , , , , , , , , , , , , , , | Leave a Comment »

A TO Z trial. Atkins tops?

Posted by Colin Rose on March 12, 2007

The recent publication of the results of the A TO Z trial of four weight-loss “diets” made headlines around the world: “ATKINS DIET TOPS”. The group on the Atkins diet lost about 10 pounds, a few more pounds than the others, after one year of “dieting”.

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Did anyone, including the paper’s reviewers, actually look at the numbers behind this conclusion? Table 1 shows the baseline parameters.

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Note that the average BMI was about 32. One is considered to be obese above a BMI of 30. So most were obese. Note also the weights. About 85 kg. Now look at the results in Table 2 (below). Remember that these numbers are derived by SELF REPORTING of food consumption and exercise. The subject could tell the investigators anything. There was no check on what they said. They were paid, so the subjects had an incentive to the investigators what the subjects thought the investigators wanted to hear. The subjects claimed to be eating about 1900 kcal/day at the outset of the trial. Any adult who eats only 1900 kcal/day is UNLIKELY TO GET OBESE in the first place. During the trial they claimed to be eating only about 1500 kcal/day. So even if they hadn’t increased exercise they should have had a deficit of 400 kcal/day, 2800 kcal/wk. One pound of fat is about 3500 kcal. So, if we are to believe what they reported, they should have lost at least 3 pounds per month or 36 pounds per year. But even the Atkins group only lost 10 pounds. It gets worse. They reported total energy expenditure of about 35 kcal/kg/day. Multiply by their weight and you get about 3000 kcal/day. But they claimed to be eating only 1500 kcal/day. So they should have lost two to three pounds per week, at least 100 pounds per year. Also note that total calorie intake remained about the same in all groups in spite or a wide range of percentages of protein, fat and carbohydrate and by the end of the trial these percentages tended towards the same fraction in all groups. The First Law of Thermodynamics says energy cannot be created or destroyed. Any study of energy flows that cannot first show that energy is conserved should never be published. The methods employed by the study are fatally flawed. No conclusion can be drawn from this data. Many interpretations are possible. So, if all groups ate the same REPORTED calories on the average and burnt the same REPORTED calories on average, why did the Atkins group lose a little more weight? Maybe the Atkins group did a little more exercise. Who knows? They were lying about everything. Or, maybe, for some reason those presumably following the Atkins diet were slightly less proficient liars as the others.

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That obese people lie about food intake was proven beyond doubt by a study using doubly-labeled water to measure true energy expenditure. About 65% of these subjects were overweight or obese. They claimed to be eating only about 1500 kcal/day but were burning 2500. So, they should have had a deficit of 1000 kcal/day and be losing weight dramatically but their weights were stable. Ergo they were “misreporting”, a euphemism for lying.

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The real cause of obesity is food addiction. Like alcoholics food addicts will deny they consume too much and/or exercise too little. See my photo essay on the topic. Which diet is this lady on?

Food Addiction

Is she on a low-fat or low-carb diet?

Posted in cholesterol, diet, exercise | Tagged: , , , , , , , , , , , , , , , | Leave a Comment »

 
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