Panaceia or Hygeia

immunize yourself against the pandemic of lifestyle diseases

Posts Tagged ‘Antonio Gotto’

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 »

Statins added to WHO list of “essential” drugs

Posted by Colin Rose on May 10, 2007

Well, it finally happened. The statin peddlers convinced WHO to add statins to the list of essential drugs.

But look at who was behind the initiative, Dr Gotto

Dr. Gotto receives many thousands of dollars from statin peddlers.

Here is a disclosure statement from a recent publication

“Antonio M. Gotto, Jr., MD, DPhil, serves as a consultant for
AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson-Merck, Kos
Pharmaceuticals, Kowa, Merck & Co., Inc., Merck-Schering Plough,
Novartis, Pfizer Inc, and Reliant Pharmaceuticals.”

Surely this should have been mentioned in the Cornell press release.

Personally, I refuse to take any advice from anyone who receives even one cent from a drug dealer.

I completely agree with Dr Kishore’s statement:

“Increasingly, ‘Western’ high-fat diets, tobacco use and urbanization have
helped make heart disease a bigger killer than ‘The Big Three’—HIV/AIDS,
tuberculosis and malaria—combined.”

Indeed, high risk individuals have high risk lifestyles.

But the FIRST thing to do is change the diet and eliminate tobacco BEFORE labeling statins essential drugs. To do otherwise will reduce any incentive to improve lifestyle and make the obesity and diabetes pandemic even worse.

Do you think that the “developing” world is going to be happy with generic simvastatin? Not likely. They are going to start demanding patented Crestor and Vytorin, just like the rich Americans.

Cubans take no statins but live longer than Americans? If statins are not essential in Cuba, why should they be in Africa?
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Weill Cornell Medical College Students Help Change Global Health Policy

NEW YORK (May 21, 2007) – In a move to improve global public health, Weill
Cornell Medical College students have helped place a lifesaving heart
disease drug onto the World Health Organization’s (WHO) list of essential
medicines. This list is a guideline for developing countries to choose which
high-priority drugs should be supplied to their citizens inexpensively.

Students from Weill Cornell’s chapter of Universities Allied for Essential
Medicines (UAEM) answered the charge of Dr. David Skorton, President of
Cornell University, and Dr. Antonio M. Gotto Jr., dean of Weill Cornell
Medical College, to “seek new strategies for Cornell to advance public
health” across the globe.

“I am extremely proud that the students at Weill Cornell Medical College
have had such an admirable influence on global health policy,” says Dr.
Skorton, who is also a professor of internal medicine and pediatrics. “Such
actions by our students show the promise of their future leadership.”

“Adding this medicine to the list of essential medicines represents an
exceptional achievement by our students,” says Dr. Gotto, an internationally
renowned expert in heart disease prevention, who served as the senior
advisor for the project. “Because of the students’ success, over 150
national governments that work with WHO will be encouraged to recognize
heart disease as a serious health concern deserving of great medical
attention.”

UAEM comprises a national group of students whose goal is to determine how
universities can help ensure that biomedical products, including medicines,
are made more accessible in poor countries and further the amount of
research conducted on neglected diseases affecting the poor.

“For years, it was thought that heart disease was a concern of affluent
countries. But, today, nearly 80 percent of all deaths due to heart disease
occur in the developing world,” says Sandeep Kishore, an MD-PhD student at
Weill Cornell Medical College who helped spearhead the initiative with UAEM.
“Increasingly, ‘Western’ high-fat diets, tobacco use and urbanization have
helped make heart disease a bigger killer than ‘The Big Three’—HIV/AIDS,
tuberculosis and malaria—combined.”

Kishore and Ben Herbstman, UAEM members, petitioned WHO that simvastatin
(Zocor)—originally manufactured by Merck—be added to the list. Simvastatin
was selected based on its worldwide availability, cost-effectiveness and the
interest of generic firms in producing it. Such statin medicines have been
shown to lower low-density lipoprotein cholesterol (LDL) levels, commonly
known as “bad cholesterol,” by 25-30 percent in individuals at high-risk for
heart disease.

Last month, the students from UAEM — with the assistance of medical
librarians from Weill Cornell’s Samuel J. Wood Library & C.V. Starr
Biomedical Information Center — were successful in their efforts to get a
generic version of Zocor included on the list of essential medicines. Now,
the United Nations and other philanthropic foundations can donate large
numbers of the statin drug to the national pharmaceutical inventories of
developing countries.

Furthermore, generic versions of the medicine will be sold at a fraction of
their original price tag. The drug will cost as little as $40 per year per
person—10 cents a day—down from nearly $1,200 a couple of years ago.

The announcement comes on the heels of Cornell University’s new Africa
Initiative, a university-wide movement to promote sub-Saharan African
development and health.
The Weill Cornell chapter of UAEM has hosted an ongoing series of global
health events. On June 15, the former CEO of Merck, Inc., Dr. Roy Vagelos,
will present a lecture titled “Corporations Can and Should Do Social Good”
in a seminar exploring new academic-pharmaceutical alliances to increase
access to medicines worldwide.
Weill Cornell Medical College

Weill Cornell Medical College—located in New York City—is committed to
excellence in research, teaching, patient care and the advancement of the
art and science of medicine. Weill Cornell, which is a principal academic
affiliate of NewYork-Presbyterian Hospital, offers an innovative curriculum
that integrates the teaching of basic and clinical sciences, problem-based
learning, office-based preceptorships, and primary care and doctoring
courses. Physicians and scientists of Weill Cornell Medical College are
engaged in cutting-edge research in such areas as stem cells, genetics and
gene therapy, geriatrics, neuroscience, structural biology, cardiovascular
medicine, AIDS, obesity, cancer and psychiatry—and continue to delve ever
deeper into the molecular basis of disease in an effort to unlock the
mysteries behind the human body and the malfunctions that result in serious
medical disorders. Weill Cornell Medical College is the birthplace of many
medical advances—from the development of the Pap test for cervical cancer to
the synthesis of penicillin, the first successful embryo-biopsy pregnancy
and birth in the U.S., and most recently, the world’s first clinical trial
for gene therapy for Parkinson’s disease. Weill Cornell’s Physician
Organization includes 650 clinical faculty, who provide the highest quality
of care to their patients. For more information, visit http://www.med.cornell.edu.

Contact:
Andrew Klein
(212) 821-0560
ank2017@med.cornell.edu

Sandeep Kishore
(917) 733-1973
sunny.kishore@gmail.com

# # #


Sandeep P. Kishore, M.Sc.
Medical Scientist Training Program (MSTP) Fellow
Weill Cornell / The Rockefeller University / Sloan-Kettering Cancer
Institute
Tri-Institutional MD-PhD Program
420 East 70th St, Suite 10M
New York, New York, USA 10021
email: sunny.kishore@gmail.com
tel: (917) 733 -1973
_______________________________

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