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Posts Tagged ‘Merck’

Harvard Medical School in Ethics Quandary

Posted by Colin Rose on March 3, 2009

March 3, 2009

BOSTON — In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

“I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.”

Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes.

They say they are concerned that the same money that helped build the school’s world-class status may in fact be hurting its reputation and affecting its teaching.

The students argue, for example, that Harvard should be embarrassed by the F grade it recently received from the American Medical Student Association, a national group that rates how well medical schools monitor and control drug industry money.

Harvard Medical School’s peers received much higher grades, ranging from the A for the University of Pennsylvania, to B’s received by Stanford, Columbia and New York University, to the C for Yale.

Harvard has fallen behind, some faculty and administrators say, because its teaching hospitals are not owned by the university, complicating reform; because the dean is fairly new and his predecessor was such an industry booster that he served on a pharmaceutical company board; and because a crackdown, simply put, could cost it money or faculty.

Further, the potential embarrassments — a Senate investigation of several medical professors, the F grade, a new state law effective July 1 requiring Massachusetts doctors to disclose corporate gifts over $50 — are only now adding to pressure for change.

The dean, Dr. Jeffrey S. Flier, who says he wants Harvard to catch up with the best practices at other leading medical schools, recently announced a 19-member committee to re-examine his school’s conflict-of-interest policies. The group, which includes three students, is to meet in private on Thursday.

Advising the group will be Dr. David Korn, a former dean of the Stanford Medical School who started work at Harvard about four months ago as vice provost for research. Last year he helped the Association of American Medical Colleges draft a model conflict-of-interest policy for medical schools.

The Harvard students have already secured a requirement that all professors and lecturers disclose their industry ties in class — a blanket policy that has been adopted by no other leading medical school. (One Harvard professor’s disclosure in class listed 47 company affiliations.)

“Harvard needs to live up to its name,” said Kirsten Austad, 24, a first-year Harvard Medical student who is one of the movement’s leaders. “We are really being indoctrinated into a field of medicine that is becoming more and more commercialized.”

David Tian, 24, a first-year Harvard Medical student, said: “Before coming here, I had no idea how much influence companies had on medical education. And it’s something that’s purposely meant to be under the table, providing information under the guise of education when that information is also presented for marketing purposes.”

The students say they worry that pharmaceutical industry scandals in recent years — including some criminal convictions, billions of dollars in fines, proof of bias in research and publishing and false marketing claims — have cast a bad light on the medical profession. And they criticize Harvard as being less vigilant than other leading medical schools in monitoring potential financial conflicts by faculty members.

Dr. Flier says that the Harvard Medical faculty may lead the nation in receiving money from industry, as well as government and charities, and he does not want to tighten the spigot. “One entirely appropriate source, if done properly, is industrial funds,” Dr. Flier said in an interview.

And school officials see corporate support for their faculty as all the more crucial, as the university endowment has lost 22 percent of its value since last July and the recession has caused philanthropic contributors to retrench. The school said it was unable to provide annual measures of the money flow to its faculty, beyond the $8.6 million that pharmaceutical companies contributed last year for basic science research and the $3 million for continuing education classes on campus. Most of the money goes to professors at the Harvard-affiliated teaching hospitals, and the dean’s office does not keep track of the total.

But no one disputes that many individual Harvard Medical faculty members receive tens or even hundreds of thousands of dollars a year through industry consulting and speaking fees. Under the school’s disclosure rules, about 1,600 of 8,900 professors and lecturers have reported to the dean that they or a family member had a financial interest in a business related to their teaching, research or clinical care. The reports show 149 with financial ties to Pfizer and 130 with Merck.

The rules, though, do not require them to report specific amounts received for speaking or consulting, other than broad indications like “more than $30,000.” Some faculty who conduct research have limits of $30,000 in stock and $20,000 a year in fees. But there are no limits on companies’ making outright gifts to faculty — free meals, tickets, trips or the like.

Other blandishments include industry-endowed chairs like the three Harvard created with $8 million from sleep research companies; faculty prizes like the $50,000 award named after Bristol-Myers Squibb, and sponsorships like Pfizer’s $1 million annual subsidy for 20 new M.D.’s in a two-year program to learn clinical investigation and pursue Harvard Master of Medical Science degrees, including classes taught by Pfizer scientists.

Dr. Flier, who became dean 17 months ago, previously received a $500,000 research grant from Bristol-Myers Squibb. He also consulted for three Cambridge biotechnology companies, but says that those relationships have ended and that he has accepted no new industry affiliations.

That is in contrast to his predecessor as dean, Dr. Joseph B. Martin. Harvard’s rules allowed Dr. Martin to sit on the board of the medical products company Baxter International for 5 of the 10 years he led the medical school, supplementing his university salary with up to $197,000 a year from Baxter, according to company filings.

Dr. Martin is still on the medical faculty and is founder and co-chairman of the Harvard NeuroDiscovery Center, which researches degenerative diseases, and actively solicits industry money to do so. Dr. Martin declined any comment.

A smaller rival faction among Harvard’s 750 medical students has circulated a petition signed by about 100 people that calls for “continued interaction between medicine and industry at Harvard Medical School.”

A leader of the group, Vijay Yanamadala, 22, said, “To say that because these industry sources are inherently biased, physicians should never listen to them, is wrong.”

Encouraging them is Dr. Thomas P. Stossel, a Harvard Medical professor who has served on advisory boards for Merck, Biogen Idec and Dyax, and has written widely on academic-industry ties. “I think if you look at it with intellectual honesty, you see industry interaction has produced far more good than harm,” Dr. Stossel said. “Harvard absolutely could get more from industry but I think they’re very skittish. There’s a huge opportunity we ought to mine.”

Brian Fuchs, 26, a second-year student from Queens, credited drug companies with great medical discoveries. “It’s not a problem,” he said, pointing out a classroom window to a 12-story building nearby. “In fact, Merck is right there.”

Merck built a corporate research center in 2004 across the street from Harvard’s own big new medical research and class building. And Merck underwrites plenty of work on the Harvard campus, including the immunology lab run by Dr. Laurie H. Glimcher — a professor who also sits on the board of the drug maker Bristol-Myers Squibb, which paid her nearly $270,000 in 2007.

Dr. Glimcher says industry money is not only appropriate but necessary. “Without the support of the private sector, we would not have been able to develop what I call our ‘bone team’ in our lab,” she said at a recent student and faculty forum to discuss industry relationships. Merck is counting on her team to help come up with a successor to Fosamax, the formerly $3 billion-a-year bone drug that went generic last year. But Dr. Marcia Angell, a faculty member and former editor in chief of The New England Journal of Medicine, is among the professors who argue that industry profit motives do not correspond to the scientific aims of academic medicine and that much of the financing needs to be not only disclosed, but banned. Too many medical schools, she says, have struck a “Faustian bargain” with pharmaceutical companies.

“If a school like Harvard can’t behave itself,” Dr. Angell said, “who can?”

Posted in cholesterol, drugs, professionalism, statins | Tagged: , , , , , | 1 Comment »

Drug Marketing by Acronym. ACCORD and the Power of Myth

Posted by Colin Rose on July 14, 2008

CHRISTMAS, COURAGE, DIAMOND, DREAM, ILLUMINATE, ILLUSTRATE, REACH, PARAGON, PRAISE, PREVENT, ONTARGET, PROVE IT, ENHANCE, ACT, BEST, ADVANCE, HOPE, LIFE, PROSPER, CALIPSO, ASTEROID, ACCORD, CASHMERE, MIRACL, SYMPHONY, all names of recent drug studies that are carefully constructed pseudo acronyms invented by highly-paid marketers, implying that the drug studied has wonderful properties to prolong your life make it much more pleasant and worry-free. The marketers have learned that the name of the trial is more important than the results of the trial. Who would be attracted to older trials named WOSCOPS or LRC-CPPT? Would it really matter what the results of DREAM were? The acronyms imply that regardless of the result of the study the drug must be good for something. If one fiddles the statistics one can always find a sub-group in which the drug had some effect. You will never see a drug trials with the acronyms, DISEASE or DEATH but many of them do result in more of either of both.

To take one example, just the association of a drug with a trial like ACCORD (Action to COntrol Cardiovascular Risk in Diabetes) will give it cachet. But the results of the drug “action” in ACCORD was that  adding more expensive drugs to the usual cocktail to markedly lower blood glucose to an arbitrary “target” in type 2 diabetics with known vascular disease caused more deaths than not meeting the “target”. The latest expensive drugs for DM2 were supplied by the usual suspects: Abbot Laboratories, Amylin, AstraZeneca, Bayer Healthcare, GlaxoSmithKline, King Pharmaceuticals, Merck, Novartis, Sanofi-Avenis, Schering-Plough. Seven of the lead authors have received drug money from multiple companies. But will the results of this study made a dent in the sales of the latest heavily-marketed, expensive drugs like Diamicron, Prandase (Precose), Amaryl, Avandia (Actos), and Byetta? Not likely. As an apologist for the drug industry who receives money from Amylin and Merck, stated in an editorial in the New England Journal of Medicine, this study “…[does] not provide a definitive answer to the problem of glycemic control and cardiovascular disease. Other ongoing clinical trials will provide additional clarification.” More dead people when taking more drugs is not clear? One of the studies we are to await is, wait for it, ORIGIN. Reminds one of the Garden of Eden. So, the myth of the necessity to “normalize” symptoms or metabolic self-abuse that might even be protective will persist and these unproven drugs will continue to be prescribed for many more years costing the medical systems of the world many $billions and making huge profits for their makers, in spite of the total absence of proof that anyone is better off or living longer swallowing these drugs.

Legal Addictions

The ACCORD-type subject

These drugs were approved for sale purely on basis of their ability to lower blood glucose, a symptom of a self-abusive, atherogenic lifestyle. Look at the baseline characteristics of participants in ACCORD. Average BMI was 32. Obese is defined as BMI greater than 30. So almost all participants were obese. Is it not unethical to perform a drug study in such a group before they have all reduced their BMIs to under 25? Normalizing their weights, by far the most important “action”, would probably cure the diabetes in many of them and they wouldn’t even be in a study on diabetes. But one cannot sell drugs to healthy people. So why would any investigator receiving money from drug dealers insist that people with self-abusive lifestyles change their lifestyles before doing a drug trial? After all, no investigator wants to risk dying of old age before he or she can collect enough “events” (i.e. deaths) to write a paper whatever the conclusion might be.

Results from ACCORD. More deaths on “intensive” (more expensive drugs) therapy

Drs Krumholz and Lee, both with no ties to drug dealers write in a Perspective article in the same issue of the NEJM. “Clearly the way in which risk factors [blood cholesterol, blood glucose, high blood pressure] are modified does matter. Lifestyle interventions may [sic] have few risks, but we cannot assume the same for drugs…”  “…ultimately we need to understand a strategy’s effects on people, not just on surrogate end points.” But even they refuse to recognize the absolute need for lifestyle change before starting drugs in patients with diseases of lifestyle. What risks could lifestyle change possibly have?

Posted in atherosclerosis, coronary artery disease, diabetes, Type 2, diet, drugs, obesity, professionalism | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a Comment »

Take the Cholesterol Pledge

Posted by Colin Rose on July 5, 2008

The AHA’s Cholesterol Pledge

Now, if you were the average red-blooded American and you had to make at least three of these choices to “lower my cholesterol” what are you likely to opt for?

Are you likely to “read food labels… and buy foods that are low in cholesterol and saturated fat”, “maintain a healthy body weight” and “participate in moderately intense physical activity”.

Or, are you more likely ” to know what my cholesterol should be”, “to have my cholesterol checked” and “take my medication as my doctor prescribed”?

What’s more, all primary prevention trials to date of cholesterol lowering with drugs (LRC-CPPTWOSCOPSASCOT-LLA) have shown no total mortality benefit and no primary prevention drug trial has ever made any serious attempt to have all participants “maintain a healthy weight”, “participate in moderately intense physical activity” or “stay tobacco free”.

The AHA, which receives major funding from drug dealers flogging cholesterol-lowering medications, considers the latter to be equivalent to the former and the latter requires absolutely no change in lifestyle by the patient. Eat anything as long as you check your blood cholesteroltake your pill. Is there any wonder there is a pandemic of obesity and Type 2 diabetes?

 

On the Take

On the Take

AHA Convention 2003. The Merck booth is next to the AHA booth. The implied endorsement of their product by the presumably altruistic AHA is worth $billions to the drug peddlers and they pay handsomely for the opportunity.

Posted in atherosclerosis, cholesterol, diet, drugs, statins | Tagged: , , , , , , | 1 Comment »

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
_______________________________

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

Get With The Guidelines – Do as the drug salesmen say

Posted by Colin Rose on May 4, 2007

Here is a classic example of drug dealers influencing the prescribing habits of doctors. If you read this GWTG-CAD carefully you will find a litany of insinuations WITHOUT PROOF. The data presented here are only observational. There is no control group. What were the lipids of the population that didn’t have a heart attack? The main insinuation is that the only cause of atherosclerosis is “dyslipidemia” and if the whole population of the world achieved “ideal” lipid levels by taking enough statins to lower their LDL to less than 70 mg/DL and somehow managed to also get their HDL higher than 60 mg/DL, there would be no heart attacks. There is NO PROOF for this hypothesis. 21% of the heart attack patients were on statins before their heart attack but still had one!

Now, if you want to know how such stupidity gets into print and gets the backing of the AHA, just look at the disclosures which are in small print at the bottom left. Enough said.

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

COURAGE demolishes the myth of the “widow maker” and the “time bomb” but does not use optimal medical therapy

Posted by Colin Rose on March 26, 2007

For 30 years since the development of a balloon-tipped catheter to dilate coronary arteries, now known as PCI (percutaneous coronary intervention), it has been revealed truth from “experts”, most of whom paid their mortgages by doing PCI’s, that all significant coronary narrowings should be dilated to prevent a heart attack. In spite of overwhelming evidence that heart attacks are caused by rupture or early, unstable, non-obstructive plaques, most cardiologists still believe that heart attacks (sudden complete blockage of a coronary artery) occur at the site of the largest plaques. Patients are shown angiograms and told they have a “widow maker” or are “sitting on a time bomb”. I refused to do angioplasties until there was some proof for this superficial but very lucrative theory. Again, it turns out I was right. Even in patients with major narrowings and symptoms, PCI does not prolong life or prevent heart attacks. Chronic symptoms were slightly more improved in the PCI group but most medically-treated patients had symptom improvement just with pills.

 

Legal Addictions

The COURAGE type subject

All cardiologists give lip service to the necessity for lifestyle change as the ultimate cure for atherosclerosis, but in this study there was no attempt at lifestyle change. Most patients were overweight or obese, gained weight over the five year study. 20% smoked and did not stop. While the authors claim to using “optimal” medical therapy, they did not even try significantly changing lifestyle, the obvious cause of the patients’ atherosclerosis. No doubt even better results that could have been obtained with just lifestyle change, without pills or PCI, as Dean Ornish showed many years ago.

If you want an explanation for why, except for a feeble attempt to raise HDL by exercise, NO attempt was made to change lifestyle meaningfully before using statins or PCI you need look no further than the source of funding and the disclosure statements of the authors. Those who recieve substantial income from drug dealers are not keen on proving that cost-free lifestyle change alone will do the same or better than expensive drugs.

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Now, why has it taken 30 years to finally prove the futility of PCI in patients with stable or stabilized coronary disease? Unlike new drugs, there are no rules and no government agency mandating that surgical procedures have to undergo clinical trials before being done on the general population. Any surgeon can develop some operation that seems superfically rational and he and his colleagues can do many thousands of those operations, costing millions or billions of dollars and risking many lives until someone gets around to actually testing it to see if the outcome is really as advertised.

Doctors profess to want to practice “evidence-based medicine” but when change negatively affects bank accounts habits change very slowly if at all. Angioplasty in stable CAD can always be rationalized by the classic, “my patient is different than those in the controlled trial”. We can predict that angioplasties in patients with stable CAD will not decline significantly until most of those trained in the procedure have retired. The system could save a lot of money by giving each of them $one million and a house in Mexico to retire to.

Posted in angioplasty, atherosclerosis, coronary artery disease, diet, drugs, professionalism, statins | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 1 Comment »