“When diet doesn’t work”

Here is a graphic illustration of the concept of moral hazard as applied to the drug treatment of lifestyle diseases.

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Reprinted from AdWatch

Many studies confirm that doctors’ behaviour can be influenced by drug advertising, but many of them are unaware of this.
Not only the advertising text, but also the images play an important part.
See below, for instance, the image in the Lescol advertisement published in the April 2008 issue of Rivista SIMG (Journal of the Italian Society of General Practitioners).

Lescol (fluvastatin sodium) is one of the statin class of drugs used to treat of high cholesterol when diet and other lifestyle changes don’t work.
The Summary of Product Characteristics states “for best results in lowering cholesterol, it is important that you closely follow the diet suggested by your doctor”.

What kind of advice could the doctor have given the two people on the beach?

They seem to be really happy and relaxed. The pastel colours, the calm sea and the blue sky in the background convey the impression that all is going well and no changes are needed.

The designer must have been influenced by the Colombian painter Fernando Botero, famous for his fat men and women, who generally emanate a sense of calmness and satisfaction.

What I can understand, as a doctor, after looking at this image?
“It doesn’t matter what I advise my patients to eat; it isn’t worth them trying to change their lifestyle behaviours.
Only the pill can make the difference!”

Yves Bolduc – Minister of Health and Drug Salesman

On learning that Quebec spends much more per capita on drugs than the Canadian average, Yves Bolduc, Quebec’s Minister of Health and Social Services, proclaimed that he wanted everyone to know that this was GOOD NEWS and that he was happy to see that Quebec was ahead of the other provinces. He added that in Quebec people take the drugs they need for their diseases while in the other provinces they don’t take the drugs they need and as a result their high blood pressure and cholesterol problem aren’t treated. He also thinks that spending more on drugs is economic because more drugs mean less is spent in other treatments.

Lets examine the Minister’s logic.

If Quebec is ahead of other provinces, in what respect is it ahead? Quebec has the same life expectancy as Ontario but less than British Columbia who spend much less on drugs. Nova Scotia which spends the most on drugs has one of the lowest life expectancies in Canada. So, there is no correlation between drug consumption and the best measure of overall health, life expectancy.

Bolduc says that drugs are needed to treat high blood pressure and cholesterol. Not true. Lifestyle change is far more efficient and cheaper than drugs for treating these “diseases” that are in most cases just symptoms of self-destructive lifestyles. He wouldn’t dare say that all weaned citizens of Quebec should follow a low-fat Mediterranean type diet, eat no junk food and have a waist circumference less than half their height before even considering drugs for lifestyle diseases, like hypertension, diabetes and atherosclerosis. Political disaster. If he did so, the highways of Quebec would be instantly blockaded by pig and dairy farmers. All fast food franchise owners, restaurant owners, junk food producers, their employees and their families would never vote Liberal.

There is not  a shred of evidence that spending more on drugs for the diseases of lifestyle to which he refers translates into less spending on other treatment for these diseases.

So why does the Minister like more drug sales in Quebec and everywhere else? Maybe it’s because drug marketing is the largest industry on the west half of the island of Montreal where there are innumerable drug marketing agencies employing thousands of people funded by profits from Big Pharma. If you run a gigantic bureaucracy like the Ministry of Health and Social Services you need a lot of money and all that tax revenue from drug profits helps your Ministry to get bigger and bigger and gives you more power. So buying more drugs is a form of hidden taxation with no significant benefits in most cases. The Minister wouldn’t dare say that most of the expensive drugs are unnecessary and lifestyle change is essential. He would be reducing his own power and making a lot of voters on the West Island, a stronghold of Liberal power, very unhappy.

Harvard Medical School in Ethics Quandary

March 3, 2009

By DUFF WILSON

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?”

‘The Heart Truth’ for both men and women

Unilever, the maker of Becel margarine, would like us to believe that Becel is a health food; the more you eat the better. To that end Unilever contributes $millions to various cardiovascular and dietetic organization who reciprocate by putting the Becel logo on their literature and web sites.

There is no such thing as a healthy refined fat. Both margarine and butter are junk food, naked calories. Besides, pure fat is tasteless. The taste in butter and margarine comes only from their salt content. Obesity is the major nutritional problem and refined fats (butter, margarine or oil)are the most concentrated form of calories and should have no place in a healthy diet.

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The Heart Truth’ for both men and women
Margaret McKellar, brand manager, Becel.
National Post
26 Feb 2009

Re: Barbara Kay, Apparently Men No Longer Have Heart Disease Or Strokes: That’s The Message From Becel Margarine And The Heart And Stroke Foundation, Feb. 16. I have had personal experience in dealing with loss due to heart disease and stroke. My…read more…

 

 

Tech Tags: National Post newspaper Letters

The Atherogenic Football Diet

Who are the coaches and “nutritionists” that advise football players to eat atherogenic, obesogenic , diabetogenic, hypertensogenic diets just so they can trample the opposing team? They should be banned from the game.

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By Madison Park
CNN

(CNN) – Football players guzzle protein shakes, down steaks and lift weights. They train and gain weight, hoping to build mass under the careful eye of the team’s coaches, nutritionists and gurus.

“It was a scripted lifestyle where they tell you how to eat, how to take care of yourself, how much body fat you should have,” said Chuck Smith, a former defensive end for the Atlanta Falcons and the Carolina Panthers.

But once their glory days are over, they have the same problem as millions of other Americans: They’re fat.

Football Team

“When I trained, they told us to eat all you can eat,” said Smith, who played in Super Bowl XXXIII with the Falcons. “Drink beer, eat peanut butter to gain weight. All those eating habits were great for football. But when I got done, no question I had to make adjustments.”

Without scheduled practices, meals, and games on Sunday, it became tougher to keep in shape.

When players were younger, they had the opposite problem.

Many tried to gain weight, believing that bigger is better. But as they age and retire from football, many are seeing that “big” is causing problems.

Smith, who weighed 274 pounds during his professional days, often had four plates of food in one sitting “to keep my weight up.” After retirement, Smith had to unlearn those habits.

“I had to retrain my thinking,” he said. “I don’t need to be full. I don’t have to stuff myself to feel comfortable. That took a long time. You stuff yourself to gain weight, then you get out of shape.”

Smith learned he had high cholesterol (he had to take Lipitor), and his blood pressure was climbing, too.

“I had to take the bon-bons out of my mouth,” said Smith, 39. “I had to empower myself. Strength coaches, nutritionists aren’t going to take care of me. Guys have to empower themselves to take care of themselves.”

Smith is now a fitness trainer at Defensive Line Incorporated, where he works with football players. Through healthy foods and workouts, he trimmed his body fat, lowered his cholesterol and shed 50 pounds.

Some players understand the risks, said Dr. Archie Roberts, a former National Football League quarterback and retired cardiac surgeon.

“They understand that if they stay 250, 300, 350 pounds as they age, that’s going to shorten their life span and cause them more health problems,” he said. “Others don’t get it and they’re unable — for whatever reason — to lose the weight, and they will suffer the consequences, just like anybody else in the general population carrying too much weight.”

Diabetes, hypertension and high cholesterol are all cardiovascular risks associated with obesity.

Roberts heads the Living Heart Foundation, a nonprofit promoting health for former football players. For five years, he has conducted research to determine whether former football players are at added risk for heart problems (they’re not).

After left tackle Bob Whitfield retired from the New York Giants in 2007, he gained 20 pounds. The 37-year-old Pro-Bowler is trying to lose 40 pounds, which would bring him to 290 pounds, the lowest he has weighed since ninth grade.

“You don’t want to be the person at the buffet and people look at you crazy,” Whitfield said. “Overall, you want to have a healthier lifestyle. It doesn’t mean you want to be muscled up. … I don’t want to be the biggest man in the room anymore.”

Looking back at his career, Whitfield doesn’t think his size made him a better player.

“When that mass gets too heavy, you decline, you can’t accelerate, you don’t have as much force,” he said. “I never felt that being bigger gives you a competitive advantage. I put it on flexibility, the explosive nature of your movements.”

Several decades ago, 300-pound players were a rarity; now, the league has more than 500, Roberts said.

Decades ago, the Washington Redskins’ offensive line was known for its size and dominance.

“They had the largest line in the NFL, called the Hogs, 20 years ago,” said Dr. Ben Levine, director of the Institute for Exercise and Environmental Medicine at Texas Health Presbyterian Hospital in Dallas, and professor of medicine. “If you go back and look at their size, they’re about the size of the running backs today. The impression was these guys were massive, huge. They couldn’t play in the NFL today. They’re too small.”

Smith said he wasn’t forced to gain weight, but perceptions exist on how a player should look based on his position. That “needs to change in the NFL,” he said.

Being faster, stronger and more aggressive is more important than size, Smith said. He drew an analogy to airline stewardesses: “We want her to be tall and slim so she can walk down the aisles. Now is there really a difference between a 135-pound woman and a 150? Well, maybe a little bit different in the hips, but the same effectiveness happens when she does her job.”

He added, “I’m a classic example that size doesn’t matter.”

But that’s not what young, aspiring players think.

Jackie Buell, director of sports nutrition at Ohio State University, said she encounters players who seek to gain as much as 30 pounds by next season and seldom care whether it’s fat or muscle.

Buell’s research examined 70 college linemen and found that nearly half have metabolic syndrome, meaning that the players have at least three of the five risk factors of developing diabetes and heart disease. Her next project is to explore whether junior high and high school football players are developing metabolic syndrome.

“My fear is, these young men have this metabolic profile, what happens when they stop working out intensively?” Buell said. 

Drug Marketing by “Study”

Men, not women, out of work

The real issue here is the proliferation of moral rot in American society which will inevitably spread to all capitalist economies, Canada included. At present the only growing American industries are junk food and “health care”, industries that employ mostly women. Obese, junk-food addicted Americans are obsessed with the mirage that diseases caused by self-destructive habits can be prevented and death can be delayed indefinitely if they take enough pills for “cholesterol”, hypertension and diabetes and have enough operations, like gastric and coronary bypasses. Such societies cannot compete against less self-indulgent economies eventually implode and are unable to defend themselves. Unless there is a major change in US society the terrorists just have to wait until it self destructs and they can walk in and create a totalitarian Islamist state. As long as Americans can get their BK Quad Stackers and Lipitor they will not resist.

 

 

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Men out of work
BY ROBERT GAVIN
National Post
10 Dec 2008

The careers of Neal Boyle and Scott Hacker couldn?t be more different. Boyle, whose education ended with high school, worked 20 years crushing rocks at the U.S. Gypsum plant in Charlestown, Mass. Mr. Hacker, who holds an MBA, changed firms several…read more…

 

 

 

 

Tech Tags: National Post newspaper Fp Working

Cardiac disease threatens diabetics

Dr. Terrence Ruddy, chief of cardiology at the University of Ottawa Heart Institute, says the increasing number of people with diabetes is a major concern across the medical profession.

“The increasing number with diabetes is directly related to the increasing number with obesity,” he says. “We have an epidemic of obesity in young and older people. In older people, that is giving them diabetes now. In younger people, it will give them diabetes in the next 20 to 40 years.” It’s vital to reduce obesity, “not just for 40- to 50-year-olds but in 10 to 20-year-olds,” he says. “We need more money flowing into educational programs focused on lifestyle changes — increased activity, appropriate diet and weight loss in young people. Decrease obesity to decrease diabetes.”

Yet at least 500 cardiologists around the world were paid by AstraZeneca to take part in JUPITER, a clinical “trial” of Crestor in which most subjects were overweight or obese and NO attempt was made to reduce their weights. 1.5% per year became diabetic due to their inflamed excess visceral fat. Probably at least US$500 million flowed into this “trial” with NO “educational programs focused on lifestyle changes”.

Doctors pay lip service to the need to fight obesity but money talks. Those cardiologists probably received at least $1000 per subject to enroll them in the JUPITER “trial”. Why would they dare to insist upon lifestyle change first before enrolling the subject and forgo this income? Members of the “JUPITER Study Group” presumably overseeing the “trial” for AstraZeneca were probably paid $100,000 each for their “consultation”. Why would they insist on lifestyle change first before agreeing to participate?

 

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Cardiac disease threatens diabetics
IRIS WINSTON CANWEST NEWS SERVICE
The Gazette
26 Nov 2008

Just one year after Dale Frayling was diagnosed with type 2 diabetes, he suffered his first heart attack. Four months later, he had a second, more severe attack followed by bypass surgery. That was 11 years ago. The Saskatoon resident, now 57, has…read more…

 

Also blogged here: 1, 2

Tech Tags: The Gazette newspaper Healthy Living

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Here is the list of the cardiologists paid to participate in the JUPITER study who care more about money than advising patients on the best way to prevent atherosclerosis and diabetes.

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

Appendix. JUPITER Clinical Sites

Argentina 253: Altamirano J, Berrizbeitia M, Boskis P, Colombo H, Cuadrado J, Cuneo
C, Diaz M, Esper R, Fernandez A, Foye R, Hershson A, Kuschnir E, La Greca R,
Lorenzatti A, Lozada A, Luciardi H, Luquez H, Maffei L, Majul C, Marin M, Muntaner
J, Nul D, Paolasso E, Rey R, Rodenas P, Rodriguez P, Rojas C, Telsolin P, Vita N,
Belgium 487: Adrianes G, Argento O, Bacart P, Baeck L, Baguet J, Balthazar Y, Battello
G, Behets J, Beke P, Bemden S, Berwouts P, Boermans P, Bolly F, Borms J, Boulad M,
Boulanger L, Bous J, Boxstael R, Brands Y, Buyse L, Calozet Y, Camps K, Capiau L,
Celis H, Coucke F, D’Argent F, De Beeck G, De Meulemeester M, De Praeter K, De
Rouck S, Delcourt A, Delvaux J, Demanet E, Derijcke M, Deruyck C, Devaux J, Dupont
C, Duyse J, Erpicum L, Gilio C, Gillet A, Grosjean J, Heeren J, Henry G, Heyvaert F,
Hollanders G, Hutsebaut A, Janssens P, Lannoy H, Ledoux C, Legros P, Leliaert R,
Martens R, Maury O, Mehuys G, Michaux J, Migeotte A, Mortelmans J, Mulders N,
Parijs P, Peer W, Pieters E, Reynders P, Riet D, Robert P, Stee J, Teheux J, Teuwen J,
Timmermans B, Tshinkulu M, Vantroyen D, Veevaete M, Vercruysse K, Vereecken G,
Vermeersch L, Vernijns J, Verspecht E, Vinck G, Vrancken F, Watte G, Weymans J,
Windmolders S, Ziekenhuis J, Ziekenhuis P, Brazil 327: Albuquerque D, Barbosa E,
Bertolami M, Blacher C, Brasileiro A, Eliaschewitz F, Esteves J, Feitosa G, Filho H,
Filho R, Fonseca F, Forti A, Francischetti E, Franco R, Gomes M, Gross J, Jardim P,
Kohlmann O, Loures-Vale A, Magalhaes M, Maia L, Moriguchi E, Nogueira P, Oigman W,
Repetto G, Saraiva J, Xavier H, Bulgaria 197: Balanescu S, Benov H, Chompalova B,
Donova T, Gocheva N, Goudev A, Grigorov M, Gruev T, Hergeldjieva V, Marchev S,
Mihov A, Pasheva V, Penev A, Popov A, Raev D, Sirakova V, Slavcheva A, Stoikov A,
Stoilov R, Tisheva S, Todorov G, Torbova S, Uzunangelov J, Canada 2020: Achyutna G,
Akhras R, Arun N, Barriere G, Bartlett J, Behiels S, Bell A, Bergeron J, Berlingieri J,
Bhamjee H, Bodok-Nutzati R, Booth W, Boyd C, Brault S, Bruckswaiger D, Bukovy B,
Campbell G, Carlson B, Cha J, Chehayeb R, Cheng W, Chilvers M, Chouinard G,
Chow W, Conter H, Conway J, Craig D, Dattani I, Del Grande R, Dharamshi S,
Dickson M, Dion D, Dowell A, Drexler J, Dube S, Dupont A, Dworkin B, Fields L,
Filteau P, Gardiner E, Gervais B, Gillis G, Girard R, Goldman H, Gorfinkel I, Goulet S,
Greenspoon A, Gritter R, Gupta A, Gupta M, Habib R, Harding R, Hart R, Henein S,
Henry D, Hirsch A, Ho K, Hoag G, Houde D, Howlett E, Ing G, Jadd J, Janes J, Jardine F,
Johnston T, Kanani S, Kazimirski M, Kelly A, Klajner F, Kooy J, Lalani A, Lam S,
Laranjeiro J, Larose D, Leiter L, Leung W, Li J, Lowe D, Luces K, Ma P, MacKinnon R,
Martinho V, Matangi M, McCrossin M, McIsaac J, McMullen W, Mehta P, Meunier M,
Misik K, Ng A, Nigro F, Noronha L, O’Mahony W, Pandey S, Papp E, Patel V , Patrick L,
Peddle C, Pinsky N, Poirier P, Powell C, Price J, Rolfe A, Saliba N, Sawkiw R, Senior R,
Shu D, Smith R, Somani R, Soowamber M, Stakiw K, Talbot P, Taliano J, Tan K,
Teitelbaum I, Threoux P, Tremblay G, Turcotte C, Tytus R, Walsh P, Webb G,
Willoughby P, Woo V, Woodland R, Yee G, Chile 83: Blanco M, Cardenas N,
Dominguez J, Gutierrez M, Jalaf M, Olivares P, Rodriguez B, Saelezer C, Stockins B,
Colombia 345: Ardila W, Aschner P, Botero J, Botero R, Calderon C, Casas L,
Castellanos R, Chaves A, Cure C, Escobar I, Fortich A, Garcia L, Hernandez E, Isaza D,
Jaramillo N, Kattah W, Marin M, Matiz C, Quintero A, Rizcala A, Rodriguez N, Ruiz A,
Urina M, Valenzuela A, Costa Rica 270: Cob-Sanchez A, Gutreiman-Golberg M,
Lainez-Ventosilla A, Ramirez-Zamoraa L, Slon-Hitti C, Vinocour-Fornieri M, Denmark
336: Hansen H, Nordestgaard B, Steffensen R, Stender S, El Salvador 162: Abrego H,
Renderos J, Rivera-Ochoa L, Estonia 85: Eha J, Jaanson E, Kaasik U, Keba E, Maetos E,
Petersen M, Reinmets S, Roostalu U, Vahula V, Veidrik K, Germany 222: Bellmann R,
Hanefeld M, Horacek T, Klein C, Knels R, Koenig W, Laus S, Meibner G, Mondorf C,
Schell E, Schuster H, Sehnert W, Stahl H, Szelazek G, Winkelmann B, Witczak E, Israel
143: Avishay E, Gavish A, Grossman E, Haratz D, Hussein O, Keider S, Levy Y, Shapiro
I, Shveydel E, Wolfovitz E, Yogev R, Zeltser D, Mexico 741: Escarcega J, Galvez G,
Gonzalez J, Guajardo S, Gutierrez-Fajardo P, Ibara M, Leon J, Lozano F, Munoz E, Pina
J, Romero-Zazueta A, Sanchez R, Takahashi H, Villalpando C, Villegas E, Netherlands
987: Agous I, Bak A, Bartels G, Basart D, Cornel J, De Schipper L, Holwerda N, Kose
V, Koster Y, Lok D, Lokhorst B, Mosterd A, Nierop P, Oude Ophuis A, Somer S, Tiebesl
J, Trip M, Van Hessen M, Van Kempen W, Wassenaar M, Norway 204: Andresen M,
Berz A, Bjurstrom M, Bo P, Brunstad O, Daae-Johansen T, Elle S, Fauske J, Fossdal B,
Gjefsen O, Hallaraker A, Haugen J, Helberg S, Holm-Johnsen S, Istad H, Jacobsen T,
Johansen R, Jorstad T, Jorum I, Kjorlaug K, Kontny F, Langaker K, Larsen B, Lonning
S, Loraas A, Mansilla-Tinoco R, Medhus R, Meyer I, Nasrala S, Ofjord E, Ose L, Palmas
J, Risberg K, Sandberg A, Sirnes P, Skjegstad E, Skjelvan G, Solnor L, Storm-Larsen A,
Tandberg A, Tomala T, Torkelsen A, Ursin A, Valnes K, Walaas K, Panama 202: Binns
R, Delgado A, Lombana B, Noriega L, Trujillo R, Poland 804: Artemiuk E, Asankowicz-
Bargiel B, Banas I, Baranska E, Baranski M, Bijata-Bronisz R, Sikorska A, Blasszczyk B,
Bolanowski J, Brokl-Stolarczyk B, Brzecki K, Buczkowski K, Chmielewski T, Chojnowska-
Jezierska J, Chwist-Nowak A, Cygan W, Czajkowska-Kaczmarek E, Dargiewicz A,
Dluzniewski M, Dudka C, Fares I, Flasinska J, Gadzinski W, Gaszczyk G, Golebiowski G,
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JUPITER is a gas giant

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.

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.

For an insightful analysis of the obfuscation in the reporting of mortality data in JUPITER see here.

Another devastating critique of Jupiter by the Michel de Lorgeril who many years ago proved that simple diet changes could dramatically prevent heart attacks and prolong life after a heart attack with NO statins.

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.

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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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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.

What typical JUPITER subjects would look like. These are "apparently healthy" people?

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 20006, 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.

Disaster! Americans stop taking Lipitor.

Well, I predicted many years ago that the exorbitant cost of drugs for lifestyle diseases would at some point destroy the cherished American ideal of unlimited consumption. It has happened a lot sooner than even I thought. The same attitude that powered the myth of free money and endless consumption of houses and goods is responsible for the myth of harmless gluttony while taking pills for “cholesterol”, hypertension and Type 2 diabetes, all, to a large extent, diseases of lifestyle.  Most of these drugs have never been shown to prolong life in the general population and should never have been prescribed in the first place. The same thing happens in Canada. I just saw a patient with normal blood sugar and normal “cholesterol” who was prescribed metformin and Lipitor “just in case”.

The profligate American lifestyle is undergoing a profound change. In the financial crunch It has finally dawned on a lot of people that they really don’t need those “cholesterol” pills, that they might be much better off if they just changed some of their greedy habits. In most cases it is not a choice between “meals and medication”. Less meals = less medication. Most Americans are eating far too much anyway.

Two-thirds of the US population is now overweight or obese, all “high risk” people on multiple drugs for treating the symptoms of inflammatory excess visceral fat. I predict we will witness a stabilization of amelioration of the pandemic of obesity and a marked drop in the costs of treating it’s complications, now about $75 billion per year in the US. It will be discovered anew that obesity is not genetic and one really doesn’t need a “gastric bypass” to lose weight. All you have to do is eat less.

You read it here first. Nothing like a financial collapse to cure gluttony.

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From the New York Times

By STEPHANIE SAUL
Published: October 21, 2008

For the first time in at least a decade, the nation’s consumers are trying to get by on fewer prescription drugs.

As people around the country respond to financial and economic hard times by juggling the cost of necessities like groceries and housing, drugs are sometimes having to wait.

“People are having to choose between gas, meals and medication,” said Dr. James King, the chairman of the American Academy of Family Physicians, a national professional group. He also runs his own family practice in rural Selmer, Tenn.

“I’ve seen patients today who said they stopped taking their Lipitor, their cholesterol-lowering medicine, because they can’t afford it,” Dr. King said one recent morning.

“I have patients who have stopped taking their osteoporosis medication.”

On Tuesday, the drug giant Pfizer, which makes Lipitor, the world’s top-selling prescription medicine, said United States sales of that drug were down 13 percent in the third quarter of this year.

Through August of this year, the number of all prescriptions dispensed in the United States was lower than in the first eight months of last year, according to a recent analysis of data from IMS Health, a research firm that tracks prescriptions.

Although other forces are also in play, like safety concerns over some previously popular drugs and the transition of some prescription medications to over-the-counter sales, many doctors and other experts say consumer belt-tightening is a big factor in the prescription downturn.

The trend, if it continues, could have potentially profound implications.

If enough people try to save money by forgoing drugs, controllable conditions could escalate into major medical problems. That could eventually raise the nation’s total health care bill and lower the nation’s standard of living.

Martin Schwarzenberger, a 56-year-old accounting manager for the Boys and Girls Clubs of Greater Kansas City, is stretching out his prescriptions. Mr. Schwarzenberger, who has Type 1 diabetes, is not cutting his insulin, but has started scrimping on a variety of other medications he takes, including Lipitor.

“Don’t tell my wife, but if I have 30 days’ worth of pills, I’ll usually stretch those out to 35 or 40 days,” he said. “You’re trying to keep a house over your head and use your money to pay all your bills.”

Although the overall decline in prescriptions in the IMS Health data was less than 1 percent, it was the first downturn after more than a decade of steady increases in prescriptions, as new drugs came on the market and the population aged.

From 1997 to 2007, the number of prescriptions filled had increased 72 percent, to 3.8 billion last year. In the same period, the average number of prescriptions filled by each person in this country increased from 8.9 a year in 1997 to 12.6 in 2007.

Dr. Timothy Anderson, a Sanford C. Bernstein & Company pharmaceutical analyst who analyzed the IMS data and first reported the prescription downturn last week, said the declining volume was “most likely tied to a worsening economic environment.”

In some cases, the cutbacks might not hurt, according to Gerard F. Anderson, a health policy expert at Johns Hopkins Bloomberg School of Public Health. “A lot of people think there there’s probably over-prescribing in the United States,” Mr. Anderson said.

But for other patients, he said, “the prescription drug is a lifesaver, and they really can’t afford to stop it.”

Dr. Thomas J. Weida, a family physician in Hershey, Pa., said one of his patients ended up in the hospital because he was unable to afford insulin.

Not everyone simply stops taking their drugs.

“They’ll split pills, take their pills every other day, do a lot of things without conferring with their doctors,” said Jack Hoadley, a health policy analyst at Georgetown University.

“We’ve had focus groups with various populations,” Mr. Hoadley said. “They’ll look at four or five prescriptions and say, ‘This is the one I can do without.’ They’re not going to stop their pain medication because they’ll feel bad if they don’t take that. They’ll stop their statin for cholesterol because they don’t feel any different whether they take that or not.”

Overall spending in the United States for prescription drugs is still the highest in the world, an estimated $286.5 billion last year. But that number makes up only about 10 percent of this country’s total health expenditures of $2.26 trillion.

Pharmaceutical companies have long been among those arguing that drugs are a cost-effective way to stave off other, higher medical costs.

The recent prescription cutbacks come even as the drug industry was already heading toward the “generic cliff,” as it is known — an approaching period when a number of blockbuster drugs are scheduled to lose patent protection. That will be 2011 for Lipitor.

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Already, a migration to generic drugs means that 60 percent of prescriptions over all are filled by off-brand versions of drugs. But with money tight, even cheaper generic drugs may not always be affordable drugs.

Factors other than the economy that may also be at play in the prescription downturn include adverse publicity about some big-selling medications — like the cholesterol medications Zetia and Vytorin, marketed jointly by Merck and Schering-Plough. And sales of Zyrtec, a popular allergy medication, moved out of the prescription category earlier this year when Johnson & Johnson began selling it as an over-the-counter medication.

Diane M. Conmy, the director of market insights for IMS Health, said the drop in prescriptions might also be partly related to the higher out-of-pocket drug co-payments that insurers are asking consumers to pay.

“Some consumers are making decisions based on the fact that they are bearing more of the cost of medicines than they have in the past,” Ms. Conmy said.

The average co-payment for drugs on insurers’ “preferred” lists rose to $25 in 2007, from $15 in 2000, according to the Kaiser Family Foundation, a nonprofit health care research organization. And, of course, lots of people have no drug insurance at all. That includes the estimated 47 million people in the United States with no form of health coverage, but it is also true for some people who have medical insurance that does not include drug coverage — a number for which no good data may exist.

For older Americans, the addition of Medicare drug coverage in 2006 through the Part D program has meant that 90 percent of Medicare-age people now have drug insurance. And in the early going, Part D had helped stimulate growth in the nation’s overall number of prescriptions, as patients who previously had no coverage flocked to Part D.

But a potential coverage gap in each recipient’s benefit each year — the so-called Part D doughnut hole — means that many Medicare patients are without coverage for part of the year.

The recent IMS Health figures reveal that prescription volume declined in June, in July and again in August, mirroring studies from last year suggesting that prescription use begins dropping at about the time more Medicare beneficiaries begin entering the doughnut hole.

Under this year’s rules, the doughnut hole opens when a patient’s total drug costs have reached $2,510, which counts the portion paid by Medicare as well as the patient’s own out-of-pocket deductibles and co-payments.

The beneficiary must then absorb 100 percent of the costs for the next $3,216, until total drug costs for the year have reached $5,726, when Medicare coverage resumes.

Gloria Wofford, 76, of Pittsburgh, said she recently stopped taking Provigil, prescribed for her problem of falling asleep during the day, because she could no longer afford it after she entered the Medicare doughnut hole.

Her Provigil had been costing $1,695 every three months. “I have no idea who could do it,” she said. “There’s no way I could handle that.”

Without the medication, Ms. Wofford said, she falls asleep while sitting at her computer during the day but then cannot sleep during the night. Because she feels she has no choice, Ms. Wofford is paying out of pocket to continue taking an expensive diabetes medication that costs more than $500 every three months.

For some other people, the boundaries of when and where to cut back are less distinct.

Lori Stewart of Champaign, Ill., is trying to decide whether to discontinue her mother’s Alzheimer’s medications, which seem to have only marginal benefit.

“The medication is $182 a month,” said Ms. Stewart, who recently wrote about the dilemma on her personal blog.

“It’s been a very agonizing decision for me. It is literally one-fifth of her income.”