Medical ethics. In the toilet?

[Guest guest]

> JustSayNo

> Thu, 15 Jul 2004 18:50:27 -0700 (PDT)

> [sSRI-Research] Medical ethics. In the

> toilet?

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

>

> Scientific journal editors are scrambling about how

> to

> react to bad publicity emanating from public

> disclosure that the scientific reports they have

> published are likely to be biased because the

> authors'

> had financial ties to the companies whose drugs /

> devices they report on favorably-and that

> information

> was withheld from readers.

>

> A newly released survey by the Center for Science

> for

> the Public Interest (CSPI) looked at articles that

> appeared during a 3 month period--between December

> 2003 and February 2004--in four premier scientific

> journals--the New England Journal of Medicine, the

> Journal of the American Medical Association,

> Environmental Health Perspectives and Toxicology and

> Applied Pharmacology--finding that even in these

> journals, 8% of authors failed to disclose conflicts

> of interest.

>

> Among the reports cited by CSPI whose authors failed

> to disclose their financial conflicts: " Frank D.

> Kolodgie and Renu Virmani, two scientists at the

> U.S.

> Armed Forces Institute of Pathology, failed to

> disclose their consulting relationships with 20

> companies in the heart-disease treatment field in a

> December article in the New England Journal of

> Medicine about the formation of plaque in coronary

> arteries. " [Ref. 1]

>

> Inasmuch as biased science affects public health

> policies and misleads treating physicians who may be

> unwittingly doing harm to patients, is it not the

> responsibility of science journals to ensure that

> they

> provide accurate, full information to readers?

>

> Here are two modest recommendations: Journal editors

> should make an effort to publish an update, listing

> articles whose authors failed to disclose their

> financial ties to drug companies.

>

> Furthermore, it is essential for journals to retract

> clinical trial reports that were based on only

> partial--favorable-data. The results are false and

> misleading, and may be leading physicians to

> prescribe

> medications whose risks outweigh any benefits.

> [References 2]

>

> The same day that CSPI's survey was reported in the

> press, the journal, Circulation, published a report

> announcing new federally endorsed recommendations

> for

> the treatment of heart disease--more accurately,

> recommendations for the increased use of cholesterol

> lowering drugs. The recommendations were made by a

> panel convened by the National Cholesterol Education

> Program on the supposition that they will prevent

> heart disease. The recommendations will

> dramatically

> increase the use of statins to control cholesterol

> levels.

>

> Statins sales for the current 26 million Americans

> taking them reach $15 billion. The new

> recommendations will increase the number of users to

> 36 million and increase sales to $20.8 billion.

>

> The Wall Street Journal reports today, that the FDA

> is

> about to approve Vytorin, a drug, " which packs two

> cholesterol fighters into one pill. It combines

> Zetia, a cholesterol-blocker from Schering-Plough

> Corp., with Merck & Co.'s Zocor, the

> second-most-prescribed brand in the class of

> powerful

> drugs known as statins: " Just as heart patients and

> their doctors are grappling with updated government

> guidelines for dramatically lowering cholesterol, a

> new drug is about to be approved that is sure to

> deepen the confusion over choosing proper

> treatment. "

> [Ref 3]

>

> Since the NIH recommendations clearly provide statin

> drug manufacturers with a mega-billion dollar profit

> enhancement-and the rationale is

> controversial--isn't

> a bit of skepticism in order?

>

> For starters, why has no one questioned the absence

> of

> financial disclosure by the panel members that

> recommend the new guidelines? Have editors of the

> journal Circulation not heard about disclosure

> requirements? [Ref. 4]

>

> Why have reporters failed to ask about possible

> financial conflicts of interest that may have a

> bearing on these recommendations? [Ref. 5]

>

> Why has no one in the mainstream media seen fit to

> inform the public that there are scientists around

> the

> world who are skeptical about the intensive

> statin-cholesterol push, calling it " massive hype "

> by

> " Rent-A-Quote " Doctors? [Ref. 6]

>

> Doesn't good science depend upon open debate?

>

> The new recommendations were immediately endorsed by

> the National Heart, Lung and Blood Institute

> (NHLBI);

> the American Heart Association (AHA); and the

> American

> College of Cardiology (ACC). But these institutions

> have a checkered record of endorsing expensive

> treatments that were no better than cheaper ones,

> and

> potentially made matters worse.

>

> For example, the ALLHAT study conducted by NHLBI

> ( " antihypertensive and lipid lowering to prevent

> heart

> attack trial " ) tested the effectiveness of both

> antihypertensive and lipid treatments. It was

> published in JAMA (2002) and is cited in the

> journal,

> Circulation. The ALLHAT study was critically

> reviewed

> in the British Medical Journal (2003), noting that

> in

> BOTH arms of this government sponsored study neither

> expensive treatment endorsed by the AHA and ACC

> demonstrated better results than cheaper treatments

> which proved safer. [Ref 7]

>

> Indeed, a cheap diuretic proved safer and more

> effective against heart attack than either expensive

> calcium channel blockers and ACE inhibitors or lipid

> lowering statins which " showed no statistically

> significant reduction in cardiovascular disease

> event

> rates or in deaths. "

>

>

> Of special note is that this study tested statins in

> patients with higher risk of heart disease--because

> such patients had generally shown a greater benefit

> from statins than do lower risk patients--yet the

> outcome was negative.

>

> However, the negative ALLHAT study findings were

> never

> publicized and the PR firm handling Pfizer's

> marketing

> of the expensive drug, of Cardura, didn't challenge

> the findings because " The reality is no one promotes

> a

> diuretic. So you've got one study that says yes,

> you

> should [use a diuretic], then starting the day

> after,

> you've got a $10bn [sic] industry. . . and 55

> promotional events . . . for an ACE inhibitor... "

> [Ref 7]

>

> Incredibly, none of the journalists in the major

> media--including Gina Kolata (NYT), Rob Stein (Wash

> Post), Ron Winslow (WSJ), among others--saw fit to

> even mention the serious risks associated with

> statins. These include: a potential increase in

> liver

> enzymes, muscle aches, weakness, immune system

> suppression, an increase in cancer risk, and a

> serious

> degenerative muscle tissue condition called

> rhabdomyolysis-and the depletion of Q10, the

> co-enzyme

> for the production of cellular energy.

>

> What is Q10? Dr. Peter Langsjoen, an expert

> cardiologist who has done original research into

> Q10,

> says this co-enzyme " is responsible for over 80 per

> cent of energy and if you knock the level of this

> essential nutrient down, nothing works as well.

> Those

> tissues and organs that use a lot of energy are the

> first to be affected. The heart, for example, uses

> a

> huge amount of juice and if you cut it back with the

> use of a statin, what you start having first and

> foremost is lack of energy -you start getting

> sluggish. So the clinical consequences come about

> gradually and this weakening - fatigue, getting

> winded

> when you're walking up the stairs.It's extremely

> widespread. If you look for it, you'll see it in

> just

> about every single new patient who has been on a

> statin. " [Ref. 8]

>

> Science journalists seem to have very short memories

> about universally recommended preventive treatments

> that turned out to increase harm-the hormone

> replacement therapy debacle seems to have taught

> them

> nothing.

>

> The 2003 BMJ report uncovered evidence of Pfizer

> financial largesse-not surprising, the beneficiaries

> were the endorsers of Pfizer's high priced

> cholesterol

> lowering drugs. Even the NHLBI investigators walked

> away from their negative study findings, insisting:

> " we know [statins] work. " Is this science or faith?

> The NHLBI scientists went on to raise questions

> about

> their own methodology.

>

>

> But Dr. Marcia Angell noted that questions about

> study results should be " hypothesis generating " and

> cannot be assumed as fact until they are tested.

> She

> suggested that what's true of the ALLHAT drug study

> " may be true of an awful lot of drugs. A lot of

> newer

> drugs may not only not be better-they may be worse. "

> The problem arises, Dr. Angell said, because " most

> drug companies don't want a head to head [study].

> And

> the FDA allows trials to run that are rigged where a

> drug is tested against placebo or a drug of the same

> class that is inadequately dosed, or they look at

> the

> wrong group of people or the wrong endpoints so

> their

> drug looks good. " [Ref. 7]

>

> Why, then, have healthcare journalists who reported

> about statin-sales boosting recommendations fail to

> raise questions about the risks of statins, or to

> inform readers how much financial support / grants

> the

> manufacturers of statins provide to the three

> institutions that endorsed the recommendations?

>

> Must we always have to wait for the British to

> publish

> reports that raise serious questions about

> healthcare

> promotions? Must we wait for the BMJ to investigate

> unacknowledged financial incentives that may have

> persuaded those who promote the increased use of

> statins and other expensive new drugs?

>

> ~~~~~~~~~~~~~~~~~~~~~ References: 1. THE WALL

> STREET

> JOURNAL. Research Conflicts Go Undisclosed Study

> Says

> Medical Journals Don't Effectively Monitor Financial

> Ties of Authors. By ROBERT TOMSHO, July 13, 2004;

> Page D3

>

http://online.wsj.com/article/0,,SB108967337655561782,00.html

>

>

> 2.British Medical Journal. Efficacy and safety of

> antidepressants for children and Adolescents. Jon N

> Jureidini, et al. online free at:

>

http://bmj.bmjjournals.com/cgi/content/full/328/7444/879?

>

>

> See: The Lancet. Selective serotonin reuptake

> inhibitors in childhood depression: systematic

> review

> of published versus unpublished data. Craig J

> Whittington, et al. Volume 363, Number 9418, April

> 24, 2004, online free at:

> http://www.thelancet.com/journal/journal.isa

>

> 3. THE WALL STREET JOURNAL. New Option for

> Fighting

> Cholesterol FDA Is Expected to Approve Pill That

> Mixes

> Two Drugs; What the Lower Target Means By SCOTT

> HENSLEY , July 14, 2004; Page D1

>

> 4. NCEPAT Panel: Scott M. Gundy, James I Cleeman,

> Noel C Mertz, H. Bryan Brewer, Luther T. Clark,

> Donald B. Hunninghage, Richard C. Pasternak,

> Sidney

> C. Smith, Neil J. Stone,

>

> 5. The New York Times. Experts Set a Lower Low for

> Cholesterol Levels By GINA KOLATA July 13, 2004,

> A-1.

>

http://www.nytimes.com/2004/07/13/health/13heart.html?hp= & pagewantedprint & p

> osition=

>

> WASHINGTON POST. Lower Cholesterol Targets Urged By

> Rob Stein

>

http://www.washingtonpost.com/wp-dyn/articles/A44702-2004Jul12.html

>

> THE WALL STREET JOURNAL. New, Lower Goal Is Set for

> Cholesterol High-Risk Patients Are Urged to Consider

> Getting Their LDL Below 70 as Opposed to 100 By RON

> WINSLOW July 13, 2004; Page D1

>

> 6. See articles and reports by members of The

> International Network of Cholesterol Skeptics: " The

> International Network of Cholesterol Skeptics

> (THINCS)

> is a steadily growing group of scientists,

> physicians,

> other academicians and science writers from various

> countries. " http://www.thincs.org/Malcolm.htm

>

> 7. British Medical Journal. Spin doctors doctors

> soft pedal data on antihypertensives. By Jeanne

> Lenzer, BMJ 2003;326:170 ( 18 January

>

)http://bmj.bmjjournals.com/cgi/content/full/326/7381/170/DC1

>

> 8. See: Nicholas Regush interview Dr. Peter

> Langsjoen, a pioneering researcher and cardiologist

> who has brought considerable attention to a mighty

> nutrient called " Co-Enzyme Q10 " about the hazards of

> statins. Langsjoen has been involved in some of the

> key original work showing the link between Q10

> depletion and heart disease. His concerns and

> warnings about statin use come at a time when statin

> therapy is being very aggressively promoted by the

> drug industry

>

> http://redflagsweekly.com/RFD_Interviews/index.html

>

>

> Contact: Vera Hassner Sharav Tel: 212-595-8974

> e-mail:

> veracare