Fw: Selective reporting of pharmaceutical data leads major medical journals to change editorial policy ~ CJEM

[Guest guest]

----- Original Message -----

From: " ilena rose " <ilena@...>

Sent: Tuesday, January 15, 2002 11:00 PM

Subject: Selective reporting of pharmaceutical data leads major medical

journals to change editorial policy ~ CJEM

> ~~~ Thanks much to Judith for this article.

>

> IMHOO, it was during the reign of the former Exec Editor of the NEJM,

> Marcia Angell~ who is also an extremely vital part of the Junk Science

> Team ~ when this type of Pharmaceutical Journalism was at its peak.

>

> The " studies " in her " peer reviewed " Journal on breast implants in the

> early nineties were the best silicone dollars could buy and the epitome of

> " junk " or " corporate science. "

>

> Still quoted today, they looked only at records of women implanted under

> 10 years ~ way too early to draw conclusions on systemic illness and had

> less than 2000 women ~ some implanted only months ~ ACSH and Fumento and

> Milloy and Angell have bandied these about as if they were gospel.

>

> These are the " peer reviewed " that the Flack Robots demand, " is it peer

> reviewed? is it peer reviewed?is it peer reviewed?is it peer reviewed?is

> it peer reviewed?is it peer reviewed?is it peer reviewed?is it peer

> reviewed? " then " I don't see any evidence.I don't see any evidence.I don't

> see any evidence.I don't see any evidence.I don't see any evidence. "

>

> These were " peer reviewed " as are the studies in this article below ...

> and premature and inaccurate conclusions were drawn from them.

>

> By the time the Junk Scientists can't deny the evidence anymore, as in the

> breast implant travesty, is after 40 years of manufacturers and plastic

> surgeons marketing and PR'ing and implanting several million women ...

> many if not most who will have multiple surgeries, oft at very inopportune

> times, and a body having to deal with a foreign object 24/7 ... at best.

>

> My evening's thoughts ...

>

> http://www.BreastImplantAwareness.Org

>

>

> The Silicone Science Debacle mirrors the Tobacco History ...

>

> The Silicone Smokescreen

>

http://groups.google.com/groups?hl=en & selm=ilena-1708011354480001%4024-25-20

1-23

> 1.san.rr.com

>

> Marcia Angell: Medical Deity or Silicone Spin Doctor

>

http://groups.google.com/groups?q=%22silicone+spin+doctor%22+%22marcia+angel

l%22

>

& hl=en & safe=off & scoring=d & rnum=2 & selm=ilena-2508011156010001%4024-25-201-231

..san

> .rr.com

>

>

> Selective reporting of pharmaceutical data leads major medical journals to

> change editorial policy

> http://www.caep.ca/004.cjem-jcmu/004-00.cjem/vol-3.2001/v34-321.htm

>

>

> Controverses

>

> Vol. 3, No 4, October / octobre 2001

>

> Selective reporting of pharmaceutical data leads major medical journals to

> change editorial policy

>

> Tom , MD

> ------------------------------------------------------------------------

> Departments of Medicine and Pharmacology and Therapeutics, University of

> British Columbia, Vancouver, BC

>

> The publication in Fall 2000 of the CLASS and VIGOR trials in JAMA and the

> New England Journal of Medicine (respectively) provided strong evidence

> for the cyclooxygenase (COX)-2 hypothesis: that COX-2 selective NSAIDs

> confer a gastrointestinal (GI) safety advantage over predecessor NSAIDs

> such as ibuprofen, naproxen or diclofenac.1,2 The publicity resulting from

> these trials helped prolong a multibillion dollar boom3 in North American

> sales of celecoxib (Celebrex) and rofecoxib (Vioxx), which are the first

> COX-2 agents licensed in the US and Canada. But more complete information

> recently submitted to the US Food and Drug Administration (FDA) has

> prompted an outcry that Celebrex manufacturer Pharmacia and prominent US

> clinical investigators did not present their trial data fairly.

>

> On Aug. 5, 2001, the Washington Post published a story entitled, " Missing

> data on Celebrex: Full study altered picture of drug. " 4 The article

> recounts JAMA's publication of the CLASS study, which concluded that

> celecoxib might confer a GI safety advantage over ibuprofen and

> diclofenac. Boston gastroenterologists Drs. R. Lichtenstein and M.

> Wolfe had written a cautiously favourable editorial about the

> study in the same issue of JAMA.5 However, last February, when Dr. Wolfe

> was shown the full study as a member of the FDA Arthritis Advisory

> Committee, he saw that the complete trial data painted a different

> picture, and that celecoxib did not appear to offer a significant safety

> advantage over the older, less expensive medications.

>

> " We were flabbergasted, " said Dr. Wolfe,4 after learning that what the

> authors had represented as a single 6-month trial was actually a combined

> analysis of the first 6 months of 2 separate 12-month trials. The authors

> had omitted the second 6-month data set, in which the apparent celecoxib

> advantage melted away. JAMA Editor D. DeAngelis said the journal

> was not informed about the missing data. " I am disheartened to hear that

> they had those data at the time that they submitted to us. We are

> functioning on a level of trust that was, perhaps, broken. " 4

>

> This and similar incidents, plus the fact that research is now funded to a

> very large extent by pharmaceutical firms who have vested financial

> interests in the results, prompted the 11 editors of the Vancouver Group

> (International Committee of Medical Journal Editors) to issue new

> requirements for acceptance for publication of research funded by industry

> sponsors.6 The requirements permit journal editors to review protocols and

> research contracts between the companies and investigators. Contracts that

> inhibit the full freedom of researchers to conduct the studies as they see

> fit and publish when they want may not be published.

>

> University of British Columbia clinical pharmacologist Dr. is

> cited in the Washington Post article for having alerted JAMA to the

> misreporting of the CLASS trial data. and colleagues at the UBC

> Therapeutics Initiative (www.ti.ubc.ca) submitted a letter to JAMA in July

> 2001 suggesting that the complete data from the CLASS trial indicate that

> celecoxib may cause more serious adverse events than ibuprofen or

> diclofenac (Dr. J. , UBC Therapeutics Initiative, Vancouver:

> personal communication, 2001).

>

> In its Aug. 22/29, 2001, issue,3 JAMA published a Cleveland Clinic

> meta-analysis of the CLASS and VIGOR trials, 2 smaller unpublished

> robecoxib trials, and the full trial data submitted to the FDA, focussing

> on the risk of cardiovascular events associated with selective COX-2

> inhibitors. This post-hoc analysis suggests that both rofecoxib and

> celecoxib may increase the risk of thrombotic cardiovascular events,

> including myocardial infaction, unstable angina, sudden death and ischemic

> stroke, when compared with other NSAIDs or with placebo. Rofecoxib was

> also associated with more frequent hypertension in the VIGOR trial, with

> mean blood pressure increases (systolic, 4.6 mm Hg; diastolic, 1.7 mm Hg)

> comparable but opposite to the mean effect of ramipril in the HOPE7 trial.

> Equivalent data were not available from the CLASS study. Pending

> clarification from a prospective trialspecifically assessing

> cardiovascular effects of COX-2 selective NSAIDs, the authors suggest " we

> urge caution in prescribing these agents to patients at risk for

> cardiovascular morbidity. "

>

> Competing interests: Dr. works part time for the University of

> British Columbia Therapeutics Initiative.

>

> References

>

>

> 1. Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A,

> et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal

> anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis. The

> CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis

> Safety Study. JAMA 2000;284(10):1247-55.

> 2. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, B,

> et al. Comparison of upper gastrointestinal toxicity of rofecoxib and

> naproxen in patients with rheumatoid arthritis. VIGOR [Vioxx

> Gastrointestinal Outcomes Research] study group. N Engl J Med

> 2000;343:1520-8.

> 3. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events

> associated with selective COX-2 inhibitors. JAMA 2001;286(8):954-9.

> 4. Okie S. Missing data on Celebrex: Full study altered picture of drug.

> Washington Post 2001 Aug 5;Sect A:11.

> 5. Lichtenstein DR, Wolfe MM. COX-2-selective NSAIDs: New and improved?

> [editorial]. JAMA 2000;284(10):1297-9.

> 6. off F, DeAngelis CD, Drazen JM, Nicholls MG, Hoey J, Hojgaard L,

> et al. Sponsorship, authorship and accountability. CMAJ 2001;165(6):786-8.

> 7. Yusef S, Sleight P, Pogue J. Bosch J, Davies R, Dagenais G, for the

> Heart Outcomes Prevention Evaluation Study Investigators. Effects of an

> angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular

> events in high-risk patients. N Engl J Med 2000;342:145-53.

>

>

>

>

> Correspondence to: Dr. Tom , Department of Medicine, University

> Hospital, 2211 Wesbrook Mall, Vancouver BC V6T 2B5;

> tperryjr@...

>

> ------------------------------------------------------------------------

>

> Editor's note: My Concise Oxford Dictionary defines the adjective honest

> as " free of deceit; truthful and sincere. " It defines ethical as, " of or

> relating to moral principles or the branch of knowledge concerned with

> these. " These are simple enough concepts and ones that those in the health

> care professions should naturally embrace.

>

> Pharmaceutical companies play a large role in our health care system. They

> have gained academic credibility by infiltrating prominent universities

> and courting influential physicians. Drug company funded studies now

> comprise a substantial proportion of all research published in

> peer-reviewed medical journals, and their increasing influence on medical

> practice is a growing controversy. For-profit companies wish to portray

> their products in a positive light, and physicians should interpret

> research findings with this in mind; but if the " industry standard " is to

> release only selected trial data to clinical investigators and medical

> editors, how can we believe anything we read?

>

> The recent scandal surrounding the CLASS study was perhaps the last straw,

> and 11 of the world's most prominent medical journals have joined forces

> to try to ensure articles have a sound, non-industry biased foundation.

> The editors of these journals may now refuse to print

> pharmaceutical-sponsored studies unless the researchers involved are

> guaranteed scientific independence and full access to the data.

>

> CJEM applauds this move and encourages readers to cultivate and maintain

> their own critical appraisal skills.

>

> Ross, MD

> Associate Editor

> CJEM

>

> PS: The next time you're gorging yourself at a drug company sponsored

> event, take time to reflect on the line that separates knowledge

> enhancement from marketing.

>

>

>