Whos Who In Whoo Whoo Clinical Practice Guidelines

By Norman E. Kjono, May 8, 2007

From Winnepeg Free Press, May 8, 2007, "WHO Guidelines Often Lack Evidence, Study Says," by Maria Cheng: 

LONDON -- When developing "evidence-based" guidelines, the World Health Organization routinely forgets one key ingredient: evidence. That's the verdict from a study published in The Lancet online today. The medical journal's criticism of WHO could shock many in the global health community, as one of WHO's main jobs is to produce guidelines on everything from fighting the spread of bird flu and malaria control to enacting anti-tobacco legislation. 'This is a pretty seismic event,' Lancet editor Dr. Richard Horton, who was not involved in the research for the article. 'It undermines the very purpose of WHO.' The study was conducted by Dr. Andrew Oxman and Dr. Atle Fretheim, of the Norweigian Knowledge Centre for Health Services, and Dr. John Lavis at McMaster University in Hamilton, Ont. They interviewed senior WHO officials and analyzed various guidelines to determine how they were produced. What they found was a distinctly non-transparent process. 'It's difficult to judge how much confidence you can have in WHO guidelines if you're not told how they were developed,' Oxman said. 'In that case, you're left with blind trust.' . . . WHO's Director of Research Policy Dr. Tikki Pang said that some of his WHO colleagues were shocked by The Lancet's study, but he acknowledged the criticism had merit, and explained that time pressures and a lack of both information and money sometimes compromised WHO work. 'We know our credibility is at stake,' Pang said, 'and we are now going to get our act together.'" (Underline added.) 

 

The first point to be understood about the World Health Organization (WHO) is that its credibility is not at stake.  WHO's credibility stands indisputably clear as it is. Those with an interest in exploring that subject further might want to begin with Forces archive about WHO.  I recommend that particular attention be focused on how WHO uses the World Bank and terms of lending to member countries to force international compliance with tobacco control mandates.  

 

Tobacco control advocates are fond of saying "It's inevitable" about their mandates. The only inevitable things about tobacco control mandates are that they will be based on fatally-flawed, selected evidence, hyped beyond what the scanty evidence employed can possibly justify, and that coercive tactics will be employed to enforce them. WHO's implementation of tobacco treatment guidelines is a prime example of such unseemly conduct. 

 

Accordingly, WHO's credibility is not at stake. It has already been sacrificed on the altar of special-interest politics. Mr. Pang's concerns should be more aggressively focused on restoring WHO's credibility rather than vain attempts to preserve what is already been lost. Those who have a legitimate interest in and who are genuinely concerned about honest public health guidelines await the outcome with baited breath. While WHO teeters on the verge of incompetent pandering to special-interest guidelines about tobacco people die daily from medical conditions that matter, such as malaria.  

 

February 8, 2007 the Wall Street Journal published a related article about medical practice guidelines, "Nicotine Fix Behind Antismoking Policy, Influence of Drug Industry."  I wrote about Mr. Helliker's article in The Light Begins to Break Through, II, published by Forces.org February 12, 2007.  

 

The Journal's article was written by its Pulitzer prize winning chief of the Chicago Bureau, Kevin Helliker.  Mr. Helliker shares his Pulitzer for Explanatory Reporting with Thomas M. Burton, also with the Wall Street Journal. In his February 8, 2007 Mr. Helliker wrote:  

"Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion - reflected in current federal guidelines - is based on scientific evidence from hundreds of studies. . . . At stake is one of the most important issues in the nation's public health-policy. Cigarettes kill an estimated 440,000 American each year. Helping America's 45 million smokers kick the addiction could save untold numbers of people. . . . Dr. Fiore and other members of the Society for Research on Nicotine and Tobacco refuse to accept any and funds from the tobacco industry, even unrestricted research grants. . . . Reflecting the view of many in the antitobacco camp, Harry Lando, a University of Minnesota nicotine researcher, says 'I view the pharmaceutical industry as our ally.' . . . Pressure may be growing for doctors to follow the federal guidelines. An article in the December issue of the journal Tobacco Control argued that failure to follow the guidelines could be deemed medical malpractice." 

The medical malpractice study published by the journal Tobacco Control to which Mr. Helliker refers, "The US Public Health Service 'Treating Tobacco Use and Dependence Clinical Practice Guidelines' as a Legal Standard of Care"  can be accessed by clicking on the preceding bold letters. I wrote about that subject in my commentary That's Ridiculous! published by Forces.org November 30, 2007.

A little history is in order. I wrote about Dr. Fiore in my March 16, 1998 commentary, GLAXO WELLCOME AND SMITHKLINE DRUG MARKETING published by Forces, which included the following excerpt: 

Dr. Michael Fiore from the University of Wisconsin Center for Tobacco Research and Intervention testified at the Madison hearing, in support of the smoking ban. There was an interesting twist, however: a professorship in Nicotine Dependency at the University of Wisconsin was funded by a grant from the drug company Glaxo Wellcome, according to a March 5, 1998 article in the Madison, Wisconsin Capital Times. The headline for the article by staff writer Gwen Carelton is "Grants to UW Would Fund Asthma, Smoking, Leukemia Research." Is Dr. Fiore's paycheck dependent on a drug company? 

Due to a merger in 2000, Glaxo Wellcome is now part of GlaxoSmithKline. The merger reportedly created the largest pharmaceutical company in the world at the time. Glaxo Wellcome was distributing the anti-depressant smoking cessation drug Zyban and SmithKline Beecham distributed Nicorette gum when the merger occurred. The merged company also paid an annual fee to the American Cancer Society for the use the society's seal to market Nicotine Replacement therapy (NRT) smoking cessation products like Nicorette. Today, GlaxoSmithKline is the distributor for NicoDerm CQ patches, Nicorette gum, and Commit nicotine lozenges. 

Dr. Fiore's comments were featured in a September 7, 2005 Robert Wood Johnson Foundation news release concerning the U.S. Justice Department's Racketeer Influenced and Corrupt Organizations (RICO) lawsuit against tobacco companies. That article was titled "Looking to the Future: Helping 33 Million Smokers Quit."   An interesting excerpt from that work is:

"Spending $5 billion a year on tobacco cessation for 25 years would profoundly improve the health of Americans," said Michael Fiore, M.D., M.P.H., author of the article and the government's expert tobacco-cessation witness in the Department of Justice trial. "This is why it is such a tragedy that the Justice Department backed away from their original cessation remedy.  Can you imagine what would happen if, as we projected with this plan, one million additional smokers quit each year-33 million over time?" (Underline added.)  

The above being Social Marketing an on demand sound bite de jour to support the foundation's transparent and conflicting financial interests. As of this writing the Robert Wood Johnson Foundation is reported by Yahoo finance to be among the top five institutional shareholders of Johnson & Johnson (56 million shares valued at about $3.7 billion). Johnson & Johnson subsidiary ALZA Corp. has manufactured NicoDerm CQ patches since 2001. In June  2006 Johnson & Johnson announced that it acquired Pfizer, including Nicorette gum. During the 1990s, while the American Cancer society was the nationwide manager for the George H.W. Bush administration's $135 1991 to 1998 American Stop Smoking Intervention Study (Project ASSIST), Johnson & Johnson was distributing Nicotrol smoking cessation products and the foundation provided more than $10 million in grants to the society.

Dr. Fiore also lead a group of researchers in developing the policy referenced in the above news release excerpt. That effort was reported in a Robert Wood Johnson Foundation news feature, "Ten Policy Changes That Could Curb Tobacco Addiction:
 

"The panel, established by Department of Health and Human Services Secretary Tommy Thompson, was a subcommittee of the department's Interagency Committee on Smoking and Health (ICSH). It was led by Michael C. Fiore, M.D., M.P.H., director of the University of Wisconsin Medical School's Center for Tobacco Research and Intervention, and a director of the Foundation-funded national program Addressing Tobacco in Managed Care . The group's task was to craft a set of bold, evidence-based recommendations to promote tobacco cessation. The group met five times between October 2002 and January 2003. In February 2003, the group's report was unanimously endorsed by the ICSH and was sent to Secretary Thompson. The report appears in the Feb. 9, 2004, issue of the American Journal of Public Health. . . . The federal recommendations, which the panel suggests should go into effect by fiscal year 2005, would cost more than $5 billion each year. Funding would come from the $2-per-pack tax. Half of the estimated $28 billion in annual revenue generated by the tax will be earmarked for programs that help people to quit smoking or prevent them from starting."  

In September 2006, shortly before Mr. Hellikers article was published, the Robert Wood Johnson Foundation published a review of an article that Dr. Fiore co-authored. The article, published in the American Journal of Prevenitve Medicine, was about the use of smoking cessation products and clinical guidelines. The foundation's review, "Promoting Smoking Cessation in the Health Care Environment: 10 Years Later,"   includes the following: 

"A decade ago there was great optimism about achieving national goals for reductions in the prevalence of tobacco use. This article assesses developments in integrating evidence-based tobacco dependence treatment into health care and finds enormous progress overall. The need for system-level changes to reflect knowledge about the health impact and cost effectiveness of smoking-cessation treatment has gained increased attention and inspired guidelines. Published research underscores the effectiveness of system-level strategies, such as adding smoking as a vital sign. Less clear are the effects of financial incentives and reimbursement. (Underline added.) 

"Positive developments cited by the authors include:

  • More frequent inclusion of coverage for evidence-based tobacco-cessation treatments in public insurance benefits;
  • an increase in the number of states offering quit-lines over the past decade (from four to 45 states);
  • greater availability of over-the-counter pharmacological therapies for quitting smoking; and
  • more physicians routinely advising their patients to quit smoking."  

Dr. Fiore is also a Robert Wood Johnson Foundation grant manager and beneficiary. See, for example, the following representative grant report from the foundation: 

University of Wisconsin Medical School (Madison,  WI)

 

·         Development of a Blueprint for Disseminating Tobacco Dependence Guidelines
Amount: $ 53,909
Dates: September 2001 to May 2002
ID#:  043405

·         Completing and Implementing a National Blueprint to Promote Tobacco Cessation
Amount: $ 53,732
Dates: May 2002 to November 2002
ID#:  045383

 

Contact

Michael C. Fiore, M.D., M.P.H.
(608) 262-8673
mcf@ctri.medicine.wisc.edu 

 

The World Health Organization is also directly involved in the Robert Wood Johnson Foundation's grant programs. See, for example, "Web-Based Database Lights Up Issues Surrounding Smoking Cessation:"   

In 2001, the Society for Nicotine and Tobacco, working in partnership with the World Health Organization (WHO), unveiled a Web-based database on tobacco dependence treatment. The site serves as an evidence-based Internet resource for researchers, policy makers and practitioners working in the field of tobacco dependence treatment. The Robert Wood Johnson Foundation (RWJF) provided a grant of $226,800 to develop and maintain the database from December 2001 through June 2003. (See Appendix 1 for a list of other funders.)

 

GRANT DETAILS & CONTACT INFORMATION

 

Project

Web-based Database for Tobacco Dependence Treatment

 

Grantee

Society for Research on Nicotine and Tobacco (Middleton,  WI)

 

  • Amount: $ 226,800
    Dates: December 2001 to June 2003
    ID#:  042510

 

Contact

Dorothy K. Hatsukami, Ph.D.
(612) 627-1808
hatsu001@mum.edu

Other Funders

 

From 2000 to December 2002, the Society for Research on Nicotine and Tobacco received support from the following organizations in addition to RWJF:

 

·         National Institute on Drug Abuse (USA) $25,000

·         National Cancer Institute (USA) $24,750

·         Pharmacia (now Pfizer) $25,000

·         Novartis Consumer Health $25,000

·         GlaxoSmithKline $20,000

·         American Cancer Society (USA) $2,500

 

Section Heads of Database Content Areas

Efficacy
Chair:
Lindsay Stead
The Cochrane Collaboration
Oxford, U.K.

Members
Michael Fiore
University of Wisconsin
Madison, Wis.

As noted above,

 

And Dr. Fiore was also the chair person for a Planning Conference Committee for distribution of smoking cessation guidelines: 

 

GRANT DETAILS & CONTACT INFORMATION

Project

AHCPR's Smoking Cessation Guidelines: Conference and Proceedings

Grantee

Pinney Associates, Inc. (Bethesda,  MD)

·         Conference on Policy Issues Related to Implementation of AHCPR's Clinical Practice Guideline on Smoking Cessation
Amount: $ 64,478
Dates: February 1996 to November 1996
ID#:  027474

Contact

John M. Pinney
(301) 718-8440

Grantee

Burness Communications, Inc. (Bethesda,  MD)

·         Communications Support for a Conference on AHCPR's Smoking Cessation Guideline
Amount: $ 16,978
Dates: September 1996 to January 1997
ID#:  030308

Contact

Andrew I. Burness
(301) 652-1558

Grantee

Pinney Associates, Inc. (Bethesda,  MD)

·         Preparation of Proceedings from the Conference on AHCPR's Smoking Cessation Guideline
Amount: $ 35,500
Dates: October 1996 to March 1998
ID#:  030465

 

Contact

John M. Pinney
(301) 718-8440

APPENDICES

 

Appendix 1

(Current as of the time of the grant; provided by the grantee organization; not verified by RWJF.)

Conference Planning Committee

Michael Fiore, MD, Chair
University of Wisconsin
Madison, Wis. 

 

Pinney Associates is a consulting firm that includes GlaxoSmithKline among its clients. Many of its associates, such as Dr. Saul Shiffman, conduct studies concerning the efficacy of Nicotine Replacement Therapy (NRT) products such as NicoDerm CQ patches, Nicorette gum, and Commit lozenges. Two studies about NRT products that Dr. Shiffman co-authored are revealing: 

 

Tobacco Control 2003;12:21-27

A meta-analysis of the efficacy of over-the-counter nicotine replacement

J R Hughes, S Shiffman, P Callas and J Zhang

Received 20 March 2002 Accepted 4 December 2002 

 

The long term (that is, greater than six months) quit rates for OTC NRT was 1% and 6% in two studies and 8-11% in five other studies. These results were not homogenous; however, when combined the estimated OR was 7%. (Underline added.) 

 

Tobacco Control 2003;12:310-316

Persistent use of nicotine replacement therapy: an analysis of actual purchase patterns in a population based sample

S Shiffman, J R Hughes, J L Pillitteri and S L Burton

Received 10 October 2002 Accepted 7 May 2003 

 

 . . . . That is, among those who start using nicotine gum, 6.7% are likely to still be using it after six months. Among those who engaged in persistent use in this sample, the duration of such use averages 8.6 months (that is, once users cross the six month threshold, they use for another 8.6 months, on average). Using the formula specified in Kleinbaum et al38 . . .  we estimate that 36.6% of current gum users (in cross section) are engaged in persistent use. (Underline added.) 

 

Dr. Fiore and tobacco control advocates provide a stellar example of why WHO guidelines are not supported by the evidence and are often rank speculation. Few could be more directly involved in the drafting, publication, and promotion of clinical guidelines that serve the purpose of hustling 7 percent effective (therefore 93 percent ineffective) pharmaceutical products on "Target Group" consumers.  

 

Finally, Dr. Fiore's published works are also cited in studies about doctors recommending the use of Nicotine Replacement therapy products for smoking cessation products. See, for example, the June 2006 Robert Wood Johnson Foundation grant results report, "Study Finds Most Doctors Don't Smoke; But They Don't Press Patients to Quit.

 

SUMMARY

From July 2003 to February 2004, researchers from Mathematica Policy Research (Princeton, N.J.) conducted a national survey of 2,804 health professionals to determine their knowledge, attitudes, beliefs and behavior regarding smoking and smoking cessation. The Robert Wood Johnson Foundation (RWJF) provided $724,777 to support this solicited contract from 2002 through 2004.

Key Findings
Researchers reported the following key findings to RWJF and in an unpublished manuscript:

 

  • Few clinicians currently smoke.
  • Primary care physicians are more likely to counsel smokers and offer cessation assistance than other clinicians, but quit advice and support are infrequent across groups.
  • Few clinicians are aware of treatment guidelines.
  • The structure of clinical practices raises barriers to improved cessation practices.
  • There are differences in assessment, treatment and perceived barriers by clinician ethnic group, tobacco use and practice setting.

THE PROBLEM

Most smokers would like to quit, but each year less than 5 percent of smokers are able to quit without assistance (Fiore et al., Respiratory Care, 45(10): 2000)

 

GRANT DETAILS & CONTACT INFORMATION

 

Project

Surveys of Health Professionals' Knowledge, Attitudes, Beliefs and Behaviors about Tobacco Cessation Counseling

Grantee

Mathematica Policy Research (Princeton,  NJ)

 

  • Amount: $ 724,777
    Dates: October 2002 to October 2004
    ID#:  043562

Contact

Richard C. Strouse
(215) 579-0757
richardstrouse@verizon.net  

 

The obvious solution to the "problem" of doctors not recommending Nicotine Replacement Therapy products that are 93 percent ineffective for their intended use as smoking cessation aids, and for which a reported 36 percent of current consumers are unwitting chronic, long-term users, is to threaten to smack physicians in the back of the head with a tort malpractice law suit if they don't wise up and get with the program. "Prescribe or pay" appears to be the order of the day. 

Dr. Fiore backs that threat up with not only his tobacco control credentials and grant influence but also his abusing tobacco consumers with his testimony at public hearings for smoking bans dating as far back as 1998, when his Chair in Nicotine Dependence was financed by Zyban distributor then-Glaxo Wellcome.  

 

Those who would like an answer as to why the World Health Organization (WHO) is among the leading purveyors of quackery whoo whoo clinical guidelines need look no further than the above information. WHO clinical guidelines may often be, as the Winnepeg Free Press reports, devoid of "evidence," but judging by tobacco control smoking cessation standards the evidence concerning how and why their guidelines get published in the first place is now abundantly clear. Simply put, the WHO guidelines for smoking cessation are a tawdry and self-serving product produced by an incestuous group think of Big Drugs corporate and Big Health private foundation insiders. Consumer insult is added to public health injury when the entire racket is financed by punitive cigarette taxes and public ban scorn is focused on the group think's "Target Group" of choice and physicians are threatened with law suits to prescribe ineffective, addicting products that keep the entire public policy Ponzi scheme rolling in the cash. 

 

The question left begging by the medical malpractice issue is what doctor in their right mind could possibly recommend and prescribe medications that the manufacturer's and distributor's own studies reveal to be only 7 percent effective and which impose and  risk of their patient becoming addicted to medication? 

 

Mr. Pang need not be concerned about the credibility of the World Health Organization. That evaporated into a cloud of special-interest foggy evidence the day WHO embraced tobacco control. Having squandered the credibility of WHO and irresponsibly consumed its resources in do-nothing public policy about the evil weed its controlling person now face a richly-deserved comeuppance in the court of world opinion and accountability. 

 

That comeuppance will only accelerate so long as WHO is associated with any person or any advocacy group that has anything whatsoever to do with tobacco control. When the organization shows the moxy, common sense and decency to throw anti-tobacco sycophants out of legitimate health policy we can revisit whether WHO has embarked on a course to genuinely restore its credibility. Children who are dying of malaria and malnutrition worldwide while GlaxoSmithKline, Johnson & Johnson and the Robert Wood Johnson Foundation pork it up through self-serving guidelines anxiously await WHO's response.  

 

Until then we simply take WHO and its guidelines at face value: the product of self-serving and ineffective incompetents who seek to garner through public deception and mandates what they lack the ability to earn through honest endeavor and on their own merit. 

 

Norman E. Kjono


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