Problems with new US Quitting Guidelines

Joel
Joel

May 8th, 2008, 10:01 am #1

We are starting a new thread in our Quitting Aids Category here to attach articles and commentaries about the new US Quit Smoking Guidelines released today. Here is the first article I have seen that just came through the AP:

Chantix recommended to quit smoking despite safety concerns May 7, 6:57 PM (ET)

By CARLA K. JOHNSON


CHICAGO (AP) - The federal government's new advice to doctors for helping smokers quit recommends the drug Chantix, which has recently been linked with depression and suicidal behavior. The new guidelines mention the psychiatric risks but also say the popular Pfizer Inc. (PFE) drug is the most effective at helping people get off cigarettes.

The guidelines mention other options, too, and highly recommend combining counseling and medication. But doctors are encouraged to talk to all smokers who want to quit about trying medication.

Consumer advocates cautioned that the safety picture on Chantix is incomplete because it's a relatively new drug, on the market just since 2006.

"It is somewhat better than other therapies; on the other hand, it appears to have more risk," said Dr. Sidney Wolfe of the watchdog group Public Citizen. "That part of the risk-benefit equation is missing, and it's changing rapidly."


Another issue with the quit-smoking guidelines, released this week by the U.S. Public Health Service, is the lead author's past connections with Pfizer. Dr. Michael Fiore, an expert on smoking and health issues, was a consultant to the maker of Chantix. But he said he cut those ties in 2005. Fiore's views are shaped by his past ties to the drug industry, and those ties still pose a conflict, at least one consumer advocate said. John Polito, a smoking cessation educator who runs the WhyQuit.com site advocating quitting "cold turkey," called the revised guidelines "a sales pitch" for the drug industry.

The task force overlooked research showing that quitting cold turkey works, Polito said, and studies showing Chantix is superior don't reflect how it's used "in the real world."

"People are quitting smoking to save their lives," Polito said. If Chantix's risks outweigh its benefits, "then it's insane for people to risk their lives" by using it, he said.

The guidelines are based on an extensive review of scientific evidence, were reviewed by 90 independent experts and were endorsed by 60 public health entities, Fiore said, adding that his past financial ties to the drug industry had no influence.

"Independent reviewers of it came to the conclusion that this is a document that reflects the science, and that's what we were charged to do," Fiore said.

The guideline authors analyzed 83 studies and found that Chantix helped 33 percent stay off tobacco for six months after quitting, compared with a nearly 14 percent abstinence rate for dummy pills.

The guidelines recommend combining counseling and medication as the most effective way to kick the tobacco habit, stating "both counseling and medication should be provided to patients trying to quit smoking."

Medications have not been shown to be effective in certain groups, the guidelines say. Those groups include pregnant women, smokeless tobacco users, light smokers and adolescents.

The guidelines say doctors should consider asking about their patients' psychiatric history before prescribing Chantix. Doctors also should monitor patients for changes in mood and behavior while on the drug.

Lois Biener, a researcher of tobacco use and control efforts at the University of Massachusetts in Boston, said most people who quit do so without smoking-cessation drugs.

There's little evidence that these drugs are superior in the long run to quitting without help, and while a few studies have shown some benefit, it's "way less than what is claimed" by medication advocates, Biener said.

Three of 24 panelists who wrote the guidelines reported "significant financial interests" in the pharmaceutical industry, including speaking fees and stock ownership.

---


Associated Press Medical Writer Lindsey Tanner contributed to this report.
Quote
Share

Joel
Joel

May 8th, 2008, 10:02 am #2

From the thread Who Should You Believe?

Not sure how much news coverage it will receive but the U.S. Public Health Service has released an updated clinical practice guideline which, to none of our surprise, pushes the use of pharmacological interventions to "help" people quit smoking. I thought it would be a good idea to pop up this string and attach the following articles to give a little background of the public health community's views on the topic of smoking cessation:
Pharmacological Aids to Smoking Cessation
Pharmacological Aids Part II
40 Years of Progress?
Quitting Methods: Who Should You Believe?
So How Did Most Successful Ex-Smokers Actually Quit?
Most expert say "Don't quit cold turkey"
Hooked on the Cure
Wall Street Journal article explores pharmaceutical industry "Nicotine Fix"
Related Videos:
Video Title
Dial-Up
HS/BB
Audio
MP3
Length
Added
Addiction - the Surgeon General says ... 4.42mb 13.2mb 1.77mb 5.49mb 12:00 10/09/06
How did the people you know quit smoking? 1.90mb 18.8mb 0.77mb 2.34mb 05:10 09/27/06
My first encounter with NRT 3.99mb 16.1mb 2.13mb 6.66mb 14:37 11/16/06
WhyQuit's candid views about Chantix (and Champix) 17.8mb 53.3mb 7.11mb 22.0mb 48:16 10/19/07
Quote
Share

Joel
Joel

May 8th, 2008, 10:06 am #3

John wrote an indepth response to the guidelines in a press release a couple of days ago at WhyQuit.com.

For some reason the list of related links that John attached to the press release at www.whyquit.com is not pasting correctly. Here is a link to John's original article where those links can be found: http://www.whyquit.com/pr/050508.html

Here is John's original commentaries without the related links:
Does updated tobacco treatment
"Guideline" reflect sham science?
by [url=mailto:john@whyquit.com]John R. Polito[/url], Editor WhyQuit[/size]
May 5, 2008[/size]
It appears that pharmaceutical influence continues to own official U.S. smoking cessation policy. According to an advance agenda, the newest U.S. policy pronouncement will be unveiled Wednesday, May 7, at 9 a.m. in room 3C at AMA headquarters located at 515 North State Street, Chicago. The revision panel's controversial chairman, Dr. Michael C. Fiore, whose significant financial ties to the pharmaceutical quit smoking product industry made front-page ethics news in the Wall Street Journal on February 7, 2007, is scheduled to summarize "findings and recommendations" from the 2008 update of the U.S. Guideline for Treating Tobacco Use and Dependence.

According to an advance summary, as in 2000, Dr. Fiore will reveal that it is the Guideline's recommendation that, with few exceptions, "clinicians should encourage" pharmaceutical quitting product "use by all patients attempting to quit smoking." While this cessation quitting method monopoly will generate billions in pharmaceutical industry profits, does it serve public health?

Sadly, what should and could have been a national resource and treasure in helping teach physicians what is not taught in most medical schools, how to effectively counsel patient's to quit smoking, is instead little more than a glorified pharmaceutical quitting product guide and sales advertisement.

Recommendation 5 of the April 1996 Guideline presented nicotine replacement as a co-equal option to counseling, skills development and support, which had served as the historic cornerstone of abrupt nicotine cessation quitting programs. But pharmaceutical interests grew aggressive. Recommendation 7 of the June 2000 Clinical Practice Guideline update, also chaired by Dr. Fiore, totally consumed all other recommendations. It declared that, "Numerous effective pharmacotherapies for smoking cessation now exist. Except in the presence of contraindications, these should be used with all patients attempting to quit smoking."

An advance copy of Wednesday's recommendations indicates that recommendations 3, 6 and 7 will combine to continue to effectively destroy the legitimacy and prevent government backing of any and all non-pharmacology quitting programs, programs relying upon education, counseling, skills development, motivation and/or support.

While the May 2008 Guideline strongly encourages "counseling" it refuses to allow it unless accompanied by "medication." This is not a question of scientific study evidence. It is a question of policy, policy gone astray. A stroke of capitalistic genesis, it is a campaign guaranteed to make the pharmaceutical industry billions by using official government policy to criticize, belittle, isolate, marginalize and destroy competition.

We've watched as pharmacology commercials have repeatedly suggested that quitting without it is nearly impossible, when in truth, the vast majority of successful quitters during 2008 will quit cold turkey. We've watched nicotine patch and gum commercials suggest that they make quitting "easy" when research by GlaxoSmithKline's own consultants indicates that 93% of OTC NRT study participants relapsed to smoking within 6 months.

Wednesday is a golden opportunity for health journalists to at last ask the tough questions. But will they? With roughly 40% of U.S. smokers making a serious quitting attempt during 2008, with the latest cure - Chantix - asking smokers to assume risk of death, with decline in the U.S. smoking rate having ground to a halt, those addicted to smoking nicotine deserve answers. But will they get them? Below are a few questions deserving of answers:
  1. Dr. Fiore, what quitting method will be responsible for generating the most quitters during 2008 and roughly how many quitters is it expected to generate?
  2. If the number of successful cold turkey quitters during 2008 will vastly exceed those of all other quitting methods combined, why outlaw, via official policy, programs designed to educate, counsel and support non-pharmacology quitters?
  3. If cold turkey quitting produces far more successful long-term quitters than all other quitting methods combined, then why, Dr. Fiore, have you assembled an "expert" panel void of any "expert" who today teaches, counsels and supports non-pharmacology quitting?
  4. Dr. Fiore, in that you repeatedly admitted that cold turkey is today the most productive quitting method, your beef must be that its effectiveness is low. If true, please point to the chapter in the U.S. Guideline where you share the knowledge and teach the skills needed to enhance cold turkey quitting rates. It's a little hard to do when you have zero experience in educating and supporting cold turkey quitters, isn't it?
  5. How many times does the Guideline mention quitting cold turkey? Is the reference positive or negative? Dr. Fiore, do you ever once share with physicians the fact that today, in 2008, the vast majority of successful quitters will quit smoking cold turkey? Why keep it secret?
  6. Dr. Fiore, did the panel consider real-world pharmaceutical product performance findings important? If so, why does the revised Guideline fail to inform physicians that a September 2002 JAMA study analyzing California quitting survey data found NRT ineffective? Why ignore the National Cancer Institute's 2006 survey that found quitting without NRT or Zyban more effective than quitting with them? What about the 2006 Australian survey which found cold turkey twice as effective as pharmacology among patients of family practice physicians? Dr. Fiore, do you really believe that the average smoker cannot be trusted to accurately remember their last quitting attempt, whether successful and the method used? If so, where is your proof?
  7. An April 16, 2008 study of four week quitting rates achieved by England's NHS (National Health Service) Stop Smoking Services, a program offering individual and group counseling and support, found that while 51% quitting without use of any quitting product were still smoke-free -- some 14,533 strong -- that only 48% of NRT quitters were still not smoking. If true, Dr. Fiore, why effectively outlaw counseling unless accompanied by pharmacology use when the newest real-world evidence on earth suggests that counseling alone is more effective than counseling accompanied by NRT?
  8. Dr. Fiore, I expect you to assert that the reason for allowing counseling, but only when used in conjunction with pharmacology, is that you have located clinical studies showing counseling more effective when used with pharmacology. The 2007 Guideline draft I reviewed and submitted 25 pages of comments to you regarding, comments I hope were shared with other panel members, suggested that someone had cherry-picked a few extremely weak counseling studies in an obvious attempt to justify outlawing counseling as a stand-alone quitting method. Why? Is it a proper function of government to be intellectually dishonest with smokers, to use policy to limit choices and destroy competition?
  9. What is your opinion of forums like WhyQuit? Since mid-2000 WhyQuit has been the Internet's leading non-pharmacology quitting forum, in motivating, educating and supporting cold turkey nicotine cessation. Do you understand that by writing U.S. cessation policy so as to require pharmaceutical quitting product "use by all patients attempting to quit smoking," that you not only instantly damage the credibility of such programs but create license to bash and trash America's most productive quitting method, and the confidence of those engaged in it?
  10. Is it your intent, Dr. Fiore, to deprive cold turkey quitters of knowledge of the existence of non-pharmacology programs that you know would enhance their odds of success? Do you know that WhyQuit is the Internet's #2 quitting forum but due to your June 2000 mandatory pharmacology use recommendation that between 2000 and 2008 no federal or state Internet health site provided any link to any cold turkey quitting program, including WhyQuit? Are you proud of that?
  11. A June 2004 blinding review by Mooney found that NRT studies were generally not blind as claimed. In that the Guideline relies almost exclusively upon clinical trial evidence flowing from placebo controlled studies, is it possible that the entire Guideline is grounded in sham science, that it may be impossible to blind nicotine addicts having any significant quitting history, as to arrival and onset of full-blown withdrawal?
  12. Does the 2008 Guideline alert physicians as to the 2004 Mooney study and the fact that cessation pharmacology studies were generally not blind as claimed? If not, why?
  13. In Pfizer's recent Chantix studies, nearly 80% randomly assigned to receive placebo were smoking at two weeks, which is comparable to what was often seen in NRT trials. Is it possible, Dr. Fiore, that thousands randomly assigned to clinical study placebo groups dropped out in the first couple of weeks due to withdrawal recognition and frustration, not due to an inability to quit?
  14. Dr. Fiore, can you name any other pharmaceutical product study area where those randomly assigned to the placebo group are actually punished and made vastly worse than when they arrived by being thrown into full-blown chemical withdrawal? Is it really so hard to see that using placebo blinding in quit smoking studies has been a license to steal?
  15. The 2004 Mooney blinding study warned researchers that the validity of "clinical trial results could be questioned" if future studies fail to make proper blinding assessments. Dr. Fiore, do you agree that the integrity of cessation clinical trials should be questioned when researchers fail to assess whether or not the trial was blind? If so, when should researchers conduct blinding assessments, within two weeks, while memories as to assignment beliefs are still fresh and accurate, and by which time the vast majority assigned to the placebo group have relapsed, or at 6 months, or a year, as some researchers are now doing. Even then, some are only asking surviving study participants and not going back and assessing beliefs of those who relapsed early.
  16. Dr. Fiore, have you ever published any paper critical of NRT, Zyban or Chantix? Hypothetically, if you were to admit that an expanding body of survey evidence suggests that pharmacology quitting products provide no benefit over quitting without them, or, in light of the FDA recently linking Chantix to suicide, suggest that smokers would be wise to delay use of Chantix until its safety is better understood, would you expect GlaxoSmithKline and Pfizer to continue funding your research? They'd cut you off in a heart beat, wouldn't they? You've built your entire reputation on cessation pharmacology. Would you ever dare bite the hand that feeds you?
  17. Dr. Fiore, is it fair, accurate and honest for those advocating quitting pharmacology use to equate clinical trial placebo group quitters to real-world cold turkey quitters, quitters who quit cold turkey because they wanted to, not because they were forced and compelled to do so, quitters who expected to endure full-blown withdrawal, not quitters who sought medication to diminish it?
  18. The practical effect of mandating pharmacology use is to make any non-pharmacology quitting recommendation a violation of U.S. cessation policy. It means that all government health agencies, both state and federal, will be expected to continue to ignore and blacklist pharmacology's only real competition, non-pharmacology quitting. Dr. Fiore, whose interests are served by such a policy?
  19. A February 8, 2007 front-page Wall Street Journal (WSJ) article exposed your pharmaceutical industry financial ties and questioned the appropriateness of you objectively heading a panel charged with writing U.S. cessation policy. Dr. Fiore, why would you knowingly invite bias criticism of our nation's cessation policy?
  20. The WSJ article shed light on the fact that you were chairman of the June 2000 Guideline panel while sitting in a university chair from which you annually receive a grant from GlaxoSmithKline (which markets NRT products), that you direct a research center that has received millions from the pharmaceutical industry to study its quit smoking products, and that until 2005 you worked as a paid pharmaceutical industry quitting product consultant. What makes you feel it is ethical for someone with such clear and strong industry financial ties to chair a panel determining national cessation policy?
  21. Dr. Fiore, the "Panel Agreement and Financial Disclosure" form you filed with the U.S. DHHS, signed by you on September 5, 2006, and obtained under the Freedom of Information Act, advised at the top that it "applies to the past 5 years." The disclosure request states, "I certify that all my affilations with or financial involvement (e.g. employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organization or entity with a financial interest in or financial conflict with guideline matter or materials are dislosed completely here:" You chose to attach a typed document which you entitled "Statement of Disclosure," also bearing your signature which asserts, "In keeping with recent JAMA recommendations, Dr. Fiore does not accept honorarium nor do consulting work for the pharmaceutical industry. In 1998, the University of Wisconsin (UW) appointed Dr. Fiore to a named Chair, made possible by an unrestricted gift to UW from GlaxoWellcome." Dr. Fiore, in the February 7, 2007 WSJ article you claim to have stopped accepting pharmacutical industry quit smoking product consulting fees and honorariums in 2005. In testimony on May 9, 2005 in U.S. v. Philip Morris you did not then mention that you had stopped accepting consulting fees, but instead testified on PDF page 14 that, "Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year." Dr. Fiore, the obvious question becomes, if quitting product companies where paying you in 2005, which is clearly within 5 years of 2006, then why did you refuse to "disclose completely" details when requested to do so by the U.S. Department of Health? Given the above, in your opinion, would it be fair and accurate to assert that you fudged and falsified your Guideline panel financial disclosure statement, a federal form submitted to the United States government?
  22. Dr. Fiore, would you consent to bringing transparency and sunshine to the Guideline update process by voluntarily releasing to the media copies of all e-mails and letters in any way associated with the the updating process, including but not limited to all communications with those having pharmaceutical interests, or in any way discussing disclosure or ethical concerns?
  23. On May 11, 2006 the FDA announced approval of Pfizer's Chantix for smoking cessation. Dr. Fiore, your university website indicates that update of the June 2000 Guideline commenced on July 1, 2006. Did Pfizer representatives communicate with you at any time prior to July 1, 2006 about updating the June 2000 Guideline so as to include Chantix? Were pharmaceutical financial interests a primary motivation for the July 1 decision to update the Guideline?
Dr. Fiore, in that you hold yourself out as one of our nation's leading smoking cessation "experts," oh how I wish you'd accept a challenge to demonstrate via cessation competition that your advocacy, findings and Guideline pharmacology recommendations are not a scientific sham upon smokers. I offer a 6 month head-to-head competition against "real" cold turkey quitters, not frustrated quitters assigned to placebo. We could randomize 200 smokers to your choice of pharmacology or to a 12-hour cold turkey education program spanning two weeks.

In recruiting participants, I would ask that you not bias participant expectations in advance by telling them that the study involved "medication," as was recently observed on your website. Also, informed consent should be conducted after randomization. All participants would undergo cotinine testing at six months to establish cessation, and any nicotine use would constitute relapse. If your Guideline is true, how could you possibly fail?

When the 2000 Guideline was released you promised that pharmacology would "double, triple, or quadruple" success rates. It hasn't happened and you know it. You've boasted for years that what you do is unbeatable. All I'm asking is that you show us. If false, and pharmacology fails to prevail over educated cold turkey quitting, which will in fact occur, then I would hope your integrity would motivate you to fully cooperate in advocating immediate revision of the Guideline so as to permit counseling and support to occur without purchase of pharmacology products.

Dr. Fiore, it's child's play to design studies that take advantage of the average drug addict's enslavement awareness. The challenge is in successfully arresting and quieting awareness.
XXX
Last updated Tuesday, May 7, 2008 at 10:18 EST
No Copyright - This Article is Public Domain
John R. Polito is solely responsible for the content of this article.
Any factual error will be immediately corrected upon receipt of credible authority
in support of the writer's contention. E-mail comments to [url=mailto:john@whyquit.com]john@whyquit.com[/url]
Quote
Share

Ilona
Ilona

May 8th, 2008, 8:17 pm #4

Thank you for this update and the excellent list of questions. Perhaps us members could get together a petition attesting to the efficacy of cold turkey?
I have a friend who is a smoker and has AIDS and who has been prescribed Chantix. He is already depressed due to the recent progression of his disease and I worry about the side-effects of taking this drug, especially suicide...
Also, I just heard this morning on the radio that the Canadian Government (I am Canadian) is losing millions of dollars in tax revenu due to reduced sales of cigarettes (I say legal because contraband sale of cigarettes is thriving here, although large numbers are quitting).
It disgusts me that government officials continue to promote prescription drugs to line their own pockets, but it disgusts me even more that the government continues to promote the legal sale of the most lethal drug on the planet: nicotine.

Ilona
Quote
Share

John (Gold)
John (Gold)

May 8th, 2008, 9:27 pm #5

Thanks Joel. Two quick points brought up by Ilona's post. As the following article discusses, please be extremely careful around Chantix/Champix users. We discourage members from interfering in the doctor-patient relationship. If any friend is using varenicline and exhibiting disturbing symptoms encourage them to promptly seek medical attention.
Second, we understand better than most that it's extremely easy to grow frustrated by what we'll share here regarding core policy documents designed to educate physicians and health care providers as to how best to assist smoking patients in quitting. But you folks are probably some of the most educated ex-smokers on earth. We know you're reaching out to those around when their cessation efforts are not under the care and control of health care providers. As such, you need to understand what you're hearing and seeing. We do so to enhance understanding, not to divert the group from its core mission of helping each other remain nicotine-free today. The best petition possible is the big window this forum shares with the world, the one showing how sticking to a personal commitment to not put any nicotine into your bloodstream today spells freedom and healing!
Breathe deep, hug hard, live long,
John (Gold x8)


Quote
Share

John (Gold)
John (Gold)

May 9th, 2008, 4:58 pm #6

NIH Expert Panel Recommends Smoking Cessation Pharmaceuticals for Every Smoking Patient; Panel Chair and 8 Members Have Financial Ties to Big Pharma
by Michael Siegel, M.D.
An NIH expert panel this week released a 2008 update of the clinical practice guideline regarding the treatment of tobacco use and dependence (see: Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. May 2008).

The guideline recommends that every patient who wishes to quit be treated with pharmaceuticals, unless medically contraindicated. The guideline also recommends the use of Chantix, despite concerns about its potential suicide risk, a risk that is currently being investigated by the FDA. Among the pharmaceuticals recommended by the panel are:
  • buproprion;
  • nicotine gum;
  • nicotine patch;
  • nicotine nasal spray;
  • nicotine lozenge;
  • nicotine inhaler;
  • Chantix; and
  • combinations of the above.

The Rest of the Story

Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.

These 9 panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.

Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:

Michael C. Fiore: "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."

Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."

Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."

Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."

C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."

Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."

Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."

GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.

What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.

This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.

Ironically, it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable.

While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.

The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.

As my colleague Dr. Lois Biener of the University of Massachusetts Boston argued in an Associated Press article about the guideline, there is little if any "real-world evidence" that when used outside the context of clinical trials, drugs produce any long-term enhancement of smoking cessation, and certainly not the magnitude of benefit as suggested by those who are touting the importance of these drugs.

According to the article: "Lois Biener, a researcher of tobacco use and control efforts at the University of Massachusetts in Boston, said most people who quit do so without smoking-cessation drugs. There's little evidence that these drugs are superior in the long run to quitting without help, and while a few studies have shown some benefit, it's 'way less than what is claimed' by medication advocates, Biener said."

One national expert on smoking cessation who was not on the panel - John Polito - suggested in the article that the guideline is basically a "sales pitch" for the pharmaceutical industry, that the benefits of pharmaceuticals are overstated, that the value of quitting cold turkey is not considered, and that the recommendation to promote Chantix use is misguided and could cause harm.

According to the article: "Fiore's views are shaped by his past ties to the drug industry, and those ties still pose a conflict, at least one consumer advocate said. John Polito, a smoking cessation educator who runs the WhyQuit.com site advocating quitting 'cold turkey,' called the revised guidelines 'a sales pitch' for the drug industry. The task force overlooked research showing that quitting cold turkey works, Polito said, and studies showing Chantix is superior don't reflect how it's used 'in the real world.' 'People are quitting smoking to save their lives,' Polito said. If Chantix's risks outweigh its benefits, 'then it's insane for people to risk their lives' by using it, he said."

Polito has really stated it better than I could and he is right on the mark. The guideline is basically a sales pitch for the pharmaceutical industry, and it demonstrates what corporations can buy through their payments to scientific experts.


What's most disturbing to me is that while the medical field continues to move to decrease the influence of pharmaceutical companies on physicians by restricting financial benefits for doctors, the tobacco control field seems to be increasingly plagued by this pharmaceutical influence. The problem is being ameliorated in medicine, but in tobacco control, it continues to get worse.


The ultimate irony of all of this is that we in tobacco control have been so vehement in decrying the tobacco industry's influence on science. We have attacked and berated scientists for having financial ties to tobacco companies. We have discredited scientific conclusions based solely on the financial connections of the authors to Big Tobacco. But now, our national policies are being set by individuals who have equally strong connections to Big Pharma.


It may come as a surprise to many in tobacco control, but this type of science is just as bad. Bad science is bad science. Conflicts of interest are conflicts of interest. Believe me, the science doesn't get any stronger just because it is a less detestable industry. As a field which has literally helped to ruin the careers of scientists with tobacco industry connections, we should be beyond reproach in not allowing similar conflicts of interest to degrade and poison our science.
Source link
Quote
Share

Ilona
Ilona

May 10th, 2008, 1:49 am #7

Quote
Share

John (Gold)
John (Gold)

May 14th, 2008, 9:45 pm #8

U.S. quit smoking policy integrity
drowns in pharmaceutical influence
Federal disclosure regulations designed to expose financial conflicts and protect the integrity and objectivity of taxpayer funded research were ignored by the Agency for Healthcare Research and Quality (AHRQ) when assembling panels to write U.S. smoking cessation policy in August 1998 and July 2006. Their discovery and application in 2007 revealed widespread financial conflicts which resulted in a damage control nightmare. The integrity of mandatory pharmacology use recommendations in both the June 2000 and May 2008 Clinical Practice Guideline for Treating Tobacco Use and Dependence are in question.
by [url=mailto:john@whyquit.com]John R. Polito[/url], Editor WhyQuit[/size]
May 13, 2008[/size]
On May 7, 2008 the U.S. government adopted an updated national tobacco dependency treatment policy, a policy that has sellers of FDA approved quit smoking products (Pfizer, GlaxoSmithKline and Johnson & Johnson) celebrating, while leaving those dedicated to non-pharmacology quitting shaking their heads in disbelief.

Written by a 24-member private sector panel of "experts" whose extensive pharmaceutical industry financial ties have the new policy mired in controversy, the 276 page updated "Guideline" again proclaims, that with few exceptions, all smokers trying to quit should be directed to go out and purchase pharmaceutical quitting products.

What should have been a rich and empowering tool to teach physicians critical lessons largely ignored by medical school educators - how to effectively counsel and support patient nicotine dependency recovery - the Guideline is instead little more than a pharmaceutical industry quitting product shopping guide.

While the May 2008 Guideline discloses a number of panel member pharmaceutical industry financial ties, the federal agency responsible for Guideline production and conflicts investigation, the AHRQ, substantially reduced the initial conflicts disclosure period, allowed panel members identified as having "significant financial interests" to remain on the panel, and in regard to the panel chairman, ignored substance in favor of form.

The disclosures fail to provide readers awareness of funds provided to panel members or their organizations by the Robert Wood Johnson Foundation (RWJF), an organization with strong ties to Johnson & Johnson, the company which likely holds the largest share of the U.S. nicotine replacement therapy (NRT) products market. But why care?

The Guideline panel summarily dismisses, as having "methodological constraints," a growing body of real-world evidence indicating that non-pharmacology quitting is equal or superior. We should care because this national quitting method monopoly keeps quality non-pharmacology counseling and support oriented programs suppressed, hidden and forbidden as government referral resources. We should care because the panel gave Chantix an equal recommendation with NRT and Zyban when the FDA has linked Chantix to depressed mood, behavioral changes, suicidal thinking and suicide.

The June 2000 Guideline panel was the first to declare pharmacology use mandatory. It was authored by a panel on which 11 of 18 members openly acknowledged pharmaceutical industry financial ties. All eleven sought to join this panel, and last Wednesday all but one were identified as having again served as panel members.

Although survivors of eight years of government blacklisting for non-compliance, non-pharmacology quitting programs were provided a ray of hope by a February 8, 2007 front-page Wall Street Journal article by Pulitzer Prize winning journalist Kevin Helliker. Helliker questioned the policy and exposed financial conflicts.

The article should have caused the AHRQ to take swift action in fully investigating and removing all panel members having significant financial interests. It didn't. After reading it, one would think it would have caused panel members suffering from the "Dr. Drug Rep" syndrome to awaken and act responsibly. It didn't. Instead, those having significant financial and conflicts of interests, as defined by federal law, decided to stay.

In November 2007, the U.S. Centers for Disease Control announced that decline in the U.S. smoking rate had ground to a standstill. It seemed unthinkable that government health officials would continue to ignore the fact that since the June 2000 Guideline had effectively declared our nation's most productive quitting method in violation of U.S. quitting policy - non-pharmacology cold turkey quitting - that national cessation has floundered horribly.

The financial ethics nightmare infecting AHRQ Guidelines is of national concern. Smoking is our nation's leading cause of disease and pre-mature death. Through Medicare, Medicaid and higher hospital costs due to treating uninsured smoker diseases, we are each stakeholders. We've watched as the pharmaceutical empire has increasingly convinced health bureaucrats to use precious tax dollars to pay for free nicotine replacement products, products that when used as stand-alone quitting aids generate dismal 7% six-month quitting rates.
Health professors question May 2008 Guideline update
"Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States," wrote Dr. Michael Siegel, a physician and professor at the Boston University School of Public Health, the day following the Guideline's release, "the guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members."

According to May 2008 Guideline Appendix A "Financial Disclosures" (starting on PDF page 223), 3 of 28 panel members had financial interest conflicts so serious that they were excused from the panel after substantial service, possibly more than a year. One additional member voluntarily resigned. Three others were determined to have significant financial interests of at least $10,000 but for unstated reasons were allowed to remain. Six others were found to have financial interests that were not significant (less than $10,000).

What the May 2008 Guideline disclosures fail to indicate is that at least 2 panel members dismissed for serious conflicts were allowed to author the June 2000 Guideline, the Guideline panel which first took the drastic step of making pharmacology use recommendations mandatory throughout government. This effectively destroyed program credibility of thousands of neighborhood based quitting programs grounded in counseling and ongoing support.

"What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines," wrote Dr. Siegel. "The more use of pharmaceuticals they recommend, the more they stand to gain."

"This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped," Siegel wrote.

"Ironically," says Dr. Siegel, "it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable."

"While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel."

As Dr. Siegel notes, "The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids."

A May 8 Associated Press story quotes Dr. Lois Biener, a researcher at the University of Massachusetts Boston, as agreeing with Dr. Siegel. "There's little evidence that these drugs are superior in the long run to quitting without help, and while a few studies have shown some benefit, it's 'way less than what is claimed' by medication advocates."

"Most people who quit do so without smoking-cessation drugs, said Dr. Biener."

Regarding Chantix, equally disturbing is why 24 panel members, who within the Guideline refer to themselves eight times as "experts," would within those 276 pages have absolutely no risk-benefit discussion about recommending Chantix, which has quickly and clearly become the most dangerous quitting product ever.

Imagine "experts" writing a "guideline" that fails to guide health care providers in helping patients decide whether risking their life by using a new quitting product is worth it. Imagine a Guideline that recommends use of Chantix (varenicline) on PDF pages 5, 7, 25, 60 and 62 but waits until page 63 to first mention its association with suicide.

If Dr. Siegel and Dr. Biener are upset now, their concerns will likely grow once they more closely scrutinize pharmaceutical influence at play among panel members.
Quote
Share

John (Gold)
John (Gold)

May 14th, 2008, 9:53 pm #9

Page 2 - U.S. quit smoking policy integrity drowns in pharmaceutical influence

Freedom of Information Act used to obtain panel information
The day after Helliker's February 8, 2007 story, I e-mailed Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality (AHRQ) and pursuant to the Freedom of Information Act (FOIA) requested "the names of all panel members, their bios and their smoking cessation product conflicts disclosures, including how much they have accepted, when, the reason/s for payment, and from which pharmaceutical interests, or point me to Internet links disclosing this extremely critical public information."

On March 21, 2007, I was sent 825 pages of panel member resumes, what academics refer to as "curriculum vitaes" or CVs. Included were CVs of two panel members who, on some unknown date after March 21, 2007, no longer served on the panel.

On September 5, 2007, I was sent 24 signed "Panel Agreement and Financial Disclosure" forms. Nineteen were signed during July 2006, three were signed or dated in August, and the last two, those of 1996, 2000 and 2008 Guideline panel Chairman Michael Fiore and Michael Goldstein, bore the same date, 9/5/06. Each disclosure form requested "complete" disclosure of all potential financial conflicts for the "past 5 years." I could make out the signatures of all panel members except three, and each of those denied any financial interest.

The May 2008 Guideline discusses the financial disclosure process at PDF page 223. It asserts that, "Prior to the second in-person Panel meeting in June 2007, and before any decisions regarding Panel recommendations were made, Panel members were required to complete a more exhaustive disclosure process for calendar years 2005, 2006, and 2007, based on the United States Department of Health and Human Services, PHS Title 42, Chapter 1, Part 50 guidelines for the conduct of research (ori.hhs.gov/policies/fedreg42cfr50.shtml)."

The above federal regulation is not simply some "guideline" but the "law of the land" and mandatory. Section 42 CFR 50.604(g)(2) required the reporting of any conflicting interest prior to expenditure of any funds, not a full year into the panel's work.

The above Guideline statement has been modified from the one appearing in the October 2007 draft which asked readers to believe that this had been a planned process. The draft asserts, "This evaluation process entailed a rigorous and transparent two-step procedure for disclosing and handling conflict of interest on the part of panel members."

How transparent is a process when those submitting FOIA disclosure requests are not sent the more "exhaustive" disclosures? I was sent 2006 disclosures in September 2007.

Fiore's website time-line asserts that the decision to update the Guideline occurred on July 1, 2006 (50 days after the FDA announced Chantix approval), which explains why nearly all the financial disclosures I received were signed in July 2006, eleven by July 8. But how is it "more exhaustive" to narrow the pre-Panel examination window from the five year disclosures I was provided, to just 18 months prior to selecting panel members?
Did AHRQ use science integrity regulations to prevent transparency?
Did AHRQ administrators intentionally narrowed both the conflicts time window and its scope so as to avoid labeling the Panel's chairman, Fiore, as having a "significant financial interest"? Guideline page 223 asserts that a financial conflict is deemed significant if "net reportable compensation in excess of $10,000 in any reporting year."

In May 2005, Fiore testified (see PDF page 14) that, "[o]ver the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

No language in federal disclosure law told AHRQ officials to limit investigation for significant financial interests to 18 months instead of 3 or 5 years.

42 CFR 50.601 tells the AHRQ that these regulations are intended as a flexible common sense tool to promote "objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator."

What are "we the people" to think when our own government, the Agency for Healthcare Research and Quality, the federal gatekeeper agency charged with guarding research integrity, appears to have used financial conflicts laws as shields to knowingly hide serious investigator financial conflicts from public view?

Fiore also testified in May 2005 as to receiving an annual $50,000 per year unrestricted chair endowment grant from funds given to the University of Wisconsin by GlaxoSmithKline (then Glaxo Wellcome). "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence," Fiore testified. "That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."

Resolution 7594 in the minutes of the December 5, 1997 meeting of the University of Wisconsin Board of Regents (see PDF page 15) appears to support Fiore's contention that the University not Glaxo Wellcome made the decision to honor Fiore with this professorship chair. "That, upon recommendation of the Chancellor of the University of Wisconsin-Madison and the President of the University of Wisconsin System, Professor Michael C. Fiore, Department of Medicine, be appointed to the Glaxo Wellcome Professorship for Study of Tobacco Dependence, effective immediately."

On May 10, 2008 I e-mailed the University of Wisconsin Foundation asking "whether Glaxo Wellcome or the University of Wisconsin selected Dr. Fiore as the original endowment chair recipient." The Foundation's Vice-President of Legal Affairs responded on May 12 indicating, "I can tell you that the agreement mentions no individual by name. It is intended to support the University's Center for Tobacco Research and Intervention and supports the Director of that Center."

During a follow-up call, it was made clear that Glaxo Wellcome directed that the funds be used to support the Director of the Center for Tobacco Research and Intervention, who was then Dr. Michael Fiore.

If no exemption applies, Glaxo Wellcome's $50,000 per year gift to Fiore is five times greater than necessary to declare a "significant financial interest" under 42 CFR 50.603.

Can federal regulations intended to protect scientific integrity from financial influence be bypassed by use of university professorship chair endowments? If so, what government produced science relying upon professors effectively placed on the industry's permanent payroll will be worthy of belief?

Fiore's May 2005 testimony also suggested that the University of Wisconsin Center for Tobacco Research and Intervention (UW CTRI) receives in the neighborhood of $1 million per year to conduct research for pharmaceutical companies. In that the May 2008 Guideline declares AHRQ to have developed the Guideline in "partnership" with both the UW CTRI and Robert Wood Johnson Foundation (RWJF), and federal disclosure regulations require disclosure by public or private "Institutions" as well as "Investigators," where are the UW CTRI's and RWJF's conflicts disclosure?

After Helliker's story, did AHRQ look back to see if the integrity of the 1996 and 2000 Guidelines were compromised by significant conflicts of interest? On December 12, 1996 Fiore declared at an FDA advisory committee meeting that I "am speaking today as a consultant to Glaxo Wellcome." He states, "I served ... as Chair for the Clinical Practice Guideline on Smoking Cessation," released in April 1996.

Fiore research funded by Glaxo Wellcome was published in March 2000, the same period during which he chaired the June 2000 Guideline. A 2002 study financial disclosure asserts, "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."
Why were Robert Wood Johnson Foundation relationships ignored?
The Robert Woods Johnson Foundation's (RWJF) hands are all over the U.S. Guidelines. Its hands are also all over Guideline panel members. Not only did RWJF partner in funding both the June 2000 and May 2008 Guidelines, it approved and awarded Guideline panel members research project funding while in service as panel members.

Robert Wood Johnson II built the original 1886 three brother family business of Johnson & Johnson (J&J) into the world's largest health products company. Today the Johnson & Johnson "Family of Companies," subsidiaries with interlocking management, number 250. They include the ALZA Corporation which created the NicoDerm® CQ® and Clear NicoDerm® CQ® nicotine patches, McNeil Consumer Healthcare which manufactures the Nicotrol nicotine patch (that on July 3, 1996 became the first FDA approved patch approved for over-the-counter sales), licenses sales of Nicoderm nicotine patches and Nicorette® nicotine gum, and markets the Nicotrol inhaler, and McNeil Pharmaceuticals which the FDA authorized to market Nicotrol nasal spray on July 3, 1996.

When Robert Wood Johnson II died in 1968 his will devised his 10,204,377 shares of Johnson & Johnson common stock to establishment of a foundation, the foundation that today bears his name, The Robert Wood Johnson Foundation (RWJF). As of 2006, RWJF owned 55,983,308 shares of J&J common stock valued at $33.4 billion dollars.
(Click link to see RWJF Financial Statement of J&J stock ownership)
In June 2006, J&J announced it was buying Pfizer's Consumer Healthcare business for $16.6 billion dollars. The purchase was concluded on December 20, 2006 with J&J announcing that with "the acquisition, the Johnson & Johnson Consumer Group portfolio will now feature products such as ... the NICORETTE line of smoking cessation treatments."

Since its creation, the RWJF Board of Trustees charged with governing the foundation has included many J&J executives and one namesake. Today RWJF's website reports that Trustee Robert E. Campbell is a retired vice chairman of the board of directors of J&J, Trustee Edward J. Hartnett is a retired company group chairman of Johnson & Johnson, grandson and heir Robert Wood Johnson IV is a Trustee, Trustee George S. Frazza "previously served Johnson & Johnson for more than 30 years in the roles of corporate secretary, vice president and general counsel, and was a member of the executive committee," and Trustee Ralph S. Larsen is a former chairman of the board and CEO of Johnson & Johnson.

According to RWJF, it contributed $102,016 to the University of Wisconsin School of Medicine with Michael Fiore as overseer, toward creation of the June 2000 Guideline. "On September 14-15, 1999, panel members met in Madison, Wis., where they evaluated their findings and prepared a draft of the new Guideline," asserts the RWJF. "The final version was sent to RWJF, and submitted to the USPHS for approval."

On December 20, 2007, the RWJF disclosed it had awarded the University of Wisconsin School of Medicine and Public Health $100,000 for "updating, testing and disseminating the 2008 tobacco treatment guideline," with Fiore listed as one of two project directors

. The RWJF's primary asset is J&J stock. Its primary income is by earnings from, and sales of, J&J common stock. RWJF's financial well being is tied directly to J&J's stock values. Would the RWJF foundation dare make decisions harmful to its own economic interests? Has the RWJF ever once reached out to the 80-90% of smokers annually voting to attempt quitting without medications, and attempted to help save their lives by creating access to high quality non-pharmacology counseling and support programs that it knows would dramatically increase their odds of success?

Is it realistic to expect the RWJF to ever fund research that might tend to prove that Johnson & Johnson quit smoking product efficacy findings are grounded in sham clinical trials that were never blind as claimed? Does the RWJF Board of Trustees truly believe that researchers discovered some magic means to hide from nicotine addicts volunteering to participate in "medicine" clinical trials, the fact that they had instead been randomly assigned to receive a placebo device, and were, contrary to their expectations, now experiencing the onset of full-blown nicotine withdrawal? Is RWJF's focus on the integrity and quality of medical science or, in this case, its use to bolster sales and stock values?

If current federal financial disclosure regulations exempt nearly "anything of monetary value" flowing to an "Investigator" from non-profit entities ( 42 CFR 50.601), should they? Should a paid employee of the RWJF have been allowed to sit on a panel authoring U.S. cessation policy? Would all pharmaceutical companies be wise to establish their own foundation, allowing them not only to shield and hide researcher financial ties but to participate in writing government policy favorable to their founding corporation's economic interests?
Quote
Share

John (Gold)
John (Gold)

May 14th, 2008, 9:56 pm #10

Page 3 - U.S. quit smoking policy integrity drowns in pharmaceutical influence

Panel member financial disclosures and relationships
NOTE: In determining existence of a "significant financial interest" as they relate to panel member RWJF relationships listed below, current federal disclosure regulations exempt "all income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities," and "income from service on advisory committees or review panels for public or nonprofit entities."
The below panel members either made a financial disclosure that appeared within the June 2000 Guideline, May 2008 Guideline, made an industry link disclosure elsewhere or had some prior relationship with the Robert Wood Johnson Foundation. The CVs of three panel members, although expert in other fields, evidenced little or no experience in the field of smoking cessation.
  1. Bailey's May 2008 Guideline Disclosure: "William C. Bailey reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements." Bailey's five year Financial Disclosure dated 7/6/06 states in part, "I, William C. Bailey, have received research contracts from drug companies as sponsors of investigational drug research projects; I receive honoraria from pharmaceutical companies for delivering lectures as part of Continuing Medical Education programs for physicians with appropriate disclosure; ... Some of the pharmaceutical companies are: GlaxoSmithKline ... Pfizer ... "

    Bailey's June 2000 Guideline Panel Member Financial Disclosure states, "William C. Bailey has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Labratories, NcNeil, Elan Pharmaceuticals, and Glaxo Wellcome.
  2. Baker's May 2008 Guideline Disclosure: "Timothy B. Baker reported no significant financial interests. Under additional disclosures, he reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies." Baker's July 3, 2006 five year Financial Disclosure in part asserts that three of those companies were "Pfizer, Nabi and Glaxo Wellcome"

    Baker's CV indicates that he holds the position of "Director of Research, UW Medical School - Center for Tobacco Research and Intervention (UW-CTRI)." [note: UW-CTRI was founded in 1992 by Michael Fiore, where today Fiore serves as Director and Baker serves as Associated Director]
  3. Benowitz's May 2008 Guideline Disclosure: "Neal L. Benowitz reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company. Under additional disclosures, he reported providing expert testimony in lawsuits against tobacco companies." Benowitz's five year "Financial Disclosure dated 8/24/06 in part asserts, "Pfizer - scientific advisory board, GlaxoSmithKline - occasional board consultant, Nabi - occasional paid consultant .... Stock ownership Pfizer, Alexza ..."

    Benowitz's CV indicates service from "2003-now Robert Wood Johnson Foundation, Smoking Cessation Leadership Center."
  4. Curry's May 2008 Guideline Disclosure: "Susan J. Curry reported no significant financial interests and no additional disclosures." Curry's 7/12/06 five year Financial Disclosure states, "Paid honoraria for scientific consultation by Pfizer, Inc, Sanofi-Aventis

    Curry's CV indicates that from 2/04 to Present she has served on the Board of Directors for the American Legacy Foundation (ALF) [Note, fellow 2008 Guideline panel member Cheryl Healton serves as ALF President and CEO. Also of interest is that Dr. Steven A. Schroeder served as CEO and President of the Robert Wood Johnson Foundation from 1990-2002. An ALF board member since 2000, in Feb. 2003 Dr. Schroeder was named Chairman of the ALF Board of Directors, a position he held until November 2005. On January 3, 2007, during the Guideline update process, RWJF awarded ALF a grant of $720,000 to "help American adults stop smoking" using "evidence based resources."

    RWJF awarded a grant of $2,996,867 on 01/25/05 and apparently another of $1,240,783 on 04/23/07 under which Curry is project director.

    RWJF also lists Curry & Fiore as Program Directors and Orleans (as RWJF staff) in running its "Addressing Tobacco in Healthcare" website.
  5. Dorfman's May 2008 Guideline Disclosure: "Sally Faith Dorfman reported no significant financial interests. Under additional disclosures, she reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence." Dorfman's 7/10/06 five year Financial Disclosure declares "I have no relevant financial interest in the guideline panel or resulting guideline."

    Dorfman's Appendix C June 2000 Guideline Panel Member Financial Disclosure states, "Sally Faith Dorfman has served as a consultant for, given lectures sponsored by, or conducted research sponsored by various pharmaceutical companies."

    Dorfman's CV indicates that her current position is as "Associate Director, Medical Affairs (Infertility), Ferring Pharmaceuticals, Suffern, New York" since 2006. She served on the Robert Wood Johnson Foundation National Advisory Committee, Smoke-Free Families from 1995-1999.
  6. Fiore's May 2008 Guideline Disclosure: "Michael C. Fiore reported no significant financial interests. Under additional disclosures, he reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome." Fiore's Panel Agreement and Financial Disclosure dated 09/05/06 advises him that it "applies to the past 5 years" and that he disclose completely all affiliations with or financial involvement, including employment, consultancies, honoraria, stock ownership or options or grants with any entity having a financial interest in or financial conflict with guideline matter or materials. Fiore chose to attach a typed, signed document he entitled "Statement of Disclosure" in which he asserts, "In keeping with recent JAMA recommendations, Dr. Fiore does not accept honorarium nor do consulting work for the pharmaceutical industry. In 1998, the University of Wisconsin (UW) appointed Dr. Fiore to a named Chair, made possible by an unrestricted gift to UW from Glaxo Wellcome."

    As indicated above, Glaxo Wellcome directed the University of Wisconsin that the only person who could sit in the $50,000 per year professorship chair was the Director of Center for Tobacco Research and Intervention, who Glaxo Wellcome knew to be Dr. Fiore.

    In a February 7, 2007 WSJ article Fiore claimed to have stopped accepting pharmaceutical industry quit smoking product consulting fees and honorariums in 2005.

    Fiore's testimony on or about May 9, 2005 in U.S. v. Philip Morris does not mention that he stopped accepting consulting fees. He testifies on PDF page 14 that, "Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year." He testifies on page 15 that each year he receives another $50,000 from the Glaxo Wellcome Chair he occupies and references above.

    The website of the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI), founded by Fiore in 1992, and which he continues to direct, does not provide visitors with any statement as to financial conflicts.

    A May 8, 2008 article by Michael Siegel, MD of Boston University School of Public Health challenged Fiore's ethics for failure to disclose potential financial conflicts of interest in a just released article Fiore co-authored, which appeared in the American Journal of Public Health. In the article Fiore advocated increased access to pharmaceutical treatment for smoking cessation.

    Fiore's Appendix C June 2000 Guideline Panel Member Financial Disclosure stated, "Michael C. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Cib-Geigy, SmithKlineBeecham, Lederle Labratories, McNeil, Elan Pharmaceutical and Glaxo Wellcome."

    Fiore's CV indicates that from "2006-Present" he has served as "DIRECTOR, Robert Wood Johnson Foundation initiative - Addressing Tobacco in Healthcare. It further indicates that from "1997-2006" Fiore served as "DIRECTOR, Robert Woods Johnson Foundation National Program Office - Addressing Tobacco in Managed Care."

    On 12/19/03 RWJF awarded UW-CTRI, with Fiore as project director, $300,000 to translate tobacco dependence research into policy; on 01/17/05 $400,000 to evaluate the national quit line, on 07/27/05 $400,000 to build a network to fund tobacco related health care research; on 09/24/07 $99,316 to increase Medicaid recipient demand for tobacco dependence treatment; and, most recently, on 12/20/07 $100,000 for "Updating, testing and disseminating the 2008 tobacco treatment guideline."

    RWJF also lists Fiore and Curry as Program Directors and Orleans (as RWJF staff) in running its "Addressing Tobacco in Healthcare" website.

    Although unknown whether Fiore was compensated or any compensation's source, Fiore was moderator of a 09/18/07 Wisconsin "Dialogue" on smoking's economic impact, as part of a program listing Pfizer as one its "Benefactors."
  7. Froehlicher's May 2008 Guideline Disclosure: "Erika S. Froehlicher reported no significant financial interests and no additional disclosures." Froelicher's CV indicates that, as with fellow panel member Benowitz, she is a professor at UCSF, in 2002 they co-authored an article entitled "Women's Initiative for Nonsmoking: Under-use of nicotine replacement therapy (NRT)," and a second article in 2003. In August 2001 Froelicher was an invited lecturer for RWJF on smoking in nurses and during two days in August, 2003 served as a reviewer for the RWJF.
  8. Goldstein's May 2008 Guideline Disclosure: "Michael G. Goldstein reported no significant financial interests. Under additional disclosures, he reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007." Michael G. Goldstein's 9/5/06 five-year Financial Disclosure forwarded to me by the DHHS under cover letter of 09/05/07 states in part, "Bayer Pharmaceutical Corporation - employee 9/98-12/04 (however Bayer produces no tobacco dependence products) .... Pfizer - have served on advisory panels for Health Education Principles - remuneration received by Institute for Healthcare Communication."

    Goldstein's Appendix C June 2000 Guideline Panel Member Financial Disclosure stated, "... in addition to being an employee of the Bayer Corporation, has served as a consultant for, given lectures sponsored by, or had conducted research sponsored by Glaxo Wellcome, McNeil, Ciba-Geigy, SmithKline Beecham ..."
  9. Healton's May 2008 Guideline Disclosure: "Cheryl Healton reported no significant financial interests and no additional disclosures." As indicated above, Healton is CEO of American Legacy Foundation (ALF). On January 3, 2007, during the Guideline update process, RWJF awarded ALF a grant of $720,000 to "help American adults stop smoking" using "evidence based resources."
  10. Henderson's May 2008 Guideline Disclosure: "Patricia Nez Henderson reported no significant financial interests and no additional disclosures." On 12/07/07 a $49,969 grant by RWJF was awarded to develop tobacco-free and wellness policies for the Navajo nation with Henderson as project director.
  11. Jaén's May 2008 Guideline Disclosure: "Jaén Carlos Roberto Jaén reported no significant financial interests and no additional disclosures." It would appear that Jaén was named "Panel Vice Chair" to deflect fall-out from the 02/08/07 Wall Street Journal article. Jaén's study history indicates that in 1994 he co-authored a primary care nicotine patch study and in 1997 was lead author in a Medicaid study involving free nicotine patches.

    Jaén's CV indicates that in 1994 he was a RWJF Generalist Physician Faculty Scholar. Jaén's bio webpage asserts he is a "Member of the National Advisory Committee for Robert Wood Johnson Foundation's 'Prescribe for Health Program.'"

    Jaén's Appendix C June 2000 Guideline Panel Member Financial Disclosure stated he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome Pharmaceuticals."
  12. Kottke's May 2008 Guideline Disclosure: "Thomas E. Kottke reported no significant financial interests and no additional disclosures." Kottke's July 6, 2006 signed Guideline Panel Financial Disclosure asserts, "I have no relevant financial interest in the guideline panel or resulting guideline."

    A June 2007 paper co-authored by Kottke, entitled Lipid Management in Adults, contains a conflicts disclosure stating, "Thomas E. Kottke, MD has received speaker fees or honorariums from ASTRA-Zeneca, Pfizer and Sanofi-Aventis.

    Kottke's Appendix C June 2000 Guideline Panel Member Financial Disclosure asserted that he, "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by McNeil Consumer Healthcare." McNeil is a division of Johnson & Johnson which sells Nicorette gum.

    Kottke's bio webpage indicates he was a RWJF Clinical Scholar.

    Interestingly, Kottke wrote a 01/18/95 editorial entitled "Nicotine Patches: a Doubtful Key to Tobacco Control?"
  13. Lando's May 2008 Guideline Disclosure: "Harry A. Lando reported no significant financial interests. Under additional disclosures, he reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel." Lando's online "Vita" dated January 2008 asserts on pages 4-5 that he is a consultant to Pfizer Pharmaceuticals, Robert Wood Johnson Foundation and SmithKline Beecham.

    Lando's Appendix C June 2000 Guideline Panel Member Financial Disclosure stated he, "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome and SmithKline Beecham."

    As fund raising chairman for the 2008 World Conference on Tobacco or Health to be held in India, Lando arranged for Pfizer and GlaxoSmithKline to serve as conference sponsors.

    Lando was quoted in Helliker's 02/08/07 Wall Street Journal article as saying, "I view the pharmaceutical industry as our ally."
  14. Mecklenburg's May 2008 Guideline Disclosure: Robert E. Mecklenburg reported no significant financial interests. Under additional disclosures, he reported assisting Clinical Tools, Inc., through a governmental contract to develop a PHS 2000 Guideline-based Internet continuing education course. Mecklenburg's Appendix C June 2000 Guideline Panel Member Financial Disclosure stated he, "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by SmithKline Beecham and Glaxo Wellcome.

    Mecklenburg's CV appears dated but does assert "Contracts of varying length have been held between 1988 to 2006." "3. Pharmaceutical companies:" Glaxo Wellcome SmithKline Beecham."
  15. . Mermelstein's May 2008 Guideline Disclosure: Robin Mermelstein reported no significant financial interests and no additional disclosures. Mermelstein's CV asserts,"1997-2005 Robert Wood Johnson Foundation Scientific Advisory Committee Member: Addressing Tobacco in Managed Care." Also, "1999-2005 Robert Wood Johnson Foundation Tobacco Etiology Research Network, Committees on Adolescent Measures of Use and Measures of Dependence; Context Committee. Also, "2000-2005 Member, Expert Advisory Panel, Robert Wood Johnson Foundation" youth use & cessation survey.
  16. Mullen's May 2008 Guideline Disclosure: Patricia Dolan Mullen reported no significant financial interests and no additional disclosures. Mullen's CV dated 08/06 CV indicates, "Robert Woods Johnson Foundation: National Advisory Committee, Smoke-Free Families (2000-2006)
  17. Orleans' May 2008 Guideline Disclosure: C. Tracy Orleans reported significant financial interests in the form of a dependent child who owns pharmaceutical stock, and no additional disclosures. Lawrence Robinson reported no significant financial interests and no additional disclosures. Orleans' July 26, 2006 signed Financial Disclosure states, "I have no relevant financial interests in the guideline panel or resulting guideline."

    RWJF claims Orleans is the RWJF's senior scientist and "leads the Foundation's efforts to develop and disseminate science-based strategies for addressing the major behavioral causes of preventable death and chronic disease" "She oversees a current portfolio of more than $375 million in RWJF national programs and grants." "Recruited to the Foundation in 1996 as a national leader in tobacco control and health behavior change research and practice, Orleans focused through 1999 on expanding the Foundation's investments in policy-based approaches to tobacco cessation ..." "She is especially pleased that her early innovative work in tobacco control and cessation programs continue to have wide impact in helping smokers quit, including the Johnson & Johnson worksite tobacco control program; 'Free & Clear'..."

    RWJF identifies Orleans as "RWJF staff" in running its "Addressing Tobacco in Healthcare" website, with Fiore and Curry as Directors.

    Orleans and Fiore co-authored papers in 2002 (also with Curry), 2004, 2005, 2006 and 2008.
  18. Stitzer's May 2008 Guideline Disclosure: Maxine L. Stitzer reported no significant financial interests. Under additional disclosures, she reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication. Stitzer's signed 7/5/06 five-year Financial Disclosure does not reference the above but instead states, "Pfizer Pharmaceuticals - promotional speaker."

    Footnotes to a November 2006 study recites that "Maxine L. Stitzer, Ph.D., has received promotional speaker support from Pfizer."

    Stitzer's Appendix C June 2000 Guideline Panel Member Financial Disclosure stated she, "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by McNeil and SmithKline Beecham.

    Stitzer's CV asserts that since 2000 she has been on an advisory board to "University of Wisconsin Center for Tobacco Research & Intervention" a/k/a Fiore's UW-CTRI
  19. Wewers's May 2008 Guideline Disclosure: Mary Ellen Wewers reported no significant financial interests and no additional disclosures. Wewers' online bio page indicates, "National Advisory Committee, Robert Wood Johnson Foundation Smoking Cessation Leadership Center, 2003-present."
XXX
Last updated Wednesday, May 14, 2008 at 05:02 EST
No Copyright - This Article is Public Domain
John R. Polito is solely responsible for the content of this article.
Given its length and detail, the author acknowledges the possibility of factual errors.
Any error will be immediately corrected upon receipt of credible authority
in support of the writer's contention. E-mail comments to [url=mailto:john@whyquit.com]john@whyquit.com[/url]
Quote
Share