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  Big Pharmaceutical: Doctors must not be lapdogs to drug firms
Posted on Sunday, November 19 @ 08:19:32 EST by samantha
 
 
  The World Doctors and drug firms update



JAMA editors allegedly threatened tipster
Professor raised concerns of study author’s ties to drug industry
March 30th 2009
CHICAGO - The American Medical Association is seeking an investigation of claims that editors of its leading medical journal threatened a whistleblower who pointed out a researcher’s conflict of interest.
Editors of the Journal of the American Medical Association deny threatening a professor who raised concerns about a study author’s undisclosed financial link to a drug company when JAMA published the study last year. JAMA, like most leading medical journals, has a policy of noting scientists’ industry connections.
According to the Wall Street Journal, JAMA editors threatened to ban the professor from their journal and ruin his medical school’s reputation if he didn’t stop talking to reporters.
The editors deny that. But the flap prompted them to spell out what amounts to a gag order on anyone who alerts the medical journal about suspicions that a researcher has undisclosed industry ties. The journal editors argue that any suspicions should be kept secret until JAMA can complete its own probe. That is an existing policy, JAMA’s editor-in-chief, Dr. Catherine DeAngelis, told The Associated Press on Monday.
AMA journals are independent and the medical association doesn’t interfere with what they publish. But AMA said Friday it has asked an independent oversight committee to investigate how JAMA editors handled the issue.
“As owner and publisher of JAMA, we take these concerns very seriously,” AMA board chairman Dr. Joseph Heyman said in a written statement.
The issue involves a study published in JAMA last May that said the drug Lexapro prevents depression in stroke patients. A Tennessee university professor who reads JAMA told the editors in October that he had learned that a study author had served as a speaker for Lexapro’s maker. Though other industry ties were noted in the journal, that one was not.
JAMA editors vowed to investigate.
The professor, Jonathan Leo of Lincoln Memorial University, also discussed his concerns in a March 5 letter posted on a different medical journal’s Web site.
On March 11, JAMA editors published a correction revealing the undisclosed ties to Lexapro’s maker.
JAMA’s editors acknowledged in a March 20 editorial being upset about Leo airing his concerns. They argue that publicizing unconfirmed allegations about study authors could unfairly damage reputations and interfere with JAMA’s own investigations.
http://www.msnbc.msn.com/id/29961791/
A line between docs and drugs
February 25, 2008
Third in a series
PRESCRIPTION drug companies develop, manufacture, and sell powerful medicines. Academic medical centers treat patients and train physicians. Both the drug industry and the teaching hospitals play essential roles in modern medicine, but their functions need to be kept separate, as they will be under a policy recently unveiled by UMass Memorial Medical Center in Worcester.
more stories like thisHealth insurance companies and state governments have encouraged physicians to prescribe generic products, and the rate of prescription drug inflation has diminished significantly. But keeping inflation down is a constant battle in healthcare. Academic medical centers, as shapers of physician opinion, ought to lead the way in protecting physician education from marketing by drug companies and their companion industry, the manufacturers of medical devices.
The UMass Memorial policy, up for final approval Wednesday, would prohibit hospital physicians from receiving gifts or meals from drug companies. Doctors wouldn't be able to accept drug samples, which would instead be distributed by the central pharmacy. Donations to physicians for educational programs would be banned. Companies could contribute to a hospital fund for education or direct money to a department, but administrators would determine the content of the program.
This policy goes against a tradition of drug company largesse, but hospitals around the country are realizing that they can no longer serve as marketing adjuncts. In Massachusetts, a nonprofit coalition under the umbrella of the Prescription Project is shaping opinion to a strict standard. Last summer, Boston Medical Center adopted a policy similar to UMass's, although physicians can partake of free food off campus if they "use discretion."
Elsewhere in Boston, Tufts-New England Medical Center bans gifts, and, assisted by the Prescription Project, is working on a comprehensive policy. The Partners network imposes restrictions, but many can be waived by a department chief. Drug companies can offer informational meetings, with a meal if the food costs less than $20 per person and the chief approves. Samples can be accepted, if the program or department allows them, as can gifts worth less than $100. At Beth Israel Deaconess, a company can pay for food at seminars as long as the department approves. Doctors can get samples (for poor patients), and gifts, too, up to an annual $300 limit.
Partners, at least, is working on a tougher policy. Dr. Daniel Podolsky, its chief academic officer, cautioned, "We want doctors to know what is the best state-of-the-art care." Drug and devices companies spend billions of dollars on marketing, and they'll get their message out one way or the other. Hospitals need to make sure the information is not tainted by even a tiny bit of physician self-interest.
Read
Drugmakers spend billions a year wooing doctors with gifts and free trips.
By Barbara Basler
January 2008
For years, pharmaceutical companies have courted America's doctors with an ever-growing intensity, showering them with billions of dollars' worth of gifts, consulting fees and trips to persuade them to prescribe their drugs. But now, patient advocates and lawmakers are out to break up those relationships, arguing that physicians—working amid the clutter of the drug industry's free samples, pens, clipboards, calculators and pizza boxes—often lose sight of the patient's best interests.
Read More

House Panel Seeks Data On Researchers
By DAVID ARMSTRONG
October 23, 2007
A congressional committee is asking the National Cancer Institute to scrutinize the financial records of about 50 researchers leading a big government study of whether annual medical scans of smokers' lungs can save lives.
The request came in a letter from the House Energy and Commerce Committee, which oversees medical-research issues. The committee said it was concerned that potential conflicts of interest "could damage the credibility" of the decadelong, $200 million National Lung Screening Trial. The results are expected to have a significant impact in standards for lung-cancer screening and who will pay for it.
Two of the trial's principal investigators have testified as paid experts for tobacco companies facing lawsuits seeking to force them to pay for smokers' annual CT scans.
The expert work by the researchers "goes to the heart of the research questions" at issue in the government-funded study, said the letter, co-signed by Rep. John Dingell, the Michigan Democrat who is chairman of the committee. "The tobacco industry has clear financial interest in the outcome of the NLST. If the NLST produces a negative or inconclusive result, the tobacco industry could use these findings to defend itself from litigation seeking low-dose CT screening of lung cancer as a remedy."
One of the researchers who testified for tobacco companies is Denise Aberle, who is one of the study's two national leaders. She is a professor of radiology at the University of California Los Angeles. The other, William Black, is at Dartmouth College. Dr. Aberle and Dr. Black have said the trial work has no influence on their government studies.
A National Cancer Institute spokesman said that he hadn't seen the letter and that the official to whom it was addressed was out of the office.
Rep. Dingell noted in the letter that most of the investigators overseeing research at about 30 study sites work for medical schools or academic hospitals, and he expressed concern that the institute doesn't subject them to the same detailed conflicts reviews that government-employed researchers undergo.
The committee sought information on the researchers' consulting relationships, expert-witness work, funding sources on other research and conflicts that could arise from work for firms that make screening equipment.
Read

Smoking Bans Proliferate
Since California's inception of a complete smoking ban in 1998, the trend has trickled eastward at a rapid pace and has become a concern not only for certain cities, but entire states as well. To date, more than 30 states have enacted some sort of smoking ban, and the trend isn't likely to taper off anytime soon as anti-smoking legislation and rallied support continues, says to Michael J. McFadden, author of "Dissecting Antismokers' Brains" and Mid-Atlantic regional director of the Smokers Club Inc. ( www.smokersclub.com), an organization aimed at educating the public on the effects of smoking bans.
"For the most part, bar owners take the 15- to 30-percent loss in business and swallow it because they have no choice," he says. "After a year or two, a certain percentage of bars will have closed because the bans put them over the economic edge." 
Read February, 2006:  Nightclub & Bar Magazine

Smoking?!
February 19th, 2007
Juanita Ramirez
Yeah! I enjoy smoking tobacco. They tell me there are only 25% of us die-hards in the good old U S A who do now. Is that because of education or intimidation or, dare I name it, extortion.
I do not advocate any life-style for anyone else on the face of the earth. I simply propose that no other advocate mine…nor regulate it. I cannot tell anyone else how many sodas or hamburgers to consume. Why should anyone else be able to tell me whether I can enjoy a little tobacco? I have not seen any scientific proof that unless you inhale it yourself; you are at any risk. Even so, I have never in my whole life made anyone else uncomfortable by blowing smoke in his face or clouding a closed environment with it. I never even thought about the second-hand smoke aspect or the legal ramifications. It was simple respect.
Now, we have legislation, which is nothing more than legalized extortion against the tobacco companies. Even when the tobacco companies adhere to this extortion it isn’t enough for some. They ridicule the efforts of the tobacco companies to advertise their extorted funds in efforts to promote a general welfare among all people. These concern the hours given by employees of tobacco companies to literacy projects, health care organizations, and foundations for the humanities. Is this the infamous slippery slope? You bet it is!
Is it okay to put exorbitant taxes on smokers and punitive fines on tobacco companies and then use the money to further the cause of political ambitions? Do we have a crisis here or not? I say, name it! If it were typhoid or yellow fever we would contain it and eradicate it in a hurry. Nay, my fellow citizens, I say, “live and let live.” If there are only 25% of us die-hards out there, let us have our tobacco and let companies who wish to provide it do so. Let us have our enclaves where we get together and enjoy a beer, a smoke, and a game of pool or darts. Let us have our restaurants where we enjoy a smoke after dinner. If you don’t like it, don’t go there…but don’t regulate us… and the business owner, who wishes to provide it, and, the waiters who make good tips from serving it, out of business.
My hat’s off to you, Rob Reiner! You are a “meathead.” Your barely passed tax on the smokers of California has resulted in a black-market in the streets of Los Angeles and elsewhere. Your tax!, has been thought to be allocated to saving the budgets of many ill-managed communities. Most of all, “meathead,” if you still have a voice, tell them to stop the commercials with little kid voices telling those of us who are grown up and working every day what we should think. If you wish to address grown-ups do it in a closed environment of grown-ups….please! Clear the room of the kids and let’s have it out like your dad would have done.
My ending remarks on this whole subject are:
1. Politicians…make up your mind…is tobacco evil or isn’t it?
2. Fellow citizens…make up your mind…will you allow us 25% to have our space or not?
3. United States of America…make up your mind…will you allow the freedoms of the few to be extorted by your government or not?
Read

Behind Antismoking Policy, Influence of Drug Industry Government Guidelines
Don't Push Cold Turkey; Advisers' Company Ties

By KEVIN HELLIKER
February 7, 2007 11:21 p.m.; Page A1

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.
. Terri Cullen's husband Gerry stopped smoking cold turkey, rejecting
nicotine-replacement treatments to ease withdrawal. But it hasn't been easy:
Gerry's been irritable, shaky, and he's gained weight. Is there a better way
to quit?
Now debate is growing about that evidence, and about who should be entrusted
to interpret it. Some public-health officials say industry-funded doctors
are ignoring other studies that suggest cold turkey is just as effective or
even superior to nicotine patches and other pharmaceuticals over the long
run, not to mention cheaper.
At stake is one of the most important issues in the nation's public-health
policy. Cigarettes kill an estimated 440,000 Americans a year. Helping
America's 45 million smokers kick the addiction could save untold numbers of
people.
The Public Health Service, part of the Department of Health and Human
Services, issued guidelines in 2000 calling for smokers to use nicotine
patches, gums and other pharmaceutical aids to quit, with a few exceptions
such as pregnant women. Dr. Fiore, a University of Wisconsin professor of
medicine, headed the 18-member panel that created those guidelines. He and
at least eight others on it had ties to the makers of stop-smoking products.
Those opposed to urging medication on most quitters note that cold turkey is
the method used by the vast majority of former smokers. They fear the
federal government's campaign could discourage potential quitters who don't
want to spend money on quitting aids or don't like the idea of treating
their nicotine addiction with more nicotine.
"To imply that medications are the only way is inappropriate," says Lois
Biener, a senior research fellow at the University of Massachusetts at
Boston who has surveyed former smokers in her state. "Most people don't want
them. Most of the people who do quit successfully do so without them."
Guidelines Revision
The panel is now working on a revision of the guidelines, scheduled for
completion early next year. Dr. Fiore, an internist, is again chairman. He
says this time only seven of 26 members have industry ties. Karen Migdail, a
spokeswoman for the revision effort, says it involves so many voices that
"it's hard for one perspective to have an influence on the process." She
says Dr. Fiore is "one of the leading experts" in smoking cessation and
well-suited to the job.
Dr. Fiore says his panel will give a fair hearing to all points of view on
smoking cessation. He says the process is sufficiently collaborative to
prevent bias, his or anyone else's, from creeping into the final product. He
notes that many of the studies questioning the effectiveness of stop-smoking
medication arose after the publication of the 2000 guidelines. The panel
will scrutinize them closely before reaching any conclusions, he says.
David Blumenthal, director of the Institute for Health Policy at
Massachusetts General Hospital, questions the government's choice of Dr.
Fiore. "The chairman of the committee should be unquestionably impartial,"
says Dr. Blumenthal, who has published extensively on conflicts of interest.
Pharmaceutical companies make several products to help smokers quit. Some
give a nicotine fix without a cigarette, such as GlaxoSmithKline PLC's
Nicorette gum and nicotine-laced Commit lozenges. Nicotine, the addictive
agent in cigarettes, is considered benign relative to the carcinogens in
cigarettes. Bupropion, an antidepressant, and Pfizer Inc.'s Chantix -- both
pills available only by prescription -- aim to reduce cravings without using
nicotine.
Many clinical trials have randomly assigned smokers to take one of these
products or a placebo. Such randomized trials are considered the gold
standard in many medical fields, and they have consistently shown that
nicotine-replacement therapy or other medicine confers a benefit.
But these trials have limitations. They tend to compare quitters who wanted
medication and got it with those who wanted medication and didn't get it --
which is a different group from quitters ready to try going cold turkey.
Also, clinical trials tend to attract highly motivated quitters who may not
represent the population as a whole. Even the placebo group in these trials
often boasts double the success rate of the population of quitters
generally.
Studies of quitters outside clinical trials have shown no consistent
advantage for medicine over cold turkey, the pharmaceutical industry's
primary competitor. An unpublished National Cancer Institute survey of 8,200
people who tried quitting found that at three months, users of the nicotine
patch and users of bupropion remained abstinent at higher rates than did
users of no medication. But at nine months, the no-medication group held an
advantage over every category of stop-smoking medicine. The study was
presented at a world tobacco conference last summer.
Real-World Situations
Similar so-called population studies -- which review results of people who
already quit or tried to, rather than prospectively randomizing subjects
into groups -- have also suggested that cold-turkey quitting can compete
with medication in real-world situations. These studies, in California,
Massachusetts and Australia, have their own limitations. One is that they
depend on people to remember what they did rather than monitoring them in a
controlled experiment
The surgeon general's five-day program for smokers preparing to quit
recommends nicotine patches or other medication.
Kenneth Strahs, GlaxoSmithKline's vice president of smoking-control research
and development, notes that his company's products won approval from
regulators at the Food and Drug Administration who demand randomized
clinical trials. "The FDA does not conclude either safety or efficacy based
on retrospective population studies," says Dr. Strahs. Smoking-control
products account for a small fraction of the company's revenue.
The researcher who raised the first serious questions about
nicotine-replacement therapy says it may fall into a rarely discussed gap
between efficacy in clinical trials and effectiveness in the real world.
Greater use of medication is not "associated with any increase in successful
quitting in the population," says John Pierce, a University of California,
San Diego, professor of medicine who was lead author of a 2002 Journal of
the American Medical Association article finding no superior benefit from
over-the-counter nicotine substitutes in California.
"If we're going to be intellectually honest, we have to be willing to
examine the issue of whether current users [of medication] are obtaining
long-term rates of abstinence that are higher than anyone else," says
Kenneth Warner, a tobacco researcher and dean of the University of Michigan
School of Public Health. "That's going to be very hard for people to do in
the smoking-cessation community," because belief in the value of medication
runs so deep, he adds.
All sides in the debate agree that intervention by doctors and other
health-care providers to confront smokers can be effective in encouraging
quitting. Dr. Fiore says the primary goal of the guidelines is to spur such
intervention, and he says they have been successful in sharply raising the
proportion of doctors who discuss smoking with their patients. Also
undisputed is that behavioral support, whether from professional therapists
or quit-line counselors, can be valuable.
As the federal government weighs the data in making new recommendations,
many of its advisers are receiving money from companies with a stake in the
outcome. Dr. Fiore holds a chair at Wisconsin that is funded by
GlaxoSmithKline. He directs a tobacco research center that received nearly
$1 million in funding from makers of quit-smoking medicine in 2004 and
$400,000 in 2005. Between 1999 and 2004, Dr. Fiore personally pocketed
$10,000 to $40,000 a year from the quitting-aid industry for honorariums and
consulting work. He says he stopped such work in 2005.
In the U.S. government's 2005 civil case against the tobacco industry, it
chose Dr. Fiore as an expert witness. He was asked to estimate the damages
owed to federal taxpayers as a result of smoking and to devise a plan for
spending those damages. Dr. Fiore came up with an estimate of $130 billion,
and a plan to spend about $5.2 billion a year of that mostly on counseling
and medication -- a measure that could have doubled the size of the
stop-smoking medicine market. (Later, the government reduced its request for
damages to $10 billion.)
The American Cancer Society has allowed its logo to be placed on
stop-smoking products in exchange for money. A Cancer Society spokesman
defends that decision, crediting the pharmaceutical industry for bringing
invaluable marketing muscle to the society's Great American Smokeout every
November.
Those who advocate medication sometimes fail to disclose that they have
financial ties to companies. In an article on Voice of America's Web site
last year, Jack Henningfield, identified only as a smoking-cessation expert,
urged smokers to "go to the consumer-friendly Web site that I like, which is
www.quit.com."
Dr. Henningfield is a principal of Pinney Associates, a consulting firm
whose largest client is GlaxoSmithKline, operator of the quit.com site.
Other articles citing Dr. Henningfield's views on smoking have identified
him as a professor at Johns Hopkins School of Medicine without mentioning
the GlaxoSmithKline connection. Dr. Henningfield, who holds a doctorate in
psychology, is an adjunct professor at Johns Hopkins. He says only 10% of
his income comes from Hopkins.
Dr. Henningfield says he always tells journalists about his financial ties
to industry. But in an interview with The Wall Street Journal last summer,
Dr. Henningfield promoted the use of stop-smoking medicine without
volunteering any information about those ties. He says he thought
GlaxoSmithKline's public-relations firm had already provided the
information.
In at least two medical-journal articles that Dr. Fiore wrote or co-wrote
promoting the use of stop-smoking medicine, no mention was made of his
financial ties to the makers of those treatments. Dr. Fiore says the editors
of those journals may have ignored his disclosure or he may have failed to
provide it. If the latter, "I am sorry about that," he says, adding that
those are two of more than 150 medical-journal articles he has published.
Dr. Fiore and other members of the Society for Research on Nicotine and
Tobacco refuse to accept any funds from the tobacco industry, even
unrestricted research grants. Smoking-control activists say there's a big
difference between tobacco companies, which they say engaged in scientific
deceit for a half-century, and drug makers that are trying to help smokers
quit. 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."
After the federal panel with industry-funded scientists came out with its
guidelines in 2000, a campaign against cold turkey took root. The Web site
of the highest-ranking physician in America -- the surgeon general -- calls
it a "myth" that cold turkey is the best way to quit. In November 2006,
during the week of the Great American Smokeout, doctors around the country
participated in a campaign called "Don't Go Cold Turkey." The creator of the
campaign was GlaxoSmithKline.
Advocate Rejected
The how-to-quit Web site of the federal Centers for Disease Control and
Prevention rejected a request from John Polito, an ex-smoker in Mount
Pleasant, S.C., to include a link to his Web site, WhyQuit.com, which
advocates cold-turkey quitting. In a 2002 letter explaining the rejection,
the agency told Mr. Polito that drug therapy has been shown to double quit
rates.
In an interview, CDC epidemiologist Corinne Husten said the real reason for
the rejection is that the CDC doesn't recommend private Web sites. However,
the CDC site long included a link to GlaxoSmithKline's quit.com site. Asked
about that, Dr. Husten said, "Some things have gotten on the [CDC] Web site
that shouldn't be there." (After the interview, the CDC removed the quit.com
link.)
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.
Some health officials don't go along with the federal government's tilt
against cold turkey. The state of California's help-line for smokers
presents cold turkey as an equally viable option to medication. "The
effectiveness of pharmaceutical aids has been proven short-term; long-term,
it's still in debate," says Hao Tang, a research scientist with the state
department of health services. California has succeeded in reducing its
smoking rate to 14%, six percentage points below the national average.
After three decades of smoking, Linda Holstein quit nearly three years ago
using a nicotine patch as well as nicotine gum, which on occasion she still
pops into her mouth. Elated at being free from cigarettes, Ms. Holstein, a
Minneapolis attorney, says, "The gum helped very much."
Others say ingesting medicinal nicotine prolonged withdrawal, leading them
ultimately back to cigarettes. During the 20 years that Tanya Blakey, a
Georgia teacher, smoked two packs a day, she tried to quit countless times
using nicotine-replacement therapy. "Every time I stopped using the NRT,
I was smoking again within two or three days," says Ms. Blakey. This week
she is celebrating two years without a cigarette, this time having used no
medication.
Read

The Gov't Lied to us Again....
By 2001 I'd developed a belief that Michael Fiore had done more to damage effective U.S. cessation policy than anyone whose work I'd studied. I've tried to keep an open mind but he continues to hide the dark side of cessation pharmacology in all he does. For example, we only have two nicotine patch studies examining success rates for second time patch users, Tonessen 1993 and Gourlay 1995. In Tonessen 100% of second-time patch users relapsed to smoking within 6 months and in Gourlay 99% relapsed.
Imagine being either unwilling or financially unable to share this potentially life and death piece of information with the hundreds of thousands of U.S. smokers who have now tried and failed with the nicotine patch on more than one occasion. As Chairman of both the 1996 and 2000 Guidelines he had a golden opportunity to issue powerful warnings regarding dramatically declining NRT rates with repeat use, growing concerns about getting hooked on the cure, and most important of all, exposing the fact that clinical NRT studies experienced major blinding failures with the very first nicotine gum studies, and all replacement devices since have been plagued by blinding failures.
Everything I've read convinces me that NRT is grounded in junk science and has no business being in the evidence base. I primarily hold a lack of government oversight responsible but when pointing to individuals Fiore tops the list.
Look at PDF page 14 at the above link. It's purports to be a speech given by Fiore to the FDA's Center for Drug Evaluation and Research "Drug Abuse Advisory Committee" on December 12, 1996. In it he states his credentials and then tells the committee, "I have served as Principal Investigator on the Bupropion Combination study and am speaking today as a consultant to Glaxo Wellcome, but the views expressed are my own." Talk about double-talk. Well which is it? Is he speaking to the FDA as Glaxo Wellcome's consultant or as his own person?
Is Fiore's failure to up front, fully detail and disclose the dollar extent and sources of his financial conflicts in both the June 2000 Guideline and at his website (as noted by Dr. Siegel) any different than the word games he played with the FDA on 12/12/96?
Please study closely the above Robert Wood Johnson Foundation (RWKF) document. It names Fiore as the August 1998 grant contact to update the U.S. Clinical Practice Guideline. This is 19 months after boasting to the FDA that he's a Zyban consultant. Also of intense interest is the following quote from the document:
"On September 14-15, 1999, panel members met in Madison, WI, where they evaluated their findings and prepared a draft of the new Guideline. Seventy experts provided external reviews for incorporation into the final document. The final version was submitted to RWJF and the USPHS for approval."
Who were the 70 "experts" who provided input, where can "we the people" go to see those comments and what business does the RWJF, the political arm of Johnson & Johnson (whose corporate subsidary was approved by the FDA to market the over-the-counter Nicotrol patch on 7/3/96, nicotine nasal spray on 3/25/96 and the nicotine inhaler on 5/6/97).
Who picked the Guideline panel members of which 11 of 17 had pharmaceutical industry financial ties?
Whose idea was it to update the Guideline? More importantly, whose idea was it to make pharmacology use mandatory for all quitters?
Why would it be the RWJF's responsibility to undertake arranging for an official government Guideline to be updated?
Why would the RWJF have "approval" authority over U.S. national cessation policy?
Who inside the U.S. government had conflict of interest oversight responsibity?
Why were no non-pharmacology cessation counselors
The 2000 U.S. Guideline isn't just "recommendations" but were adopted as official government health policy. They almost immediately caused destruction of nearly all hospital based and community cessation programs that were either cold turkey or non-pharmacology. How? Compare the language of the 1996 Guideline to what Fiore went back and changed.
Recommendation 5 of the 1996 Guideline stated:
"5. Three treatment elements, in particular, are effective, and one or more of these elements should be included in smoking cessation treatment: (1) nicotine replacement therapy (nicotine patches or gum), (2) social support (clinician-provided encouragement and assistance), and (3) skills training/problem solving (techniques on achieving and maintaining abstinence)."
Recommendation 7 of the 2000 Guideline reads in part:
"7. Numerous effective pharmacotherapies for smoking cessation now exist. Except in the presence of contraindications, these should be used with all patients who are attempting to quit smoking."
Suddenly U.S. policy declared that nicotine replacement was required and nicotine cessation outlawed. This year about 80% of smokers attempting to quit will trust their instincts and quit cold turkey but everywhere they turn their government is telling them they're doing it wrong? Why?
I beg you to look closely at the picture on PDF page 4 of the following 2004 financial report by Fiore's organization that was cited by Dr. Siegal.
http://www.ctri.wisc.edu/Publica...n.Rpt.FINAL.pdf
My government hid important truths from me. It had me running from useless cure to useless to cure while citing efficacy and ignoring effectiveness. I'll accept responsibility for getting hooked but by golly my government had an obligation to tell the truth about quitting. Nicotine is not medicine. It is a super toxin whose use is not therapy. In that almost all successful long-term quitters during 2007 will again quit cold turkey it is outright fraud to suggest that quitting cold turkey is nearly impossible. It's time to start sharing cold turkey quitting insights, not adhering to policy that continues to outlaw their sharing.
John R. Polito
Nicotine Cessation Educator
Read

Doctors must not be lapdogs to drug firms
Adriane Fugh-Berman
ajf29@georgetown.edu

BMJ 2006;333:1027 (11 November), doi:10.1136/bmj.39024.654086.59

Last month I gave a talk at Presbyterian Hospital in Albuquerque, New Mexico, about the influence of the drug industry on continuing medical education. As usual, pharmaceutical companies contributed funds to the conference, and there was a small exhibition area with the usual monopoly of drug firms.

Immediately after my talk, one pharmaceutical company representative announced to a conference organiser that her company would no longer support the annual conference. Another packed up his exhibit and walked out. Other drug representatives were observed muttering angrily into their cell phones, which may, or may not, have been related to the near total exhibitor boycott the next day. Only one exhibitor showed up, prompting a physician friend of mine to remark, "Maybe he missed your talk."

I had been so thrilled to receive my first United States invitation (outside of my university) to speak about how pharmaceutical companies manipulate prescribing. OK, to be entirely accurate, I was invited to speak about herb-drug interactions. But my "buy one get one free" lecture offer was taken up, and the organisers arranged a debate with a sales representative on whether pharmaceutical companies should fund continuing medical education for physicians.

The drug representative who agreed to the debate later backed out on the advice of "legal." Despite having been offered equal time, this is the same person who announced that her company would not support future conferences.

My talk covered the costs of drugs, the costs of promoting drugs to doctors, the salaries of drug representatives, the funding of continuing medical education, and the connection between polypharmacy and adverse drug events. I also covered psychological profiling and monitoring of physicians, including prescription tracking.

The audience of physicians, nurses, and allied health professionals seemed immensely interested—and acutely aware of the rarity of an occasion in which the relationship between medicine and the drug industry was questioned. Several physicians noted on their comment forms that the organisers were brave to address the subject. Some delegates even offered to pay higher registration fees in the future to offset the drug firms' defection.

However, the conference organisers were inclined to mollify the miffed companies, perhaps by explaining that my talk was important to prescribers. That will not work, of course, because the pharmaceutical firms are not interested in presenting information important to prescribers, unless it is also important to the drug industry. The suggestion that we need only soothe ruffled feathers gives drug representatives the status of offended friends. The notion that explaining our stand will buy forgiveness gives drug representatives the status of colleagues. Grovelling might work, says a colleague who used to be a drug rep. An apology, for example, could persuade drug companies to restore funding to the conference at Presbyterian—in exchange for, say, a promise never to invite me to speak again, and the inclusion in future talks of several speakers preferred by the drug companies.

Corporate support of continuing medical education courses, meals, and treats are not merely our just rewards for being hardworking, dedicated doctors. The illusion that the relationship between medicine and the drug industry is collegial, professional, and personal is carefully maintained by the drug industry, which actually views all transactions with physicians in finely calculated financial terms. Drug representatives are paid to be nice to us, as long as we cooperate, sustaining our market share of targeted drugs and limiting our continuing medical education lectures to messages that increase drug sales. This is an unspoken agreement, but no less clear for being covert.

The drug industry is happy to play the generous and genial uncle until physicians want to discuss subjects that are off limits, such as the benefits of diet or exercise, or the relationship between medicine and pharmaceutical companies. Any subject with the potential to reduce drug sales is anathema. Fair enough. He who pays the piper calls the tune. If we remain dependent on pharmaceutical companies for sponsoring continuing medical education, then these courses will remain under the control of the drug industry. This control is not contractual, but it is enforced through psychological manipulation.

If corporate sponsorship of medical meetings is deemed indispensable, why limit sponsorship to pharmaceutical companies? Surely the manufacturers of cars, luggage, and travel services would pony up for the opportunity to sell their goods to physicians. Conference organisers could solicit sponsorship from firms that market practice management software, office furniture, or other business related goods. As a last resort, we physicians could actually pay for our continuing education, as do lawyers, accountants, business people, and aerobics teachers, to mention a few. Medicine must shed both its docility and the corporate leash. Let us not be a lapdog to the pharmaceutical industry. Rather than sitting contentedly in our master's lap, let us turn around and bite something tender. Freedom calls.


The drug industry is happy to play the genial uncle until physicians want to discuss subjects that are off limits
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