The Joint Commission is a body that sets standards for the accreditation of hospitals and health care facilities. Since most states require hospitals to be accredited to receive Medicaid reimbursement, following the standards set by the Joint Commission is quite important for most hospitals.
Recently, a panel of the Joint Commission developed standards regarding tobacco use screening and treatment. These standards go into effect in January 2012 and they therefore become a part of the accreditation assessment for hospitals.
While some aspects of the standards set by the panel are straightforward and non-controversial (e.g., all patients should be screened for tobacco use), one striking aspect of the standards is that every patient should be treated with smoking cessation drugs, unless there is a specific contraindication.
As stated by the panel, the smoking treatment standards are "consistent with the 2008 United States Public Health Service Guideline, Treating Tobacco Use and Dependence" and require "that all tobacco users be identified, that tobacco users be provided or offered both evidence-based counseling and medications during the hospitalization and upon discharge, and that tobacco use status be assessed post-discharge."
According to the panel's standards, not only must every patient be treated with smoking drugs during hospitalization (unless contraindicated), but every patient should be prescribed an FDA-approved smoking cessation drug upon discharge.
This recommendation is not exactly evidence-based, because there is a large body of research showing that FDA-approved smoking cessation drugs are highly ineffective, failing to work in the overwhelming majority of patients who are treated with them. Long-term success rates with these drugs are on the order of about 8%. Thus, they have about a 92% failure rate. This makes the recommendation that every patient be prescribed one of these drugs upon discharge quite curious.
The Rest of the Story
Perhaps the recommendation that every patient be prescribed one of the dismally effective FDA-approved smoking cessation drugs is not so mysterious when one learns that the chair of the Joint Commission panel that set this standard has a conflict of interest by virtue of his receiving grant funding from a pharmaceutical company that is in the late stages of developing what it hopes will soon be ...
... an FDA-approved smoking cessation drug.
Moreover, panel chair has a long history of financial conflicts of interest with pharmaceutical companies that manufacture FDA-approved smoking cessation drugs.
The panel chair is Dr. Michael Fiore, who is currently receiving grant funding from Nabi Pharmaceuticals, which has a smoking cessation drug in the late stages of development. The drug is a nicotine vaccine which has been given fast track status by the FDA "for use as a therapeutic for smoking cessation."
Clearly, it is to Nabi Pharmaceutical's great financial interest to have in place as it begins to market this drug a hospital standard requiring all smokers to be prescribed at discharge and FDA-approved smoking cessation drug.
We are talking about an enormous amount of money here. Nabi Pharmaceuticals estimates that the nicotine vaccine market will be $2.1 billion in sales: "The smoking cessation Rx market is young and growing. Datamonitor estimates that the market will grow at a compound annual growth rate of 11% and will reach approximately $3.8 billion by 2018. Datamonitor forecasts that nicotine vaccines will account for $2.1 billion of these sales."
Thus, NicVAX is projected to be the most prescribed smoking cessation medication and the drug to benefit most from the Joint Commission panel's recommendation that every smoking patient leave the hospital with a smoking cessation drug prescription in hand. In fact, giving patients the nicotine vaccine prior to discharge will become the easiest way for hospitals to meet the Joint Commission panel's standards.
On top of the current financial conflict of interest with Big Pharma, Dr. Fiore has a long history of similar conflicts: In 2008, Dr. 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."
In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."
According to Dr. Fiore's testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. 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." Dr. Fiore recently gave up this endowed Chair position, but the past conflict is enormous and it appears that much of the panel's work occurred during a time when this conflict was still present.
In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. 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."
In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."
I have no problem with researchers receiving pharmaceutical funding to conduct clinical research. However, scientists with financial conflicts of interest should not be put in a position of making national recommendations regarding the use of those medications. And they absolutely should not be in the position of setting standards for hospital accreditation when those standards involve the use of medications made by companies with which they have financial conflicts of interest.
This is not an issue of small potatoes. We're talking about potentially $2.1 billion of sales for Nabi Pharmaceuticals. Having Dr. Fiore as chair of the technical advisory panel for the Joint Commission on smoking cessation treatment standards is like giving Big Pharma a seat at the table. Why not just allow the pharmaceutical companies to write the standards that dictate hospitals' prescribing patterns for smoking cessation drugs? Frankly, such a process would have resulted in precisely the same recommendation as this expert panel.
It's a shame that the Joint Commission allowed financially conflicted scientists to participate in the setting of standards for hospitals. It gives pharmaceutical company interests an undue influence - albeit indirectly - on drug prescription policy.