In an article published last week in the New England Journal of Medicine, Dr. Michael Fiore and colleagues defend the new Joint Commission tobacco cessation performance measure set for hospitals, which - strikingly - insists that every smoking patient be discharged with a prescription for a smoking cessation drug (unless it is specifically contraindicated or the patient refuses).
(See: Fiore MC, Goplerud E, Schroeder SA. The Joint Commission's new tobacco-cessation measures -- will hospitals do the right thing? New England Journal of Medicine 2012; 10.1056/NEJMp1115176.)
The most glaringly odd recommendation is that every patient - whether or not NRT or Chantix or Zyban is right for them - whether or not they have tried these medications in the past and failed, must be prescribed a smoking cessation drug. It is not even clear that a recommendation to consider using over-the-counter products such as many NRT products, would constitute a valid "prescription."
As I have argued, the requirement is inappropriate because it requires hospitals to offer smoking cessation medication to every smoking patient, even if in the judgment of the treating physician, prescribing a smoking cessation drug is not the most appropriate and effective treatment for his or her patient.
There are many available treatments for smoking dependence and the most effective treatment plan should be individualized. As with most other aspects of medicine, there is no room for a one-size-fits-all, strictly prescribed treatment plan for every patient, regardless of individual circumstances.
Take the example of type II diabetes. One would not set a standard that requires every patient diagnosed with type II diabetes to be treated with an FDA-approved diabetes medication. In fact, 90% of cases of type II diabetes can be adequately treated with exercise and diet alone. To require every hospital to prescribe a diabetes medication to every type II diabetes patient upon discharge would be inappropriate. The appropriate treatment depends on the individual circumstances.
However, the Joint Commission panel's requirement ignores individual circumstances and undermines the judgment of the treating physician in favor of setting a one-size-fits-all mandate that every smoker be prescribed an FDA-approved smoking cessation drug. In many cases, this will not be the most appropriate choice of treatment. Yet hospitals may risk losing accreditation if they fail to follow the standard.
For example, consider a patient with the following history:
Patient X is admitted and treated for a kidney stone. She has a 25 year history of smoking. She has tried nicotine replacement therapy on six different occasions and failed to quit smoking on any of those occasions. She tried Chantix once but discontinued the drug because of severe side effects. Two years ago, she tried hypnotherapy which was very successful. She kept off cigarettes for nearly two years. However, she resumed smoking one month prior to admission due to the stress related to the loss of her job. She is now employed at a new position which she loves, but she hasn't tried to quit smoking since she resumed working.
In this case, the treating physician might legitimately and appropriately believe that the best treatment for the patient would be to try hypnotherapy again. She tried NRT six times and failed so prescribing NRT does not seem likely to be effective. Prescribing Chantix is probably not appropriate given the severe side effects the patient experienced. However, the patient has already been quite successful with hypnotherapy and her sustained period of cessation was interrupted only because of severe stress, which has now been relieved. It seems that a second trial of hypnotherapy might be the most effective and appropriate approach. At very least, it would be reasonable for a physician to so opine.
The Joint Commission panel's standard, however, would find this physician and this hospital in non-compliance. The patient must be offered an FDA-approved smoking cessation drug. Hypnosis doesn't cut it. Acupuncture doesn't cut it. Electronic cigarettes do not cut it. Even if the patient has previously had success with one of these approaches and no success with FDA-approved cessation drugs.
In many ways, this violates a basic principle of medicine: that each patient should be treated in that patient's best interests, without regard to the financial profits of corporations. In this case, the decision is being made not based on what is best for the patient, but what is best for the pharmaceutical companies.
The Rest of the Story
It would be problematic if the recommendation of the Joint Commission were simply a violation of the basic principles of medicine. That such a requirement was developed by a panel whose chair has a history of financial conflicts of interest with Big Pharma makes it completely unacceptable.
The rest of the story is 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, the panel chair has a long history of financial conflicts of interest with pharmaceutical companies that manufacture FDA-approved smoking cessation drugs.
The panel chair was Dr. Michael Fiore, who received 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.
Physicians Starting to React
The comments section of the article shows that physicians are now starting to react to this odd recommendation which usurps their autonomy and clinical judgment for the benefit of Big Pharma profits.
One physician - Dr. Stephen Kirk of Salem, New Hampshire - questions the wisdom of a one-size-fits-all policy that undermines clinical judgment of physicians, and which may actually cause patient harm by leading physicians to perhaps prescribe a drug which has severe side effects like suicide (e.g., Chantix).
Dr. Kirk writes: "Unfortunately, this editorial is yet another example of the poor understanding academics have of the practice of primary care medicine. The editorialists seem to have the opinion that smoking cessation is yet another aspect of medicine that can be managed with a TJC promulgated checklist. Despite their opinion, smoking cessation is a common aspect of primary care medicine best addressed between a patient and a physician who has an ongoing relationship with a patient. Several prescription smoking cessation agents have "black box" warnings regarding their potential psychiatric ramifications. Will busy hospital based physicians explore the psychiatric history of their patients prior to their prescribing? Who will be responsible for following these medications over time? With the poor state of inpatient-outpatient communication, isn't such a situation rife with the potential for problematic follow-up? It's unfortunate the editorialists seem to deny the importance of a primary care-patient relationship and applaud subsuming that relationship to yet another "benchmark"."
Another physician - Dr. J. Franklin Roessner of Indianapolis - points out that in his judgment, prescribing drugs is often not the best way to treat smoking dependence (a fact that is borne out in many published studies). Why should he be required to practice medicine in a way that he believes is not going to be effective, or is not in the best interest of his patients? He writes:
"As a pulmonologist in my 10th year of private practice, I have a vast experience treating smokers and helping them quit. I am truly distressed to read that Joint Commission guidelines for tobacco-cessation measures require a prescription be written. I consider myself to be aggressive with smoking cessation counseling and estimate a success rate that is a multiple of those published by the prescription manufacturers. I do offer prescriptions but rarely write one (less than 5 in the last year). Included my counseling is education about "quit aids" and encouraging their use. However, I favor over-the-counter nicotine replacements as they allow the patient greater flexibility and control specifically because there is no prescription required. Further, I also inform patients that the vast majority of people who quit successfully do so "without doctors or prescriptions". Cigarette smoking is a behavior related health care issue similar to obesity and the cognitive-behavioral aspect of treatment is most important aspect. The Federal requirement that hospitalized smokers receive a prescription is an example which highlights many of the problems of our healthcare system."
I wonder whether Dr. Kirk and Dr. Roessner, and many of the other physicians reading the Joint Commission standards, are aware of the severe financial conflicts of interest that led to the Commission's recommendations.
I think that awareness of this long line of conflicts of interest might help these physicians understand where these guidelines are coming from, and whose interests they serve.