Friday, August 31, 2007
A View from the Trenches: Delaware
"Although the spin that one hears from the pharmaceutical industry and some physician organizations is that these practices [giving lavish gifts to docs] have been clamped down upon; the author knows for a fact that this is not true. I have seen many instances of physicians and even mid-level providers making their patients wait in their exam rooms [while] they were in their offices or even in the hallways negotiating additional funding for a weekend at a regional or local hotel or resort, not just for themselves, but for their children as well. I have seen doctors set themselves up with things such as free tee times, free dinners at expensive eateries, airline flights, mixers, or arrangements to be a 'speaker' or 'consultant' even though they seemed to lack even the most basic knowledge of recent studies concerning the specific topic..."
Dr. Campo concludes, "We are physicians, not prostitutes. It is time that at least some of us act more like the former."
Campo D. Big Pharma. Del Med J 79: 243-45, June 2007.
Physicians' Denial of Side Effects: Brainwashed by Whom?
Golomb et al. went after samples of the population known to have suffered side effects from statin drugs. Of those they surveyed who had widely-reported statin side effects such as muscle aches, 87 percent talked with their physicians about their symptoms, in virtually all cases with the patient and not the physician initiating the discussion. Only 39 percent then reported that the physician had endorsed the possibility that the symptoms might be caused by the statin. Nearly a third of the physicians dismissed the possibility, and 29 percent were noncommittal.
Why should physicians be so ready to deny that these symptoms were medication-caused side effects? Let me note first that in my own practice as a family physician, I was usually slow to diagnose this side effect syndrome. The reason is that a patient may be on statins for months or years before the symptoms appear. It is then hard to think of an association between the drug and the problem. But to my credit, if the patient actually reminded me that these symptoms might be statin-related, I would hope I would then have said, "oh, yeah" and at least been open-minded. (Let's face it, no one is taking a statin to be cured of a deadly disease he has right this minute. Mostly we are aiming for long term prevention. What's the harm of stopping the statin for a few weeks to see if the symptoms go away or not?)
So the first reason that strikes me, to be in this state of denial, is the physician's ego. When the patient says that the statin we prescribed might be causing a side effect, it might sound to us like, "You did this to me." This could lead to a wrong-headed and ultimately inexcusable, but emotionally understandable defensive denial.
Another possibility also looms. If the vast majority of physicians get most of their drug information from industry sources; and if (as is reviewed in HOOKED) most industry sources, especially drug reps, say less about side effects than any other bit of information about the drugs--then the physician's reflex denial that the drug could be causing side effects might be one more example of pharmaceutical marketing-induced brainwashing.
Golomb BA, McGraw JJ, Evans MA, Dimsdale JE. Physician response to patient reports of adverse drug effects: implications for patient-targeted adverse effect surveillance. Drug Safety 30:669-675, 2007.
Ganguli I. Is your doctor in denial? Survey finds physicians often dismiss complaints about drugs' side effects. Washington Post, August 28, 2007: HE04.
Wednesday, August 29, 2007
The Inside Scoop on Reps: Who's Right?
When I saw the article by Ahari and Fugh-Berman in PLoS Medicine, in which the first author describes his fomer career as a drug rep (see my posts on the article dated April 26, 2007), I was pleased to see a general confirmation of what I had written, along with additional details as to the precise psychological profiling techniques that reps use to size up each physician and to select the sales approach that works best for each.
Now, Kevin O'Reilly, writing in American Medical News, has dug out (rather belatedly one would think) the Ahari-Fugh-Berman paper, and provides a summary of their report along with denials from a couple of former drug reps. (I am quoted at the end of the article as supporting Ahari's account.)
The former reps who took issue with Ahari's characterization (I should add that Ahari has an MPH and is now doing health services research at UCSF) are:
- Pam Marinko: "the very kind of thing that gives drug reps such a bad reputation"... Ahari "cherry-picked" certain sales practices and "served it all up in a negative light"..."It's absurd to suggest that a physician would make a prescribing decision based on whether he liked a drug rep."
- Sarah Taylor: "My experience wasn't anything like that"
Just what do these former reps do today? Marinko is CEO of Proficient Learning LLC, a drug rep training firm in Wilmington, NC. Taylor is author of The Secrets of Successful Pharmaceutical Salespeople. I will let you decide whether those people sound suficiently free of bias to commment fairly on Ahari's allegations.
(Incidentally, another former drug rep, now an academic, who paints a picture of the rep business in terms very similar to Ahari's is Michael Oldani, now a professor of anthropology--see HOOKED for references to his publications.)
Just a nice extra touch--Marinko is so convinced that detailing is the best way for docs to get the latest drug information, that she refuses to go to any physician who has a won't-see-drug-reps policy. I wish her well.
O'Reilly K. Professional issues: Drug rep creates stir with details on tricks of his trade. American Medical News, Sept. 3, 2007.
Sunday, August 26, 2007
Student, Resident Members Urge Family Medicine Academy to Get Strict with Pharma
Meeting August 2-4. the congresses encouraged more study of the results of pharmaceutical company interactions with family physicians; and the residents called for the AAFP to explore more ways to fund its annual conferences without pharmaceutical funding and commit to a pharm-free conference by 2012.
Comment: As a long-time AAFP member I applaud this action by the students and residents. I am about to attend what is strangely my first AAFP annual scientific assembly, in Chicago in October, where I am supposed to participate in two panels on the role of the pharmaceutical industry. The rumor mill has always held that the exhibit hall at AAFP is one of the most extreme displays of commercialism at any medical organization meeting, though reportedly there have been serious efforts to rein in the excesses in more recent years. I hope to have a report following the meeting.
Champlin L, Porter S. Residents, students wrestle with health system reform, other issues. AAFP News Now, Aug. 10, 2007;
http://www.aafp.org/online/en/home/publications/news/news-now/resident-student-focus/20070810studentresidentcongress.html
Saturday, August 25, 2007
Industry CME Spending Increases; What Does It Signify?
HOOKED explains that in 2003-4, two events occurred that would have appeared to make CME a less attractive investment for the drug industry. First, the Office of the Inspector General, DHHS, issued a stern report warning the industry that if they did not create secure firewalls between their marketing activities and CME support, they might be in violation of Federal anti-kickback laws. Second, the group that oversees CME, ACCME, introduced strict new rules to prevent speakers from parroting the industry message at conferences.
It was an open question what the response of industry would be to these changes. Some predicted a major falling-off in commercial support for CME. Others wondered if the industry, as it always had before, would simply find the seams in the new rules and continue on its merry way. My conclusion in HOOKED: too soon to tell.
The announced increase in industry CME support might at first glance persuade the paranoids that the new "strict" guidelines must after all not be working. My own conclusion at this point is the same as before--too soon to tell. Some factors mitigate the possibility that the industry is again in the CME driver's seat. The low 2005 funding figures might simply represent that the industry was holding back, waiting to see what action DHHS planned to take on the anti-kickback front. The slight increase in 2006 vs. 2005 might show that the industry is now confident that it has figured out the legally safe ways to invest in CME. MM&M notes that the venues seeing the largest increase in 2006 were medical schools and medical societies. The industry may have reasoned that supporting CME in those institutions was safest overall in terms of showing the Feds that a real firewall was in place, and that marketers were not controlling CME content. (This does not mean that CME at medical schools and medical society meetings is free of commercial bias; but it may mean that at least, the industry continues to live in fear of the DHHS Inspector General.)
Iskowitz M. Pharma pursued safe haven for its CME spend last year. Medical Marketing & Media On-Line, July 19, 2007; http://www.mmm-online.com/Pharma-pursued-safe-haven-for-its-CME-spend-last-year/article/24565/
Friday, August 24, 2007
Epstein vs. Relman: A Debate to Overlook
I have not read Epstein's book, and based on HOOKED you can presume that I would tend to disagree with most of what he says. Epstein also wrote a paper published last winter in Perspectives in Biology and Medicine on conflict of interest, and I disagreed with most of what he said in that paper. All of which is beside the point here, as the question is rather what one might learn from this exchange of views.
Alas, it is disappointing. Relman beats up on Epstein for two cardinal sins. First, Epstein is a frequent consultant for the drug industry and is also an economic disciple of Milton Friedman. Second, Epstein is a lawyer writing about health care matters. Both sins show that he is an idiot and that he cannot possibly therefore be correct about anything further.
Epstein replies in kind. Since Relman is a physician without any additional training, he clearly knows nothing about law, or economics, or corporations, so he's incompetent to pass judgment on any of these issues. And since Relman rejects Friedman, he must be an unreconstructed New Dealer (proof: he was born in 1923!) and is therefore completely unreliable on anything related to either economics or government.
Just how this pissing contest is supposed to enlighten the rest of us is never explained by either party.
Because Epstein assumes that Relman is an ignoramus, he proceeds to teach Relman (and the weary reader) a course in Econ 101 as he sees it. Industry must make a profit or else it will have to shut down. Regulation has costs as well as (purported) benefits. Advertising lets consumers know that there is a product out there that they might wish to consume. Drug companies spend a lot on research. Gee, thanks for all of these insights.
If we are going to keep score, I give the win to Relman. He accuses Epstein of being an unabashed apologist for the industry, citing all the arguments that support the industry position, selectively remaining silent on any point that is not in the industry's favor. Epstein, in his Econ 101 course, basically acts in such a way as to verify Relman's description of him. As my printout of his rebuttal runs 16 pages, single spaced, I can give only one example. Epstein says that as a consumer who has no special training in drugs, he naturally goes out and hires a professional--a physician--to advise him on medical matters. But in the next paragraph, he says that if he had a serious or terminal illness, he would not wish to wait for the randomized controlled trials to be finished. For such a person, he says, "the fetish over clinical trials is a death sentence." He goes on to praise the Abigail Alliance for demanding a legal right to access to any experimental drug that the patient and physician think might be life-saving.
Now, what Epstein never explains, and seems completely unaware of, is the contradiction between saying that he would hire a doctor to give him the good advice he needs on drugs, and depriving that same doctor of what is today considered the best possible evidence of what drugs work and for whom (that is, the randomized clinical trial). How is the doctor that he prudently hires supposed to get the information on which to base his advice--tea leaves?
Fortunately this is not about keeping score. It is about figuring out these thorny policy issues, and we cannot do so if we have a cardboard caricature of free-market worship on one side, and a cardboard caricature of anti-free-market attack on the other.
Instead, read two different books. First read Medicine and the Market by Callahan and Wasunna. You will find a careful analysis of both the ethics and the facts related to markets as a means of organizing medical care. Among other things you will read that in most of the civilized world, it is simply a given that we need both private markets and government regulation, and that regulation helps markets run well by leveling the playing field. Only in the U.S. do we find the ideological fervor that insists that we worship at the altar of the "pure" free market and the government be damned.
Next, read Leonard Weber's Profits Before People? Weber (an esteemed colleague of mine, who taught at University of Detroit-Mercy) has taught and written about business ethics in health care. His book on the pharmaceutical industry could be viewed as an ethics consultation, as if the industry had noted its poor PR lately and asked Weber for his ethical advice. Weber tries to give them the advice that he thinks a good business ethicist would. And his advice is markedly different from the Milton Friedman school. In fact, Weber ends up saying just about the same bad things about the drug industry as do its more strident critics like Angell (and me for that matter). I'd like to hear Epstein explain how it is that Weber knows nothing about corporations and markets and the realities of business.
Relman AJ. To lose trust, every day. The New Republic, July 23, 2007: 36.
Epstein RA. Cambridge v. Chicago: an answer to0 Dr. Arnold Relman's New Republic review of Overdose. August 22, 2007; http://www.pointoflaw.com/columns/archives/004194.php
Callahan D. Wasunna AA. Medicine and the Market: Equity v. Choice. Baltimore: Johns Hopkins University Press, 2006.
Weber LJ. Profits Before People? Ethical Standards and the Marketing of Prescription Drugs. Bloomington, IN: University of Indiana Press, 2006.
Wednesday, August 22, 2007
Pharma Goal: "Expand the Druggable Universe"
In Boston early this month was held the Drug Discovery and Development of Innovative Therapeutics conference. Senior executives from the big firms showed up to tip their hands on their future research agendas.
Dr. Melvyn Turner, senior VP of external research at Merck, indicated that one of his company's prime goals was the oncology drug sector, particularly the new area of RNA interference compounds. He said Merck found this area attractive because of the technology's ability to "expand the druggable universe."
I am sure that Dr. Turner meant nothing sinister by this phraseology. Nevertheless, for paranoids like me, it does seem to capture rather nicely what seems to be the overall agenda of Big Pharma.
The old joke had it that what kept the puritan awake nights was the abiding fear that somewhere, somebody was having fun. I assume by the same logic, what keeps pharma execs awake at night is the abiding fear that somewhere in the world, somebody is not taking drugs.
Breaking news on drug discovery.
http://www.drugresearcher.com/news/printNewsBis.asp?id=79011