Monday, March 31, 2008

Give Me a Break Dept.: Encourage More Drug Rep Gifts to Lower Health Costs

Christopher R. Anderson, president of the Massachusetts High Technology Council, contributed this op-ed to the Boston Globe today:

Anderson says some pretty sensible things, at first, noting that the much-touted Massachusetts healthcare-for-all plan is in serious jeopardy because it lacks cost control features, a point made early on by many policy wonks. But then he gets to the pharmaceutical industry and goes off the deep end.

First he suggests that it's a cost saving measure to encourage docs to visit with reps and get information from them-- I'm sorry, that's "education" according to Anderson. He objects to the total gift ban that's part of the bill introduced by MA Senate President Therese Murray. Anderson reasons that "educated" docs will prescribe more newer drugs, patients will get better faster, and that will lower costs. Righto.

Next Anderson plays the fear card--if you ban Pharma gifts to docs, then you are undercutting the state's biotech industry. He notes figures showing that the large drug firms, between 2000 and 2006, invested $13.4B in the state's biotech firms. The not-so-obvious chain of logic here is that if you won't let Pharma have its way with bribing docs with nice gifts, then Pharma will be put out with you, and it will take its biotech investments to some friendlier state, and jobs will hemorrhage from yours. (Presumably Massachuasetts is in great jeopardy for losing biotech jobs--instead of having really prestigious universities aaround to attract industry research investment, it has to make do with such second-rate places as Harvard, MIT, etc.) It is funny how this veiled threat grows such long legs--I heard the same threat uttered in testimony from one of Anderson's counterparts in Texas when testifying a year ago on a Senate bill to require public reporting of gifts to docs (far less ban them completely).

Sunday, March 30, 2008

Postcard from Mumbai: The Same, only Worse

Thanks to the Indian Journal of Medical Ethics, we now have a peek at drug promotional practices in Mumbai, a qualitative study based on interviews with drug company executives, pharmacists (chemists), physicians, and drug reps. The findings largely reinforce the findings of the Consumers International report on drug promotion in the developing world ( Some highlights:

  • Indian drug reps apparently make considerable use of flip charts to do their pitches--one rep said that Glaxo introduced these in 1972 and immediately doubled its sales, so now all follow suit. The docs never get to keep any information on the flip charts, and every few months the current charts are recalled by the companies and destroyed. There are commonly inconsistencies between what's on the flip charts and what's in the published literature.
  • Docs are as readily brainwashed in India as here. All denied ever being influenced by "gifts" from the companies, though they all know of colleagues who had been.
  • The "gifts" are of two levels. Docs receive the usual "reminder" items plastered with the company logo and drug brand name. But high prescribers also get more substantial "gifts" which today are usually blatant bribes, as the ever-more competitive drug marketplace demand that reps not give out big ticket items without proven performance. Some slum-neighborhood doctors were offered a cell phone handset for prescribing 1000 tablets of one drug, an air cooler for 5000, and a motorcycle for 10,000.
  • The complexity of medical practice and the lack of legal oversight allow practices in India that would not occur in the U.S., such as chemists selling drugs without prescriptions, and traditional Indian (ayurvedic) physicians prescribing Western medicines despite being officially prohibited from doing so. Accordingly both sets of practitioners receive due attention from the reps.
  • High tech seems not yet to have come to India--reps cannot get a computer download of their local physicians' prescribing patterns as they routinely can in the U.S. They have to go to the local chemist and pay for a prescription audit.
  • Marketing extends sometimes to frankly defamatory campaigns waged against competitor drugs, often stressing side effects.
The investigators concluded, "A wide range of questionable, or unethical, or frankly illegal trade practices were described." They report with regret that few organizations representing any public interests currently seem to be taking a stand against these practices in India.

Roy N, Madhiwalla N, Pai SA. Drug promotional practices in Mumbai: a qualitative study. Ind J Med Ethics 4:57-61, 2007.

Voices From the Past: Consumer Reports, 1961

First I'll offer some quotes from a volume called The Medicine Show: Some Plain Truths about Popular Remedies for Common Ailments, by the editors of Consumer Reports, published by Simon and Schuster in 1961. Next I'll make some comments.

The volume begins with an "Introduction" by Dexter Masters, Director, Consumers Union:

A good many of the ailments which the subtitle of this book refers to as common...are more annoying than dangerous, more a bother than a threat. They are part of the occupational hazard of living, and it is likely that, left to our own devices, we would be quite capable of getting along with them during their comings and goings. But we are not left to our own devices. Indeed, we are all but overwhelmed with the devices of others, the popular products which have occupied the drugstores, which stare at us from advertisements in the newspapers and magazines, and which give us our instructions from the television screens they now command. Our peace is endangered if not our health, and at least the economic threat has become real.
...[O]ne of the plain truths which emerge from the chapters of this book is that we are here in the presence of something irrational.
For the popular products in their bottles and jars and tubes have become a major reliance of a considerable part of this country's population, and the sellers have become the prime source of medical education for ther buyers. It is demonstrable that the contents of the bottles and jars and tubes are most often a good deal less than represented and that many are worthless. But none of this is to be learned from the representation, which therefore cannot be said to represent very well. ...[V]irtually all of them proceed in the same pattern, inducing alarms so that they can offer assurances, and stating at best no more than is in the sellers' interest, since selling is their first function. But selling is not a function which rationally can be associated with education, at least not with good education, and most decidedly not with anything so complex as medical education.

Most of the rest of the book deals with over-the-counter remedies, but a short section deals with prescription drugs. The introduction to that section is titled "A Perspective on Medical 'Miracles'". The editors there begin by defining an "ethical" drug as ones sold only by prescription, hence suggesting a "dignity and seriousness of purpose" not shared with over-the-counter nostrums. They then list the various ways that "ethical" medicines are marketed to physicians--direct mailings of glossy brochures; medical journal ads; throwaway journals that exist almost solely as adverising vehicles; exhibits and social events at medical conventions; and the ubiquitous "detail men":

Thus the spirit, the values, and the tactics of of patent medicine promoter now hold sway over the "ethical" drug. We who listen hours a day to the conflicting claims made for various brands of deodorants, cold remedies, toothpastes, weight reducers, hair dyes, headache remedies, and laxatives cannot help but feel a sympathetic uneasiness for our physicians, now subject to so intensive and extravagant a hard sell on behalf of the drugs they prescribe. And the uneasiness is heightened by the fact that, in many instances, the very same companies making exaggerated claims to sell patent remedies to us are also sellers and promoters of prescription drugs to the doctors.

Comments: I discovered this volume through an excellent recent historical study by Nancy Tomes (see below). As we near the half-century point since the publication of this book, it is worth being reminded of just how far back the marketing practices and the inappropriately cozy relationships between medicine and Pharma actually go. Reading such materials, I am always struck by how few changes would be necessary to transpose these passages into a publication of last week's vintage.

Tomes N. The great American medicine show revisited. Bull Hist Med 79:627-63, 2005.

The Ideal COI Policy: Why You'll Never See It

In the previous post I suggested some problems with the recent AAMC-AAU report on institutional conflicts of interest (COI). As I was reading the model policy, and reflecting on the various documents that I have had to sign recently when I agree to give a talk for a continuing-medical-education function to assure that I personally had no relevant conflicts of interest, it occurred to me what an ideal university or medical center individual COI policy would look like. (I report in the previous post a little bit of what I think the institutional COI policy should look like, which is quite a different matter.) First I'll give you the policy, and then discuss a little of why it says what it says (and why, hence, you'll never see such a policy actually adopted).

Medical Center of the University of Southern North Dakota at Hoople
Individual COI Policy

  1. If you're a member of our faculty and staff, and we find that you are involved in a COI that compromises your position of trust in research, teaching, or patient care, we'll beat the holy crap out of you. (If you wonder what a COI is, read that excellent volume, HOOKED.)
  2. If you find us about to beat the crap out of you, and you think that this is not fair, you may request an appeal to our COI Committee, made up of a group of your peers.
  3. The COI Committee will review your case in detail and reach one of the following three conclusions:
  4. First, that there is no significant COI, and we blew it, in which case we'll apologize and stop beating you up.
  5. Second, that there is a significant COI, and that anyone who claims to be as smart as you are ought to have known it, in which case we'll resume beating you up.
  6. Third, that there may or may not be a significant COI, but that the circumstances aren't clear, in which case we'll talk about it some more.
  7. Presumably you don't like to have the holy crap beaten out of you, and we don't like the bad rep that we get when we have to do such things to our own faculty. Therefore we strongly recommend that before you get into a situation that later could look like a significant COI, you talk with your dean or department chair or somebody who doesn't have their hand in the same till, who can advise you and warn you off before any damage happens.
This policy seems to have the following advantages:
  • It puts faculty on warning that the institution takes COI seriously and that violations will result in bad stuff happening.
  • It recognizes that the criteria for COI cannot always be completely specified in detail in advance of a concrete situation.
  • Rather than make faculty fill out endless reports and make committees read over all those reports, it relies on an appeal to professional judgment, responsibility, and discretion.
  • It focuses on the faculty who are engaged in questionable behavior and leaves alone faculty who engage in no such behavior.
You can see from the way that it is written that however sensible it is, or perhaps because of how sensible it is, no university or medical center will adopt such a policy in a gazillion years.

AAMC Policy on Institutional COI: An Assessment

In February, the Association of American Medical Colleges and the Association of American Universities jointly released a report on financial conflicts of interest in human subjects research (link is to new release which in turn has a link to the complete document):

While you could not necessarily tell from the unwieldy title, the focus of this document is on institutional conflicts of interest. The AAMC has already issued reports on how academic centers ought to handle individual faculty conflicts of interest, and had previously issued a preliminary report on institutional conflicts. The intent of this report is apparently to complete work on the institutional COI front, and the report contains as an appendix a template for a detailed university or medical center policy to that end. The report calls for all U.S. institutions doing human subjects research to have such a policy in place within the next 2 years.

Now, to assess such a document, it is reasonable to keep in mind some important "test cases" for institutional COI policies. Two recent challenges to institutional integrity are:
  1. The 1999 Jesse Gelsinger case from U. Pennsylvania, in which a healthy 18-year-old died in a gene therapy experiment, with both the principal investigator and the University itself owning part of the biotech statup company that would have profited had the therapy worked, and later questions about the adequacy of risk disclosure
  2. The 1998 deal between Novartis and UC-Berkeley, in which the University received $25M in exchange for first rights over the next 5 years to any research discoveries from the Department of Plant and Microbial Biology, and imposing a confidentiality agreement on all department faculty
The AAMC-AAU report does a number of things that in my view are positive. It sees the COI problem related to human-subjects research as dual--there is the need to protect the subjects of the research from undue risk, and the need to protect the integrity of the research process to attempt to discover scientific truth, rather than the answer the manufacturer wants to sell a product. It recognizes that "institutional" COI can come in two forms. First, a highly placed official such as a dean may own stock in a company or otherwise be conflicted, and the problem is to make sure that that individual official's activities do not create a problem for research integrity or subject safety. Second, the university as a whole can be so dependent upon a large gift or grant, from a commercial source, as to raise questions about integrity that cannot be assigned to any one official (none of whom may actually receive any personal financial benefits from that source). Both of our test cases highlight the latter version.

The actual policies for oversight and review contained in the report and in the model policy appendix seem generally decent, and are certainly better than nothing, given that so few universities today have any sort of policy.

But there are also serious problems. The model policy offers a definition of institutional COI that is impossibly broad: "An institution may have a conflict of human subjects research whenever the financial interests of the institution...might affect--or reasonably appear to affect--institutional processes for the design, conduct, reporting, review, or oversight of human subjects research." By this definition it is hard to see what aspect of institutional activity is not a COI. The ethical point of COI is missed, which is the concern that a financial or commercial interest comes into conflict with the institution's duty to maintain research integrity and to project subjects from harm or exploitation. (Admittedly, if you read all of that page of the document, the preceding discussion makes the point much clearer; but if a policy document has a specific passage called "definition," we ought to have reason to hope that what is offered there accurately defines the term in question.)

The far more serious problem is that the policy seems toothless to address serious institutional-level COI of the sort at Berkeley and Penn, when the institution as a whole is in bed with the business interests that create the COI. The best that the policy can come up with is the idea that there might be a 7-member committee to review allegations of COI, and that 2 of the 7 might be "public" members who are not on the institution's payroll in any way (though 1 of the 2 might have another tie such as being an alum). Certainly having some sort of public involvement in institutional oversight is a good idea. But the problem remains that if, for example, the President of the University decided to sell off the Department of Orthopedic Surgery to a maker of artificial knee prostheses, we would somehow have to expect the COI committee to have the backbone to tell the President and the Trustees that this is a bad idea.

By contrast, as I briefly discussed in HOOKED, some Canadian commentators seemed to grasp what was needed when they called for each Canadian university to agree to submit such complaints and concerns to a super-committee that would function at the national level and that would not be beholden to any individual university. I see no obvious U.S. national body that could function in quite that fashion, so as a substitute, I would wonder about some sort of round-robin arrangement, in which certain sorts of institutional COI issues at University A would be referred for review to a committee based at University B, University B send its dirty laundry off to University C, and so on. (You would avoid pairing off A and B, for instance, so as to avoid any charges that the review was simply an ol' boys' club of "You scratch my back, I'll scratch yours.")

The bottom line, I would propose, is that if a University claimed that a committee that consisted mostly of those on the University payroll could adequately policy institutional COI matters involving the entire University, it would be more or less like an individual COI review process that proposed to resolve all COI at the faculty level by identifying all faculty who had indefensible commercial COIs, and locking them all together in a room and requiring that they work it all out among themselves.

Friday, March 28, 2008

The View from the Trenches--(Non-) Free Samples Not Much Help

I happily turn over the bully pulpit to a family physician colleague that I have never met, Gail Hacker of Oregon, author of this op-ed in the Eugene Register-Guard:

Hacker does a very nice job of explaining why so-called "free" samples are of so little use even in a clinic that serves mostly indigent and uninsured patients--and what practical approaches work better. She also correctly notes that both the "free" samples, as well as all the gifts and goodies physicians accept from Pharma, drive up the costs of medication for everyone, but especially for her indigent clientele.

I've said elsewhere that any physicians who devotes their careers mainly to serving lower income patients are heroes in my book, and the last thing I would ever want to do is beat them up if they find that they can do this better by the use of industry promotional samples (and can find a way actually to get the samples--as Dr. Hacker points out, the reps usually give her indigent clinics a wide berth). But Dr. Hacker reminds us that in some cases where the clinic has previously relied on samples, there may actually be better alternatives.

Thanks to the Prescription Project Weekly Reader for alerting me to this valuable article!

Tuesday, March 25, 2008

Pharma, the FDA, and Legal Immunity

A helpful article on how Pharma is winning its battle in the U.S. court system to effectively destroy consumers' rights to bring suits for faulty or unsafe drugs:

One of the nasties in this piece is Daniel Troy, the pro-industry lawyer appointed by the Bushies to a high FDA post, now a powerful industry lobbyist. I have never seen a photo of Troy, but from what all of us have read about him, I imagine he wears a black cloak and has a long mustache with curly ends, like Snidely Whiplash, the stereotyped villain of melodrama in the old Rocky and Bullwinkle TV cartoon show.

Anyway, the way I try to put this in perspective--as I explained briefly in HOOKED, the industry and the FDA have a funny sort of relationship. The industry needs the FDA to be just powerful enough and not too powerful. If the FDA is too powerful, it will force the industry actually to shape up, which is bad for profits. (The industry of course does not see this as "shaping up" but rather as "meddlesome government regulation that stifles entrepreneurial creativity.") But if the FDA is too weak, then it is very clear to all parties that the industry is having its own way, which means that if something goes wrong, then the industry knows the blame will land squarely on its own doorstep. In a pinch the industry wants to be able to say, "Don't blame us, we were just doing what the FDA told us to." In the past, when the GOP small-government zealots in Congress actually seemed ready to abolish the FDA, Pharma had to rush to the agency's rescue.

The legal immunity battle reveals the ideal industry strategy. What if you could do two things at once--actually emasculate the FDA, and still persuade the outside world that the agency is an 800-pound gorilla? Then you get the best of both worlds. Blame the agency when things go wrong, but in the meantime, do whatever the hell you please.

The current Troy theory that the pro-corporation court system is eagerly lapping up is just such a two-faced strategy. The companies cannot be sued for an unsafe drug or device that kills thousands of people, because the drug or device would not be on the market in the first place if the FDA had not approved it. How could a court substitute its puny scientific expertise for the FDA with its extensive staff and advisory committees? But, in actuality, we have seen plenty of evidence that today's FDA is largely a creature of the industry, dependent on industry funds for more than half its drug approval and review budget, very easily manipulated by the drug companies--just as Troy and the Bushies want it.

The good news in all this is that there does not seem to be any basic constitutional right in play. The legal rationale the courts are using for declaring the companies immune from suits appears to relate solely to FDA regulatory law. That means that Congress has the power to amend those laws in response to court decisions that are unduly tilted pro-industry. The drug lobby will doubtless spend millions to fight off such amendments, so we will see what happens if the Congress remains under Democratic control. (On the failure of the Dems to face up to the powerful Pharma lobby so far see the previous post,

Monday, March 24, 2008

Devices and Orthopedic Consultants: When the Feds Get Serious

The New York Times recently updated us on the federal investigation into kickback payments from the medical device industry to orthopedic surgeons:

Round One of this probe netted five leading manufacturers of artificial joints. By any standards, the action was a huge success. While not admitting any criminal wrongdoing, the companies agreed to stop doing what they were doing, paid $310M in fines, and placed themselves under federal supervision for a year in exchange for being let off the hook. The Feds now get to approve in advance any deals these companies make involving payments to orthopedic surgeons in 2008.

The Feds have now gone to a not exactly friendly venue--the American Academy of Orthopedic Surgeons--to announce Round Two. In this round they will take a much closer look at the physician end of the bargain.

As Christopher J. Christie, U.S. attorney in Newark, explaind it, "I've dealt with the supply issue, now I need to deal with the demand issue." I take that language to mean that his office does not view the docs as innocently walking down the street and being accosted by device manufacturers offering them bribes. I gather that instead, he views the highest-rolling surgeons as being in the shakedown business--give me a 6-figure consulting contract and I'll keep using the expensive device your company makes; otherwise I'll jump ship.

Now, if you ask the orthopedists, they say that this has all gotten blown way out of proportion. They insist that most new medical devices are invented by surgeons, and are improved by other surgeons who tinker around with them. Those consulting fees, that is, are paid for real creative work and are not bribes at all. The docs also say that surgeons get used to a particular device because they like its feel or the feel of the tools you use to put it in. They are not going to switch to another just because somebody pays them off.

I have not had an opportunity to ask an orthopedist what he thought about all this. But I did ask a distinguished senior general surgeon, and his reply was not exactly printable. He made it quite clear that he did not think that anywhere near as much real "consulting" ever got done as cash flowed into docs' pockets.

Leaving aside who's right on the device/invention/consulting business, what I am most impressed by in this whole thing is what has happened in a very short span of time because the Feds decided to make a case out of this. Now, maybe nothing like this could happen in pharmaceuticals. Maybe the relatively small number of device manufacturers and surgeons who use the devices, plus the huge sums that were being paid out, allowed the Feds to move ahead in the device arena in a way they never could with drugs. But keep in mind (as I explained in HOOKED) that the very same law is on the books for all physicians. If you see any patients under Medicare or Medicaid, and you accept a gift of any value (including a pen) from a firm that sells stuff (like drugs) to Medicare or Medicaid, and a partial result of that interaction is that you could be influenced to prescribe that drug, then you could be looking at a cell in Leavenworth, according to the letter of the anti-kickback statute.

I guess all it takes is the will.

Feder BJ. New focus of inquiry into bribes: doctors. New York Times, March 22, 2008.

Tuesday, March 18, 2008

University of Toronto: Doing It Again?

The Prescription Project reports that Dr. Claire Bombardier has been named to a new rheumatology chair in the University of Toronto Faculty of Medicine, to be funded by a $1.5M grant from Pfizer:

Dr. Bombardier is well known to us critics of medicine-Pharma relationships as the principal author of the VIGOR study (New England Journal, 2000) that purported to show that rofecoxib (Vioxx) caused significantly fewer serious gastrointestinal bleeds than a standard anti-inflammatory medication for arthritis. So we might ask about this lovely marriage between Dr. B. and Toronto. The material for discussion is all documented carefully in HOOKED.

On Dr. B's side, we have the interesting fact that VIGOR actually contained within it much of the data needed to conclude that Vioxx caused more heart attacks than GI bleeds prevented--four years before Vioxx was finally taken off the market--even though the authors, apparently with the active complicity of the NEJM editors, did their best to conceal this inconvenient truth. Later NEJM tried to get off the hook by issuing an Expression of Concern (whatever that is) claiming that Dr. B. and her group had withheld from NEJM the reports of several heart attacks in the Vioxx arm of the trial. That apparently did happen, but NEJM did not follow its own proper internal procedures in making that charge. It remains the case that even without those extra heart attacks, Jim Wright of the Therapeutics Initiative, U. British Columbia, and John Abramson in his excellent book Overdosed America, were each able independently to calculate from the VIGOR data that Vioxx posed an excess risk of heart attacks.

On the Toronto side, we have the fact that the University has been implicated previously in not one but two scandals that involved taking money (or wanting to take money) from big drug firms. First there was the infamous case of Dr. Nancy Olivieri, who was severely mistreated by the Hospital for Sick Children when she got crosswise with the generic drug company Apotex over a drug for iron overload in thalassemia. (Apotex had made known its intention of donating multiple millions of dollars for a new research building at Toronto.) Next was the case of Dr. David Healy, who was hired by Toronto to head a psychiatric research institute, then unceremoneously de-hired when he dissed Prozac, which was manufactured by Eli Lilly, one of the major donors to the institute.

Subsequently, officials of the University of Toronto published a paper defending the institution's reputation and insisting that new, strict guidelines had been put in place since the Olivieri incident in particular; and they were backed up by no less a source than Robert Steinbrook, who frequently contributes commentaries critical of industry conflict of interest to NEJM. (For citations see HOOKED, p. 336, note 23.) The new professorship and the recruitment of Dr. Bombardier does not suggets that they have done much to turn over a new leaf. I once asked a colleague who works at a different Canadian university for his take on the Olivieri matter; and his reply was that in his circles, Toronto is generally regarded as the "whore of the Canadian universities."

Friday, March 14, 2008

Another Medical Center Adopts Pharm-Free Policy

I spent yesterday attending the American Medical Students Association convention up the road in Houston, and came away very impressed and inspired by the energy of the medical students involved with AMSA's PharmFree campaign ( which I hope to post a more extensive blog in the near future.

Meanwhile, another academic medical center has joined the increasing numbers of those adopting strict policies to keep drug reps and their "free" lunches mostly off the campus. This one is our partner University of Texas institution up the road in San Antonio. Their new policy seems appropriately hard-nosed (, and can be used to put to shame the other UT campuses that have not yet adopted such policies.

Dems Equally Putty in PhRMA's Hands; More on That Bus

Jeffrey Birnbaum writes in the Washington Post (you may need to register to view the article) that anyone imagining that with Democrats in control of Congress, we'd start to see legislation that reduces the power and influence of Pharma, should think again:

Birnbaum notes:
  • how many former Democratic lawmakers and staff have been quickly signed up as lobbyists by PhRMA;
  • how PhRMA campaign contributions, previously 75% of which went to the GOP, are now being divided up 50-50 between the major parties;
  • how, as a result, two major Democratic campaign issues--buying cheap drugs from Canada, and using the bulk purchasing power of the government to bargain down Medicare drug prices--seem to be going nowhere in Congress
Birnbaum also notes that there has been some of the more old-fashioned horse-trading. PhRMA wants to see SCHIP expanded as much as the Democrats do (so more people can pay for prescription drugs); so it joined such pro-SCHIP groups as AARP and Families USA (ordinarily strongly anti-PhRMA) in working with the Dems to try to push SCHIP through against Republican opposition--unsuccessfully as it turned out.

Now, before we view this as just one more example of the ugly side of Washington where money rules--which of course it is--I feel a need to say something about the two "losing" issues, besides SCHIP. Buying cheaper drugs from Canada is believed by no policy wonk to be any sort of long term solution to the problems with drug prices in the US; it is a popular Band-aid, no more. And the failure to approve of government bargaining to reduce Medicare drug prices comes in the wake of data showing that the present arrangement of Medicare Part D has actually succeeded in holding down prices more than anyone expected. (Is the present arrangement good policy? Hardly. But if it is somehow working, despite all its flaws, the smart thing to do might be to give it another year or two before calling for a major overhaul.) So the real test of these new lobbying investments by PhRMA (increasing their lobbying last year to $22 M, up 25 percent from 2006) will come with more substantive legislation.

As a relative side note Birnbaum mentions the drug industry's Partnership for Prescription Assistance, which has sent its fancy buses to all 50 states amid much media hoopla, as depicted on numerous TV ads showing talk-show host Montel Williams. Reportedly this program has provided low- or no-cost drugs to nearly 5 million people. So is the industry really reforming itself and getting serious about the uninsured?

The "Partnership" was in force the last year I was seeing patients as a family physician (2006) and I could not tell that anything new was happening in the ability of my patients to get drugs at no cost. I had impoverished patients turned down for no reason after spending a long time filling out forms. My practitioner friends tell me that it is still like pulling teeth to get charitable drugs for needy patients, and involves the same paperwork hassles as previously (which the Partnership was supposed to reduce). Now I learn from fellow blogger Roy Poses about the campaign by a resident of US Virgin Islands, Carol LeKashman, to try to shame the big drug firms into allowing US citizens who live in the territories to receive charitable drugs through the program. She has to take a number of medications for her condition, one of which costs $600 a month, and was initially told that she could apply for charitable drugs as a US citizen; but later she was told that she was ineligible because she lived in the Virgin Islands. (If you want to help her in her campaign, e-mail her at

Bottom line: PrHMA is certainly doing a public service when it allows needy patients to get drugs for free. But its much touted "Partnership" and their buses seem to be long on PR for the industry and short on actual help for the needy.

Birnbaum JH. Drug firms woo Democrats, helping defeat their bills. Washington Post, March 12, 2008: D1.

Tuesday, March 11, 2008

More on "Intellectual Conflict of Interest"

I previously posted on "Intellectual bias" as a red herring in the conflict-of-interest debate:

Now, Peter Lurie of Public Citizen has put together a slide show (as his presentation before the new Institute of Medicine Committee on Conflict of Interest), which among other things nicely develops the notion of intellectual conflict of interest:

What I say here is basically stolen from Slide 9 in Dr. Lurie's presentation. The discussion attached to that slide goes:

Frequently, one hears that there are both financial and intellectual conflicts of interest; somehow this argument is offered as evidence to downplay the importance of the financial conflicts. While intellectual conflicts are important, they can readily be distinguished from financial ones. Financial conflicts of interest are extrinsic to the scientific endeavor, whereas intellectual conflict is the very way science moves forward. Financial conflicts can occur at variable levels – some people have them, some people don’t – and they can be quantified, whereas intellectual conflicts are ubiquitous and not susceptible to quantification in the same way. Moreover, in the context of debate on an advisory committee, for example, it is unlikely that the financial conflict information will naturally emerge, whereas it is likely that any relevant intellectual one will. There are relatively straight-forward methods to alleviate financial conflicts, whereas it’s not nearly as clear how one should approach intellectual conflicts. Finally, our legal system has long recognized the distinctions between the two.

I believe that this is a wonderful, succinct explanation of why these two diffferent forms of conflict are quite different and should be handled as different in any public policy. It explains why intellectual conflict of interest is on the one hand much harder to eliminate (if it could be eliminated at all), and yet poses a much lesser threat to the integrity of science.

Tuesday, March 4, 2008

Drug Advertising that Doesn't Work--Is It Possible?

No less a guru than Dr. Peter Mansfield, the main guy at Australia's Healthy Skepticism website, says so.

Two articles in the Medical Journal of Australia (, free access, but you have to register) tell the story. It seems that a few years back, when Australian GPs were (unlike most of their U.S. counterparts) eagerly embracing the electronic health record with computerized prescription writing and other features, they were offered two software packages-- a more expensive one that was advertising-free, and a less expensive system that was supported in part by advertising, primarily pharmaceutical. The ads run in two sizes and are typically changed each month. They are programmed so as to pop up when the physician performs certain tasks--for example, when a doc clicks on an area of the medical chart that records cardiac risk factors, a Lipitor ad might then be triggered.

Joan Henderson and colleagues from Sydney took advantage of an ongoing survey of GP practice patterns to compare the prescribing behavior of GPs who used the ad-containing software with those using the ad-free software. They looked at a number of variables and data adjustments but were unable to find any difference.

Mansfield, in his commentary on their research, agreed that they had rigorously controlled for as many variables as possible, so that their findings were probably reliable. If so, then the drug companies seem to have broken new ground--finding a method of spending their advertising dollars that does not actually change physicians' behavior. Mansfield speculates that the annoyance factor may have actually have swamped out the usual value of ads. He offers the possibility that the ads may prove more effective in future years when the docs have become more habituated to them and so the annoyance variable fades.

I am no advertising expert (thank heaven) but would offer a slightly different hypothesis, or maybe the same hypothesis worded differently. How does pharmaceutical advertising work? Many docs (like me for instance) are quite sure that they completely skip over the drug ads in medical journals, for example, yet most company studies show that the return-on-investment for journal ad dollars is pretty good. I think the secret of a successful ad campaign is that there is no one element working in isolation. The physician hears a consistent message simultaneously from several sources (drug reps, journal ads, patients coming in reporting TV ads in the U.S., and now these software ads Down Under), each reinforcing the other. It's human nature to imagine that what you hear from one place might be false, but what you hear over and over from numerous sources must be true.

Henderson et al. assume quite reasonably that the companies must have gathered data of their own on the apparent effectiveness of their advertising expenditures; and she invited them to make these data public so that her group's results could be compared. Companies making public their proprietary marketing data? As the Russians used to like to remark, when pigs fly.

Henderson J, Miller G, Pan Y, Britt H. The effect of advertising in clinical software on general practitioners' prescribing behaviour. Med J Aust 188:15-20, 7 January 2008.

Mansfield PR. Do advertisements in clinical software influence prescribing? Med J Aust 188:13-14, 7 January 2008.

A Nation of Drugseekers, Priced Out of the Market

It's not often that we get to see the complete causal chain all wrapped up in one brief newspaper article, but USA Today managed it:

At issue: a recent USA Today/Kaiser Family Foundation/Harvard School of Public Health poll that revealed that about a third of us go to "ask our doctor" after seeing a TV drug advertisement, and that 82% of those who ask end up with some prescription or other. Also, 29% reported not being able to fill a prescription sometime in the last 2 years because of cost; 23% had to cut pills in half or skip doses due to cost; and 41% of families have some sort of problem due to the cost of drugs.

The poll showed that slightly more than half of the "ask your doctor" crowd ended up with a prescription for a different drug than the one advertised. On the one hand, that sounds good, as if physicians might actually be wisely suggesting lower cost generic equivalents. On the other hand, we have to wonder if 82% of those who asked (by the way, up from 75% in a 2005 poll) truly needed a prescription medication for whatever their problem was--especially given the tendency of direct-to-consumer ads to persuade us over time that more and more of what we used to call normal living is actually a previously unknown disease and needs aggressive therapy with drugs.

DTC advertising, at one point thought to have peaked and to be on the downslope, obviously is highly effective in generating pharma revenue, and the article reports that spending on such ads in 2006 reached record levels of $4.8B.

The poll showed a 47-44% split of those having favorable and unfavorable views of the drug industry, respectively. Billy Tauzin, president of PhRMA, gamely argued that people don't really dislike the drug companies. Rather, they react with anger to the higher co-pays that insurance companies slap them with, and that makes them feel sour about the drug company. Presumably it's the insurers who are the rapacious bastards, not your friendly pharmaceutical industry. (In that he is no doubt right, but I'll let other bloggers on health reform take that up.)

So here we have the entire package deal. DTC ads are turning us into a nation of drugseekers, which enhances revenue for the industry, but also drives up the prices of drugs, which makes drugs less affordable for an increasing percentage of us.

Saturday, March 1, 2008

Check Out Consumers Union Campaign

A very nice person at Consumers Union e-mailed me to ask that I consider a post on this topic, and I am glad to oblige, even though it is a bit outside the usual focus of the blog.

CU has a campaign to petition the FDA to force all drug ads, including those on TV, to include an 800 number where people can report adverse drug reactions:

There are two reasons why such a move would be highly useful. First, the current FDA system for reporting adverse drug reactions is incredibly antiquated and catches, at best, 1 out of 10 such reactions. A true drug safety surveillance system would tap into existing large databases of patient medical records to give a genuine early warning of previously unknown drug reactions in real time.

But that in turn assumes that physicians are alert to drug reactions and faithfully mention them in the medical record. Recent research has shown troublesome findings in this area--physicians often blow off patient reports of even well-documented drug reactions. So there needs to be an independent route by which patients can directly report to the FDA.

Consumers Union has been on top of the issues of drug safety and drug costs, and deserves support. (Full disclosure: my wife and I subscribe to Consumer Reports, the magazine that CU publishes.) The Prescription Project, another top-notch outfit, is partnering with CU on this campaign, I am informed.