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: http://prescriptionproject.org/blog/?p=112.
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."
Tuesday, March 18, 2008
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 (http://www.amsa.org/prof/pharmfree.cfm)--about 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 (http://www.uthscsa.edu/hop2000/word/7.7.3.doc), and can be used to put to shame the other UT campuses that have not yet adopted such policies.
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 (http://www.uthscsa.edu/hop2000/word/7.7.3.doc), 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:
http://www.washingtonpost.com/wp-dyn/content/article/2008/03/11/AR2008031102620.html?sub=AR
Birnbaum notes:
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 clekashman@gmail.com.)
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.
http://www.washingtonpost.com/wp-dyn/content/article/2008/03/11/AR2008031102620.html?sub=AR
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
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 clekashman@gmail.com.)
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: http://brodyhooked.blogspot.com/2007/12/intellectual-bias-latest-salvo-from.html
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: http://www.citizen.org/publications/release.cfm?ID=7553&secID=1656&catID=126
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.
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: http://www.citizen.org/publications/release.cfm?ID=7553&secID=1656&catID=126
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 (http://www.mja.com.au/, 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.
Two articles in the Medical Journal of Australia (http://www.mja.com.au/, 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:
http://www.usatoday.com/news/health/2008-02-29-drugs-main_N.htm
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.
http://www.usatoday.com/news/health/2008-02-29-drugs-main_N.htm
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:
https://secure.consumersunion.org/site/SPageServer?pagename=Rx_Drug_Ads_Petition&JServSessionIdr005=ilt7lf2tp1.app44a
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.
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:
https://secure.consumersunion.org/site/SPageServer?pagename=Rx_Drug_Ads_Petition&JServSessionIdr005=ilt7lf2tp1.app44a
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.
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