The print media is continuing to take advantage of Minnesota's law requiring the reporting of payments from pharmaceutical companies to physicians. Earlier in the year, the New York Times printed several articles that shone a light on suspicious practices by comparing the list of physicians receiving payments to the physicians prescribing certain drugs for Medicaid.
Now, the Associated Press has brought forth the news that two members of the Minnesota Medicaid Drug Formulary Committee, that decides important questions as to which drugs will be reimbursed by the Medicaid system, have both received big bucks from the industry. A psychiatrist earned $350,000 (most presumably in speakers' fees) over a 2-year period; a pharmacist earned $78,000 during that time.
Both of them, plus the committee chairman, stated that these payments did not affect their work on the committee. I guess they have to say that, as unbelievable as it must sound to anyone with half a brain. However, the Committee is now thinking about (!) instituting some new rules to deal with conflicts of interest.
I admit that for a while I was rather skeptical about the value of gift disclosure laws such as Minnesota's. The goal is to stop these conflicts of interest in medicine, not to disclose them. But given the way that publicity is being used in the right hands to stimulate change, I am becoming convinced that this is at least a necessary intermediate step, however much work still remains to be done.
Associated Press. Financial ties link docs, drug companies. August 21, 2007; http://www.msnbc.msn.com/id/20379563/
Wednesday, August 22, 2007
Tuesday, August 21, 2007
Pharma Loses Crucial Court Battle in UK
It's fascinating to contrast two different postings on PharmaLive.com. The first, from Datamonitor, an industry data management firm, crows about the hoped-for victory in which "patient power" wins in a British court, and the mean old National Health Service and its National Institute for Health and Clinical Excellence (NICE) lose. At stake is whether NHS patients with mild Alzheimer's disease are allowed to obtain drugs to slow the progression of their condition.
The second post reports that the court threw out 5 of the 6 charges against NICE, leaving NICE "guilty" only on a small technicality that it can easily address.
The reason the court found in favor of NICE, in hindsight, is simple. All the scientific evidence goes to show that these drugs, which have precious little effect on Alzheimer's at any stage, are especially ineffective when given early in the course of the disease. The Datamonitor article notes that Alzheimer's is a terrible disease; and that it is becoming more common with the aging of the population. Both true. But neither means that the drugs work, as much as we might wish they did.
This victory is a very important one because my colleagues who study "evidence-based medicine" view NICE as the single most important body in the world for trying to bring rational cost control to medicine. The agency basically looks at the scientific evidence about both the benefits and the costs of treatment and then issues a ruling about whether the benefits are great enough to be worth it. (Many people think if we are ever going to have meaningful control of medical costs in the U.S., it will only be because we manage to invent NICE's U.S. equivalent.) The reason why no court challenges like this (or at least few) have occurred till now is that NICE has been very nice to the drug industry. Most treatments, even some thought to be questionable, have previously been approved. The mild Alzheimer's case is one of the relatively rare instances of NICE digging in its heels. (Which means that had the court overruled it here, it would have been especially unfortunate.)
Datamonitor made a big deal of "patient power" in the form of the Alzheimer's Society, which joined the two drug makers, Eisai and Pfizer, in the court suit. The Society's presence proved that this was all about patients getting the drugs that they have a right to, and not about greedy companies making more money. It was considered unimportant that the Alzheimer's Society receives generous funding from the two drug companies. The Society primly pointed out that it used funds from other sources to pay its court costs. (See HOOKED for a more extensive discussion of "astroturf," or how the industry creates supposedly "grass roots" action that happen to favor its products by laundering its money through PR middleman firms and through these patient advocacy groups.)
http://pharmalive.com/news/Print.cfm?articleid=465454
http://pharmalive.com/news/Print.cfm?articleid=466840
The second post reports that the court threw out 5 of the 6 charges against NICE, leaving NICE "guilty" only on a small technicality that it can easily address.
The reason the court found in favor of NICE, in hindsight, is simple. All the scientific evidence goes to show that these drugs, which have precious little effect on Alzheimer's at any stage, are especially ineffective when given early in the course of the disease. The Datamonitor article notes that Alzheimer's is a terrible disease; and that it is becoming more common with the aging of the population. Both true. But neither means that the drugs work, as much as we might wish they did.
This victory is a very important one because my colleagues who study "evidence-based medicine" view NICE as the single most important body in the world for trying to bring rational cost control to medicine. The agency basically looks at the scientific evidence about both the benefits and the costs of treatment and then issues a ruling about whether the benefits are great enough to be worth it. (Many people think if we are ever going to have meaningful control of medical costs in the U.S., it will only be because we manage to invent NICE's U.S. equivalent.) The reason why no court challenges like this (or at least few) have occurred till now is that NICE has been very nice to the drug industry. Most treatments, even some thought to be questionable, have previously been approved. The mild Alzheimer's case is one of the relatively rare instances of NICE digging in its heels. (Which means that had the court overruled it here, it would have been especially unfortunate.)
Datamonitor made a big deal of "patient power" in the form of the Alzheimer's Society, which joined the two drug makers, Eisai and Pfizer, in the court suit. The Society's presence proved that this was all about patients getting the drugs that they have a right to, and not about greedy companies making more money. It was considered unimportant that the Alzheimer's Society receives generous funding from the two drug companies. The Society primly pointed out that it used funds from other sources to pay its court costs. (See HOOKED for a more extensive discussion of "astroturf," or how the industry creates supposedly "grass roots" action that happen to favor its products by laundering its money through PR middleman firms and through these patient advocacy groups.)
http://pharmalive.com/news/Print.cfm?articleid=465454
http://pharmalive.com/news/Print.cfm?articleid=466840
How Is Merck Faring in Vioxx Lawsuits? Very Well, Thank You
If ever a company looked as if it was all set to lose its shirt in court, it was Merck, when it was finally forced to withdraw Vioxx from the market in 2004. The published evidence, in hindsight, was crystal clear that the company should have known about the risks of heart attack as far back as the late 1990s, and internal company documents only confirmed the company's awareness of the risks. Yet Merck continued not only to sell the drug, but to market it heavily--and as a first line choice, not merely for those thought to be at higher risk of stomach bleeding (the purported main advantage of the class of drugs).
So now it's three years down the road. And, as Alex Berenson reports in the New York Times, the liability risk once estimated to be as high as $25 billion has shrunk to $5 billion. And after Merck stock plunged at the first adverse jury award, it has since regained 80 percent of its value.
How has Merck done it? It has simply decided to use its financial muscle ($1 billion so far spent on legal fees) to fight each case individually, and to appeal every adverse ruling all the way up. The courts have helped by insisting that each case be tried separately and opposing any class action suits.
The medical facts work in Merck's favor in such a setting. We can know, on a population basis, that there may have been as many as 140,000 excess heart attacks in the U.S. during the five years that Vioxx was on the market after the risks were clear. The problem is to translate that number into the reasonable certainty that John Doe of Podunk, East Dakota was one of those heart attacks--that he had his particular heart attack when he did because he took Vioxx, and that his high blood pressure, high cholesterol, or other risk factors had nothing to do with it. So far, in most cases that have come to court, Merck lawyers have managed to create reasonable doubt that Vioxx was the cause of the heart attack. And, in the case of Robert Ernst, where the jury found against the company and demanded $253 million, the case is still tied up in appeals and the Ernst family lawyer predicts that if they see any money at all, it won't be until 2010.
I'm no legal expert, but it seems from this vantage point that if you want to have your day in court in the U.S., having an extra billion or so dollars in your pocket does not hurt.
Berenson A. Plaintiffs find payday elusive in Vioxx cases. New York Times, Aug. 21, 2007.
So now it's three years down the road. And, as Alex Berenson reports in the New York Times, the liability risk once estimated to be as high as $25 billion has shrunk to $5 billion. And after Merck stock plunged at the first adverse jury award, it has since regained 80 percent of its value.
How has Merck done it? It has simply decided to use its financial muscle ($1 billion so far spent on legal fees) to fight each case individually, and to appeal every adverse ruling all the way up. The courts have helped by insisting that each case be tried separately and opposing any class action suits.
The medical facts work in Merck's favor in such a setting. We can know, on a population basis, that there may have been as many as 140,000 excess heart attacks in the U.S. during the five years that Vioxx was on the market after the risks were clear. The problem is to translate that number into the reasonable certainty that John Doe of Podunk, East Dakota was one of those heart attacks--that he had his particular heart attack when he did because he took Vioxx, and that his high blood pressure, high cholesterol, or other risk factors had nothing to do with it. So far, in most cases that have come to court, Merck lawyers have managed to create reasonable doubt that Vioxx was the cause of the heart attack. And, in the case of Robert Ernst, where the jury found against the company and demanded $253 million, the case is still tied up in appeals and the Ernst family lawyer predicts that if they see any money at all, it won't be until 2010.
I'm no legal expert, but it seems from this vantage point that if you want to have your day in court in the U.S., having an extra billion or so dollars in your pocket does not hurt.
Berenson A. Plaintiffs find payday elusive in Vioxx cases. New York Times, Aug. 21, 2007.
Monday, August 20, 2007
Some Discouraging News about Training Pharmacy Residents
Previous studies on what happens when you train medical residents about how to interact with drug company detailers ("reps") have been somewhat mixed and not all that encouraging. For one thing, you do not get residents who turn down opportunities to take stuff from the reps. But at least some studies show that residents can become more skeptical about the marketing messages received from the industry as a result of such training.
A recent study looking at pharmacy residents is discouraging even on this count.
Ashker and Burkiewicz reported on a web-based survey of 496 pharmacy residents (estimated to be about a third of potential responders). One-quarter of the residents who responded had received some sort of training regarding interactions with industry, and 60 percent said their institutions had policies regarding such interactions--though over half of that subset reported that the policies did not change their interactions.
The group, by overwhelming margins, viewed as appropriate education gifts, free samples, and attendance at dinners and meals. They balked only at "noneducational" gifts which 69 percent viewed as somewhat or very inappropriate.
Interestingly, residents at institutions that had policies, or that had received training, were less likely to believe that they or their peers were influenced by industry marketing. They did, however, receive fewer gifts (as self-reported) and were more likely to view noneducational gifts as inappropriate.
There are a number of limitations for this survey and its methods, but if we take the results at face value, it certainly is not very reassuring that educating residents (in this case, pharmacy residents, who if anything ought to be more skeptical about the industry's message than medical residents) produces the changes in behavior that I would see as desirable. I would argue that this is one more bit of evidence that it is vain to imagine that the status quo in interactions between medicine and the industry is a given, and so the best we can do is educate our trainees to act more appropriately in this environment. The only effective activity is something that changes the status quo.
Ashker S, Burkiewicz JS. Pharmacy residents' attitudes toward pharmaceutical industry promotion. Am J Health-Syst Pharm 64:1724-31, August 15, 2007
A recent study looking at pharmacy residents is discouraging even on this count.
Ashker and Burkiewicz reported on a web-based survey of 496 pharmacy residents (estimated to be about a third of potential responders). One-quarter of the residents who responded had received some sort of training regarding interactions with industry, and 60 percent said their institutions had policies regarding such interactions--though over half of that subset reported that the policies did not change their interactions.
The group, by overwhelming margins, viewed as appropriate education gifts, free samples, and attendance at dinners and meals. They balked only at "noneducational" gifts which 69 percent viewed as somewhat or very inappropriate.
Interestingly, residents at institutions that had policies, or that had received training, were less likely to believe that they or their peers were influenced by industry marketing. They did, however, receive fewer gifts (as self-reported) and were more likely to view noneducational gifts as inappropriate.
There are a number of limitations for this survey and its methods, but if we take the results at face value, it certainly is not very reassuring that educating residents (in this case, pharmacy residents, who if anything ought to be more skeptical about the industry's message than medical residents) produces the changes in behavior that I would see as desirable. I would argue that this is one more bit of evidence that it is vain to imagine that the status quo in interactions between medicine and the industry is a given, and so the best we can do is educate our trainees to act more appropriately in this environment. The only effective activity is something that changes the status quo.
Ashker S, Burkiewicz JS. Pharmacy residents' attitudes toward pharmaceutical industry promotion. Am J Health-Syst Pharm 64:1724-31, August 15, 2007
Thursday, August 16, 2007
Avorn: Give FDA Committees Some Credit
People like me tend to think badly of the FDA's recent track record. The FDA funding bill now in House-Senate conference committee perpetuates the system of allowing industry user fees to fund much of the drug review process, making the agency more beholden to the industry. The Senators who shepherded the bipartisan compromise bill through, Kennedy and Enzi, seem to have bought into the line of bunkum that if the FDA advisory committees were actually required to exclude those who had financial conflicts of interest, there would be no "experts" left to fill the committee slots.
Dr. Jerry Avorn of Harvard, author of Powerful Medicines and a well-known critic of the pharmaceutical industry and regulatory system, writes in this week's New England Journal that it is not as bad as all that. He reviews several recent decisions from FDA scientific advisory committees that show considerable backbone in standing up for drug safety and protecting the U.S. public. He compares the recent drug action to an action on a similar drug within the past decade, and shows that for the drugs Arcoxia (anti-inflammatory) and rimonabant (weight loss), the recent decision was much more scientifically defensible and hard-nosed than was the previous one. The one disappointment he admits to is Avandia, noting that its advantages as a drug for diabetes are so meager that it is hardly defensible to keep it on the market in light of fears of increased heart risks.
Avorn has basically given up on the FDA or Congress cleaning up its own messes and so calls on the scientists who serve on the external advisory committes to shoulder the burden of standing up for the facts. He reminds us that when we compare the regulation of the drug industry with the energy, defense and finance sectors, we have it head and shoulders above them in our ability to bring rationality and science to bear on the problems, even with our present flawed system.
Avorn J. Keeping science on top in drug evaluation [perspective]. New England Journal of Medicine 357:633-35, Aug. 16, 2007.
Dr. Jerry Avorn of Harvard, author of Powerful Medicines and a well-known critic of the pharmaceutical industry and regulatory system, writes in this week's New England Journal that it is not as bad as all that. He reviews several recent decisions from FDA scientific advisory committees that show considerable backbone in standing up for drug safety and protecting the U.S. public. He compares the recent drug action to an action on a similar drug within the past decade, and shows that for the drugs Arcoxia (anti-inflammatory) and rimonabant (weight loss), the recent decision was much more scientifically defensible and hard-nosed than was the previous one. The one disappointment he admits to is Avandia, noting that its advantages as a drug for diabetes are so meager that it is hardly defensible to keep it on the market in light of fears of increased heart risks.
Avorn has basically given up on the FDA or Congress cleaning up its own messes and so calls on the scientists who serve on the external advisory committes to shoulder the burden of standing up for the facts. He reminds us that when we compare the regulation of the drug industry with the energy, defense and finance sectors, we have it head and shoulders above them in our ability to bring rationality and science to bear on the problems, even with our present flawed system.
Avorn J. Keeping science on top in drug evaluation [perspective]. New England Journal of Medicine 357:633-35, Aug. 16, 2007.
New England Journal Study: DTC Ads Increase
A study published in today's New England Journal shows that despite some predictions, industry spending on direct-to-consumer (DTC) ads have steadily increased over the past several years, both in absolute dollars and as a percentage of total advertising costs. An unlooked-for finding is that in 2005, for the first time, spending on drug detailing dropped from the previous year. (The figures were obtained from PhRMA and from various commercial firms that track industry marketing trends.)
Specifically, DTC ads fell off a little in 2002 but then rebounded from 2003 to 2005 (the last year for which data are available). In 2005, the industry spent $4.2B on DTC, which was 14 percent of total promotional spending. By contrast, in 2004, the industry spent $7.6B on detailing (26 percent); the next year this figure dropped to $6.8B (22.6 percent), all figures being converted to 2005 dollars.
Total spending for promotion in 2005 was $29.9 B, which increased from $11.4B in 1996. That represented 18.2 percent of total industry sales revenues.
While DTC ads expanded, the ability and/or willingness of the FDA to police them dropped off. In 1997, the FDA issued 142 notification letters for violation of regulations in advertising; this had fallen to 21 in 2006. The authors note data from the FDA that make it much more likely this drop was due to lack of personnel than to improved compliance.
The authors also provide data to show that the DTC budget is skewed toward a few heavily advertised drugs. The list of leading drugs for DTC is headed by Nexium, Lunesta, Vytorin, Crestor, Advair, and Nasonex. Nexium, as the top drug, had $224M spent in DTC ads. By contrast, drug #7, Flonase, had only $111M, and drug #20, Prevacid, got only $71M.
Comments: The total promotional spending figure of almost $30B is news; previous articles had tended to repeat the earlier figure of around $21B. According to the analysis offered by Marcia Angell in her book, The Truth about the Drug Companies, the true figure is still higher than this and probably tops $40B, due to so many of the true promotional costs being hidden. I also believe that this figure is low because of the author's claim that companies spend only 18 percent of revenue on promotion; for reasons explained in HOOKED, I think the better estimate is nearer 30 percent.
It had been widely predicted in recent years that DTC spending had topped and was about to drop, due to the public apparently having become saturated with ads so that they were losing effectiveness. The makers of that funny stuff called "Head On" seem to have figured out that annoying the heck out of you with their ads is actually a good way to sell theior product, and maybe Pharma is reading out of the same playbook.
While noting that DTC still represents a small slice of promotional costs compared to detailing and "free" samples, it is proportionately growing, especially now that costs of detailing have actually dropped-- apparently due to recently announced layoffs in sales force as the reps trip over each other all trying to see a limited number of physicians. If so we might see even lower figures for detailing costs when 2006 and 2007 numbers become available.
Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer advertising of prescription drugs. New England Journal of Medicine 357:673-81, Aug. 16, 2007.
Specifically, DTC ads fell off a little in 2002 but then rebounded from 2003 to 2005 (the last year for which data are available). In 2005, the industry spent $4.2B on DTC, which was 14 percent of total promotional spending. By contrast, in 2004, the industry spent $7.6B on detailing (26 percent); the next year this figure dropped to $6.8B (22.6 percent), all figures being converted to 2005 dollars.
Total spending for promotion in 2005 was $29.9 B, which increased from $11.4B in 1996. That represented 18.2 percent of total industry sales revenues.
While DTC ads expanded, the ability and/or willingness of the FDA to police them dropped off. In 1997, the FDA issued 142 notification letters for violation of regulations in advertising; this had fallen to 21 in 2006. The authors note data from the FDA that make it much more likely this drop was due to lack of personnel than to improved compliance.
The authors also provide data to show that the DTC budget is skewed toward a few heavily advertised drugs. The list of leading drugs for DTC is headed by Nexium, Lunesta, Vytorin, Crestor, Advair, and Nasonex. Nexium, as the top drug, had $224M spent in DTC ads. By contrast, drug #7, Flonase, had only $111M, and drug #20, Prevacid, got only $71M.
Comments: The total promotional spending figure of almost $30B is news; previous articles had tended to repeat the earlier figure of around $21B. According to the analysis offered by Marcia Angell in her book, The Truth about the Drug Companies, the true figure is still higher than this and probably tops $40B, due to so many of the true promotional costs being hidden. I also believe that this figure is low because of the author's claim that companies spend only 18 percent of revenue on promotion; for reasons explained in HOOKED, I think the better estimate is nearer 30 percent.
It had been widely predicted in recent years that DTC spending had topped and was about to drop, due to the public apparently having become saturated with ads so that they were losing effectiveness. The makers of that funny stuff called "Head On" seem to have figured out that annoying the heck out of you with their ads is actually a good way to sell theior product, and maybe Pharma is reading out of the same playbook.
While noting that DTC still represents a small slice of promotional costs compared to detailing and "free" samples, it is proportionately growing, especially now that costs of detailing have actually dropped-- apparently due to recently announced layoffs in sales force as the reps trip over each other all trying to see a limited number of physicians. If so we might see even lower figures for detailing costs when 2006 and 2007 numbers become available.
Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer advertising of prescription drugs. New England Journal of Medicine 357:673-81, Aug. 16, 2007.
Monday, August 6, 2007
Excellent Series in LA Times on Pharma's Influence
Los Angeles Times reporter Melisa Healy has assembled a great series of articles, appearing today (August 6) in the Health section of that paper:
http://www.latimes.com/features/health/la-he-drugintro6aug06,1,6647049.story?coll=la-headlines-health
See this article and click the several links for "related articles." Disclosure: Yours truly is prominently featured in the last in the series.
Here are some fact-updates from a couple of the articles:
According to Dartmouth marketing professor Scott Neslin, the return on investment for $1 spent on the following marketing techniques by the drug industry are: advertising in medical journals, $5.00; meetings or continuing education, $3.56; direct to consumer ads, $1.37; average detailing of drugs to physicians, $1.72; detailing of aggressively marketed drugs, >$10. (This shows why the industry is starting to sour on DTC ads, and continues to surprise us as to how great the payoff is from the old-fashioned journal ad.)
Data on drug reps: Healy estimates there are still about 100,000 of them despite recent talk of layoffs; they earn on average $81K annually (she does not say if this is before or after bonuses).
http://www.latimes.com/features/health/la-he-drugintro6aug06,1,6647049.story?coll=la-headlines-health
See this article and click the several links for "related articles." Disclosure: Yours truly is prominently featured in the last in the series.
Here are some fact-updates from a couple of the articles:
According to Dartmouth marketing professor Scott Neslin, the return on investment for $1 spent on the following marketing techniques by the drug industry are: advertising in medical journals, $5.00; meetings or continuing education, $3.56; direct to consumer ads, $1.37; average detailing of drugs to physicians, $1.72; detailing of aggressively marketed drugs, >$10. (This shows why the industry is starting to sour on DTC ads, and continues to surprise us as to how great the payoff is from the old-fashioned journal ad.)
Data on drug reps: Healy estimates there are still about 100,000 of them despite recent talk of layoffs; they earn on average $81K annually (she does not say if this is before or after bonuses).
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