Many people think that laughter is really the only sensible reaction to the advertising excesses of the drug industry. Check out this site:
http://www.havidol.com/
An article in BMJ explains that this site is the brainchild of Australian artist Justine Cooper. What's scary, however, is that it has apparently been mistaken for a serious pharmaceutical website by many users and cross-listed on websites dealing with anxiety and depression. (The drug Havidol purports to treat the dread disease "DSACDAD" or "dysphoric social attention consumption deficit anxiety disorder", and of course the website features the obligatory quiz to tell you if you have this disease and so can qualify for taking Havidol for the rest of your life.)
Coombes R. Having the last laugh at big pharma. BMJ 334:396-97, 2007.
Wednesday, February 28, 2007
The Prescription Project: New Link
I've just added a link to The Prescription Project, funded by the Pew Charitable Trusts and affiliated with the Institute on Medicine as a Profession at Columbia. It's an outgrowth of a key paper published a little more than a year ago in JAMA, calling for major policy changes in academic medical centers to eliminate the conflicts of interest created by too-cozy relationships with the pharmaceutical industry (Brennan TA, Rothman DJ, Blank L, et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers.
JAMA 2006;295:429-433). Time will tell whether this new organization will become a forceful player on the U.S. scene.
JAMA 2006;295:429-433). Time will tell whether this new organization will become a forceful player on the U.S. scene.
Sunday, February 25, 2007
Patents: A Helpful Analysis
The current issue of the Hastings Center Report contains a 36-page supplement, "Patents, Biomedical Research, and Treatments: Examining Concerns, Canvassing Solutions," by Josephine Johnston and Angela A. Wasunna. The report provides an extensive review of the current status of patents and licenses in pharmaceutical marketing, with special focus on problems in the developing world, with an especially complete catalogue of possible reform measures.
The report nicely supplements the discussion of patents in HOOKED, and confirms the position that patents are tools of public policy, not basic rights (as the oft-used phrase, "intellectual property rights," is intended to convey). If patents produce consequences that run contrary to good public policy, as often occurs in pharmaceuticals, then we need additional measures of some sort to mitigate those bad consequences. High on the list are questions of whether people in developing countries will be able to afford medications needed for life and health; and whether in the future, pharmaceutical firms will discover desperately needed new medicines for afflictions prevalent in poorer nations.
Johnston J, Wasunna AA. Patents, biomedical research, and treatments: examining concerns, canvassing solutions. Hastings Center Report 37(1):S1-S36, 2007; http://www.thehastingscenter.org/patents-biomedical-research-treatment.asp
The report nicely supplements the discussion of patents in HOOKED, and confirms the position that patents are tools of public policy, not basic rights (as the oft-used phrase, "intellectual property rights," is intended to convey). If patents produce consequences that run contrary to good public policy, as often occurs in pharmaceuticals, then we need additional measures of some sort to mitigate those bad consequences. High on the list are questions of whether people in developing countries will be able to afford medications needed for life and health; and whether in the future, pharmaceutical firms will discover desperately needed new medicines for afflictions prevalent in poorer nations.
Johnston J, Wasunna AA. Patents, biomedical research, and treatments: examining concerns, canvassing solutions. Hastings Center Report 37(1):S1-S36, 2007; http://www.thehastingscenter.org/patents-biomedical-research-treatment.asp
Thursday, February 22, 2007
Patient Advocacy Groups: In the Pockets of Industry?
Michael Day, writing in BMJ (the British Medical Journal in olden days), relates an account of a World Health organization official who apparently tried to launder a drug company contribution through the European Parkinson's Disease Association. The WHO rules don't allow accepting drug company money to fund reports and othjer activities of WHO; but WHO is chronically short of money. In an ironic twist, when the company (GlaxoSmithKline) found out about this plan, which would deny it any credit for supporting the WHO report, it refused to go along, indignantly protesting the hypocrisy of the arrangement.
One quote from the article is worth the price of admission: Tim Reid, identified as European director of Health Action International, dedicated to supporting the rational and ethical use of drugs, said, "Patients' groups are so close to the industry, that they might as well be taking money straight out of the drug company advertising budgets."
On the U.S. scene, there are a few indications that the wind may be shifting slightly, as Marc Santora wrote last fall in the New York Times. He described how the American Diabetes Association, stung by negative publicity, is trying to tighten up its rules about accepting industry donations. (In the case of the ADA the PR problem was less drug company money--with which ADA is replete by the way--and rather accepting money from manufacturers of junk foods.)
Day M. Who's funding WHO? BMJ 334: 338-40, Feb. 17, 2007.
Santora M. In diabetes fight, raising cash and keeping trust. New York Times, Nov. 26, 2006: A1.
One quote from the article is worth the price of admission: Tim Reid, identified as European director of Health Action International, dedicated to supporting the rational and ethical use of drugs, said, "Patients' groups are so close to the industry, that they might as well be taking money straight out of the drug company advertising budgets."
On the U.S. scene, there are a few indications that the wind may be shifting slightly, as Marc Santora wrote last fall in the New York Times. He described how the American Diabetes Association, stung by negative publicity, is trying to tighten up its rules about accepting industry donations. (In the case of the ADA the PR problem was less drug company money--with which ADA is replete by the way--and rather accepting money from manufacturers of junk foods.)
Day M. Who's funding WHO? BMJ 334: 338-40, Feb. 17, 2007.
Santora M. In diabetes fight, raising cash and keeping trust. New York Times, Nov. 26, 2006: A1.
Wednesday, February 21, 2007
A Doctor Takes his Camera to the Medical Conference
In HOOKED, Chapter 11 I offer the reader a sort of guided tour of the pharamceutical exhibits at a major medical conference--in that case, the Berlin Psychiatric Congress. Staying a bit closer to home, "Kevin, MD," a practicing primary care physician, has collected a photo collage of the exhibit hall of a U.S. primary care conference, "Pri-Med". Check it out on his blog-site:
http://www.kevinmd.com/blog/2006/10/how-to-get-doctors-attention-or-how.html
Be sure to read the comments-- they are very insightful. Especially one commenting that the surgeons, at their conferences, have MUCH more professional looking sales folks selling them stuff, and none of this carnival-sideshow stuff.
http://www.kevinmd.com/blog/2006/10/how-to-get-doctors-attention-or-how.html
Be sure to read the comments-- they are very insightful. Especially one commenting that the surgeons, at their conferences, have MUCH more professional looking sales folks selling them stuff, and none of this carnival-sideshow stuff.
Tuesday, February 20, 2007
Ads in Medical Journals: A Serious Problem?
In HOOKED, I spent relatively little space discussing pharmaceutical ads in medical journals. I did this in part because I figured that ads are less worrisome as a source of influence over physicians, due to the fact that they are very clearly labeled as "ads" and no one tries to pretend that they are education, etc.--unlike other practices such as continuing education, visits from drug detail people, etc. Had I seen a paper that appeared last summer, I might have devoted more attention to the issue.
Fugh-Berman and colleagues (writing in PLoS Medicine, an internet journal that accepts no advertising) dug deeper than I had, especially in spotlighting the ways that medical journals go fishing for ad business. They had the good sense to check out some of the medical journals' own websites in which the abjectly plead for advertising revenue, putting forward an image that is pretty far removed from their "public" image as dispasionate, incorruptable purveyors of scientific truth. The authors conclude that the near-total reliance of the journals on ad revenue from the pharmaceutical industry cannot help but bias the editorial decisions. They make the interesting suggestion that it has long been thought "professional" that top-notch journals only advertise pharmaceuticals and things that are part of direct service to patients; they do not run ads for cars, or things that have to do with the physician's own lifestyle. Fugh-Berman et al argue that this "professionalism" actually undermines professional values in medicine and that if the advertising in medical journals was more diversified, it would at least be a help.
Fugh-Berman A, Alladin K, Chow J. Advertising in medical journals: should current practices change? PLoS Med 3:e130, 2006. http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0030130
Fugh-Berman and colleagues (writing in PLoS Medicine, an internet journal that accepts no advertising) dug deeper than I had, especially in spotlighting the ways that medical journals go fishing for ad business. They had the good sense to check out some of the medical journals' own websites in which the abjectly plead for advertising revenue, putting forward an image that is pretty far removed from their "public" image as dispasionate, incorruptable purveyors of scientific truth. The authors conclude that the near-total reliance of the journals on ad revenue from the pharmaceutical industry cannot help but bias the editorial decisions. They make the interesting suggestion that it has long been thought "professional" that top-notch journals only advertise pharmaceuticals and things that are part of direct service to patients; they do not run ads for cars, or things that have to do with the physician's own lifestyle. Fugh-Berman et al argue that this "professionalism" actually undermines professional values in medicine and that if the advertising in medical journals was more diversified, it would at least be a help.
Fugh-Berman A, Alladin K, Chow J. Advertising in medical journals: should current practices change? PLoS Med 3:e130, 2006. http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0030130
Saturday, February 10, 2007
More Teen Suicides Due to Less Medication?
According to CDC statistics, teen suicides rose from 2.2 per 100,000 to 2.6 per 100,000 in 2004, an 18% increase. This was the first increase seen in more than a decade:
http://www.medpagetoday.com/tbprint.cfm?tbid=5005&topicid=138
The article reporting this finding (which had originally appeared in the journal Pediatrics) quoted several experts claiming that a likely cause of this rise was the new black box warning that the FDA required to be placed on SSRI antidepressants (selective serotonin reuptake inhibitors), warning of the increased risk of suicidal behavior in children and teens.
In HOOKED, I reviewed some of the evidence on how the pharmaceutical industry tried its best to hide and to deny this risk, which is a small but real concern. (See post below on the BBC program "Panorama" from last month which looked at this story.)
There has been a standard response from many child psychiatrists, most often those in bed with the industry--that it's terrible to impugn the SSRI drugs, because it will prompt physicians to stop prescribing them for teens, which will lead to untreated and worsening depression among teens, which will cause many more suicides than would ever be the case had SSRIs been widely used. (This response came only after the first industry ploy failed--that kids who engaged in suicidal behavior did so not because of the drug, but due to the underlying depression. That has been shown to be false since non-depressed teens given SSRIs have been shown to display the same sort of behavior.)
So when I saw psychiatrists claiming that this increase in suicide is due to the mean old FDA beating up the poor drug companies, I naturally wondered about the money trail.
Two major authorities are cited in the MedPage article: Dr. Charles Nemeroff of Emery University, and Dr. David Fassler, affiliated with the University of Vermont. Dr. Nemeroff is probably Exhibit A for unrepentent conflict of interest in high places in American medicine. He was exposed last year in the Wall Street Journal after he was forced to resign as editor of a psychiatric journal, due to the journal publishing a paper that he wrote advocating an implanted electric device for treating depression, without disclosing that Nemeroff was a shareholder in the company that makes the device. That led to a maudlin letter to the editor from 40-odd psychiatrists, all protesting that their colleague was a person of the highest integrity and how dare the WSJ impugn his honor.
Dr. Fassler has published much less in scholarly journals lately and so I was unable to see if he has direct financial ties to drug companies. He is a member of the board of Mental Health America. This is a legitimate advocacy organization, with numerous local chapters, which is supported in part by the MacArthur Foundation. But it also boasts among its donors most of the major drug companies, to the tune of $500K to $1M each.
So: did decreased use of SSRIs lead to this increase in teen suicide? Well, first one would like to know if there are any data that fewer SSRIs were in fact prescribed. Studies in the past have shown that physicians are actually pretty good at ignoring black box warnings. Second, to make the claim plausible, one would need to believe that the SSRI drugs are really very effective in treating depression in teens. But the available studies in fact show either no effect or very little effect. The relatively poor performance of SSRI drugs generally, not to mention their risks, is one of the better-kept secrets in drug industry marketing.
MedPage, to its credit, indicated skepticism as to whether the black-box-warning claim was the true reason for the rise in suicides.
What is perhaps saddest about this dispute is that it probably never had to arise at all. I am not a child psychiatrist or an expert in the use of SSRIs. But as best as I can understand, the behavioral syndrome that is related to SSRIs, and that prompts the suicidal or occasionally homicidal behavior, is a very specific syndrome called akithisia. It typically occurs in the first few weeks of starting therapy with an SSRI. Most patients have oppressive, intrustive thoughts of harming themselves or others, and had they immediately stopped taking the drug when those thoughts occurred, the harm would probably have been prevented in almost all cases.
Now, suppose the drug companies had been interested in science and patient care, instead of marketing and sales. As soon as this risk became known, it might have been widely publicized. Doctors could have been told by the ubiquitous drug sales reps: Watch your patients like a hawk for the first few weeks of treatment for this specific syndrome. Make sure that they and their family members know to stop the drug right away if it occurs. If after those first few weeks you haven't seen this--and thankfully it is rare--you are probably home free. This warning would have reduced the risk of anyone being harmed by this side effect by perhaps 90% at least, while still allowing physicians to prescribe SSRIs widely (assuming that they really work--see above). But no, the companies had to let their marketing concerns override quality medical care.
http://www.medpagetoday.com/tbprint.cfm?tbid=5005&topicid=138
The article reporting this finding (which had originally appeared in the journal Pediatrics) quoted several experts claiming that a likely cause of this rise was the new black box warning that the FDA required to be placed on SSRI antidepressants (selective serotonin reuptake inhibitors), warning of the increased risk of suicidal behavior in children and teens.
In HOOKED, I reviewed some of the evidence on how the pharmaceutical industry tried its best to hide and to deny this risk, which is a small but real concern. (See post below on the BBC program "Panorama" from last month which looked at this story.)
There has been a standard response from many child psychiatrists, most often those in bed with the industry--that it's terrible to impugn the SSRI drugs, because it will prompt physicians to stop prescribing them for teens, which will lead to untreated and worsening depression among teens, which will cause many more suicides than would ever be the case had SSRIs been widely used. (This response came only after the first industry ploy failed--that kids who engaged in suicidal behavior did so not because of the drug, but due to the underlying depression. That has been shown to be false since non-depressed teens given SSRIs have been shown to display the same sort of behavior.)
So when I saw psychiatrists claiming that this increase in suicide is due to the mean old FDA beating up the poor drug companies, I naturally wondered about the money trail.
Two major authorities are cited in the MedPage article: Dr. Charles Nemeroff of Emery University, and Dr. David Fassler, affiliated with the University of Vermont. Dr. Nemeroff is probably Exhibit A for unrepentent conflict of interest in high places in American medicine. He was exposed last year in the Wall Street Journal after he was forced to resign as editor of a psychiatric journal, due to the journal publishing a paper that he wrote advocating an implanted electric device for treating depression, without disclosing that Nemeroff was a shareholder in the company that makes the device. That led to a maudlin letter to the editor from 40-odd psychiatrists, all protesting that their colleague was a person of the highest integrity and how dare the WSJ impugn his honor.
Dr. Fassler has published much less in scholarly journals lately and so I was unable to see if he has direct financial ties to drug companies. He is a member of the board of Mental Health America. This is a legitimate advocacy organization, with numerous local chapters, which is supported in part by the MacArthur Foundation. But it also boasts among its donors most of the major drug companies, to the tune of $500K to $1M each.
So: did decreased use of SSRIs lead to this increase in teen suicide? Well, first one would like to know if there are any data that fewer SSRIs were in fact prescribed. Studies in the past have shown that physicians are actually pretty good at ignoring black box warnings. Second, to make the claim plausible, one would need to believe that the SSRI drugs are really very effective in treating depression in teens. But the available studies in fact show either no effect or very little effect. The relatively poor performance of SSRI drugs generally, not to mention their risks, is one of the better-kept secrets in drug industry marketing.
MedPage, to its credit, indicated skepticism as to whether the black-box-warning claim was the true reason for the rise in suicides.
What is perhaps saddest about this dispute is that it probably never had to arise at all. I am not a child psychiatrist or an expert in the use of SSRIs. But as best as I can understand, the behavioral syndrome that is related to SSRIs, and that prompts the suicidal or occasionally homicidal behavior, is a very specific syndrome called akithisia. It typically occurs in the first few weeks of starting therapy with an SSRI. Most patients have oppressive, intrustive thoughts of harming themselves or others, and had they immediately stopped taking the drug when those thoughts occurred, the harm would probably have been prevented in almost all cases.
Now, suppose the drug companies had been interested in science and patient care, instead of marketing and sales. As soon as this risk became known, it might have been widely publicized. Doctors could have been told by the ubiquitous drug sales reps: Watch your patients like a hawk for the first few weeks of treatment for this specific syndrome. Make sure that they and their family members know to stop the drug right away if it occurs. If after those first few weeks you haven't seen this--and thankfully it is rare--you are probably home free. This warning would have reduced the risk of anyone being harmed by this side effect by perhaps 90% at least, while still allowing physicians to prescribe SSRIs widely (assuming that they really work--see above). But no, the companies had to let their marketing concerns override quality medical care.
Friday, February 9, 2007
Following the Money Trail: Much Quicker for the Media Today
One theme I expect to be taking up frequently in this blog is: are we seeing, today, a shift in public and political sentiment against the drug industry, so that momentum is increasing for the sorts of reforms recommended in HOOKED? Or is everything pretty much the same except for occasional blips?
I'll offer as a bit of evidence in favor of momentum how the press responded the Texas Gov. Perry's executive order last week that made Texas the first state in the nation to mandate immunizing preteen girls for the human papillomavirus (HPV), that causes most cases of cervical cancer:
http://www.chron.com/disp/story.mpl/ap/health/4523542.html
This Houston Chronicle article comes from the Associated Press, whose reporter, Liz Peterson, apparently had no trouble connecting the dots. The same article that mentioned the executive order simultaneously shone the light on two key connections--first, Perry's ties to Merck, the manufacturer of the vaccine; and second, Perry's connections with Women in Government and how that organization had received funding from Merck to push the adoption of the vaccine.
Contrast this with press coverage of the debate over Medicare Part D in 2003. As recounted in HOOKED, p. 236, when the AARP opposed some features of the bill, notably the prohibition against direct Medicare negotiations with the drug industry for volume discounts, it found itself opposed by organizations called United Seniors Association, 60 Plus Association, and Seniors Coalition. At first the media reported as if there was a genuine division of opinion among the elderly. As best as I recall, it took the press some time to figure out that these other groups were all "astroturf" (fake grass roots). They were funded solely by PR firms that were in turn funded by the drug companies; they had no offices and no membership lists.
It appears that some things the drug industry used to get away with routinely are now much more difficult to pull off--more people are on to them. None of which answers the question: is it a good or a bad thing to mandate the use of the HPV vaccine? I'll vote with the American Academy of Pediatrics that it is probably premature at this point to have mandatory requirements. But drug industry money has so polluted both the political and the scientific processes, that once it became known that Merck was behind this effort, the scientific pros and cons were quickly lost sight of. That's why I argue that it's actually in the industry's interest, as well as the public's, to clean up this mess pronto.
Incidentally, while I have not done a lot of research on the term "astroturf," I assume that the use of fake grass inside domed stadiums began with the Houston Astrodome, so it is nice to see this language coming back home to Texas where it began.
I'll offer as a bit of evidence in favor of momentum how the press responded the Texas Gov. Perry's executive order last week that made Texas the first state in the nation to mandate immunizing preteen girls for the human papillomavirus (HPV), that causes most cases of cervical cancer:
http://www.chron.com/disp/story.mpl/ap/health/4523542.html
This Houston Chronicle article comes from the Associated Press, whose reporter, Liz Peterson, apparently had no trouble connecting the dots. The same article that mentioned the executive order simultaneously shone the light on two key connections--first, Perry's ties to Merck, the manufacturer of the vaccine; and second, Perry's connections with Women in Government and how that organization had received funding from Merck to push the adoption of the vaccine.
Contrast this with press coverage of the debate over Medicare Part D in 2003. As recounted in HOOKED, p. 236, when the AARP opposed some features of the bill, notably the prohibition against direct Medicare negotiations with the drug industry for volume discounts, it found itself opposed by organizations called United Seniors Association, 60 Plus Association, and Seniors Coalition. At first the media reported as if there was a genuine division of opinion among the elderly. As best as I recall, it took the press some time to figure out that these other groups were all "astroturf" (fake grass roots). They were funded solely by PR firms that were in turn funded by the drug companies; they had no offices and no membership lists.
It appears that some things the drug industry used to get away with routinely are now much more difficult to pull off--more people are on to them. None of which answers the question: is it a good or a bad thing to mandate the use of the HPV vaccine? I'll vote with the American Academy of Pediatrics that it is probably premature at this point to have mandatory requirements. But drug industry money has so polluted both the political and the scientific processes, that once it became known that Merck was behind this effort, the scientific pros and cons were quickly lost sight of. That's why I argue that it's actually in the industry's interest, as well as the public's, to clean up this mess pronto.
Incidentally, while I have not done a lot of research on the term "astroturf," I assume that the use of fake grass inside domed stadiums began with the Houston Astrodome, so it is nice to see this language coming back home to Texas where it began.
The Olivieri Case: She Said, They Said...
The worst nightmare of an author is that the day your book comes out, the news headlines proclaim that a basic fact, on which your book is based, has just been conclusively disproven. Fortunately this has not happened to me regarding HOOKED, but perhaps the nearest approach relates to my portrayal of the case of Dr. Nancy Olivieri of Toronto (Chapter 6, pp. 98-103).
The fly in the ointment is a newer book, by Dr. Miriam Shuchman, that tells a very different story from the accounts of the case that I relied on. I became aware of Shuchman's book only as HOOKED was going through its final round of revisions. I was able to get a footnote inserted at least to acknowledge the existence of the Shuchman book (note 2, pp. 113-14). But I had insufficient time to read and study the Shuchman volume. If I had had the time, I would probably have altered what I said about the Olivieri case.
The case, as it is generally known, is a compelling story of how the rapacious drug industry nearly ruins the career of an honest scientist who discovers a new, dangerous side effect to a potentially lucrative drug. It was so compelling that John Le Carre adapted it for his novel, The Constant Gardener. And the case appears to be impeccably documented--we have the 500-page, thoroughly referenced volume, The Olivieri Report, from the Canadian Association of University Teachers investigative team.
Shuchman, by contrast, tells quite a different story. How about: "Ambitious, vindictive scientist unfairly trashes the reputation of a good drug for a rare disease"? Dr. Olivieri comes across as a much more flawed and problematic character in the Shuchman account--one who, in all likelihood, brought a lot of her problems down around her own head. More important, according to Shuchman, are the scientific facts about the drug deferiprone (L1), used to prevent iron buildup in patients with the rare, inherited anemia, thalassemia major. Olivieri and her sympathizers, Shuchman says, have managed to persuade most US and Canadian physicians not to use the drug. But it has been widely used in Europe and elsewhere, and to date, its track record has been pretty good--far from the huge risk to patients' lives that Olivieri's research claimed it to be.
Dr. Olivieri's response to this so far has been a letter to CMAJ, the Canadian medical association journal (Olivieri N. A response from Dr. Nancy Olivieri [letter]. CMAJ 174(5):661-62, 2006). The letter is not terribly helpful; it is mostly an ad hominem attack against Shuchman, claiming that since her husband was associated with some of Olivieri's enemies, that proves that her account is flawed.
At this stage I am pessimistic that we will ever know the truth about this case. The people in a position to tell investigators what really happened and when, have divided themselves into pro- and anti-Olivieri camps; and depending on which side any new investigator appears to be on, one group will talk with her and the other will refuse to be interviewed. My tentative conclusion is that while the CAUT report is very well documented and persuasive on its face, any account of the Olivieri case based on that report will have to have an asterisk next to it, like the home run record of a baseball slugger accused of taking steroids.
Shuchman M. The drug trial: Nancy Olivieri and the science scandal that rocked the Hospital for Sick Children. Toronto: Random House Canada, 2005.
Thompson J, Baird P, Downie J. The Oliviert report: the complete text of the report of the independent inquiry commissioned by the Canadian Association of University Teachers. Toronto: John Lorimer and Company, 2001.
The fly in the ointment is a newer book, by Dr. Miriam Shuchman, that tells a very different story from the accounts of the case that I relied on. I became aware of Shuchman's book only as HOOKED was going through its final round of revisions. I was able to get a footnote inserted at least to acknowledge the existence of the Shuchman book (note 2, pp. 113-14). But I had insufficient time to read and study the Shuchman volume. If I had had the time, I would probably have altered what I said about the Olivieri case.
The case, as it is generally known, is a compelling story of how the rapacious drug industry nearly ruins the career of an honest scientist who discovers a new, dangerous side effect to a potentially lucrative drug. It was so compelling that John Le Carre adapted it for his novel, The Constant Gardener. And the case appears to be impeccably documented--we have the 500-page, thoroughly referenced volume, The Olivieri Report, from the Canadian Association of University Teachers investigative team.
Shuchman, by contrast, tells quite a different story. How about: "Ambitious, vindictive scientist unfairly trashes the reputation of a good drug for a rare disease"? Dr. Olivieri comes across as a much more flawed and problematic character in the Shuchman account--one who, in all likelihood, brought a lot of her problems down around her own head. More important, according to Shuchman, are the scientific facts about the drug deferiprone (L1), used to prevent iron buildup in patients with the rare, inherited anemia, thalassemia major. Olivieri and her sympathizers, Shuchman says, have managed to persuade most US and Canadian physicians not to use the drug. But it has been widely used in Europe and elsewhere, and to date, its track record has been pretty good--far from the huge risk to patients' lives that Olivieri's research claimed it to be.
Dr. Olivieri's response to this so far has been a letter to CMAJ, the Canadian medical association journal (Olivieri N. A response from Dr. Nancy Olivieri [letter]. CMAJ 174(5):661-62, 2006). The letter is not terribly helpful; it is mostly an ad hominem attack against Shuchman, claiming that since her husband was associated with some of Olivieri's enemies, that proves that her account is flawed.
At this stage I am pessimistic that we will ever know the truth about this case. The people in a position to tell investigators what really happened and when, have divided themselves into pro- and anti-Olivieri camps; and depending on which side any new investigator appears to be on, one group will talk with her and the other will refuse to be interviewed. My tentative conclusion is that while the CAUT report is very well documented and persuasive on its face, any account of the Olivieri case based on that report will have to have an asterisk next to it, like the home run record of a baseball slugger accused of taking steroids.
Shuchman M. The drug trial: Nancy Olivieri and the science scandal that rocked the Hospital for Sick Children. Toronto: Random House Canada, 2005.
Thompson J, Baird P, Downie J. The Oliviert report: the complete text of the report of the independent inquiry commissioned by the Canadian Association of University Teachers. Toronto: John Lorimer and Company, 2001.
Tuesday, February 6, 2007
BBC Airs Documentary on Concealed Risks of Paxil
BBC News "Panorama" on 1/29/07 aired an hour-long documentary on how GlaxoSmithKline concealed the risks of suicidal behavior among children and adolescents taking the antidepressant Paxil (as known in the U.S.; Seroxat in the U.K).
I tell the basic story of the concealment of these risks in the "Introduction" to HOOKED. The BBC documentary fleshes out the story considerably, based on access to internal GSK e-mails unearthed as part of the legal discovery process as families have sued the company. The printed version of the story can be found at: http://newsvote.bbc.co.uk/mpapps/pagetools/print/news.bbc.co.uk/1/hi/programmes/panorama/6291773.stm
The entire documentary can also be viewed online at the BBC website:
http://news.bbc.co.uk/1/hi/programmes/panorama/6291773.stm
Obviously GSK does not emerge from this documentary looking very good; but in my view, the people who come off least well in this debacle are some of the "expert" physicians who are part of GSK's expert speaker's bureau and who appear here to be little more than paid shills.
I tell the basic story of the concealment of these risks in the "Introduction" to HOOKED. The BBC documentary fleshes out the story considerably, based on access to internal GSK e-mails unearthed as part of the legal discovery process as families have sued the company. The printed version of the story can be found at: http://newsvote.bbc.co.uk/mpapps/pagetools/print/news.bbc.co.uk/1/hi/programmes/panorama/6291773.stm
The entire documentary can also be viewed online at the BBC website:
http://news.bbc.co.uk/1/hi/programmes/panorama/6291773.stm
Obviously GSK does not emerge from this documentary looking very good; but in my view, the people who come off least well in this debacle are some of the "expert" physicians who are part of GSK's expert speaker's bureau and who appear here to be little more than paid shills.
More Medical Centers Off Limits to Drug Reps
One of the significant developments during 2006 was the increasing number of medical schools and academic medical centers that have adopted strict new policies to limit the influence of the pharmaceutical industry, including taking steps to exclude pharmaceutical sales reps from many areas of campus where they used to have free access. The single policy that probably got the most press was at Stanford University; see their policy at: http://med.stanford.edu/coi/siip/documents/siip_policy_aug06.pdf
Other medical centers adopting tough policies in 2006 included Yale, UCLA, and Henry Ford in Detroit, with the U. of Virginia considering following suit (Zinie Chen Sampson, Associated Press, 1/18/07). Earlier schools to join the list include Wisconsin, Michigan and Pennsylvania. A more recent article in the LA Times indicated that UC-Davis was also about to adopt such a policy:
http://www.latimes.com/news/printedition/la-me-pharma4feb04,1,1930699.story
In at least some cases, the impetus for these policies may have been less a matter of ethical sensitivity on the part of the medical center, and more a fear of increased costs as reps marketed the most expensive new drugs to faculty and house staff. (Anecdotal reports would seem to indicate that the drug bills for some of these academic medical centers did indeed fall after the reps were largely banned.) More recently, I sense that there is a true concern for ethics and professionalism in prompting these measures--and this was the angle stressed by the LA Times story, which focused on the "pharm-free" movement among medical students. If in fact the wind is starting to blow in an anti-Pharma direction, these policies may be a bellwether. According to the LA Times account, a turning point may have been the appearance of an article by a number of distinguished academic physicians in JAMA about a year ago calling for these tough new policies in academic medical centers: Brennan TA, Rothman TJ, Blank L, et al. Health industry practices that cretae conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295:429-433.
Other medical centers adopting tough policies in 2006 included Yale, UCLA, and Henry Ford in Detroit, with the U. of Virginia considering following suit (Zinie Chen Sampson, Associated Press, 1/18/07). Earlier schools to join the list include Wisconsin, Michigan and Pennsylvania. A more recent article in the LA Times indicated that UC-Davis was also about to adopt such a policy:
http://www.latimes.com/news/printedition/la-me-pharma4feb04,1,1930699.story
In at least some cases, the impetus for these policies may have been less a matter of ethical sensitivity on the part of the medical center, and more a fear of increased costs as reps marketed the most expensive new drugs to faculty and house staff. (Anecdotal reports would seem to indicate that the drug bills for some of these academic medical centers did indeed fall after the reps were largely banned.) More recently, I sense that there is a true concern for ethics and professionalism in prompting these measures--and this was the angle stressed by the LA Times story, which focused on the "pharm-free" movement among medical students. If in fact the wind is starting to blow in an anti-Pharma direction, these policies may be a bellwether. According to the LA Times account, a turning point may have been the appearance of an article by a number of distinguished academic physicians in JAMA about a year ago calling for these tough new policies in academic medical centers: Brennan TA, Rothman TJ, Blank L, et al. Health industry practices that cretae conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295:429-433.
Monday, February 5, 2007
Welcome to the HOOKED blog
Welcome! I am creating this blog to accompany the recent publication of my book, Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry (Rowman and Littlefield, January 2007--see links). My major goal with this blog is to allow updates on the book's contents. The topic--the relationship between medicine and the pharmaceutical industry--is hot right now, and practically every day, new developments occur and new information is published. I wanted to have a platform to inform interested readers of those developments that seem to me especially pertinent or important, and that might modify some statement or fact given in the book.
I finished work on the book's manuscript in July 2006 (more or less). There is therefore a backlog of material that has been accumulating since then, that ideally would be made available to the book's readers to provide updates on important matters. In the course of the next several weeks I hope to attack that backlog and post those items to the blog. (As you can tell, I am not much of a blogger, else I'd have had the foresight to create the blog right off and keep up with that material .)
A blog also allows comments to be posted from readers and others, and I look forward to those opportunities to hear from you as well!
Thanks for visiting.
I finished work on the book's manuscript in July 2006 (more or less). There is therefore a backlog of material that has been accumulating since then, that ideally would be made available to the book's readers to provide updates on important matters. In the course of the next several weeks I hope to attack that backlog and post those items to the blog. (As you can tell, I am not much of a blogger, else I'd have had the foresight to create the blog right off and keep up with that material .)
A blog also allows comments to be posted from readers and others, and I look forward to those opportunities to hear from you as well!
Thanks for visiting.
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