Latest Drugwonks' Blog
The word is that drug companies are now seeking to determine whether diabetes drugs can be used to prevent diabetes in those people who are on the cusp of the condition. I am waiting for the Seattle Times or another media outlet to run a story claiming that this effort to treat diabetes before it progresses is disease mongering designed to "get rich" just as it slimed effort to treat "pre-hypertension" as disease mongering a while ago. But of course, rolling out high priced products to treat people who are very sick is gouging those who have no choice. And since the data comes from drug companies or researchers who receive drug company money, the results can't be trusted in any event.
So we should simply ignore the evidence and medicine until truly pure research conducted on people at death's door is generated and results in medicines that are given away for free or at a generic price are made available.
But maybe I am being too idealistic....
So we should simply ignore the evidence and medicine until truly pure research conducted on people at death's door is generated and results in medicines that are given away for free or at a generic price are made available.
But maybe I am being too idealistic....
Another example of how and why drug safety is divorced from personal responsibility...talk shows seeking to depict those who abuse them as victims. This is post from an Ambien addiction website:
Hi Everyone,
I've been reading everyone's posts and I can truly say that Ambien seems to be affecting more and more people in this regard than many might think. I'm an associate producer for the Montel Williams Show and we're currently doing research on Ambien addiction and sleep disorders in conjunction with a sleep clinic here in NY. If you're interested in trying to beat this addiction or if you would like to share your story regarding sleep disorders, you're not alone and maybe we can help.
Feel free to contact me any time for more information
mike@montelshow.com
Now in fairness Montel Williams usually plays this kind of thing straight but to suggest that "Ambien affects more and more people..." is the sort of claim that one hopes is placed in context.
Hi Everyone,
I've been reading everyone's posts and I can truly say that Ambien seems to be affecting more and more people in this regard than many might think. I'm an associate producer for the Montel Williams Show and we're currently doing research on Ambien addiction and sleep disorders in conjunction with a sleep clinic here in NY. If you're interested in trying to beat this addiction or if you would like to share your story regarding sleep disorders, you're not alone and maybe we can help.
Feel free to contact me any time for more information
mike@montelshow.com
Now in fairness Montel Williams usually plays this kind of thing straight but to suggest that "Ambien affects more and more people..." is the sort of claim that one hopes is placed in context.
do prices never increase...as in the average premiums of Medicare part D plans. In the first phase of the program some plans had some incredibly low monthly premiums...about $4 a month for a standard plan with $250 deductible. Now these plans are raising the deductible to about $11 a month -- the outrage! -- with some plans that have no deductible actually lowering their premiums. That's what Aetna and Humana have done with some plans that fill the coverage gap. And some managed care plans are lowering premiums for programs that include drugs and all other care -- integrating coverage in order to insure that drugs are used to reduce the total cost of care if possible. But that never enters into Waxman's calculations.
I've penned a new op-ed running in today's edition of the San Diego Union-Tribune on the issue that won't go away -- drug importation. Even though it says it's authored by Leonard Pitts, it's actually written by yours truly (note citation at the end of the article). We rarely get confused in person.
Click on this link and then go to "Today's Paper" and then to "Opinion."
http://www.signonsandiego.com
Have a look and spread the word that we must transcend the soundbites about drug importation.
Click on this link and then go to "Today's Paper" and then to "Opinion."
http://www.signonsandiego.com
Have a look and spread the word that we must transcend the soundbites about drug importation.
From today's edition of the Wall Street Journal ...
Faster FDA Cures
Whoever controls Congress next year, the Food and Drug Administration is sure to be a political battleground. The controversial Prescription Drug User Fee Act of 1992 is scheduled for reauthorization, and the conventional political wisdom holds that the FDA is too "cozy" with Big Pharma and thus overeager to rubber-stamp dangerous new drugs.
So allow us to draw attention to an important and undernoticed study, "Assessing the Safety and Efficacy of the FDA," published by the National Bureau of Economic Research. Its surprising conclusion is that the FDA does a pretty good job managing "the central speed-safety trade-off" involved in drug approvals -- and might even do well to move faster.
The authors looked at 662 drugs approved between 1979 and 2002, a period that included the passage of the Prescription Drug User Fee Act that allowed drug companies to help fund the FDA budget in exchange for faster reviews. They found that the resulting modest gains in drug review times have produced unambiguous public benefits.
In monetary terms, the authors estimate that the law improved consumer welfare by as much as $19 billion. But more importantly, they found that more rapid access to beneficial drugs saved between 180,000 and 310,000 "life-years." By contrast, assuming that every risky drug withdrawn in that period was the fault of the Prescription Drug User Fee Act produces an upper-bound estimate of only 56,000 life-years lost.
This study deserves a lot more attention than it's been getting, since the Washington debate is dominated by bad ideas about how to make FDA regulation much more onerous. In particular, a recent report from the National Academy of Science's Institute of Medicine (IOM) is being spun as evidence that the FDA is somehow "broken" and in need of fundamental reform.
We've looked at the IOM report in detail, and it's hardly as damning of the FDA as media reports suggest. For example, the report explicitly rejects the idea that high-profile drug withdrawals -- such as Vioxx -- "represent de facto failures of the drug safety regulatory system. . . This is not so." The IOM also rejects the basic idea behind legislation sponsored by Senators Chuck Grassley and Chris Dodd that the FDA should have a drug safety office separate from the office that approves drugs in the first place: "Risk and benefit cannot be considered in isolation from one another."
But despite these sensible observations, the IOM still wants more regulation. Among its recommendations are vastly increased levels of post-approval safety monitoring. That might make sense if the goal is making regulators comfortable with the idea of approving drugs more quickly. But that doesn't appear to be what the IOM and its cheering section want.
The IOM also proposes draconian restrictions on new-drug advertising and tighter conflict-of-interest standards for FDA advisory panel members. This despite the fact that the most qualified scientists and doctors have substantial sources of private income, and despite a study by the Naderite Public Citizen group that failed to find one instance of a panel recommendation that would have changed if allegedly conflicted members had been excluded.
Most fundamentally, the IOM presents little evidence that there is even a problem to remedy. By contrast, the National Bureau authors at least attempt to put some real facts on the table. They note that the absence of other attempts at hard, quantitative analysis in the great FDA debate is "somewhat paradoxical, since despite the agency's strict adherence to evidence-based evaluation of products overseen, there is less evidence on its own safety and efficacy. Put differently, no product application would pass the FDA approval process with the quality and type of evidence that currently exists for evaluating the FDA policies themselves."
The upshot of the economists' report is that the 1992 Prescription Drug User Fee Act deserves reauthorization. But the evidence also suggests Congress should probably be looking for other ways to make FDA approvals still faster. Despite the high-profile Vioxx panic, the FDA is far more likely to kill by depriving you of a drug than allowing you to take a dangerous one.
Faster FDA Cures
Whoever controls Congress next year, the Food and Drug Administration is sure to be a political battleground. The controversial Prescription Drug User Fee Act of 1992 is scheduled for reauthorization, and the conventional political wisdom holds that the FDA is too "cozy" with Big Pharma and thus overeager to rubber-stamp dangerous new drugs.
So allow us to draw attention to an important and undernoticed study, "Assessing the Safety and Efficacy of the FDA," published by the National Bureau of Economic Research. Its surprising conclusion is that the FDA does a pretty good job managing "the central speed-safety trade-off" involved in drug approvals -- and might even do well to move faster.
The authors looked at 662 drugs approved between 1979 and 2002, a period that included the passage of the Prescription Drug User Fee Act that allowed drug companies to help fund the FDA budget in exchange for faster reviews. They found that the resulting modest gains in drug review times have produced unambiguous public benefits.
In monetary terms, the authors estimate that the law improved consumer welfare by as much as $19 billion. But more importantly, they found that more rapid access to beneficial drugs saved between 180,000 and 310,000 "life-years." By contrast, assuming that every risky drug withdrawn in that period was the fault of the Prescription Drug User Fee Act produces an upper-bound estimate of only 56,000 life-years lost.
This study deserves a lot more attention than it's been getting, since the Washington debate is dominated by bad ideas about how to make FDA regulation much more onerous. In particular, a recent report from the National Academy of Science's Institute of Medicine (IOM) is being spun as evidence that the FDA is somehow "broken" and in need of fundamental reform.
We've looked at the IOM report in detail, and it's hardly as damning of the FDA as media reports suggest. For example, the report explicitly rejects the idea that high-profile drug withdrawals -- such as Vioxx -- "represent de facto failures of the drug safety regulatory system. . . This is not so." The IOM also rejects the basic idea behind legislation sponsored by Senators Chuck Grassley and Chris Dodd that the FDA should have a drug safety office separate from the office that approves drugs in the first place: "Risk and benefit cannot be considered in isolation from one another."
But despite these sensible observations, the IOM still wants more regulation. Among its recommendations are vastly increased levels of post-approval safety monitoring. That might make sense if the goal is making regulators comfortable with the idea of approving drugs more quickly. But that doesn't appear to be what the IOM and its cheering section want.
The IOM also proposes draconian restrictions on new-drug advertising and tighter conflict-of-interest standards for FDA advisory panel members. This despite the fact that the most qualified scientists and doctors have substantial sources of private income, and despite a study by the Naderite Public Citizen group that failed to find one instance of a panel recommendation that would have changed if allegedly conflicted members had been excluded.
Most fundamentally, the IOM presents little evidence that there is even a problem to remedy. By contrast, the National Bureau authors at least attempt to put some real facts on the table. They note that the absence of other attempts at hard, quantitative analysis in the great FDA debate is "somewhat paradoxical, since despite the agency's strict adherence to evidence-based evaluation of products overseen, there is less evidence on its own safety and efficacy. Put differently, no product application would pass the FDA approval process with the quality and type of evidence that currently exists for evaluating the FDA policies themselves."
The upshot of the economists' report is that the 1992 Prescription Drug User Fee Act deserves reauthorization. But the evidence also suggests Congress should probably be looking for other ways to make FDA approvals still faster. Despite the high-profile Vioxx panic, the FDA is far more likely to kill by depriving you of a drug than allowing you to take a dangerous one.
Yesterday I was privileged to participate in the latest in a series of Senator John Breaux’s “Ceasefire†debates. (Ceasefire events bring together a variety of speakers with opposing viewpoints in an effort to find common ground. Past speakers include former Speaker of the House Newt Gingrich, Senator Hillary Rodham Clinton, Former Secretaries of HHS Donna Shalala and Tommy Thompson, Press Secretaries Ari Fleischer and Mike McCurry, and former Senators Tom Daschle and Ron Nickles. The Ceasefire on Healthcare series is made possible by a grant from Pfizer Inc.)
I was paired with David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project at the Progressive Policy Institute.
We had, what’s the right word here, a robust conversation. The entire debate will shortly be posted (as a podcast) at http://www.ceasefireonhealthcare.org/podcast, but I wanted to share two things that seemed especially germane and interesting –
(1) We debated whether or not physician “pay-for-performance†is a good thing. (My position is that it all depends on what “performance†means.) Consider this – if we limit what medicines doctors can prescribe based on cost-centric rather than patient-centric models, how can we possibly measure “performance†outcomes?
(2) Senator Breaux asked if we thought health care would play a major role in the up coming Presidential election. David said, “yes.†I said “no.â€
If the current debate over health care is any indication, what we’re in store for is too many months of sounds bites, finger pointing, and pharma bashing.
And that is not a debate over health care.
I was paired with David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project at the Progressive Policy Institute.
We had, what’s the right word here, a robust conversation. The entire debate will shortly be posted (as a podcast) at http://www.ceasefireonhealthcare.org/podcast, but I wanted to share two things that seemed especially germane and interesting –
(1) We debated whether or not physician “pay-for-performance†is a good thing. (My position is that it all depends on what “performance†means.) Consider this – if we limit what medicines doctors can prescribe based on cost-centric rather than patient-centric models, how can we possibly measure “performance†outcomes?
(2) Senator Breaux asked if we thought health care would play a major role in the up coming Presidential election. David said, “yes.†I said “no.â€
If the current debate over health care is any indication, what we’re in store for is too many months of sounds bites, finger pointing, and pharma bashing.
And that is not a debate over health care.
Maclean's, Mon 16 Oct 2006
Byline: DANYLO HAWALESHKA
In the pivotal courtroom scene from A Few Good Men, Tom Cruise shouts, "I want the truth!" at Jack Nicholson, whose truculent character is testifying. "You can't handle the truth!" Nicholson famously retorts. Today, in a real-life courtroom drama, CanWest MediaWorks Inc. has, in a manner, assumed Cruise's role, with a somewhat less altruistic goal in mind than simple verity.
In a civil lawsuit now before Ontario's Superior Court of Justice, CanWest contends Canadians are being denied important truths about prescription medications because of strict limits on drug advertising. Canada's largest media company claims the regulations thwart its constitutional right to freedom of expression.
CanWest's suit against the attorney general of Canada casts the country's Food and Drugs Act as the villain. The act forbids direct-to-consumer advertising (DTCA) that ties a prescription drug to a treatment, cure or disease. (It is illegal for CanWest to, for instance, run an ad to promote Viagra for impotence, but quite legal to separately publicize the brand, or the condition; there are no such restrictions on ads that target physicians exclusively in, say, trade journals.) In a sworn statement, Arturo Duran, a CanWest MediaWorks president, claims permitting DTCA in Canada would educate the public about drug risks and benefits. "There is no evidence to justify a ban on truthful advertising of prescription drugs," Duran says.
Byline: DANYLO HAWALESHKA
In the pivotal courtroom scene from A Few Good Men, Tom Cruise shouts, "I want the truth!" at Jack Nicholson, whose truculent character is testifying. "You can't handle the truth!" Nicholson famously retorts. Today, in a real-life courtroom drama, CanWest MediaWorks Inc. has, in a manner, assumed Cruise's role, with a somewhat less altruistic goal in mind than simple verity.
In a civil lawsuit now before Ontario's Superior Court of Justice, CanWest contends Canadians are being denied important truths about prescription medications because of strict limits on drug advertising. Canada's largest media company claims the regulations thwart its constitutional right to freedom of expression.
CanWest's suit against the attorney general of Canada casts the country's Food and Drugs Act as the villain. The act forbids direct-to-consumer advertising (DTCA) that ties a prescription drug to a treatment, cure or disease. (It is illegal for CanWest to, for instance, run an ad to promote Viagra for impotence, but quite legal to separately publicize the brand, or the condition; there are no such restrictions on ads that target physicians exclusively in, say, trade journals.) In a sworn statement, Arturo Duran, a CanWest MediaWorks president, claims permitting DTCA in Canada would educate the public about drug risks and benefits. "There is no evidence to justify a ban on truthful advertising of prescription drugs," Duran says.
Open Letter from the Ontario Pharmacists' Association
TORONTO, Oct. 11
Hon. Tony Clement
Minister of Health, Government of Canada
Minister's Office, Health Canada
Brooke Claxton Building, Tunney's Pasture
Ottawa, Canada K1A 0K9
Dear Minister,
Ontario pharmacists are gravely concerned about the imminent threat to Canada's prescription drug supply, and the corresponding public health and safety threat to Canadians, arising from legislative changes and relaxed enforcement measures in the United States that re-open America's border to the importation of prescription drugs by U.S. patients.
As you know, Congressional leaders struck a deal on September 29 to allow Americans to carry back from Canada a 90-day personal supply of prescription drugs through "foot traffic" importation. The Department of Homeland Security compounded this change by ceasing confiscation by Customs and Border Protection agents of drugs ordered over the Internet and mailed to Americans, effective October 9.
We appreciate that these developments represent political deal-making by American lawmakers to take high U.S. prescription drug costs off the table as an issue to protect incumbents in the U.S. mid-term elections. However, the impact on Canada is clear: we are back to a free-for-all for cross-border drug importation.
We are deeply disturbed that in spite of the serious implications for Canada's drug supply and the health and safety of Canadians, there is no evidence of consultation with the Government of Canada, or of any effort to ask how our pharmacists and drug experts view American patients raiding Canada's medicine cabinet.
Our pharmacists do not want to become America's drug store. Our job is to provide medications and expertise to Canadian patients, not provide solutions or the shortcomings of the U.S. health care system and its problem with high drug costs.
U.S. demand is more than ten times the size of Canadian supply. We do not have the capacity to feed America's need for lower-cost drugs, and unimpeded depletion of our supply poses a serious threat to public health and safety in Canada.
We are further concerned that the legitimizing of Internet drug purchases by Americans encourages fraud by offshore criminals posing as Canadian pharmacists and selling counterfeit drugs. This is a health and safety threat to both American and Canadian patients who rely on the reputation of Canadian pharmacists and buy drugs from what they believe are Canadian Internet pharmacies, believing them to be safe and genuine.
In fact, U.S. customs statistics on mail-order seizures show at least 10 per cent of packages purportedly from Canadian Internet pharmacies contain counterfeit drugs.
We believe it is prudent and reasonable to also call attention at this time to the renewed emergence with these U.S. legislative and enforcement changes of a national security vulnerability in both the U.S. and Canada arising from the re-opening of the door to the potential for drug terrorism, with drugs sent by mail used as a vehicle of attack on innocent members of the public.
In this respect, an April 2005 report to Congress warned "the nation's medicine supply is vulnerable to exploitation by organized criminals, drug traffickers and terrorists. We should not contemplate opening our borders to threats to our medicine supply when in all other aspects we are searching for ways to tighten the security of our borders."
While the legislative changes enacted to date do not support bulk importation, we note that proponents of the changes in Congress have indicated their interest and intent to bring forward "full-blown" importation legislation in the future. We must warn unequivocally that bulk importation would quickly deplete the Canadian drug supply and cause a crisis in drug
availability for Canadians - in one credible U.S. analysis, within 38 days.
We also have a more fundamental concern that these developments further encourage the use of Internet pharmacies by patients who bypass their own community pharmacists. Patients who do so jeopardize their health and risk dangerous drug interactions by relinquishing expert consultation and crucial pharmacist-patient interaction.
We are disappointed that the Government of Canada has stood idly by while the U.S. has made changes that threaten the Canadian prescription drug supply, pose a danger to the health and safety of Canadians, raise national security vulnerabilities and undermine the important, long-standing relationship between pharmacists and patients.
We respectfully call on the Government of Canada to take immediate action to protect Canada's prescription drug supply by banning prescription drug sales to U.S. patients by all means, including "foot traffic", Internet and mail order.
We look forward to your reply at your earliest convenience.
Marc Kealey
Chief Executive Officer
Ontario Pharmacists' Association
For further information: or to set up an interview, please contact: Mary-Anne Cedrone, Manager of Communications, Ontario Pharmacists' Association, (416) 441-0788 ext.4266, Cell: (416) 278-5582
TORONTO, Oct. 11
Hon. Tony Clement
Minister of Health, Government of Canada
Minister's Office, Health Canada
Brooke Claxton Building, Tunney's Pasture
Ottawa, Canada K1A 0K9
Dear Minister,
Ontario pharmacists are gravely concerned about the imminent threat to Canada's prescription drug supply, and the corresponding public health and safety threat to Canadians, arising from legislative changes and relaxed enforcement measures in the United States that re-open America's border to the importation of prescription drugs by U.S. patients.
As you know, Congressional leaders struck a deal on September 29 to allow Americans to carry back from Canada a 90-day personal supply of prescription drugs through "foot traffic" importation. The Department of Homeland Security compounded this change by ceasing confiscation by Customs and Border Protection agents of drugs ordered over the Internet and mailed to Americans, effective October 9.
We appreciate that these developments represent political deal-making by American lawmakers to take high U.S. prescription drug costs off the table as an issue to protect incumbents in the U.S. mid-term elections. However, the impact on Canada is clear: we are back to a free-for-all for cross-border drug importation.
We are deeply disturbed that in spite of the serious implications for Canada's drug supply and the health and safety of Canadians, there is no evidence of consultation with the Government of Canada, or of any effort to ask how our pharmacists and drug experts view American patients raiding Canada's medicine cabinet.
Our pharmacists do not want to become America's drug store. Our job is to provide medications and expertise to Canadian patients, not provide solutions or the shortcomings of the U.S. health care system and its problem with high drug costs.
U.S. demand is more than ten times the size of Canadian supply. We do not have the capacity to feed America's need for lower-cost drugs, and unimpeded depletion of our supply poses a serious threat to public health and safety in Canada.
We are further concerned that the legitimizing of Internet drug purchases by Americans encourages fraud by offshore criminals posing as Canadian pharmacists and selling counterfeit drugs. This is a health and safety threat to both American and Canadian patients who rely on the reputation of Canadian pharmacists and buy drugs from what they believe are Canadian Internet pharmacies, believing them to be safe and genuine.
In fact, U.S. customs statistics on mail-order seizures show at least 10 per cent of packages purportedly from Canadian Internet pharmacies contain counterfeit drugs.
We believe it is prudent and reasonable to also call attention at this time to the renewed emergence with these U.S. legislative and enforcement changes of a national security vulnerability in both the U.S. and Canada arising from the re-opening of the door to the potential for drug terrorism, with drugs sent by mail used as a vehicle of attack on innocent members of the public.
In this respect, an April 2005 report to Congress warned "the nation's medicine supply is vulnerable to exploitation by organized criminals, drug traffickers and terrorists. We should not contemplate opening our borders to threats to our medicine supply when in all other aspects we are searching for ways to tighten the security of our borders."
While the legislative changes enacted to date do not support bulk importation, we note that proponents of the changes in Congress have indicated their interest and intent to bring forward "full-blown" importation legislation in the future. We must warn unequivocally that bulk importation would quickly deplete the Canadian drug supply and cause a crisis in drug
availability for Canadians - in one credible U.S. analysis, within 38 days.
We also have a more fundamental concern that these developments further encourage the use of Internet pharmacies by patients who bypass their own community pharmacists. Patients who do so jeopardize their health and risk dangerous drug interactions by relinquishing expert consultation and crucial pharmacist-patient interaction.
We are disappointed that the Government of Canada has stood idly by while the U.S. has made changes that threaten the Canadian prescription drug supply, pose a danger to the health and safety of Canadians, raise national security vulnerabilities and undermine the important, long-standing relationship between pharmacists and patients.
We respectfully call on the Government of Canada to take immediate action to protect Canada's prescription drug supply by banning prescription drug sales to U.S. patients by all means, including "foot traffic", Internet and mail order.
We look forward to your reply at your earliest convenience.
Marc Kealey
Chief Executive Officer
Ontario Pharmacists' Association
For further information: or to set up an interview, please contact: Mary-Anne Cedrone, Manager of Communications, Ontario Pharmacists' Association, (416) 441-0788 ext.4266, Cell: (416) 278-5582
If you want a concise explanation as to why the drug safety issue is spiraling out of control and how the media's reporting on such issues contributes to a sense of danger in every drug, read this excellent post from The Scientist.....
A few years ago Princeton health economist Uwe Reinhardt, Dartmouth geriatrician Joann Lynn, and I filmed a documentary on the effect of advancing biomedical technology on affordable healthcare in the United States. Five hours of interviews were reduced to 10-minute bookends for a set of short, emotional stories that obliterated the complexities of the issues. As Reinhardt quipped in our cab, repeating the oft-cited quote, the plural of anecdote is not data. Except on television.
We've all had this experience: You bring work home and talk about concepts central to biomedical research such as evidence-based medicine, controlled trials, equipoise, peer-review, or impact factor. Friends' eyes roll up into their skulls in boredom. Yet the same topics come up in everyday conversation all the time, just framed in a different way: "I know a person who lost his house to the cost of drugs," and "you know a guy who is alive because of Lipitor." Heated arguments ensue about real problems in science, but driven by someone's single story.
Stories are not the enemy of good science and evidence-based medicine. Physicians make crucial but subtle changes in their practices based on individual experiences. Scientists all use intuition and inductive reasoning in the nascent period of an investigation. But anecdotes cannot substitute for either ethnography or controlled study. When Terri Schiavo became the world's test case for diagnosing persistent vegetative state (PVS), the emotional intonations about Ms. Schiavo waking up began to sound like Intelligent Design.
A paradox of biomedical research is that huge controlled trials, meta-analyses, and reviews of the literature are ubiquitous, but the number of "case reports" - and journals comprised entirely of incidental "findings" - is growing.
The media has no idea how to deal with case reports. The worst example of this in recent times was a case study of Zolpidem, the nonbenzodiazepine-branded 'Ambien' and approved by the US Food & Drug Administration for the treatment of insomnia. Physicians Ralf Clauss and Wally Nel have published, a few cases at a time, their very different use of the medication. The Guardian carried a breathless report of Clauss et al's August report in the journal NeuroRehabilitation of three cases involving patients who have been in PVS, they report, for more than three years. Claus and Nel grabbed the front page with the Guardian's report that they used Ambien to wake up these patients.
The 'investigators' had administered Zolpidem for between three and six years and saw each of the three 'treated' patients wake up each day as a result of the medication; one even "caught a baseball." When the medication wore off, the patients dropped back into PVS each evening.
Stunning science? It seemed so, too, back in 2000, when Claus and a different set of South African colleagues published in the South African Medical Journal on a single case with essentially the same outcome. In 2001 they made the same claim in a letter to the same journal. At no point did the investigators conduct an actual study of the phenomenon, with an IRB-approved research protocol or informed consent. Again and again they "wrote up" their "cases," describing their work as innovative medical management rather than research. Journal editors, asleep at the switch, have been derelict in publishing bad research disguised as cases - in this instance a case with the impact of finding a life-extending potion or the presence of extraterrestrial life.
Investigators who jumpstart their programs with case reports are often in search of research support, as was Claus - who as a result of the case report is now funded. In this respect they, and the journals who publish nothing but these case reports, are like the television producers I worked with: They aim at using the power of stories to make the claims and reap the rewards that come from research, but without doing the research. The victims are journalists, readers, and in the Claus case the patients and their families, who are exposed to uncontrolled experiments framed as good medicine. It is time for editors, journalists, the FDA, and the US Health & Human Services Office for Human Research Protections (OHRP) to clamp down on the "case study."
Glenn McGee is the director of the Alden March Bioethics Institute at Albany Medical College, where he holds the John A. Balint Endowed Chair in Medical Ethics.
gmcgee@the-scientist.com
A few years ago Princeton health economist Uwe Reinhardt, Dartmouth geriatrician Joann Lynn, and I filmed a documentary on the effect of advancing biomedical technology on affordable healthcare in the United States. Five hours of interviews were reduced to 10-minute bookends for a set of short, emotional stories that obliterated the complexities of the issues. As Reinhardt quipped in our cab, repeating the oft-cited quote, the plural of anecdote is not data. Except on television.
We've all had this experience: You bring work home and talk about concepts central to biomedical research such as evidence-based medicine, controlled trials, equipoise, peer-review, or impact factor. Friends' eyes roll up into their skulls in boredom. Yet the same topics come up in everyday conversation all the time, just framed in a different way: "I know a person who lost his house to the cost of drugs," and "you know a guy who is alive because of Lipitor." Heated arguments ensue about real problems in science, but driven by someone's single story.
Stories are not the enemy of good science and evidence-based medicine. Physicians make crucial but subtle changes in their practices based on individual experiences. Scientists all use intuition and inductive reasoning in the nascent period of an investigation. But anecdotes cannot substitute for either ethnography or controlled study. When Terri Schiavo became the world's test case for diagnosing persistent vegetative state (PVS), the emotional intonations about Ms. Schiavo waking up began to sound like Intelligent Design.
A paradox of biomedical research is that huge controlled trials, meta-analyses, and reviews of the literature are ubiquitous, but the number of "case reports" - and journals comprised entirely of incidental "findings" - is growing.
The media has no idea how to deal with case reports. The worst example of this in recent times was a case study of Zolpidem, the nonbenzodiazepine-branded 'Ambien' and approved by the US Food & Drug Administration for the treatment of insomnia. Physicians Ralf Clauss and Wally Nel have published, a few cases at a time, their very different use of the medication. The Guardian carried a breathless report of Clauss et al's August report in the journal NeuroRehabilitation of three cases involving patients who have been in PVS, they report, for more than three years. Claus and Nel grabbed the front page with the Guardian's report that they used Ambien to wake up these patients.
The 'investigators' had administered Zolpidem for between three and six years and saw each of the three 'treated' patients wake up each day as a result of the medication; one even "caught a baseball." When the medication wore off, the patients dropped back into PVS each evening.
Stunning science? It seemed so, too, back in 2000, when Claus and a different set of South African colleagues published in the South African Medical Journal on a single case with essentially the same outcome. In 2001 they made the same claim in a letter to the same journal. At no point did the investigators conduct an actual study of the phenomenon, with an IRB-approved research protocol or informed consent. Again and again they "wrote up" their "cases," describing their work as innovative medical management rather than research. Journal editors, asleep at the switch, have been derelict in publishing bad research disguised as cases - in this instance a case with the impact of finding a life-extending potion or the presence of extraterrestrial life.
Investigators who jumpstart their programs with case reports are often in search of research support, as was Claus - who as a result of the case report is now funded. In this respect they, and the journals who publish nothing but these case reports, are like the television producers I worked with: They aim at using the power of stories to make the claims and reap the rewards that come from research, but without doing the research. The victims are journalists, readers, and in the Claus case the patients and their families, who are exposed to uncontrolled experiments framed as good medicine. It is time for editors, journalists, the FDA, and the US Health & Human Services Office for Human Research Protections (OHRP) to clamp down on the "case study."
Glenn McGee is the director of the Alden March Bioethics Institute at Albany Medical College, where he holds the John A. Balint Endowed Chair in Medical Ethics.
gmcgee@the-scientist.com
Now that the Yankees were eliminated from the ALCS in humiliating fashion I have found myself channel surfing to fill the time....I stumbled upon a C-SPAN broadcast of the debate between Congressman Harold Ford, Jr. and Bob Corker, the Dem and GOP candidates for Bill Frist's Tennessee Senate seat. I might have been hallucinating but I think I heard Ford say 2-3 times that if the government negotiated with drug companies (price controls) it could save Medicare $1 trillion. Since the Part D program will spend about $500 billion over ten years, I am waiting for Ford to explain his math. Or does he have a plan to force drug companies to kick in twice what the government spends on medicines? Or maybe this is over 100 years...
In any event, Ford's koolaid drinking on price controls contrasts with the bill he co-sponsored with Cal Dooley in 2003 which itself sounds and adds up remarkably like the Part D program now in operation. In case Ford forgot or you didn't know about it, here it is:
Zero-Premium, High-Cost Protection, Part B Drug Benefit
Universal ... Progressive ... Affordable
• Zero Premium: This benefit would be incorporated into the existing Medicare Part B
program. No separate premium and no increase in Part B premium.
• Universal Eligibility: All Part B enrollees.
• Universal Protection Against High Drug Costs: Medicare will pay 80 percent of the
cost of drugs after beneficiary has total drug costs of $4,000. The individual will pay
based on a flat three-tiered co-payment: $4/$16/$24*
• Benefit Counts All Drug Spending: Negotiated drug costs Β not just the
beneficiaries= out-of-pocket spending Î’ counts toward the $4,000 deductible.
• Low-Income Benefits: Beneficiaries up to 200 percent of poverty will be eligible to
receive enhanced benefits via Medicare drug discount cards, Medicare+Choice,
Medicaid, Medigap, and other new coverage options.
Medicaid – 135% of fpl tiered co-payment: $4/$16/$24*
135% - 150% of fpl tiered co-payment: $6/$24/$36**
150% - 200% of fpl tiered co-payment: $10/$40/$60***
(State option with a federal/state match at the SCHIP rate)
• Universal Benefit Via Medicare Approved Drug Card Plans: A wide variety of
Medicare approved drug card plans including PBMs, State Assistance Plans, retiree
coverage, Medigap, Medicare + Choice, Medicaid and others that offer all seniors access
to the market-based discounts widely available to people with private insurance. These
discounts would apply to all drug purchases.
• Universal Benefit Via Current Coverage: Encourage the continuation of current
drug coverage through Employer/Retiree plans, Medigap plans, Medicaid, State
pharmaceutical assistance plans, or Medicare+Choice plans; all based on
reimbursement agreements with Medicare.
• CBO Cost Estimate: Under $400 billion
"Market-based discounts" "PBMs" "Under 400 billion" Sounds like a program we already know.
I am still waiting to see how the D's will 'negotiate' down drug prices without closing down formularies and restricting choices like the VA does. Can anyone say Third Rail?
In any event, Ford's koolaid drinking on price controls contrasts with the bill he co-sponsored with Cal Dooley in 2003 which itself sounds and adds up remarkably like the Part D program now in operation. In case Ford forgot or you didn't know about it, here it is:
Zero-Premium, High-Cost Protection, Part B Drug Benefit
Universal ... Progressive ... Affordable
• Zero Premium: This benefit would be incorporated into the existing Medicare Part B
program. No separate premium and no increase in Part B premium.
• Universal Eligibility: All Part B enrollees.
• Universal Protection Against High Drug Costs: Medicare will pay 80 percent of the
cost of drugs after beneficiary has total drug costs of $4,000. The individual will pay
based on a flat three-tiered co-payment: $4/$16/$24*
• Benefit Counts All Drug Spending: Negotiated drug costs Β not just the
beneficiaries= out-of-pocket spending Î’ counts toward the $4,000 deductible.
• Low-Income Benefits: Beneficiaries up to 200 percent of poverty will be eligible to
receive enhanced benefits via Medicare drug discount cards, Medicare+Choice,
Medicaid, Medigap, and other new coverage options.
Medicaid – 135% of fpl tiered co-payment: $4/$16/$24*
135% - 150% of fpl tiered co-payment: $6/$24/$36**
150% - 200% of fpl tiered co-payment: $10/$40/$60***
(State option with a federal/state match at the SCHIP rate)
• Universal Benefit Via Medicare Approved Drug Card Plans: A wide variety of
Medicare approved drug card plans including PBMs, State Assistance Plans, retiree
coverage, Medigap, Medicare + Choice, Medicaid and others that offer all seniors access
to the market-based discounts widely available to people with private insurance. These
discounts would apply to all drug purchases.
• Universal Benefit Via Current Coverage: Encourage the continuation of current
drug coverage through Employer/Retiree plans, Medigap plans, Medicaid, State
pharmaceutical assistance plans, or Medicare+Choice plans; all based on
reimbursement agreements with Medicare.
• CBO Cost Estimate: Under $400 billion
"Market-based discounts" "PBMs" "Under 400 billion" Sounds like a program we already know.
I am still waiting to see how the D's will 'negotiate' down drug prices without closing down formularies and restricting choices like the VA does. Can anyone say Third Rail?
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
