Latest Drugwonks' Blog
here's my latest thoughts on the TB patient and what the limited significance of the case is versus the massive importance of TB itself.
This was my Oped in yesterday's Boston Globe.
Flying clear of tuberculosis
By Marc Siegel | June 6, 2007
FOLLOWING the news of Andrew Speaker's honeymoon escapade, where he flew unchecked while harboring a resistant tuberculosis bug, many of my patients have begun to ask me what their risks are of catching TB on a plane. The simple answer I give them is "extremely low." Big HEPA filters screen out more than 99 percent of viral and bacterial particles, including tuberculosis. The risk of Speaker infecting another passenger when he reportedly wasn't coughing, had no fever, and was receiving some treatment is probably less than 1 percent. The chance of an actual case of serious TB resulting from this exposure is even less than that, as there has not yet been a single case of active tuberculosis found to be the result of exposure on a plane.
Speaker suffers from the extensively drug resistant kind of tuberculosis, which is quite rare, with only 49 cases reported in the United States since 1993. TB itself is common, infecting one-third of the world's population, with more than 8 million people getting sick from it every year. Even with billions of airplane passengers every year, the plane is an unlikely place for TB transmission. There have been several small studies that have followed exposure to active TB on planes. From 1992 to 1994, the Centers for Disease Control and Prevention followed six passengers and a crew member who had TB in their sputum and exhibited active symptoms. Of the 2,600 contacts of these TB patients (two were deliberately flying without alerting the airline, the other five didn't know they had TB), only a few people showed subsequent transmission of TB and none got sick.
These patients were not only much sicker than Speaker, they were spewing TB in their sputum. The gold standard of transmissibility is the presence of the tuberculosis bacillus in the sputum or mucous of a patient. Speaker has been tested repeatedly, and his mucous is clear.
I have worked on the Chest Service of Bellevue Hospital where Speaker was briefly interned. It is routine practice for doctors there to remove masks and allow patients to roam the ward and even go home once their mucous tests negative. Speaker was no different. Isolation only became necessary once it was determined that his TB was so resistant that none of the standard treatments work for it. The fact that his brand of TB is so difficult to cure makes it that much more important to prevent spread even to a single person.
Speaker's case is a wakeup call for improved patient compliance. TB drug resistance is a growing problem, in part due to patients stopping their medicines partway through the treatment. It is often the same patients who don't take their medicines who also don't exercise the proper caution and put others at some risk. This is a good time for public health to employ more advanced genetic techniques to detect all drug resistance earlier and then restrict travel on an as-needed basis.
It is also a good time for public health officials to learn to communicate risk through facts rather than fear. Because of media dramatizations of rare killers, we tend to overpersonalize the dangers of the latest mystery bacteria or virus. Worldwide, tuberculosis itself is well worth being afraid of, but the numbers in the United States are much lower (14,000 cases per year). Americans fear it more now because of the hype, much as we once feared anthrax, smallpox, Mad Cow Disease, bird flu, and SARS. It is human nature to fear the unknown, but it is not good science.
Our civil rights should protect us from excess scrutiny every time we board a plane. But fear and distrust tend to erode these rights, which is why it is so important that we draw the right conclusions from the Speaker case.
Tuberculosis, a tiny hook-shaped airborne bacteria, is transmitted by deep coughing and prolonged exposure. Initial infections are generally very mild and TB goes on to cause significant disease in only 5 percent of cases, many of whom suffer from HIV or other chronic diseases.
More than 2 billion passengers fly on planes every year, but there has yet to be a documented case of someone getting sick with TB from an airplane exposure. Though TB kills close to 2 million people per year worldwide and cannot be trivialized, the more important lesson from Speaker is about public and media overreaction to remote risks.
This was my Oped in yesterday's Boston Globe.
Flying clear of tuberculosis
By Marc Siegel | June 6, 2007
FOLLOWING the news of Andrew Speaker's honeymoon escapade, where he flew unchecked while harboring a resistant tuberculosis bug, many of my patients have begun to ask me what their risks are of catching TB on a plane. The simple answer I give them is "extremely low." Big HEPA filters screen out more than 99 percent of viral and bacterial particles, including tuberculosis. The risk of Speaker infecting another passenger when he reportedly wasn't coughing, had no fever, and was receiving some treatment is probably less than 1 percent. The chance of an actual case of serious TB resulting from this exposure is even less than that, as there has not yet been a single case of active tuberculosis found to be the result of exposure on a plane.
Speaker suffers from the extensively drug resistant kind of tuberculosis, which is quite rare, with only 49 cases reported in the United States since 1993. TB itself is common, infecting one-third of the world's population, with more than 8 million people getting sick from it every year. Even with billions of airplane passengers every year, the plane is an unlikely place for TB transmission. There have been several small studies that have followed exposure to active TB on planes. From 1992 to 1994, the Centers for Disease Control and Prevention followed six passengers and a crew member who had TB in their sputum and exhibited active symptoms. Of the 2,600 contacts of these TB patients (two were deliberately flying without alerting the airline, the other five didn't know they had TB), only a few people showed subsequent transmission of TB and none got sick.
These patients were not only much sicker than Speaker, they were spewing TB in their sputum. The gold standard of transmissibility is the presence of the tuberculosis bacillus in the sputum or mucous of a patient. Speaker has been tested repeatedly, and his mucous is clear.
I have worked on the Chest Service of Bellevue Hospital where Speaker was briefly interned. It is routine practice for doctors there to remove masks and allow patients to roam the ward and even go home once their mucous tests negative. Speaker was no different. Isolation only became necessary once it was determined that his TB was so resistant that none of the standard treatments work for it. The fact that his brand of TB is so difficult to cure makes it that much more important to prevent spread even to a single person.
Speaker's case is a wakeup call for improved patient compliance. TB drug resistance is a growing problem, in part due to patients stopping their medicines partway through the treatment. It is often the same patients who don't take their medicines who also don't exercise the proper caution and put others at some risk. This is a good time for public health to employ more advanced genetic techniques to detect all drug resistance earlier and then restrict travel on an as-needed basis.
It is also a good time for public health officials to learn to communicate risk through facts rather than fear. Because of media dramatizations of rare killers, we tend to overpersonalize the dangers of the latest mystery bacteria or virus. Worldwide, tuberculosis itself is well worth being afraid of, but the numbers in the United States are much lower (14,000 cases per year). Americans fear it more now because of the hype, much as we once feared anthrax, smallpox, Mad Cow Disease, bird flu, and SARS. It is human nature to fear the unknown, but it is not good science.
Our civil rights should protect us from excess scrutiny every time we board a plane. But fear and distrust tend to erode these rights, which is why it is so important that we draw the right conclusions from the Speaker case.
Tuberculosis, a tiny hook-shaped airborne bacteria, is transmitted by deep coughing and prolonged exposure. Initial infections are generally very mild and TB goes on to cause significant disease in only 5 percent of cases, many of whom suffer from HIV or other chronic diseases.
More than 2 billion passengers fly on planes every year, but there has yet to be a documented case of someone getting sick with TB from an airplane exposure. Though TB kills close to 2 million people per year worldwide and cannot be trivialized, the more important lesson from Speaker is about public and media overreaction to remote risks.
In case you didn't see it in many press accounts, here's some of the exchanges between Steve Nissen and members of the House Oversight Committee
Patrick McHenry, R-N.C.: At what point did you begin your conversations
with
Chairman Waxman and his staff?
Steven Nissen: In February, I had looked at the DREAM and the ADOPT
study,
but I didn't have enough information actually to answer the question
scientifically. ...At the time, I was discussing with various
congressional
committees the pending legislation around the similar version of the
Kennedy/Enzi bill on the House side, and so I mentioned to them I had
concerns about the cardiovascular safety of Avandia. And I actually
requested their assistance in getting access to the data. I had
essentially
a scientific mystery: I didn't have the means to answer the question in
a
robust scientific way, and I really was looking for help.
McHenry: Did you provide your interim analysis to any member of the
Hill or
staff?
Nissen: There were no interim results. Basically what we had done was a
very
preliminary analysis - nothing formal...
McHenry: Did you provide a preliminary analysis?
Nissen: Yes.
McHenry: At what point did you have that and did you share it with Mr.
Waxman's staff?
Nissen: The same time - February.
McHenry: So they were aware you were going through the process?
Nissen: They were aware.
McHenry: Why didn't you discuss your preliminary analysis with the Food
and
Drug Administration?
Nissen: The Food and Drug Administration had all of these studies on
record.
When you do a study, you submit a study report to the FDA.
McHenry: But you were actually submitting to a medical journal a new
study.
...You proffer your work as original do you not?
Nissen: It is original.
McHenry: Then why didn't you share that study with the Food and Drug
Administration? After all, as members of Congress we have a regulatory
structure we put in place for drug safety. Why didn't you go to the
FDA?
Nissen: This is not how it's done.
McHenry: So, going to Capitol Hill for political purpose to get
publicity
during a hearing is actually the way it is done?
Nissen: With all due respect, sir, this is about patients, and it's not
about politics....
McHenry: If it is about patients, why would you not go to the regulator
who
has the authority and oversight of drug safety?
Nissen: This is about patients - not politics. I had a preliminary
result. I
was looking for assistance to complete the study. When it was
completed, I
did what any scientist would do. I sent that for peer review and for
publication.
McHenry: What peers do you have on the Oversight and Government Reform
staff
- the Democrat staff? Because you shared your findings with them. Is
that
what you consider peer review? Is that what you consider putting
patients
above politics?
Nissen: I did not give out my manuscript to this committee or anybody
else
until it was published.
McHenry: It seems very peculiar to me that if you are considering the
patients first that you not go to the regulator who is overseeing drug
safety, that you would go to Capitol Hill ... and we don't have any
authority to take a drug off the market like the FDA does.
Nissen: The regulatory agency had all of the data that I had and much,
much
more. ...It made no sense for me to take study-level data and submit it
to
the FDA when they already had the patient-level data. So I would not
have
given them anything they hadn't had for many, many months.
Elijah Cummings, D-Md.: I hate that we have to make these accusations
that
people [are] putting politics over the health of the American people.
That
bothers me. ...Dr. Buse and Dr. Psaty you've heard this line of
questioning.
You've heard what Dr. Nissen has said. Do you all have any issues with
the
professionalism that he has [exhibited] doing what he has done to get
this
information published?
John Buse, University of North Carolina: I have no issues at all, and I
think he did a nice job of organizing data and setting out that it was
imperfect but important for people hear about.
Patrick McHenry, R-N.C.: At what point did you begin your conversations
with
Chairman Waxman and his staff?
Steven Nissen: In February, I had looked at the DREAM and the ADOPT
study,
but I didn't have enough information actually to answer the question
scientifically. ...At the time, I was discussing with various
congressional
committees the pending legislation around the similar version of the
Kennedy/Enzi bill on the House side, and so I mentioned to them I had
concerns about the cardiovascular safety of Avandia. And I actually
requested their assistance in getting access to the data. I had
essentially
a scientific mystery: I didn't have the means to answer the question in
a
robust scientific way, and I really was looking for help.
McHenry: Did you provide your interim analysis to any member of the
Hill or
staff?
Nissen: There were no interim results. Basically what we had done was a
very
preliminary analysis - nothing formal...
McHenry: Did you provide a preliminary analysis?
Nissen: Yes.
McHenry: At what point did you have that and did you share it with Mr.
Waxman's staff?
Nissen: The same time - February.
McHenry: So they were aware you were going through the process?
Nissen: They were aware.
McHenry: Why didn't you discuss your preliminary analysis with the Food
and
Drug Administration?
Nissen: The Food and Drug Administration had all of these studies on
record.
When you do a study, you submit a study report to the FDA.
McHenry: But you were actually submitting to a medical journal a new
study.
...You proffer your work as original do you not?
Nissen: It is original.
McHenry: Then why didn't you share that study with the Food and Drug
Administration? After all, as members of Congress we have a regulatory
structure we put in place for drug safety. Why didn't you go to the
FDA?
Nissen: This is not how it's done.
McHenry: So, going to Capitol Hill for political purpose to get
publicity
during a hearing is actually the way it is done?
Nissen: With all due respect, sir, this is about patients, and it's not
about politics....
McHenry: If it is about patients, why would you not go to the regulator
who
has the authority and oversight of drug safety?
Nissen: This is about patients - not politics. I had a preliminary
result. I
was looking for assistance to complete the study. When it was
completed, I
did what any scientist would do. I sent that for peer review and for
publication.
McHenry: What peers do you have on the Oversight and Government Reform
staff
- the Democrat staff? Because you shared your findings with them. Is
that
what you consider peer review? Is that what you consider putting
patients
above politics?
Nissen: I did not give out my manuscript to this committee or anybody
else
until it was published.
McHenry: It seems very peculiar to me that if you are considering the
patients first that you not go to the regulator who is overseeing drug
safety, that you would go to Capitol Hill ... and we don't have any
authority to take a drug off the market like the FDA does.
Nissen: The regulatory agency had all of the data that I had and much,
much
more. ...It made no sense for me to take study-level data and submit it
to
the FDA when they already had the patient-level data. So I would not
have
given them anything they hadn't had for many, many months.
Elijah Cummings, D-Md.: I hate that we have to make these accusations
that
people [are] putting politics over the health of the American people.
That
bothers me. ...Dr. Buse and Dr. Psaty you've heard this line of
questioning.
You've heard what Dr. Nissen has said. Do you all have any issues with
the
professionalism that he has [exhibited] doing what he has done to get
this
information published?
John Buse, University of North Carolina: I have no issues at all, and I
think he did a nice job of organizing data and setting out that it was
imperfect but important for people hear about.
SO many things of interest from yesterday's House Oversight hearing, but by far the most memorable one was Dr. Steven Nissen answering a direct question with a direct answer.
The question was "Would you tell doctors to stop prescribing Avandia." And his answer was "No."
Indeed, the good doctor made the point that prescribing decisions should be made by a doctor in consultation with his patient and based on the available information.
We agree. It was a considered and measured response -- and under oath.
And we were surprised -- considering that it came from the same guy who a few evenings earlier on Nightline compared Avandia to "9-11."
We don't agree about that. It was a response considered and measured to maximize media coverage.
The take-away here is that there's too much hyperbole and hysteria out there right now -- and none of it's beneficial to anything other than politics. Scaring patients and physicians makes nothing safer. (Unfortunatly, it makes for terrific headlines.)
When it comes to advancing the public health, better to rely on 4-1-1 than 9-11.
The question was "Would you tell doctors to stop prescribing Avandia." And his answer was "No."
Indeed, the good doctor made the point that prescribing decisions should be made by a doctor in consultation with his patient and based on the available information.
We agree. It was a considered and measured response -- and under oath.
And we were surprised -- considering that it came from the same guy who a few evenings earlier on Nightline compared Avandia to "9-11."
We don't agree about that. It was a response considered and measured to maximize media coverage.
The take-away here is that there's too much hyperbole and hysteria out there right now -- and none of it's beneficial to anything other than politics. Scaring patients and physicians makes nothing safer. (Unfortunatly, it makes for terrific headlines.)
When it comes to advancing the public health, better to rely on 4-1-1 than 9-11.
China said late Tuesday that it was overhauling its food and drug safety regulations and would introduce nationwide inspections.
According to the New York Times, “The announcement, from the State Council, the nation’s highest administrative body, is the strongest signal yet that Beijing is moving to crack down on the sale of dangerous food and medicine and trying to calm fears that some of its exports pose health problems.
The government said in its announcement that it planned by 2010 to place new controls on food and drug imports and exports and to step up random testing on medicines. It also said that it would have information on inspections of 90 percent of all food products, although it was unclear how that would work.
Food and drug safety experts have complained for years about a flawed system that has led to food scares or mass poisonings tied to counterfeit or substandard medicines on the market.â€
Here’s a link to the complete article:
http://www.nytimes.com/2007/06/07/business/worldbusiness/07safety.html?hp
If our political leaders are truly concerned about drug safety (as so many are and as many others claim to be) we should hold China’s feet to the fire and make sure these reforms (which sound good) are implemented – and with alacrity.
According to the New York Times, “The announcement, from the State Council, the nation’s highest administrative body, is the strongest signal yet that Beijing is moving to crack down on the sale of dangerous food and medicine and trying to calm fears that some of its exports pose health problems.
The government said in its announcement that it planned by 2010 to place new controls on food and drug imports and exports and to step up random testing on medicines. It also said that it would have information on inspections of 90 percent of all food products, although it was unclear how that would work.
Food and drug safety experts have complained for years about a flawed system that has led to food scares or mass poisonings tied to counterfeit or substandard medicines on the market.â€
Here’s a link to the complete article:
http://www.nytimes.com/2007/06/07/business/worldbusiness/07safety.html?hp
If our political leaders are truly concerned about drug safety (as so many are and as many others claim to be) we should hold China’s feet to the fire and make sure these reforms (which sound good) are implemented – and with alacrity.
Here's Rita Rubin about the chain of events leading up to the black box warning about congestive heart failure and PPARs at the FDA:
"Grassley, whose office released the letter Wednesday, asked von Eschenbach to respond to allegations that Johann-Liang had been reprimanded for agreeing with her staff's recommendation that Avandia needed a black-box warning about congestive heart failure and stronger warnings about macular edema, a serious eye condition."
Let's be clear about who Johann-Liang is and her history. She is the same person who was selectively leaking stuff to Grassley on Ketek and recommended pulling the drug altogether. Her actions and dalliance with Grassley's staff have led delays and increased costs in antibiotic research. Her demand for a black box was in advance of both the Glaxo meta analysis, the DREAM results and the RECORD study. And both Takeda and Actos had previously sent out letters to prescribers warning about the elevated risks of their drugs to patients with a history of heart failure.
"The FDA, which had received data from Glaxo last August suggesting a 30% increased risk of heart attacks in Avandia users, did not alert patients and doctors about that possibility until Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, reported a similar finding, posted May 21 on The New England Journal of Medicine's website."
The facts are that the FDA had been working on this issue well in advance of the NIssen article -- as Nissen himself admitted in his testimony. Nissen's article was timed to pre-empt a pending FDA decision.
Rita again: " Glaxo should have begun enrolling high-risk diabetes patients in a large, long-term study when Avandia was approved in 1999. By now, Nissen said, the results would be in."
In fact, Glaxo did begin enrolling "high-risk diabetes patients in large long term study when Avandia was approved in 1999." It was called the DREAM study. It looked at heart problems as a secondary endpoint and was expected to have it's data blended with other studies looking at heart safety since the sample size alone was considered to be underpowered to determine RARE risks.
That's how safety signals are validated today in the absence of new IT and genomic tools. We could do it faster, better, more personalized and predictive.
Which is why Andy Von E kept on calling for more resources, not more authority to improve post market surveillance.
That's the rest of the story.
"Grassley, whose office released the letter Wednesday, asked von Eschenbach to respond to allegations that Johann-Liang had been reprimanded for agreeing with her staff's recommendation that Avandia needed a black-box warning about congestive heart failure and stronger warnings about macular edema, a serious eye condition."
Let's be clear about who Johann-Liang is and her history. She is the same person who was selectively leaking stuff to Grassley on Ketek and recommended pulling the drug altogether. Her actions and dalliance with Grassley's staff have led delays and increased costs in antibiotic research. Her demand for a black box was in advance of both the Glaxo meta analysis, the DREAM results and the RECORD study. And both Takeda and Actos had previously sent out letters to prescribers warning about the elevated risks of their drugs to patients with a history of heart failure.
"The FDA, which had received data from Glaxo last August suggesting a 30% increased risk of heart attacks in Avandia users, did not alert patients and doctors about that possibility until Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, reported a similar finding, posted May 21 on The New England Journal of Medicine's website."
The facts are that the FDA had been working on this issue well in advance of the NIssen article -- as Nissen himself admitted in his testimony. Nissen's article was timed to pre-empt a pending FDA decision.
Rita again: " Glaxo should have begun enrolling high-risk diabetes patients in a large, long-term study when Avandia was approved in 1999. By now, Nissen said, the results would be in."
In fact, Glaxo did begin enrolling "high-risk diabetes patients in large long term study when Avandia was approved in 1999." It was called the DREAM study. It looked at heart problems as a secondary endpoint and was expected to have it's data blended with other studies looking at heart safety since the sample size alone was considered to be underpowered to determine RARE risks.
That's how safety signals are validated today in the absence of new IT and genomic tools. We could do it faster, better, more personalized and predictive.
Which is why Andy Von E kept on calling for more resources, not more authority to improve post market surveillance.
That's the rest of the story.
From the Food and Drug Letter...
Senate Passes PDUFA Reauthorization Bill
The Senate passed a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) after adding an amendment to increase penalties for noncompliant drugmakers and narrowly rejecting two amendments that would have augmented other safety regulations in the bill.
We will see if certain senators have the stomach for their own show trial after Dr. Nissen's embarassing performance today.
Senate Passes PDUFA Reauthorization Bill
The Senate passed a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) after adding an amendment to increase penalties for noncompliant drugmakers and narrowly rejecting two amendments that would have augmented other safety regulations in the bill.
We will see if certain senators have the stomach for their own show trial after Dr. Nissen's embarassing performance today.
Nissen's entire approach is a case study of how to use statistical tools to manufacture biased results. In “Why Most Scientific Research Findings Are False†John Ioaniddis, a professor nstitute for Clinical Research and Health Policy Studies, Department of Medicine, Tufts-New England Medical Centera notes that a study relying on meta-analytic finding from inconclusive studies where pooling is used to “correct†the low power of single studies, is probably false and biased.
Research findings from underpowered, early-phase clinical trials would be true about one in four times, or even less frequently if bias is present. Epidemiological studies of an exploratory nature perform even worse, especially when underpowered, but even well-powered epidemiological studies may have only a one in five chance being true. Nissen’s research which combines small clinical trials to conduct a epidemiological study of an exploratory nature that deliberately excludes patients without heart attacks, that does not independent confirm if one took place and does not have access to patient level data, to find a risk he believes is there may or may not be true but it is certainly biased and likely to be false.
Indeed, stating that there is a increase of 40 percent risk in heart attacks relative in Avandia users compared to others raises two other troubling questions. First, it is generally true that, as Ioannidis claims that independent of molecular or genetic confirmation of a cause and effect, “too large and too highly significant effects may actually be more likely to be signs of large bias in most fields of modern research.â€
They should lead investigators to careful critical thinking about what might have gone wrong with their data, analyses, and results.
For instance, in the 1980s a Swedish epidemiological study found that people with hip and knee replacements had a 30 percent greater increase of kidney cance than those who had no surgery. That study did not cause the authors to run to Congress and the media with results at a politically sensitive time. Instead, it suggested further epidemiological analysis and observational analysis which lead to the conclusion that the ‘relationship’ between orthopedic implants and kidney cancer was “noise†as opposed toa signal of something going wrong.
The proper response to the Avandia exercise would be to conduct further research and to put the general risk of heart events in context, Nissen, the authors of the editorials supporting his claim and the NEJM have not done either. Instead Nissen ran to the media and Congress with a highly speculative report. The NEJM gave the article prominence and failed to run a cautionary editorial.
Research findings from underpowered, early-phase clinical trials would be true about one in four times, or even less frequently if bias is present. Epidemiological studies of an exploratory nature perform even worse, especially when underpowered, but even well-powered epidemiological studies may have only a one in five chance being true. Nissen’s research which combines small clinical trials to conduct a epidemiological study of an exploratory nature that deliberately excludes patients without heart attacks, that does not independent confirm if one took place and does not have access to patient level data, to find a risk he believes is there may or may not be true but it is certainly biased and likely to be false.
Indeed, stating that there is a increase of 40 percent risk in heart attacks relative in Avandia users compared to others raises two other troubling questions. First, it is generally true that, as Ioannidis claims that independent of molecular or genetic confirmation of a cause and effect, “too large and too highly significant effects may actually be more likely to be signs of large bias in most fields of modern research.â€
They should lead investigators to careful critical thinking about what might have gone wrong with their data, analyses, and results.
For instance, in the 1980s a Swedish epidemiological study found that people with hip and knee replacements had a 30 percent greater increase of kidney cance than those who had no surgery. That study did not cause the authors to run to Congress and the media with results at a politically sensitive time. Instead, it suggested further epidemiological analysis and observational analysis which lead to the conclusion that the ‘relationship’ between orthopedic implants and kidney cancer was “noise†as opposed toa signal of something going wrong.
The proper response to the Avandia exercise would be to conduct further research and to put the general risk of heart events in context, Nissen, the authors of the editorials supporting his claim and the NEJM have not done either. Instead Nissen ran to the media and Congress with a highly speculative report. The NEJM gave the article prominence and failed to run a cautionary editorial.
"I provided a preliminary analysis to congressional staff" prior to giving it the FDA and NEJM..
Dr. Nissen regards this as moral and ethical.
Dr. Nissen regards this as moral and ethical.
Today's hearing was supposed to be Steve Nissen and Henry Waxman's grand unveiling of a new master plan for FDA reform. Instead it was an embarassing examination of how Nissen's effort to explain away why he went to Congress (rather than the FDA) with a preliminary analysis of Avandia.
Now of the more zealous critics of the FDA are now left hanging out to dry by Nissen's own measured statements about not recommending that any doctor stop prescribing or not prescribe Avandia on the basis of his study. Of course to say that totally contradicts his claim that Avandia was "worse than 9/11" is an understatment. Too bad the head of GSK research didn't have the chance to take him head on. CMPI will try to offer him that opportunity as well as the researchers of the RECORD study.
That did not stop Bruce Psaty from waving the bloody shirt of safety at the hearings, though he was reduced to irrelevancy by the end.
One by one the safety extremists are marginalizing themselves. Dr. Nissen was alternately defensive, evasive and hesitant.
Now of the more zealous critics of the FDA are now left hanging out to dry by Nissen's own measured statements about not recommending that any doctor stop prescribing or not prescribe Avandia on the basis of his study. Of course to say that totally contradicts his claim that Avandia was "worse than 9/11" is an understatment. Too bad the head of GSK research didn't have the chance to take him head on. CMPI will try to offer him that opportunity as well as the researchers of the RECORD study.
That did not stop Bruce Psaty from waving the bloody shirt of safety at the hearings, though he was reduced to irrelevancy by the end.
One by one the safety extremists are marginalizing themselves. Dr. Nissen was alternately defensive, evasive and hesitant.
One of these things is not like the other ...
Analysis of Avandia Finds
No Increased Risk of Death
-- Wall Streeet Journal
Glaxo: Diabetes pill does not raise heart risk
-- USA Today
Avandia No Riskier Than Other Diabetes Drugs Says Interim Study
-- Medical News Today
Diabetes Drug Still Has Heart Risks, Doctors Warn
-- New York Times
Analysis of Avandia Finds
No Increased Risk of Death
-- Wall Streeet Journal
Glaxo: Diabetes pill does not raise heart risk
-- USA Today
Avandia No Riskier Than Other Diabetes Drugs Says Interim Study
-- Medical News Today
Diabetes Drug Still Has Heart Risks, Doctors Warn
-- New York Times
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.
