Latest Drugwonks' Blog
http://www.tnr.com/doc.mhtml?i=w070409&s=cohn041007
According to Jonathan Cohn of The New Republic universal health care ala Europe (note he excludes Canada!) is a great model for America because....
"You don't see their citizens choosing between prescriptions and groceries, or declaring bankruptcy, because of medical bills. "
Well Jon, that's because the European bankruptcy system is based on a debt counseling model while in the US (and Canada) we have an easier path to permit public assumption of private debt. Given Canada's social safety net, in 1997, the incidence of personal bankruptcy was 3 in 1000 there cf to 5 in 1000 in the US.
Oh.
Moreover, according to the Federal Reserve, debt as a percentage of household income is higher in the UK, Japan and Canada than it is in the US (which has the same ratio as Germany and higher than France).
Oh.
There are surveys galore that also claim up to 35 percent of seniors choose between food and home heating bills.
Should we have universal food insurance or universal heating coverage too, with consumption and price levels set by government?
If Cohn and other liberals want to diddle around about whether you can get better care in the US or Europe or Canada or Japan that's fine. The reality is that everyone else waits longer than Americans for all kinds of care, particularly cancer care and low birth weight babies are less likely to receive life sustaining care anywhere else on the planet. We do have gaps and holes in our system of coverage but they are created because of duplication and regulations that protect corporations, insurance companies and unions from market competition.
America has a health system better prepared to deal with an aging society, better positioned to invest in the health of its citizens for long term prosperity and independence, more dedicated to extending and enriching life at both it's beginning and end and poised to achieve in greater gains against infectious diseases and chronic illnesses than any other nation in the history of mankind.
Europe's health care system is tethered to an unsustainable method of financing --a shrinking work force paying higher taxes -- and is propped up in the short term as it's military by an indirect subsidy from America's technological superiority and inventiveness. That too is coming to a quick end as health systems throughout the continent are explicitly and implicitly rationing access to the best and newer medicines.
Cohn and other liberals want us to believe universal health care leads to better health. But the gap in health status between rich and poor, educated and uneducated here and abroad are largely the same.. Health care might be free but if you lead a chaotic and disorganized life or engage in risky behavior or postpone seeking care your chances of survival decline. And time is not free to anyone regardless of income. Ultimately, time has a cost and it exacts a particularly heavy one on the poor and elderly. Countries that ration access to the right treatment at the optimal time through waiting, canceling appointments, gatekeepers etc, step therapy kill their society from within.
As quick PS added April 11... The tool the Euros use to ration? Comparative effectiveness analysis. Which is what the Dems are pushing for in order to push down drug prices and access to new drugs.
According to Jonathan Cohn of The New Republic universal health care ala Europe (note he excludes Canada!) is a great model for America because....
"You don't see their citizens choosing between prescriptions and groceries, or declaring bankruptcy, because of medical bills. "
Well Jon, that's because the European bankruptcy system is based on a debt counseling model while in the US (and Canada) we have an easier path to permit public assumption of private debt. Given Canada's social safety net, in 1997, the incidence of personal bankruptcy was 3 in 1000 there cf to 5 in 1000 in the US.
Oh.
Moreover, according to the Federal Reserve, debt as a percentage of household income is higher in the UK, Japan and Canada than it is in the US (which has the same ratio as Germany and higher than France).
Oh.
There are surveys galore that also claim up to 35 percent of seniors choose between food and home heating bills.
Should we have universal food insurance or universal heating coverage too, with consumption and price levels set by government?
If Cohn and other liberals want to diddle around about whether you can get better care in the US or Europe or Canada or Japan that's fine. The reality is that everyone else waits longer than Americans for all kinds of care, particularly cancer care and low birth weight babies are less likely to receive life sustaining care anywhere else on the planet. We do have gaps and holes in our system of coverage but they are created because of duplication and regulations that protect corporations, insurance companies and unions from market competition.
America has a health system better prepared to deal with an aging society, better positioned to invest in the health of its citizens for long term prosperity and independence, more dedicated to extending and enriching life at both it's beginning and end and poised to achieve in greater gains against infectious diseases and chronic illnesses than any other nation in the history of mankind.
Europe's health care system is tethered to an unsustainable method of financing --a shrinking work force paying higher taxes -- and is propped up in the short term as it's military by an indirect subsidy from America's technological superiority and inventiveness. That too is coming to a quick end as health systems throughout the continent are explicitly and implicitly rationing access to the best and newer medicines.
Cohn and other liberals want us to believe universal health care leads to better health. But the gap in health status between rich and poor, educated and uneducated here and abroad are largely the same.. Health care might be free but if you lead a chaotic and disorganized life or engage in risky behavior or postpone seeking care your chances of survival decline. And time is not free to anyone regardless of income. Ultimately, time has a cost and it exacts a particularly heavy one on the poor and elderly. Countries that ration access to the right treatment at the optimal time through waiting, canceling appointments, gatekeepers etc, step therapy kill their society from within.
As quick PS added April 11... The tool the Euros use to ration? Comparative effectiveness analysis. Which is what the Dems are pushing for in order to push down drug prices and access to new drugs.
In an effort to find a counterpoint to industry concerns about follow on biologic legislation (here's goes my chance to land on his speed dial) Robert Pear mis-characterizes Janet Woodcock's clear and unambiguous testimony stating that the FDA had the regulatory authority and know how to develop a pathway for the approval of FOBs. He makes it seem that Woodcock claims you don't need human testing to establish that two biologics are interchangeable.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''
Woodcock said nothing of the sort. Here is what she said:
"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."
Here is a link to Dr. Woodcock's testimony.
http://www.fda.gov/ola/2007/protein32607.html
Pear thinks it gave legislation for FOBs an "unexpected boost."
Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''
Woodcock said nothing of the sort. Here is what she said:
"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."
Here is a link to Dr. Woodcock's testimony.
http://www.fda.gov/ola/2007/protein32607.html
Pear thinks it gave legislation for FOBs an "unexpected boost."
Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings.
Much chatter about contaminated pet food.
Not surprisingly, media focus is on grieving pet owners rather than on the real issue -- why did it happen and how can it be prevented from happening again.
The answer, more money for the FDA. If you think that FDA is under-funded when it comes to drugs and devices -- check out the abysmally low budgets for CFSAN and CVM.
Penny wise and pound (no pun intended) foolish? Neither. Dangerous.
Not surprisingly, media focus is on grieving pet owners rather than on the real issue -- why did it happen and how can it be prevented from happening again.
The answer, more money for the FDA. If you think that FDA is under-funded when it comes to drugs and devices -- check out the abysmally low budgets for CFSAN and CVM.
Penny wise and pound (no pun intended) foolish? Neither. Dangerous.
I'm looking forward to the results of the NIH trial, but I don't think there is truly much controversy about the usefulness of this test, esp. in the right hands.
Perhaps politically, smokers aren't the most popular group, and a nicotine-blocking drug like Chantix has been a wonderful addition to my clinical arsenal. Better to be a non-smoker, whereupon the risks drop dramatically. I've written previously - 1-06 - for the Wash Post about how quitting can best be accomplished by a change in lifestyle, and how quitting decreases both short term and long term health risks.
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/02/AR2006010201507.html?nav=rss_health
But for those who haven't quit, and even for those who have, screening at some regular interval has important health benefits.
Here's an interesting study just published - the mention is in Cancer Research UK:
Lung cancer screening effective for high-risk groups, says US group
FRIDAY 30 MARCH 2007
Screening high-risk individuals for lung cancer with an annual 'CT' scan may be able to detect tumours when they are most treatable, according to new US research.
The New York Early Lung Cancer Action Project study, published in the April edition of Radiology, examined the screening results of 6,295 former smokers aged over 60.
A total 124 of these people were diagnosed with lung cancer.
Almost nine in every ten of those diagnosed were found to have tumours that that had not yet spread.
Lung cancer screening is an area of intense interest, as currently most lung cancers are not detected until they are at an advanced stage when the disease is extremely difficult to treat successfully.
The new findings run counter to research published in March in the Journal of the American Medical Association, which suggested that CT screening may not significantly reduce death rates, despite detecting more cancers.
Some scientists think that CT screening may also be detecting slow-growing tumours that would not cause harm, leading people to be treated unnecessarily.
"The JAMA article was the first application of a newly developed computer model which predicted expected deaths from lung cancer, and there are numerous concerns about its validity," said Dr Henschke.
The US National Cancer Institute is funding a large trial, NLST, involving over 50,000 people, with results expected in 2009. This trial should answer questions over the effectiveness of CT screening and chest x-rays in reducing lung cancer deaths.
Perhaps politically, smokers aren't the most popular group, and a nicotine-blocking drug like Chantix has been a wonderful addition to my clinical arsenal. Better to be a non-smoker, whereupon the risks drop dramatically. I've written previously - 1-06 - for the Wash Post about how quitting can best be accomplished by a change in lifestyle, and how quitting decreases both short term and long term health risks.
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/02/AR2006010201507.html?nav=rss_health
But for those who haven't quit, and even for those who have, screening at some regular interval has important health benefits.
Here's an interesting study just published - the mention is in Cancer Research UK:
Lung cancer screening effective for high-risk groups, says US group
FRIDAY 30 MARCH 2007
Screening high-risk individuals for lung cancer with an annual 'CT' scan may be able to detect tumours when they are most treatable, according to new US research.
The New York Early Lung Cancer Action Project study, published in the April edition of Radiology, examined the screening results of 6,295 former smokers aged over 60.
A total 124 of these people were diagnosed with lung cancer.
Almost nine in every ten of those diagnosed were found to have tumours that that had not yet spread.
Lung cancer screening is an area of intense interest, as currently most lung cancers are not detected until they are at an advanced stage when the disease is extremely difficult to treat successfully.
The new findings run counter to research published in March in the Journal of the American Medical Association, which suggested that CT screening may not significantly reduce death rates, despite detecting more cancers.
Some scientists think that CT screening may also be detecting slow-growing tumours that would not cause harm, leading people to be treated unnecessarily.
"The JAMA article was the first application of a newly developed computer model which predicted expected deaths from lung cancer, and there are numerous concerns about its validity," said Dr Henschke.
The US National Cancer Institute is funding a large trial, NLST, involving over 50,000 people, with results expected in 2009. This trial should answer questions over the effectiveness of CT screening and chest x-rays in reducing lung cancer deaths.
I've just returned from a breakfast (kindly organized by the Government of France) with seven leading French journalists. The topic: health care. Needless to say, it was a wide-ranging conversation. A few items of note:
(1) My French is really rusty.
(2) While the systems in France and the US are very different, we share many of the same problems -- the biggest being government focus on cost rather than care.
(3) We spent a lot of time talking about how to measure the beneft of incremental innovation -- as well as what incremental innovation means and why any conversation on this topic must also include (and to a very large extent) how to expand the use of existing medicines in additional ways. We talked off-label usage.
(4) We talked comparative effectiveness and whether or not current measurements of such are legitimate ways to determine reimbursement decisions. (In other words, we spent a lot of time talking about the inappropriate ways payors -- public and private, HAS and DERP -- use general population RCTs to make "me too"/either-or decisions.
(5) And we talked about patient information. Empowering the consumer? Mon Dieu!
(6) And the fact that patient groups that are government funded are unlikely to be real patient advocates when it comes to therapeutic reimbursement decisions.
(7) And we talked about the importance of prevention programs. (Although I must add that, after the breakfast was over, they all went outside for a smoke.)
But the general theme that drove the entire conversation was, as mentioned above, what happens when cost trumps care and short-term political concerns dwarf long-term consequences.
And, no matter what language you're speaking, it sure sounds familiar.
(1) My French is really rusty.
(2) While the systems in France and the US are very different, we share many of the same problems -- the biggest being government focus on cost rather than care.
(3) We spent a lot of time talking about how to measure the beneft of incremental innovation -- as well as what incremental innovation means and why any conversation on this topic must also include (and to a very large extent) how to expand the use of existing medicines in additional ways. We talked off-label usage.
(4) We talked comparative effectiveness and whether or not current measurements of such are legitimate ways to determine reimbursement decisions. (In other words, we spent a lot of time talking about the inappropriate ways payors -- public and private, HAS and DERP -- use general population RCTs to make "me too"/either-or decisions.
(5) And we talked about patient information. Empowering the consumer? Mon Dieu!
(6) And the fact that patient groups that are government funded are unlikely to be real patient advocates when it comes to therapeutic reimbursement decisions.
(7) And we talked about the importance of prevention programs. (Although I must add that, after the breakfast was over, they all went outside for a smoke.)
But the general theme that drove the entire conversation was, as mentioned above, what happens when cost trumps care and short-term political concerns dwarf long-term consequences.
And, no matter what language you're speaking, it sure sounds familiar.
"We all do no end of feeling and we mistake it for thinking. And out of it we get an aggregation which we consider a boon. Its name is public opinion. It is held in reverence. It settles everything. Some think it is the voice of God."
Mark Twain
I was going to download a webcast of Barack Obama's community meeting on healthcare in Seacoast, NH but found a newspaper account first. I am glad I did not waste the bandwidth.
If it was a battle between being banal (Barack) or bereft of insight (the attendees from Seacoast) they would still be slugging it out for first prize.
How do the Seacoasters and Obama fare? Let's restage it as drama:
Barack:"When I take office, I have to feel I have a mandate for change."
Laurie MaCray: "I don't want anymore competition - it's too confusing, it's trying to compare apples and oranges,I want a system with no deductibles, no co-pays. I want a national standard that insurers have to adhere to or not sell insurance."
Richard Friedman, MD "The problem is overuse of testing and high-priced drugs."
"We don't care how the system is managed as long as it is affordable and accessible to everyone."
Obama: ""Ultimately, (my plan) will be my best take on a comprehensive health care policy.
"I'm not going to be able to do this by myself."
My advice. Don't count on Seacoast for direction.
PS. Isn't that what people are electing YOU for?
Mark Twain
I was going to download a webcast of Barack Obama's community meeting on healthcare in Seacoast, NH but found a newspaper account first. I am glad I did not waste the bandwidth.
If it was a battle between being banal (Barack) or bereft of insight (the attendees from Seacoast) they would still be slugging it out for first prize.
How do the Seacoasters and Obama fare? Let's restage it as drama:
Barack:"When I take office, I have to feel I have a mandate for change."
Laurie MaCray: "I don't want anymore competition - it's too confusing, it's trying to compare apples and oranges,I want a system with no deductibles, no co-pays. I want a national standard that insurers have to adhere to or not sell insurance."
Richard Friedman, MD "The problem is overuse of testing and high-priced drugs."
"We don't care how the system is managed as long as it is affordable and accessible to everyone."
Obama: ""Ultimately, (my plan) will be my best take on a comprehensive health care policy.
"I'm not going to be able to do this by myself."
My advice. Don't count on Seacoast for direction.
PS. Isn't that what people are electing YOU for?
Here's an interesting story by the Healthday reporter which was published in the Wash Post, Forbes, and several other places.
I was quoted extensively about neuraminidase inhibitors in the context of cautioning overuse based on FEAR, but of course avocating appropriate use.
Resistance patterns are emerging in Japan in Influenza B strains according to a new study out of the University of Tokyo.
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/03/AR2007040301282.html
I was quoted extensively about neuraminidase inhibitors in the context of cautioning overuse based on FEAR, but of course avocating appropriate use.
Resistance patterns are emerging in Japan in Influenza B strains according to a new study out of the University of Tokyo.
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/03/AR2007040301282.html
An editorial in today’s edition of the Minneapolis Star Tribune calls for consumers to “weed out conflicts in prescription drugs.â€
According to the Star Tribune ...
“If you've taken a prescription drug lately, you might be feeling a little queasy about two recent Star Tribune stories showing that hundreds of Minnesota physicians accepted millions of dollars in fees, trips and other payments from the nation's drug manufacturers. Even assuming that doctors adhere to the highest professional standards, even assuming that the drug companies have the purest motives, this has to leave the average patient wondering if he or she got the safest, cheapest, most appropriate medicine on the market -- or the one that a drug company is pushing hardest at the moment.â€
Talk about a loaded question!
But wait, it gets worse. The editorial continues …
“Consumers who are asking that question have a new ally called the Prescription Project. It's a coalition supported by Consumer Reports magazine and funded by the Pew Charitable Trusts to reduce conflicts of interest and make sure doctors are using the best unbiased research. The Minnesota Medical Association recently endorsed the website it uses to help inform consumers.â€
But the editorial fails to mention that Consumer Reports also receives significant funding from the Engleberg Foundation – whose dollars come from no less a personage than Alfred Engleberg – who has earned northward of $100 million by successfully challenging the validity and enforceability of pharmaceutical patents and has generously shared in the resulting profits shared by generic drug makers. And, curiously enough, that funding is used to operate CR’s pharmaceutical “Savings Advisor†that offers, among other suggestions, “best buys†for Alzheimer’s medications.
An oversight on the part of the Star Tribune editorial page? Or just the most recent example of selective transparency?
Here’s a link to the full editorial:
http://www.startribune.com/561/story/1098522.html
If the Star Tribune believes that health care consumers deserve transparency, they should Gopher broke and do it right.
According to the Star Tribune ...
“If you've taken a prescription drug lately, you might be feeling a little queasy about two recent Star Tribune stories showing that hundreds of Minnesota physicians accepted millions of dollars in fees, trips and other payments from the nation's drug manufacturers. Even assuming that doctors adhere to the highest professional standards, even assuming that the drug companies have the purest motives, this has to leave the average patient wondering if he or she got the safest, cheapest, most appropriate medicine on the market -- or the one that a drug company is pushing hardest at the moment.â€
Talk about a loaded question!
But wait, it gets worse. The editorial continues …
“Consumers who are asking that question have a new ally called the Prescription Project. It's a coalition supported by Consumer Reports magazine and funded by the Pew Charitable Trusts to reduce conflicts of interest and make sure doctors are using the best unbiased research. The Minnesota Medical Association recently endorsed the website it uses to help inform consumers.â€
But the editorial fails to mention that Consumer Reports also receives significant funding from the Engleberg Foundation – whose dollars come from no less a personage than Alfred Engleberg – who has earned northward of $100 million by successfully challenging the validity and enforceability of pharmaceutical patents and has generously shared in the resulting profits shared by generic drug makers. And, curiously enough, that funding is used to operate CR’s pharmaceutical “Savings Advisor†that offers, among other suggestions, “best buys†for Alzheimer’s medications.
An oversight on the part of the Star Tribune editorial page? Or just the most recent example of selective transparency?
Here’s a link to the full editorial:
http://www.startribune.com/561/story/1098522.html
If the Star Tribune believes that health care consumers deserve transparency, they should Gopher broke and do it right.
A new Austrailian report estimates that government spending on the private health insurance rebate, which costs about $3 billion Aussie dollars a year, will grow at 4.4 per cent a year -- nearly three times the expected real growth of the economy over the next 40 years.
Sound familiar?
The opposition's health spokeswoman, Nicola Roxon, said the report showed the Government was "once again shutting its eyes to the implications of chronic disease."
"The glaring gap in the previous intergenerational report was an assessment of the impact of chronic disease and preventable disease on current health expenditure, future health expenditure, workforce participation and productivity and, staggeringly, that mistake is repeated in the report released today," Ms Roxon said.
Saying it is the first step towards addressing it. Where are the American elected officials talking about the need to focus on dealing with chronic diseases (such as diabetes, hypertension, high cholesterol, etc.)?
The single biggest recent step towards getting tens of millions of Americans properly treated for chronic disease is Part D. More seniors are being properly diagnosed and treated for chronic diseases today than ever before -- a direct result of Part D.
(A fact that, mysteriously, didn't make the recent 60 Minutes story on the MMA vote.)
Beyond Part D, however, all players in the health care game (government, pharma, providers, private payors, and John Q.Patient) need to team up to address chonic disease in ALL populations ... before we find ourselves, well, down under.
Sound familiar?
The opposition's health spokeswoman, Nicola Roxon, said the report showed the Government was "once again shutting its eyes to the implications of chronic disease."
"The glaring gap in the previous intergenerational report was an assessment of the impact of chronic disease and preventable disease on current health expenditure, future health expenditure, workforce participation and productivity and, staggeringly, that mistake is repeated in the report released today," Ms Roxon said.
Saying it is the first step towards addressing it. Where are the American elected officials talking about the need to focus on dealing with chronic diseases (such as diabetes, hypertension, high cholesterol, etc.)?
The single biggest recent step towards getting tens of millions of Americans properly treated for chronic disease is Part D. More seniors are being properly diagnosed and treated for chronic diseases today than ever before -- a direct result of Part D.
(A fact that, mysteriously, didn't make the recent 60 Minutes story on the MMA vote.)
Beyond Part D, however, all players in the health care game (government, pharma, providers, private payors, and John Q.Patient) need to team up to address chonic disease in ALL populations ... before we find ourselves, well, down under.
I don't want to say too much about this until the smoke clears, but some early observations:
1 - the drug was quite effective in some patients with severe irritable bowel symptoms esp. constipation, but many others with milder symptoms respond to miralax and fiber.
2 - 29 placebo controlled 1-3 month trials of over 11,600 patients receiving Zelnorm and over 7000 receiving placebo show a slight increase in the risk of cardiovascular events including angina, heart attacks, and strokes in those taking zelnorm - .01% on placebo, .1% on the drug, but these studies for the most part involve patients in higher risk groups than those i and others would prescribe it for and for some also a longer use of the drug.
3 - but the FDA acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the U.S. So why isn't the FDA being praised for its action on behalf of drug safety?
it makes sense to keep this drug in reserve for those in lower risk groups who really need it. It makes sense to not inflame this news and start criticizing everyone in sight. The FDA is being cautious - Novartis is being co-operative.
1 - the drug was quite effective in some patients with severe irritable bowel symptoms esp. constipation, but many others with milder symptoms respond to miralax and fiber.
2 - 29 placebo controlled 1-3 month trials of over 11,600 patients receiving Zelnorm and over 7000 receiving placebo show a slight increase in the risk of cardiovascular events including angina, heart attacks, and strokes in those taking zelnorm - .01% on placebo, .1% on the drug, but these studies for the most part involve patients in higher risk groups than those i and others would prescribe it for and for some also a longer use of the drug.
3 - but the FDA acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the U.S. So why isn't the FDA being praised for its action on behalf of drug safety?
it makes sense to keep this drug in reserve for those in lower risk groups who really need it. It makes sense to not inflame this news and start criticizing everyone in sight. The FDA is being cautious - Novartis is being co-operative.
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.
