Latest Drugwonks' Blog
http://www.bmj.com/cgi/content/full/327/7429/1459?eaf
Hazardous journey
Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials
Gordon C S Smith, professor1, Jill P Pell, consultant2
1 Department of Obstetrics and Gynaecology, Cambridge University, Cambridge CB2 2QQ, 2 Department of Public Health, Greater Glasgow NHS Board, Glasgow G3 8YU
Correspondence to: G C S Smith gcss2@cam.ac.uk
Abstract
Objectives To determine whether parachutes are effective in preventing major trauma related to gravitational challenge.
Design Systematic review of randomised controlled trials.
Data sources: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists.
Study selection: Studies showing the effects of using a parachute during free fall.
Main outcome measure Death or major trauma, defined as an injury severity score > 15.
Results We were unable to identify any randomised controlled trials of parachute intervention.
Conclusions As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.
I am sure CBO's Peter Orzag, who has been pushing comparative effectiveness as a way to reduce costs by denying access to new technology will be the first to volunteer....
Hazardous journey
Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials
Gordon C S Smith, professor1, Jill P Pell, consultant2
1 Department of Obstetrics and Gynaecology, Cambridge University, Cambridge CB2 2QQ, 2 Department of Public Health, Greater Glasgow NHS Board, Glasgow G3 8YU
Correspondence to: G C S Smith gcss2@cam.ac.uk
Abstract
Objectives To determine whether parachutes are effective in preventing major trauma related to gravitational challenge.
Design Systematic review of randomised controlled trials.
Data sources: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists.
Study selection: Studies showing the effects of using a parachute during free fall.
Main outcome measure Death or major trauma, defined as an injury severity score > 15.
Results We were unable to identify any randomised controlled trials of parachute intervention.
Conclusions As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.
I am sure CBO's Peter Orzag, who has been pushing comparative effectiveness as a way to reduce costs by denying access to new technology will be the first to volunteer....
If the lightbulb is meant to shine a light on the value of new healthcare-related technologies in the context of healthcare technology assessment (HTA) -- then the answer is "one."
And the "one" is Dr. Frank Lichtenberg of Columbia University.
According to Frank, for HTA to yield valid decisions in practice, it is necessary to have reliable estimates of:
ΔCOST
ΔQALY
and VSLY (Value of a Statistical Life Year)
And his main point is that the devil is in the details.
He believes that incorrect estimates of some or all of these key inputs are often used:
ΔCOST is frequently overestimated
ΔQALY and VSLY are frequently underestimated
And due to these estimation biases, health technologies that are truly cost-effective may often be rejected as cost-ineffective.
Per the recent debate over the utility of new cancer treatments, he makes a very interesting point -- that even though, over the past 30 years, the U.S. Mortality Age-Adjusted Rates for cancer have remained relatively constant -- (leading to such mainstream media headlines as Fortune Magazine's "Why have we made so little progress in the War on Cancer?†and NEJM articles like "The effect of new treatments for cancer on mortality has been largely disappointing†-- the often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.
For more specifics on both the economic impact of new treatments and their impact on cancer survival, please see the paper that Dr. Lichtenberg wrote for the Center for Medicine in the Public Interest in 2007:
Click here:
http://www.cmpi.org
Then go to the heading "Reports" and click on "Value of Cancer Drugs."
Lichtenberg cites two crucial studies, pointing out how health care economists must seriously reconsider the outdated estimates of a QALY:
Viscusi and Aldy: The value of a statistical life for prime-aged workers has a median value of about $7 million in the United States
Viscusi, W. Kip and Joseph E. Aldy, “The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World,†The Journal of Risk and Uncertainty, 27:1; 5–76, 2003.
and
Murphy and Topel: The value of a life year is $373,000.
Murphy, Kevin M., and Robert H. Topel, “The value of health and longevity,†Journal of Political Economy, 2006.
Attention must be paid. Hello NICE. Hello IQWiG. Hello Senators Baucus and Conrad.
Here is Dr. Lichtenberg's presentation on these issues -- spelled out and supported by both facts and examples:
Download file
If the devil is in the details (and it is) -- it's time for a deep dive beyond simplistic and self-serving "comparative effectivess."
And the "one" is Dr. Frank Lichtenberg of Columbia University.
According to Frank, for HTA to yield valid decisions in practice, it is necessary to have reliable estimates of:
ΔCOST
ΔQALY
and VSLY (Value of a Statistical Life Year)
And his main point is that the devil is in the details.
He believes that incorrect estimates of some or all of these key inputs are often used:
ΔCOST is frequently overestimated
ΔQALY and VSLY are frequently underestimated
And due to these estimation biases, health technologies that are truly cost-effective may often be rejected as cost-ineffective.
Per the recent debate over the utility of new cancer treatments, he makes a very interesting point -- that even though, over the past 30 years, the U.S. Mortality Age-Adjusted Rates for cancer have remained relatively constant -- (leading to such mainstream media headlines as Fortune Magazine's "Why have we made so little progress in the War on Cancer?†and NEJM articles like "The effect of new treatments for cancer on mortality has been largely disappointing†-- the often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.
For more specifics on both the economic impact of new treatments and their impact on cancer survival, please see the paper that Dr. Lichtenberg wrote for the Center for Medicine in the Public Interest in 2007:
Click here:
http://www.cmpi.org
Then go to the heading "Reports" and click on "Value of Cancer Drugs."
Lichtenberg cites two crucial studies, pointing out how health care economists must seriously reconsider the outdated estimates of a QALY:
Viscusi and Aldy: The value of a statistical life for prime-aged workers has a median value of about $7 million in the United States
Viscusi, W. Kip and Joseph E. Aldy, “The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World,†The Journal of Risk and Uncertainty, 27:1; 5–76, 2003.
and
Murphy and Topel: The value of a life year is $373,000.
Murphy, Kevin M., and Robert H. Topel, “The value of health and longevity,†Journal of Political Economy, 2006.
Attention must be paid. Hello NICE. Hello IQWiG. Hello Senators Baucus and Conrad.
Here is Dr. Lichtenberg's presentation on these issues -- spelled out and supported by both facts and examples:
Download file
If the devil is in the details (and it is) -- it's time for a deep dive beyond simplistic and self-serving "comparative effectivess."
After reading the FDA's documents prepared for the ODAC review of ESAs I am struck by how primitive and incomplete the brief about the safety problems associated with the anemia drugs are and how short-sided the FDA is in how to assess risk and benefit of the drugs going forward.
1. The FDA memo ignores quality of life benefits and it's risk management of the drug ignores the opportunity to use electronic medical records and observational studies to determine which dose works for what patients. It rewrites the standard for demonstrating quality of life to require randomized controlled trials to demonstrate such benefits....
2. The FDA memo ignores patient preferences and would radically limit the freedom of doctors to prescribe drugs based on their real world experience as opposed to the results of clinical trials focusing on higher than label doses.
3. The FDA ignores the fact that there are no randomized clinical trials assessing the impact of transfusion on survival or mortality.
4. Rather it cites the decline in transfusion-related infections even though the principle reason for using ESAs in chemo-related anemia was to reduce fatigue and sustain hemoglobin levels more efficiently in tandem with newer and more powerful cytotoxic agents/regimens.
5. The FDA ignores the fact that requiring RCTs to establish safety would entail studies of such power that doing so will be nearly impossible. Imposing this standard on all drugs would eliminate many drugs from regular use.
The fix is in. To a large extent the companies have themselves to blame for not tracking the risk and benefits of these medicines more consistently. However denying access to patients who feel better on the drug and who know the relative and absolute risks associated with their use is wrong. And it sends a message to companies that efforts to demonstrate risks and benefits in the post market consistent with the Critical Path will be rejected. The FDA's use of unsophisticated arguments and models in pressing for ESA restrictions underscores that trying to create a patient-centered pathway is simply not worth it. And if it isn't, how serious can the agency be about Critical Path and including patient preferences in its evaluations?
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4345b2-00-FDA-index.htm
1. The FDA memo ignores quality of life benefits and it's risk management of the drug ignores the opportunity to use electronic medical records and observational studies to determine which dose works for what patients. It rewrites the standard for demonstrating quality of life to require randomized controlled trials to demonstrate such benefits....
2. The FDA memo ignores patient preferences and would radically limit the freedom of doctors to prescribe drugs based on their real world experience as opposed to the results of clinical trials focusing on higher than label doses.
3. The FDA ignores the fact that there are no randomized clinical trials assessing the impact of transfusion on survival or mortality.
4. Rather it cites the decline in transfusion-related infections even though the principle reason for using ESAs in chemo-related anemia was to reduce fatigue and sustain hemoglobin levels more efficiently in tandem with newer and more powerful cytotoxic agents/regimens.
5. The FDA ignores the fact that requiring RCTs to establish safety would entail studies of such power that doing so will be nearly impossible. Imposing this standard on all drugs would eliminate many drugs from regular use.
The fix is in. To a large extent the companies have themselves to blame for not tracking the risk and benefits of these medicines more consistently. However denying access to patients who feel better on the drug and who know the relative and absolute risks associated with their use is wrong. And it sends a message to companies that efforts to demonstrate risks and benefits in the post market consistent with the Critical Path will be rejected. The FDA's use of unsophisticated arguments and models in pressing for ESA restrictions underscores that trying to create a patient-centered pathway is simply not worth it. And if it isn't, how serious can the agency be about Critical Path and including patient preferences in its evaluations?
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4345b2-00-FDA-index.htm
I am currently "on the road" in Europe with Dr. Frank Lichtenberg of Columbia University. We're speaking on the topic of healthcare technology assessment (HTA). We've already spoken in Brussels (cold and wet) and Rome (sunny and fattening). Today we are in Berlin.
When it comes to health care there are a lot of acronyms. When it comes to cost-containment strategies the main ones are:
HTA: Healthcare Technology Assessment
EBM: Evidence-Based Medicine
CER: Comparative Effectiveness Research
RUM: Rational Use of Medicine
But no matter the acronym, these are all cost-based practices designed to reduce costs and restrict patient care. They are acronyms of denial.
Today, Healthcare Technology Assessment is a short-term, short-sighted, politically-driven policy that results in one-size-fits-all medicine. And while it may provide transitory savings in the short-term, current HTA strategies result in a lower quality of care that result in higher health care costs over time.
Restrictive formularies and health care systems that deny patients access to the right medicine in the right dose at the right time but pay for more invasive and expensive procedures later on have their priorities upside down.
So why is the current HTA model enjoying such wide support? Because it drapes a veil of pseudo-science around the blunt instrument of one-size-fits-all price controls. Consider what Sir Michael Rawlings of NICE said about comparative effectiveness in front of the British House of Commons:
“It is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists we have approached across the country. It is elusive."
IQWiG in Germany claims that it makes its decisions based on "international standards." But such "standards" do not exist. Nice try though.
HTA, as it is currently designed, places into conflict the short-term budgeting dilemmas of governments elected for relatively short periods of time with the ever-lengthening life spans of its electorate.
HTA is a creature not of health care professionals, but of economists being paid by governments (aka: "payers"). Hardly a group of disinterested academics.
HTA is widely based on the concept of “patient variation,†that the same care should be applied to every patient suffering from the same disease based on evidence derived from RCTs.
In other words, if one medicine is effective for 40% of the target population and another drug within the same therapeutic category if also effective for 40% of the population – but we cannot (because of the design of these RCTs) clinically predict which 40% will respond to either treatment – what kind of evidence is that?
What’s a regulator to do? Their only alternative, as they see it, is to rely on cost-based comparisons. In other words, if two medicines are “equally effective†at 40% -- then they will opt to reimburse the one that costs less.
That isn’t evidence-based medicine. That’s bad medicine.
21st Century HTA models should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, and prevent disease. A rapidly aging society demands a new health care paradigm capable of providing for its needs in the 21st century. Equality of Care must be matched with Quality of Care.
The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, of “me-too†medicines over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health.
As Mark McClellan said, “Looking at a gigantic uniform solution for everything is never going to work.â€
We're not at the end of this debate. We're not at the beginning of the end of this debate. But we are at the end of the beginning where at least we can all agree that this is not, and must not be exclusively a debate about saving money. It must be about patient care.
When it comes to health care there are a lot of acronyms. When it comes to cost-containment strategies the main ones are:
HTA: Healthcare Technology Assessment
EBM: Evidence-Based Medicine
CER: Comparative Effectiveness Research
RUM: Rational Use of Medicine
But no matter the acronym, these are all cost-based practices designed to reduce costs and restrict patient care. They are acronyms of denial.
Today, Healthcare Technology Assessment is a short-term, short-sighted, politically-driven policy that results in one-size-fits-all medicine. And while it may provide transitory savings in the short-term, current HTA strategies result in a lower quality of care that result in higher health care costs over time.
Restrictive formularies and health care systems that deny patients access to the right medicine in the right dose at the right time but pay for more invasive and expensive procedures later on have their priorities upside down.
So why is the current HTA model enjoying such wide support? Because it drapes a veil of pseudo-science around the blunt instrument of one-size-fits-all price controls. Consider what Sir Michael Rawlings of NICE said about comparative effectiveness in front of the British House of Commons:
“It is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists we have approached across the country. It is elusive."
IQWiG in Germany claims that it makes its decisions based on "international standards." But such "standards" do not exist. Nice try though.
HTA, as it is currently designed, places into conflict the short-term budgeting dilemmas of governments elected for relatively short periods of time with the ever-lengthening life spans of its electorate.
HTA is a creature not of health care professionals, but of economists being paid by governments (aka: "payers"). Hardly a group of disinterested academics.
HTA is widely based on the concept of “patient variation,†that the same care should be applied to every patient suffering from the same disease based on evidence derived from RCTs.
In other words, if one medicine is effective for 40% of the target population and another drug within the same therapeutic category if also effective for 40% of the population – but we cannot (because of the design of these RCTs) clinically predict which 40% will respond to either treatment – what kind of evidence is that?
What’s a regulator to do? Their only alternative, as they see it, is to rely on cost-based comparisons. In other words, if two medicines are “equally effective†at 40% -- then they will opt to reimburse the one that costs less.
That isn’t evidence-based medicine. That’s bad medicine.
21st Century HTA models should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, and prevent disease. A rapidly aging society demands a new health care paradigm capable of providing for its needs in the 21st century. Equality of Care must be matched with Quality of Care.
The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, of “me-too†medicines over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health.
As Mark McClellan said, “Looking at a gigantic uniform solution for everything is never going to work.â€
We're not at the end of this debate. We're not at the beginning of the end of this debate. But we are at the end of the beginning where at least we can all agree that this is not, and must not be exclusively a debate about saving money. It must be about patient care.
After a national search for a new CDER director -- the best and the brightest was chosen.
Dr.Janet Woodcock is returning as full-time center director.
An overdue homerun for the FDA.
Dr.Janet Woodcock is returning as full-time center director.
An overdue homerun for the FDA.
Leave it to the conflict of interest police to dig an even deeper hole for academic researchers and destroy American competitiveness: NIH funding is declining, restrictions on NIH researchers and NIH supported researchers are tighter than ever and now the conflict Kapos want to prohibit researchers from any sort of collaboration with drug companies or biotech firms.
A group of some of the most prestigious research groups in the country says that five years of flat budgets for the National Institutes of Health is threatening to deter an entire generation of young researchers. Scientists from UCLA, Harvard, Vanderbilt and four other research institutions say that the stagnant NIH budget is persuading young researchers to go into other careers or move to other countries which have proved more generous to biomedical research. To drive that point home, the report--"A Broken Pipeline"--profiles 12 young researchers engaged in groundbreaking work on stem cells, cancer and kidney disease and their difficulty finding new grants.
"This is a real problem, discussed at almost every meeting one attends on campus, that can't be simply dismissed," said Drew Faust, Ph.D., president of Harvard University. "This is about the investment that America is--or is not--making in the health of its citizens and its economy. Right now, the nation's brightest young researchers, upon whom the future of American medicine rests, are getting the message that biomedical research may be a dead end and they should explore other career options--and in too many cases, they're taking that message to heart. The president's latest budget proposal that calls for another year without an increase will only make the problem worse."
fiercebioresearcher.com
They live in a la-la- land where the government will just double NIH funding by raising taxes and -- according to the Soros-funded Institute for Medicine as Profession -- also add billions more to carry out drug development.
Why doesn't the media ever look at the implications of these ideas. I have always said, people like the folks at Healthcare Renewal, Sid Wolfe, Marcia Angell, Merrill Goozner, etc are willing to harm the public health en route to killing the private sector's role in drug development. If their conflict of inflict agenda is adopted -- which also opens doctors to the increased threat of lawsuits from trial attorneys -- they will have taken a strong stride towards that misanthropic goal....
A group of some of the most prestigious research groups in the country says that five years of flat budgets for the National Institutes of Health is threatening to deter an entire generation of young researchers. Scientists from UCLA, Harvard, Vanderbilt and four other research institutions say that the stagnant NIH budget is persuading young researchers to go into other careers or move to other countries which have proved more generous to biomedical research. To drive that point home, the report--"A Broken Pipeline"--profiles 12 young researchers engaged in groundbreaking work on stem cells, cancer and kidney disease and their difficulty finding new grants.
"This is a real problem, discussed at almost every meeting one attends on campus, that can't be simply dismissed," said Drew Faust, Ph.D., president of Harvard University. "This is about the investment that America is--or is not--making in the health of its citizens and its economy. Right now, the nation's brightest young researchers, upon whom the future of American medicine rests, are getting the message that biomedical research may be a dead end and they should explore other career options--and in too many cases, they're taking that message to heart. The president's latest budget proposal that calls for another year without an increase will only make the problem worse."
fiercebioresearcher.com
They live in a la-la- land where the government will just double NIH funding by raising taxes and -- according to the Soros-funded Institute for Medicine as Profession -- also add billions more to carry out drug development.
Why doesn't the media ever look at the implications of these ideas. I have always said, people like the folks at Healthcare Renewal, Sid Wolfe, Marcia Angell, Merrill Goozner, etc are willing to harm the public health en route to killing the private sector's role in drug development. If their conflict of inflict agenda is adopted -- which also opens doctors to the increased threat of lawsuits from trial attorneys -- they will have taken a strong stride towards that misanthropic goal....
Two articles in the Wall Street Journal regarding the use, misuse and theft of drug patents...Of course all the drugs made by Thai-government run companies will be used for the poor and be of top quality....And none of them will ever make it onto the black market because there are SO many limits placed on selling inferior or bogus drugs to unsuspecting people in poor countries...
http://online.wsj.com/article/SB120515886199824251.html?mod=djempersonal
http://online.wsj.com/article/BT-CO-20080310-706680.html?mod=djempersonal
http://online.wsj.com/article/SB120515886199824251.html?mod=djempersonal
http://online.wsj.com/article/BT-CO-20080310-706680.html?mod=djempersonal
The House Energy and Commerce Committee's health subcommittee is scheduled to pick up Tuesday where it left off Thursday, discussing and possibly amending the tobacco-control legislation before certain passage. The full committee would then take up the bill, and passage there appears certain as well.
Then it's on to the House, where a bit more than half its members (220, to be precise) are co-sponsors of the bill. In the Senate, similar legislation has 56 co-sponsors – including Senators McCain, Clinton, and Obama.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the proposed legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. If FDA became the nation's tobacco czar, it would become difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself if this is really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
So for now, thank you for not regulating.
FYI -- the Center for Medicine in the Public Interest (the sponsor of drugwonks.com) does not accept funding from the tobacco industry.
Then it's on to the House, where a bit more than half its members (220, to be precise) are co-sponsors of the bill. In the Senate, similar legislation has 56 co-sponsors – including Senators McCain, Clinton, and Obama.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the proposed legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. If FDA became the nation's tobacco czar, it would become difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself if this is really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
So for now, thank you for not regulating.
FYI -- the Center for Medicine in the Public Interest (the sponsor of drugwonks.com) does not accept funding from the tobacco industry.
Leave it to the mainstream media to pump out the ultimate scare: Big Pharma pollutes the water supply!!!!
AP probe finds drugs in drinking water
By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers
"A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows."
What no Viagra? What about OTC products? Is this some off-label use conspiracy?
"To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe."
Trillion? How about gazillion?
"But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health."
Which scientists? I don't think AP could find one to comment...or at least one that wouldn't stop laughing long enough to do so.
"And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife."
Yes, truly alarming, especially when you claim we don't know the risks.
"We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency."
Yes and so does I.M. Krankee assistant administrator for administrators at the EPA.
The evidence is overwhelming. The AP actually conducted a 5 month investigation.
Most significant:
"Anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.A sex hormone was detected in San Francisco's drinking water."
Why am I not surprised. But no cocaine, pot or heroin? Are those drugs too?
The rest of the article breathlessly details the peril parts per trillion pharmaceuticals impose on the planet. It ends with this observation:
"We know we are being exposed to other people's drugs through our drinking water, and that can't be good," says Dr. David Carpenter, who directs the Institute for Health and the Environment of the State University of New York at Albany."
Very scientific judgment David. I know some people who should be drinking heavily...or have been. It's the birdbrains at AP who put this story together...
Read Article Here
AP probe finds drugs in drinking water
By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers
"A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows."
What no Viagra? What about OTC products? Is this some off-label use conspiracy?
"To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe."
Trillion? How about gazillion?
"But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health."
Which scientists? I don't think AP could find one to comment...or at least one that wouldn't stop laughing long enough to do so.
"And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife."
Yes, truly alarming, especially when you claim we don't know the risks.
"We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency."
Yes and so does I.M. Krankee assistant administrator for administrators at the EPA.
The evidence is overwhelming. The AP actually conducted a 5 month investigation.
Most significant:
"Anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.A sex hormone was detected in San Francisco's drinking water."
Why am I not surprised. But no cocaine, pot or heroin? Are those drugs too?
The rest of the article breathlessly details the peril parts per trillion pharmaceuticals impose on the planet. It ends with this observation:
"We know we are being exposed to other people's drugs through our drinking water, and that can't be good," says Dr. David Carpenter, who directs the Institute for Health and the Environment of the State University of New York at Albany."
Very scientific judgment David. I know some people who should be drinking heavily...or have been. It's the birdbrains at AP who put this story together...
Read Article Here
What constitutes a "complete and reviewable" submission for DDMAC review of a DTC ad?
For a complete answer, see here:
http://www.fda.gov/cder/ddmac/submissions.htm
And for an insight into regulatory creep, consider this little codicil:
"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."
This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.
After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.
Verifiable? How about verifiably inane.
For a complete answer, see here:
http://www.fda.gov/cder/ddmac/submissions.htm
And for an insight into regulatory creep, consider this little codicil:
"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."
This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.
After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.
Verifiable? How about verifiably inane.
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.
