Latest Drugwonks' Blog
I am not making this up ... Yet another example that proves my point that we are so bored, risk averse, and unwilling to take personal responsiblity that we clear the field for so-called public health advocates to blame lung disease on popcorn.
Doctor warns consumers of popcorn fumes
"Consumers, not just factory workers, may be in danger from fumes from buttery flavoring in microwave popcorn, according to a warning letter to federal regulators from a doctor at a leading lung research hospital."
But only if you have 12 bag a day jones for the stuff. Or at least the smell of burning kernels in your nostrils.
"(T)he ailing patient, a man whom she wouldn't identify, consumed "several bags of extra butter flavored microwave popcorn" every day for several years.
He described progressively worsening respiratory symptoms of coughing and shortness of breath. Tests found his ability to exhale was deteriorating, Rose said, although his condition seemed to stabilize after he quit using microwave popcorn.
She said her staff measured airborne levels of diacetyl in the patient's home when he cooked the popcorn. The levels were "similar to those reported in the microwave oven exhaust area" at the quality assurance unit of the popcorn plant where the affected employees worked, she said."
Similar to a microwave oven exhaust area? Did this guy even stop scarfing popcorn to go to the bathroom?
The article discusses "exposure to diecytl" as the culprit. Sounds horrible right? Until you read the CDC and NIOSH findings suggesting either a tenuous link or "ventilation" as the right response. Is exposure related to increased risk of irreversible lung disease? Enough to cause lawsuits a'poppin.
Coming to a store near you. Black box warnings on the package of microwaveable popcorn.
http://news.rgj.com/apps/pbcs.dll/article?AID=/20070905/FOOD/709050313
Doctor warns consumers of popcorn fumes
"Consumers, not just factory workers, may be in danger from fumes from buttery flavoring in microwave popcorn, according to a warning letter to federal regulators from a doctor at a leading lung research hospital."
But only if you have 12 bag a day jones for the stuff. Or at least the smell of burning kernels in your nostrils.
"(T)he ailing patient, a man whom she wouldn't identify, consumed "several bags of extra butter flavored microwave popcorn" every day for several years.
He described progressively worsening respiratory symptoms of coughing and shortness of breath. Tests found his ability to exhale was deteriorating, Rose said, although his condition seemed to stabilize after he quit using microwave popcorn.
She said her staff measured airborne levels of diacetyl in the patient's home when he cooked the popcorn. The levels were "similar to those reported in the microwave oven exhaust area" at the quality assurance unit of the popcorn plant where the affected employees worked, she said."
Similar to a microwave oven exhaust area? Did this guy even stop scarfing popcorn to go to the bathroom?
The article discusses "exposure to diecytl" as the culprit. Sounds horrible right? Until you read the CDC and NIOSH findings suggesting either a tenuous link or "ventilation" as the right response. Is exposure related to increased risk of irreversible lung disease? Enough to cause lawsuits a'poppin.
Coming to a store near you. Black box warnings on the package of microwaveable popcorn.
http://news.rgj.com/apps/pbcs.dll/article?AID=/20070905/FOOD/709050313
News from today's meeting of the European Society of Cardiology Congress 2007 (also in The British Journal of Cardiology) -- An observational study of a large United Kingdom primary care database showed that patients who were switched from established Lipitor therapy to generic simvastatin experienced a 30% increase in relative risk of cardiovascular events or death compared to patients who remained on Lipitor therapy.
The study was conducted by, among others, scientists from Pfizer.
The data, which included records from October 1997 to June 2005, were generated from a retrospective analysis of a medical database of anonymous patient records entered by general practitioners in the United Kingdom known as The Health Improvement Network (THIN).
The analysis included 11,520 patients (2,511 patients who had taken Lipitor for six months or more and were switched to simvastatin vs. 9,009 patients who were taking Lipitor for six months or more and then remained on Lipitor therapy).
While the reasons these patients were switched is not known -- it is certainly not inconceivable that it might have had something to do with ... short term costs to the system. Another example of cost-based medcine trumping patient-centric care.
“Today, many health care payors including governments and managed care companies are encouraging patients who are well-established on one therapy to switch to a different statin therapy,†said Dr. Michael Berelowitz, senior vice president of Pfizer’s global medical division. “This study raises concerns about those policies. It suggests the potential for poorer cardiovascular outcomes associated with switching patients from established Lipitor therapy to simvastatin.â€
A secondary analysis of the same data showed that patients who were switched from Lipitor to generic simvastatin were more than twice as likely to discontinue their treatment compared to those who remained on Lipitor therapy (20.5 percent versus 7.62 percent, p<0.001). The reasons for discontinuation were not available from the database, though disruption in treatment has been associated with poor adherence in previous studies of statins and other medications.
And we strongly support Dr. Berelowitz's statement that, “Observational studies help the medical community better appreciate what is really happening in doctors’ offices, and are commonly used by healthcare payors to set medical practice guidelines. This analysis highlights the need to carefully consider individual patient circumstances and cardiovascular risk because indiscriminate switching may adversely affect some patients.â€
Here is a link to the poster presentation:
Download file
Power to the Physician! Power to the Patient! THIN is in.
The study was conducted by, among others, scientists from Pfizer.
The data, which included records from October 1997 to June 2005, were generated from a retrospective analysis of a medical database of anonymous patient records entered by general practitioners in the United Kingdom known as The Health Improvement Network (THIN).
The analysis included 11,520 patients (2,511 patients who had taken Lipitor for six months or more and were switched to simvastatin vs. 9,009 patients who were taking Lipitor for six months or more and then remained on Lipitor therapy).
While the reasons these patients were switched is not known -- it is certainly not inconceivable that it might have had something to do with ... short term costs to the system. Another example of cost-based medcine trumping patient-centric care.
“Today, many health care payors including governments and managed care companies are encouraging patients who are well-established on one therapy to switch to a different statin therapy,†said Dr. Michael Berelowitz, senior vice president of Pfizer’s global medical division. “This study raises concerns about those policies. It suggests the potential for poorer cardiovascular outcomes associated with switching patients from established Lipitor therapy to simvastatin.â€
A secondary analysis of the same data showed that patients who were switched from Lipitor to generic simvastatin were more than twice as likely to discontinue their treatment compared to those who remained on Lipitor therapy (20.5 percent versus 7.62 percent, p<0.001). The reasons for discontinuation were not available from the database, though disruption in treatment has been associated with poor adherence in previous studies of statins and other medications.
And we strongly support Dr. Berelowitz's statement that, “Observational studies help the medical community better appreciate what is really happening in doctors’ offices, and are commonly used by healthcare payors to set medical practice guidelines. This analysis highlights the need to carefully consider individual patient circumstances and cardiovascular risk because indiscriminate switching may adversely affect some patients.â€
Here is a link to the poster presentation:
Download file
Power to the Physician! Power to the Patient! THIN is in.
Whose giving what to whom? Well, since you asked ...
According to the Institute for Health and Socio-Economic Policy, the research arm of the California Nurses Association/ National Nurses Organizing Committee (CNA/NNOC compiled the research report in concert with the release of director Michael Moore's SiCKO, so consider the source), Democratic and Republican presidential candidates have accepted more than $3.7 million in campaign contributions this year from health-care industry sources, with more than 45% of the money going to just two candidates, Senator Hillary Clinton, D-N.Y., and former Massachusetts Governor Mitt Romney. Overall, health-care contributions to the 18 announced Republican and Democratic presidential candidates total an aggregate $12.8 million since 1989--with 29% of that total donated just in the first quarter of 2007.
Ms. Clinton topped the recipient list with $868,722, which is 23% of all the health-care money donated to candidates this year. Mr. Romney was a close second at $833,385, which is 22% of the total. Senator Barack Obama, D-Ill., received 15% of the total, or $574,268; Senator John McCain, R-Ariz., received 11%, or $423,751; former New York Mayor Rudy Giuliani also received 11%, or $408,822; and former Senator John Edwards received 6%, or $222,950.
For more on this and come choice comments on SiCKO, click on this link:
Download file
And, remember -- it's not what you say ... it's what you don't say.
According to the Institute for Health and Socio-Economic Policy, the research arm of the California Nurses Association/ National Nurses Organizing Committee (CNA/NNOC compiled the research report in concert with the release of director Michael Moore's SiCKO, so consider the source), Democratic and Republican presidential candidates have accepted more than $3.7 million in campaign contributions this year from health-care industry sources, with more than 45% of the money going to just two candidates, Senator Hillary Clinton, D-N.Y., and former Massachusetts Governor Mitt Romney. Overall, health-care contributions to the 18 announced Republican and Democratic presidential candidates total an aggregate $12.8 million since 1989--with 29% of that total donated just in the first quarter of 2007.
Ms. Clinton topped the recipient list with $868,722, which is 23% of all the health-care money donated to candidates this year. Mr. Romney was a close second at $833,385, which is 22% of the total. Senator Barack Obama, D-Ill., received 15% of the total, or $574,268; Senator John McCain, R-Ariz., received 11%, or $423,751; former New York Mayor Rudy Giuliani also received 11%, or $408,822; and former Senator John Edwards received 6%, or $222,950.
For more on this and come choice comments on SiCKO, click on this link:
Download file
And, remember -- it's not what you say ... it's what you don't say.
Adult women are more than twice as likely to know how much they weighed in high school as they are to know their current cholesterol number, and only half of women have had their cholesterol tested in the past year, according to the results of a nationwide survey released today.
Why do you think this is?
Here's a link to an article about the study
http://www.news-medical.net/?id=28935
And for the clueless and cave dwellers here's a link to the infamous Q and A with the young lady who is the most famous person in US/America, at least for now.
http://www.youtube.com/watch?v=lj3iNxZ8Dww
Why do you think this is?
Here's a link to an article about the study
http://www.news-medical.net/?id=28935
And for the clueless and cave dwellers here's a link to the infamous Q and A with the young lady who is the most famous person in US/America, at least for now.
http://www.youtube.com/watch?v=lj3iNxZ8Dww
First research comes out showing that women need different treatment than men for heart disease. Then a study comes out show thousands of new lung cancer tumors -- with unique subgroupings based on pathogenesis -- will extend treatment to thousands. Now this from the Venter Institute a new genome sequence refining and identifying more precisely that humant to human variation in response to disease and medicines.
Why does the Agency for Health Care Qualty and Research still spend a dime on dross from the Drug Effectiveness Research Project which does nothing but catalogue outdated data? Why would the Bush Administration pave the way for single payer health care with a one size fits all coverage decision on blood boosting drugs that will be used differently in differnt people?
Do insurance companies really think they are going to get a comparative effectiveness board of the ground in the face of the individualizaation of medicine?
Comparative effectiveness is rationing in health economist clothing. To suggest it promotes "best practice" (Hillary) or increases value to the patient are ignoring the rapid changes in medical science and the heavy handedness of their own methods which are driven more by a hatred of drug companies than a concern for patients.
I woud be happy to debate anyone, anytime, anywhere on this subject. But I don't think they (and they know who "they" are) will. Because they are not interested in advancing well-being because it will obviously lead to an increase in the use of most new drugs and devices. They are interested in legislative victories and cost containment in the short term.
For more info about the Venter breakthrough go to http://www.JCVI.org.
Why does the Agency for Health Care Qualty and Research still spend a dime on dross from the Drug Effectiveness Research Project which does nothing but catalogue outdated data? Why would the Bush Administration pave the way for single payer health care with a one size fits all coverage decision on blood boosting drugs that will be used differently in differnt people?
Do insurance companies really think they are going to get a comparative effectiveness board of the ground in the face of the individualizaation of medicine?
Comparative effectiveness is rationing in health economist clothing. To suggest it promotes "best practice" (Hillary) or increases value to the patient are ignoring the rapid changes in medical science and the heavy handedness of their own methods which are driven more by a hatred of drug companies than a concern for patients.
I woud be happy to debate anyone, anytime, anywhere on this subject. But I don't think they (and they know who "they" are) will. Because they are not interested in advancing well-being because it will obviously lead to an increase in the use of most new drugs and devices. They are interested in legislative victories and cost containment in the short term.
For more info about the Venter breakthrough go to http://www.JCVI.org.
In his recent Wall Street Journal op-ed, Scott Gottlieb reveals how government-run comparative studies reflect a desire to focus on cost rather than care – and not (as often claimed) to usher in an era of science-based efficiency in medicine.
The Center for Medicine in the Public Interest recently held a conference on large scale comparative effectiveness studies. (Report can be found at http://cmpi.org/archives/2007/08/new_cmpi_report.php) As Gottlieb mentioned, one government study (ALLHAT) didn’t prove its hypothesis that older drugs are more effective in controlling blood pressure.
At the CMPI conference Dr. Michael Weber (an original member of the ALLHAT team) revealed that “ALLHAT exposed African-American patients for several years to treatments investigators knew would not be effective in controlling their blood pressure -- something so unethical that if a pharmaceutical company had done it or any of us as individual academics had done it, we would not only be thrown out of our jobs, we would be pilloried and maybe even be facing criminal charges. The study was driven entirely by a 40% excess stroke rate in black patients that was predictable before the study began. And they used that as their reason to claim superiority of the diuretic.â€
The government ran a study denying African Americans needed care to make a political point: cheaper drugs are better. Because ALLHAT is perceived as anti-industry no one cares if the regimen harms people. Is this the kind of comparative effectiveness we want – or that patient’s need?
The Center for Medicine in the Public Interest recently held a conference on large scale comparative effectiveness studies. (Report can be found at http://cmpi.org/archives/2007/08/new_cmpi_report.php) As Gottlieb mentioned, one government study (ALLHAT) didn’t prove its hypothesis that older drugs are more effective in controlling blood pressure.
At the CMPI conference Dr. Michael Weber (an original member of the ALLHAT team) revealed that “ALLHAT exposed African-American patients for several years to treatments investigators knew would not be effective in controlling their blood pressure -- something so unethical that if a pharmaceutical company had done it or any of us as individual academics had done it, we would not only be thrown out of our jobs, we would be pilloried and maybe even be facing criminal charges. The study was driven entirely by a 40% excess stroke rate in black patients that was predictable before the study began. And they used that as their reason to claim superiority of the diuretic.â€
The government ran a study denying African Americans needed care to make a political point: cheaper drugs are better. Because ALLHAT is perceived as anti-industry no one cares if the regimen harms people. Is this the kind of comparative effectiveness we want – or that patient’s need?
I am sure the black helicopter types who believe drug companies are actually colluding in ways to medicate children for mental illness...but is there any self-respecting psychiatrist who would actually fit this statement from an AP article on the increase in diagnoses for pediatric manic depression.
"Some doctors believe bipolar disorder doesn't occur in children, and until last month there was only one drug approved to treat the illness in kids."
The reporter never identifies those scholars. And then to link this statement with the fact that most pediatric drugs are used off-label. (Better to treat and observe than use kids as lab rats)
Yeah, and there are no drugs approved to treat stomach cancer in kids but they use them anyways.
Here's the entire article:
http://news.yahoo.com/s/ap/20070903/ap_on_he_me/bipolar_kids_3
"Some doctors believe bipolar disorder doesn't occur in children, and until last month there was only one drug approved to treat the illness in kids."
The reporter never identifies those scholars. And then to link this statement with the fact that most pediatric drugs are used off-label. (Better to treat and observe than use kids as lab rats)
Yeah, and there are no drugs approved to treat stomach cancer in kids but they use them anyways.
Here's the entire article:
http://news.yahoo.com/s/ap/20070903/ap_on_he_me/bipolar_kids_3
If you decided to use MapQuest for directions to better drug safety ideas, it might very well direct you to the intersection of Information and Engagement.
Nowhere is this made more clear than with a new program called iGuard. According to their website (http://www.iguard.org):
"iGuard is the fastest and easiest way for you to get personalized alerts and updates on the safety of your medicines.
We are the catalyst for the new conversation among patients, physicians, pharmacists, drug researchers and the government. Launched in 2007 as a startup venture funded by Quintiles Transnational, "iGuard puts the power of drug safety in the hands of each American, right where it should be," states Dr. Hugo Stephenson, founder and president of iGuard.
We facilitate the virtual flow of communication among patients, physicians, and researchers according to two guiding principles:
With iGuard, patients can feel safer because they will be sent the drug safety information they need, when they need it.
The more people that join iGuard, the faster we can help researchers identify safety problems - and communicate this information back to patients, caregivers, and their providers."
It's worth a look -- because it provides a hopeful glimpse into the future of drug safety.
I have seen the future -- and it is collaborative.
Nowhere is this made more clear than with a new program called iGuard. According to their website (http://www.iguard.org):
"iGuard is the fastest and easiest way for you to get personalized alerts and updates on the safety of your medicines.
We are the catalyst for the new conversation among patients, physicians, pharmacists, drug researchers and the government. Launched in 2007 as a startup venture funded by Quintiles Transnational, "iGuard puts the power of drug safety in the hands of each American, right where it should be," states Dr. Hugo Stephenson, founder and president of iGuard.
We facilitate the virtual flow of communication among patients, physicians, and researchers according to two guiding principles:
With iGuard, patients can feel safer because they will be sent the drug safety information they need, when they need it.
The more people that join iGuard, the faster we can help researchers identify safety problems - and communicate this information back to patients, caregivers, and their providers."
It's worth a look -- because it provides a hopeful glimpse into the future of drug safety.
I have seen the future -- and it is collaborative.
And ALLHAT Jazz too.
Important op-ed by Scott Gottlieb in today's Wall Street Journal on the continuing jihad against incremental innovation via poorly designed studies and slanted reporting thereof.
As Scott writes:
"The difficult nature of these "comparative" drug studies, the sort contemplated in Schip, requires more care, not less. These studies are hard to execute by their nature, a fact given short shrift by policy makers who believe the conclusions gleaned from the research will provide immediate cost savings.
For one thing, as the Allhat study proved, detecting small clinical differences between two active drugs, such as whether one pill lowers blood pressure more than another, requires very large studies that often fail to capture all of the patient preferences and characteristics that go into real world medical decisions. And once the study is completed, determining whether small differences are clinically meaningful can take years of follow up.
When the trials are under-funded and too small, or are poorly designed or conducted, important differences are not detected, which supports the theory that older drugs are as good as newer ones even if that is not true. This flawed science seems just fine with those who support these trials largely for cost purposes."
And many top clinical experts agree. Click on the link below and see what Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University have to say on the topic.
Download file
No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine. This language disintermediates physicians, hurts patients and helps nobody other than payors (both public and private).
And that's not public health -- it's politics
Important op-ed by Scott Gottlieb in today's Wall Street Journal on the continuing jihad against incremental innovation via poorly designed studies and slanted reporting thereof.
As Scott writes:
"The difficult nature of these "comparative" drug studies, the sort contemplated in Schip, requires more care, not less. These studies are hard to execute by their nature, a fact given short shrift by policy makers who believe the conclusions gleaned from the research will provide immediate cost savings.
For one thing, as the Allhat study proved, detecting small clinical differences between two active drugs, such as whether one pill lowers blood pressure more than another, requires very large studies that often fail to capture all of the patient preferences and characteristics that go into real world medical decisions. And once the study is completed, determining whether small differences are clinically meaningful can take years of follow up.
When the trials are under-funded and too small, or are poorly designed or conducted, important differences are not detected, which supports the theory that older drugs are as good as newer ones even if that is not true. This flawed science seems just fine with those who support these trials largely for cost purposes."
And many top clinical experts agree. Click on the link below and see what Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University have to say on the topic.
Download file
No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine. This language disintermediates physicians, hurts patients and helps nobody other than payors (both public and private).
And that's not public health -- it's politics
Here's a really superb example of health care grass roots "social marketing" -- made all the more exciting since it bubbled up all by itself ...
http://nocnews.blogspot.com/2007/08/healthcare-prescriptions-and-insurance.html
And in case you cannot link to the Pharmaceutical Executive article mentioned there, here's a better link ...
http://cmpi.org/archives/2007/08/opinion_fewer_cents_more_sense.php
(And, yes, it's the same Nazareth that's in The Band song "The Weight.")
Pulled into Nazareth ...
http://nocnews.blogspot.com/2007/08/healthcare-prescriptions-and-insurance.html
And in case you cannot link to the Pharmaceutical Executive article mentioned there, here's a better link ...
http://cmpi.org/archives/2007/08/opinion_fewer_cents_more_sense.php
(And, yes, it's the same Nazareth that's in The Band song "The Weight.")
Pulled into Nazareth ...
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.
