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09/06/2007 09:06 AM |
Hillary, Obama, Edwards, et al still continue to point to the VA system as a model for how to handle prescription drugs. Let it be noted that Lipitor is not on the VA formulary and patients are usually started out on a generic statin. Now cut to the following headline:
From The Times (UK)
September 6, 2007
Switch to cheap statins 'raises risk of heart attack or stroke'
Report on risk research undertaken by maker of the market leader in branded statins
Nigel Hawkes, Health Editor
Millions of patients being transferred to cheaper generic versions of statin drugs may suffer a greater risk of heart attacks and strokes, a study says.
Patients in Britain who have been prescribed branded statins such as Lipitor or Crestor are being switched by their GPs to a cheaper drug, simvastatin, to save money.
The claim is that simvastatin is similar in its effects to Lipitor, the market leader in branded statins, so that nobody will suffer by the switch and the NHS will save tens of millions of pounds a year.
Pfizer, which makes Lipitor, investigated whether such switches were really risk-free by using an NHS data-base compiled from GP data.
It reported yesterday at the European Society of Cardiology Congress in Vienna that patients switched from Lipitor to simvastatin had a 43 per cent higher chance of a major cardiovascular event, such as a heart attack."
And here's the key point that liberals and the comparative effectiveness crowd willfully ignores explaining why stroke and heart attack rates were up:
"One possible explanation, he said, was that statins are actually different in their effects. The sample, of 2,511 people who had been switched, did not show any difference in the level of “bad†LDL cholesterol, but relatively few GPs had recorded the data.
“We only have that data for 15 per cent of the sample,†Dr Phillips said. “Maybe if we had more it would show that switching leads to higher LDL levels, which could help explain the findings.â€
Previous head-to-head comparisons of statins had shown that the choice of drug had little effect on death rates, he said, except in very high-risk patients.
The differences tended to be seen in morbidity, he said: how ill people were and how well their symptoms were controlled."
And that's the model the know-it-alls want to shove down the throats of the rest of us.
http://www.timesonline.co.uk/tol/news/uk/health/article2395284.ece Read More & Comment...
From The Times (UK)
September 6, 2007
Switch to cheap statins 'raises risk of heart attack or stroke'
Report on risk research undertaken by maker of the market leader in branded statins
Nigel Hawkes, Health Editor
Millions of patients being transferred to cheaper generic versions of statin drugs may suffer a greater risk of heart attacks and strokes, a study says.
Patients in Britain who have been prescribed branded statins such as Lipitor or Crestor are being switched by their GPs to a cheaper drug, simvastatin, to save money.
The claim is that simvastatin is similar in its effects to Lipitor, the market leader in branded statins, so that nobody will suffer by the switch and the NHS will save tens of millions of pounds a year.
Pfizer, which makes Lipitor, investigated whether such switches were really risk-free by using an NHS data-base compiled from GP data.
It reported yesterday at the European Society of Cardiology Congress in Vienna that patients switched from Lipitor to simvastatin had a 43 per cent higher chance of a major cardiovascular event, such as a heart attack."
And here's the key point that liberals and the comparative effectiveness crowd willfully ignores explaining why stroke and heart attack rates were up:
"One possible explanation, he said, was that statins are actually different in their effects. The sample, of 2,511 people who had been switched, did not show any difference in the level of “bad†LDL cholesterol, but relatively few GPs had recorded the data.
“We only have that data for 15 per cent of the sample,†Dr Phillips said. “Maybe if we had more it would show that switching leads to higher LDL levels, which could help explain the findings.â€
Previous head-to-head comparisons of statins had shown that the choice of drug had little effect on death rates, he said, except in very high-risk patients.
The differences tended to be seen in morbidity, he said: how ill people were and how well their symptoms were controlled."
And that's the model the know-it-alls want to shove down the throats of the rest of us.
http://www.timesonline.co.uk/tol/news/uk/health/article2395284.ece Read More & Comment...
09/06/2007 08:31 AM |
According to a new study, the rates of diagnosis and treatment of depression among adults have declined significantly since the FDA's warning about the possible risk of suicide among teens when they're treated with SSRIs.
"While some degree of decline in antidepressant prescribing was not unexpected after the black box warning was issued, few if any had predicted diagnosing to decline, or that other modes of treatment (psychotherapy or other medications) would remain relatively unchanged," Dr. Robert J. Valuck told Reuters Health. "It was thought that the latter two may increase to compensate for fewer antidepressant prescriptions being written."
That's worth repeating -- the black box warning has resulted in a decline not only in prescribing (no surprise there) but in diagnosis.
Does this meant that we can rid our nation of depression via fear of pharmaceuticals? That's a pretty frightening proposition.
Valuck, from the University of Colorado at Denver, and colleagues examined data relating to depression among 400,000 adult patients enrolled in managed care plans.
Hmm -- "in managed care plans." Is cost once again trumping care? Or is depression really one of those "made-up" diseaese we're reading about so much these days?
In the five years before the SSRI warning about teen suicide, the rate of diagnosed episodes of depression increased steadily from 6 to 11 per 1000 enrollees, the investigators report in the American Journal of Psychiatry.
The percentage of patients who had at least one psychotherapy session, and the percentage of depressive episodes for which possible alternatives to antidepressants were prescribed, did not change significantly after the advisory, the researchers found.
"We believe that there are likely to be many factors involved in the changes that we observed, and that they are very deserving of further study," Valuck said. "Physicians and policy makers should be aware of the power of these regulatory tools, both for the intended and unintended consequences that they may cause."
Did somebody say "unintended consequences?"
Indeed, let's not forget that in the June issue of the journal PLos Medicine a study reported that rather than boosting suicide rates, SSRIs have actually saved thousands of lives by preventing suicides since they were introduced in 1988.
For this study, the authors analyzed federal data on suicide rates since 1960, along with sales of fluoxetine (Prozac) since it became available in 1988. Analysis was continued through 2002. Prozac was used as a benchmark for the broader class of drugs.
Between the early 1960s and 1988, suicide rates held relatively steady, fluctuating between 12.2 per 100,000 and 13.7 per 100,000.
Since 1988, however, suicide rates have been on a gradual decline, with the lowest point being 10.4 per 100,000 in 2000. During the same time frame, Prozac prescriptions rose, from 2,469,000 in 1988 to 33,320,000 in 2002.
Using mathematical modeling, the investigators estimated the rates of suicide if the pre-1988 trends had continued, estimating that there would have been an additional 33,600 suicides if the pre-1988 trends had been maintained.
With that in mind, moves to restrict the use of SSRI antidepressants could have a harmful effect, the authors stated.
“I don’t think these claims that antidepressants increase suicide have a solid base,†said Dr. Julio Licinio, lead author of the study and Chairman of the Department of Psychiatry and Behavioral Sciences at the University of Miami.
“If you have a drug that’s supposed to be causing something, the more of the drug that’s used, the more of the bad outcome you would have. What we show is the converse.â€
But, hey, if we just stop diagnosing the disease, then the problem will go away all by itself, right? Wrong!
This should serve as another wake-up call to those who applaud the wholesale expansion of FDA black box warnings. Read More & Comment...
"While some degree of decline in antidepressant prescribing was not unexpected after the black box warning was issued, few if any had predicted diagnosing to decline, or that other modes of treatment (psychotherapy or other medications) would remain relatively unchanged," Dr. Robert J. Valuck told Reuters Health. "It was thought that the latter two may increase to compensate for fewer antidepressant prescriptions being written."
That's worth repeating -- the black box warning has resulted in a decline not only in prescribing (no surprise there) but in diagnosis.
Does this meant that we can rid our nation of depression via fear of pharmaceuticals? That's a pretty frightening proposition.
Valuck, from the University of Colorado at Denver, and colleagues examined data relating to depression among 400,000 adult patients enrolled in managed care plans.
Hmm -- "in managed care plans." Is cost once again trumping care? Or is depression really one of those "made-up" diseaese we're reading about so much these days?
In the five years before the SSRI warning about teen suicide, the rate of diagnosed episodes of depression increased steadily from 6 to 11 per 1000 enrollees, the investigators report in the American Journal of Psychiatry.
The percentage of patients who had at least one psychotherapy session, and the percentage of depressive episodes for which possible alternatives to antidepressants were prescribed, did not change significantly after the advisory, the researchers found.
"We believe that there are likely to be many factors involved in the changes that we observed, and that they are very deserving of further study," Valuck said. "Physicians and policy makers should be aware of the power of these regulatory tools, both for the intended and unintended consequences that they may cause."
Did somebody say "unintended consequences?"
Indeed, let's not forget that in the June issue of the journal PLos Medicine a study reported that rather than boosting suicide rates, SSRIs have actually saved thousands of lives by preventing suicides since they were introduced in 1988.
For this study, the authors analyzed federal data on suicide rates since 1960, along with sales of fluoxetine (Prozac) since it became available in 1988. Analysis was continued through 2002. Prozac was used as a benchmark for the broader class of drugs.
Between the early 1960s and 1988, suicide rates held relatively steady, fluctuating between 12.2 per 100,000 and 13.7 per 100,000.
Since 1988, however, suicide rates have been on a gradual decline, with the lowest point being 10.4 per 100,000 in 2000. During the same time frame, Prozac prescriptions rose, from 2,469,000 in 1988 to 33,320,000 in 2002.
Using mathematical modeling, the investigators estimated the rates of suicide if the pre-1988 trends had continued, estimating that there would have been an additional 33,600 suicides if the pre-1988 trends had been maintained.
With that in mind, moves to restrict the use of SSRI antidepressants could have a harmful effect, the authors stated.
“I don’t think these claims that antidepressants increase suicide have a solid base,†said Dr. Julio Licinio, lead author of the study and Chairman of the Department of Psychiatry and Behavioral Sciences at the University of Miami.
“If you have a drug that’s supposed to be causing something, the more of the drug that’s used, the more of the bad outcome you would have. What we show is the converse.â€
But, hey, if we just stop diagnosing the disease, then the problem will go away all by itself, right? Wrong!
This should serve as another wake-up call to those who applaud the wholesale expansion of FDA black box warnings. Read More & Comment...
09/05/2007 06:51 PM |
The NEJM can't get over the fact that the FDA Adcomm ignored their wizened advice and Steven Nissen/their best efforts to get Avandia canned, so on the heels of the incredibly inaccurate and whiny article by Jerry Avorn, it publishes yet another screed by Sheila Smith about how the FDA has failed to respond to the IOM recommendations -- which of course were made by Bruce Psaty, David Blumenthal and Sheila Burke.
Let's remember at the Avandia meeting David Graham used meta-analysis and unpublished data from an observational study that did not have safety as a primary endpoint to remove a drug. I guess that's what Sheila Smith means in her article about giving safety staff a strong voice.
http://content.nejm.org/cgi/content/full/357/10/960?query=TOC Read More & Comment...
Let's remember at the Avandia meeting David Graham used meta-analysis and unpublished data from an observational study that did not have safety as a primary endpoint to remove a drug. I guess that's what Sheila Smith means in her article about giving safety staff a strong voice.
http://content.nejm.org/cgi/content/full/357/10/960?query=TOC Read More & Comment...
09/05/2007 06:09 PM |
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 Read More & Comment...
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 Read More & Comment...
09/05/2007 09:00 AM |
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. Read More & Comment...
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. Read More & Comment...
09/05/2007 08:27 AM |
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. Read More & Comment...
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. Read More & Comment...
09/04/2007 04:10 PM |
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 Read More & Comment...
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 Read More & Comment...
09/04/2007 11:26 AM |
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. Read More & Comment...
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. Read More & Comment...
09/04/2007 08:10 AM |
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? Read More & Comment...
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? Read More & Comment...
09/03/2007 09:37 PM |
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 Read More & Comment...
"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 Read More & Comment...
08/31/2007 02:01 PM |
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. Read More & Comment...
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. Read More & Comment...
08/30/2007 10:00 AM |
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 Read More & Comment...
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 Read More & Comment...
08/29/2007 07:10 AM |
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 ... Read More & Comment...
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 ... Read More & Comment...
08/28/2007 12:56 PM |
Oh, and the percentage of poor kids without health care coverage, the ones already eligible for Medicaid or SCHIP increased.
So, of course, the solution is to expand government coverage to rich white families.
http://www.census.gov/Press-Release/www/releases/archives/news_conferences/010500.html Read More & Comment...
So, of course, the solution is to expand government coverage to rich white families.
http://www.census.gov/Press-Release/www/releases/archives/news_conferences/010500.html Read More & Comment...
08/28/2007 12:41 PM |
Carol Crim is not a name you will read about in the newspapers, although perhaps now you will read her obituary. But no tribute, no matter how well written, could possibly capture the impact this elegant lady had on America's health -- and on me personally.
I knew Carol in her role as executive secretary to Mark McClellan when he was FDA Commissioner. But she had served other Commissioners before him. She represented the Commissioner, the Office of the Commissioner, and the FDA to a wide variety of people both inside and outside of government, regardless of political affiliation, nationality, or degree of scientific standing with something so crucial, yet so lacking in so much of Washington, DC today. Class.
Those who knew her and worked along side her know what I mean. She helped keep us focused, keep our perspective, keep us on schedule and, on many occasions, keep our sanity.
When she became ill her friends and colleagues hoped publicly and wept privately.
Today, we weep publicly.
Carol, thanks for all the small favors, for loyalty and honesty, for precision and professionalism. And thanks for your friendship.
I miss you. Read More & Comment...
I knew Carol in her role as executive secretary to Mark McClellan when he was FDA Commissioner. But she had served other Commissioners before him. She represented the Commissioner, the Office of the Commissioner, and the FDA to a wide variety of people both inside and outside of government, regardless of political affiliation, nationality, or degree of scientific standing with something so crucial, yet so lacking in so much of Washington, DC today. Class.
Those who knew her and worked along side her know what I mean. She helped keep us focused, keep our perspective, keep us on schedule and, on many occasions, keep our sanity.
When she became ill her friends and colleagues hoped publicly and wept privately.
Today, we weep publicly.
Carol, thanks for all the small favors, for loyalty and honesty, for precision and professionalism. And thanks for your friendship.
I miss you. Read More & Comment...
08/28/2007 11:21 AM |
along with others in a concise National Review Online symposium..
http://article.nationalreview.com/?q=ZmQwZTIzODQxYWQ3ZDlkNmVlZjVjYzA3MTA3ZTBkNzU= Read More & Comment...
http://article.nationalreview.com/?q=ZmQwZTIzODQxYWQ3ZDlkNmVlZjVjYzA3MTA3ZTBkNzU= Read More & Comment...
08/28/2007 10:37 AM |
Not really, but Drew Altman of the Kaiser Family Foundation inadvertently comes up with great idea in plugging KFF's latest waste of money.
On the heels of co-sponsoring the hard hitting survey showing that poor seniors without Medicare part D coverage paid more for drugs than those without, KFF spent part of it's billions ona poll examining just how many people were affected by "Sicko."
Turns out that less than 4 percent of Americans saw the movie, give or take a couple of percentage points (that includes folks who saw it on the Web for free). Needless to say that's not the story KFF wanted to tell. So it asked who had heard of Michael Moore and Sicko right after the both had been basted with a huge marketing blitz. (Ok to market Sicko but not drugs, right?)
"The new poll finds that almost half (46%) had seen the movie or heard or read something about it a little over a month after its national release. This is not much less than the share of adults (61%) who were aware of "An Inconvenient Truth," the documentary on climate change featuring former Vice President Al Gore released in May 2006."
Well, at least Gore can say he won that race.
So what's the precious dross we can take away from this KFF poll?
"Our poll shows how the combination of good timing, a controversial director, and lots of free media attention can generate real impact for a film that very few people have actually seen," said Kaiser President and CEO Drew E. Altman, Ph.D. "'Sicko' is not a commercial juggernaut like 'Transformers' or 'Harry Potter,' and we're not likely to find Michael Moore action figures at fast food restaurants any time soon. But we are starting to see how films about social issues that capitalize on free media rather than traditional marketing can become social phenomena too."
A Michael Moore action figure at a fast food restaurant. Now THAT is funny. Maybe KFF would also be interested in my concept for a health care action movie. It would start Bruce Willis as a NYPD type in London who rescues Michael Moore when is taken hostage by a NHS doctor who is also a terrorist. It's called Fat Free or Die Hard.
PS Does a KFF poll promoting "Sicko" count as 'free media' or 'traditional marketing?' Read More & Comment...
On the heels of co-sponsoring the hard hitting survey showing that poor seniors without Medicare part D coverage paid more for drugs than those without, KFF spent part of it's billions ona poll examining just how many people were affected by "Sicko."
Turns out that less than 4 percent of Americans saw the movie, give or take a couple of percentage points (that includes folks who saw it on the Web for free). Needless to say that's not the story KFF wanted to tell. So it asked who had heard of Michael Moore and Sicko right after the both had been basted with a huge marketing blitz. (Ok to market Sicko but not drugs, right?)
"The new poll finds that almost half (46%) had seen the movie or heard or read something about it a little over a month after its national release. This is not much less than the share of adults (61%) who were aware of "An Inconvenient Truth," the documentary on climate change featuring former Vice President Al Gore released in May 2006."
Well, at least Gore can say he won that race.
So what's the precious dross we can take away from this KFF poll?
"Our poll shows how the combination of good timing, a controversial director, and lots of free media attention can generate real impact for a film that very few people have actually seen," said Kaiser President and CEO Drew E. Altman, Ph.D. "'Sicko' is not a commercial juggernaut like 'Transformers' or 'Harry Potter,' and we're not likely to find Michael Moore action figures at fast food restaurants any time soon. But we are starting to see how films about social issues that capitalize on free media rather than traditional marketing can become social phenomena too."
A Michael Moore action figure at a fast food restaurant. Now THAT is funny. Maybe KFF would also be interested in my concept for a health care action movie. It would start Bruce Willis as a NYPD type in London who rescues Michael Moore when is taken hostage by a NHS doctor who is also a terrorist. It's called Fat Free or Die Hard.
PS Does a KFF poll promoting "Sicko" count as 'free media' or 'traditional marketing?' Read More & Comment...
08/28/2007 08:21 AM |
Guarantees are hard to come by. Even with medicine, doctors would be hard-pressed to tell patients that the drug they're prescribing is certain to work. After all, thanks to different medical histories, personal biochemistries, and physiologies, everyone is different. There's no such thing as a "me-too" patient.
That's why patients and their doctors often try a variety of different drugs before finding one that works - because there's no such thing as a "me-too" medicine. But in the interest of saving a few bucks, such personalized treatments may soon become a thing of the past.
This fundamental misunderstanding is being advanced by politicians grasping for answers to questions on health care. For an example, look no further than Reps. Tom Allen, D-ME, and Jo Ann Emerson, R-MO, whose Enhanced Health Care Value for All Act would increase spending on one-size-fits-all, top-down solutions.
The bill would authorize $3 billion of investment on new research "on the comparative effectiveness of health care services (including prescription drugs, medical devices, procedures, and other treatments) to inform health care providers' decisions." Senator Hillary Clinton also has advocated a similar program.
Here's the rest of the story, courtesy of the Tampa Tribune ...
http://www2.tbo.com/content/2007/aug/27/na-one-size-medicine-does-not-fit-all/?news-opinion-commentary
Comparative Effectiveness -- the Hanging Chad of Health Care Read More & Comment...
That's why patients and their doctors often try a variety of different drugs before finding one that works - because there's no such thing as a "me-too" medicine. But in the interest of saving a few bucks, such personalized treatments may soon become a thing of the past.
This fundamental misunderstanding is being advanced by politicians grasping for answers to questions on health care. For an example, look no further than Reps. Tom Allen, D-ME, and Jo Ann Emerson, R-MO, whose Enhanced Health Care Value for All Act would increase spending on one-size-fits-all, top-down solutions.
The bill would authorize $3 billion of investment on new research "on the comparative effectiveness of health care services (including prescription drugs, medical devices, procedures, and other treatments) to inform health care providers' decisions." Senator Hillary Clinton also has advocated a similar program.
Here's the rest of the story, courtesy of the Tampa Tribune ...
http://www2.tbo.com/content/2007/aug/27/na-one-size-medicine-does-not-fit-all/?news-opinion-commentary
Comparative Effectiveness -- the Hanging Chad of Health Care Read More & Comment...
08/28/2007 06:04 AM |
Commentary from today's edition of The Wall Street Journal ...
Patent Remedy
By RONALD A. CASS
The European Union's trade commissioner, Peter Mandelson, recently joined the U.S. in protesting Thailand's effective theft of pharmaceutical companies' intellectual property. Despite efforts of health activists to portray the world community as accepting -- even endorsing -- Thailand's conduct, there is growing appreciation that trampling patents to allow a middle-income nation to cut its spending on drugs seriously threatens the world's system of protections for innovation.
The basic issues are relatively simple. Improvements in the way we treat diseases, communicate, store information and do so much else depend on innovation. To encourage innovators, laws give them the right to control the uses of their inventions for a period of time, to decide who makes products using their innovations, and to set the price for access to this "intellectual property."
The World Trade Organization's agreement on Trade-Related Aspects of Intellectual Property Rights (Trips) ties other trade rights to adequate respect for partners' patents, copyrights and trademarks. Compulsory licensing -- forcing patent owners to allow others to manufacture products using their innovations at prices set by the government -- is permitted under extraordinary conditions, such as when a critical patent is not being used to produce essential goods. This has always been understood as limited to a small set of special cases.
While the system of IP protections has worked well to encourage investment in innovations, some groups oppose protection of all property rights. Over the past decade, these groups have worked hard to alter the meaning of the Trips agreement and to encourage governments to use compulsory licensing to break IP protections.
These groups gained a small victory when the WTO said in 2001 that Trips encompassed "flexibilities" -- including compulsory licensing -- that allow governments to deal with health emergencies such as might be posed by epidemics of tuberculosis, malaria or HIV/AIDS in sub-Saharan Africa. WTO ministers agreed as well that there was not a single definition for all nations at all times of what constitutes an appropriate sort of emergency to justify compulsory licensing.
The activists used that declaration to argue that Trips authorizes any nation to impose compulsory licensing on any patent, especially any drug patent, for any reason. The military-backed Thai government's compulsory licensing initiative, pushed by its Public Health Ministry, is the first fruit of the activists' campaign -- a relatively developed nation facing no epidemic, just seeking to shift its spending priorities by taking someone else's property.
The U.S. clearly signaled its view that this works a radical change in the legal system for protecting IP. It put Thailand on the Priority Watch list for nations violating IP rights and formally protested Thailand's action. These moves could lead to trade sanctions on Thailand.
The EU's letter, adding Europe's voice, is especially interesting given the attacks that Neelie Kroes, the EU's competition minister, has launched on IP rights. While Ms. Kroes blithely assumes that her assertion of control over the uses and prices of IP created by firms like Microsoft won't harm innovation, Mr. Mandelson recognizes that any government's assault on the system of IP protections can unravel a thread that supports an increasing proportion of the global economy.
Having set the stage for a potentially disastrous turn in world protection of IP rights, Thailand has a chance to show leadership in a very different way. If its prime minister reins in its Public Health Ministry, Thailand can remind those in Europe and the U.S. who waver on protection for IP rights that the costs of undermining innovation vastly exceed short-term gains from cutting prices on patented drugs. Protecting the benefits from innovation and trade should matter more than pleasing the activists -- no matter how loudly they complain.
Mr. Cass is chairman of the Center for the Rule of Law, dean emeritus of Boston University School of Law and former vice chairman of the U.S. International Trade Commission. Read More & Comment...
Patent Remedy
By RONALD A. CASS
The European Union's trade commissioner, Peter Mandelson, recently joined the U.S. in protesting Thailand's effective theft of pharmaceutical companies' intellectual property. Despite efforts of health activists to portray the world community as accepting -- even endorsing -- Thailand's conduct, there is growing appreciation that trampling patents to allow a middle-income nation to cut its spending on drugs seriously threatens the world's system of protections for innovation.
The basic issues are relatively simple. Improvements in the way we treat diseases, communicate, store information and do so much else depend on innovation. To encourage innovators, laws give them the right to control the uses of their inventions for a period of time, to decide who makes products using their innovations, and to set the price for access to this "intellectual property."
The World Trade Organization's agreement on Trade-Related Aspects of Intellectual Property Rights (Trips) ties other trade rights to adequate respect for partners' patents, copyrights and trademarks. Compulsory licensing -- forcing patent owners to allow others to manufacture products using their innovations at prices set by the government -- is permitted under extraordinary conditions, such as when a critical patent is not being used to produce essential goods. This has always been understood as limited to a small set of special cases.
While the system of IP protections has worked well to encourage investment in innovations, some groups oppose protection of all property rights. Over the past decade, these groups have worked hard to alter the meaning of the Trips agreement and to encourage governments to use compulsory licensing to break IP protections.
These groups gained a small victory when the WTO said in 2001 that Trips encompassed "flexibilities" -- including compulsory licensing -- that allow governments to deal with health emergencies such as might be posed by epidemics of tuberculosis, malaria or HIV/AIDS in sub-Saharan Africa. WTO ministers agreed as well that there was not a single definition for all nations at all times of what constitutes an appropriate sort of emergency to justify compulsory licensing.
The activists used that declaration to argue that Trips authorizes any nation to impose compulsory licensing on any patent, especially any drug patent, for any reason. The military-backed Thai government's compulsory licensing initiative, pushed by its Public Health Ministry, is the first fruit of the activists' campaign -- a relatively developed nation facing no epidemic, just seeking to shift its spending priorities by taking someone else's property.
The U.S. clearly signaled its view that this works a radical change in the legal system for protecting IP. It put Thailand on the Priority Watch list for nations violating IP rights and formally protested Thailand's action. These moves could lead to trade sanctions on Thailand.
The EU's letter, adding Europe's voice, is especially interesting given the attacks that Neelie Kroes, the EU's competition minister, has launched on IP rights. While Ms. Kroes blithely assumes that her assertion of control over the uses and prices of IP created by firms like Microsoft won't harm innovation, Mr. Mandelson recognizes that any government's assault on the system of IP protections can unravel a thread that supports an increasing proportion of the global economy.
Having set the stage for a potentially disastrous turn in world protection of IP rights, Thailand has a chance to show leadership in a very different way. If its prime minister reins in its Public Health Ministry, Thailand can remind those in Europe and the U.S. who waver on protection for IP rights that the costs of undermining innovation vastly exceed short-term gains from cutting prices on patented drugs. Protecting the benefits from innovation and trade should matter more than pleasing the activists -- no matter how loudly they complain.
Mr. Cass is chairman of the Center for the Rule of Law, dean emeritus of Boston University School of Law and former vice chairman of the U.S. International Trade Commission. Read More & Comment...
08/27/2007 10:19 AM |
This one showing that poor seniors who don't enroll in part D are more likely to have higher out of pocket costs than seniors that do enroll.
Imagine the brainpower it took to come to that conclusion.
Next study from Commonwealth: People with insurance have more coverage than people who don't have insurance.
Oh the humanity.
http://www.kff.org/medicare/med082107nr.cfm Read More & Comment...
Imagine the brainpower it took to come to that conclusion.
Next study from Commonwealth: People with insurance have more coverage than people who don't have insurance.
Oh the humanity.
http://www.kff.org/medicare/med082107nr.cfm Read More & Comment...
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