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Drugwonks.com is the web log of the Center for Medicine in the Public Interest (CMPI), a forum offering rigorous and compelling research on the most critical issues affecting current drug policy.
Drugwonks.com is the web log of the Center for Medicine in the Public Interest (CMPI), a forum offering rigorous and compelling research on the most critical issues affecting current drug policy.
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
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
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.
"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.
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
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
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.
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.
