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Comparative effectiveness? Well since you mentioned it ...
CBO’s Estimate of the Budgetary Impact of Section 904
(Sec. 904. Comparative effectiveness research. Establishes within the Agency of Healthcare Research and Quality a Center for Comparative Effectiveness Research to conduct research on the outcomes, effectiveness, and appropriateness of health care services.Also establishes an independent Comparative Effectiveness Research Commission to set priorities and ensure credibility for the Center’s work. It also establishes a Comparative Effectiveness Research Trust Fund, initially funded through the Medicare trust fund, to support the work of the Center and the Commission.)
* CBO estimates that Section 904 of the CHAMP act (H.R. 3162) would increase Federal spending (Medicare, Medicaid, and FEHBP) by $600 million between 2008 to 2012, and $2.4 billion from 2008-2017.
* While the agency estimates that the bill could reduce public and private health spending by up to $6 billion, direct Federal spending would only be reduced by $100 million over the 2008-2012 period and $1.3 billion between 2008 and 2017. (Those amounts would constitute a very small fraction of overall federal outlays for those programs.)
* Thus, enacting section 904 would increase federal direct spending by $0.5 billion over five years and $1.1 billion over 10 years.
* CBO assumes that the provision would result in better information about which health care services and procedures are ineffective and some changes in coverage rules that can be implemented under current law.
Well that's certainly reassuring.
CBO’s Estimate of the Budgetary Impact of Section 904
(Sec. 904. Comparative effectiveness research. Establishes within the Agency of Healthcare Research and Quality a Center for Comparative Effectiveness Research to conduct research on the outcomes, effectiveness, and appropriateness of health care services.Also establishes an independent Comparative Effectiveness Research Commission to set priorities and ensure credibility for the Center’s work. It also establishes a Comparative Effectiveness Research Trust Fund, initially funded through the Medicare trust fund, to support the work of the Center and the Commission.)
* CBO estimates that Section 904 of the CHAMP act (H.R. 3162) would increase Federal spending (Medicare, Medicaid, and FEHBP) by $600 million between 2008 to 2012, and $2.4 billion from 2008-2017.
* While the agency estimates that the bill could reduce public and private health spending by up to $6 billion, direct Federal spending would only be reduced by $100 million over the 2008-2012 period and $1.3 billion between 2008 and 2017. (Those amounts would constitute a very small fraction of overall federal outlays for those programs.)
* Thus, enacting section 904 would increase federal direct spending by $0.5 billion over five years and $1.1 billion over 10 years.
* CBO assumes that the provision would result in better information about which health care services and procedures are ineffective and some changes in coverage rules that can be implemented under current law.
Well that's certainly reassuring.
In my op-ed in today's Washington Times I compare Jerry Avorn's disdain of a drug for blacks that reduces death from stroke by 43 percent with his love of a one-size fits all prescribing pattern that raises it by 40 percent.
Why does he love one and hate the other?
Because one favors new drugs and the other favors old drugs.
http://washingtontimes.com/article/20070907/EDITORIAL/109070006/1013/EDITORIAL
Why does he love one and hate the other?
Because one favors new drugs and the other favors old drugs.
http://washingtontimes.com/article/20070907/EDITORIAL/109070006/1013/EDITORIAL
Two cheers for the American Cancer Society's efforts to focus attention and its advertising dollars on the nation's health access problem -- specifically the uninsured. We're holding the third cheer in reserve because of our concern that policymakers will interpret these commercials as an endorsement of a single-payer, "universal" healthcare system. We're also not 100% convinced that this is the best way for the ACS to spend its money -- but that's their business.
The ACS says that is has "no position" on what kind of health system should be in place in the U.S. Here's a suggestion -- how about one that delivers the highest rate of cancer survival in the world.
According to a recent study in the respected Lancet Oncology -- the most comprehensive ever conducted -- America's cancer-survival rate is the highest in the world among both men and women. By contrast, Britain -- despite its reputation as a utopia of "free" healthcare -- has some of the lowest survival rates in the western world.
Improved access is an worthy goal -- but a single-payer system is not the answer -- especially for cancer patients.
And the American Cancer Society should be brave enough to say so.
The ACS says that is has "no position" on what kind of health system should be in place in the U.S. Here's a suggestion -- how about one that delivers the highest rate of cancer survival in the world.
According to a recent study in the respected Lancet Oncology -- the most comprehensive ever conducted -- America's cancer-survival rate is the highest in the world among both men and women. By contrast, Britain -- despite its reputation as a utopia of "free" healthcare -- has some of the lowest survival rates in the western world.
Improved access is an worthy goal -- but a single-payer system is not the answer -- especially for cancer patients.
And the American Cancer Society should be brave enough to say so.
FiercePharma call the increase in suicides in the wake of SSRI fearmongering "unforseen." I love FiercePharma's reporting but I think they are wrong in this instance. Unforseen? About as unforseen as insulin going out of control when you stop using Avandia.
http://www.fiercepharma.com
Given the huge body of evidence that the decline in the use of anti-depressants has fueled an increase in suicides, the fearmongers now blame an increase in the use of anti-psychotics. That includes David Healy, the well-paid expert witness for trial attorneys now suing the likes of Eli Lilly who make...anti-psychotics.
Can we say conflict of interest?
Where will Healy, David Graham and the rest go to wash the blood off their hands? And will the FDA do the right thing and stop handing black boxes out to protect themselves from Senator Grassley and the press?
http://www.fiercepharma.com
Given the huge body of evidence that the decline in the use of anti-depressants has fueled an increase in suicides, the fearmongers now blame an increase in the use of anti-psychotics. That includes David Healy, the well-paid expert witness for trial attorneys now suing the likes of Eli Lilly who make...anti-psychotics.
Can we say conflict of interest?
Where will Healy, David Graham and the rest go to wash the blood off their hands? And will the FDA do the right thing and stop handing black boxes out to protect themselves from Senator Grassley and the press?
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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.
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.
