Latest Drugwonks' Blog
We are sharnig, ahead of an embargo, an editorial and a release on two separate articles being issued by JAMA on Sept 11. One co-authored written by Curt Furberg and his colleagues at Wake Forest is entitled " Long-term Risk of Cardiovascular Events with Rosiglitazone" (Avandia) and another by Steve Nissen and colleauges on Pioglitazone and Risk of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus A Meta-analysis of Randomized Trials (Actos) The one by Nissen claims that Actos reduces risk of heart problems but has no impact on overall death from heart disease. This claim is made from a dataset that is observational, does not control for serverity of heart problems and does not have MI or heart safety as a primary endpoint. The one by Furberg -- a meta-analysis of only 4 clinical trials (a meta-analysis that must set some sort of record for being the smallest ever accepted for publication) claims that Avandia long term has a high risk of MI among long term users yet has no long term impact on total incidence of death from heart problems. That's sort of like saying that driving a certain kind of car leads to more car crashes by no increase in accidents or deaths.
We feel that the increased need for transparency, particularly in the wake of disturbing revelations that the release of safety studies directly to the media or to Congress have lead in the case of SSRIs, diabetes drugs and even pain killers to an over reaction of the public with adverse public health consequences justifies ignores this embargo. Indeed, the embargo is being used to subvert and undermine the ongoing post market review process of the FDA with respect to TZDs.
Both articles ignore and fail to cite the FDA data claiming no increased risk of heart problems apart from heart failure from Avandia and the problems of using observational data that did not have MI as a primary endpoint. Both articles fail to include more recent meta-analysis and re-analysis showing a lower risk of heart problems from Avandia from the Archives of Internal Medicine. (Diamond GA, Bax L, Kaul S. Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death. Ann Intern Med. 2007 Aug 6; [Epub ahead of print] ) Who's doing the peer review at JAMA these days?
And of course the articles are followed by an editioral calling for Avandia to be yanked from the market. That's a far cry from even a recommendation for a black box for MI which even Nissen et al conjecture might be associated with high cholesterol and treated with statins in this article.
The authors could have very well presented these findings at the Adcomm. Knowing the timing of the publication process as we do, it is clear that JAMA, NIssen and Furberg had the information in this article in advance of the FDA Adcomm hearing. Indeed, their reference to the proceedings, their willful refusal to acknowledge alternative findings from the hearings or from other peer-reviewed journals suggest that the publication of these articles are yet another attempt, much like the release of the original NEJM article to usurp the FDA's authority, engage in fearmongering and undo a careful consensus on drug safety evaluation.
Honoring an embargo that undermines the authority of duly constituted regulatory agency is not honorable. The first time it led to chaos and a near public health crisis. We release these articles now with our comments in the hope that we can contain whatever damage Nissen, Furberg and JAMA intended with the anticipated publicity. These articles should have been part of the public record and public debate. They were deliberately withheld to allow them to engage in drug safety vigilantism. That is an abuse of power that honoring the embargo only perpetuates at the expense of the FDA's authority.
Glycemic Control Medication Pioglitazone Appears to Have Overall Favorable Effect Regarding Risk of Cardiovascular Events
CHICAGO – A meta-analysis of previous research suggests that use of pioglitazone, a glycemic control medication for patients with type 2 diabetes, significantly reduces the risk of heart attack, stroke and death, but increases the risk for serious heart failure, according to an article in the September 12 issue of JAMA.
A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic, conducted a meta-analysis of research to evaluate the effect of pioglitazone on the incidence of ischemic cardiovascular complications for patients with type 2 diabetes. Previous evidence had been insufficient to evaluate this effect. This analysis included 19 randomized trials and 16,390 patients. Duration of pioglitazone use ranged from 4 months to 3.5 years.
The researchers found that heart attack, stroke or death occurred in 375 (4.4 percent) of 8,554 patients receiving pioglitazone and 450 (5.7 percent) of 7,836 patients treated with control therapy, an 18 percent relative reduction. These outcomes were all reduced by a similar magnitude with pioglitazone treatment. Serious heart failure was reported in 200 (2.3 percent) of pioglitazone-treated patients and 139 (1.8 percent) of control patients.
“These findings suggest that the net clinical cardiovascular benefit with pioglitazone therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications,†the authors write.
(JAMA. 2007;298(10):1180-1188.)
Long-Term Use of Glycemic Control Medication Rosiglitazone Associated With Increased Risk of Heart Attack and Heart Failure
Patients with type 2 diabetes or impaired glucose tolerance who take the medication rosiglitazone appear to be at increased risk for a heart attack or heart failure, according to a meta-analysis article in this issue of JAMA.
Sonal Singh, M.D., of the Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues reviewed research to examine the risk of heart attack, heart failure and cardiovascular death with long-term rosiglitazone use. There have been recent reports of serious adverse events with rosiglitazone use, but information available to clinicians on the magnitude and public health impact of these events has been limited.
The researchers compiled data from four randomized trials that included 14,291 patients (n = 6,421 receiving rosiglitazone; n = 7,870 receiving control therapy). Follow-up for these studies was 1-4 years.
The pooled data from the trials indicated that rosiglitazone, compared with controls, significantly increased the risk of heart attack by 42 percent (94 of 6,421 patients who received rosiglitazone vs. 83 of 7,870 patients who received control therapy) and doubled the risk of heart failure (102 of 6,421 patients vs. 62 of 7,870 patients). Use of rosiglitazone was not associated with a significant increase in risk of cardiovascular death.
“Our findings have potential regulatory and clinical implications. These data suggest a reversal of the benefit-to-harm balance for rosiglitazone present at the time of approval. Thus, currently there appear to be much safer treatment alternatives. Regulatory agencies ought to reevaluate whether rosiglitazone should be allowed to remain on the market. Health plans and physicians should not wait for regulatory actions. They should avoid using rosiglitazone in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available,†the authors conclude.
(JAMA. 2007;298(10):1189-1195.)
Editorial: Cardiovascular Risk and the Thiazolidinediones – Déjà Vu All Over Again?
In an accompanying editorial, Daniel H. Solomon, M.D., M.P.H., and Wolfgang C. Winkelmayer, M.D., Sc.D., of Brigham and Women’s Hospital, Harvard Medical School, Boston, comment on the findings in this week’s JAMA regarding glycemic control medications and drug safety.
“The previous episode with the selective COX-2 inhibitors and the current one with the thiazolidinediones are instructive for designing a better drug safety system. First, early safety concerns must prompt strong and clear regulatory action. … Second, postmarketing adverse events not frequently observed in premarketing studies should be expected when there is incomplete understanding of the mechanism of action of a drug.â€
“Third, after several drugs are available for a given indication, new drug approval should be based on improvement in clinical outcomes, not surrogate measures. … Fourth, the decisions for initial approval of a drug and subsequent continued marketing should by symmetric. … Finally, and perhaps most difficult, safety and efficacy must be explicitly balanced when drugs are being considered for approval or for continued marketing.â€
(JAMA. 2007;298(10):1216-1218.
We feel that the increased need for transparency, particularly in the wake of disturbing revelations that the release of safety studies directly to the media or to Congress have lead in the case of SSRIs, diabetes drugs and even pain killers to an over reaction of the public with adverse public health consequences justifies ignores this embargo. Indeed, the embargo is being used to subvert and undermine the ongoing post market review process of the FDA with respect to TZDs.
Both articles ignore and fail to cite the FDA data claiming no increased risk of heart problems apart from heart failure from Avandia and the problems of using observational data that did not have MI as a primary endpoint. Both articles fail to include more recent meta-analysis and re-analysis showing a lower risk of heart problems from Avandia from the Archives of Internal Medicine. (Diamond GA, Bax L, Kaul S. Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death. Ann Intern Med. 2007 Aug 6; [Epub ahead of print] ) Who's doing the peer review at JAMA these days?
And of course the articles are followed by an editioral calling for Avandia to be yanked from the market. That's a far cry from even a recommendation for a black box for MI which even Nissen et al conjecture might be associated with high cholesterol and treated with statins in this article.
The authors could have very well presented these findings at the Adcomm. Knowing the timing of the publication process as we do, it is clear that JAMA, NIssen and Furberg had the information in this article in advance of the FDA Adcomm hearing. Indeed, their reference to the proceedings, their willful refusal to acknowledge alternative findings from the hearings or from other peer-reviewed journals suggest that the publication of these articles are yet another attempt, much like the release of the original NEJM article to usurp the FDA's authority, engage in fearmongering and undo a careful consensus on drug safety evaluation.
Honoring an embargo that undermines the authority of duly constituted regulatory agency is not honorable. The first time it led to chaos and a near public health crisis. We release these articles now with our comments in the hope that we can contain whatever damage Nissen, Furberg and JAMA intended with the anticipated publicity. These articles should have been part of the public record and public debate. They were deliberately withheld to allow them to engage in drug safety vigilantism. That is an abuse of power that honoring the embargo only perpetuates at the expense of the FDA's authority.
Glycemic Control Medication Pioglitazone Appears to Have Overall Favorable Effect Regarding Risk of Cardiovascular Events
CHICAGO – A meta-analysis of previous research suggests that use of pioglitazone, a glycemic control medication for patients with type 2 diabetes, significantly reduces the risk of heart attack, stroke and death, but increases the risk for serious heart failure, according to an article in the September 12 issue of JAMA.
A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic, conducted a meta-analysis of research to evaluate the effect of pioglitazone on the incidence of ischemic cardiovascular complications for patients with type 2 diabetes. Previous evidence had been insufficient to evaluate this effect. This analysis included 19 randomized trials and 16,390 patients. Duration of pioglitazone use ranged from 4 months to 3.5 years.
The researchers found that heart attack, stroke or death occurred in 375 (4.4 percent) of 8,554 patients receiving pioglitazone and 450 (5.7 percent) of 7,836 patients treated with control therapy, an 18 percent relative reduction. These outcomes were all reduced by a similar magnitude with pioglitazone treatment. Serious heart failure was reported in 200 (2.3 percent) of pioglitazone-treated patients and 139 (1.8 percent) of control patients.
“These findings suggest that the net clinical cardiovascular benefit with pioglitazone therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications,†the authors write.
(JAMA. 2007;298(10):1180-1188.)
Long-Term Use of Glycemic Control Medication Rosiglitazone Associated With Increased Risk of Heart Attack and Heart Failure
Patients with type 2 diabetes or impaired glucose tolerance who take the medication rosiglitazone appear to be at increased risk for a heart attack or heart failure, according to a meta-analysis article in this issue of JAMA.
Sonal Singh, M.D., of the Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues reviewed research to examine the risk of heart attack, heart failure and cardiovascular death with long-term rosiglitazone use. There have been recent reports of serious adverse events with rosiglitazone use, but information available to clinicians on the magnitude and public health impact of these events has been limited.
The researchers compiled data from four randomized trials that included 14,291 patients (n = 6,421 receiving rosiglitazone; n = 7,870 receiving control therapy). Follow-up for these studies was 1-4 years.
The pooled data from the trials indicated that rosiglitazone, compared with controls, significantly increased the risk of heart attack by 42 percent (94 of 6,421 patients who received rosiglitazone vs. 83 of 7,870 patients who received control therapy) and doubled the risk of heart failure (102 of 6,421 patients vs. 62 of 7,870 patients). Use of rosiglitazone was not associated with a significant increase in risk of cardiovascular death.
“Our findings have potential regulatory and clinical implications. These data suggest a reversal of the benefit-to-harm balance for rosiglitazone present at the time of approval. Thus, currently there appear to be much safer treatment alternatives. Regulatory agencies ought to reevaluate whether rosiglitazone should be allowed to remain on the market. Health plans and physicians should not wait for regulatory actions. They should avoid using rosiglitazone in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available,†the authors conclude.
(JAMA. 2007;298(10):1189-1195.)
Editorial: Cardiovascular Risk and the Thiazolidinediones – Déjà Vu All Over Again?
In an accompanying editorial, Daniel H. Solomon, M.D., M.P.H., and Wolfgang C. Winkelmayer, M.D., Sc.D., of Brigham and Women’s Hospital, Harvard Medical School, Boston, comment on the findings in this week’s JAMA regarding glycemic control medications and drug safety.
“The previous episode with the selective COX-2 inhibitors and the current one with the thiazolidinediones are instructive for designing a better drug safety system. First, early safety concerns must prompt strong and clear regulatory action. … Second, postmarketing adverse events not frequently observed in premarketing studies should be expected when there is incomplete understanding of the mechanism of action of a drug.â€
“Third, after several drugs are available for a given indication, new drug approval should be based on improvement in clinical outcomes, not surrogate measures. … Fourth, the decisions for initial approval of a drug and subsequent continued marketing should by symmetric. … Finally, and perhaps most difficult, safety and efficacy must be explicitly balanced when drugs are being considered for approval or for continued marketing.â€
(JAMA. 2007;298(10):1216-1218.
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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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