Latest Drugwonks' Blog
Courtesy of OpinionJournal - Best of the Web yesterday by Jim Taranto.
Great Moments in Socialized Medicine
Englishwoman Olive Beal has a hearing problem. According to London's Guardian, she "finds it difficult to hear with her five-year-old analogue [hearing] aid and needs a digital version that cuts out background noise and makes conversation easier."
Mrs. Beal went to the Eastern and Coastal Kent Primary Care Trust, her local office of the National Health Service. No problem, they told her, she'll get a hearing aid. But it'll take her 18 months to get to the top of the waiting list:
Mrs Beal, a former piano teacher who was involved in the suffragette movement, would be 110 by the time she gets her new hearing aid. "I could be dead by then," she said yesterday.
Drugwonks comment: Yes, that's the idea.
Great Moments in Socialized Medicine
Englishwoman Olive Beal has a hearing problem. According to London's Guardian, she "finds it difficult to hear with her five-year-old analogue [hearing] aid and needs a digital version that cuts out background noise and makes conversation easier."
Mrs. Beal went to the Eastern and Coastal Kent Primary Care Trust, her local office of the National Health Service. No problem, they told her, she'll get a hearing aid. But it'll take her 18 months to get to the top of the waiting list:
Mrs Beal, a former piano teacher who was involved in the suffragette movement, would be 110 by the time she gets her new hearing aid. "I could be dead by then," she said yesterday.
Drugwonks comment: Yes, that's the idea.
The FDA Adcomm voted 22-1 to keep Avandia on the market, probably with some changes in the label to identify specific risks but no black box. Here's my take:
1. Steve Nissen is the Mike Nifong of health care. His analysis was shredded and dismissed as a cover-up of all the evidence.
2. David Graham came off as shrill and heartless.
3. The media was rebuked several times for contributing to hysteria and patient deaths. That means the NYT, USA Today and NEJM.
4. Glaxo and other companies had better do a better job of matching the right drug to the right patient. It's the right thing to do and the smart thing to do from a business perspective. And the old way of collecting data and avoiding answers and questions you would rather not know about is not going to work any more. People and doctors want and deserve better post market data sooner.
1. Steve Nissen is the Mike Nifong of health care. His analysis was shredded and dismissed as a cover-up of all the evidence.
2. David Graham came off as shrill and heartless.
3. The media was rebuked several times for contributing to hysteria and patient deaths. That means the NYT, USA Today and NEJM.
4. Glaxo and other companies had better do a better job of matching the right drug to the right patient. It's the right thing to do and the smart thing to do from a business perspective. And the old way of collecting data and avoiding answers and questions you would rather not know about is not going to work any more. People and doctors want and deserve better post market data sooner.
Read this piece from today's Financial Times -- and pay particular attention to the last paragraph.
Cholesterol drugs lower heart disease deaths
30 August, 2007 - Statins, the cholesterol-lowering drugs, are contributing to a big fall in the numbers of people dying from heart disease in the UK, according to data released on Friday.
About 3m Britons take the drugs for heart disease, which is the single most common cause of death in the UK.
According to the British Heart Foundation, statins reduce the risk of dying from coronary heart disease by 25 per cent. “Statins are saving between 9,000 and 10,000 lives in the UK every year,†said Professor Roger Boyle, national director for heart disease and stroke at the Department of Health.
Death rates from cardiovascular disease (CVD) fell 36 per cent between 1996 and 2004. Prof Boyle said about 60 per cent of the reduction was due to improvements in lifestyle such as stopping smoking and taking more exercise. But the remaining 40 per cent was directly attributed to medical treatment with cholesterol-lowering drugs, such as statins.
These drugs work by lowering the amount of LDL (low-density lipoprotein) cholesterol in blood. This “bad†cholesterol is a big risk factor for heart disease, heart attack and stroke because it contributes to the build-up of plaque that clogs the walls of arteries.
CVD has become a leading cause of death worldwide, with figures in some industrialised countries reaching epidemic proportions. In the UK, mortality from cardiovascular disease exceeds that from cancer, accounting for more than 208,000 deaths every year.
Heart disease is a huge annual burden on the UK economy. The cost of healthcare for heart patients is more than £1.7bn a year. According to the BHF report, the cost of NHS prescriptions for cholesterol-lowering drugs was £625m in 2005.
Last June, the National Institute for Clinical Excellence unveiled guidelines, recommending that statins should be prescribed to people with a 20 per cent risk of developing heart disease. If the recommendations were followed, the number of people taking the drug on prescription would double.
Cholesterol drugs lower heart disease deaths
30 August, 2007 - Statins, the cholesterol-lowering drugs, are contributing to a big fall in the numbers of people dying from heart disease in the UK, according to data released on Friday.
About 3m Britons take the drugs for heart disease, which is the single most common cause of death in the UK.
According to the British Heart Foundation, statins reduce the risk of dying from coronary heart disease by 25 per cent. “Statins are saving between 9,000 and 10,000 lives in the UK every year,†said Professor Roger Boyle, national director for heart disease and stroke at the Department of Health.
Death rates from cardiovascular disease (CVD) fell 36 per cent between 1996 and 2004. Prof Boyle said about 60 per cent of the reduction was due to improvements in lifestyle such as stopping smoking and taking more exercise. But the remaining 40 per cent was directly attributed to medical treatment with cholesterol-lowering drugs, such as statins.
These drugs work by lowering the amount of LDL (low-density lipoprotein) cholesterol in blood. This “bad†cholesterol is a big risk factor for heart disease, heart attack and stroke because it contributes to the build-up of plaque that clogs the walls of arteries.
CVD has become a leading cause of death worldwide, with figures in some industrialised countries reaching epidemic proportions. In the UK, mortality from cardiovascular disease exceeds that from cancer, accounting for more than 208,000 deaths every year.
Heart disease is a huge annual burden on the UK economy. The cost of healthcare for heart patients is more than £1.7bn a year. According to the BHF report, the cost of NHS prescriptions for cholesterol-lowering drugs was £625m in 2005.
Last June, the National Institute for Clinical Excellence unveiled guidelines, recommending that statins should be prescribed to people with a 20 per cent risk of developing heart disease. If the recommendations were followed, the number of people taking the drug on prescription would double.
Adcomm members trashed David Graham -- he who sets himself up as the arbiter of what is the best data -- for slipping in non-peer-reviewed data about the safety of Actos that is non-comparable, observational study to boot and absent a comparable meta-analysis. They obviously are angry about being used and how the media has run with this comparision when it is half-baked and unscientific.
The new standard for David Graham and his ilk: "As long as we have the evidence we want, we have the evidence we need. "
To wit: If we have evidence of harm of one drugs from a meta-analyses but measly evidence of other drugs then by definition the other drugs are safe...
Or: "The safest drug to take for diabetes is placebo."
To wit: If we have evidence of harm of one drugs from a meta-analyses but measly evidence of other drugs then by definition the other drugs are safe...
Or: "The safest drug to take for diabetes is placebo."
"There are people with so much antipathy for companies making money from drugs that they would rather people die than be helped from a new medicine"
The politicization of medicine. Why are such tactics necessary if the science speaks for itself. Why do how researchers who employ those tactics be relied upon as reliably as those that do not. "
Editorials that are one sided that give the media a field day for bashing. This is not a civilized world. Bashing should not be part of our culture. I heard today that A1C is not the gold standard but it is associated with a decrease in duration...so why is that now a problem. Why was there no evidence on statin use?
Charlie Steele, diabetes patient. Focuses on limb losses. 225 a day lose their leg because of diabetes. My A1C is creeping up. The longer you have diabetes the more likely this will happen. As a patient I want as many drugs. I am concerned about the hype. It makes one head spin. We need all the weapons we need. The 84 year old mother. She tried diabetic meds and could not tolerate them.. Avandia worked but now she doesn't take it because of the Nissen study.
Jerome Tolbott, endocrinologist. Had a patient demand to be taken off Avandia. Family demanded he be taken off the Avandia because of the media report. Doctors are just stopping the medication and it will worsen the diabetes problem. The TZDs are the only drugs that target insulin resistance. I have treated many patients with Avandia. Longshoreman was afraid to use a needle. After about five years with Avandia and two other oral agents his diabetes is under control. Two third of patients fail to control their A1C properly. The result is blindness, kidney failure, amputation. I need Avandia to help my patients. The media is terrorizing my patients.
We have set meta analysis up as a quasi null hypothesis that clinical data cannot refute..".J Richard Turner. PhD (Meanwhile, David Graham based on relatively little data claims Actos is a safer and better drug)
A physician survey showed that 75 percent of all diabetes doctors have seen reduced compliance or abandonment of Avandia.
The politicization of medicine. Why are such tactics necessary if the science speaks for itself. Why do how researchers who employ those tactics be relied upon as reliably as those that do not. "
Editorials that are one sided that give the media a field day for bashing. This is not a civilized world. Bashing should not be part of our culture. I heard today that A1C is not the gold standard but it is associated with a decrease in duration...so why is that now a problem. Why was there no evidence on statin use?
Charlie Steele, diabetes patient. Focuses on limb losses. 225 a day lose their leg because of diabetes. My A1C is creeping up. The longer you have diabetes the more likely this will happen. As a patient I want as many drugs. I am concerned about the hype. It makes one head spin. We need all the weapons we need. The 84 year old mother. She tried diabetic meds and could not tolerate them.. Avandia worked but now she doesn't take it because of the Nissen study.
Jerome Tolbott, endocrinologist. Had a patient demand to be taken off Avandia. Family demanded he be taken off the Avandia because of the media report. Doctors are just stopping the medication and it will worsen the diabetes problem. The TZDs are the only drugs that target insulin resistance. I have treated many patients with Avandia. Longshoreman was afraid to use a needle. After about five years with Avandia and two other oral agents his diabetes is under control. Two third of patients fail to control their A1C properly. The result is blindness, kidney failure, amputation. I need Avandia to help my patients. The media is terrorizing my patients.
We have set meta analysis up as a quasi null hypothesis that clinical data cannot refute..".J Richard Turner. PhD (Meanwhile, David Graham based on relatively little data claims Actos is a safer and better drug)
A physician survey showed that 75 percent of all diabetes doctors have seen reduced compliance or abandonment of Avandia.
Robert Meyer of the FDA slammed David Graham for ignoring other risks and problems that diabetics have.
Now the Wellpoint observational data shows that Avandia patients were twice as likely to have a prior heart problem.... oh.
No statistical signficance associated with either TZD...
Subgroup analysis of monotherapy..no statistical significance.
Now the Wellpoint observational data shows that Avandia patients were twice as likely to have a prior heart problem.... oh.
No statistical signficance associated with either TZD...
Subgroup analysis of monotherapy..no statistical significance.
Dr. David Graham of the tort lawer funded Goverment Accountability Project told the FDA that Avandia, along with "one meelion" other drugs should be yanked from the market.
Graham ostensibly "works" for the FDA but splits his time between GAP, having lunch with Senator Charles Grassley and talking to reporters. In his presentation to the FDA Graham never quite explained how a the RECORD study on Avandia, a prospective, observational study with defined endpoints that was reviewed and approved by the European Medicines Evaluation Agency could be considered inferior data to the retrospective Kaiser database he used to deem Vioxx dangerous.
http://news.yahoo.com/s/ap/20070730/ap_on_he_me/diabetes_drug
PS...Karen Mahoney of the FDA dumped all over Graham and Del Pan's rationale for rejecting RECORD namely that it was designed to capture how diabetes is actually treated. Of course the media will not capture this important difference.
Graham ostensibly "works" for the FDA but splits his time between GAP, having lunch with Senator Charles Grassley and talking to reporters. In his presentation to the FDA Graham never quite explained how a the RECORD study on Avandia, a prospective, observational study with defined endpoints that was reviewed and approved by the European Medicines Evaluation Agency could be considered inferior data to the retrospective Kaiser database he used to deem Vioxx dangerous.
http://news.yahoo.com/s/ap/20070730/ap_on_he_me/diabetes_drug
PS...Karen Mahoney of the FDA dumped all over Graham and Del Pan's rationale for rejecting RECORD namely that it was designed to capture how diabetes is actually treated. Of course the media will not capture this important difference.
From today's edition of the Washington Times ...
Dingell, Stark and Medi-scare
There is no truth to the rumors that Democratic Reps. Fortney "Pete" Stark of California and John Dingell of Michigan secretly jumped ship and are helping Republicans recapture the majority in the House. But you would never know it based on their health-care agenda. The two liberal old bulls who face little-to-no personal electoral vulnerability seem determined to march their caucus back to minority status by forcing them to cast a highly unpopular vote to cut Medicare.
A peak below the surface reveals why these two lawmakers' ideological crusade could put House Speaker Nancy Pelosi back in the minority leader's suite. This week, two House committees began consideration of legislation to reauthorize and expand the State Children's Health Initiative Program. Predictably, Democrats want to balloon it into a massive Leviathan costing more than $50 billion over the next five years. This large an expansion will induce millions to drop their private insurance coverage to feast at the taxpayer's expense. The program could accomplish its objectives with a lot less money, but consider who is in charge of Congress now.
But here's the kicker. To pay for this new largesse, Messrs. Stark and Dingell set their sights on cutting Medicare Advantage — a popular alternative to traditional fee-for-service. Medicare Advantage offers seniors an option of lower costs and more benefits in a managed-care setting. For over 8 million people in this rapidly growing program — nearly one out of every five seniors — this is their Medicare. For them, reducing funding means higher health-care costs and fewer benefits.
A recent national survey by Democratic pollster Mark Mellman underscores this point, noting "a vote to cut Medicare Advantage will elicit major negative political consequences." Mr. Mellman's data shows over half (52 percent) believe "a member of Congress who promised not to cut Medicare would be breaking their promise if they voted to cut Medicare Advantage." It's now Messrs. Stark and Dingell who want to "end Medicare as we know it" for a good number of seniors.
And while they will claim cuts to Medicare Advantage simply bring the program's funding into parity with fee-for-service, the real motivation is different. This alternative to traditional Medicare is one of the only hopes of reforming this exploding entitlement program. It provides seniors choices in health care and uses private -sector competition to drive down costs. But its biggest offense in eyes of the left is it doesn't fit their one-size-fits-all ideology. The Democrats should beware following Messrs. Stark and Dingell's ideologically driven lead. They are marching their party back to minority status while by breaking promises to seniors.
Dingell, Stark and Medi-scare
There is no truth to the rumors that Democratic Reps. Fortney "Pete" Stark of California and John Dingell of Michigan secretly jumped ship and are helping Republicans recapture the majority in the House. But you would never know it based on their health-care agenda. The two liberal old bulls who face little-to-no personal electoral vulnerability seem determined to march their caucus back to minority status by forcing them to cast a highly unpopular vote to cut Medicare.
A peak below the surface reveals why these two lawmakers' ideological crusade could put House Speaker Nancy Pelosi back in the minority leader's suite. This week, two House committees began consideration of legislation to reauthorize and expand the State Children's Health Initiative Program. Predictably, Democrats want to balloon it into a massive Leviathan costing more than $50 billion over the next five years. This large an expansion will induce millions to drop their private insurance coverage to feast at the taxpayer's expense. The program could accomplish its objectives with a lot less money, but consider who is in charge of Congress now.
But here's the kicker. To pay for this new largesse, Messrs. Stark and Dingell set their sights on cutting Medicare Advantage — a popular alternative to traditional fee-for-service. Medicare Advantage offers seniors an option of lower costs and more benefits in a managed-care setting. For over 8 million people in this rapidly growing program — nearly one out of every five seniors — this is their Medicare. For them, reducing funding means higher health-care costs and fewer benefits.
A recent national survey by Democratic pollster Mark Mellman underscores this point, noting "a vote to cut Medicare Advantage will elicit major negative political consequences." Mr. Mellman's data shows over half (52 percent) believe "a member of Congress who promised not to cut Medicare would be breaking their promise if they voted to cut Medicare Advantage." It's now Messrs. Stark and Dingell who want to "end Medicare as we know it" for a good number of seniors.
And while they will claim cuts to Medicare Advantage simply bring the program's funding into parity with fee-for-service, the real motivation is different. This alternative to traditional Medicare is one of the only hopes of reforming this exploding entitlement program. It provides seniors choices in health care and uses private -sector competition to drive down costs. But its biggest offense in eyes of the left is it doesn't fit their one-size-fits-all ideology. The Democrats should beware following Messrs. Stark and Dingell's ideologically driven lead. They are marching their party back to minority status while by breaking promises to seniors.
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.
