Latest Drugwonks' Blog
Okay, the good news is a 22-1 Avandia vote, a bitch slap to David Graham, a view of the Steve Nissen spin machine in action, and a reminder that the FDA really does act in the best interests of the public health.
So far, media reporting on the Avandia vote has been mostly accurate, but (IMHO) there are too many folks being quoted as to "why was this drug approved in the first place?" Such citations miss the entire point and further grease the skids downwards into the Land of the Precautionary Principle.
That being said, the 30,000 foot issue is -- Can the FDA own safety?
(The short answer is that it must -- and must work immediately with skill and diligence to achieve that goal.)
At present, politicians and pundits (not to mention trial lawyers) own safety. They're the ones talking about it. They're the ones the media goes to when they write about it. Have a look at a sampling of today's Avandia press coverage and see who's quoted and what they're saying.
The struggle over control of the drug safety story is, shall say, not going the right way for the agency.
And what about the role of Big PhRMA, the other group being flayed with the safety knout? What have we heard from them on the issue of safety? Some, but not enough.
Americans woke up the morning after the Vioxx recall and were amazed to discover that drugs have risks. Good lord. Who let that happen! Avandia, in that respect, was Son of Vioxx. And, like any sequel, new actors were brought in to spice up the story.
Truth be told (because it’s about time that it is), the current "safety circus" demonstrates three important things. The first (contrary to political bloviating and various and sundry pilings on) is that the system works. Can it be made better? Of course. Must it be made better. Absolutely. The second is that the general public (and, it seems, some of our elected officials) doesn’t understand how FDA works. And third, the twin terms of “safety†and “risk†need to be more clearly communicated to both physicians and patients (otherwise known as “consumers").
Who does that and how it is done is where the rubber meets the road. After all, as the saying goes, everything you read in the paper is true except for those things you know about personally. Such is the case for the drug safety imbroglio currently surrounding the Food & Drug Administration.
When it comes to patient trust, it shouldn’t be a choice between politics and public health – but those battle lines are being drawn. Unfortunately complex systems make for bad media coverage, while simplistic, dramatic demagoguing makes for sexier headlines and potent fundraising letters.
There’s an apt Japanese proverb that bears repeating – “Don’t fix the blame. Fix the problem.†Unfortunately, the recent FDA-bashing isn’t about making things better – it’s about making headlines, making money, settling old scores, and generally pursuing various agendas – none of which are designed to “make drugs safer.â€
It's time for the grown-ups to step forward and take charge of the debate on drug safety.
So far, media reporting on the Avandia vote has been mostly accurate, but (IMHO) there are too many folks being quoted as to "why was this drug approved in the first place?" Such citations miss the entire point and further grease the skids downwards into the Land of the Precautionary Principle.
That being said, the 30,000 foot issue is -- Can the FDA own safety?
(The short answer is that it must -- and must work immediately with skill and diligence to achieve that goal.)
At present, politicians and pundits (not to mention trial lawyers) own safety. They're the ones talking about it. They're the ones the media goes to when they write about it. Have a look at a sampling of today's Avandia press coverage and see who's quoted and what they're saying.
The struggle over control of the drug safety story is, shall say, not going the right way for the agency.
And what about the role of Big PhRMA, the other group being flayed with the safety knout? What have we heard from them on the issue of safety? Some, but not enough.
Americans woke up the morning after the Vioxx recall and were amazed to discover that drugs have risks. Good lord. Who let that happen! Avandia, in that respect, was Son of Vioxx. And, like any sequel, new actors were brought in to spice up the story.
Truth be told (because it’s about time that it is), the current "safety circus" demonstrates three important things. The first (contrary to political bloviating and various and sundry pilings on) is that the system works. Can it be made better? Of course. Must it be made better. Absolutely. The second is that the general public (and, it seems, some of our elected officials) doesn’t understand how FDA works. And third, the twin terms of “safety†and “risk†need to be more clearly communicated to both physicians and patients (otherwise known as “consumers").
Who does that and how it is done is where the rubber meets the road. After all, as the saying goes, everything you read in the paper is true except for those things you know about personally. Such is the case for the drug safety imbroglio currently surrounding the Food & Drug Administration.
When it comes to patient trust, it shouldn’t be a choice between politics and public health – but those battle lines are being drawn. Unfortunately complex systems make for bad media coverage, while simplistic, dramatic demagoguing makes for sexier headlines and potent fundraising letters.
There’s an apt Japanese proverb that bears repeating – “Don’t fix the blame. Fix the problem.†Unfortunately, the recent FDA-bashing isn’t about making things better – it’s about making headlines, making money, settling old scores, and generally pursuing various agendas – none of which are designed to “make drugs safer.â€
It's time for the grown-ups to step forward and take charge of the debate on drug safety.
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.
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