Latest Drugwonks' Blog
Brain electrodes help man speak again
By MALCOLM RITTER, AP Science Writer
He was beaten and left for dead one night in a robbery while walking home in 1999. His skull was crushed and his brain severely damaged. The doctor said if he pulled through at all, he'd be a vegetable for the rest of his life.
For six years, the man could not speak or eat.
On occasion he showed signs of awareness, and he moved his eyes or a thumb to communicate. His arms were useless. He was fed through a tube.
But researchers chose him for an experimental attempt to rev up his brain by placing electrodes in it. And here's how his mother describes the change in her son, now 38:
"My son can now eat, speak, watch a movie without falling asleep," she said Wednesday while choking back tears during a telephone news conference. "He can drink from a cup. He can express pain. He can cry and he can laugh.
"The most important part is he can say, `Mommy' and `Pop.' He can say, `I love you, Mommy' ... I still cry every time I see my son, but it's tears of joy."
Gee, maybe we should wait until we have randomized clinical trials or some sort of meta analysis before allowing people to have access to such advances once they become commercially available. You know, it might be cheaper just to keep people in a vegetative state because at a $50000 QALY....
I know I am supposed to be constructive and work with the "stakeholders" and all that. But let me just say what a waste of time it all is and to be the first to warn all the patient groups that are sucking up to all the "stakeholders" how they are being used.
http://news.yahoo.com/s/ap/20070801/ap_on_he_me/brain_damage
By MALCOLM RITTER, AP Science Writer
He was beaten and left for dead one night in a robbery while walking home in 1999. His skull was crushed and his brain severely damaged. The doctor said if he pulled through at all, he'd be a vegetable for the rest of his life.
For six years, the man could not speak or eat.
On occasion he showed signs of awareness, and he moved his eyes or a thumb to communicate. His arms were useless. He was fed through a tube.
But researchers chose him for an experimental attempt to rev up his brain by placing electrodes in it. And here's how his mother describes the change in her son, now 38:
"My son can now eat, speak, watch a movie without falling asleep," she said Wednesday while choking back tears during a telephone news conference. "He can drink from a cup. He can express pain. He can cry and he can laugh.
"The most important part is he can say, `Mommy' and `Pop.' He can say, `I love you, Mommy' ... I still cry every time I see my son, but it's tears of joy."
Gee, maybe we should wait until we have randomized clinical trials or some sort of meta analysis before allowing people to have access to such advances once they become commercially available. You know, it might be cheaper just to keep people in a vegetative state because at a $50000 QALY....
I know I am supposed to be constructive and work with the "stakeholders" and all that. But let me just say what a waste of time it all is and to be the first to warn all the patient groups that are sucking up to all the "stakeholders" how they are being used.
http://news.yahoo.com/s/ap/20070801/ap_on_he_me/brain_damage
According to new IMS data, Medicare Part D has increased sales of cholesterol-lowering statins by 7 percent.
That increase represents more people being appropriately treated for a chronic health problem (in this case hyperlipidemia) that, when appropriately treated, stops them from progressing to more serious acute health conditions (heart attack, stroke, etc.).
And that, dear friends, saves not only lives, but money -- lots of money. This demonstrates once again the prescience of the underlying philosphy behind the MMA -- catch disease early, treat it chronically, reduce acute care costs, enhance and prolong the lives of our citizens. And not necessarily in that order.
And remember, "appropriate" care means the care a physician deems best for the patient -- not "payor permitted" care -- that which is least expensive. Clearly there are many issues at stake here, not the least of which is forced switching of medicines such as (yes, you guessed it) statins.
The facts, the evidence is becoming clearer every day -- "cost-centric" care is penny-wise and pound foolish when compared to "patient-centric" care -- the real evidence-based medicine.
That increase represents more people being appropriately treated for a chronic health problem (in this case hyperlipidemia) that, when appropriately treated, stops them from progressing to more serious acute health conditions (heart attack, stroke, etc.).
And that, dear friends, saves not only lives, but money -- lots of money. This demonstrates once again the prescience of the underlying philosphy behind the MMA -- catch disease early, treat it chronically, reduce acute care costs, enhance and prolong the lives of our citizens. And not necessarily in that order.
And remember, "appropriate" care means the care a physician deems best for the patient -- not "payor permitted" care -- that which is least expensive. Clearly there are many issues at stake here, not the least of which is forced switching of medicines such as (yes, you guessed it) statins.
The facts, the evidence is becoming clearer every day -- "cost-centric" care is penny-wise and pound foolish when compared to "patient-centric" care -- the real evidence-based medicine.
"The fact that the National Health Service — the "envy of the world" in every British politician's absurdly parochial cliché — has to hire Wahhabist doctors with no background checks tells you everything about where the country's heading..."
http://www.steynonline.com/content/view/405/
http://www.steynonline.com/content/view/405/
Strong medicine from Trevor Butterworth of the Huffington Post..
"In one of the most devious pieces of reporting, the New York Times characterized Nissen's critics as "Republicans on Capitol Hill and others." How many New York Times readers just read "Republicans" and automatically dismissed the idea that Nissen's data was impeachable? Shouldn't readers have been told that the "others" consisted of leading medical experts?
If The Problem is Diabetes, Talk to Endocrinologists (At Some Point in the Story)
One of the bizarre aspects of the media coverage of Avandia is the second-tier status given to endocrinologists. Hello! These are the people who are managing the diabetes epidemic, doing the research, and prescribing the drugs; and yet, their voices were subordinated to a handful of critics, none of whom appeared to be involved in the clinical treatment of the disease. It should have given reporters some pause for thought that the doctors who denounced Avandia were not endocrinologists - and that pause should have raised questions such as, if this drug is as useless, as the FDA's associate director for science and medicine in the office of surveillance and epidemiology, David Graham, claims, why has it been so widely prescribed? "
http://www.huffingtonpost.com/trevor-butterworth/so-what-did-we-learn-from_b_58597.html
"In one of the most devious pieces of reporting, the New York Times characterized Nissen's critics as "Republicans on Capitol Hill and others." How many New York Times readers just read "Republicans" and automatically dismissed the idea that Nissen's data was impeachable? Shouldn't readers have been told that the "others" consisted of leading medical experts?
If The Problem is Diabetes, Talk to Endocrinologists (At Some Point in the Story)
One of the bizarre aspects of the media coverage of Avandia is the second-tier status given to endocrinologists. Hello! These are the people who are managing the diabetes epidemic, doing the research, and prescribing the drugs; and yet, their voices were subordinated to a handful of critics, none of whom appeared to be involved in the clinical treatment of the disease. It should have given reporters some pause for thought that the doctors who denounced Avandia were not endocrinologists - and that pause should have raised questions such as, if this drug is as useless, as the FDA's associate director for science and medicine in the office of surveillance and epidemiology, David Graham, claims, why has it been so widely prescribed? "
http://www.huffingtonpost.com/trevor-butterworth/so-what-did-we-learn-from_b_58597.html
Tip of the hat to Trevor Butterworth ...
The toll from diabetes each day in the United States
4,100 new cases
810 people die
230 amputations are performed
120 people experience kidney failure
55 people go blind
(Source, MedStar Research Institute.)
Drugwonks comment: And people really think we need fewer pharmaceutical options?
The toll from diabetes each day in the United States
4,100 new cases
810 people die
230 amputations are performed
120 people experience kidney failure
55 people go blind
(Source, MedStar Research Institute.)
Drugwonks comment: And people really think we need fewer pharmaceutical options?
We see the outlines of what's at stake and how the self-annointed protectors of the public health play their game.
1. They switch standards of evidence based on what is politically expedient. Now meta-analysis is the gold standard for drug safety. That, and non-peer reviewed, noncomparable observational data of the drug not in question that appears safer than the drug you want to yank. But before that, short term data was insufficient. Question to David Graham and the media: would they accept from Aventis safety data on Ketek of the type and quality Graham introduced about Actos? Squirm out of that one you weasel. Oh, and that statement about metformin. I do recall a black box on that one regarding heart failure. It's ignored because of the same sort of observational data you dismissed about Avandia.
2. Let's see where the FDA Adcomm comes out on Tysabri and Crohn's Disease. Clinical trials show that this is a fast acting drug for a horrible illness with no cure. It has the same PML risk for folks with MS. It is already being used off-label. FDA staff (a different division) have issued CYA briefing papers and the media have already sent up the fear flags. Come on guys, you are all smart and excellent writers AND the public does depend on you.
3. Let's see where Nissen and the rest stand on all the lawsuits that will still be pursued. Will Furberg offer his services as an expert witness in such cases as he has in Rezulin and Zyprexa. Will the Government Accountability Project that Furberg advises and makes its money from such litigation go head and sue? What about the Prescription Project, all tort lawyer funded, which Furberg, Avorn and others have ties to? What about SKAPP at GW which is funded by breast implant lawsuit settlement money?
4. The tort lawyer -- public health purists connection is worth pursuing. First in terms of how the purists are corrupting science and seeking to hijack the FDA to undermine its authority -- all to the benefit of the tort bar. Second, in terms of the public health havoc it has wreaked. Let's stack up the death and suffering from the snap judgements and sound bite prescriptions Nissen, Avorn, Angell, Wolfe, Psaty, etc have peddled to the media through willing tabloid medical journals in the areas of women's health, pain, heart problems, depression, and diabetes. Let's look at the grand experiments they have gotten the government to pay for -- ALLHAT and CATIE -- and what the impact they would have had on human well-being -- and how proposed plans for comparative effectiveness would have in the future.
4. The body count -- teen suicides, increased heart attacks, more blindness, shorter lives (thanks to government formularies) because they have undermined science to the goal of screwing drug companies because the make money is considerable. These self-annointed regulators and health care policy elites should be held accountable for the chaos and carnage they have caused and will cause.
None of this will stand. The battle will be joined with renewed vigor. I follow the Patton approach: "Attack rapidly, ruthlessly, viciously, without rest, however tired and hungry you may be, the enemy will be more tired, more hungry. Keep punching."
1. They switch standards of evidence based on what is politically expedient. Now meta-analysis is the gold standard for drug safety. That, and non-peer reviewed, noncomparable observational data of the drug not in question that appears safer than the drug you want to yank. But before that, short term data was insufficient. Question to David Graham and the media: would they accept from Aventis safety data on Ketek of the type and quality Graham introduced about Actos? Squirm out of that one you weasel. Oh, and that statement about metformin. I do recall a black box on that one regarding heart failure. It's ignored because of the same sort of observational data you dismissed about Avandia.
2. Let's see where the FDA Adcomm comes out on Tysabri and Crohn's Disease. Clinical trials show that this is a fast acting drug for a horrible illness with no cure. It has the same PML risk for folks with MS. It is already being used off-label. FDA staff (a different division) have issued CYA briefing papers and the media have already sent up the fear flags. Come on guys, you are all smart and excellent writers AND the public does depend on you.
3. Let's see where Nissen and the rest stand on all the lawsuits that will still be pursued. Will Furberg offer his services as an expert witness in such cases as he has in Rezulin and Zyprexa. Will the Government Accountability Project that Furberg advises and makes its money from such litigation go head and sue? What about the Prescription Project, all tort lawyer funded, which Furberg, Avorn and others have ties to? What about SKAPP at GW which is funded by breast implant lawsuit settlement money?
4. The tort lawyer -- public health purists connection is worth pursuing. First in terms of how the purists are corrupting science and seeking to hijack the FDA to undermine its authority -- all to the benefit of the tort bar. Second, in terms of the public health havoc it has wreaked. Let's stack up the death and suffering from the snap judgements and sound bite prescriptions Nissen, Avorn, Angell, Wolfe, Psaty, etc have peddled to the media through willing tabloid medical journals in the areas of women's health, pain, heart problems, depression, and diabetes. Let's look at the grand experiments they have gotten the government to pay for -- ALLHAT and CATIE -- and what the impact they would have had on human well-being -- and how proposed plans for comparative effectiveness would have in the future.
4. The body count -- teen suicides, increased heart attacks, more blindness, shorter lives (thanks to government formularies) because they have undermined science to the goal of screwing drug companies because the make money is considerable. These self-annointed regulators and health care policy elites should be held accountable for the chaos and carnage they have caused and will cause.
None of this will stand. The battle will be joined with renewed vigor. I follow the Patton approach: "Attack rapidly, ruthlessly, viciously, without rest, however tired and hungry you may be, the enemy will be more tired, more hungry. Keep punching."
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.
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.
