Latest Drugwonks' Blog
Drug-safety 'advocates'
Earlier this week, a joint session of two Food and Drug Administration advisory committees recommended that Avandia, one of two drugs that reduce insulin resistance, stay on the market with added information about which patients should avoid taking the medicine in order to reduce the risk of heart attacks. The recommendation, based on a careful evaluation of a massive amount of data, focused on whether it was possible to tailor the use of Avandia, which has helped people with diabetes stave off blindness, leg amputations and kidney failure, to groups of patients that might be a higher risk for heart problems.
It remains to be seen whether the measured recommendation puts to rest both the controversy and hysteria surrounding Avandia and the FDA. Dr. Steven Nissen simultaneously released his "study" about Avandia's supposed heart-attack risk and told ABC's "Nightline" that Avandia would kill more people than the September 11 terrorists. Dr. Nissen also shared his data with congressional Democrats and timed his study to come out in advance of the FDA's ongoing review of Avandia, which ultimately proved to be more rigorous, more detailed and more useful in making a decision about clinical use, a decision that ironically mirrors how the drug is being used already.
The fact is, Dr. Nissen and some drug-safety officials at the FDA did nothing to make medicines safer. Rather, their effort is designed to foment fear, politicize science and most immediately gain control over FDA in concert with politicians such as Rep. Henry Waxman and Sen. Charles Grassley. With Avandia, the gimmick was to hype the danger by claiming that meta-analysis, a statistical technique used to cherry-pick and then combine a number of short-term studies, should be the new gold standard for yanking drugs from the market. Such short-term studies were rejected by self-styled FDA whistleblower David Graham and the claims about heart problems associated with Vioxx. Dr. Graham's effort to bolster claims that Avandia could be pulled off the market with safety data on a completely different drug that had not been peer reviewed angered the committee members and exposed Dr. Graham as someone willing to suborn sound science for the sake of power.
It is time to investigate whether these self-proclaimed drug-safety advocates are acting in our best interest.
Nearly 75 percent of diabetes specialists report that their patients on Avandia are concerned, want to go off or have taken themselves off the drug. Many doctors have stopped prescribing or are afraid to prescribe Avandia because of lawsuit concerns. Tort lawyers are using media reports and the Nissen article to build their case against Avandia, though the FDA committee voted to keep it on the market.
Much has been said about the FDA being broken. In truth, those who want to usurp its power have vandalized it. They have undermined the public health and the integrity of medical science. Perhaps the FDA advisory action on Avandia will restore both.
http://www.washingtontimes.com/apps/pbcs.dll/article?AID=/20070802/EDITORIAL/108020002/1013
Thoughts and comments most welcome.
Earlier this week, a joint session of two Food and Drug Administration advisory committees recommended that Avandia, one of two drugs that reduce insulin resistance, stay on the market with added information about which patients should avoid taking the medicine in order to reduce the risk of heart attacks. The recommendation, based on a careful evaluation of a massive amount of data, focused on whether it was possible to tailor the use of Avandia, which has helped people with diabetes stave off blindness, leg amputations and kidney failure, to groups of patients that might be a higher risk for heart problems.
It remains to be seen whether the measured recommendation puts to rest both the controversy and hysteria surrounding Avandia and the FDA. Dr. Steven Nissen simultaneously released his "study" about Avandia's supposed heart-attack risk and told ABC's "Nightline" that Avandia would kill more people than the September 11 terrorists. Dr. Nissen also shared his data with congressional Democrats and timed his study to come out in advance of the FDA's ongoing review of Avandia, which ultimately proved to be more rigorous, more detailed and more useful in making a decision about clinical use, a decision that ironically mirrors how the drug is being used already.
The fact is, Dr. Nissen and some drug-safety officials at the FDA did nothing to make medicines safer. Rather, their effort is designed to foment fear, politicize science and most immediately gain control over FDA in concert with politicians such as Rep. Henry Waxman and Sen. Charles Grassley. With Avandia, the gimmick was to hype the danger by claiming that meta-analysis, a statistical technique used to cherry-pick and then combine a number of short-term studies, should be the new gold standard for yanking drugs from the market. Such short-term studies were rejected by self-styled FDA whistleblower David Graham and the claims about heart problems associated with Vioxx. Dr. Graham's effort to bolster claims that Avandia could be pulled off the market with safety data on a completely different drug that had not been peer reviewed angered the committee members and exposed Dr. Graham as someone willing to suborn sound science for the sake of power.
It is time to investigate whether these self-proclaimed drug-safety advocates are acting in our best interest.
Nearly 75 percent of diabetes specialists report that their patients on Avandia are concerned, want to go off or have taken themselves off the drug. Many doctors have stopped prescribing or are afraid to prescribe Avandia because of lawsuit concerns. Tort lawyers are using media reports and the Nissen article to build their case against Avandia, though the FDA committee voted to keep it on the market.
Much has been said about the FDA being broken. In truth, those who want to usurp its power have vandalized it. They have undermined the public health and the integrity of medical science. Perhaps the FDA advisory action on Avandia will restore both.
http://www.washingtontimes.com/apps/pbcs.dll/article?AID=/20070802/EDITORIAL/108020002/1013
Thoughts and comments most welcome.
The hypocritcal statements being made by members of Congress about FDA staff bonuses are incredible. Let's set aside the fact that retention bonuses are used throughout governmenet and private sector. It is a well-known and poor reported fact that underpaid hill staffers get bonuses (usually around Christmas time) and that bonuses are often paid to retain the most senior staffers. If I were Dingell or Barton, I would not want someone to investigate how they have doled out bonuses.
Not making this one up...
Canadian man rescued after chaining self to tree
Wed Aug 1, 1:19 PM ET
"VANCOUVER, British Columbia (Reuters) - A man has been rescued after he spent nearly a week chained to a tree in a mountain forest near Vancouver in what police believe was a failed suicide attempt.
Hikers searching for a lost dog near the city on Canada's Pacific coast heard the 48-year-old man's calls for help late on Tuesday. They alerted police, who eventually needed a helicopter to pull the man out safety because of the difficult mountain terrain.
West Vancouver Police said the man told them he went to a remote area of the Vancouver suburb six days ago to take his own life and chained himself to the tree in the process.
His injuries were not considered life threatening."
And once again, animals get faster service than humans...
Canadian man rescued after chaining self to tree
Wed Aug 1, 1:19 PM ET
"VANCOUVER, British Columbia (Reuters) - A man has been rescued after he spent nearly a week chained to a tree in a mountain forest near Vancouver in what police believe was a failed suicide attempt.
Hikers searching for a lost dog near the city on Canada's Pacific coast heard the 48-year-old man's calls for help late on Tuesday. They alerted police, who eventually needed a helicopter to pull the man out safety because of the difficult mountain terrain.
West Vancouver Police said the man told them he went to a remote area of the Vancouver suburb six days ago to take his own life and chained himself to the tree in the process.
His injuries were not considered life threatening."
And once again, animals get faster service than humans...
There has been a lot of talk about how wonderful the Swiss health care system and what a wonderful model it would be for universal health care here in the US. Far be it from me to argue with anyone from the Harvard Business School where all thoughts are patented and original. However, one should consider the following caveats:
1. Health insurance premiums in Switzerland are price controlled and community rated.
2. The benefits package is largely one size fits all and is exceedingly generous with very low deductibles and co-pays.
3. There is little competition on the basis of quality.
4. Hospital costs are paid for largely by federal, state and local authorities.
5. The Swiss system has an any willing provider, fee for service model of care.
6. Dr. Herzlinger makes the same serious mistake those on the Left commit in correlating mortality rates and costs without adjusting for differences in race, age, severity of illness when she writes: "We found lower death rates and spending of only $2,952 per capita versus Connecticut's $4,623. Swiss physicians earn nearly as much as American physicians, and the country has proportionately more expensive resources like MRI machines." So what? And France has more hospitals per capita and doctors get paid way less and similar life expectancy rates as Michael Moore points out. Such comparisons are useless and misleading. The Swiss and French are not like us....
I am not opposed to universal access to health care coverage. But we need a uniquely American response that rewards consumers and recognizes that the real barrier is not so much cost as convenience and education. We need a retail/online model of care not the 19th century model Bismarkian or turn of the century public health model or -- G-d forbid -- the SCHIP model which is just the most inconvenient and uncomfortable form of private health insurance ever invented because it was invented by government. And by the way, the notion that the Swiss model was the light unto the nations is not new. It was first advanced by Peter Zweifel an economist at the University of Zurich. Which is not Harvard. That should tell you that a brand name is sometime is more important than what's being peddled. After all, Aquafina IS just tap water.
1. Health insurance premiums in Switzerland are price controlled and community rated.
2. The benefits package is largely one size fits all and is exceedingly generous with very low deductibles and co-pays.
3. There is little competition on the basis of quality.
4. Hospital costs are paid for largely by federal, state and local authorities.
5. The Swiss system has an any willing provider, fee for service model of care.
6. Dr. Herzlinger makes the same serious mistake those on the Left commit in correlating mortality rates and costs without adjusting for differences in race, age, severity of illness when she writes: "We found lower death rates and spending of only $2,952 per capita versus Connecticut's $4,623. Swiss physicians earn nearly as much as American physicians, and the country has proportionately more expensive resources like MRI machines." So what? And France has more hospitals per capita and doctors get paid way less and similar life expectancy rates as Michael Moore points out. Such comparisons are useless and misleading. The Swiss and French are not like us....
I am not opposed to universal access to health care coverage. But we need a uniquely American response that rewards consumers and recognizes that the real barrier is not so much cost as convenience and education. We need a retail/online model of care not the 19th century model Bismarkian or turn of the century public health model or -- G-d forbid -- the SCHIP model which is just the most inconvenient and uncomfortable form of private health insurance ever invented because it was invented by government. And by the way, the notion that the Swiss model was the light unto the nations is not new. It was first advanced by Peter Zweifel an economist at the University of Zurich. Which is not Harvard. That should tell you that a brand name is sometime is more important than what's being peddled. After all, Aquafina IS just tap water.
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."
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.
