Latest Drugwonks' Blog
One of the biggest complaints about DTC pharmaceutical advertising is that it doesn't give patients (aka: consumers) enough information about either the advertised medicine or about the disease under discussion. Now there's a new twist -- consumers (aka: patients) have access to too much information.
In Europe, where there is no pharmaceutical advertising, the debate is about "information to patients," or "ITP."
But no matter what you call it, there's tremendous value in reading a very thought-provoking article in the Baltimore Sun ...
"At a time when more information than ever is broadly available about illnesses and the effects - positive and negative - of the drugs used to treat them, doctors and patients are facing a growing challenge as they attempt to sort out the benefits and risks of medications and therapies.
Every week, professional journals and other sources report the results of new medical studies - a rising tide of information that sometimes seems contradictory. Patients can read the studies on the Internet, or read about them in newspapers, and bombard their doctors with questions that frequently don't have simple answers.
So many patients go on the Internet now and with what the press bombards them with, they have a lot of information. They need to be able to understand the literature, so they can take it to the doctor and ask informed questions, said Erik Rifkin, a retired environmental consultant and co-author of The Illusion of Certainty, a new book that argues for increased clarity in the reporting of medical research.
Rifkin and his co-author, Edward J. Bouwer, both of whom live in Baltimore, say researchers should state findings in terms that are easier to understand. Statistics used in studies - and repeated in news reports - are often misleading, they say."
Here is a link to the article:
http://www.baltimoresun.com/news/health/bal-id.hs.risk05aug05,0,3165339.story
Is more information better? It depends who you ask. According to one patient interviewed for the Sun story, ""I got so much information that I had to quit because with the Internet, there was so much out there." And that was someone searching for information about a condition that predisposed him to cancer.
Too much? Too little? Too complicated? Too simplified?
Too important not to debate and discuss.
In Europe, where there is no pharmaceutical advertising, the debate is about "information to patients," or "ITP."
But no matter what you call it, there's tremendous value in reading a very thought-provoking article in the Baltimore Sun ...
"At a time when more information than ever is broadly available about illnesses and the effects - positive and negative - of the drugs used to treat them, doctors and patients are facing a growing challenge as they attempt to sort out the benefits and risks of medications and therapies.
Every week, professional journals and other sources report the results of new medical studies - a rising tide of information that sometimes seems contradictory. Patients can read the studies on the Internet, or read about them in newspapers, and bombard their doctors with questions that frequently don't have simple answers.
So many patients go on the Internet now and with what the press bombards them with, they have a lot of information. They need to be able to understand the literature, so they can take it to the doctor and ask informed questions, said Erik Rifkin, a retired environmental consultant and co-author of The Illusion of Certainty, a new book that argues for increased clarity in the reporting of medical research.
Rifkin and his co-author, Edward J. Bouwer, both of whom live in Baltimore, say researchers should state findings in terms that are easier to understand. Statistics used in studies - and repeated in news reports - are often misleading, they say."
Here is a link to the article:
http://www.baltimoresun.com/news/health/bal-id.hs.risk05aug05,0,3165339.story
Is more information better? It depends who you ask. According to one patient interviewed for the Sun story, ""I got so much information that I had to quit because with the Internet, there was so much out there." And that was someone searching for information about a condition that predisposed him to cancer.
Too much? Too little? Too complicated? Too simplified?
Too important not to debate and discuss.
From today's edition of Newsday ...
Lesson from a savvy doctor
BY MARC SIEGEL. Dr. Marc Siegel, an associate professor of medicine at the New York University School of Medicine, is the author of "False Alarm: The Truth About the Epidemic of Fear."
August 5, 2007
You wouldn't know it from the political debate, but health care is much more than just bald statistics about probability, necessity and risk. It is shaped by the quirks and characteristics of its practitioners.
When Dr. Jeffrey Siegel was killed by a hit-and-run motorist and taken last month at age 48 from his life as a prominent Long Island pulmonologist, the world lost a particular sort of physician. Our identities as doctors were molded in the Bellevue Hospital melting pot of the 1980s. He was the Siegel who cooperated; I was the Siegel (no relation) who fought.
Though he was my supervising chief resident for only a few rotations, I remember our clashes, as Jeff Siegel tried to teach me to be more politic and less confrontational. I was often arguing with nurses as well as patients, trying to get my points across, while Jeff was soft-spoken and known to be very persuasive.
Residency training was a cauldron, and as my medical personality was forged I began to learn from Jeff and others that I was often too forceful and that even when a patient's life is on the line it is still possible to negotiate. On the other hand, as I came into my own as a physician I also found that my outrage could help position me as a patient advocate.
Even with all the technology and the growing bottom-line thinking about cost-effective medical care, at the heart of the process are individual doctors who apply their personality traits to patient care. Jeff and I had very different styles, but we shared a tenacity that was essential at a busy city hospital like Bellevue. We were at our best as a team. Even as I was learning to be more politic, he was learning to be more gruff.
Once, a 55-year-old ironworker was admitted to the hospital with a severe heart attack and immediately demanded to leave the same day. As his resident, I was focused on keeping him alive medically.
I was so irritated at his self-destructive refusal of treatment that I began to argue with him relentlessly even as his stretcher was rolling him, still protesting, toward the operating room for cardiac bypass surgery. "You're giving me chest pains," he said, which brought me to my senses as I suddenly realized that I might be jeopardizing his heart further. It took Jeff, as my chief resident, to come by and calmly convince him to agree to the operation.
Afterward, Jeff quietly told me never to raise my voice with a patient, and he left it at that.
The surgery didn't go well, and in the recovery room, as the man's heart ballooned from damage and his lungs continued to fill with fluid, the staff was ready to give up. At which point I erupted in favor of toughing it out, this time directing my blunt insistence not at the patient but at the team working on him. Fortunately, we carried on, and the man's heart began to slowly recover.
I had learned from Jeff that there was little to be gained by yelling at a patient, but I learned for myself there was much to be gained from channeling my strong, stubborn emotions into not giving up. As he recovered, the patient began to see the benefits of my stubbornness on his behalf and grew to like me for it. Of course, he knew that he also owed his life to Jeff's very different intervention. He had strong relationships with both of us, which I am certain helped him get well faster.
Managed care and and health insurance policy arguments can leave us thinking that physicians are just interchangeable, replaceable cogs in a complex machine that doesn't run as well as it used to. Yet the human element remains essential.
Medicine is as much about the developing personalities of those who administer treatment as it is about the technology that measures metabolism. That's the lesson I got from Jeff Siegel's too-short life.
.
Lesson from a savvy doctor
BY MARC SIEGEL. Dr. Marc Siegel, an associate professor of medicine at the New York University School of Medicine, is the author of "False Alarm: The Truth About the Epidemic of Fear."
August 5, 2007
You wouldn't know it from the political debate, but health care is much more than just bald statistics about probability, necessity and risk. It is shaped by the quirks and characteristics of its practitioners.
When Dr. Jeffrey Siegel was killed by a hit-and-run motorist and taken last month at age 48 from his life as a prominent Long Island pulmonologist, the world lost a particular sort of physician. Our identities as doctors were molded in the Bellevue Hospital melting pot of the 1980s. He was the Siegel who cooperated; I was the Siegel (no relation) who fought.
Though he was my supervising chief resident for only a few rotations, I remember our clashes, as Jeff Siegel tried to teach me to be more politic and less confrontational. I was often arguing with nurses as well as patients, trying to get my points across, while Jeff was soft-spoken and known to be very persuasive.
Residency training was a cauldron, and as my medical personality was forged I began to learn from Jeff and others that I was often too forceful and that even when a patient's life is on the line it is still possible to negotiate. On the other hand, as I came into my own as a physician I also found that my outrage could help position me as a patient advocate.
Even with all the technology and the growing bottom-line thinking about cost-effective medical care, at the heart of the process are individual doctors who apply their personality traits to patient care. Jeff and I had very different styles, but we shared a tenacity that was essential at a busy city hospital like Bellevue. We were at our best as a team. Even as I was learning to be more politic, he was learning to be more gruff.
Once, a 55-year-old ironworker was admitted to the hospital with a severe heart attack and immediately demanded to leave the same day. As his resident, I was focused on keeping him alive medically.
I was so irritated at his self-destructive refusal of treatment that I began to argue with him relentlessly even as his stretcher was rolling him, still protesting, toward the operating room for cardiac bypass surgery. "You're giving me chest pains," he said, which brought me to my senses as I suddenly realized that I might be jeopardizing his heart further. It took Jeff, as my chief resident, to come by and calmly convince him to agree to the operation.
Afterward, Jeff quietly told me never to raise my voice with a patient, and he left it at that.
The surgery didn't go well, and in the recovery room, as the man's heart ballooned from damage and his lungs continued to fill with fluid, the staff was ready to give up. At which point I erupted in favor of toughing it out, this time directing my blunt insistence not at the patient but at the team working on him. Fortunately, we carried on, and the man's heart began to slowly recover.
I had learned from Jeff that there was little to be gained by yelling at a patient, but I learned for myself there was much to be gained from channeling my strong, stubborn emotions into not giving up. As he recovered, the patient began to see the benefits of my stubbornness on his behalf and grew to like me for it. Of course, he knew that he also owed his life to Jeff's very different intervention. He had strong relationships with both of us, which I am certain helped him get well faster.
Managed care and and health insurance policy arguments can leave us thinking that physicians are just interchangeable, replaceable cogs in a complex machine that doesn't run as well as it used to. Yet the human element remains essential.
Medicine is as much about the developing personalities of those who administer treatment as it is about the technology that measures metabolism. That's the lesson I got from Jeff Siegel's too-short life.
.
Have a look at our two new podcasts -- and he beginning of our new "Know Your Pills" campaign.
They can be found at http://www.cmpi.org under the "Special Features/Podcasts" section.
They can be found at http://www.cmpi.org under the "Special Features/Podcasts" section.
"Sweden’s English-language news outlet reported in June that the government’s employment service had granted Roger Tullgren, 42, supplemental income benefits based on his illness of addiction to heavy-metal music. Tullgren said he had been addicted for 10 years but finally got three psychologists to sign off on calling his condition a disability. His employer now permits Tullgren to play his music at his dishwashing job."
http://www.kansascity.com/238/story/214321.html
I've heard that Zyprexa can be used to wean people off of Megadeth...
http://www.kansascity.com/238/story/214321.html
I've heard that Zyprexa can be used to wean people off of Megadeth...
Tysabri gets Adcomm approval for Chrohn's disease....now it's time to undo the attack on acccelerated approval of cancer drugs that Padzur is leading.
http://www.forbes.com/business/feeds/afx/2007/08/01/afx3974633.html
http://www.forbes.com/business/feeds/afx/2007/08/01/afx3974633.html
Here's how the Journal of Life Sciences introduces it's current web-edition cover story on FDA reform:
The FDA needs to rethink the way it communicates in an age of empowered patients.
MUCH HAS CHANGED over the past 25 years, but one of the immutables has been that FDA tries to communicate important health messages without the resources or attitude necessary to do it well on a consistent basis, according to Peter J. Pitts, president of the Center for Medicine in the Public Interest. A big part of the problem is that not only have communications tools changed, but so have people and society. He says the FDA needs to change as well.
Here's the rest of the story:
http://www.tjols.com/index.jsp
And the good news is that Commissioner von Eschenbach believes in strident and robust constituency outreach.
The FDA needs to rethink the way it communicates in an age of empowered patients.
MUCH HAS CHANGED over the past 25 years, but one of the immutables has been that FDA tries to communicate important health messages without the resources or attitude necessary to do it well on a consistent basis, according to Peter J. Pitts, president of the Center for Medicine in the Public Interest. A big part of the problem is that not only have communications tools changed, but so have people and society. He says the FDA needs to change as well.
Here's the rest of the story:
http://www.tjols.com/index.jsp
And the good news is that Commissioner von Eschenbach believes in strident and robust constituency outreach.
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.
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.
