Latest Drugwonks' Blog
The FDA announced today that all supplements and products derived from kryptonite would have a black box warning. Dr. David Graham had pressured the agency after noting that the presence of kryptonite would pose a serious and life threatening danger to Superman, Supergirl and other survivors of the planet Krypton. Graham had been pushing Congress to expand it's drug safety program to move beyond "merely planetary surveillance activities" and into galactic exploration of pharmacovigilance matters. The FDA said in a press release " this pilot project is part of our effort to develop a global and indeed galactic risk management program." The agency had planned to establish this program in partnership with Luthor Industries and the Justice League of America but was attacked by members of Congress for being too "cozy" with special interests.
When it comes to what this Congress is trying to do to the public health, we refuse to sit by and take a postion of, er, non-intereference.
Here's a new piece from today's edition of the Chicago Tribune:
http://www.chicagotribune.com/news/opinion/chi-0704230346apr24,0,7088012.story?coll=chi-newsopinioncommentary-hed
Hopefully some prominent Chicago officials (like Barack Obama and Rahm Emanuel) will see this and see the light. But we'll keep our expectations realistic and just hope they see it.
Here's a new piece from today's edition of the Chicago Tribune:
http://www.chicagotribune.com/news/opinion/chi-0704230346apr24,0,7088012.story?coll=chi-newsopinioncommentary-hed
Hopefully some prominent Chicago officials (like Barack Obama and Rahm Emanuel) will see this and see the light. But we'll keep our expectations realistic and just hope they see it.
Again, I am not making this up.....
New breakthrough research demonstrates for the first time that spending 5 minutes with a drug rep alters the subconscious mind of doctors in subtle ways, causing them to prescribe drugs that no one really need or wants or even uses.
The survey of 116 visits to 97 doctors found that after a five minute "session" with a drug rep, doctors were 46 percent more likely to prescribe a drug or recommend it to their colleagues.
One of the author's of this groundbreaking study, Dr. Michael Steinman of the San Francisco Veteran's Affairs Hospital said: "The remarkable thing is how effective a very brief visit by a drug representative -- most often less than five minutes -- can be in influencing physicians' choices to use a drug for an unapproved indication,"
Besides free drug samples, salespeople often bring gifts, lunch for the doctor or office staff, new pens and coffee mugs. "The doctor feels subtly, even subconsciously, indebted to the representative," Steinman said.
The study appears in the April 24, 2007 issue of PLoS Medicine. Co-authors of the study were G. Michael Harper, MD, Mary-Margaret Chren, MD, and C. Seth Landefeld, MD, of SFVAMC and UCSF.
Steinman, Landefeld, and Chren served as unpaid expert witnesses for the plaintiff in the litigation from which the source data for the study was obtained.
What a surprise.
The study was supported by funds from the Veterans Health Administration, the National Institute on Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the John A. Hartford Foundation, and the California Tobacco-Related Disease Research Programs.
What is government money doing supporting such crap?
New breakthrough research demonstrates for the first time that spending 5 minutes with a drug rep alters the subconscious mind of doctors in subtle ways, causing them to prescribe drugs that no one really need or wants or even uses.
The survey of 116 visits to 97 doctors found that after a five minute "session" with a drug rep, doctors were 46 percent more likely to prescribe a drug or recommend it to their colleagues.
One of the author's of this groundbreaking study, Dr. Michael Steinman of the San Francisco Veteran's Affairs Hospital said: "The remarkable thing is how effective a very brief visit by a drug representative -- most often less than five minutes -- can be in influencing physicians' choices to use a drug for an unapproved indication,"
Besides free drug samples, salespeople often bring gifts, lunch for the doctor or office staff, new pens and coffee mugs. "The doctor feels subtly, even subconsciously, indebted to the representative," Steinman said.
The study appears in the April 24, 2007 issue of PLoS Medicine. Co-authors of the study were G. Michael Harper, MD, Mary-Margaret Chren, MD, and C. Seth Landefeld, MD, of SFVAMC and UCSF.
Steinman, Landefeld, and Chren served as unpaid expert witnesses for the plaintiff in the litigation from which the source data for the study was obtained.
What a surprise.
The study was supported by funds from the Veterans Health Administration, the National Institute on Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the John A. Hartford Foundation, and the California Tobacco-Related Disease Research Programs.
What is government money doing supporting such crap?
The Thai dictatorship clearly has Abbott in is sights. Working hand in glove with NGOs it clearly picked a fight over the price of its HIV drugs to distract attention over the suspension of civil liberties. It is disturbing to see Oxfam -- which boycotts Israel over so-called human rights abuses -- working with Thailand's military junta to demonize drug companies yet again and get away with it. But that is how the media and most of the world sees things. So ultimately Abbott had no choice but to cave, at least for now.
Long term, drug companies need to rethink their approach to emerging markets. Time and the wealth are on the side of innovation and property rights, not the thugs and NGOs who prop them up. They would do well to increase investment in global health policy, entrepreneurship in middle markets, and support partnerships with people interested in delivering new products throughout the world at market relevant prices.
Long term, drug companies need to rethink their approach to emerging markets. Time and the wealth are on the side of innovation and property rights, not the thugs and NGOs who prop them up. They would do well to increase investment in global health policy, entrepreneurship in middle markets, and support partnerships with people interested in delivering new products throughout the world at market relevant prices.
AP's Andrew Bridges reports today that
" Health officials repeated safety concerns about an experimental group of HIV drugs Friday, days before government advisers will recommend whether the first drug from the class merits approval.
Pfizer Inc. seeks Food and Drug Administration approval for maraviroc, potentially the first in a novel group of drugs to fight HIV, the virus that causes AIDS. Pfizer proposes marketing maraviroc as Celsentri.
Pfizer believes there is a clear unmet need for new drugs to fight HIV in patients for whom other, older drugs no longer work. Celsentri is unlike any other HIV medicines now on the market in that it targets the cells of patients and not the virus itself.
The FDA has scheduled a Tuesday meeting of outside experts to discuss Pfizer's application for approval. The FDA has asked the experts whether Celsentri, if approved, would require special labeling or if further study of the drug's safety is needed before it can be sold. FDA also asked whether the drug should be studied further in women and blacks."
Is this a strategic attempt to get the "bad news" out ahead of the Adcomm meeting or an effort to scuttle the drug in order to avoid looking bad? CCR5 inhibitors have been associated with an increased risk of liver damage and lymphoma but I don't know what that risk is relative to other drugs such as tylenol or other viruses left untreated. More worrisome perhaps: Maraviroc not only targets specific cells, but it will be marketed with a protein assay that will identify which patients that are high responders. Personalized medicine. Which means that the risk benefit profile will be higher still. I don't get this need for studying African Americans and women when you have a genetic test. Why not study Ashkenazic Jews still suffering from last night's Yankee game who live in New Jersey while your at it?
A first in class personalized medicine for a fatal disease and still the agency is screwing around with safety issues. Just how high does the bar have to be to get a drug approved?
" Health officials repeated safety concerns about an experimental group of HIV drugs Friday, days before government advisers will recommend whether the first drug from the class merits approval.
Pfizer Inc. seeks Food and Drug Administration approval for maraviroc, potentially the first in a novel group of drugs to fight HIV, the virus that causes AIDS. Pfizer proposes marketing maraviroc as Celsentri.
Pfizer believes there is a clear unmet need for new drugs to fight HIV in patients for whom other, older drugs no longer work. Celsentri is unlike any other HIV medicines now on the market in that it targets the cells of patients and not the virus itself.
The FDA has scheduled a Tuesday meeting of outside experts to discuss Pfizer's application for approval. The FDA has asked the experts whether Celsentri, if approved, would require special labeling or if further study of the drug's safety is needed before it can be sold. FDA also asked whether the drug should be studied further in women and blacks."
Is this a strategic attempt to get the "bad news" out ahead of the Adcomm meeting or an effort to scuttle the drug in order to avoid looking bad? CCR5 inhibitors have been associated with an increased risk of liver damage and lymphoma but I don't know what that risk is relative to other drugs such as tylenol or other viruses left untreated. More worrisome perhaps: Maraviroc not only targets specific cells, but it will be marketed with a protein assay that will identify which patients that are high responders. Personalized medicine. Which means that the risk benefit profile will be higher still. I don't get this need for studying African Americans and women when you have a genetic test. Why not study Ashkenazic Jews still suffering from last night's Yankee game who live in New Jersey while your at it?
A first in class personalized medicine for a fatal disease and still the agency is screwing around with safety issues. Just how high does the bar have to be to get a drug approved?
Lots of folks exercising their right to free speech over the issue of limiting free speech, aka: DTC advertising. The latest is the legislative attempt to give the FDA authority to ban advertising for the first two years after a drug is approved.
Here’s Senator Kennedy’s perspective:
"What we are looking at is the very rare circumstance. It would be used in the most limited kinds of circumstances, where the FDA … wants to give approval for a drug but is not sure and fears advertising will lead to massive use of the drugs.â€
But FDA already negotiates such circumstances. That’s the key word, “negotiate.†And it’s not a finesse. Minus that word it’s … unconstitutional.
And there are many people, far less holy than Senator Kennedy, who see this as the first step towards banning pharmaceutical advertising altogether.
Consider what a Consumer Reports analyst said, "We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people. The real testing of these drugs takes place after a pill hits the market, and that's why the advertising needs to be regulated."
Drugwonks does not believe that less information makes anything or anyone safter.
Make no mistake – this is a battle not only over the future role of the empowered health care consumer – but for the First Amendment.
Others are now saying, based on this new negative momentum, that DTC television ads will need to be more than one minute long to appropriately convey fair balance and adequate provision.
But it’s not a question of the time – it’s a question of the presentation. Can ads do a better job properly balancing risk and benefit? Most certainly. But it’s not necessarily a question of “more†as much as it is a question of “better.†And that means the FDA and industry (along with their advertising agencies) need better social science to determine how to best communicate such information to consumers.
Sounds like a good opening assignment for the agency’s new advisory committee on risk communications.
If we truly want to create a situation where our medicines are “safer†we must learn how to better communicate risk and benefit – not limit it.
Otherwise the empowered health care consumer might very well be gone in 60 seconds.
Here’s Senator Kennedy’s perspective:
"What we are looking at is the very rare circumstance. It would be used in the most limited kinds of circumstances, where the FDA … wants to give approval for a drug but is not sure and fears advertising will lead to massive use of the drugs.â€
But FDA already negotiates such circumstances. That’s the key word, “negotiate.†And it’s not a finesse. Minus that word it’s … unconstitutional.
And there are many people, far less holy than Senator Kennedy, who see this as the first step towards banning pharmaceutical advertising altogether.
Consider what a Consumer Reports analyst said, "We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people. The real testing of these drugs takes place after a pill hits the market, and that's why the advertising needs to be regulated."
Drugwonks does not believe that less information makes anything or anyone safter.
Make no mistake – this is a battle not only over the future role of the empowered health care consumer – but for the First Amendment.
Others are now saying, based on this new negative momentum, that DTC television ads will need to be more than one minute long to appropriately convey fair balance and adequate provision.
But it’s not a question of the time – it’s a question of the presentation. Can ads do a better job properly balancing risk and benefit? Most certainly. But it’s not necessarily a question of “more†as much as it is a question of “better.†And that means the FDA and industry (along with their advertising agencies) need better social science to determine how to best communicate such information to consumers.
Sounds like a good opening assignment for the agency’s new advisory committee on risk communications.
If we truly want to create a situation where our medicines are “safer†we must learn how to better communicate risk and benefit – not limit it.
Otherwise the empowered health care consumer might very well be gone in 60 seconds.
I agree with Bob Goldberg's recent post refering to the uses of anti-psychotics and how they might have helped control the Virginia Tech killer, if they were taken, a big IF.. I also believe that universities should be able to mandate ongoing psychiatric care for someone like this - "if you don't like it, then leave the university."
which is not the say that a treating psychiatrist would have been able to intervene in time. It is not for sure that the killer would have revealed his plan beforehand. But if he had, then the treating psychiatrist would have had an obligation to admit him for acute homicidal ideation. It is also obvious that a person like this, with such a known psych history, especially with violent ideation, should not be allowed to purchase guns, and certainly computers could be used to create such a useful databank that gun stores could adhere to.
There is another issue to address - one that I have written extensively about in my book False Alarm: the Truth About the Epidemic of Fear.
Namely that it is too easy to personalize what you see in the news, too easy to attach yourself voyeuristically to a crime like Columbine or this one and feel as if it is going to happen to you.
THis kind of fear is infectious, and the killer knew this, which was one of the reasons he may have chosed a Columbine-like model.
My friend Gary Baumgarten of Paltalk, formerly of CNN radio, has written about this fear factor today in his blog and cited my book.
http://www.paltalk.com/newstalk/msiegel_041907_archive.shtml#comments
which is not the say that a treating psychiatrist would have been able to intervene in time. It is not for sure that the killer would have revealed his plan beforehand. But if he had, then the treating psychiatrist would have had an obligation to admit him for acute homicidal ideation. It is also obvious that a person like this, with such a known psych history, especially with violent ideation, should not be allowed to purchase guns, and certainly computers could be used to create such a useful databank that gun stores could adhere to.
There is another issue to address - one that I have written extensively about in my book False Alarm: the Truth About the Epidemic of Fear.
Namely that it is too easy to personalize what you see in the news, too easy to attach yourself voyeuristically to a crime like Columbine or this one and feel as if it is going to happen to you.
THis kind of fear is infectious, and the killer knew this, which was one of the reasons he may have chosed a Columbine-like model.
My friend Gary Baumgarten of Paltalk, formerly of CNN radio, has written about this fear factor today in his blog and cited my book.
http://www.paltalk.com/newstalk/msiegel_041907_archive.shtml#comments
She writes about a new drug designed to reduce the number of times a woman menstruates as if this were something drug companies were trying to take away from women or make them ashamed of. Why can't women choose to take control of their bodies? And incredibly THIS gets front page coverage at the NYT but not the article about the benefits of antidepressants. In fact the NYT did not assign a staff reporter to that important story. Disgusting.
http://www.nytimes.com/2007/04/20/health/20period.html?_r=1&oref=slogin
http://www.nytimes.com/2007/04/20/health/20period.html?_r=1&oref=slogin
Why? Because they support Medicare advantage plans that give low income and chronically ill seniors more benefits at a cost with free drugs.... (Refer to Peter's post on Mark McClellan on how this happened..)
Krugman always writes like someone who finds it helpful to grind his axe on the necks of others. This piece is no different. Read all about it in his latest meltdown....
The Plot Against Medicare
"The plot against Social Security failed: President Bush's attempt to privatize the system crashed and burned when the public realized what he was up to. But the plot against Medicare is faring better: the stealth privatization embedded in the Medicare Modernization Act, which Congress literally passed in the dead of night back in 2003, is proceeding apace.
Worse yet, the forces behind privatization not only continue to have the G.O.P. in their pocket, but they have also been finding useful idiots within the newly powerful Democratic coalition. And it's not just politicians with an eye on campaign contributions. There's no nice way to say it: the NAACP and the League of United Latin American Citizens have become patsies for the insurance industry. "
Krugman always writes like someone who finds it helpful to grind his axe on the necks of others. This piece is no different. Read all about it in his latest meltdown....
The Plot Against Medicare
"The plot against Social Security failed: President Bush's attempt to privatize the system crashed and burned when the public realized what he was up to. But the plot against Medicare is faring better: the stealth privatization embedded in the Medicare Modernization Act, which Congress literally passed in the dead of night back in 2003, is proceeding apace.
Worse yet, the forces behind privatization not only continue to have the G.O.P. in their pocket, but they have also been finding useful idiots within the newly powerful Democratic coalition. And it's not just politicians with an eye on campaign contributions. There's no nice way to say it: the NAACP and the League of United Latin American Citizens have become patsies for the insurance industry. "
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.
