Latest Drugwonks' Blog
As Mark Twain -- an author of choice here at drugwonks -- once said: "Presume you were an idiot. Then presume you were a member of Congress. But I repeat myself."
Can any be so stupid and petty as to quibble about having the inventor of the artificial heart promoting as important a drug as Lipitor?
Apparently Bart Stupak and John Dingell think it rises to a high enough crime to demand a congressional investigation. And Katie Watson of the Medical Humanities and Bioethics Program at Northwestern University agrees: "To have a celebrity physician associated with cardiac health telling me I need Lipitor and when it costs significantly more than a generic alternative that might be appropriate for me— that's a physician motivated by a paycheck, not by patient health."
Let it be noted that Ms. Watson is famous for her lecture "Playing Doctor: Improvisational Theater & the Medical Encounter" which was presented at the Searle Seminar Room in the Medical Humanites and Bioethics building. That's Searle, as in the drug company, better known as Pharmacia which is now part of...you guessed it...Pfizer.
But I digress. So apparently it is unethical to have a famous doctor who does not practice medicine promoting a brand drug that works. It is ethical to have someone playing doctor promote a generic drug that doesn't? Or how about a Nobel Prize Winner who is no longer licensed promoting a new drug? And how does Ms. Watson know if the Nobel Prize winner is motivated by a paycheck and not patient health? Is it wrong to accept a paycheck in the process of advancing patient care by being a spokesperson.
Back to Ms. Watson. " Katie is also the author of the screenplay Sperm Daddy, and a contributor to the TimeOut Chicago humor back page and the WBEZ news magazine 848." I wonder if she is motivated by a paycheck or patient health?
http://www.sirensimprov.com/katie.html
Can any be so stupid and petty as to quibble about having the inventor of the artificial heart promoting as important a drug as Lipitor?
Apparently Bart Stupak and John Dingell think it rises to a high enough crime to demand a congressional investigation. And Katie Watson of the Medical Humanities and Bioethics Program at Northwestern University agrees: "To have a celebrity physician associated with cardiac health telling me I need Lipitor and when it costs significantly more than a generic alternative that might be appropriate for me— that's a physician motivated by a paycheck, not by patient health."
Let it be noted that Ms. Watson is famous for her lecture "Playing Doctor: Improvisational Theater & the Medical Encounter" which was presented at the Searle Seminar Room in the Medical Humanites and Bioethics building. That's Searle, as in the drug company, better known as Pharmacia which is now part of...you guessed it...Pfizer.
But I digress. So apparently it is unethical to have a famous doctor who does not practice medicine promoting a brand drug that works. It is ethical to have someone playing doctor promote a generic drug that doesn't? Or how about a Nobel Prize Winner who is no longer licensed promoting a new drug? And how does Ms. Watson know if the Nobel Prize winner is motivated by a paycheck and not patient health? Is it wrong to accept a paycheck in the process of advancing patient care by being a spokesperson.
Back to Ms. Watson. " Katie is also the author of the screenplay Sperm Daddy, and a contributor to the TimeOut Chicago humor back page and the WBEZ news magazine 848." I wonder if she is motivated by a paycheck or patient health?
http://www.sirensimprov.com/katie.html
Have a look at today’s New York Times house editorial, “Cholesterol Drug Bombs.â€
http://www.nytimes.com/2008/01/16/opinion/16wed2.html?_r=1&ref=opinion&oref=slogin
There are a number of issues going on here, but pay particular attention to these two paragraphs:
“There are reasons to be cautious about interpreting these results. The number of patients was relatively small. And many of them may have used different drug treatments for years before entering the trial, possibly diminishing the effectiveness of adding Zetia …
The findings also raise doubts about the current belief that lowering cholesterol is the key to cardiovascular health. The study showed that Vytorin reduced bad cholesterol significantly more than Zocor alone. The problem was that it failed to reduce the formation of plaque.â€
Here’s what well-respected cardiologist (and CMPI board chairman) Dr. Michael Weber has to say:
“The study with Vytorin looked only at surrogate endpoints, not morbidity and mortality. The ongoing clinical outcomes trials will answer the questions definitively. We must hope that the alarmist comments by certain opinion leaders quoted in the lay press will not compromise the integrity of these critical studies by intimidating the patients who have been enrolled. We should not forget that many people simply cannot use statins in full doses due to side effects, so properly studying Zetia and Vytorin is absolutely vital.â€
As to whether or not clinical data was withheld (or as the Times writes, “cynically" sat on) is another issue altogether and cannot be allowed to muddy the far more important clinical questions.
http://www.nytimes.com/2008/01/16/opinion/16wed2.html?_r=1&ref=opinion&oref=slogin
There are a number of issues going on here, but pay particular attention to these two paragraphs:
“There are reasons to be cautious about interpreting these results. The number of patients was relatively small. And many of them may have used different drug treatments for years before entering the trial, possibly diminishing the effectiveness of adding Zetia …
The findings also raise doubts about the current belief that lowering cholesterol is the key to cardiovascular health. The study showed that Vytorin reduced bad cholesterol significantly more than Zocor alone. The problem was that it failed to reduce the formation of plaque.â€
Here’s what well-respected cardiologist (and CMPI board chairman) Dr. Michael Weber has to say:
“The study with Vytorin looked only at surrogate endpoints, not morbidity and mortality. The ongoing clinical outcomes trials will answer the questions definitively. We must hope that the alarmist comments by certain opinion leaders quoted in the lay press will not compromise the integrity of these critical studies by intimidating the patients who have been enrolled. We should not forget that many people simply cannot use statins in full doses due to side effects, so properly studying Zetia and Vytorin is absolutely vital.â€
As to whether or not clinical data was withheld (or as the Times writes, “cynically" sat on) is another issue altogether and cannot be allowed to muddy the far more important clinical questions.
Representative Rosa DeLauro has introduced the Cloned Food Labeling Act, which would require the FDA and the Department of Agriculture (USDA) to mandate that all food derived from cloned animals be labeled.
She’s not happy with the FDA’s stance on the safety of food:
“The studies on which the FDA is basing its assessment include very little information on the specific question of whether food from cloned animals is safe."
But, according to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals."
The agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated.
Representative DeLauro, rather than shooting from the hip, should call the FDA and ask for a briefing.
She’s not happy with the FDA’s stance on the safety of food:
“The studies on which the FDA is basing its assessment include very little information on the specific question of whether food from cloned animals is safe."
But, according to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals."
The agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated.
Representative DeLauro, rather than shooting from the hip, should call the FDA and ask for a briefing.
How can we trust that the drugs will be safe or effective? Since Gates Foundation President Yamada is under investigation by Senator Grassley and Cong. DeLauro for his role in talking to Dr. John Buse about Avandia nearly a decade ago, obviously any money he doles out while at Gates must be considered tainted and therefore the results of any studies cannot be trusted. And if the orphan drug for sleeping sickness uses Critical Path steps developed by the Reagan Udall Foundation how do we know they actually are not steps that weaken standards of safety and efficacy to simply line the pockets of the company that the Gates Foundation gave the grant to? We all know that's what the Critical Path is all about: watering down standards so that foundations can give grants to companies who in turn can develop at cost an orphan drug that is neither safe or effective because it uses biomarkers.
http://www.nytimes.com/2008/01/08/health/research/08slee.html?_r=1&ref=health&oref=slogin
http://www.nytimes.com/2008/01/08/health/research/08slee.html?_r=1&ref=health&oref=slogin
I took Senator Grassley to task for suggesting that unhappy reviewers and other malcontents air the grievances and differences with FDA division decisions at AdComm meetings a while back. Now from the other side, people and companies who complain about the lack of consistent or guidance from the FDA regarding the reason for holding up an approval also want transparency.
Transparency is the refuge of those who, short of being able to control the outcome, want to at least try to control perception. The FDA needs less transparency and more consistency based on better science. And it needs leadership regarding the question of "Whose life and health care decision is it anyway?" The Critical Path is designed to help shift that decisionmaking to doctors and individuals.
What I'd like to know is, where do the presidential candidates stand on The Critical Path? Do they care? Or are they more interested in making sure there are cheap knock offs of old drugs and faster FDA inspections for UPS shipments of medicines ordered online?
http://www.fool.com/investing/high-growth/2008/01/14/score-one-for-dendreon-and-disclosure.aspx
Transparency is the refuge of those who, short of being able to control the outcome, want to at least try to control perception. The FDA needs less transparency and more consistency based on better science. And it needs leadership regarding the question of "Whose life and health care decision is it anyway?" The Critical Path is designed to help shift that decisionmaking to doctors and individuals.
What I'd like to know is, where do the presidential candidates stand on The Critical Path? Do they care? Or are they more interested in making sure there are cheap knock offs of old drugs and faster FDA inspections for UPS shipments of medicines ordered online?
http://www.fool.com/investing/high-growth/2008/01/14/score-one-for-dendreon-and-disclosure.aspx
While lots of folks are making much ado about whether or not to readjust the athero endpoint of the Vytorin study because of hard to read ultrasounds (remember Steve Nissen and Atherogenics?) the the results of the study demonstrate, once again, just how hard it is to use statins to get reversal of plaque. We need better drugs. Good article from cnn.com on what the study shows and don't. Ignore the Congressional witchhunt threats and the whining of the "Kill Pharma Even If People Die" bloggers...
http://money.cnn.com/news/newsfeeds/articles/djf500/200801141513DOWJONESDJONLINE000640_FORTUNE5.htm
http://money.cnn.com/news/newsfeeds/articles/djf500/200801141513DOWJONESDJONLINE000640_FORTUNE5.htm
My book review of Embryo: A Defense of Human Life...
http://www.nypost.com/seven/01132008/postopinion/postopbooks/the_born_identity_433669.htm
http://www.nypost.com/seven/01132008/postopinion/postopbooks/the_born_identity_433669.htm
Here are two of the qualities Leon Wieseltier in The New Republic like about about John McCain that make him a nearly ideal presidential candidate. "anxiety over the environment and contempt for pharmaceutical companies."
Contempt for pharmaceutical companies? And how does that translate into good public policy? Pushing for drug reimportation? Patent seizures?
I think there is a bit of projection on Leon's part but what prompts this hatred? What did drug company's do wrong that deserves contempt? I know this will tick off the whack jobs that equate anything that is sponsored by drug companies as a pollutant or a criminal activity, but I really would like to know.
Contempt for pharmaceutical companies? And how does that translate into good public policy? Pushing for drug reimportation? Patent seizures?
I think there is a bit of projection on Leon's part but what prompts this hatred? What did drug company's do wrong that deserves contempt? I know this will tick off the whack jobs that equate anything that is sponsored by drug companies as a pollutant or a criminal activity, but I really would like to know.
The U.S. Supreme Court has, without comment, opted not to accept an appeal of Abigail Alliance v. von Eschenbach. This means the federal appeals court ruling that patients do not have a constitutional right to experimental drugs stands.
This is a tough, emotional issue and, with such heated rhetoric on both sides, it's easy to lose sight of the fact that everyone wants the same thing -- expanded access to drugs under clinical investigation.
That's precisely why, when I was at the FDA, we stopped calling clinical trials "compassionate use." It sounded too paternalistic. Allowing desperately ill patients into clinical trial programs shouldn't be an act of noblesse oblige it should be an act of civil society.
The question is, how to do so with greater alacrity and responsible, robust oversight.
When it comes to pharmaceutical safety, pure libertarianism isn't in the best interests of the public health. Expanded access to experimental drugs simply can't and shouldn't morph into total, unfettered access.
That doesn't mean the status quo is working. What it means is that the FDA needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review. And the Abigail Alliance and its supporters need to keep up the pressure to reform the current system.
We believe this is best done in a spirit of collegiality rather than a confrontational courtroom or in Congress.
And we believe the time for all parties to sit down for serious discussions is immediately. Lives hang in the balance.
This is a tough, emotional issue and, with such heated rhetoric on both sides, it's easy to lose sight of the fact that everyone wants the same thing -- expanded access to drugs under clinical investigation.
That's precisely why, when I was at the FDA, we stopped calling clinical trials "compassionate use." It sounded too paternalistic. Allowing desperately ill patients into clinical trial programs shouldn't be an act of noblesse oblige it should be an act of civil society.
The question is, how to do so with greater alacrity and responsible, robust oversight.
When it comes to pharmaceutical safety, pure libertarianism isn't in the best interests of the public health. Expanded access to experimental drugs simply can't and shouldn't morph into total, unfettered access.
That doesn't mean the status quo is working. What it means is that the FDA needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review. And the Abigail Alliance and its supporters need to keep up the pressure to reform the current system.
We believe this is best done in a spirit of collegiality rather than a confrontational courtroom or in Congress.
And we believe the time for all parties to sit down for serious discussions is immediately. Lives hang in the balance.
Page One story in today's New York Times continues the debate over whether or not fibromyalgia is a "real" disease. After all -- it's just a "women's problem," right?
Why is this on Page One? Surprise! Because one of the storylines is about how evil drug companies (in cahoots with the FDA) are spending money creating and promoting drugs for this faux syndrome.
But there is one paragraph worth sharing. The focus is on why the FDA chose to approve Lyrica (pregabalin) -- with an indication for treating fibromyalgia -- over the objection of some (unnamed) junior reviewers.
“While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,†Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.
Risk. Benefit. Fibromyalgia. Millions of women. Millions of dollars. After all, if Pharma can help -- then there must be a hidden agenda. Ergo, pitch it for Page One, baby.
Nonsense. What would Hillary say? Someone should ask her about this during the next debate?
At the end of the day, it's a balanced article and an interesting issue. Alex Berenson does a nice job. But there's nothing new. Isn't there any real news that can be reported on the wood of our nation's newspaper of record?
Why is this on Page One? Surprise! Because one of the storylines is about how evil drug companies (in cahoots with the FDA) are spending money creating and promoting drugs for this faux syndrome.
But there is one paragraph worth sharing. The focus is on why the FDA chose to approve Lyrica (pregabalin) -- with an indication for treating fibromyalgia -- over the objection of some (unnamed) junior reviewers.
“While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,†Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.
Risk. Benefit. Fibromyalgia. Millions of women. Millions of dollars. After all, if Pharma can help -- then there must be a hidden agenda. Ergo, pitch it for Page One, baby.
Nonsense. What would Hillary say? Someone should ask her about this during the next debate?
At the end of the day, it's a balanced article and an interesting issue. Alex Berenson does a nice job. But there's nothing new. Isn't there any real news that can be reported on the wood of our nation's newspaper of record?
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.
