Latest Drugwonks' Blog
Should Representative Pelosi become Speaker Pelosi we can almost certainly expect another round of absurdity surrounding the issue of drugs "from Canada." (Again and as always, please note the quotation marks.)
I had dinner last night with some Canadian policy wonks who are very concerned about the sanctity of their own legitimate supply of pharmaceuticals -- and rightly so. Legalized importation would create a giant sucking sound, the end result being the Great White North being drug-free -- and not in a good way.
There is, at present at least one private member's bill that I know of in Ottawa that would ban bulk exports of pharmaceuticals to the US (thus making it illegal for whole states -- like California and Illinois -- and programs -- like Part D -- to source their medicines supply from Canada). But it's an opposition member and not likely to go anywhere.
Prime Minister Harper had better wake up to the reality that, should Mrs. Pelosi's 100 Hour Reign of Terror become reality it won't be "Just say no to drugs," it'll be "Just say no drugs."
Oh Canada!
I had dinner last night with some Canadian policy wonks who are very concerned about the sanctity of their own legitimate supply of pharmaceuticals -- and rightly so. Legalized importation would create a giant sucking sound, the end result being the Great White North being drug-free -- and not in a good way.
There is, at present at least one private member's bill that I know of in Ottawa that would ban bulk exports of pharmaceuticals to the US (thus making it illegal for whole states -- like California and Illinois -- and programs -- like Part D -- to source their medicines supply from Canada). But it's an opposition member and not likely to go anywhere.
Prime Minister Harper had better wake up to the reality that, should Mrs. Pelosi's 100 Hour Reign of Terror become reality it won't be "Just say no to drugs," it'll be "Just say no drugs."
Oh Canada!
Here's a link to my commentary in Commentary on Peter Huber's article "Of Pills and Profits: In Defense of Big Pharma." (Peter's excellent article can be accessed via the Manhattan Institute website: http://www.manhattan-institute.org
Click below and please let me know your thoughts and comments.
http://www.cmpi.org/viewstddoccontent.asp?detailid=181&contenttypeid=2
Click below and please let me know your thoughts and comments.
http://www.cmpi.org/viewstddoccontent.asp?detailid=181&contenttypeid=2
I have a son in the Israeli army. He deferred attending George Washington U (with a scholarship) to do so. John Kerry's remark might have been targeted at Bush in his own mind but his reference point was a stereotype of why people join the military. His comments reflect the elitism and hollow intellect of many in his party. They impugn those who voluntarily perform military service because they believe that supporting a democracy in a war against terror is a just and noble purpose.
Similarly, I believe that Democrats -- until proven otherwise -- are a danger to medical innovation. (Not that they won't have the help of some Republicans). Quick to invoke the stereotype that any involvement with corporations stink, their very rhetoric demoralizes and discourages those who engage in research because they care and hope to cure. And their actions -- as I blogged on the exodus of NIH scientists -- based on that rhetoric has consequences.
Talk is not cheap. Talk imposes a heavy cost on those who actually seek a newer and brighter world. I thought politicians were supposed to empower those with such intentions instead of embarassing and attacking them.
Similarly, I believe that Democrats -- until proven otherwise -- are a danger to medical innovation. (Not that they won't have the help of some Republicans). Quick to invoke the stereotype that any involvement with corporations stink, their very rhetoric demoralizes and discourages those who engage in research because they care and hope to cure. And their actions -- as I blogged on the exodus of NIH scientists -- based on that rhetoric has consequences.
Talk is not cheap. Talk imposes a heavy cost on those who actually seek a newer and brighter world. I thought politicians were supposed to empower those with such intentions instead of embarassing and attacking them.
The biggest savings in the Democrats' plan would be a pledge to give the federal government the authority to negotiate lower drug prices for Medicare. Sen. Edward M. Kennedy (D-Mass.) and Rep. Henry A. Waxman (D-Calif.) have estimated that Medicare could save $190 billion over the next decade if the seniors' program adopted the price-negotiating model of the Department of Veterans Affairs.
Let's translate: "The price negotiating model" is the one 40 percent of veterans want to LEAVE but can't, robs seniors of half the drugs now they choose from, forces them to buy from government run pharmacies, and denies them access to 90 percent of the 80 or more drugs the FDA gave priority approval to since 1997. Oh, and the whole process shortens the lives of seniors.
If seniors want many of the medicines they now depend on for their health, they will have to pay for them out of pocket to the tune of billions of dollars a year. And the loss of profits -- yes profits -- over ten years will hurt biotech firms and their investments, reducing the number of new medicines for fatal and degenerative illnesses by 50 percent.
Let's translate: "The price negotiating model" is the one 40 percent of veterans want to LEAVE but can't, robs seniors of half the drugs now they choose from, forces them to buy from government run pharmacies, and denies them access to 90 percent of the 80 or more drugs the FDA gave priority approval to since 1997. Oh, and the whole process shortens the lives of seniors.
If seniors want many of the medicines they now depend on for their health, they will have to pay for them out of pocket to the tune of billions of dollars a year. And the loss of profits -- yes profits -- over ten years will hurt biotech firms and their investments, reducing the number of new medicines for fatal and degenerative illnesses by 50 percent.
Research, as the saying goes, is like a bikini. What it shows you is interesting – but what it conceals is essential.
Today’s case-in-point is a new study by AHRQ. The headline on the UPI wire is “Study: Brand-name drugs fuel cost increase."
The lede graph reads as follows:
WASHINGTON, Oct. 31 (UPI) -- U.S. brand-name drug spending helped fuel a doubling of spending on outpatient prescription drugs from 1999 to 2003, a new study says. During those years, total consumer spending on drugs purchased outside of hospitals increased to $178 billion per year, according to a new report by Health and Human Services' Agency for Healthcare Research and Quality.
Interesting numbers, big numbers – but without any real context. For example, what percentage of that spend is for medicines not previously available? What’s the breakdown between new and existing scripts? How does that increase corelate to reduced costs in, for example, hospitalization?
And what about improved patient outcomes?
Minus these important variables, all this new report will do is aid and abet the Evangelists of Evidence-Based Medicine and fuel the fire of those pundits and politicians for whom the crisis in American health care can be simplistically summed in the four words, “drugs are too expensive.â€
Today’s case-in-point is a new study by AHRQ. The headline on the UPI wire is “Study: Brand-name drugs fuel cost increase."
The lede graph reads as follows:
WASHINGTON, Oct. 31 (UPI) -- U.S. brand-name drug spending helped fuel a doubling of spending on outpatient prescription drugs from 1999 to 2003, a new study says. During those years, total consumer spending on drugs purchased outside of hospitals increased to $178 billion per year, according to a new report by Health and Human Services' Agency for Healthcare Research and Quality.
Interesting numbers, big numbers – but without any real context. For example, what percentage of that spend is for medicines not previously available? What’s the breakdown between new and existing scripts? How does that increase corelate to reduced costs in, for example, hospitalization?
And what about improved patient outcomes?
Minus these important variables, all this new report will do is aid and abet the Evangelists of Evidence-Based Medicine and fuel the fire of those pundits and politicians for whom the crisis in American health care can be simplistically summed in the four words, “drugs are too expensive.â€
I am preparing for my very first colonoscopy today. Scheduled for tomorrow morning at 10 am. I am looking at it as getting done to me what Democrats will do to seniors and medical progress if they win control of Congress and get a hold of Medicare.
Very important story by Steve Usdin in this week's edition of BioCentury.
The first paragraph sets the stage:
"FDA's rejection of Replidyne Inc.'s farapenem medoxomil has removed nearly all doubt the agency has resolved a long-running internal debate over the acceptability of non-inferiority studies to support efficacy in most community-acquired bacterial infections. But the absence of agency guidance forces developers to guess what protocols might work, a burden industry may not choose to take on despite the fact that the U.S. spends $8.5 billion on oral antibiotics in the U.S. annually."
And further ...
"The agency's action reflects arguments that the effectiveness of comparator antibiotics has not been established against placebo, making a non-inferiority result of doubtful value. And with the exception of CAP (community-acquired pneumonia), where the role an antibiotics isn't questioned and where FDA will still accept non-inferiority studies, the other indications are self-limiting, and thus the urgency to treat is said to be lower."
Many issues here, not the least of which are the ethical implications. As Usdin points out, "By requiring superiority trials in ABS (acute bacterial sinusitis) and AECB (acute exacerbation of chronic bronchitis), FDA has taken sides in a debate among clinicians, academic researchers, politicians and industry over whether it is necessary, ethical, or possible to conduct such trials."
On one side is Donald Poretz, Georgetown School of Medicine and a member of the FDA's Anti-Infective Drugs adcomm, "For years we thought is was unethical to do placebo-controlled trials in sinusitis, bronchitis, and otitis media, but now it seems it is ethical" ... because it isn't clear that antibiotics are helpful.
On the other side, James Hadley, University of Rochester Medical Center and past president of the American Academy of Otolaryngology, "It is very difficult in the U.S. under current law and regulations, and with IRBs that regulate clinical trials to offer a placebo to patients in view of an active disease process."
Show me the guidance!
The first paragraph sets the stage:
"FDA's rejection of Replidyne Inc.'s farapenem medoxomil has removed nearly all doubt the agency has resolved a long-running internal debate over the acceptability of non-inferiority studies to support efficacy in most community-acquired bacterial infections. But the absence of agency guidance forces developers to guess what protocols might work, a burden industry may not choose to take on despite the fact that the U.S. spends $8.5 billion on oral antibiotics in the U.S. annually."
And further ...
"The agency's action reflects arguments that the effectiveness of comparator antibiotics has not been established against placebo, making a non-inferiority result of doubtful value. And with the exception of CAP (community-acquired pneumonia), where the role an antibiotics isn't questioned and where FDA will still accept non-inferiority studies, the other indications are self-limiting, and thus the urgency to treat is said to be lower."
Many issues here, not the least of which are the ethical implications. As Usdin points out, "By requiring superiority trials in ABS (acute bacterial sinusitis) and AECB (acute exacerbation of chronic bronchitis), FDA has taken sides in a debate among clinicians, academic researchers, politicians and industry over whether it is necessary, ethical, or possible to conduct such trials."
On one side is Donald Poretz, Georgetown School of Medicine and a member of the FDA's Anti-Infective Drugs adcomm, "For years we thought is was unethical to do placebo-controlled trials in sinusitis, bronchitis, and otitis media, but now it seems it is ethical" ... because it isn't clear that antibiotics are helpful.
On the other side, James Hadley, University of Rochester Medical Center and past president of the American Academy of Otolaryngology, "It is very difficult in the U.S. under current law and regulations, and with IRBs that regulate clinical trials to offer a placebo to patients in view of an active disease process."
Show me the guidance!
While looking for a white paper on the WHO website I was surprised, excited, and pleased to see that their updated fact sheet on counterfeit drugs cites CMPI on the projected growth of global sales of fake medicines.
Here's the precise citation:
"The Centre for Medicine in the Public Interest, in the United States, predicts that counterfeit drug sales will reach US$75 globally in 2010, an increase of more than 90% from 2005."
So, now that we've given ourselves a nice pat on the back (and don't you love the quaint spelling of "Centre"), it's important to pass along the link for the WHO fact sheet. It's an important reference.
Have a look:
http://www.who.int/mediacentre/factsheets/fs275/en/print.html
Here's the precise citation:
"The Centre for Medicine in the Public Interest, in the United States, predicts that counterfeit drug sales will reach US$75 globally in 2010, an increase of more than 90% from 2005."
So, now that we've given ourselves a nice pat on the back (and don't you love the quaint spelling of "Centre"), it's important to pass along the link for the WHO fact sheet. It's an important reference.
Have a look:
http://www.who.int/mediacentre/factsheets/fs275/en/print.html
Want to know what happens when the NIH toes the conflict free holier than thou line espoused by Marcia Angell, JAMA, NEJM.....
"Ethics rules send NIH scientists packing
By RITA BEAMISH, Associated Press WriterSat Oct 28, 6:06 PM ET
Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income.
Most scientists say the ethics crackdown is too severe, and nearly three-quarters of them believe it will hinder the government's ability to attract and keep medical researchers, according to a survey commissioned by the government's premier medical research agency.
The tightened rules were put in place last year after NIH found dozens of scientists had run afoul of existing restrictions on private consulting deals that had enriched them with money from drug and biotechnology companies.
Outside income from such companies is now banned. NIH also is placing greater restrictions and disclosure requirements on employees' financial holdings....."
What's so delicious about all this is Jim Greenwood, now chairman of BIO was one of the Congressman who beat up NIH on this COI issue. Now BIO is bemoaning the fact that NIH is losing the smartest people, particularly at NCI and testified before the NIH Blue Ribbon Panel on conflict of interest against the very limits that are sending scientists packing.
And if you think it's bad now, just wait till Dingell and Waxman get control of the relevant committees....Fewer scientists conducting less research in cooperation with scientists in academia and companies in such areas as stem cell research, Alzheimer's, cancer, etc. That means less investment in these critical areas and less progress. Way to go.
"Ethics rules send NIH scientists packing
By RITA BEAMISH, Associated Press WriterSat Oct 28, 6:06 PM ET
Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income.
Most scientists say the ethics crackdown is too severe, and nearly three-quarters of them believe it will hinder the government's ability to attract and keep medical researchers, according to a survey commissioned by the government's premier medical research agency.
The tightened rules were put in place last year after NIH found dozens of scientists had run afoul of existing restrictions on private consulting deals that had enriched them with money from drug and biotechnology companies.
Outside income from such companies is now banned. NIH also is placing greater restrictions and disclosure requirements on employees' financial holdings....."
What's so delicious about all this is Jim Greenwood, now chairman of BIO was one of the Congressman who beat up NIH on this COI issue. Now BIO is bemoaning the fact that NIH is losing the smartest people, particularly at NCI and testified before the NIH Blue Ribbon Panel on conflict of interest against the very limits that are sending scientists packing.
And if you think it's bad now, just wait till Dingell and Waxman get control of the relevant committees....Fewer scientists conducting less research in cooperation with scientists in academia and companies in such areas as stem cell research, Alzheimer's, cancer, etc. That means less investment in these critical areas and less progress. Way to go.
When it comes to improving postmarketing surveillance there are a few acronyms to keep in mind: FDA, MIT, and AEGIS.
Note to publicity hungry politicians, pundits, and Prophets of the Precautionary Principle: One acronym not mentioned above (or in the important article below) is"CYA."
Have a look and see what real progress looks like:
Download file
Note to publicity hungry politicians, pundits, and Prophets of the Precautionary Principle: One acronym not mentioned above (or in the important article below) is"CYA."
Have a look and see what real progress looks like:
Download file
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.
