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Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
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TortsProf
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11/02/2006 09:17 AM |
I find it incredible that the media slams drug companies for marketing medicines that undergo years of rigorous clinical testing yet fail to investigate schlockmeister's like Kevin Trudeau or the most recent peddler of pharmaceutical porn, Joseph Mercola. Mercola is supposedly an osteopath who has a book entitled the Great Bird Flu Hoax on the NY Times Best seller list. The book claims that world wide concern about avian flu was concocted to gin up huge profits for companies that Rumsfeld and Cheney had ties to. I guess that means the WHO and UN were also on the take but no matter.
Ironically, the way Mercola got the book onto the best seller list was by getting people to preorder the book in massive enough quantities to qualify as a best seller. You might say that's a way of manufacturing a hoax to generate massive profits as well but perhaps that is too fine a distinction.
In fairness to Mercola, some of the products he peddles -- krill oil tablets -- have a modicum of clinical research to support claims that they help reduce cholesterol or alleviate PMS. But he hypes them endlessly, asserting without substantial evidence beyond smaller clinical studies that products such as coconut oil or krill oil can prevent infections, arthritis, etc. And he promotes a study claiming that neptune krill oil "alleviate symptoms caused by rheumatoid arthritis and osteoarthritis, including joint pain, stiffness and functional impairment and significantly inhibit inflammation as shown by a decrease in C-Reactive Protein (CRP) -- a biomarker for inflammation." There is no such study in the medical literature...
Mercola has also been cited by the FDA on a couple of occasions for making medical claims for products without any evidence.
All the while he flogs drugs and vaccines as dangerous and deadly, using newspaper accounts for he source material.
Despite overwhelming evidence that mercury does not cause neurological damage he continues to whip up conspiracy sentiment that it does. And now, though scientific evidence overwhelmingly demonstrates that aspartame is extremely safe for the vast majority of consumers, Mercola is about to come out with a book called "Sweet Deception" that -- of course -- will conclude that the government and corporations colludes to cover up the TRUTH about artificial sweeteners and the mind numbering and cancer causing effects they have.
And of course Mercola will have a NY Times best seller ready to be pre-sold.
Along with a sugar alternative that he will be hawking as well.
Sometimes coincidences are sweet too. Read More & Comment...
Ironically, the way Mercola got the book onto the best seller list was by getting people to preorder the book in massive enough quantities to qualify as a best seller. You might say that's a way of manufacturing a hoax to generate massive profits as well but perhaps that is too fine a distinction.
In fairness to Mercola, some of the products he peddles -- krill oil tablets -- have a modicum of clinical research to support claims that they help reduce cholesterol or alleviate PMS. But he hypes them endlessly, asserting without substantial evidence beyond smaller clinical studies that products such as coconut oil or krill oil can prevent infections, arthritis, etc. And he promotes a study claiming that neptune krill oil "alleviate symptoms caused by rheumatoid arthritis and osteoarthritis, including joint pain, stiffness and functional impairment and significantly inhibit inflammation as shown by a decrease in C-Reactive Protein (CRP) -- a biomarker for inflammation." There is no such study in the medical literature...
Mercola has also been cited by the FDA on a couple of occasions for making medical claims for products without any evidence.
All the while he flogs drugs and vaccines as dangerous and deadly, using newspaper accounts for he source material.
Despite overwhelming evidence that mercury does not cause neurological damage he continues to whip up conspiracy sentiment that it does. And now, though scientific evidence overwhelmingly demonstrates that aspartame is extremely safe for the vast majority of consumers, Mercola is about to come out with a book called "Sweet Deception" that -- of course -- will conclude that the government and corporations colludes to cover up the TRUTH about artificial sweeteners and the mind numbering and cancer causing effects they have.
And of course Mercola will have a NY Times best seller ready to be pre-sold.
Along with a sugar alternative that he will be hawking as well.
Sometimes coincidences are sweet too. Read More & Comment...
11/02/2006 09:14 AM |
Here is the official response to my article in the Daily News. It does not address the substance of my concerns: that Breast Cancer Action discourages women from obtaining mammograms and from using medicines that can actually treat breast cancer when detecting and instead urges women to wait till we identify and eliminate every evironmental toxin that in the judgement of Breast Cancer Action causes breast cancer to get well....
http://www.nydailynews.com/news/ideas_opinions/story/466935p-392909c.html
Cancer research
San Francisco: Robert Goldberg's Op-Ed, "End sick crusade against breast cancer research" (Oct. 29), was full of factual errors. It also mischaracterized Breast Cancer Action and our 16 years of supporting the voices of those affected by the disease. We encourage pink-ribbon consumers to get informed, provide women with the facts so they can make informed choices about their health and organize people to do something about breast cancer besides worry. We also call for research to focus on key unanswered questions about breast cancer. We value transparency and are highly regarded in the cancer world, Goldberg's diatribe notwithstanding.
Barbara A. Brenner Executive Director Read More & Comment...
http://www.nydailynews.com/news/ideas_opinions/story/466935p-392909c.html
Cancer research
San Francisco: Robert Goldberg's Op-Ed, "End sick crusade against breast cancer research" (Oct. 29), was full of factual errors. It also mischaracterized Breast Cancer Action and our 16 years of supporting the voices of those affected by the disease. We encourage pink-ribbon consumers to get informed, provide women with the facts so they can make informed choices about their health and organize people to do something about breast cancer besides worry. We also call for research to focus on key unanswered questions about breast cancer. We value transparency and are highly regarded in the cancer world, Goldberg's diatribe notwithstanding.
Barbara A. Brenner Executive Director Read More & Comment...
11/02/2006 07:57 AM |
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! Read More & Comment...
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! Read More & Comment...
11/02/2006 05:46 AM |
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 Read More & Comment...
Click below and please let me know your thoughts and comments.
http://www.cmpi.org/viewstddoccontent.asp?detailid=181&contenttypeid=2 Read More & Comment...
11/01/2006 03:14 PM |
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. Read More & Comment...
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. Read More & Comment...
11/01/2006 02:45 PM |
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. Read More & Comment...
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. Read More & Comment...
11/01/2006 09:56 AM |
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.†Read More & Comment...
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.†Read More & Comment...
10/31/2006 02:50 PM |
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. Read More & Comment...
10/31/2006 10:20 AM |
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! Read More & Comment...
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! Read More & Comment...
10/31/2006 09:29 AM |
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 Read More & Comment...
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 Read More & Comment...
10/30/2006 08:08 PM |
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. Read More & Comment...
"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. Read More & Comment...
10/30/2006 07:22 AM |
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 Read More & Comment...
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 Read More & Comment...
10/29/2006 11:10 AM |
My oped today in the NY Dailly News nydailynews.com
End sick crusade against breast cancer research
By ROBERT GOLDBERG
Saturday, October 28th, 2006
Every October, as Breast Cancer Awareness Month rolls around, we wear pink ribbons and focus our attention on a terrible disease that takes the lives of some 40,000 American women every year. But this year, a group known as Breast Cancer Action has seized the stage - and, claiming to speak on behalf of breast cancer patients themselves, is making conspiratorial, offensive and irresponsible statements. They must be exposed as the fearmongers they are.
In a national media campaign that includes newspaper and TV ads, the upstart organization is advising women to "think before you pink" because - get this - they consider corporate donations to fight cancer research tainted by the profit motive. The group warns women against the breakthrough treatments corporate-funded research might yield.
And most alarmingly, the organization has advised against mammograms, apparently believing that they too are part of some corporate conspiracy. According to Barbara Brenner, executive director of the group, "benefit of routine mammograms for healthy premenopausal women is unproven."
This is a blatant lie that threatens women's lives. The scientific consensus is that routine mammography reduces the risk of dying of breast cancer in women 50 and older by up to 30%.
And in their crusade against corporate-funded research, what kind of breakthroughs is Breast Cancer Action targeting? Work by people like Northwestern University's Dr. Boris Pasche. By identifying women with variations of two specific genes that have been linked to an increased risk of cancer, Pasche and his colleagues are approaching a breakthrough that could successfully test for cancer risk in 30% of women. That could spare mothers needless trips to the doctor, exhausting rounds of chemotherapy and hospitalitzation.
In the perverse world of Breast Cancer Action, Dr. Pasche's research is suspect - because part of his financial support comes from the Avon Foundation. What's wrong with the Avon Foundation? Well, it seems the mere fact that it's linked to a profit-making company is cause enough for concern: "Breast cancer has become the poster child of corporate cause-related marketing campaigns, as companies try to boost their image and their profits by connecting themselves to a good cause," Breast Cancer Action complains on its Web site.
Perversely, this organization blames corporations for doing too much - and, at the very same time, not enough. As Brenner recently explained, "I understand that people want to do something, but if shopping could cure breast cancer, it would be cured by now." Brenner apparently isn't aware that over the last decade, thanks to countless researchers and millions of dollars in funding, the death rate from breast cancer has declined by 2.3% per year for all women. And it could go down much further, much faster, if research accelerates.
Breast Cancer's Action's twisted crusade would have corporations forget research funding and have women forgo potentially livesaving treatments. And what should replace research and science? A fight for a cleaner environment. In particular, the group insists there is irrefutable proof that chemicals called PCBs - pollutants that were in some manufactured goods before being banned in 1977 - cause breast cancer. There's no biological evidence to support such a link.
During Breast Cancer Awareness Month, this terrible disease is a formidable enough target for America to fight. We shouldn't also have to contend with the lies and hysteria being peddled by Breast Cancer Action. Read More & Comment...
End sick crusade against breast cancer research
By ROBERT GOLDBERG
Saturday, October 28th, 2006
Every October, as Breast Cancer Awareness Month rolls around, we wear pink ribbons and focus our attention on a terrible disease that takes the lives of some 40,000 American women every year. But this year, a group known as Breast Cancer Action has seized the stage - and, claiming to speak on behalf of breast cancer patients themselves, is making conspiratorial, offensive and irresponsible statements. They must be exposed as the fearmongers they are.
In a national media campaign that includes newspaper and TV ads, the upstart organization is advising women to "think before you pink" because - get this - they consider corporate donations to fight cancer research tainted by the profit motive. The group warns women against the breakthrough treatments corporate-funded research might yield.
And most alarmingly, the organization has advised against mammograms, apparently believing that they too are part of some corporate conspiracy. According to Barbara Brenner, executive director of the group, "benefit of routine mammograms for healthy premenopausal women is unproven."
This is a blatant lie that threatens women's lives. The scientific consensus is that routine mammography reduces the risk of dying of breast cancer in women 50 and older by up to 30%.
And in their crusade against corporate-funded research, what kind of breakthroughs is Breast Cancer Action targeting? Work by people like Northwestern University's Dr. Boris Pasche. By identifying women with variations of two specific genes that have been linked to an increased risk of cancer, Pasche and his colleagues are approaching a breakthrough that could successfully test for cancer risk in 30% of women. That could spare mothers needless trips to the doctor, exhausting rounds of chemotherapy and hospitalitzation.
In the perverse world of Breast Cancer Action, Dr. Pasche's research is suspect - because part of his financial support comes from the Avon Foundation. What's wrong with the Avon Foundation? Well, it seems the mere fact that it's linked to a profit-making company is cause enough for concern: "Breast cancer has become the poster child of corporate cause-related marketing campaigns, as companies try to boost their image and their profits by connecting themselves to a good cause," Breast Cancer Action complains on its Web site.
Perversely, this organization blames corporations for doing too much - and, at the very same time, not enough. As Brenner recently explained, "I understand that people want to do something, but if shopping could cure breast cancer, it would be cured by now." Brenner apparently isn't aware that over the last decade, thanks to countless researchers and millions of dollars in funding, the death rate from breast cancer has declined by 2.3% per year for all women. And it could go down much further, much faster, if research accelerates.
Breast Cancer's Action's twisted crusade would have corporations forget research funding and have women forgo potentially livesaving treatments. And what should replace research and science? A fight for a cleaner environment. In particular, the group insists there is irrefutable proof that chemicals called PCBs - pollutants that were in some manufactured goods before being banned in 1977 - cause breast cancer. There's no biological evidence to support such a link.
During Breast Cancer Awareness Month, this terrible disease is a formidable enough target for America to fight. We shouldn't also have to contend with the lies and hysteria being peddled by Breast Cancer Action. Read More & Comment...
10/27/2006 07:48 AM |
Here are some of the more interesting headlines from this week's health and medical breakthrough news:
From Sciencenewsdaily.com
Elderly Men With Low Testosterone Levels More Likely To Fall
Low testosterone levels may be associated with a higher risk of falling in older men, according to a report in the October 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals....
Punchlines are welcome
And then there's this from that cutting edge healthcare system North of the border
Unique Bra Eases Women's Recovery From Heart Surgery
A national clinical trial led by a University of Calgary researcher has found that wearing a specialized compression bra significantly reduces women's breast pain following heart surgery.
So let's get this straight. HealthCanada will pay for this but not Plavix or Herceptin...
The autism aliens will not be convinced that mercury (the element, not the planet) does not cause that disease not matter how much scientific evidence is amassed and no matter how many death threats they send to scientists and public health officials...
Government rejects vaccine petition
By ANDREW BRIDGES, Associated Press Writer
A group called the Coalition for Mercury-free Drugs petitioned the Food and Drug Administration in 2004 seeking the restrictions on thimerosal, citing concerns that the preservative is linked to autism. In a reply dated Sept. 26 but made public only Tuesday, the FDA rejected the petition.
Federal health officials won't put new restrictions on the use of a mercury-based preservative in vaccines and other medicines, denying a petition that sought the limits because of health concerns.
"We're not accepting that answer," said Dr. Mark Geier, one of the petitioners.
Gee, what a surprise.
And speaking of not pleasing the paranoid, here's a headline that will make Steve Nissen, Curt Furberg and Ariana Huffington (who would ever think to see them in the same sentence?) miserable:
From Medical News Today
Popular ADHD Drug Safe And Effective For Pre-schoolers But Monitor Youngsters Closely For Side Effects, Researchers Caution
No heart problems guys. However, the study shows that in some kids side effects can include weight loss limits on height. It did not compare the impact of Ritalin with Strattera which is not a stimulant and does not have the same effect on appetite... Read More & Comment...
From Sciencenewsdaily.com
Elderly Men With Low Testosterone Levels More Likely To Fall
Low testosterone levels may be associated with a higher risk of falling in older men, according to a report in the October 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals....
Punchlines are welcome
And then there's this from that cutting edge healthcare system North of the border
Unique Bra Eases Women's Recovery From Heart Surgery
A national clinical trial led by a University of Calgary researcher has found that wearing a specialized compression bra significantly reduces women's breast pain following heart surgery.
So let's get this straight. HealthCanada will pay for this but not Plavix or Herceptin...
The autism aliens will not be convinced that mercury (the element, not the planet) does not cause that disease not matter how much scientific evidence is amassed and no matter how many death threats they send to scientists and public health officials...
Government rejects vaccine petition
By ANDREW BRIDGES, Associated Press Writer
A group called the Coalition for Mercury-free Drugs petitioned the Food and Drug Administration in 2004 seeking the restrictions on thimerosal, citing concerns that the preservative is linked to autism. In a reply dated Sept. 26 but made public only Tuesday, the FDA rejected the petition.
Federal health officials won't put new restrictions on the use of a mercury-based preservative in vaccines and other medicines, denying a petition that sought the limits because of health concerns.
"We're not accepting that answer," said Dr. Mark Geier, one of the petitioners.
Gee, what a surprise.
And speaking of not pleasing the paranoid, here's a headline that will make Steve Nissen, Curt Furberg and Ariana Huffington (who would ever think to see them in the same sentence?) miserable:
From Medical News Today
Popular ADHD Drug Safe And Effective For Pre-schoolers But Monitor Youngsters Closely For Side Effects, Researchers Caution
No heart problems guys. However, the study shows that in some kids side effects can include weight loss limits on height. It did not compare the impact of Ritalin with Strattera which is not a stimulant and does not have the same effect on appetite... Read More & Comment...
10/27/2006 07:40 AM |
In case your copy of the People's Daily didn't arrive this morning, some important news ...
Chinese get genetic tests to determine disease risk
More than 300 Chinese have undergone genetic testing to determine their odds of developing cancers and other diseases. According to China's first and only genetic testing clinic at the No.1 hospital affiliated with Zhejiang University School of Medicine, more than 300 Chinese have had their DNA sampled at the center since it opened last October. "We look at a patient's medical history and family history, take their blood to analyze their DNA to look for genes that would possibly cause diseases," said Qi Ming, director of the center and professor at the university. Such tests help identify people more likely to get a disease and allow patients to take action to reduce their risk, he said. More than 1,000 genes have been found to relate to diseases. Breast cancer, colon cancer, abnormal heart rate, amyotrophic lateral sclerosis and other diseases can be detected by the DNA tests, Qi said. The tests cost between 75 U.S. dollars and several hundred dollars, he said.
This needs to become standard practice in the US if we are to successfully scale the Great Wall of EBM (evidence-based medicine). Read More & Comment...
Chinese get genetic tests to determine disease risk
More than 300 Chinese have undergone genetic testing to determine their odds of developing cancers and other diseases. According to China's first and only genetic testing clinic at the No.1 hospital affiliated with Zhejiang University School of Medicine, more than 300 Chinese have had their DNA sampled at the center since it opened last October. "We look at a patient's medical history and family history, take their blood to analyze their DNA to look for genes that would possibly cause diseases," said Qi Ming, director of the center and professor at the university. Such tests help identify people more likely to get a disease and allow patients to take action to reduce their risk, he said. More than 1,000 genes have been found to relate to diseases. Breast cancer, colon cancer, abnormal heart rate, amyotrophic lateral sclerosis and other diseases can be detected by the DNA tests, Qi said. The tests cost between 75 U.S. dollars and several hundred dollars, he said.
This needs to become standard practice in the US if we are to successfully scale the Great Wall of EBM (evidence-based medicine). Read More & Comment...
10/27/2006 07:24 AM |
On the heels of a report that a state legislator in NY wants to make it illegal to drive while under the influence of Ambien, this piece of chilling news....
There is a massive increase in the number of people who have cars in developing countries where road traffic accidents are the fourth leading cause of death in adults aged 15-59.
Can't you see the connection? It's the Ambien, stupid. Where is Senator Grassley when we need him? Read More & Comment...
There is a massive increase in the number of people who have cars in developing countries where road traffic accidents are the fourth leading cause of death in adults aged 15-59.
Can't you see the connection? It's the Ambien, stupid. Where is Senator Grassley when we need him? Read More & Comment...
10/27/2006 06:36 AM |
In the November issue of Commentary I make the point that Big Pharma needs to be seen as focusing more on promoting the public health than they do on promoting products.
Pfizer has just taken a significant step in that direction.
The world's biggest pharmaceutucal company has announced a collaboration that gives access to its library of medicinal compounds – the world’s largest – and also brings scientists from developing countries into Pfizer’s laboratories for training in drug discovery techniques.
The collaboration with The Special Program for Research and Training in Tropical Diseases of the WHO (WHO/TDR) is part of a new effort to link the research resources of a major pharmaceutical company to a global network of discovery research, and speed the search for new drugs to combat some of the world’s most deadly parasitic diseases, including malaria, leishmaniasis, African trypanosomiasis, onchocerciasis, schistosomiasis and Chagas' disease.
Under the arrangement, scientists in institutes affiliated with the WHO/TDR-sponsored Compound Evaluation Network are testing thousands of compounds from the Pfizer library. In a process called “screeningâ€, the researchers are seeking to identify “hits†– compounds that show initial activity against a range of tropical parasites.
Well done! Read More & Comment...
Pfizer has just taken a significant step in that direction.
The world's biggest pharmaceutucal company has announced a collaboration that gives access to its library of medicinal compounds – the world’s largest – and also brings scientists from developing countries into Pfizer’s laboratories for training in drug discovery techniques.
The collaboration with The Special Program for Research and Training in Tropical Diseases of the WHO (WHO/TDR) is part of a new effort to link the research resources of a major pharmaceutical company to a global network of discovery research, and speed the search for new drugs to combat some of the world’s most deadly parasitic diseases, including malaria, leishmaniasis, African trypanosomiasis, onchocerciasis, schistosomiasis and Chagas' disease.
Under the arrangement, scientists in institutes affiliated with the WHO/TDR-sponsored Compound Evaluation Network are testing thousands of compounds from the Pfizer library. In a process called “screeningâ€, the researchers are seeking to identify “hits†– compounds that show initial activity against a range of tropical parasites.
Well done! Read More & Comment...
10/26/2006 11:37 AM |
The WSJ reported a day ago that if the Dems take over control of Congress they plan to investigate Republicans who went to work or lobby for drug interests. No limit on how far back they will go. I guess that means William Seward (Lincoln) and Harvey WIley (first FDA commissioner under TR) are fair game.
I think I have a good idea just who ever made this threat had in mind. Let's be clear: this is either settling personal scores or a way to shakedown the GOP leaning lobbying firms in DC to create jobs for Democrat types. As in, we will call off the dogs if you hire our friends. The Republicans did the same thing when Delay pressured lobbying firms to hire more GOPers. The D's are adding a new thuggist wrinkle to the game by using the congressional supeona power as a job search engine for their pals. Read More & Comment...
I think I have a good idea just who ever made this threat had in mind. Let's be clear: this is either settling personal scores or a way to shakedown the GOP leaning lobbying firms in DC to create jobs for Democrat types. As in, we will call off the dogs if you hire our friends. The Republicans did the same thing when Delay pressured lobbying firms to hire more GOPers. The D's are adding a new thuggist wrinkle to the game by using the congressional supeona power as a job search engine for their pals. Read More & Comment...
10/24/2006 06:59 AM |
According to Mikhail Zurabov, the Russian Health and Social Protection Minister, the number of counterfeit drugs has "significantly" decreased, and now amounts to 3-4% of the Russian drug market. Mr. Zurabov relayed this information at a meeting with Russian President Vladimir Putin at the Kremlin earlier this week.
Most international organizations put the rate of counterfeits in the Russian health care system at 12%. Reducing this exposure to 3-4% is an exaggeration of truly Soviet agitprop proportions.
How did the Comrade Minister accomplish such a feat? Why he changed the law! (And we all know how much the Russian Mafia believes in the rule of law.)
Mr. Zurbov commented, "The penalties for such drugs has been defined and the decision was made to revoke the license of a company producing counterfeit drugs.â€
That’s right, they reduced counterfeit medicines almost entirely by threatening to “revoke†the license of counterfeiters.
Surprisingly, the Minister neglected to mention the number of "licenses revoked," people arrested, or counterfeit medicines seized (and to reduce the Russion national volume from 12% to 3% there must have been quite a lot.) Maybe he's just really modest.
In any event, now that Russian drugs are so safe, maybe we should introduce legislation to allow importation into the US market. Read More & Comment...
Most international organizations put the rate of counterfeits in the Russian health care system at 12%. Reducing this exposure to 3-4% is an exaggeration of truly Soviet agitprop proportions.
How did the Comrade Minister accomplish such a feat? Why he changed the law! (And we all know how much the Russian Mafia believes in the rule of law.)
Mr. Zurbov commented, "The penalties for such drugs has been defined and the decision was made to revoke the license of a company producing counterfeit drugs.â€
That’s right, they reduced counterfeit medicines almost entirely by threatening to “revoke†the license of counterfeiters.
Surprisingly, the Minister neglected to mention the number of "licenses revoked," people arrested, or counterfeit medicines seized (and to reduce the Russion national volume from 12% to 3% there must have been quite a lot.) Maybe he's just really modest.
In any event, now that Russian drugs are so safe, maybe we should introduce legislation to allow importation into the US market. Read More & Comment...
10/23/2006 10:41 PM |
I had the opportunity to be briefed by the chair and staff of the IOM committee responsible for the drug safety report that came out recently. I was pretty rough on the study when it first came out and was hoping that a second pass might lead me to a sunnier set of conclusions.
But the thrust of the IOM report -- increasing the amount of time and money the FDA spends on claims data from HMOs to search for safety signals in order to generate post market studies to seek out rare safety problems -- is simply asking for troubling instead of eliminating it in the first place. And worse, it smacks of self dealing: after all once the IOM group decided to have nothing to do with anyone who had expertise in the science of drug development it was left with people that had ties to HMOs and the CERTs who just happen to rely on the purchase of claims data and contracts for data dredging to form the "expert" panel.
And the idea of increasing the number of safety reviews and adding people from the Office of Drug Safety to "restore the balance" between efficacy and safety as IOM safety chair Sheila Burke stated is overkill. What is preclinical, Phase I and Phase II dosing studies but safety related research? Or am I missing something? Maybe Ms. Burke could point to some evidence apart from the so -called culture gap she kept on referring to in her meeting and in the report since it was not to be found.
Finally, the IOM folks claimed that they did not believe that their recommendations would slow down drug approvals in any way and that they were not responsible for the actions of members of Congress who used the IOM report to support their pet regulations....Fat chance. It is already happening.
Following on the heels of Senator Grassley and Congressman Waxman beating up on the FDA for using non-inferiority trials to approve antibiotics we now see the FDA rejecting two new antibiotics just after asking sponsors to provide data that they were as effective as existing drugs. Now the FDA is asking Replidyne for example to conduct four additional trials to demonstrate faropenem's superiority - compared to a placebo or existing drug right after the company had completed 11 late-stage clinical trials and a safety database of more than 5,000 patients. The additional research will take at least two years and require millions more.
The company said it was disappointed. What it was cannot be published on a family blog. And unfortunately it is a harbinger of what will happen when the folks from the Office of Drug Safety empowered and encouraged by Grassley et al make their way on to the committees reviewing drugs will be doing. Drug development, even in those areas where medicines are badly needed, will become more expensive and more time consuming. And why in the world would a company take the Critical Path seriously after a stunt like this? Read More & Comment...
But the thrust of the IOM report -- increasing the amount of time and money the FDA spends on claims data from HMOs to search for safety signals in order to generate post market studies to seek out rare safety problems -- is simply asking for troubling instead of eliminating it in the first place. And worse, it smacks of self dealing: after all once the IOM group decided to have nothing to do with anyone who had expertise in the science of drug development it was left with people that had ties to HMOs and the CERTs who just happen to rely on the purchase of claims data and contracts for data dredging to form the "expert" panel.
And the idea of increasing the number of safety reviews and adding people from the Office of Drug Safety to "restore the balance" between efficacy and safety as IOM safety chair Sheila Burke stated is overkill. What is preclinical, Phase I and Phase II dosing studies but safety related research? Or am I missing something? Maybe Ms. Burke could point to some evidence apart from the so -called culture gap she kept on referring to in her meeting and in the report since it was not to be found.
Finally, the IOM folks claimed that they did not believe that their recommendations would slow down drug approvals in any way and that they were not responsible for the actions of members of Congress who used the IOM report to support their pet regulations....Fat chance. It is already happening.
Following on the heels of Senator Grassley and Congressman Waxman beating up on the FDA for using non-inferiority trials to approve antibiotics we now see the FDA rejecting two new antibiotics just after asking sponsors to provide data that they were as effective as existing drugs. Now the FDA is asking Replidyne for example to conduct four additional trials to demonstrate faropenem's superiority - compared to a placebo or existing drug right after the company had completed 11 late-stage clinical trials and a safety database of more than 5,000 patients. The additional research will take at least two years and require millions more.
The company said it was disappointed. What it was cannot be published on a family blog. And unfortunately it is a harbinger of what will happen when the folks from the Office of Drug Safety empowered and encouraged by Grassley et al make their way on to the committees reviewing drugs will be doing. Drug development, even in those areas where medicines are badly needed, will become more expensive and more time consuming. And why in the world would a company take the Critical Path seriously after a stunt like this? Read More & Comment...
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