Latest Drugwonks' Blog
When is a drug risk not a drug risk? When you don't understand it. I refer, of course, to the so-called "Brief Summary" which, as some say, is like the Holy Roman Empire -- neither brief nor a summary.
A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.
The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org
Not rocket science. Social science
A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.
The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org
Not rocket science. Social science
President Bush's State of the Union discussion of tax credits for health insurance should remind us all that the goal of health care shouldn't be, exclusively, to deal with acute medical problems -- but rather to provide patients with both the opportunity and the incentive to pursue care for chronic conditions (such as hypertension). Because, even with all of the advances in hospital care, it's still a much better deal -- both financially and personally -- to address a condition (such as hypertension) before it results in an acute, life-threatening event.
It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).
Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).
And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union.
It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).
Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).
And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union.
I was both an attendee and speaker at the MedAdNews Drug Development Summit.
Two important takeaway points. Make that three. Ok four.
1. Companies are refilling their pipelines with new drugs that will hit new targets for unmet medical needs in areas like Alzheimer's, cancer, schizophrenia, Parkinson's, respiratory infections and stroke.
2. Companies are doing a better job of weeding out medicines that won't work or would "fail" because of toxicity issues earlier than ever. Drug development is becoming more predictive.
3. Many of the Critical Path recommendations are being adopted. Adaptive trial designs, bio-imaging, exploratory INDs are all being used.
4. Companies are interested in doing more collaborative work to identify biomarkers, both efficacy and safety. Creating the framework for doing so is difficult.
The takeaway: this is an industry furiously seeking to change. It probably should be more transparent and collaborative and find a better way to market its medicines but that will happen too.
The question is, why do some many people still believe that drug companies are sitting on cures for diseases so they can make money? I can't tell you how many otherwise intelligent people have actually asked me if this is true.... Another reason that biotech and drug companies need to tell the public what they do.
Two important takeaway points. Make that three. Ok four.
1. Companies are refilling their pipelines with new drugs that will hit new targets for unmet medical needs in areas like Alzheimer's, cancer, schizophrenia, Parkinson's, respiratory infections and stroke.
2. Companies are doing a better job of weeding out medicines that won't work or would "fail" because of toxicity issues earlier than ever. Drug development is becoming more predictive.
3. Many of the Critical Path recommendations are being adopted. Adaptive trial designs, bio-imaging, exploratory INDs are all being used.
4. Companies are interested in doing more collaborative work to identify biomarkers, both efficacy and safety. Creating the framework for doing so is difficult.
The takeaway: this is an industry furiously seeking to change. It probably should be more transparent and collaborative and find a better way to market its medicines but that will happen too.
The question is, why do some many people still believe that drug companies are sitting on cures for diseases so they can make money? I can't tell you how many otherwise intelligent people have actually asked me if this is true.... Another reason that biotech and drug companies need to tell the public what they do.
The left has been complaining for years about how the tax system is unfair to the poor and working class. So when the president comes along with a plan level the playing field where it really counts -- a tax cut that makes health care affordable no matter where you are or whether you are working -- their reaction is predictable: spend money (either directly or in the form of tax credits) to shove people into Medicaid.
Here's Ron Pollack's predictable response to the tax cut:
“Instead of this ill-advised proposal, the President should expand health coverage for the 9 million children who are uninsured when Congress reauthorizes the State Children’s Health Insurance Program (SCHIP) later this year.â€
Right. The same 9 million kids who have not been enrolled since SCHIP started in 1997. Hey Ron, Families USA has been shoveled millions of bucks to do outreach and enrollment over the past decade.
Wonder why people didn't sign up despite your winning personality?
Because SCHIP equals Medicaid. Pollack and other child "advocates" call SCHIP a medical home for uninsured kids but that's like calling public housing as good as a private home. People want to buy into the real thing, something they can own, not some government assistance they have to apply for.
But the Left hates giving people control over health care dollars because that means they lose control over them. I once debated one of the advocates and asked them why they opposed just giving people money to buy health care. Did she think the same people they believe should have the choice about abortion were too stupid to choose which health plan to have the abortion in? She had no answer.
Here's Ron Pollack's predictable response to the tax cut:
“Instead of this ill-advised proposal, the President should expand health coverage for the 9 million children who are uninsured when Congress reauthorizes the State Children’s Health Insurance Program (SCHIP) later this year.â€
Right. The same 9 million kids who have not been enrolled since SCHIP started in 1997. Hey Ron, Families USA has been shoveled millions of bucks to do outreach and enrollment over the past decade.
Wonder why people didn't sign up despite your winning personality?
Because SCHIP equals Medicaid. Pollack and other child "advocates" call SCHIP a medical home for uninsured kids but that's like calling public housing as good as a private home. People want to buy into the real thing, something they can own, not some government assistance they have to apply for.
But the Left hates giving people control over health care dollars because that means they lose control over them. I once debated one of the advocates and asked them why they opposed just giving people money to buy health care. Did she think the same people they believe should have the choice about abortion were too stupid to choose which health plan to have the abortion in? She had no answer.
We are not making this up.
AIDS group sues over Viagra ads
Andrew Bridges
The Associated Press
Tuesday, January 23, 2007
WASHINGTON -- An AIDS organization sued Pfizer Inc. on yesterday over ads the group says encourage use of Viagra as a party drug. The nonprofit group said such recreational use furthers the spread of HIV and other sexually transmitted diseases.
The suit, filed in Los Angeles by the AIDS Healthcare Foundation, calls Pfizer's ads for the impotence drug false and misleading. The suit echoes allegations made in an ad campaign announced by the group last month.
The nonprofit group alleges the marketing of Viagra has fostered an increase in the spread of STDs. Studies have found the drug is used -- illegally -- in conjunction with crystal methamphetamine to form a party drug "cocktail."
Drugwonks believes that the combo of crystal meth and Viagra is an off-label use that Pfizer has never promoted. There is no truth to the rumor that the company sought product placement in episodes of Six Feet Under, Entourage or Queer as Folk....
AIDS group sues over Viagra ads
Andrew Bridges
The Associated Press
Tuesday, January 23, 2007
WASHINGTON -- An AIDS organization sued Pfizer Inc. on yesterday over ads the group says encourage use of Viagra as a party drug. The nonprofit group said such recreational use furthers the spread of HIV and other sexually transmitted diseases.
The suit, filed in Los Angeles by the AIDS Healthcare Foundation, calls Pfizer's ads for the impotence drug false and misleading. The suit echoes allegations made in an ad campaign announced by the group last month.
The nonprofit group alleges the marketing of Viagra has fostered an increase in the spread of STDs. Studies have found the drug is used -- illegally -- in conjunction with crystal methamphetamine to form a party drug "cocktail."
Drugwonks believes that the combo of crystal meth and Viagra is an off-label use that Pfizer has never promoted. There is no truth to the rumor that the company sought product placement in episodes of Six Feet Under, Entourage or Queer as Folk....
Ask the 10,000 people at Pfizer who are losing their jobs.
After hearing from Representative Emerson, perhaps it's time to listen to the other famous American of the same name -- Ralph Waldo Emerson -- who said:
"No one cares how much you know until they know how much you care."
Words to remember as we fight for the future of America's health and health care system.
"No one cares how much you know until they know how much you care."
Words to remember as we fight for the future of America's health and health care system.
Story Landis, director of the NIH's National Institute of Neurological Disorders and Stroke testified before a Senate committee today that need for federal funding for embyronic stem cell research was compelling:
"Science works best when scientists can pursue all avenues of research," Landis said. "If the cure for Parkinson's disease or juvenile diabetes lay behind one of four doors, wouldn't you want the option to open all four doors at once instead of one door?"
That's fine. Everyone's in favor of funding one form of stem cell research or another. But why then support a bill that would kill private sector funding of stem cell research or undermine private sector investment that complements or builds on federal funding. Namely the Wyden-Snowe bill requiring direct government negotiation -- meaning price controls, restricting/delaying access to new medicines -- under the following circumstances --
Under the Snowe-Wyden proposal, that ban would be lifted and the HHS Secretary would be required to negotiate if:
* A drug is a single source drug, which means there is only one brand name of the drug available;
* A drug was created with substantial taxpayer funding for its research and development;
* A private insurance plan requests help; and
* For any fallback plan for which the Secretary must provide.
A cure for Parkinson's would definitely pull a hat trick under this ingenious piece of legislation. Why not just hang out a sign that says: "Companies that successfully invest in stem cell research will be punished for doing so?"
"Science works best when scientists can pursue all avenues of research," Landis said. "If the cure for Parkinson's disease or juvenile diabetes lay behind one of four doors, wouldn't you want the option to open all four doors at once instead of one door?"
That's fine. Everyone's in favor of funding one form of stem cell research or another. But why then support a bill that would kill private sector funding of stem cell research or undermine private sector investment that complements or builds on federal funding. Namely the Wyden-Snowe bill requiring direct government negotiation -- meaning price controls, restricting/delaying access to new medicines -- under the following circumstances --
Under the Snowe-Wyden proposal, that ban would be lifted and the HHS Secretary would be required to negotiate if:
* A drug is a single source drug, which means there is only one brand name of the drug available;
* A drug was created with substantial taxpayer funding for its research and development;
* A private insurance plan requests help; and
* For any fallback plan for which the Secretary must provide.
A cure for Parkinson's would definitely pull a hat trick under this ingenious piece of legislation. Why not just hang out a sign that says: "Companies that successfully invest in stem cell research will be punished for doing so?"
Here's a story right out of the movie "The Barbarian Invasions" and it can be summed up in two words, "Hello Plattsburgh."
For those who think that we should adopt the Canadian health care model this should serve as yet another cold shower of reality or, in the words of Stephen Colbert, a "Truth Mitzvah."
MDs forced abroad for scanner training
Limited access to cancer-detecting machines spurs Ontario university to look elsewhere
LISA PRIEST
Toronto Globe and Mail
January 19, 2007
The use of crucial cancer-detecting PET machines is so restricted in Ontario that one university must send its medical residents to the United States and elsewhere for training. The low number of cancer patients eligible for PET screening means University of Western Ontario residents cannot obtain the experience they require. St. Joseph's Health Care in London scans as few as four patients a week, sometimes none. The rest of the time it experiments on laboratory-bred dogs and pigs.
Of all the provinces that have Positron Emission Tomography scanners, Ontario has the most restrictive access. That's because it is running clinical trials to determine how best to use them on cancer patients.
"It breaks our hearts to have to send them [students] away," said Damien Maharaj, program director of nuclear medicine at Western's Schulich School of Medicine & Dentistry. “We simply have to meet their [Royal College of Physicians and Surgeons of Canada] guidelines. Failure to do so would be noted and the potential to go on probation exists."
The development follows an evaluation conducted by the Royal College of Physicians and Surgeons of Canada, a body that accredits postgraduate medical programs in addition to certifying specialists. The college told the university that the lack of resident training in PET scanning was a weakness that required a remedy.
The university was asked to put in writing its plan for ensuring that nuclear-medicine residents receive the necessary PET training elsewhere, Dr. Maharaj confirmed. He stressed the program remains fully accredited and that London produces some of the best nuclear-medicine specialists in Canada. Ultimately, though, Dr. Maharaj said: "PET is not a research tool, it's a clinical tool. We really should be offering it to people."
Cancer patients can access Ontario's nine PET scanners under five clinical trials or through a patient registry introduced a year ago. The registry is limited to suspected recurrent colorectal, thyroid or germ-cell cancer and patients with certain solitary pulmonary nodules. As of Oct. 31, 408 Ontario patients had obtained PET scans through the registry and 926 patients had scans as part of the clinical trials.
Compare that to Quebec, a province that provides the broadest access to PET scans; this year, it plans to do 21,000 scans. Patients can access PET scans in British Columbia, Alberta, Manitoba and New Brunswick. Nova Scotia also plans to purchase a scanner and expects to have it operating by the fall.
"It's terrible," said Christopher O'Brien, vice-president of the Canadian Association of Nuclear Medicine. "You have one of the major teaching programs that can't meet the Royal College standards because of a government moratorium on access to PET scanning."
Though Dr. Maharaj said the university will try to help defray the costs, ultimately it is a "financial hardship" for the residents who will have to pay rent in two cities, in addition to covering transportation and food costs for three months. Potential training spots include Duke University in North Carolina, Harvard in Boston and centres in Canada, possibly Winnipeg or Sherbrooke, he said.
Training in the United States poses a particular problem: malpractice insurance does not cover the residents so they can act only as observers and cannot interpret the scans. That is why J. C. Warrington, the chief nuclear-medicine resident at the University of Western Ontario, is hoping to relocate to another Canadian city. "We would prefer to not to have to go further than is absolutely required because of our expenses required with travel," said Dr. Warrington, a fourth-year nuclear-medicine resident, one of two who will have to relocate this July.
All other nuclear-medicine residents training at Western will also have to relocate for three months in their final year of training, until the hospital is able to provide more PET scans to patients, Dr. Maharaj said.
A PET scan can find a lung cancer that has spread, preventing a futile operation. Colorectal cancer patients may discover tumours on their liver can be safely removed. A scan can also help determine when chemotherapy is not working, prompting doctors to change a drug cocktail. It costs about $2,500.
Whatever the case, the results need to be carefully interpreted as non-cancerous conditions can resemble cancer; only a biopsy can confirm the presence of cancer.
Dr. Warrington said though relocating may pose an imposition, it is a far greater imposition for cancer patients to travel out of province or country to obtain PET scans. In 2005-2006, 82 Ontarians were sent out of country for PET scans at a cost of $653,255, while 42 others were denied, according to Health Ministry figures provided by John Letherby. However, the process of sending patients to the United States has been winding down since late August.
Figures obtained under a Freedom of Information and Protection of Privacy Act request reveals that Ontario has sent cancer patients to 20 different U.S. hospitals for PET scans for 18 different conditions, many of them cancers or suspected cases of cancer since April 1, 2002.
They include Duke University -- the very institution to which nuclear-medicine residents may be sent for training. As well, patients have been sent to Johns Hopkins in Baltimore; the Mayo Clinic in Rochester, Minn., and Scottsdale, Ariz.; Detroit Medical Centre; and Cleveland Clinic Foundation.
Of those sent to the United States, the patients had lymphoma and cancers of the breast, brain, esophagus, testes and lung.
For those who think that we should adopt the Canadian health care model this should serve as yet another cold shower of reality or, in the words of Stephen Colbert, a "Truth Mitzvah."
MDs forced abroad for scanner training
Limited access to cancer-detecting machines spurs Ontario university to look elsewhere
LISA PRIEST
Toronto Globe and Mail
January 19, 2007
The use of crucial cancer-detecting PET machines is so restricted in Ontario that one university must send its medical residents to the United States and elsewhere for training. The low number of cancer patients eligible for PET screening means University of Western Ontario residents cannot obtain the experience they require. St. Joseph's Health Care in London scans as few as four patients a week, sometimes none. The rest of the time it experiments on laboratory-bred dogs and pigs.
Of all the provinces that have Positron Emission Tomography scanners, Ontario has the most restrictive access. That's because it is running clinical trials to determine how best to use them on cancer patients.
"It breaks our hearts to have to send them [students] away," said Damien Maharaj, program director of nuclear medicine at Western's Schulich School of Medicine & Dentistry. “We simply have to meet their [Royal College of Physicians and Surgeons of Canada] guidelines. Failure to do so would be noted and the potential to go on probation exists."
The development follows an evaluation conducted by the Royal College of Physicians and Surgeons of Canada, a body that accredits postgraduate medical programs in addition to certifying specialists. The college told the university that the lack of resident training in PET scanning was a weakness that required a remedy.
The university was asked to put in writing its plan for ensuring that nuclear-medicine residents receive the necessary PET training elsewhere, Dr. Maharaj confirmed. He stressed the program remains fully accredited and that London produces some of the best nuclear-medicine specialists in Canada. Ultimately, though, Dr. Maharaj said: "PET is not a research tool, it's a clinical tool. We really should be offering it to people."
Cancer patients can access Ontario's nine PET scanners under five clinical trials or through a patient registry introduced a year ago. The registry is limited to suspected recurrent colorectal, thyroid or germ-cell cancer and patients with certain solitary pulmonary nodules. As of Oct. 31, 408 Ontario patients had obtained PET scans through the registry and 926 patients had scans as part of the clinical trials.
Compare that to Quebec, a province that provides the broadest access to PET scans; this year, it plans to do 21,000 scans. Patients can access PET scans in British Columbia, Alberta, Manitoba and New Brunswick. Nova Scotia also plans to purchase a scanner and expects to have it operating by the fall.
"It's terrible," said Christopher O'Brien, vice-president of the Canadian Association of Nuclear Medicine. "You have one of the major teaching programs that can't meet the Royal College standards because of a government moratorium on access to PET scanning."
Though Dr. Maharaj said the university will try to help defray the costs, ultimately it is a "financial hardship" for the residents who will have to pay rent in two cities, in addition to covering transportation and food costs for three months. Potential training spots include Duke University in North Carolina, Harvard in Boston and centres in Canada, possibly Winnipeg or Sherbrooke, he said.
Training in the United States poses a particular problem: malpractice insurance does not cover the residents so they can act only as observers and cannot interpret the scans. That is why J. C. Warrington, the chief nuclear-medicine resident at the University of Western Ontario, is hoping to relocate to another Canadian city. "We would prefer to not to have to go further than is absolutely required because of our expenses required with travel," said Dr. Warrington, a fourth-year nuclear-medicine resident, one of two who will have to relocate this July.
All other nuclear-medicine residents training at Western will also have to relocate for three months in their final year of training, until the hospital is able to provide more PET scans to patients, Dr. Maharaj said.
A PET scan can find a lung cancer that has spread, preventing a futile operation. Colorectal cancer patients may discover tumours on their liver can be safely removed. A scan can also help determine when chemotherapy is not working, prompting doctors to change a drug cocktail. It costs about $2,500.
Whatever the case, the results need to be carefully interpreted as non-cancerous conditions can resemble cancer; only a biopsy can confirm the presence of cancer.
Dr. Warrington said though relocating may pose an imposition, it is a far greater imposition for cancer patients to travel out of province or country to obtain PET scans. In 2005-2006, 82 Ontarians were sent out of country for PET scans at a cost of $653,255, while 42 others were denied, according to Health Ministry figures provided by John Letherby. However, the process of sending patients to the United States has been winding down since late August.
Figures obtained under a Freedom of Information and Protection of Privacy Act request reveals that Ontario has sent cancer patients to 20 different U.S. hospitals for PET scans for 18 different conditions, many of them cancers or suspected cases of cancer since April 1, 2002.
They include Duke University -- the very institution to which nuclear-medicine residents may be sent for training. As well, patients have been sent to Johns Hopkins in Baltimore; the Mayo Clinic in Rochester, Minn., and Scottsdale, Ariz.; Detroit Medical Centre; and Cleveland Clinic Foundation.
Of those sent to the United States, the patients had lymphoma and cancers of the breast, brain, esophagus, testes and lung.
Now that the Democrats control the purse strings, left wing organizations will try to force their ideology on to science-based federal agencies. It will happen with the FDA and it has just happened with NIH where the crazies have decided that because researchers consult for industry they are a notch below or above being criminals. It's not enough that talented NIH scientists are leaving the agency in droves. Now anyone who lectures on subjects they know about can't participate in guideline development. That leaves people who, of course, are loyal to the left wing agenda of groups like the Center for the Science in the Public Interest.
As if THAT group is so pure and perfect. Center for the Science for in the Public Interest makes over 70 percent of its income from subscriptions to its monthly Nutrition Action Healthletter. The letter has passed out inaccurate information over the decades and the parent organization has claimed transfats were good and that salt was directly linked to 150,000 deaths a year. So an organization that makes money peddling health scares and false medical claims believes it is the moral authority when it comes to how the NIH should determine who should be on consensus guideline panels.
Well, not exactly. It reached out to Marcia Angell -- who believes that there is no evidence that people respond differently to the same drugs -- and Jerome Kassirer who perfected the marketing practice of selling drug ads in the same edition of the NEJM that favorable studies of the same drug would run and selling reprints to drug reps...The same Angell and Kassirer who , when they were running NEJM, never asked physicians who made money serving as experts in personal injury trials to disclose their conflicts.
Or to quote Oliver Goldsmith: "You can preach a better sermon with your life than with your lips."
All this puts a chill on freedom of expression and impugns the reputation of decent and dedicated researchers.
NIH Cancels Meeting on Herpes --- Treatment Review Panel Faces Criticism Over Ties To Pharmaceutical Firms - 19 January 2007 The Wall Street Journal - By David Armstrong
The National Institutes of Health abruptly canceled a meeting scheduled for next month to draft guidelines for treating pregnant women and babies with herpes, after concerns were raised about conflicts of interest among a panel of experts tapped to review the issue.
The action came after a group of physicians, medical researchers and consumer and health groups urged the NIH in a letter yesterday to bar experts who are paid by drug makers from helping to draft government guidelines for how doctors treat diseases. Their action was touched off by the NIH's recent naming of five experts to present evidence at a conference next month aimed at drafting guidelines for treating pregnant women with herpes and babies born with the condition.
The five experts, including one who is responsible for coordinating the writing of the guidelines, are doctors employed at academic medical centers. Four of the five experts, including the writing coordinator, have financial ties to makers of herpes drugs, resulting in a panel that "is completely unbalanced," the letter says. The five were the only experts listed as presenters on an NIH draft agenda for the meeting.
In an email, an NIH spokeswoman said the agency "has canceled the meeting out of concern that misperceptions about this meeting could not be resolved prior to the scheduled meeting date." She said no decision has been made on whether the meeting, originally slated for Feb. 20, will be rescheduled.
The action comes amid concern that clinical guidelines that form the basis for how physicians and hospitals treat patients are being unduly influenced by the drug industry. In several recent cases, including one involving kidney treatment with the drug erythropoetin, guidelines composed by experts paid by drug companies have promoted treatment regimens that some other experts contended brought harm to patients while promoting wider use of a drug.
The letter was signed by 44 individuals and 16 organizations. Among the individuals were Richard Horton, editor of the British medical journal Lancet; Marcia Angell and Jerome Kassirer, both former editors of the New England Journal of Medicine; and doctors from medical schools including Harvard and Johns Hopkins. The organizations included the Center for Science and the Public Interest, the National Women's Health Network and the publisher of Consumer Reports.
The group wrote that the NIH agency "must be an honest broker in the development of medical evidence that will inform clinical practice" and that the NIH must ensure that all members of guideline-writing committees are "free from conflicts of interest."
As reported, several doctors who are paid consultants or speakers for GlaxoSmithKline PLC, maker of the best-selling herpes drug Valtrex, have traveled the country to promote testing and treatment of pregnant women with herpes as a way of preventing babies from picking up the infection. Newborn herpes, though rare, can be fatal. That treatment strategy, however, is controversial. Critics say that there isn't any evidence that treating pregnant women with herpes drugs will reduce cases of newborns born with the infection and that exposing as many as a million women a year to herpes medication could result in dangerous side effects for mother and baby.
The letter writers said the scheduled meeting on herpes added to a "sad record" at the NIH of drafting treatment guidelines using panels composed largely of experts receiving money from drug companies. They said that 2004 guidelines for treating cholesterol were drafted by a committee of nine physicians, eight of whom had financial relationships with makers of statins, which are widely given for high cholesterol.
According to a draft agenda of the Feb. 20 meeting, University of Washington obstetrician Zane Brown was to have presented information on testing pregnant women for herpes. Dr. Brown is a frequent speaker for Glaxo on herpes issues. In an interview with The Wall Street Journal for a prior story on the subject, Dr. Brown estimated he gives two to three lectures a week advocating universal testing of pregnant women, earning $1,000 to $2,500 a talk. The doctor who was slated to lead the session on writing the guidelines, Richard Whitley, is a pediatrician at the University of Alabama at Birmingham medical school who is a member of the Glaxo speakers bureau.
Also on the panel was Anna Wald, a University of Washington epidemiologist, who said yesterday she has been a consultant to Novartis AG, which makes a herpes drug, and has done research funded by Glaxo. Dr. Brown didn't respond to an email, and attempts to reach Dr. Whitley through a representative were unsuccessful.
The fourth member identified in the letter as having a conflict was Massachusetts General Hospital obstetrician Laura Riley, who is the secretary and treasurer of the American Herpes Foundation, a nonprofit largely funded by herpes drug makers. Dr. Riley says she has received a few $1,000 stipends for attending meetings of the herpes foundation, but doesn't receive a salary or other pay for her work at the organization.
As if THAT group is so pure and perfect. Center for the Science for in the Public Interest makes over 70 percent of its income from subscriptions to its monthly Nutrition Action Healthletter. The letter has passed out inaccurate information over the decades and the parent organization has claimed transfats were good and that salt was directly linked to 150,000 deaths a year. So an organization that makes money peddling health scares and false medical claims believes it is the moral authority when it comes to how the NIH should determine who should be on consensus guideline panels.
Well, not exactly. It reached out to Marcia Angell -- who believes that there is no evidence that people respond differently to the same drugs -- and Jerome Kassirer who perfected the marketing practice of selling drug ads in the same edition of the NEJM that favorable studies of the same drug would run and selling reprints to drug reps...The same Angell and Kassirer who , when they were running NEJM, never asked physicians who made money serving as experts in personal injury trials to disclose their conflicts.
Or to quote Oliver Goldsmith: "You can preach a better sermon with your life than with your lips."
All this puts a chill on freedom of expression and impugns the reputation of decent and dedicated researchers.
NIH Cancels Meeting on Herpes --- Treatment Review Panel Faces Criticism Over Ties To Pharmaceutical Firms - 19 January 2007 The Wall Street Journal - By David Armstrong
The National Institutes of Health abruptly canceled a meeting scheduled for next month to draft guidelines for treating pregnant women and babies with herpes, after concerns were raised about conflicts of interest among a panel of experts tapped to review the issue.
The action came after a group of physicians, medical researchers and consumer and health groups urged the NIH in a letter yesterday to bar experts who are paid by drug makers from helping to draft government guidelines for how doctors treat diseases. Their action was touched off by the NIH's recent naming of five experts to present evidence at a conference next month aimed at drafting guidelines for treating pregnant women with herpes and babies born with the condition.
The five experts, including one who is responsible for coordinating the writing of the guidelines, are doctors employed at academic medical centers. Four of the five experts, including the writing coordinator, have financial ties to makers of herpes drugs, resulting in a panel that "is completely unbalanced," the letter says. The five were the only experts listed as presenters on an NIH draft agenda for the meeting.
In an email, an NIH spokeswoman said the agency "has canceled the meeting out of concern that misperceptions about this meeting could not be resolved prior to the scheduled meeting date." She said no decision has been made on whether the meeting, originally slated for Feb. 20, will be rescheduled.
The action comes amid concern that clinical guidelines that form the basis for how physicians and hospitals treat patients are being unduly influenced by the drug industry. In several recent cases, including one involving kidney treatment with the drug erythropoetin, guidelines composed by experts paid by drug companies have promoted treatment regimens that some other experts contended brought harm to patients while promoting wider use of a drug.
The letter was signed by 44 individuals and 16 organizations. Among the individuals were Richard Horton, editor of the British medical journal Lancet; Marcia Angell and Jerome Kassirer, both former editors of the New England Journal of Medicine; and doctors from medical schools including Harvard and Johns Hopkins. The organizations included the Center for Science and the Public Interest, the National Women's Health Network and the publisher of Consumer Reports.
The group wrote that the NIH agency "must be an honest broker in the development of medical evidence that will inform clinical practice" and that the NIH must ensure that all members of guideline-writing committees are "free from conflicts of interest."
As reported, several doctors who are paid consultants or speakers for GlaxoSmithKline PLC, maker of the best-selling herpes drug Valtrex, have traveled the country to promote testing and treatment of pregnant women with herpes as a way of preventing babies from picking up the infection. Newborn herpes, though rare, can be fatal. That treatment strategy, however, is controversial. Critics say that there isn't any evidence that treating pregnant women with herpes drugs will reduce cases of newborns born with the infection and that exposing as many as a million women a year to herpes medication could result in dangerous side effects for mother and baby.
The letter writers said the scheduled meeting on herpes added to a "sad record" at the NIH of drafting treatment guidelines using panels composed largely of experts receiving money from drug companies. They said that 2004 guidelines for treating cholesterol were drafted by a committee of nine physicians, eight of whom had financial relationships with makers of statins, which are widely given for high cholesterol.
According to a draft agenda of the Feb. 20 meeting, University of Washington obstetrician Zane Brown was to have presented information on testing pregnant women for herpes. Dr. Brown is a frequent speaker for Glaxo on herpes issues. In an interview with The Wall Street Journal for a prior story on the subject, Dr. Brown estimated he gives two to three lectures a week advocating universal testing of pregnant women, earning $1,000 to $2,500 a talk. The doctor who was slated to lead the session on writing the guidelines, Richard Whitley, is a pediatrician at the University of Alabama at Birmingham medical school who is a member of the Glaxo speakers bureau.
Also on the panel was Anna Wald, a University of Washington epidemiologist, who said yesterday she has been a consultant to Novartis AG, which makes a herpes drug, and has done research funded by Glaxo. Dr. Brown didn't respond to an email, and attempts to reach Dr. Whitley through a representative were unsuccessful.
The fourth member identified in the letter as having a conflict was Massachusetts General Hospital obstetrician Laura Riley, who is the secretary and treasurer of the American Herpes Foundation, a nonprofit largely funded by herpes drug makers. Dr. Riley says she has received a few $1,000 stipends for attending meetings of the herpes foundation, but doesn't receive a salary or other pay for her work at the organization.
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