Latest Drugwonks' Blog
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.
Lest anyone thinks that the brilliant suggestion that the government use its bulk purchasing power to drive down drug prices using the VA system is something new or will work like a charm...step into drugwonks Wayback machine and journey back to the year 2000, the last time the Yankees were World Champions and Al Gore did not tip the scales at 300 pounds......
This from US Medicine Information Central...
" While it may take two to tango, the SAMBA issue hanging over the Department of Veterans Affairs and pharmaceutical manufacturers is drawing a full dance card.
SAMBA in this case stands for the Special Agents Mutual Benefit Association, a participant in the Federal Employees Health Benefits Program (FEHBP). It covers about 16,000 employees and retirees of the Federal Bureau of Investigation and other federal law enforcement agencies and their dependents.
Under a two-year pilot project now in effect, SAMBA will have access to the Federal Supply Schedule (FSS) and its discounted drug prices as a means of holding down the size of premium increases. Office of Personnel Management (OPM) officials, who approved the pilot after SAMBA requested access to the FSS, say the "experiment" will provide valuable experience in establishing a schedule similar to the FSS for the entire FEHBP.
FSS discounted pricing generally is available only to the "big four" federal agencies that provide health care directly�VA, the Defense Department, the Public Health Service and the Coast Guard. Drug manufacturers are concerned that the SAMBA pilot could lead to a drop in revenues by making discounted pricing available to the entire FEHBP, which covers about 9 million "beneficiary lives"�and perhaps even extending it to other big-ticket programs such as medicare and medicaid."
A no-brainer right? In more ways than one...
Seems as though the VA had a problem or two with the project...
"Veterans advocates caution that the pilot ultimately could cut into the funds available to care for veterans by prompting manufacturers to raise the discounted prices they give to VA to make up for the funds lost because of the pilot or the creation of a new FEHBP pricing schedule. The issue is a complex one involving subparts of federal regulations and bureaucratic purchasing arrangements between drug firms, pharmacy benefit managers and the VA. A meeting held for manufacturers last month at OPM drew a full house but few questions, especially after an attorney from the Pharmaceutical Research and Manufacturers of America (PhRMA) cautioned that individual company reactions to the pilot program could not be discussed without violating antitrust regulations."
And companies simply walked away...
Washington Matters - November 2000
from Drug Benefit Trends
Big Drug Makers Scuttle New Drug Coverage
The federal government has backed off from a test of a new way to pay for the medications used by its employees. The reason for scuttling the pilot project is that both Pfizer and Merck refused to go along. The idea was that the 16,000 active and retired federal law enforcement employees who receive health care coverage through the health plan of the Special Agents Mutual Benefits Association (SAMBA) would be able to buy medications by mail and have them supplied through the Federal Supply Schedule (FSS). The FSS lists the price the government will pay for 17,000 drugs -- generally, about half the wholesale price of the product or around what the drug makers charge to their best private sector customers. The federal Office of Personnel Management (OPM) decided it could not go forward with the plan with the 2 major suppliers, who refused to fill orders from SAMBA enrollees at FSS prices."
Imagine what would happen if Medicare tried to extend VA prices to 50 million seniors.
Walk away? More like a stampede.
This from US Medicine Information Central...
" While it may take two to tango, the SAMBA issue hanging over the Department of Veterans Affairs and pharmaceutical manufacturers is drawing a full dance card.
SAMBA in this case stands for the Special Agents Mutual Benefit Association, a participant in the Federal Employees Health Benefits Program (FEHBP). It covers about 16,000 employees and retirees of the Federal Bureau of Investigation and other federal law enforcement agencies and their dependents.
Under a two-year pilot project now in effect, SAMBA will have access to the Federal Supply Schedule (FSS) and its discounted drug prices as a means of holding down the size of premium increases. Office of Personnel Management (OPM) officials, who approved the pilot after SAMBA requested access to the FSS, say the "experiment" will provide valuable experience in establishing a schedule similar to the FSS for the entire FEHBP.
FSS discounted pricing generally is available only to the "big four" federal agencies that provide health care directly�VA, the Defense Department, the Public Health Service and the Coast Guard. Drug manufacturers are concerned that the SAMBA pilot could lead to a drop in revenues by making discounted pricing available to the entire FEHBP, which covers about 9 million "beneficiary lives"�and perhaps even extending it to other big-ticket programs such as medicare and medicaid."
A no-brainer right? In more ways than one...
Seems as though the VA had a problem or two with the project...
"Veterans advocates caution that the pilot ultimately could cut into the funds available to care for veterans by prompting manufacturers to raise the discounted prices they give to VA to make up for the funds lost because of the pilot or the creation of a new FEHBP pricing schedule. The issue is a complex one involving subparts of federal regulations and bureaucratic purchasing arrangements between drug firms, pharmacy benefit managers and the VA. A meeting held for manufacturers last month at OPM drew a full house but few questions, especially after an attorney from the Pharmaceutical Research and Manufacturers of America (PhRMA) cautioned that individual company reactions to the pilot program could not be discussed without violating antitrust regulations."
And companies simply walked away...
Washington Matters - November 2000
from Drug Benefit Trends
Big Drug Makers Scuttle New Drug Coverage
The federal government has backed off from a test of a new way to pay for the medications used by its employees. The reason for scuttling the pilot project is that both Pfizer and Merck refused to go along. The idea was that the 16,000 active and retired federal law enforcement employees who receive health care coverage through the health plan of the Special Agents Mutual Benefits Association (SAMBA) would be able to buy medications by mail and have them supplied through the Federal Supply Schedule (FSS). The FSS lists the price the government will pay for 17,000 drugs -- generally, about half the wholesale price of the product or around what the drug makers charge to their best private sector customers. The federal Office of Personnel Management (OPM) decided it could not go forward with the plan with the 2 major suppliers, who refused to fill orders from SAMBA enrollees at FSS prices."
Imagine what would happen if Medicare tried to extend VA prices to 50 million seniors.
Walk away? More like a stampede.
The always astute (and sometimes ascerbic) Steve Usdin of BioCentury has written an important and stimulating article on the road to PDUFA reauthorization.
Must reading.
Here's the link:
Download file
And many thanks to BioCentury for their permission to post this article in its entirety.
Must reading.
Here's the link:
Download file
And many thanks to BioCentury for their permission to post this article in its entirety.
I've been getting a bunch of calls in the wake of the announcement that Alex Azar will resign as Deputy Secretary of HHS. People want to know what will it mean for this, what will it mean for that. But here's what's important: Alex brought the power of both compassion and intellect to HHS. His departure doesn't mean we'll see any particular shift for any given industry or issue, but it does mean that HHS will lose a certain dimension of thought leadership and sophistication.
Good Luck Alex.
Good Luck Alex.
Here's the story according to AP
"Cancer deaths in the United States have dropped for a second straight year, confirming that a corner has been turned in the war on cancer.
After a decline of 369 deaths from 2002 to 2003, the decrease from 2003 to 2004 was 3,014 — or more than eight times greater, according to a review of U.S. death certificates by the American Cancer Society.
The drop from 2002 to 2003 was the first annual decrease in total cancer deaths since 1930. But the decline was slight, and experts were hesitant to say whether it was a cause for celebration or just a statistical fluke.
The trend seems to be real, Cancer Society officials said.
"It's not only continuing. The decrease in the second year is much larger," said Ahmedin Jemal, a researcher at the organization.
Cancer deaths dropped to 553,888 in 2004, down from 556,902 in 2003 and 557,271 in 2002, the Cancer Society found.
Experts are attributing the success to declines in smoking and to earlier detection and more effective treatment of tumors. Those have caused a fall in the death rates for breast, prostate and colorectal cancer — three of the most common cancers."
In the wake of this good news, the Dems are seeking to price control unique drugs -- breakthrough medicines in otherwords.
Which means medicines like those that helped reduce dying due to cancer.
Which means medicines from biotech firms that create these miracles.
The Clintons tried proposing a breakthrough drug pricing trigger in 1994 that would hammer and yammer about the price of first in class meds and whether they were all so cost effective or not. It caused biotech stocks to tank and venture capital to vanish.
I hope the D's listen to the Ron Pollacks of the world again and go ahead and do just that. As the Penn and Schoen poll shows, when people find out that price controls also mean an end to miracle cures, they hate price controls. But the D's are driven by their Beltway advisers and power brokers more than they are what people and patients truly want.
"Cancer deaths in the United States have dropped for a second straight year, confirming that a corner has been turned in the war on cancer.
After a decline of 369 deaths from 2002 to 2003, the decrease from 2003 to 2004 was 3,014 — or more than eight times greater, according to a review of U.S. death certificates by the American Cancer Society.
The drop from 2002 to 2003 was the first annual decrease in total cancer deaths since 1930. But the decline was slight, and experts were hesitant to say whether it was a cause for celebration or just a statistical fluke.
The trend seems to be real, Cancer Society officials said.
"It's not only continuing. The decrease in the second year is much larger," said Ahmedin Jemal, a researcher at the organization.
Cancer deaths dropped to 553,888 in 2004, down from 556,902 in 2003 and 557,271 in 2002, the Cancer Society found.
Experts are attributing the success to declines in smoking and to earlier detection and more effective treatment of tumors. Those have caused a fall in the death rates for breast, prostate and colorectal cancer — three of the most common cancers."
In the wake of this good news, the Dems are seeking to price control unique drugs -- breakthrough medicines in otherwords.
Which means medicines like those that helped reduce dying due to cancer.
Which means medicines from biotech firms that create these miracles.
The Clintons tried proposing a breakthrough drug pricing trigger in 1994 that would hammer and yammer about the price of first in class meds and whether they were all so cost effective or not. It caused biotech stocks to tank and venture capital to vanish.
I hope the D's listen to the Ron Pollacks of the world again and go ahead and do just that. As the Penn and Schoen poll shows, when people find out that price controls also mean an end to miracle cures, they hate price controls. But the D's are driven by their Beltway advisers and power brokers more than they are what people and patients truly want.
A federal court judge has imposed a temporary injunction against the FDA over the agency's drug pedigree requirements, on the basis that the regulations leave sections of the supply chain unguarded and threaten the survival of smaller drug distributors.
Here’s a link to the complete story:
The Prescription Drug Marketing Act (PDMA), originally put into force in 1988, outlines the requirement for a drug pedigree – a statement of origin that identifies each prior sale, purchase or trade of a drug right back to the manufacturer. However, Authorized Distributors (ADs) are exempt from having to provide pedigrees for the drugs they provide, thus leaving sections of the supply chain unmonitored and pedigrees hard to establish further down the line. Authorized distributors are somewhat hazily defined as those who have ongoing relationships with manufacturers, identifiable by evidence of repeated transactions with the manufacturer. Over 90 per cent of the drug wholesale industry in the US is controlled by a handful of companies who are authorized distributors. This group is commonly referred to as the Big Five, made up of McKesson, Bergen Brunswig, AmeriSource, Cardinal Health and Bindley Western.
The exemption means that ADs tend not to maintain or pass on pedigrees for the products they obtain from manufacturers. This becomes problematic when those further down the supply chain, ‘unauthorized’ distributors for example, are required to provide pedigrees right back to the manufacturer. It also means that over 90 per cent of the prescription drugs in the US are essentially uncovered by the PDMA’s security measures.
This issue is further exacerbated by the fact that ADs are not required to provide a pedigree even if they themselves obtained the products from a secondary wholesaler. The FDA themselves noted that some drugs may go through several transaction cycles involving multiple primary and secondary wholesalers before arriving at their retail destination. According to the National Wholesale Druggists’ Association, the Big Five purchase 2-4 per cent of their products from sources other than manufacturers, and one of the group reported that $350 million of their total inventory came from non-manufacturer vendors.
Here’s a link to the complete story:
The Prescription Drug Marketing Act (PDMA), originally put into force in 1988, outlines the requirement for a drug pedigree – a statement of origin that identifies each prior sale, purchase or trade of a drug right back to the manufacturer. However, Authorized Distributors (ADs) are exempt from having to provide pedigrees for the drugs they provide, thus leaving sections of the supply chain unmonitored and pedigrees hard to establish further down the line. Authorized distributors are somewhat hazily defined as those who have ongoing relationships with manufacturers, identifiable by evidence of repeated transactions with the manufacturer. Over 90 per cent of the drug wholesale industry in the US is controlled by a handful of companies who are authorized distributors. This group is commonly referred to as the Big Five, made up of McKesson, Bergen Brunswig, AmeriSource, Cardinal Health and Bindley Western.
The exemption means that ADs tend not to maintain or pass on pedigrees for the products they obtain from manufacturers. This becomes problematic when those further down the supply chain, ‘unauthorized’ distributors for example, are required to provide pedigrees right back to the manufacturer. It also means that over 90 per cent of the prescription drugs in the US are essentially uncovered by the PDMA’s security measures.
This issue is further exacerbated by the fact that ADs are not required to provide a pedigree even if they themselves obtained the products from a secondary wholesaler. The FDA themselves noted that some drugs may go through several transaction cycles involving multiple primary and secondary wholesalers before arriving at their retail destination. According to the National Wholesale Druggists’ Association, the Big Five purchase 2-4 per cent of their products from sources other than manufacturers, and one of the group reported that $350 million of their total inventory came from non-manufacturer vendors.
House-passed drug price bill has very little clout
By David Nicklaus
ST. LOUIS POST-DISPATCH
In any negotiation, the power lies with the person who's willing to walk away. That simple truth is obvious to anyone who's ever bought a car or a house, but somehow it escapes a majority of members of the House of Representatives.
When the House passed the Medicare Prescription Drug Price Negotiation Act last week, it ordered the government to lean on the big, bad pharmaceutical companies to get lower prices. But it also prohibited Medicare from establishing a formulary that would pay for some drugs and not others.
In other words, Medicare would have to ask drug companies to cut their prices, but it would have no leverage. It would have to cover all drugs, regardless of price. This is a change from current law, which bars the government from negotiating prices, but it's a change without substance.
You don't have to take my word for it. You can read a letter that the Congressional Budget Office sent to Rep. John Dingell, D-Mich. It says that the Price Negotiation Act "would have a negligible effect" and predicts that the government "would be unable to negotiate prices … more favorable than those obtained by prescription drug plans under current law."
Why would Congress ask Medicare to dicker with drug companies while banning the one tool that would really give Medicare some clout? The politicians apparently want to curry favor with elderly voters and with lobbying groups like AARP.
Senior citizens may worry about high prescription costs, but they certainly don't want any bureaucrat telling them which medications they can or cannot take.
A truly low-cost drug plan would have to look something like the one available to military veterans. The Department of Veterans Affairs formulary covers only 1,300 drugs, compared with 4,300 available in the typical Medicare Part D plan, says Peter Pitts, director of the Center for Medicine in the Public Interest. Thirty percent of veterans, he says, would like to switch to Part D, but they're not eligible because they already have VA coverage.
Part D plans are offered by private insurance companies, which have the option of using restrictive formularies. Most of them keep their coverage broad in order to attract customers, but just having the right to drop a drug — like threatening to walk away even though you really like the car — gives the insurers clout.
The Congressional Budget Office says insurance companies have "both the incentives and the tools to negotiate drug prices that the government, under the legislation, would not have."
If Congress really wants to reduce health care costs, it's looking in the wrong place. Prescription drugs account for just 11 cents of each health care dollar, compared with 32 cents spent at hospitals. By giving senior citizens easier access to the drugs that help manage chronic conditions, one could argue that Medicare Part D has kept many people out of hospitals.
Pitts, a former associate commissioner of the Food and Drug Administration, says Part D has surprised critics by becoming enormously popular with the over-65 crowd.
"The premiums are coming in below expectations, the cost to government is below expectations and the coverage is very good. That sounds to me like a program that is working," he said.
Congress, unfortunately, has never shied away from fixing things that are not broken.
By David Nicklaus
ST. LOUIS POST-DISPATCH
In any negotiation, the power lies with the person who's willing to walk away. That simple truth is obvious to anyone who's ever bought a car or a house, but somehow it escapes a majority of members of the House of Representatives.
When the House passed the Medicare Prescription Drug Price Negotiation Act last week, it ordered the government to lean on the big, bad pharmaceutical companies to get lower prices. But it also prohibited Medicare from establishing a formulary that would pay for some drugs and not others.
In other words, Medicare would have to ask drug companies to cut their prices, but it would have no leverage. It would have to cover all drugs, regardless of price. This is a change from current law, which bars the government from negotiating prices, but it's a change without substance.
You don't have to take my word for it. You can read a letter that the Congressional Budget Office sent to Rep. John Dingell, D-Mich. It says that the Price Negotiation Act "would have a negligible effect" and predicts that the government "would be unable to negotiate prices … more favorable than those obtained by prescription drug plans under current law."
Why would Congress ask Medicare to dicker with drug companies while banning the one tool that would really give Medicare some clout? The politicians apparently want to curry favor with elderly voters and with lobbying groups like AARP.
Senior citizens may worry about high prescription costs, but they certainly don't want any bureaucrat telling them which medications they can or cannot take.
A truly low-cost drug plan would have to look something like the one available to military veterans. The Department of Veterans Affairs formulary covers only 1,300 drugs, compared with 4,300 available in the typical Medicare Part D plan, says Peter Pitts, director of the Center for Medicine in the Public Interest. Thirty percent of veterans, he says, would like to switch to Part D, but they're not eligible because they already have VA coverage.
Part D plans are offered by private insurance companies, which have the option of using restrictive formularies. Most of them keep their coverage broad in order to attract customers, but just having the right to drop a drug — like threatening to walk away even though you really like the car — gives the insurers clout.
The Congressional Budget Office says insurance companies have "both the incentives and the tools to negotiate drug prices that the government, under the legislation, would not have."
If Congress really wants to reduce health care costs, it's looking in the wrong place. Prescription drugs account for just 11 cents of each health care dollar, compared with 32 cents spent at hospitals. By giving senior citizens easier access to the drugs that help manage chronic conditions, one could argue that Medicare Part D has kept many people out of hospitals.
Pitts, a former associate commissioner of the Food and Drug Administration, says Part D has surprised critics by becoming enormously popular with the over-65 crowd.
"The premiums are coming in below expectations, the cost to government is below expectations and the coverage is very good. That sounds to me like a program that is working," he said.
Congress, unfortunately, has never shied away from fixing things that are not broken.
Remember when we suggested that polls showing the American public strongly in favor of "government pricing" for Part D might be, er, influenced by the way the questions were posed("The Big Muscle," drugwonks.com, December 8, 2006)?
Well according to Mark Penn (aka: Hillary's new chief campaign strategist), that's precisely the case.
And the "Her" is Speaker Pelosi.
Penn, Schoen & Berland Associates and The Tarrance Group recently conducted a joint national poll measuring public opinion on the current legislative proposal that would require Congress to negotiate Medicare prescription drugs prices with pharmaceutical companies.
The summary below is really a summary judgement against "government pricing."
When Downsides are Understood, Voters Oppose Government Negotiation
While voters offer initial support for the current proposal that would require Congress to negotiate Medicare prescription drug prices with pharmaceutical companies, once voters are educated about the potential implications of the proposal, the public overwhelmingly opposes it.
* Initially, 76% of voters support government negotiation and 24% oppose it. However, when this question is asked, voters have received no details about the proposal or its possible consequences.
* After being asked about the negative implications of the proposal, opinion flips – only 35% support government negotiation and 65% oppose it. There is majority opposition across Democrats, Republicans and Independents.
Fear of the Government Limiting Access to Prescription Drugs Shifts Public Opinion
Learning that the proposal could limit access to prescription drugs dramatically erodes support for government negotiation.
* 89% oppose the proposal when they learn it could limit access to new prescription drugs.
* 87% oppose the proposal when they learn it could restrict choice of prescription drugs.
* 86% oppose the proposal when they learn similar proposals in other countries like Great Britain and Australia have restricted access to prescription drugs.
* 77% oppose the proposal when they learn that it give the government the right to create a single list of government-approved prescription drugs.
* 80% of voters judge the proposal as “not worth it†after learning that the Congressional Budget Office has reported that granting the federal government the power to negotiate drug prices will not save enough money to fill gaps in coverage.
Voters Have Clear Reservations about Government Negotiation
Voters were asked a series of questions about their opinions of government negotiation, which collectively suggest deep reservations about the proposal.
* 81% agree that the government is not a good price negotiator
* 78% agree that government negotiation would limit access to prescription drugs
* 75% agree that the market should set prescription drug prices, not the government
* 66% agree that government negotiation gives the federal government too much authority and is a dangerous precedent
Medicare Part D is Currently Well Received
Currently, opinion on the Medicare Part D prescription Drug program is very positive and improving.
* 55% of voters nationally have a favorable opinion of the program
* 61% of voters nationally say enrollees are saving money
* 68% of voters nationally say the program a step in the right direction
Other public surveys have repeatedly reported that satisfaction levels among enrollees are much higher; roughly eight-in-ten enrollees expressing satisfaction with their plans.
In conclusion, any legislation that jeopardizes the success of the Medicare Part D Prescription Drug Program would likely have a negative impact on the general public’s opinion of Congress.
Methodology
Penn, Schoen & Berland Associates and The Tarrance Group conducted 1,098 national interviews between December 19 - 22, 2006.
Interviews were conducted among Americans who voted in the 2006 midterm elections.
The overall margin of sampling error is +/-2.96% and larger among subgroups.
Well according to Mark Penn (aka: Hillary's new chief campaign strategist), that's precisely the case.
And the "Her" is Speaker Pelosi.
Penn, Schoen & Berland Associates and The Tarrance Group recently conducted a joint national poll measuring public opinion on the current legislative proposal that would require Congress to negotiate Medicare prescription drugs prices with pharmaceutical companies.
The summary below is really a summary judgement against "government pricing."
When Downsides are Understood, Voters Oppose Government Negotiation
While voters offer initial support for the current proposal that would require Congress to negotiate Medicare prescription drug prices with pharmaceutical companies, once voters are educated about the potential implications of the proposal, the public overwhelmingly opposes it.
* Initially, 76% of voters support government negotiation and 24% oppose it. However, when this question is asked, voters have received no details about the proposal or its possible consequences.
* After being asked about the negative implications of the proposal, opinion flips – only 35% support government negotiation and 65% oppose it. There is majority opposition across Democrats, Republicans and Independents.
Fear of the Government Limiting Access to Prescription Drugs Shifts Public Opinion
Learning that the proposal could limit access to prescription drugs dramatically erodes support for government negotiation.
* 89% oppose the proposal when they learn it could limit access to new prescription drugs.
* 87% oppose the proposal when they learn it could restrict choice of prescription drugs.
* 86% oppose the proposal when they learn similar proposals in other countries like Great Britain and Australia have restricted access to prescription drugs.
* 77% oppose the proposal when they learn that it give the government the right to create a single list of government-approved prescription drugs.
* 80% of voters judge the proposal as “not worth it†after learning that the Congressional Budget Office has reported that granting the federal government the power to negotiate drug prices will not save enough money to fill gaps in coverage.
Voters Have Clear Reservations about Government Negotiation
Voters were asked a series of questions about their opinions of government negotiation, which collectively suggest deep reservations about the proposal.
* 81% agree that the government is not a good price negotiator
* 78% agree that government negotiation would limit access to prescription drugs
* 75% agree that the market should set prescription drug prices, not the government
* 66% agree that government negotiation gives the federal government too much authority and is a dangerous precedent
Medicare Part D is Currently Well Received
Currently, opinion on the Medicare Part D prescription Drug program is very positive and improving.
* 55% of voters nationally have a favorable opinion of the program
* 61% of voters nationally say enrollees are saving money
* 68% of voters nationally say the program a step in the right direction
Other public surveys have repeatedly reported that satisfaction levels among enrollees are much higher; roughly eight-in-ten enrollees expressing satisfaction with their plans.
In conclusion, any legislation that jeopardizes the success of the Medicare Part D Prescription Drug Program would likely have a negative impact on the general public’s opinion of Congress.
Methodology
Penn, Schoen & Berland Associates and The Tarrance Group conducted 1,098 national interviews between December 19 - 22, 2006.
Interviews were conducted among Americans who voted in the 2006 midterm elections.
The overall margin of sampling error is +/-2.96% and larger among subgroups.
We are often criticized for being too critical of people in the public eye. So I will try and be extra careful in my remarks about Jo Ann Emerson of Missouri. She stood with Democrats to sponsor HR 4 the bill that would have required price controls for prescription drugs in the Medicare program. And she is a co-sponsor of a bill that would require reimportation of drug from foreign countries, a bill that would make it a criminal activity for companies to determine which wholesalers they want to sell to and would turn the FDA into a parcel service for European middlemen. Ms. Emerson has been vocal, indeed eloquent in her support for price controls on drugs and for allowing the importation of drugs that are cheaper from other countries due to government price controls and not because of any ingenious production method or competitive practice of another company.
Ms. Emerson says "The high cost of prescription drugs in the U.S. demands that we improve Americans' market access to safe, affordable supplies of medicines."
One of the medicines Ms. Emerson is so concerned about?
"Prilosec, they use it for gas and that sort of thing..."
Setting aside Ms. Emerson's deep knowledge of phamacotherapy, it appears her concern about the high cost of products and free trade does not extend to steel or wheat or . fertilizer from Mother Russia...
She, supported American steel companies seeking duties up to 40 percent on imported metal products and sought to ban the importation of low priced Canadian wheat. At the same time. she has opposed an International Trade Commission ruling that Russia was dumping fertilizers into America at predatory prices, because the resulting tariffs would hurt farmers.
So she opposes the importation of low priced products when it comes to wheat and steel, supports the importation of fertilizers because it helps farmers.
And she supports signficant increases in agricultural subsidies, most of which go to large corporate farms on grounds of national security....
"Re-authorizing the farm bill is the best thing to do right now," she said. "Because if we want to be dependent on countries in the world who hate us for our nation's food, then we might as well fold up shop."
But being depending on countries who hate us for our medicines is ok? Does she know who works at most of the major ports in Europe and Canada by the way?
If you find no logic or consistency to this voting -- if you smell rank opportunism as opposed to intellect driving these decisions you are not alone. For more evidence, I offer the following quote from Ms. Emerson herself explaining why she is voting with the Democrats, now that they’re in the majority, rather than with her leadership (from the NY Times):
"You're freer to vote your conscience," said Rep. Jo Anne Emerson (R-Mo.), who received an 88 percent voting record from the American Conservative Union in 2005 but has so far sided with Democrats on new budget rules, Medicare prescription-drug negotiations, raising the minimum wage and funding stem cell research. "Or, really, I feel free to represent my constituents exactly as they want me to be."
Translation: My principles. They use it for gas and that sort of thing.
Ms. Emerson says "The high cost of prescription drugs in the U.S. demands that we improve Americans' market access to safe, affordable supplies of medicines."
One of the medicines Ms. Emerson is so concerned about?
"Prilosec, they use it for gas and that sort of thing..."
Setting aside Ms. Emerson's deep knowledge of phamacotherapy, it appears her concern about the high cost of products and free trade does not extend to steel or wheat or . fertilizer from Mother Russia...
She, supported American steel companies seeking duties up to 40 percent on imported metal products and sought to ban the importation of low priced Canadian wheat. At the same time. she has opposed an International Trade Commission ruling that Russia was dumping fertilizers into America at predatory prices, because the resulting tariffs would hurt farmers.
So she opposes the importation of low priced products when it comes to wheat and steel, supports the importation of fertilizers because it helps farmers.
And she supports signficant increases in agricultural subsidies, most of which go to large corporate farms on grounds of national security....
"Re-authorizing the farm bill is the best thing to do right now," she said. "Because if we want to be dependent on countries in the world who hate us for our nation's food, then we might as well fold up shop."
But being depending on countries who hate us for our medicines is ok? Does she know who works at most of the major ports in Europe and Canada by the way?
If you find no logic or consistency to this voting -- if you smell rank opportunism as opposed to intellect driving these decisions you are not alone. For more evidence, I offer the following quote from Ms. Emerson herself explaining why she is voting with the Democrats, now that they’re in the majority, rather than with her leadership (from the NY Times):
"You're freer to vote your conscience," said Rep. Jo Anne Emerson (R-Mo.), who received an 88 percent voting record from the American Conservative Union in 2005 but has so far sided with Democrats on new budget rules, Medicare prescription-drug negotiations, raising the minimum wage and funding stem cell research. "Or, really, I feel free to represent my constituents exactly as they want me to be."
Translation: My principles. They use it for gas and that sort of thing.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
