Latest Drugwonks' Blog
Somehow the idea that the FDA will get a handle on this by forcing track and trace technology on distributors anytime soon is a joke. When will the importation kool-aid drinkers wake up?
Security concerns raised as China fills U.S. medicine chest
By Tim Johnson, McClatchy Newspapers
BEIJING — The medicine cabinet in the average U.S. home is filling with drugs made in China , and some experts say that could be a prescription for trouble.
China's booming pharmaceutical industry has doubled exports to the United States in the past five years, undercutting competitors and making American consumers reliant on the safety of Chinese factories and captive to any disruptions in Sino-U.S. commerce.
It might seem like merely a trade issue. But industry experts in Europe and the United States say national-security concerns are edging into the debate.
Consider this scenario:
If a major anthrax attack were to occur in the United States — larger than the one in 2001, when five people died— pharmaceutical companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once American stockpiles were exhausted. Those ingredients no longer are made in the West.
A Portuguese company that ramped up doxycycline production in 2001 at Washington's request said China now controlled the flow of its crucial drug component.
http://news.yahoo.com/s/mcclatchy/20071206/wl_mcclatchy/2774948
Security concerns raised as China fills U.S. medicine chest
By Tim Johnson, McClatchy Newspapers
BEIJING — The medicine cabinet in the average U.S. home is filling with drugs made in China , and some experts say that could be a prescription for trouble.
China's booming pharmaceutical industry has doubled exports to the United States in the past five years, undercutting competitors and making American consumers reliant on the safety of Chinese factories and captive to any disruptions in Sino-U.S. commerce.
It might seem like merely a trade issue. But industry experts in Europe and the United States say national-security concerns are edging into the debate.
Consider this scenario:
If a major anthrax attack were to occur in the United States — larger than the one in 2001, when five people died— pharmaceutical companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once American stockpiles were exhausted. Those ingredients no longer are made in the West.
A Portuguese company that ramped up doxycycline production in 2001 at Washington's request said China now controlled the flow of its crucial drug component.
http://news.yahoo.com/s/mcclatchy/20071206/wl_mcclatchy/2774948
Rosa DeLauro continues her mission against any one affiliated with companies who in turn want to work with the Reagan Udall foundation. This time it's president of the Bill and Melinda Gates Foundation Global Health Program, Dr. Tadataka (Tachi) Yamada who leads the foundation’s efforts to help develop and deliver low-cost, life-saving health tools for the developing world. He oversees our global health grant portfolio and Global Health Advocacy.
Before joining the foundation, Yamada served as Chairman of Research and Development and was a member of the Board of Directors at GlaxoSmithKline. Prior to that, he was chairman of the Department of Internal Medicine at the University of Michigan Medical School and Physician-in-Chief at the University of Michigan Medical Center. Yamada is a past president of the American Gastroenterological Association and the Association of American Physicians, a master of the American College of Physicians, and a member of the Institute of Medicine of the National Academy of Science in the United States and the Academy of Medical Sciences in the United Kingdom.
DeLauro wants Yamada's appointment investigated because when he was with GSK nearly ten years ago -- which is yesterday in politics, Yamada complained to John Buse, a University of North Carolina doctor (and now head of the American Diabetes Association) after he said at a 1999 medical conference that Avandia could cause heart attacks. Buse told Yamada to knock it off after Yamada made a phone call to Buse's boss, who Yamada calls "an old friend, so I felt comfortable calling him to probe informally about his opinion of Dr. Buse."
Before joining the foundation, Yamada served as Chairman of Research and Development and was a member of the Board of Directors at GlaxoSmithKline. Prior to that, he was chairman of the Department of Internal Medicine at the University of Michigan Medical School and Physician-in-Chief at the University of Michigan Medical Center. Yamada is a past president of the American Gastroenterological Association and the Association of American Physicians, a master of the American College of Physicians, and a member of the Institute of Medicine of the National Academy of Science in the United States and the Academy of Medical Sciences in the United Kingdom.
DeLauro wants Yamada's appointment investigated because when he was with GSK nearly ten years ago -- which is yesterday in politics, Yamada complained to John Buse, a University of North Carolina doctor (and now head of the American Diabetes Association) after he said at a 1999 medical conference that Avandia could cause heart attacks. Buse told Yamada to knock it off after Yamada made a phone call to Buse's boss, who Yamada calls "an old friend, so I felt comfortable calling him to probe informally about his opinion of Dr. Buse."
Steve Usdin has an excellent piece in this week's Biocentury on how Roche addressed concerns that there was a connection between Tamiflu, influenza and psychiatric problems in children...sort of an SSRI redux. It begins:
"Roche navigated through an important inflection point in the drug safety tempest last week, charting a course that other sponsors might use to overcome concerns that arise when drugs are a s s o c i a t e d with very rare, serious adverse effects.
The company deployed observational data to persuade FDA’s Pediatric Advisory
Committee to recommend that the agency tone down c a u t i o n s about Tamiflu
oseltamivir, an antiviral drug that has been associated with troubling neuropsychiatric events. The Tamiflu story provided an opportunity to test the hypothesis that even in an era when FDA and its advisory committees are loathe to take risks, good data can reverse the slide into the precautionary abyss. It also concretely demonstrated how
difficult it can be to determine causality when apparent drug safety issues emerge."
The data showed that the link between psychiatric problems was linked with the flu and not the drug by following groups that had the flu alone as well as careful tracking of each of the handful of cases among the millions of Tamiflu users world wide."
As Usdin reports:
"During the discussion, committee chair Rappley argued ROG should not be punished
for responding to the advisory committee’s request for additional information
on Tamiflu’s safety. And several committee members said they were pleased by ROG’s response. “This is a case where the system worked. We asked for more information a couple of years ago and a year ago. I feel quite a bit more informed and reassured,†Newman said. “I am reassured by most of what I saw today. I think the system
worked,†Daum said."
Chalk one up for commonsense and science.
"Roche navigated through an important inflection point in the drug safety tempest last week, charting a course that other sponsors might use to overcome concerns that arise when drugs are a s s o c i a t e d with very rare, serious adverse effects.
The company deployed observational data to persuade FDA’s Pediatric Advisory
Committee to recommend that the agency tone down c a u t i o n s about Tamiflu
oseltamivir, an antiviral drug that has been associated with troubling neuropsychiatric events. The Tamiflu story provided an opportunity to test the hypothesis that even in an era when FDA and its advisory committees are loathe to take risks, good data can reverse the slide into the precautionary abyss. It also concretely demonstrated how
difficult it can be to determine causality when apparent drug safety issues emerge."
The data showed that the link between psychiatric problems was linked with the flu and not the drug by following groups that had the flu alone as well as careful tracking of each of the handful of cases among the millions of Tamiflu users world wide."
As Usdin reports:
"During the discussion, committee chair Rappley argued ROG should not be punished
for responding to the advisory committee’s request for additional information
on Tamiflu’s safety. And several committee members said they were pleased by ROG’s response. “This is a case where the system worked. We asked for more information a couple of years ago and a year ago. I feel quite a bit more informed and reassured,†Newman said. “I am reassured by most of what I saw today. I think the system
worked,†Daum said."
Chalk one up for commonsense and science.
You know it's a slow news cycle when various media outlets stumble over themselves to report what every endo has known for years: long term use of Avandia in women with low bone density can contribute to bone thinning. Easily mitigated by treatment with an osteoporosis drug. Duh. And the Nature Medicine article simply identified the specific receptor the PPAR pathway targeted that caused the degeneration in mice, it did not discover the mechanism of degeneration. That was discovered a long time ago. Not one article suggested that there was a benefit to continuing Avandia or put the bone loss risk in context with blindness, kidney loss, amputation as a result of diabetes.
Here are some sources in case journalists are interested in reading....
Rosiglitazone causes bone loss in mice by suppressing osteoblast differentiation and bone formation.
[Endocrinology. 2005]
Aging increases stromal/osteoblastic cell-induced osteoclastogenesis and alters the osteoclast precursor pool in the mouse.
[J Bone Miner Res. 2005]
Surface-specific effects of a PPARgamma agonist, darglitazone, on bone in mice.
[Bone. 2006]
Netoglitazone is a PPAR-gamma ligand with selective effects on bone and fat.
[Bone. 2006]
Rosiglitazone impacts negatively on bone by promoting osteoblast/osteocyte apoptosis.
[J Endocrinol. 2004]
Here are some sources in case journalists are interested in reading....
Rosiglitazone causes bone loss in mice by suppressing osteoblast differentiation and bone formation.
[Endocrinology. 2005]
Aging increases stromal/osteoblastic cell-induced osteoclastogenesis and alters the osteoclast precursor pool in the mouse.
[J Bone Miner Res. 2005]
Surface-specific effects of a PPARgamma agonist, darglitazone, on bone in mice.
[Bone. 2006]
Netoglitazone is a PPAR-gamma ligand with selective effects on bone and fat.
[Bone. 2006]
Rosiglitazone impacts negatively on bone by promoting osteoblast/osteocyte apoptosis.
[J Endocrinol. 2004]
Today CMPI helped with the formal launch of IGuard.org, the first personalized drug safety tool developed for consumers and created by consumers that will tell, in real time, what drugs are working best for what people. iGuard provides patients with free medication safety checks, personalized safety alerts and updates, and the opportunity to share medication experiences with others. And, by monitoring outcomes across its user community, iGuard can help the FDA and other researchers identify problems faster than ever. Who will benefit from iGuard. Consumers who want to learn more about how the medicines, vitamins and supplements they are taking or plan to take will affect them as individuals. Drug companies should want to get involved to learn sooner rather than later about the consumer's experience with a drug, including how they are benefitting, drug-drug interactions, drug-disease interactions, as well as companies who want to communicate with consumers about ways to improve their experience with a medicine. It's a much better way to communicate with customers than through meta-analysis conducted by Steve Nissen.
IGuard is a free service to anyone who signs up and use of information for research purposes is confidential and voluntary.
Registration is free online at www.iGuard.org.
IGuard is a free service to anyone who signs up and use of information for research purposes is confidential and voluntary.
Registration is free online at www.iGuard.org.
Jamie Love thinks he has Big Pharma in zugzwang. (That's a chess term referring to a position where one player is reduced to utter helplessness -- but must continue to play even though every additional move makes his position worse.)
Here’s what he has to say this week in Fortune Magazine about his plan to replace pharmaceutical patents with “prizes†…
"It's either going to be price controls or prizes.â€
Not so. And even though he's King of the Big Lie -- say it enough times and maybe people will begin to think it’s true -- it just isn't so. There are many alternatives that are, well, sane ones.
But as the article (authored by John Simons) concludes …
“Clearly, if industry wants to avoid this (Jamie Love's) scenario, they had better start fashioning some new ideas of their own.â€
How about a more robust discussion of a patient-centric Critical Path program for Comparative Effectiveness?
Here’s the rest of the story from Fortune:
http://money.cnn.com/2007/11/28/magazines/fortune/simons_patent.fortune/index.htm
Next up on this front is just how far Senator Bernie Sanders' Prizes vs. Patents bill gets in the Senate.
Here’s what he has to say this week in Fortune Magazine about his plan to replace pharmaceutical patents with “prizes†…
"It's either going to be price controls or prizes.â€
Not so. And even though he's King of the Big Lie -- say it enough times and maybe people will begin to think it’s true -- it just isn't so. There are many alternatives that are, well, sane ones.
But as the article (authored by John Simons) concludes …
“Clearly, if industry wants to avoid this (Jamie Love's) scenario, they had better start fashioning some new ideas of their own.â€
How about a more robust discussion of a patient-centric Critical Path program for Comparative Effectiveness?
Here’s the rest of the story from Fortune:
http://money.cnn.com/2007/11/28/magazines/fortune/simons_patent.fortune/index.htm
Next up on this front is just how far Senator Bernie Sanders' Prizes vs. Patents bill gets in the Senate.
When is off-label promotion not off-label promotion? Well, as with so much in the world of FDA regulations -- it depends.
In this case it depends on the FDA's decision to relace ambiguity with a draft guidance on the matter. But the question remains, is this even within the agency's jurisdiction?
Of course, we can always depend on Henry Waxman (America's Oversighter-in-Chief) for a fair and balanced comment. Here's one sentence from his 11 page letter to the FDA on the leaked draft of the draft guidance:
"It would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs."
But Henry, what do you really think?
At the end of the day, shouldn't physicians have free and unfettered access to publicly available, peer-reviewed scientific information?
Oh yes, and then there's that First Amendment thing.
In this case it depends on the FDA's decision to relace ambiguity with a draft guidance on the matter. But the question remains, is this even within the agency's jurisdiction?
Of course, we can always depend on Henry Waxman (America's Oversighter-in-Chief) for a fair and balanced comment. Here's one sentence from his 11 page letter to the FDA on the leaked draft of the draft guidance:
"It would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs."
But Henry, what do you really think?
At the end of the day, shouldn't physicians have free and unfettered access to publicly available, peer-reviewed scientific information?
Oh yes, and then there's that First Amendment thing.
But Ralph -- what have you done lately?
Many congrats.
Ralph Snyderman, M.D., Chancellor Emeritus at Duke University and Founder and Chairman of Prevents, Inc., receives the 2007 Leadership in Personalized Medicine Award today from the Personalized Medicine Coalition (PMC) for his efforts in advancing predictive and targeted therapies on a national scale.
The annual PMC award recognizes the contributions of a visionary individual whose actions in science, business, or policy have advanced the frontier of personalized medicine.
Many congrats.
Ralph Snyderman, M.D., Chancellor Emeritus at Duke University and Founder and Chairman of Prevents, Inc., receives the 2007 Leadership in Personalized Medicine Award today from the Personalized Medicine Coalition (PMC) for his efforts in advancing predictive and targeted therapies on a national scale.
The annual PMC award recognizes the contributions of a visionary individual whose actions in science, business, or policy have advanced the frontier of personalized medicine.
PRESS ADVISORY: Science Board to the Food and Drug Administration
Date and Time: Monday, December 3, from 8:00 a.m. to 5:30 p.m.
Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, Salons A, B, and C
Key item: Presentation of the report FDA Science and Mission at Risk
12:30 p.m. Report of the Subcommittee on Science and Technology, Gail Cassell, PhD, D.Sc. (hon), Subcommittee Chair
2:00 p.m. Science Board Q&A and Discussion of the Subcommittee Report
PRESS ADVISORY: Media conference call with Dr. Cassell and other authors of: FDA Science and Mission at Risk
Date and Time: Tuesday, December 4, at 10 a.m.
Call-in number: 1-888-622-5357; Participant: 453189#
Date and Time: Monday, December 3, from 8:00 a.m. to 5:30 p.m.
Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, Salons A, B, and C
Key item: Presentation of the report FDA Science and Mission at Risk
12:30 p.m. Report of the Subcommittee on Science and Technology, Gail Cassell, PhD, D.Sc. (hon), Subcommittee Chair
2:00 p.m. Science Board Q&A and Discussion of the Subcommittee Report
PRESS ADVISORY: Media conference call with Dr. Cassell and other authors of: FDA Science and Mission at Risk
Date and Time: Tuesday, December 4, at 10 a.m.
Call-in number: 1-888-622-5357; Participant: 453189#
A subcommittee of the FDA’s Science Board (headed by the talented Dr. Gail Cassell of Eli Lilly & Company) says the agency suffers from a "plethora of inadequacies," including an "appallingly low'' rate of food inspections and a lack of scientists who understand new technologies.
According to a new report issued by the subcommittee, the FDA needs more money, better computer systems, and should be restructured to include a scientific leader.
"Without a substantial increase in resources, the agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public. This will damage not only the health of the population of the U.S., but also the health of our economy.''
The report describes rapidly developing advances in areas such as genomics, wireless health-care devices and nanotechnology, and says the FDA can't adequately monitor products because it can't keep up with the science. The FDA suffers `"serious scientific deficiencies,'' the report concluded. The subcommittee consulted more than 25 specialists in industry, academics and government
The report blames Congress for requiring the FDA to take on more responsibilities without providing enough funding to hire staff.
Each American pays about 1 1/2 cents a day to fund the FDA, and an increase to 3 cents a day wouldn't "be a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world,'' according to the report.
And that shouldn't be a problem – after all, everybody else seems to want to give the FDA their two cents worth.
According to a new report issued by the subcommittee, the FDA needs more money, better computer systems, and should be restructured to include a scientific leader.
"Without a substantial increase in resources, the agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public. This will damage not only the health of the population of the U.S., but also the health of our economy.''
The report describes rapidly developing advances in areas such as genomics, wireless health-care devices and nanotechnology, and says the FDA can't adequately monitor products because it can't keep up with the science. The FDA suffers `"serious scientific deficiencies,'' the report concluded. The subcommittee consulted more than 25 specialists in industry, academics and government
The report blames Congress for requiring the FDA to take on more responsibilities without providing enough funding to hire staff.
Each American pays about 1 1/2 cents a day to fund the FDA, and an increase to 3 cents a day wouldn't "be a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world,'' according to the report.
And that shouldn't be a problem – after all, everybody else seems to want to give the FDA their two cents worth.
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.
