Latest Drugwonks' Blog
What do Jamie-Lynn Spears and Steve Nissen have in common? While only one looks good with a partially exposed tummy, both are dubious sources of advice in their chosen fields of expertise. At least Jamie-Lynne has the good sense not to move forward with her book about parenting -- while Steve Nissen will continue to find products to make people afraid about using meta-analysis as his weapon of choice.
http://www.chicagotribune.com/entertainment/chi-lynn-spears,1,3749621.story
http://www.chicagotribune.com/entertainment/chi-lynn-spears,1,3749621.story
Here's a house editorial from today's edition of the Wall Street Journal.
Stopping Medicine's Machines
The Vioxx panic seems to have subsided, but the same kind of alarmism is beginning to wash over health-care fields other than pharmaceuticals. The most recent is medical technology. Now Congress is ready to intervene, so let's try to separate good sense from exaggeration.
On the front-burner for Congressional action is Medtronic, a major medical-device maker, and the controversy surrounding a component of its heart defibrillators. Surgically implanted near the shoulder, these devices treat cardiac arrest by electrically shocking the heart back into regular rhythm. In October, in the face of escalating criticism over safety concerns, Medtronic voluntarily withdrew from the market a type of the complex wires -- called leads -- that connect a defibrillator to the heart muscle and tell it when to deliver therapy.
These Sprint Fidelis leads have a smaller diameter than most others available. Cardiologists have been calling for narrower models because they are easier to thread through the veins during surgery. Once implanted, they are less likely to lead to blood clots or obstructions, or distort heart valves.
While all leads break or "fracture," some evidence began to emerge this year that the Fidelis line, which was made available in the U.S. in 2004 and rapidly adopted, was more prone to early malfunction compared to older alternatives. A fracture can cause painful misfires, or a failure to deliver effective shocks to a dying patient.
Medtronic at first maintained the data weren't conclusive. After further internal studies and advice from its outside panel of heart doctors, it pulled the product. About 268,000 people have the implants world-wide; fractures may have contributed to five deaths. According to the company's composite estimates, 97.7% of the leads will still operate properly after 30 months in the body. The rate for Medtronic's older lead is 99.1%, a difference that isn't statistically meaningful but will be if trends remain constant.
Medtronic CEO Bill Hawkins told us that pulling Fidelis was ultimately "a judgment call." No doubt the medical side of the ledger is vastly complex. Researchers only have a limited understanding of why the leads may be less reliable. Because they were thinner, they may be more vulnerable to stress. Failures may be due to a surgeon's implant technique, or simply due to complications in patients with chronic medical conditions.
But Medtronic's withdrawal may also have been driven by legal and political calculations. Post-Vioxx, companies are under pressure to get out in front of even modest health risks. All therapies carry some risk, so these withdrawals strip choices from patients and their doctors. Mr. Hawkins notes that "society's tolerance for any risks associated with medical technology is nearing zero." The trial bar is a main offender. The first lawsuits against Medtronic were filed literally the morning after the withdrawal announcement, with many to come.
Politically, it's one thing to raise legitimate safety concerns, quite another to turn them into a pretext for longstanding agendas. Republican Senator Chuck Grassley, for instance, is targeting the device makers' consulting agreements with physicians. The implication, as with his campaign against Big Pharma, is that "kickbacks" lead to inferior products and buy "a doctor's allegiance to a particular product line." With Medtronic as Exhibit A, Mr. Grassley is pushing legislation to require regular public disclosure of the terms of all financial relationships.
The device industry says it's fine with transparency -- and who isn't? Well, doctors. Publishing such information without protections, when liability insurance costs are already through the ceiling, would do little more than create a registry of the deepest pockets for trial lawyer browsing.
The collaborations that consulting fees underpin drive innovation. Unlike new drugs, devices aren't "discovered"; they're engineered to fill specific medical needs, which requires the expertise of practicing clinicians. We're going to see a lot fewer advances in technology like defibrillators -- to say nothing of stents, artificial knees and hips, cochlear implants, deep-brain stimulators and so forth -- if doctors can't be fairly compensated for R&D participation.
Other innovation disincentives are provided by Henry Waxman, chairman of the never-sleeping House Committee on Oversight and Government Reform. He's kicked off an investigation into "what is apparently a serious shortcoming" in the FDA's device-approval process, and legislation to make it even more restrictive can't be far behind.
Devices undergo extensive laboratory "bench tests" to simulate how they'll behave under the stresses of the human body. Requiring premarket clinical trials wouldn't even detect the rare or long-term problems like the one that brought down Fidelis, and refinements of existing designs don't need square-one scrutiny. Postmarket surveillance, of the kind Medtronic and other makers conduct with their products, is a better way to monitor safety.
As with so many other medical scandals, the real danger to public health is overreaction to medical risk. Several cardiologists we spoke with (some affiliated with Medtronic) offered anecdotal evidence of high-risk patients refusing care due to the "anxiety-ridden environment," as one electrophysiologist called it. Not having a device is far worse for them than the possibility of malfunction. It might be fatal. That might not be the intent of the politicians and trial lawyers, but it is a consequence of their opportunism.
Stopping Medicine's Machines
The Vioxx panic seems to have subsided, but the same kind of alarmism is beginning to wash over health-care fields other than pharmaceuticals. The most recent is medical technology. Now Congress is ready to intervene, so let's try to separate good sense from exaggeration.
On the front-burner for Congressional action is Medtronic, a major medical-device maker, and the controversy surrounding a component of its heart defibrillators. Surgically implanted near the shoulder, these devices treat cardiac arrest by electrically shocking the heart back into regular rhythm. In October, in the face of escalating criticism over safety concerns, Medtronic voluntarily withdrew from the market a type of the complex wires -- called leads -- that connect a defibrillator to the heart muscle and tell it when to deliver therapy.
These Sprint Fidelis leads have a smaller diameter than most others available. Cardiologists have been calling for narrower models because they are easier to thread through the veins during surgery. Once implanted, they are less likely to lead to blood clots or obstructions, or distort heart valves.
While all leads break or "fracture," some evidence began to emerge this year that the Fidelis line, which was made available in the U.S. in 2004 and rapidly adopted, was more prone to early malfunction compared to older alternatives. A fracture can cause painful misfires, or a failure to deliver effective shocks to a dying patient.
Medtronic at first maintained the data weren't conclusive. After further internal studies and advice from its outside panel of heart doctors, it pulled the product. About 268,000 people have the implants world-wide; fractures may have contributed to five deaths. According to the company's composite estimates, 97.7% of the leads will still operate properly after 30 months in the body. The rate for Medtronic's older lead is 99.1%, a difference that isn't statistically meaningful but will be if trends remain constant.
Medtronic CEO Bill Hawkins told us that pulling Fidelis was ultimately "a judgment call." No doubt the medical side of the ledger is vastly complex. Researchers only have a limited understanding of why the leads may be less reliable. Because they were thinner, they may be more vulnerable to stress. Failures may be due to a surgeon's implant technique, or simply due to complications in patients with chronic medical conditions.
But Medtronic's withdrawal may also have been driven by legal and political calculations. Post-Vioxx, companies are under pressure to get out in front of even modest health risks. All therapies carry some risk, so these withdrawals strip choices from patients and their doctors. Mr. Hawkins notes that "society's tolerance for any risks associated with medical technology is nearing zero." The trial bar is a main offender. The first lawsuits against Medtronic were filed literally the morning after the withdrawal announcement, with many to come.
Politically, it's one thing to raise legitimate safety concerns, quite another to turn them into a pretext for longstanding agendas. Republican Senator Chuck Grassley, for instance, is targeting the device makers' consulting agreements with physicians. The implication, as with his campaign against Big Pharma, is that "kickbacks" lead to inferior products and buy "a doctor's allegiance to a particular product line." With Medtronic as Exhibit A, Mr. Grassley is pushing legislation to require regular public disclosure of the terms of all financial relationships.
The device industry says it's fine with transparency -- and who isn't? Well, doctors. Publishing such information without protections, when liability insurance costs are already through the ceiling, would do little more than create a registry of the deepest pockets for trial lawyer browsing.
The collaborations that consulting fees underpin drive innovation. Unlike new drugs, devices aren't "discovered"; they're engineered to fill specific medical needs, which requires the expertise of practicing clinicians. We're going to see a lot fewer advances in technology like defibrillators -- to say nothing of stents, artificial knees and hips, cochlear implants, deep-brain stimulators and so forth -- if doctors can't be fairly compensated for R&D participation.
Other innovation disincentives are provided by Henry Waxman, chairman of the never-sleeping House Committee on Oversight and Government Reform. He's kicked off an investigation into "what is apparently a serious shortcoming" in the FDA's device-approval process, and legislation to make it even more restrictive can't be far behind.
Devices undergo extensive laboratory "bench tests" to simulate how they'll behave under the stresses of the human body. Requiring premarket clinical trials wouldn't even detect the rare or long-term problems like the one that brought down Fidelis, and refinements of existing designs don't need square-one scrutiny. Postmarket surveillance, of the kind Medtronic and other makers conduct with their products, is a better way to monitor safety.
As with so many other medical scandals, the real danger to public health is overreaction to medical risk. Several cardiologists we spoke with (some affiliated with Medtronic) offered anecdotal evidence of high-risk patients refusing care due to the "anxiety-ridden environment," as one electrophysiologist called it. Not having a device is far worse for them than the possibility of malfunction. It might be fatal. That might not be the intent of the politicians and trial lawyers, but it is a consequence of their opportunism.
"VANCOUVER, Wash. -- A McDonald's employee in Vancouver is a new mom after a fast delivery at the fast-food restaurant.
Danielle Miller, 16, was working at the McDonald's on Gher Road and state Route 500 on Dec. 21 when she suddenly felt ill and ran to the bathroom, reported television station KPTV in Portland, Ore.
A friend and co-worker of Miller's followed her into the restroom and asked her if she was pregnant. Miller said no. But moments later, with the assistance of a 911 dispatcher, the friend helped Miller deliver her baby in the McDonald's restroom."
Gives a new meaning to "Do you want fries with that?"
http://www.wesh.com/family/14953330/detail.html
Danielle Miller, 16, was working at the McDonald's on Gher Road and state Route 500 on Dec. 21 when she suddenly felt ill and ran to the bathroom, reported television station KPTV in Portland, Ore.
A friend and co-worker of Miller's followed her into the restroom and asked her if she was pregnant. Miller said no. But moments later, with the assistance of a 911 dispatcher, the friend helped Miller deliver her baby in the McDonald's restroom."
Gives a new meaning to "Do you want fries with that?"
http://www.wesh.com/family/14953330/detail.html
Here's the gift that will keep on giving...
From the LA Times round up of the year's top ten scams...
"Natural" Viagra turned out to be not so natural in some cases.
Some over-the-counter supplements, with names as unsubtle as 4Everon, claimed to remedy erectile dysfunction as effectively as the prescription drug.
The Food and Drug Administration found that they indeed did their job well. But that was because the active ingredient in the concoctions was the same as in real Viagra.
The scam could have serious consequences because the "supplements" posed health problems if mixed with drugs taken for diabetes and other conditions.
The FDA forced 4Everon off the market."
As for names...I still like the Chinese rip-off of Viagra name...Big Brother
http://www.latimes.com/business/la-fi-consumer16dec16,1,2647940.story?coll=la-headlines-business
From the LA Times round up of the year's top ten scams...
"Natural" Viagra turned out to be not so natural in some cases.
Some over-the-counter supplements, with names as unsubtle as 4Everon, claimed to remedy erectile dysfunction as effectively as the prescription drug.
The Food and Drug Administration found that they indeed did their job well. But that was because the active ingredient in the concoctions was the same as in real Viagra.
The scam could have serious consequences because the "supplements" posed health problems if mixed with drugs taken for diabetes and other conditions.
The FDA forced 4Everon off the market."
As for names...I still like the Chinese rip-off of Viagra name...Big Brother
http://www.latimes.com/business/la-fi-consumer16dec16,1,2647940.story?coll=la-headlines-business
On the Presidential election and drug importation as a "hickory stick" to beat the pharmaceutical industry.
Download file
The article's conclusion says it all:
"The facts are not important. This is all about rhetoric. The facts against drug importation as sound health care policy are enormous. The argument for drug importation are political and rhetorical."
Download file
The article's conclusion says it all:
"The facts are not important. This is all about rhetoric. The facts against drug importation as sound health care policy are enormous. The argument for drug importation are political and rhetorical."
From the pages of the Boston Globe …
Judge shoots down Maine law curbing access to prescription data
BANGOR, Maine—Relying heavily on a ruling in New Hampshire, a federal judge has overturned a new state law that restricts access by medical data companies to doctors' prescription information.
U.S. District Judge John Woodcock concluded that the law, which was scheduled to take effect Jan. 1, would prohibit "the transfer of truthful commercial information" and "violate the free speech guarantee of the First Amendment."
Here’s the rest of the story:
http://www.boston.com/news/local/maine/articles/2007/12/22/judge_shoots_down_maine_law_curbing_access_to_prescription_data/
In addition to First Amendment issues, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.
When it comes to public health trumping politics -- remember the Maine verdict.
Judge shoots down Maine law curbing access to prescription data
BANGOR, Maine—Relying heavily on a ruling in New Hampshire, a federal judge has overturned a new state law that restricts access by medical data companies to doctors' prescription information.
U.S. District Judge John Woodcock concluded that the law, which was scheduled to take effect Jan. 1, would prohibit "the transfer of truthful commercial information" and "violate the free speech guarantee of the First Amendment."
Here’s the rest of the story:
http://www.boston.com/news/local/maine/articles/2007/12/22/judge_shoots_down_maine_law_curbing_access_to_prescription_data/
In addition to First Amendment issues, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.
When it comes to public health trumping politics -- remember the Maine verdict.
Hey Michael, I thought this happened only in America
Japanese woman dies searching for care
By CHISAKI WATANABE, Associated Press Writer 37 minutes ago
TOKYO - An 89-year-old woman died after an ambulance crew spent two hours trying 30 hospitals before finding one that would accept her for treatment, Japanese officials said Friday.
http://news.yahoo.com/s/ap/20071228/ap_on_re_as/japan_ambulance_deat
Japanese woman dies searching for care
By CHISAKI WATANABE, Associated Press Writer 37 minutes ago
TOKYO - An 89-year-old woman died after an ambulance crew spent two hours trying 30 hospitals before finding one that would accept her for treatment, Japanese officials said Friday.
http://news.yahoo.com/s/ap/20071228/ap_on_re_as/japan_ambulance_deat
The following article could have been written in any election cycle ...
Pocketbook worries outweigh voters' concerns over war in Iraq
By JIM KUHNHENN and TREVOR TOMPSON, Associated Press Writers
WASHINGTON (AP) — Voters began to worry more about their pocketbooks over the last month — even more than about the war in Iraq....
"...This latest AP-Yahoo! News survey of more than 1,800 people by Knowledge Networks offers a unique opportunity to track changes in public attitudes as the presidential campaign unfolds. The first poll was last month and set a base line to measure national sentiment.
In the new results, men and women approaching retirement were especially attentive to the economy and health care, with six out of 10 ranking both issues extremely important. Politically, the attention to such domestic issues hangs darkly over Republicans. Voters say they are far more likely to trust Democrats to handle the economy and health care."
Consider Linda Zimmerman, a 50-year-old sheep farmer from Thurmont, Md. Her daughter and son-in-law are having trouble keeping up with two mortgages on a town house, she said. One street in her neighborhood has five homes for sale, and one has been on the market for two years.
Registered as a Republican, she's ready to reconsider.
"We're Republicans and I'm very unhappy with them, and I've been watching the Democrats," she said. "We did better when (Bill) Clinton was in than we did with Bush. It's just terrible."
Terrible? Aren't things going better in Iraq? Wasn't that the real downer in America according to the media just a couple of months ago? And how did they ever find a sheep farmer in Thurmont, Md?
As 2008 and the election year approaches, there is really nothing new in the political playbook. For the Dems and the media worse is always better and the good news is always in the past.
http://news.yahoo.com/page/election-2008-political-pulse-voter-worries
Pocketbook worries outweigh voters' concerns over war in Iraq
By JIM KUHNHENN and TREVOR TOMPSON, Associated Press Writers
WASHINGTON (AP) — Voters began to worry more about their pocketbooks over the last month — even more than about the war in Iraq....
"...This latest AP-Yahoo! News survey of more than 1,800 people by Knowledge Networks offers a unique opportunity to track changes in public attitudes as the presidential campaign unfolds. The first poll was last month and set a base line to measure national sentiment.
In the new results, men and women approaching retirement were especially attentive to the economy and health care, with six out of 10 ranking both issues extremely important. Politically, the attention to such domestic issues hangs darkly over Republicans. Voters say they are far more likely to trust Democrats to handle the economy and health care."
Consider Linda Zimmerman, a 50-year-old sheep farmer from Thurmont, Md. Her daughter and son-in-law are having trouble keeping up with two mortgages on a town house, she said. One street in her neighborhood has five homes for sale, and one has been on the market for two years.
Registered as a Republican, she's ready to reconsider.
"We're Republicans and I'm very unhappy with them, and I've been watching the Democrats," she said. "We did better when (Bill) Clinton was in than we did with Bush. It's just terrible."
Terrible? Aren't things going better in Iraq? Wasn't that the real downer in America according to the media just a couple of months ago? And how did they ever find a sheep farmer in Thurmont, Md?
As 2008 and the election year approaches, there is really nothing new in the political playbook. For the Dems and the media worse is always better and the good news is always in the past.
http://news.yahoo.com/page/election-2008-political-pulse-voter-worries
Book argues that Bell stole phone idea (AP)
BOSTON - A new book claims to have definitive evidence of a long-suspected technological crime — that Alexander Graham Bell stole ideas for the telephone from a rival, Elisha Gray.
http://tech.yahoo.com/news/ap/techbit_bell_book
BOSTON - A new book claims to have definitive evidence of a long-suspected technological crime — that Alexander Graham Bell stole ideas for the telephone from a rival, Elisha Gray.
http://tech.yahoo.com/news/ap/techbit_bell_book
Consider the story of Eric Lester, an oncologist in St. Joseph, Michigan, who was trying to find a way save the lives of his patients with advanced lung cancer. Instead of waiting for someone else to develop diagnostic tools, Lester developed his own test to see what kind of genetic factors were causing the cancer to grow. It turned out that epidermal growth factor receptor was the culprit and that a drug called Tarceva, designed to shut off that receptor, would work.
Instead of waiting to use Tarceva when all else was failing, he decided to use it as part of a tailor-made drug cocktail for his patient based on the information from the diagnostic he developed while staying within the bounds of the FDA. The patient fared better than most of the patients Lester sees.
It’s not a cure, but the results of Lester’s experiment—and others like it—are being shared with academic researchers and drug companies to accelerate the development of cancer drugs tailored to variations of growth factors causing lung cancer. Patients like Lester’s would receive tests that look for biomarkers—biochemical indicators of a disease—to see which drug would work best with fewest side effects. Such collaboration could bring about a new generation of cancer-killing treatments in years.
For more check out the Journal of Life Sciences at:
http://www.tjols.com/article-482.html
And that will explain the title.
Instead of waiting to use Tarceva when all else was failing, he decided to use it as part of a tailor-made drug cocktail for his patient based on the information from the diagnostic he developed while staying within the bounds of the FDA. The patient fared better than most of the patients Lester sees.
It’s not a cure, but the results of Lester’s experiment—and others like it—are being shared with academic researchers and drug companies to accelerate the development of cancer drugs tailored to variations of growth factors causing lung cancer. Patients like Lester’s would receive tests that look for biomarkers—biochemical indicators of a disease—to see which drug would work best with fewest side effects. Such collaboration could bring about a new generation of cancer-killing treatments in years.
For more check out the Journal of Life Sciences at:
http://www.tjols.com/article-482.html
And that will explain the title.
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.
