Latest Drugwonks' Blog
http://washingtontimes.com/functions/print.php?StoryID=20061217-102008-3698r
Undermining drug safety
By Robert Goldberg
Published December 18, 2006
Recently the Food and Drug Administration updated its warning on the use of oral sodium phosphate products (OSPs) as a cause of kidney failure. What are OSPs? If you had a colonoscopy as I did, you drank an OSP to clear the way for your inspection. In 1998, the FDA limited the OSP bottle size to no more than 90 ml. People were going into toxic shock and dying because they were told to use a bottle of the preparation and used a 240 ml jug instead of the 45 ml or 90 ml container. The FDA just updated warning labels about exceeding recommended doses since OSP-related kidney failure is still a problem.
It seems inconceivable that you or I could find a way to take lifesaving drugs and turn them into lethal weapons. But most drugs and devices wind up causing side effects because of the human inability to follow directions. Indeed, safety problems with drug-coated heart stents boil down to this: Don't put them in patients with really blocked arteries who stop taking clot-busting medicine. The fact is, coated-stent use will be restricted, as it is with many drugs and devices, because we can't be trusted to do as we are told.
This picture of incompetence clashes with the one politicians and the Institute of Medicine peddle to the media of an FDA and drug industry rushing to approve and market medicines without regard to product safety. But a Centers for Disease Control report found that misuse and overuse of a handful of old medicines cause most dangerous side effects. Hundreds of thousands of emergency-room visits occur because of adverse drug events. The CDC notes that "Sixteen of the 18 drugs most commonly linked to adverse drug events in the study have been in clinical use for more than 20 years." The most common drug classes were insulin, painkillers containing opioids, anticlotting drugs (including aspirin), drugs containing the antibiotic amoxicillin and cold remedies.
Yet, the media and politicians pick on pills that are well known rather than risky. Ambien is a classic example. Ambien became famous (or infamous) when Rep. Patrick Kennedy claimed he crashed his car because it caused him to drive while sleeping. Thereafter, Ambien became the target of major articles in the New York Times and Washington Post for being linked to sleeping while shoplifting, midnight snacking, etc. In fact, as the folks at blogcritics.org point out: "In 2004, over 24 million prescriptions for Ambien were written. Let's say that each contained 30 pills. That's 740 million times people took this sinister drug in 2004. Timothy Morgenthaler, a Mayo Clinic researcher, reported five cases of sleepwalking in 2002. Nineteen cases were reported by one center last year. Since 1997, a whopping 207 sleepwalking incidents have been reported, most of which physicians can't link to Ambien. In fact, only 48 have been linked to this killer drug.
"It's well known that adverse incidents are under-reported, so let's assume a factor of 100... That's 4,800 incidents over, say, 8 years or 600 a year. No wonder it got banner headlines. But wait. The drug is used 740 million times a year, which means your odds of sleepwalking from using the drug are 0.00008 percent or something like 1/80,000th of a percent."
Sen. Charles Grassley wants to withdraw an antibiotic called Ketek. His evidence? The drug -- used to treat sinus infections, bronchitis and treatment-resistant pneumonia -- was approved on the basis of the nearly a decade of clinical trials, the drug's five-year safety record in Europe and a 25,000-patient study in America that unfortunately involved one doctor who faked results for about 300 patients. (The doctor was sent to prison and the results discarded.) Some claim the approval ran roughshod over time-honored FDA standards and explains why there are 23 reports of liver injury associated with 10 million Ketek prescriptions since 2003.
In fact, the FDA can approve a drug with the results of one clinical trial and prior experience with a drug. Antibiotics with amoxicillin are more likely to cause liver problems than Ketek. Acetaminophen is the most common cause of liver failure in the United States. The FDA, more concerned about drug-resistant bacteria than are fact-resistant senators, is keeping Ketek on the market.
We have defined down drug safety. What used to be our responsibility is now blamed on a FDA-industry conspiracy. We blame shoplifting and car crashes on Ambien, not on reckless behavior. Suicide, a tragic mystery, is suddenly the result of Prozac-type anti-depressants. Heart attacks are now caused by Vioxx, not by hypertension and smoking. No wonder the current FDA reform bill requires restrictions on the use of every drug that make OSP limits look like child safety locks. We want our drugs -- and our tacos -- to be 100 percent safe. They can be, if we stop making medicines available altogether. I am afraid we are already there.
Undermining drug safety
By Robert Goldberg
Published December 18, 2006
Recently the Food and Drug Administration updated its warning on the use of oral sodium phosphate products (OSPs) as a cause of kidney failure. What are OSPs? If you had a colonoscopy as I did, you drank an OSP to clear the way for your inspection. In 1998, the FDA limited the OSP bottle size to no more than 90 ml. People were going into toxic shock and dying because they were told to use a bottle of the preparation and used a 240 ml jug instead of the 45 ml or 90 ml container. The FDA just updated warning labels about exceeding recommended doses since OSP-related kidney failure is still a problem.
It seems inconceivable that you or I could find a way to take lifesaving drugs and turn them into lethal weapons. But most drugs and devices wind up causing side effects because of the human inability to follow directions. Indeed, safety problems with drug-coated heart stents boil down to this: Don't put them in patients with really blocked arteries who stop taking clot-busting medicine. The fact is, coated-stent use will be restricted, as it is with many drugs and devices, because we can't be trusted to do as we are told.
This picture of incompetence clashes with the one politicians and the Institute of Medicine peddle to the media of an FDA and drug industry rushing to approve and market medicines without regard to product safety. But a Centers for Disease Control report found that misuse and overuse of a handful of old medicines cause most dangerous side effects. Hundreds of thousands of emergency-room visits occur because of adverse drug events. The CDC notes that "Sixteen of the 18 drugs most commonly linked to adverse drug events in the study have been in clinical use for more than 20 years." The most common drug classes were insulin, painkillers containing opioids, anticlotting drugs (including aspirin), drugs containing the antibiotic amoxicillin and cold remedies.
Yet, the media and politicians pick on pills that are well known rather than risky. Ambien is a classic example. Ambien became famous (or infamous) when Rep. Patrick Kennedy claimed he crashed his car because it caused him to drive while sleeping. Thereafter, Ambien became the target of major articles in the New York Times and Washington Post for being linked to sleeping while shoplifting, midnight snacking, etc. In fact, as the folks at blogcritics.org point out: "In 2004, over 24 million prescriptions for Ambien were written. Let's say that each contained 30 pills. That's 740 million times people took this sinister drug in 2004. Timothy Morgenthaler, a Mayo Clinic researcher, reported five cases of sleepwalking in 2002. Nineteen cases were reported by one center last year. Since 1997, a whopping 207 sleepwalking incidents have been reported, most of which physicians can't link to Ambien. In fact, only 48 have been linked to this killer drug.
"It's well known that adverse incidents are under-reported, so let's assume a factor of 100... That's 4,800 incidents over, say, 8 years or 600 a year. No wonder it got banner headlines. But wait. The drug is used 740 million times a year, which means your odds of sleepwalking from using the drug are 0.00008 percent or something like 1/80,000th of a percent."
Sen. Charles Grassley wants to withdraw an antibiotic called Ketek. His evidence? The drug -- used to treat sinus infections, bronchitis and treatment-resistant pneumonia -- was approved on the basis of the nearly a decade of clinical trials, the drug's five-year safety record in Europe and a 25,000-patient study in America that unfortunately involved one doctor who faked results for about 300 patients. (The doctor was sent to prison and the results discarded.) Some claim the approval ran roughshod over time-honored FDA standards and explains why there are 23 reports of liver injury associated with 10 million Ketek prescriptions since 2003.
In fact, the FDA can approve a drug with the results of one clinical trial and prior experience with a drug. Antibiotics with amoxicillin are more likely to cause liver problems than Ketek. Acetaminophen is the most common cause of liver failure in the United States. The FDA, more concerned about drug-resistant bacteria than are fact-resistant senators, is keeping Ketek on the market.
We have defined down drug safety. What used to be our responsibility is now blamed on a FDA-industry conspiracy. We blame shoplifting and car crashes on Ambien, not on reckless behavior. Suicide, a tragic mystery, is suddenly the result of Prozac-type anti-depressants. Heart attacks are now caused by Vioxx, not by hypertension and smoking. No wonder the current FDA reform bill requires restrictions on the use of every drug that make OSP limits look like child safety locks. We want our drugs -- and our tacos -- to be 100 percent safe. They can be, if we stop making medicines available altogether. I am afraid we are already there.
Last Friday (12/15) I participated on a joint CHI (California Healthcare Institute)/PRI (Pacific Research Institute) panel called "Evidence, Economics, and Politics: Australia's Experiment in Evidence-Based Medicine."
My fellow panelists included Ruth Lopert (Harkness Fellow in Health Care Policy, George Washington University, and a member of the Pharmaceutical Policy Taskforce, Commonwealth Department of Health and Aging, Canberra, Australia), Marjorie Ginsberg (Executive Director of Sacremento Health Care Decisions), Kwabena O.M. Audbofour, MD (a GP from Stockton, CA), Meryl Comer (journalist and Alzheimer's care giver), and Randy Frankel (VP, Public Affairs, IMS Health).
We used the new IMS report, "Australia’s Centralized Cost-Effectiveness Requirement for Pharmaceuticals: Potential Implications for U.S. Patients" as our point of departure.
Consider the facts and be afraid – very afraid – of the implications.
The IMS study included examination of osteoporosis and Alzheimer’s, where Australians are regularly denied access to medicines available to American patients. According to the new IMS study:
* By 2007, approximately 9.1 million patients in the United States with osteoporosis would be denied access to treatment choices if we adopted the Australian model of cost-based (aka, “evidence-basedâ€) medicine. In Australia, for example, newer medicines for osteoporosis that are not “on the list†for reimbursement may be made available only after a patient suffers a fracture.
* IMS estimates that a 1.6 million Alzheimer’s patients could be impacted if we adopted the same system as Australia. The Aussie guidelines are identical for Aricept (donepezil), Exelon (rivastigmine), and Razadyne (galantamine) – and are highly restrictive compared with US guidelines. Australia also limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.†In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.â€
Restrictive formularies that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.
The IMS report can be found at http://www.cmpi.org
CHI will be posting a series of podcasts from the event. When these are available, we will call it to your attention. In the meantime, g'day mate.
My fellow panelists included Ruth Lopert (Harkness Fellow in Health Care Policy, George Washington University, and a member of the Pharmaceutical Policy Taskforce, Commonwealth Department of Health and Aging, Canberra, Australia), Marjorie Ginsberg (Executive Director of Sacremento Health Care Decisions), Kwabena O.M. Audbofour, MD (a GP from Stockton, CA), Meryl Comer (journalist and Alzheimer's care giver), and Randy Frankel (VP, Public Affairs, IMS Health).
We used the new IMS report, "Australia’s Centralized Cost-Effectiveness Requirement for Pharmaceuticals: Potential Implications for U.S. Patients" as our point of departure.
Consider the facts and be afraid – very afraid – of the implications.
The IMS study included examination of osteoporosis and Alzheimer’s, where Australians are regularly denied access to medicines available to American patients. According to the new IMS study:
* By 2007, approximately 9.1 million patients in the United States with osteoporosis would be denied access to treatment choices if we adopted the Australian model of cost-based (aka, “evidence-basedâ€) medicine. In Australia, for example, newer medicines for osteoporosis that are not “on the list†for reimbursement may be made available only after a patient suffers a fracture.
* IMS estimates that a 1.6 million Alzheimer’s patients could be impacted if we adopted the same system as Australia. The Aussie guidelines are identical for Aricept (donepezil), Exelon (rivastigmine), and Razadyne (galantamine) – and are highly restrictive compared with US guidelines. Australia also limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.†In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.â€
Restrictive formularies that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.
The IMS report can be found at http://www.cmpi.org
CHI will be posting a series of podcasts from the event. When these are available, we will call it to your attention. In the meantime, g'day mate.
My article in the Weekly Standard on the Democrats disastrous Medicare plan entitled
Hillarycare is Back...Here's the link for anyone who cares to read it....HillaryCare Comes Back
Hillarycare is Back...Here's the link for anyone who cares to read it....HillaryCare Comes Back
As some predicted...the joint advisory committee decided to recommend against using Ketek for sinus infections and bronchitis but leave it available for pneumonia. That's a distinction with some clinical difference but not always since at what point do you being antibiotic treatment to prevent pneumonia once you know the source of the community acquire strain of the infection? Do you simply withhold a Ketek type drug in stanching other types of infections leading up to pneumonia that are resistant to other drugs? So my guess is that there will be some retooling on the label....
As for non-inferiority trials...shame on those who call it a lower standard of approval..it is not..it is a different way of obtaining information on effectiveness and it has emerged in recognition of the existence of many new therapies that affect survival or serious morbidity, and that therefore cannot be denied patients by dumping some folks into a placebo group. So that means some people get the standard treatment and others get the new drug...isn't that what Waxman and others who are screaming about non inferiority trials with Ketek have been bitching they want more of? Or am I confused? Or are these pols so hopelessly hypocritically and twisted in knots in order to posture fot the media they don't care or is that they don't even know what an inferiority trial is or consists of? Oh, and it is not a test tube test as one ex-FDAer derided it... And let's not forget it is the basis by which many HIV and cancer drugs are approved...OK? This is what having the David Grahams of the world embedded in CDER review teams -- as the IOM in their finite wisdom has proposed -- would get us....the elimination of active controls;single well controlled trials with confirmatory evidece; creeping Grassleyism at time when personalized medicine should be bustling right along....
As Peter as noted, this is an example of the FDA just not doing a good enough job explaining what they do and how they do and the media letting blowhards like Graham distort science.... Note to Grassley...an epidemiologist does NOT conduct clinical trials or review them or know anything about infectious disease or see patients, particularl if that epidemiologist is David Graham. Rather, he just plays with his large database until he gets attention.
As for non-inferiority trials...shame on those who call it a lower standard of approval..it is not..it is a different way of obtaining information on effectiveness and it has emerged in recognition of the existence of many new therapies that affect survival or serious morbidity, and that therefore cannot be denied patients by dumping some folks into a placebo group. So that means some people get the standard treatment and others get the new drug...isn't that what Waxman and others who are screaming about non inferiority trials with Ketek have been bitching they want more of? Or am I confused? Or are these pols so hopelessly hypocritically and twisted in knots in order to posture fot the media they don't care or is that they don't even know what an inferiority trial is or consists of? Oh, and it is not a test tube test as one ex-FDAer derided it... And let's not forget it is the basis by which many HIV and cancer drugs are approved...OK? This is what having the David Grahams of the world embedded in CDER review teams -- as the IOM in their finite wisdom has proposed -- would get us....the elimination of active controls;single well controlled trials with confirmatory evidece; creeping Grassleyism at time when personalized medicine should be bustling right along....
As Peter as noted, this is an example of the FDA just not doing a good enough job explaining what they do and how they do and the media letting blowhards like Graham distort science.... Note to Grassley...an epidemiologist does NOT conduct clinical trials or review them or know anything about infectious disease or see patients, particularl if that epidemiologist is David Graham. Rather, he just plays with his large database until he gets attention.
CBS Reporter Takes Swipe at Drug Industry, Praises Politician in Blog Post
Armen Keteyian lamented 'Big Pharma's' 'control' over Americans.
By Ken Shepherd
Business & Media Institute
“What can be done to break Big Pharma’s growing control of our minds and bodies? I wish I knew,†a critic of the pharmaceutical industry wrote recently on a media blog. But the author of that post was an ostensibly unbiased investigative journalist: CBS correspondent Armen Keteyian.
Network blogs can be a valuable, unfiltered look at reporters’ biases, and Keteyian’s December 14 post to CBS’s “Primary Source†was no exception.
“No matter how you slice it Wednesday was not a great day for the FDA,†Keteyian began his blog post, recounting how the December 13 “Evening News†presented “back-to-back stories†on a new FDA warning label for antidepressants and congressional criticism of FDA’s handling of Ketek, an antibiotic that can result in liver damage to some patients.
While December 13 might not have been FDA’s finest hour for public relations, the CBS reporter failed to account for how his bias could color his perceptions.
Keteyian, a former sportscaster, peppered his blog post with more anti-industry commentary, insisting that “Big Pharma seems in control [of] much of Congress, or at least its legislative agenda†before praising Iowa Republican Charles Grassley as a “straight-talking†senator who has “stood up and called out†pharmaceutical companies.
As the Business & Media Institute documented on December 14, CBS presented a decidedly sensationalistic look at the FDA’s decision to require a “black box†warning on drugs like Paxil and Zoloft when prescribed to patients up to the age of 25. In that December 13 report, Keteyian’s colleague Sharyl Attkisson focused heavily on the grief of distraught widows of suicidal patients while finding no air time for expert medical testimony.
Of course, medical experts such as NBC News’s chief medical editor Dr. Nancy Snyderman have noted that many psychiatrists find medication a crucial part of treating depression for some patients, albeit one with risks that require careful monitoring.
That dose of reality is a bitter pill to swallow for Keteyian, who lamented in his blog post that “America is a drug dependant [sic] nation†that takes pills “for just about every illness known to man or woman.â€
What's the frequency ... Armen?
Armen Keteyian lamented 'Big Pharma's' 'control' over Americans.
By Ken Shepherd
Business & Media Institute
“What can be done to break Big Pharma’s growing control of our minds and bodies? I wish I knew,†a critic of the pharmaceutical industry wrote recently on a media blog. But the author of that post was an ostensibly unbiased investigative journalist: CBS correspondent Armen Keteyian.
Network blogs can be a valuable, unfiltered look at reporters’ biases, and Keteyian’s December 14 post to CBS’s “Primary Source†was no exception.
“No matter how you slice it Wednesday was not a great day for the FDA,†Keteyian began his blog post, recounting how the December 13 “Evening News†presented “back-to-back stories†on a new FDA warning label for antidepressants and congressional criticism of FDA’s handling of Ketek, an antibiotic that can result in liver damage to some patients.
While December 13 might not have been FDA’s finest hour for public relations, the CBS reporter failed to account for how his bias could color his perceptions.
Keteyian, a former sportscaster, peppered his blog post with more anti-industry commentary, insisting that “Big Pharma seems in control [of] much of Congress, or at least its legislative agenda†before praising Iowa Republican Charles Grassley as a “straight-talking†senator who has “stood up and called out†pharmaceutical companies.
As the Business & Media Institute documented on December 14, CBS presented a decidedly sensationalistic look at the FDA’s decision to require a “black box†warning on drugs like Paxil and Zoloft when prescribed to patients up to the age of 25. In that December 13 report, Keteyian’s colleague Sharyl Attkisson focused heavily on the grief of distraught widows of suicidal patients while finding no air time for expert medical testimony.
Of course, medical experts such as NBC News’s chief medical editor Dr. Nancy Snyderman have noted that many psychiatrists find medication a crucial part of treating depression for some patients, albeit one with risks that require careful monitoring.
That dose of reality is a bitter pill to swallow for Keteyian, who lamented in his blog post that “America is a drug dependant [sic] nation†that takes pills “for just about every illness known to man or woman.â€
What's the frequency ... Armen?
If you want to begin to understand why breast cancer rates declined so suddenly in 2003 -- and remember we are three years behind the reporting curve -- read Tara Parker-Pope's definitive article in the WSJ:
What Made Breast Cancer Decline in 2003?
The Wall Street Journal
USA, 12/15/2006 - After rising for two decades, the number of women diagnosed with breast cancer fell in 2003 by a stunning 7%.
The reasons behind the steep drop -- which translates to about 14,000 women who didn't get breast cancer that year -- aren't entirely clear. Changes in medication use, including a sharp decline in women taking menopause hormones and increased use of calcium supplements and anti-inflammatory drugs, may all have played a role. A 3% drop in mammography screening among menopausal women in the same year could also help explain why fewer breast cancers were found. "
Yes Virginia, our crazed friends at Breast Cancer Action have done a wonderful job of scaring people away from getting mammographies...
Tara takes on the issue of whether the decline in estrogen use is the sole cause, a view most other articles have been pushing despite the fact that not all breast cancers express the same way:
"One possible explanation for the decline in 2003 is that it is tied, at least in part, to the July 2002 release of the Women's Health Initiative study of estrogen and progestin, which linked the hormones with heart attacks and breast cancer in older women. The WHI, which studied Wyeth's estrogen-progestin drug Pempro, scared millions of women into stopping menopause-hormone therapy almost overnight. Since the WHI announcement, menopause-hormone use has fallen by about 30%."
However...
"While the decline in hormone use between 2002 and 2003 was dramatic, it is unlikely that hormones explain the entire drop because the incidence of ER-negative cancers -- or those that weren't boosted by estrogen -- also declined. As a result, researchers are looking at other changes during the time period that could help explain the overall drop in breast cancer. "
And then there are those horrible COX-2 drugs that David Graham proudly help push off the market:
"Other medications may also have played a role. A separate WHI observational study of more than 80,000 women showed that those who used anti-inflammatory drugs for at least five years had a 20% lower risk of breast cancer. In the U.S., prescriptions for popular anti-inflammatory drugs called Cox II inhibitors more than doubled between 1999 and 2003, according to IMS Health, which tracks pharmaceutical sales data. "
And Graham's lawyer got ticked off because I questioned Graham's judgement?
"Another explanation may be the increased use of the drug raloxifene, which is sold by Eli Lilly & Co. as Evista and was approved for the treatment of osteoporosis in 1999."
In sum, Parker-Pope's multi-factorial analysis is excellent and embodies the gold standard of medical reporting.....
What Made Breast Cancer Decline in 2003?
The Wall Street Journal
USA, 12/15/2006 - After rising for two decades, the number of women diagnosed with breast cancer fell in 2003 by a stunning 7%.
The reasons behind the steep drop -- which translates to about 14,000 women who didn't get breast cancer that year -- aren't entirely clear. Changes in medication use, including a sharp decline in women taking menopause hormones and increased use of calcium supplements and anti-inflammatory drugs, may all have played a role. A 3% drop in mammography screening among menopausal women in the same year could also help explain why fewer breast cancers were found. "
Yes Virginia, our crazed friends at Breast Cancer Action have done a wonderful job of scaring people away from getting mammographies...
Tara takes on the issue of whether the decline in estrogen use is the sole cause, a view most other articles have been pushing despite the fact that not all breast cancers express the same way:
"One possible explanation for the decline in 2003 is that it is tied, at least in part, to the July 2002 release of the Women's Health Initiative study of estrogen and progestin, which linked the hormones with heart attacks and breast cancer in older women. The WHI, which studied Wyeth's estrogen-progestin drug Pempro, scared millions of women into stopping menopause-hormone therapy almost overnight. Since the WHI announcement, menopause-hormone use has fallen by about 30%."
However...
"While the decline in hormone use between 2002 and 2003 was dramatic, it is unlikely that hormones explain the entire drop because the incidence of ER-negative cancers -- or those that weren't boosted by estrogen -- also declined. As a result, researchers are looking at other changes during the time period that could help explain the overall drop in breast cancer. "
And then there are those horrible COX-2 drugs that David Graham proudly help push off the market:
"Other medications may also have played a role. A separate WHI observational study of more than 80,000 women showed that those who used anti-inflammatory drugs for at least five years had a 20% lower risk of breast cancer. In the U.S., prescriptions for popular anti-inflammatory drugs called Cox II inhibitors more than doubled between 1999 and 2003, according to IMS Health, which tracks pharmaceutical sales data. "
And Graham's lawyer got ticked off because I questioned Graham's judgement?
"Another explanation may be the increased use of the drug raloxifene, which is sold by Eli Lilly & Co. as Evista and was approved for the treatment of osteoporosis in 1999."
In sum, Parker-Pope's multi-factorial analysis is excellent and embodies the gold standard of medical reporting.....
From the WSJ....The Food and Drug Administration won't call for major changes to the safety labeling for the Sanofi-Aventis SA antibiotic Ketek, but a public meeting today is expected to highlight debate over the agency's handling of the drug.
The agency's newest views about Ketek became public in documents posted in advance of a gathering today and tomorrow of an advisory committee that is expected to weigh safety concerns tied to the drug, along with evidence for its efficacy.
From the WSJ
The Food and Drug Administration's plan to expand warnings about a link between antidepressants and suicidal thoughts and behavior to include young adults is sparking strong push-back from psychiatrists. That, in turn, raises questions about how wide an effect the change would have on prescribing patterns.
Yesterday, the agency proposed to add adults younger than 25 years old to the at-risk groups mentioned in the strong "black box" warning on the labels of antidepressant drugs. Currently, the warning says the medicines "increased the risk" of suicidal tendencies in children and adolescents in studies. But the FDA said its analysis shows the pattern reversed itself for people older than 30, and particularly for those over 65, for whom the drugs were associated with a protective effect against suicidal behavior, a point the agency also plans to add in the black box.
The FDA also reiterated the need for doctors to carefully monitor patients taking antidepressants for the emergence of, or increase in, any suicidal tendencies.
An FDA advisory committee, meeting yesterday, endorsed the agency's latest proposal by a 6-2 vote. But it also encouraged the FDA to add language to the black box about the importance of treating depression in hopes that the addition of new warnings won't cause doctors to limit the antidepressant prescriptions.
The FDA played it straight with the data and the advisory panel reflected clinical concerns as opposed to the shrieks of the crazies....
Shame on on the shameless Shankar Vedantam of the Washington Post who continues to continue space and legitimacy to the Sciento-illogical soundings of Alliance for Allen Life Form Protection....They still pump out the sewage that there is no biological basis for mental illness, the same crap Tom Cruise dumped on Matt Lauer. It reduced TomKat to a laughing stock. It gets the Alliance more coverage from Shankar...Is there any editorial oversight at the Washington Post?
The agency's newest views about Ketek became public in documents posted in advance of a gathering today and tomorrow of an advisory committee that is expected to weigh safety concerns tied to the drug, along with evidence for its efficacy.
From the WSJ
The Food and Drug Administration's plan to expand warnings about a link between antidepressants and suicidal thoughts and behavior to include young adults is sparking strong push-back from psychiatrists. That, in turn, raises questions about how wide an effect the change would have on prescribing patterns.
Yesterday, the agency proposed to add adults younger than 25 years old to the at-risk groups mentioned in the strong "black box" warning on the labels of antidepressant drugs. Currently, the warning says the medicines "increased the risk" of suicidal tendencies in children and adolescents in studies. But the FDA said its analysis shows the pattern reversed itself for people older than 30, and particularly for those over 65, for whom the drugs were associated with a protective effect against suicidal behavior, a point the agency also plans to add in the black box.
The FDA also reiterated the need for doctors to carefully monitor patients taking antidepressants for the emergence of, or increase in, any suicidal tendencies.
An FDA advisory committee, meeting yesterday, endorsed the agency's latest proposal by a 6-2 vote. But it also encouraged the FDA to add language to the black box about the importance of treating depression in hopes that the addition of new warnings won't cause doctors to limit the antidepressant prescriptions.
The FDA played it straight with the data and the advisory panel reflected clinical concerns as opposed to the shrieks of the crazies....
Shame on on the shameless Shankar Vedantam of the Washington Post who continues to continue space and legitimacy to the Sciento-illogical soundings of Alliance for Allen Life Form Protection....They still pump out the sewage that there is no biological basis for mental illness, the same crap Tom Cruise dumped on Matt Lauer. It reduced TomKat to a laughing stock. It gets the Alliance more coverage from Shankar...Is there any editorial oversight at the Washington Post?
That's the acronym for the new agency to replace the FDA.
It stands for the Taco Purity and Direct to Consumer Advertising and Post Market Drug Safety Administration.
The basic functions of the agency will to ensure that the essential public health questions of the day...accuracy of TV drug ads, the conduct of decade long post market drug studies and taco integrity are funded -- not by user fees so as to avoid an corruption by industry -- but by the taxpayer. I mean, with the rise of internet and email and blogs, the agency will need at least 100,000 staffers to police every single communication and post alone. And think of the new inspectors it will need to insure the safety of the taco discovery and development process.....
Drugwonks wants to thank Senators Schumer, Clinton, Kohl, Grassley and Congressmen Waxman and Markey for focusing the public's attention on this urgent issues.
It stands for the Taco Purity and Direct to Consumer Advertising and Post Market Drug Safety Administration.
The basic functions of the agency will to ensure that the essential public health questions of the day...accuracy of TV drug ads, the conduct of decade long post market drug studies and taco integrity are funded -- not by user fees so as to avoid an corruption by industry -- but by the taxpayer. I mean, with the rise of internet and email and blogs, the agency will need at least 100,000 staffers to police every single communication and post alone. And think of the new inspectors it will need to insure the safety of the taco discovery and development process.....
Drugwonks wants to thank Senators Schumer, Clinton, Kohl, Grassley and Congressmen Waxman and Markey for focusing the public's attention on this urgent issues.
The GAO report on DTC is so chock-full of half-truths that it is breathtaking to behold.
Consider this subhead (page 14 of the report), "Research Suggests DTC Advertising Increases Drug Spending and Utilization." Now to the casual observer (read here "politician" or "many journalists") that means the same thing as "DTC Advertising Increases the Cost of Drugs."
Not so.
It's a GAO solipsism.
A more accurate statement would be that DTC advertising drives patients to their doctors who, in turn, reach a diagnosis and then appropriately prescribe. That DTC helps patients and their physicians diagnose an existing medical condition earlier than might otherwise occur is a tremendously positive and potent public health service.
Is that statement in the GAO report? Nope.
Also, if more people are being appropriately prescribed more medicines -- then , indeed, we will as a nation be spending more on pharmaceuticals. But the GAO report makes this sound like a nepharious scheme. And don't be surprised if this theme is taken up by the usual suspects.
What's interesting is that the GAO doesn't report that, if you look at the "list" price of all the on-patent drugs within a given therapeutic category (which almost nobody pays) and then look at their individual advertising spends, what you will not find is a causal relationship. Oops.
And it's very disturbing that the GAO report didn't even consider FDA's research on DTC and physician prescribing patterns. What the FDA found was that physicians are NOT inappropriately prescribing medicines just because their patients ask for them.
But why worry about facts when you've got rhetoric on your side.
Consider this subhead (page 14 of the report), "Research Suggests DTC Advertising Increases Drug Spending and Utilization." Now to the casual observer (read here "politician" or "many journalists") that means the same thing as "DTC Advertising Increases the Cost of Drugs."
Not so.
It's a GAO solipsism.
A more accurate statement would be that DTC advertising drives patients to their doctors who, in turn, reach a diagnosis and then appropriately prescribe. That DTC helps patients and their physicians diagnose an existing medical condition earlier than might otherwise occur is a tremendously positive and potent public health service.
Is that statement in the GAO report? Nope.
Also, if more people are being appropriately prescribed more medicines -- then , indeed, we will as a nation be spending more on pharmaceuticals. But the GAO report makes this sound like a nepharious scheme. And don't be surprised if this theme is taken up by the usual suspects.
What's interesting is that the GAO doesn't report that, if you look at the "list" price of all the on-patent drugs within a given therapeutic category (which almost nobody pays) and then look at their individual advertising spends, what you will not find is a causal relationship. Oops.
And it's very disturbing that the GAO report didn't even consider FDA's research on DTC and physician prescribing patterns. What the FDA found was that physicians are NOT inappropriately prescribing medicines just because their patients ask for them.
But why worry about facts when you've got rhetoric on your side.
The Government Accountability Office’s new report on DTC states the obvious -- the FDA lacks an effective way to screen, review and track pharmaceutical advertising.
Considering that more than 10,000 ads and Web sites are brought to the agency's attention each year, that DDMAC has but six reviewers, and that the PhRMA DTC guidelines recommend that ALL advertising be submitted for review – makes us underwhelmed by the GAO’s prescience and wisdom.
Once again drugwonks says, “show me the money.â€
In a draft of a letter to be sent today to the White House, Senator Herb Kohl, D-Wis., asks President Bush to give the FDA more money to review and regulate direct-to-consumer ads. Kohl, along with Republican Sens. Bill Frist of Tennessee and Charles Grassley of Iowa, requested the GAO report.
''If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing ads and taking swift action when necessary. This report tells us that were nowhere close to that goal,'' said Kohl, who will become chairman of the Senate panel with jurisdiction over the FDA budget.
Hello PDUFA!
Letter Imperfect
On the same topic, the GAO report comments that the FDA is sending out fewer DTC-related NOVs.
Indeed, Waxman Redux.
But the truth is that you can’t count letters and say that enforcement is better or worse. It may just as well be the case that pharmaceutical companies are being more compliant (in a regulatory sense) – as could easily be predicted since the FDA has been more precise in detailing (you should excuse the expression) what “in compliance†means. Not precise enough – but better than before.
GAO also reports that the FDA is taking longer to send out letters. This issue is more complicated, but the bottom line is that sending out poorly lawyered letters more swiftly is a fool’s errand.
Unfortunately, there are a lot of fools out there. Fools on the Hill.
Considering that more than 10,000 ads and Web sites are brought to the agency's attention each year, that DDMAC has but six reviewers, and that the PhRMA DTC guidelines recommend that ALL advertising be submitted for review – makes us underwhelmed by the GAO’s prescience and wisdom.
Once again drugwonks says, “show me the money.â€
In a draft of a letter to be sent today to the White House, Senator Herb Kohl, D-Wis., asks President Bush to give the FDA more money to review and regulate direct-to-consumer ads. Kohl, along with Republican Sens. Bill Frist of Tennessee and Charles Grassley of Iowa, requested the GAO report.
''If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing ads and taking swift action when necessary. This report tells us that were nowhere close to that goal,'' said Kohl, who will become chairman of the Senate panel with jurisdiction over the FDA budget.
Hello PDUFA!
Letter Imperfect
On the same topic, the GAO report comments that the FDA is sending out fewer DTC-related NOVs.
Indeed, Waxman Redux.
But the truth is that you can’t count letters and say that enforcement is better or worse. It may just as well be the case that pharmaceutical companies are being more compliant (in a regulatory sense) – as could easily be predicted since the FDA has been more precise in detailing (you should excuse the expression) what “in compliance†means. Not precise enough – but better than before.
GAO also reports that the FDA is taking longer to send out letters. This issue is more complicated, but the bottom line is that sending out poorly lawyered letters more swiftly is a fool’s errand.
Unfortunately, there are a lot of fools out there. Fools on the Hill.
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.
