Latest Drugwonks' Blog
And there are still people out there who say that "personalized medicine" and pharmacogenomics are science fiction. Well, fact trumps fiction.
New Chemical Is Said to Provide Early Sign of Alzheimer’s Disease
By REUTERS
A chemical designed by doctors in Los Angeles could give earlier signals of Alzheimer’s disease and provide a new way to test treatments, a study has shown.
Currently, the only way to diagnose the disease is to remove brain tissue or to perform an autopsy.
The new study, to be published today in the New England Journal of Medicine, is by doctors at the University of California, Los Angeles, and is part of a larger quest to find a better method to diagnose the condition using tracers that can be detected with a positron emission tomography, or PET, scan.
The new chemical, called FDDNP, attaches to abnormal clumps of proteins called amyloid plaques and nerve cell tangles that develop in Alzheimer’s sufferers and inhibit messages being processed by the brain.
In the study, Dr. Gary Small and his colleagues discovered that the chemical allowed doctors to pick out which of 83 volunteers had Alzheimer’s, which had mild memory problems and which were functioning normally for their age.
It was 98 percent accurate in determining the difference between Alzheimer’s and mild cognitive impairment, which surpassed the 87 percent success rate for a PET scan test that measured sugar metabolism in the brain, and the 62 percent accuracy rate when doctors used a magnetic resonance imaging.
The FDDNP signal can be seen in people years before they develop Alzheimer’s disease, Dr. Small said.
Finding an easier way to track brain deterioration would also make it easier to assess experimental treatments, as researchers try to prevent or reduce the accumulation of plaques and tangles.
Dr. Small and 4 of the other 15 authors named in the research paper have a financial interest in FDDNP, which has been licensed to the German conglomerate Siemens AG. He said he hoped to see it on the market in three years.
About 4.5 million people in the United States have Alzheimer’s, a number that is expected to grow as the population ages. About 15 million to 20 million more have the mild cognitive impairment that often leads to the disease.
New Chemical Is Said to Provide Early Sign of Alzheimer’s Disease
By REUTERS
A chemical designed by doctors in Los Angeles could give earlier signals of Alzheimer’s disease and provide a new way to test treatments, a study has shown.
Currently, the only way to diagnose the disease is to remove brain tissue or to perform an autopsy.
The new study, to be published today in the New England Journal of Medicine, is by doctors at the University of California, Los Angeles, and is part of a larger quest to find a better method to diagnose the condition using tracers that can be detected with a positron emission tomography, or PET, scan.
The new chemical, called FDDNP, attaches to abnormal clumps of proteins called amyloid plaques and nerve cell tangles that develop in Alzheimer’s sufferers and inhibit messages being processed by the brain.
In the study, Dr. Gary Small and his colleagues discovered that the chemical allowed doctors to pick out which of 83 volunteers had Alzheimer’s, which had mild memory problems and which were functioning normally for their age.
It was 98 percent accurate in determining the difference between Alzheimer’s and mild cognitive impairment, which surpassed the 87 percent success rate for a PET scan test that measured sugar metabolism in the brain, and the 62 percent accuracy rate when doctors used a magnetic resonance imaging.
The FDDNP signal can be seen in people years before they develop Alzheimer’s disease, Dr. Small said.
Finding an easier way to track brain deterioration would also make it easier to assess experimental treatments, as researchers try to prevent or reduce the accumulation of plaques and tangles.
Dr. Small and 4 of the other 15 authors named in the research paper have a financial interest in FDDNP, which has been licensed to the German conglomerate Siemens AG. He said he hoped to see it on the market in three years.
About 4.5 million people in the United States have Alzheimer’s, a number that is expected to grow as the population ages. About 15 million to 20 million more have the mild cognitive impairment that often leads to the disease.
In the wake of sensationalist articles about Zyprexa and weight gain you would think that the next big story would be all those horrible side effects caused by typical antipsychotics like Haldol - which people like Robert Rosenheck and his cheerleaders inthe NY Times claim are just as good -- and cheaper -- than Zyprexa.
Some of Haldol's side effects.
The risk of tardive dyskinesia is around 4% per year in younger patients, higher than with most other antipsychotic drugs. In patients over the age of 45, the percentage of those afflicted can be even higher. Other predispositive factors may be female gender, prexisting affective disorder and cerebral dysfunction. See chlorpromazine for further details.
Other side effects include dry mouth, lethargy, muscle-stiffness, muscle-cramping, restlessness, tremors, and weight-gain; side effects like these are more likely to occur when the drug is given in high doses and/or during long-term treatment. Depression, severe enough to result in suicide, is quite often seen during long-term treatment.
Oh, and then there's the 'revelation' that painkillers like aspirin cause more liver injury than, say, Ketek, Senator Grassley's drug of choice.
Where are the Haldol and aspirin lawsuits? Or at least where are they in proportion to lawsuits against Lilly for weight gain associated with Zyprexa or Sanofi for 12 cases of liver injury?
Slip and fall litigation is pursued without regard to public health risk but with respect to profit.
So for those of you who commented about our earlier posts regarding the source of legal documents (and more on that later) it does matter. As long as journalists think its kosher to report the sources of income of respected academic researchers in the same sentence as they report what they say about a subject, we believe it is kosher to request that they report the source of everyone's income, particularly if that information source has a vested interest in the outcome of the case or decision that the reporter is writing about.
Some of Haldol's side effects.
The risk of tardive dyskinesia is around 4% per year in younger patients, higher than with most other antipsychotic drugs. In patients over the age of 45, the percentage of those afflicted can be even higher. Other predispositive factors may be female gender, prexisting affective disorder and cerebral dysfunction. See chlorpromazine for further details.
Other side effects include dry mouth, lethargy, muscle-stiffness, muscle-cramping, restlessness, tremors, and weight-gain; side effects like these are more likely to occur when the drug is given in high doses and/or during long-term treatment. Depression, severe enough to result in suicide, is quite often seen during long-term treatment.
Oh, and then there's the 'revelation' that painkillers like aspirin cause more liver injury than, say, Ketek, Senator Grassley's drug of choice.
Where are the Haldol and aspirin lawsuits? Or at least where are they in proportion to lawsuits against Lilly for weight gain associated with Zyprexa or Sanofi for 12 cases of liver injury?
Slip and fall litigation is pursued without regard to public health risk but with respect to profit.
So for those of you who commented about our earlier posts regarding the source of legal documents (and more on that later) it does matter. As long as journalists think its kosher to report the sources of income of respected academic researchers in the same sentence as they report what they say about a subject, we believe it is kosher to request that they report the source of everyone's income, particularly if that information source has a vested interest in the outcome of the case or decision that the reporter is writing about.
A recent WSJ poll shows that 70 percent of Democrats favor having the government 'negotiate directly with drug companies' (price controls) while only half favor cutting tax breaks for oil companies.
Drugwonks is not in favor of either. But did anyone ask real questions as in "price limits like those in Europe, Australia, Canada or the VA that limit the access of new medicines to millions of patients and delays access by 3-5 years." Or what if the "cost-effectiveness criteria used to negotiate prices meant that new drugs that delay progression of Alzheimer's by five years were never developed costing our nation $10 trillion causing 2 million additional cases of the disease that might not have occured?"
Maybe a new poll is needed. One that reflects that public policy, like all of life, is a series of tradeoffs.
Drugwonks is not in favor of either. But did anyone ask real questions as in "price limits like those in Europe, Australia, Canada or the VA that limit the access of new medicines to millions of patients and delays access by 3-5 years." Or what if the "cost-effectiveness criteria used to negotiate prices meant that new drugs that delay progression of Alzheimer's by five years were never developed costing our nation $10 trillion causing 2 million additional cases of the disease that might not have occured?"
Maybe a new poll is needed. One that reflects that public policy, like all of life, is a series of tradeoffs.
Or, more to the point, the Hill.
A report released yesterday by the Government Accountability Office reports that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent and about two-thirds of the new applications were for drugs that represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.
This is yet another example of the GAO “reporting†something that is widely known, widely reported, and widely debated. But it’s worth repeating because it focuses the spotlight on the crucial need for better drug development tools – precisely the remit of the FDA’s Critical Path program.
Please refer to our report, “Prescription for Progress†which can be found at http://www.cmpi.org At that link you’ll also find video of the conference we held to discuss the future of drug development, with speakers including FDA Commissioner Andy von Eschenbach and FDA Deputy Commissioner Janet Woodcock.
But, alas, rather than using the GAO report to focus attention on the real issue, politicians are using it to pick up some cheap headlines by bashing Big Pharma.
Consider this comment by Senator Dick Durbin (D, IL), "The findings . . . raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market … Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs."
Here’s a fact that you won’t find under Durbin’s Turban – over the last 50 years the average American lifespan has increased by 10 years – a full decade, due largely to the impact of pharmaceutical research and development.
And the scary part is that 21st drug development is more complex and complicated as we move from small to large molecules and begin to aggressively research practical and personalized applications of the human genome.
But, as far as Senator Durbin is concerned, the beatings will continue until morale improves.
Step One: Give the FDA the tools it needs to help industry expedite 21st century drug development. Far too many drugs fail in Phase III. That’s not economically smart or sustainable – and it’s certainly not the best way to advance the public health. The FDA Critical Path program can help industry better understand which investigatory new drugs have the best chance for success – and which ones should be abandoned – far earlier in the process.
When asked why he was so successful, Thomas Edison replied, “Because I fail faster than everyone else.â€
GAO figure.
A report released yesterday by the Government Accountability Office reports that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent and about two-thirds of the new applications were for drugs that represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.
This is yet another example of the GAO “reporting†something that is widely known, widely reported, and widely debated. But it’s worth repeating because it focuses the spotlight on the crucial need for better drug development tools – precisely the remit of the FDA’s Critical Path program.
Please refer to our report, “Prescription for Progress†which can be found at http://www.cmpi.org At that link you’ll also find video of the conference we held to discuss the future of drug development, with speakers including FDA Commissioner Andy von Eschenbach and FDA Deputy Commissioner Janet Woodcock.
But, alas, rather than using the GAO report to focus attention on the real issue, politicians are using it to pick up some cheap headlines by bashing Big Pharma.
Consider this comment by Senator Dick Durbin (D, IL), "The findings . . . raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market … Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs."
Here’s a fact that you won’t find under Durbin’s Turban – over the last 50 years the average American lifespan has increased by 10 years – a full decade, due largely to the impact of pharmaceutical research and development.
And the scary part is that 21st drug development is more complex and complicated as we move from small to large molecules and begin to aggressively research practical and personalized applications of the human genome.
But, as far as Senator Durbin is concerned, the beatings will continue until morale improves.
Step One: Give the FDA the tools it needs to help industry expedite 21st century drug development. Far too many drugs fail in Phase III. That’s not economically smart or sustainable – and it’s certainly not the best way to advance the public health. The FDA Critical Path program can help industry better understand which investigatory new drugs have the best chance for success – and which ones should be abandoned – far earlier in the process.
When asked why he was so successful, Thomas Edison replied, “Because I fail faster than everyone else.â€
GAO figure.
There's been a lot of chatter lately about transparency -- especially when it concens conflicts of interest. And transparency is a good thing.
So why doesn't this same rule apply to, say, tort lawyers and professional medical witnesses?
Yes, as a matter of fact I do have some specific examples in mind.
The first is the justice-seeking tort lawyer featured in Alex Berenson's recent articles in the New York Times. His name is James B. Gottstein, and he is identified as "a lawyer who represents the mentally ill."
That sounds very altruistic. But is he working pro bono? If not, shouldn't the story have disclosed what his potential fee will be if he wins his pending cases? Would the public's perception of the story shift if full disclosure led to a more transparent descriptor for Mr. Gottstein that read, "a lawyer who represents the mentally ill in court cases asking for $25 million in damages of which he will receive a 25% contingency fee of over $6 million?"
I am making these numbers up -- I do not know if Mr. Gottstein is, indeed, working pro bono. I do not know what damages the lawsuits are requesting, nor do I know what his contingency fee is. Guess it's not part of "all the news that's fit to print."
Next example is Dr. David Healy. Dr. Healy recently testified at the FDA hearing on antidepressants. He is a psychiatry professor at Cardiff University in Wales but also, according to the New York Times, has worked for plaintiff's lawyers in cases brought against pharmaceutical companies. That's transparency. When I served as Associate Commissioner at the FDA, Dr. Healy visited with me -- but he never mentioned that he worked for the tort bar. That's dishonesty.
Transparency isn't a sometimes thing -- and if critics of industry and the FDA want more of it, they should do more of it themselves.
"Do as I say, not as I do" is not a workable policy -- a fact that should not be ignored by the MSM.
So why doesn't this same rule apply to, say, tort lawyers and professional medical witnesses?
Yes, as a matter of fact I do have some specific examples in mind.
The first is the justice-seeking tort lawyer featured in Alex Berenson's recent articles in the New York Times. His name is James B. Gottstein, and he is identified as "a lawyer who represents the mentally ill."
That sounds very altruistic. But is he working pro bono? If not, shouldn't the story have disclosed what his potential fee will be if he wins his pending cases? Would the public's perception of the story shift if full disclosure led to a more transparent descriptor for Mr. Gottstein that read, "a lawyer who represents the mentally ill in court cases asking for $25 million in damages of which he will receive a 25% contingency fee of over $6 million?"
I am making these numbers up -- I do not know if Mr. Gottstein is, indeed, working pro bono. I do not know what damages the lawsuits are requesting, nor do I know what his contingency fee is. Guess it's not part of "all the news that's fit to print."
Next example is Dr. David Healy. Dr. Healy recently testified at the FDA hearing on antidepressants. He is a psychiatry professor at Cardiff University in Wales but also, according to the New York Times, has worked for plaintiff's lawyers in cases brought against pharmaceutical companies. That's transparency. When I served as Associate Commissioner at the FDA, Dr. Healy visited with me -- but he never mentioned that he worked for the tort bar. That's dishonesty.
Transparency isn't a sometimes thing -- and if critics of industry and the FDA want more of it, they should do more of it themselves.
"Do as I say, not as I do" is not a workable policy -- a fact that should not be ignored by the MSM.
It is misleading that Alex Berenson relies upon James Gottstein as the entire source of his two articles on Eli Lilly's marketing practices with respect to Zyprexa. I am not going to even dignify his writing by discussing the scientific basis of using atypicals for illnesses other than mania.
Berenson failed to let you folks you know that Gottstein is not just a "lawyer who represents the mentally ill." What follows are a sample of some of Gottstein's quotes, activities and associates you won't find in Berenson's scribbles....
"...Representatives of mental health and consumer advocacy groups from throughout the USA will hold a peaceful protest and press conference in front of the headquarters of the Pharmaceutical Manufacturers and Researchers of America (PhRMA). Protesters allege that, "The pharmaceutical industry has taken over the mental health system. And we want it back."
MindFreedom International is sponsoring the legal protest at 12 noon on Monday, May 2, 2005 at PhRMA; 1100 Fifteenth Street, NW; Washington, DC.
"Join us and tell PhRMA to stop supporting forced psychiatric drugging! Tell PhRMA to be truthful about the clinical trials and side-effects of the medications that their member companies are profiting from," said Krista Erickson, board member of MindFreedom International.
Another protest speaker, attorney Jim Gottstein of the Law Project for Psychiatric Rights in Alaska, said, "PhRMA represents the Big Lie of Big Pharma, which should be called to account for its despicable sacrifice of people on the altar of corporate profits."
"......Jim Gottstein has been practicing law in Alaska for 25 years, including being an attorney advocate for people labeled with serious mental illness. Among many other things, he served as plaintiffs' counsel in the billion dollar litigation over Alaska's theft of the one million acre Alaska Mental Health Trust. Mr. Gottstein now devotes his time pro bono to the Law Project for Psychiatric Rights (www.PsychRights.org) , whose mission is to organize a serious, coordinated legal effort around the country against forced psychiatric drugging....."
"While the idea of screening kids for mental problems seems like a good idea, it ends up being nothing more than a Drugging Dragnet," says Jim Gottstein
Gottstein is also part of a coalition of anti-psychiatric drug groups including the Scientologists....... http://psychdiagnosis.net/Archive/endorsers.htm
Berenson failed to let you folks you know that Gottstein is not just a "lawyer who represents the mentally ill." What follows are a sample of some of Gottstein's quotes, activities and associates you won't find in Berenson's scribbles....
"...Representatives of mental health and consumer advocacy groups from throughout the USA will hold a peaceful protest and press conference in front of the headquarters of the Pharmaceutical Manufacturers and Researchers of America (PhRMA). Protesters allege that, "The pharmaceutical industry has taken over the mental health system. And we want it back."
MindFreedom International is sponsoring the legal protest at 12 noon on Monday, May 2, 2005 at PhRMA; 1100 Fifteenth Street, NW; Washington, DC.
"Join us and tell PhRMA to stop supporting forced psychiatric drugging! Tell PhRMA to be truthful about the clinical trials and side-effects of the medications that their member companies are profiting from," said Krista Erickson, board member of MindFreedom International.
Another protest speaker, attorney Jim Gottstein of the Law Project for Psychiatric Rights in Alaska, said, "PhRMA represents the Big Lie of Big Pharma, which should be called to account for its despicable sacrifice of people on the altar of corporate profits."
"......Jim Gottstein has been practicing law in Alaska for 25 years, including being an attorney advocate for people labeled with serious mental illness. Among many other things, he served as plaintiffs' counsel in the billion dollar litigation over Alaska's theft of the one million acre Alaska Mental Health Trust. Mr. Gottstein now devotes his time pro bono to the Law Project for Psychiatric Rights (www.PsychRights.org) , whose mission is to organize a serious, coordinated legal effort around the country against forced psychiatric drugging....."
"While the idea of screening kids for mental problems seems like a good idea, it ends up being nothing more than a Drugging Dragnet," says Jim Gottstein
Gottstein is also part of a coalition of anti-psychiatric drug groups including the Scientologists....... http://psychdiagnosis.net/Archive/endorsers.htm
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.
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.
