Latest Drugwonks' Blog
To see what happens when too many people toady up to for too long and what being imperious does to one's brain cells and personality, read Arnold Relman's screed against Richard Epstein's book "Overdose: How Excessive Government Regulation Stifles Pharmaceuetical Innovation."
To be fair, Epstein lays into Relman in his book, so Arnie is entitled to hit back. But the review is long, boring and short on detail. He never rebuts Epstein's claim. Rather he just screams that Big Pharma buys and sells the FDA and every other major political institution. Well if that's the case, why do so many of their drugs fail to make past FDA reviewers? If the marketing is so successful why not crank out one me too after another and just ram them down the throats of stupid docs and consumers? Why invest in innovation at all? Then the problem of government regulation disappears.
Relman is so obsessed with his droning that he does not realize he has no point. That is the biomarker of a zealot or some other condition.
http://www.tnr.com/doc.mhtml?i=20070723&s=relman072307
To be fair, Epstein lays into Relman in his book, so Arnie is entitled to hit back. But the review is long, boring and short on detail. He never rebuts Epstein's claim. Rather he just screams that Big Pharma buys and sells the FDA and every other major political institution. Well if that's the case, why do so many of their drugs fail to make past FDA reviewers? If the marketing is so successful why not crank out one me too after another and just ram them down the throats of stupid docs and consumers? Why invest in innovation at all? Then the problem of government regulation disappears.
Relman is so obsessed with his droning that he does not realize he has no point. That is the biomarker of a zealot or some other condition.
http://www.tnr.com/doc.mhtml?i=20070723&s=relman072307
Avandia raises good cholesterol and (however it raises bad )while controlling diabetes..how about that? To quote the study... "Pioglitazone and rosiglitazone cause a small but significant increase in high-density lipoprotein, often called "good cholesterol" because it promotes the breakdown and removal of cholesterol from the body." This has been Nissen's holy grail...it must kill him to see it reported in a drug he tried to destroy while others he has worked on have tanked...
And the study which looks at all forms a drugs to control Type 2 diabetes, many of which are used in tandem, is a kick in a teeth to Nissen's sloppy and skewed handling of the data and Furberg's hysterical handling of the results thereof. Now that they two have been added to Adcomm, let's see if they behave responsibly before, during and after the meeting instead of trying to inflame passion. My guess is, on the heels of the AHQR study and a recent microvascular study by Eric Topol and colleagues showing a protective effect impact from Avandia in certain patients with metabolic disorders undergoing revascularization, the black box warning will be mild and some primary care docs might even begin to prescribe again, though not to patients at risk for CHF.
Now let's see how the media covers this study and its rebuke to Nissen.
http://www.ahcpr.gov/news/press/pr2007/effdiabpr.htm
Seel also "Peroxisome proliferator-activated receptor gamma agonists for the Prevention of Adverse events following percutaneous coronary Revascularization--results of the PPAR study."
Am Heart J. 2007 Jul;154(1):137-43.
And the study which looks at all forms a drugs to control Type 2 diabetes, many of which are used in tandem, is a kick in a teeth to Nissen's sloppy and skewed handling of the data and Furberg's hysterical handling of the results thereof. Now that they two have been added to Adcomm, let's see if they behave responsibly before, during and after the meeting instead of trying to inflame passion. My guess is, on the heels of the AHQR study and a recent microvascular study by Eric Topol and colleagues showing a protective effect impact from Avandia in certain patients with metabolic disorders undergoing revascularization, the black box warning will be mild and some primary care docs might even begin to prescribe again, though not to patients at risk for CHF.
Now let's see how the media covers this study and its rebuke to Nissen.
http://www.ahcpr.gov/news/press/pr2007/effdiabpr.htm
Seel also "Peroxisome proliferator-activated receptor gamma agonists for the Prevention of Adverse events following percutaneous coronary Revascularization--results of the PPAR study."
Am Heart J. 2007 Jul;154(1):137-43.
When is a serious side effect not a serious side effect?
When the people who are at risk or talk about it receive support from drug companies.
At least that's what the WSJ implies in it's article about people with epilepsy who suffer seizures when they are switched -- without their consent -- to a generic version of an anti-convulsant to save a few bucks.
PILL PUSH
Industry Fights Switch
To Generics for Epilepsy
Big Drug Makers Help
Patient Groups Lobby;
More Attention to States
By SARAH RUBENSTEIN
In state legislatures across the country, the Epilepsy Foundation has been campaigning for bills that would make it harder for pharmacists to switch patients to inexpensive generic epilepsy pills. The effort is getting behind-the-scenes support from drug companies -- a sign of how the industry, long a potent lobbying force in Washington, is increasingly looking to states to achieve its goals.
http://online.wsj.com/article/SB118426152232264867-search.html?KEYWORDS=epilepsy&COLLECTION=wsjie/6month
I will get to the science behind this issue -- and there is science, though you wouldn't know it from reading the piece -- in a second. But consider this:
The WSJ piece depicts the epilepsy drug switch-side effect issue as anecdot dotted campaign led by Big Pharma to keep their drugs on formulary. Yet Steve Nissen receives money from drug companies and did a slap dash study about heart attack risk of Avandia and that was front page news. He had to pool studies of widely varying quality and size (basically pooling anecdotal information) and he was hailed by the media as a whistleblower.
Now AP reports that the FDA is getting anecdotal reports of heart attacks from Avandia users (no surprise since diabetics are 2x likely to have heart problems than others) and claims that this is evidence of Avandia's dangers previously being under-reported. "Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet."
http://news.yahoo.com/s/ap/20070713/ap_on_he_me/diabetes_drug_risks_8
Now to the evidence of drug switching triggering seizures. Anti-convulsants have very narrow therapeutic windows. So switching, whether from one brand to another or from a brand to a cheaper older med can cause problems. That is fact.
Here is one study "Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes." Epilepsia. 2007 Mar;48(3):464-9. The study found: These results reflect poor acceptance of switching AEDs (anti-epileptic drugs) to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use."
So what did we learn class?
Take adverse reports after hysterical reporting of a sloppy and politically motivated meta analysis on Avandia seriously. Why? Not generated by Big Pharma.
Ignore the reports of seizures associated with compulsory drug switching to generic anti convulsants. Why? Obviously generated by Big Pharma.
And what about the scientific basis behind the seizures? Too bad. If someone is supported by Big Pharma, then they obviously deserve to get seizures anyway.
When the people who are at risk or talk about it receive support from drug companies.
At least that's what the WSJ implies in it's article about people with epilepsy who suffer seizures when they are switched -- without their consent -- to a generic version of an anti-convulsant to save a few bucks.
PILL PUSH
Industry Fights Switch
To Generics for Epilepsy
Big Drug Makers Help
Patient Groups Lobby;
More Attention to States
By SARAH RUBENSTEIN
In state legislatures across the country, the Epilepsy Foundation has been campaigning for bills that would make it harder for pharmacists to switch patients to inexpensive generic epilepsy pills. The effort is getting behind-the-scenes support from drug companies -- a sign of how the industry, long a potent lobbying force in Washington, is increasingly looking to states to achieve its goals.
http://online.wsj.com/article/SB118426152232264867-search.html?KEYWORDS=epilepsy&COLLECTION=wsjie/6month
I will get to the science behind this issue -- and there is science, though you wouldn't know it from reading the piece -- in a second. But consider this:
The WSJ piece depicts the epilepsy drug switch-side effect issue as anecdot dotted campaign led by Big Pharma to keep their drugs on formulary. Yet Steve Nissen receives money from drug companies and did a slap dash study about heart attack risk of Avandia and that was front page news. He had to pool studies of widely varying quality and size (basically pooling anecdotal information) and he was hailed by the media as a whistleblower.
Now AP reports that the FDA is getting anecdotal reports of heart attacks from Avandia users (no surprise since diabetics are 2x likely to have heart problems than others) and claims that this is evidence of Avandia's dangers previously being under-reported. "Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet."
http://news.yahoo.com/s/ap/20070713/ap_on_he_me/diabetes_drug_risks_8
Now to the evidence of drug switching triggering seizures. Anti-convulsants have very narrow therapeutic windows. So switching, whether from one brand to another or from a brand to a cheaper older med can cause problems. That is fact.
Here is one study "Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes." Epilepsia. 2007 Mar;48(3):464-9. The study found: These results reflect poor acceptance of switching AEDs (anti-epileptic drugs) to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use."
So what did we learn class?
Take adverse reports after hysterical reporting of a sloppy and politically motivated meta analysis on Avandia seriously. Why? Not generated by Big Pharma.
Ignore the reports of seizures associated with compulsory drug switching to generic anti convulsants. Why? Obviously generated by Big Pharma.
And what about the scientific basis behind the seizures? Too bad. If someone is supported by Big Pharma, then they obviously deserve to get seizures anyway.
Sicko open last week in 300 theaters and took in $4.5 mill. This past week it took in $3.6 in over 700 theaters.
More people saw Moore get the crap kicked out of him by Sanjay Gupta on Larry King Live than went to see his movie.
More people saw Moore get the crap kicked out of him by Sanjay Gupta on Larry King Live than went to see his movie.
In another blow to those who want keep Americans taking old medicines by banning access to free samples, marketing, continuing medical education, off label use and other methods that increase new drug use, this from my former perch at the Manhattan Institute and Frank Lichtenberg:
"It is no surprise that Americans are living longer today than in previous generations. A typical baby born in 1900 was expected to live to about age 45. Today, life expectancy at birth is about 78. Less well known, however, is the fact that the gains in life expectancy have not been uniform across the country. In his new study—the first of its kind—Columbia University researcher Frank Lichtenberg set out to find out which states are the leaders, which ones are the laggards, and why.
Lichtenberg then set out to examine why this “longevity increase gap†exists by measuring the impact of several factors that researchers agree could affect life expectancy. He found that, although some obvious suspects—obesity, smoking, and the incidence of HIV/AIDS—played a role, the most important factor was “medical innovation.â€
Specifically, Lichtenberg found that longevity increased the most in those states where access to newer drugs—measured by mean “vintage†(FDA approval year)—in Medicaid and Medicare programs has increased the most. In fact, about two-thirds of the potential increase in longevity—the longevity increase that would have occurred if obesity, income, and other factors had not changed—is attributable to the use of newer drugs. "
Here's a link to the study:http://www.manhattan-institute.org/html/mpr_04.htm
"It is no surprise that Americans are living longer today than in previous generations. A typical baby born in 1900 was expected to live to about age 45. Today, life expectancy at birth is about 78. Less well known, however, is the fact that the gains in life expectancy have not been uniform across the country. In his new study—the first of its kind—Columbia University researcher Frank Lichtenberg set out to find out which states are the leaders, which ones are the laggards, and why.
Lichtenberg then set out to examine why this “longevity increase gap†exists by measuring the impact of several factors that researchers agree could affect life expectancy. He found that, although some obvious suspects—obesity, smoking, and the incidence of HIV/AIDS—played a role, the most important factor was “medical innovation.â€
Specifically, Lichtenberg found that longevity increased the most in those states where access to newer drugs—measured by mean “vintage†(FDA approval year)—in Medicaid and Medicare programs has increased the most. In fact, about two-thirds of the potential increase in longevity—the longevity increase that would have occurred if obesity, income, and other factors had not changed—is attributable to the use of newer drugs. "
Here's a link to the study:http://www.manhattan-institute.org/html/mpr_04.htm
By the looks of it and the typical Moore reaction (attacking his critics personally) CNN's Sanjay Gupta's look at the fudgy facts of Moore's movie have really hit a nerve. Moore was really steaming as Gupta continued to point out that links to MSNBC web sites are not real citations and projected numbers are not actual dollars spent.
Even when Moore's acolytes and staffers try to defend him they step in it. For example, Deborah Burger, the head of the California Nurses Association claims that Aetna CEO Troy Brennan claimed that " recent statistics from the Institution of Healthcare Improvement document "that people are waiting an average of about 70 days to see a provider."
http://www.michaelmoore.com/sicko/news/article.php?id=10023
Uh, actually the Institution FOR Healthcare Improvement document was referring to the Amarillo VA Health Care System which reorganized Primary Care in January 2000 based on the principles of Advanced Clinic Access. It had a waiting time for 76 days and reduced the time to 20 days by using the new software system. And the system is designed to reduce the backlog of no-show appointments which is unrelated to excess demand.
It took them one month to cut the waiting time by two thirds. Meanwhile, primary care waiting time for first appointments in the UK are, what, 3 months at a minimum?
And don't give me the crap from the Commonwealth Fund...that compared Medicaid recipients (government care) and the unisured poor to middle class and rich people who supplement their care with private health insurance in other countries. And Commonwealth failed to sample in rural areas internationally where health and access disparities show up. And even then, Americans did as well or better than less diverse and urbanized countries in getting prompt care. Oh, they never told you that? Neither does Michael Moore.
Read here
Even when Moore's acolytes and staffers try to defend him they step in it. For example, Deborah Burger, the head of the California Nurses Association claims that Aetna CEO Troy Brennan claimed that " recent statistics from the Institution of Healthcare Improvement document "that people are waiting an average of about 70 days to see a provider."
http://www.michaelmoore.com/sicko/news/article.php?id=10023
Uh, actually the Institution FOR Healthcare Improvement document was referring to the Amarillo VA Health Care System which reorganized Primary Care in January 2000 based on the principles of Advanced Clinic Access. It had a waiting time for 76 days and reduced the time to 20 days by using the new software system. And the system is designed to reduce the backlog of no-show appointments which is unrelated to excess demand.
It took them one month to cut the waiting time by two thirds. Meanwhile, primary care waiting time for first appointments in the UK are, what, 3 months at a minimum?
And don't give me the crap from the Commonwealth Fund...that compared Medicaid recipients (government care) and the unisured poor to middle class and rich people who supplement their care with private health insurance in other countries. And Commonwealth failed to sample in rural areas internationally where health and access disparities show up. And even then, Americans did as well or better than less diverse and urbanized countries in getting prompt care. Oh, they never told you that? Neither does Michael Moore.
Read here
The Priesthood of Pharmaceutical Purists use trial attorney winnings to in part finance their attack on industry. One of their meal tickets is going to three squares behind bars.....
"Milberg Weiss' Bershad Pleads Guilty to Conspiracy in Kickback Plan
Name partner at securities plaintiffs law firm agrees to cooperate and to forfeit $7.75 million"
David J. Bershad, a name partner at securities plaintiffs law firm Milberg Weiss & Bershad, has pleaded guilty to federal charges that he conspired in the payment of illegal kickbacks to individual class action plaintiffs.
The guilty plea by Bershad, entered Monday afternoon in federal court in Los Angeles, raises the stakes for his co-defendants, former fellow name partner Steven G. Schulman and the Milberg Weiss firm itself, as well as the other major Milberg Weiss figures, Melvyn I. Weiss and William S. Lerach, who have so far escaped indictment.
http://www.law.com/jsp/article.jsp?id=1183971987057&rss=newswire
Now Millberg Weiss is part of the Prescription Access Litigation Project (PAL). But PAL conveniently leaves the firm off it's website. But since drugwonks is all about transparency, here is a reminder of their close connection, courtesy of MassPIRG
http://masspirg.org/MA.asp?id2=5318&id3=MA& and PAL itself
http://www.prescriptionaccess.org/press/pressreleases?id=0013
"Milberg Weiss' Bershad Pleads Guilty to Conspiracy in Kickback Plan
Name partner at securities plaintiffs law firm agrees to cooperate and to forfeit $7.75 million"
David J. Bershad, a name partner at securities plaintiffs law firm Milberg Weiss & Bershad, has pleaded guilty to federal charges that he conspired in the payment of illegal kickbacks to individual class action plaintiffs.
The guilty plea by Bershad, entered Monday afternoon in federal court in Los Angeles, raises the stakes for his co-defendants, former fellow name partner Steven G. Schulman and the Milberg Weiss firm itself, as well as the other major Milberg Weiss figures, Melvyn I. Weiss and William S. Lerach, who have so far escaped indictment.
http://www.law.com/jsp/article.jsp?id=1183971987057&rss=newswire
Now Millberg Weiss is part of the Prescription Access Litigation Project (PAL). But PAL conveniently leaves the firm off it's website. But since drugwonks is all about transparency, here is a reminder of their close connection, courtesy of MassPIRG
http://masspirg.org/MA.asp?id2=5318&id3=MA& and PAL itself
http://www.prescriptionaccess.org/press/pressreleases?id=0013
Trevor Butterworth sums up the sad state of Steve Nissen, the NEJM and the media in his post. And the Priesthood of Pharmaceutical Purists, trial attorneys and assorted Whack Packers want to entrust the public health to these sort of people???
http://www.huffingtonpost.com/trevor-butterworth/a-crusading-doctor-stumbl_b_55681.html
http://www.huffingtonpost.com/trevor-butterworth/a-crusading-doctor-stumbl_b_55681.html
I wanted to call attention to my recent piece in the Florida Sun-Sentinel about insomnia, and its related health issues. The piece centers on the recent excellent Alan Berliner documentary Wide Awake on HBO.
I am what i would call a self-induced insomniac, i use it to get my writing done and meet deadlines. Unfortunately, this establishes a pattern of middle of the night wakefulness which persists even when i have no deadline. This is not good for my health. I don't currently take sleeping pills, but many of my patients find them useful - and in fact Ambien is one of those examples of good drugs that to from panacea to panic whenevever a media report focuses on the rare sleepwalker. All drugs should be managed or monitored by the doctors who prescribe them, but they are not good guys or bad guys, they are useful arrows in our medical quiver.
http://www.sun-sentinel.com/news/opinion/sfl-forum06insomnianbjul06,0,5107682.story?coll=sfla-news-opinion
I am what i would call a self-induced insomniac, i use it to get my writing done and meet deadlines. Unfortunately, this establishes a pattern of middle of the night wakefulness which persists even when i have no deadline. This is not good for my health. I don't currently take sleeping pills, but many of my patients find them useful - and in fact Ambien is one of those examples of good drugs that to from panacea to panic whenevever a media report focuses on the rare sleepwalker. All drugs should be managed or monitored by the doctors who prescribe them, but they are not good guys or bad guys, they are useful arrows in our medical quiver.
http://www.sun-sentinel.com/news/opinion/sfl-forum06insomnianbjul06,0,5107682.story?coll=sfla-news-opinion
The Journal of Life Science provides a great weekly brief of health care and medical innovation news and opinion. This week is no different.
http://www.tjols.com/wb/07jul06.html#diabetes
What I find striking is that so many of the incremental advances in medicine -- those that will lead to more predictive and preventive care -- will depend on future investment to both test the validity and reliability of new information as real products. To quote Robert Solow many if not most innovations need to be embodied in new kinds of ..... equipment before they can be made effective. Improvements in technology affect output only to the extent that they are carried into practice either by net capital formation or by the replacement of old-fashioned equipment by the latest models…â€
Of course, that process of commercialization requires profit, risk taking, marketing, industrial-academic relationships, patent protection. In short, everything need to make this world a better place through technological advancement most of what I will call the Whack Pack either opposes, makes money critcizing or suing.
Now nothing's perfect and change is constant. Compassion, trust and honesty should inform all social relations. But to suggest ridding science of commercialism will bring about a better and brave new world is...in a word, whacky and dangerous.
http://www.tjols.com/wb/07jul06.html#diabetes
What I find striking is that so many of the incremental advances in medicine -- those that will lead to more predictive and preventive care -- will depend on future investment to both test the validity and reliability of new information as real products. To quote Robert Solow many if not most innovations need to be embodied in new kinds of ..... equipment before they can be made effective. Improvements in technology affect output only to the extent that they are carried into practice either by net capital formation or by the replacement of old-fashioned equipment by the latest models…â€
Of course, that process of commercialization requires profit, risk taking, marketing, industrial-academic relationships, patent protection. In short, everything need to make this world a better place through technological advancement most of what I will call the Whack Pack either opposes, makes money critcizing or suing.
Now nothing's perfect and change is constant. Compassion, trust and honesty should inform all social relations. But to suggest ridding science of commercialism will bring about a better and brave new world is...in a word, whacky and dangerous.
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.
