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07/16/2007 10:17 PM |
"Older, cheaper diabetes drugs are as safe and effective as newer ones, concludes an analysis that is good news for diabetics and may further hurt sales of Avandia, a blockbuster pill recently tied to heart problems.
The clear winner: metformin, sold as Glucophage and generically for about $100 a year. It works as well as other diabetes pills but does not cause weight gain or too-low blood sugar, the analysis found. It also lowers LDL or bad cholesterol."
http://news.yahoo.com/s/ap/20070716/ap_on_he_me/diabetes_drugs;_ylt=AjRpOmAY4PhCXhkEvojSg37VJRIF
I guess AP was just reading the press release and not the report or even the exec summary which carried these important tidbits:
The study only focused on monotherapy while the trend in diabetes care is towards combination therapy to maintain glycemic control, blood pressure, cholesterol. Hence, Avandia or Actos will be used in combination with Glucphage or insulin, not one or the other.
The study ignored many important clinical endpoints for which combination therapies are used, hyperinsulinaemia, for instance or fat build up.
The study acknowledges that combo therapy works better than monotherapy.
It also acknowledges that the supposed superiority of weight loss associated with metformin could be due to removing a prior drug used in head to head comparision trials so that the weight loss is an artifact of an experiment not the medicine. Oh.
So why did the authors not make these caveats in their statements to the media and so eager to push metformin as the....cheapest and best? Here is what the authors siad in their article in the Annals of Internal Medicine: Drugs like metformin "lower cost, longer use in practice and more intensive scrutiny in long-term trials" But the trend is towards combination therapy. Do I detect a bias, a falling into line with a ideological bent beyond what the data suggest? Is this ALLHAT and CATIE redux?
http://www.annals.org/cgi/content/full/0000605-200709180-00178v1 Read More & Comment...
The clear winner: metformin, sold as Glucophage and generically for about $100 a year. It works as well as other diabetes pills but does not cause weight gain or too-low blood sugar, the analysis found. It also lowers LDL or bad cholesterol."
http://news.yahoo.com/s/ap/20070716/ap_on_he_me/diabetes_drugs;_ylt=AjRpOmAY4PhCXhkEvojSg37VJRIF
I guess AP was just reading the press release and not the report or even the exec summary which carried these important tidbits:
The study only focused on monotherapy while the trend in diabetes care is towards combination therapy to maintain glycemic control, blood pressure, cholesterol. Hence, Avandia or Actos will be used in combination with Glucphage or insulin, not one or the other.
The study ignored many important clinical endpoints for which combination therapies are used, hyperinsulinaemia, for instance or fat build up.
The study acknowledges that combo therapy works better than monotherapy.
It also acknowledges that the supposed superiority of weight loss associated with metformin could be due to removing a prior drug used in head to head comparision trials so that the weight loss is an artifact of an experiment not the medicine. Oh.
So why did the authors not make these caveats in their statements to the media and so eager to push metformin as the....cheapest and best? Here is what the authors siad in their article in the Annals of Internal Medicine: Drugs like metformin "lower cost, longer use in practice and more intensive scrutiny in long-term trials" But the trend is towards combination therapy. Do I detect a bias, a falling into line with a ideological bent beyond what the data suggest? Is this ALLHAT and CATIE redux?
http://www.annals.org/cgi/content/full/0000605-200709180-00178v1 Read More & Comment...
07/16/2007 05:34 PM |
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 Read More & Comment...
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 Read More & Comment...
07/16/2007 05:10 PM |
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. Read More & Comment...
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. Read More & Comment...
07/13/2007 10:08 AM |
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. Read More & Comment...
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. Read More & Comment...
07/12/2007 04:22 PM |
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. Read More & Comment...
More people saw Moore get the crap kicked out of him by Sanjay Gupta on Larry King Live than went to see his movie. Read More & Comment...
07/12/2007 08:27 AM |
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 Read More & Comment...
"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 Read More & Comment...
07/11/2007 07:52 PM |
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
Read More & Comment...
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
Read More & Comment...
07/11/2007 08:26 AM |
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 Read More & Comment...
"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 Read More & Comment...
07/11/2007 08:19 AM |
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 Read More & Comment...
http://www.huffingtonpost.com/trevor-butterworth/a-crusading-doctor-stumbl_b_55681.html Read More & Comment...
07/10/2007 11:24 AM |
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 Read More & Comment...
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 Read More & Comment...
07/09/2007 10:13 PM |
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. Read More & Comment...
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. Read More & Comment...
07/09/2007 09:55 AM |
That oft repeated question by the proponents of drug importation. Sadly, today's answer is, in Vancouver.
Here's the news from Canada's newspaper of record, the Toronto Globe & Mail.
ONLINE PHARMACIES
Counterfeit drugs caused woman's death, coroner concludes
ARMINA LIGAYA
July 6, 2007
VANCOUVER -- Shoddy pills from a bogus online pharmacy are to blame for the death of a 58-year-old woman from Vancouver Island, a coroner's report says.
Yesterday's conclusion makes Marcia Bergeron the first clear-cut case of a death stemming from counterfeit drugs bought on the Internet, but it likely won't be the last, said Rose Stanton, regional coroner for Vancouver Island.
"The quantity of seized counterfeit medication is huge," she said. "And so, what we have is the first person [for whom] we have all the facts, who we know died as a result of these drugs.
"But what we also know is lots of people are buying these drugs. So the potential for more deaths is high."
Ms. Bergeron was found by a friend on Dec. 28, 2006, in her bed in a normal sleeping position. Emergency services were called, but it was clear she had been dead for some time.
Three types of pills were found at Ms. Bergeron's home. One contained Zolpidem, a powerful hypnotic not available in Canada. Another contained the anti-anxiety medication Alprazolam, which is available with a prescription, and the third contained acetaminophen.
These drugs were later determined to be laced with extremely high quantities of metal. The acetaminophen pill had 15 times the amount of aluminum that would be fatal, Ms. Stanton said.
An autopsy showed that Ms. Bergeron died of cardiac arrhythmia stemming from metal toxicity.
In the weeks and months leading up to her death, she complained of flu-like symptoms. Ms. Bergeron said, in e-mails to a friend, that her hair was falling out, and she suffered from nausea, diarrhea, aching joints and blurry vision.
When the pills were tested, they were of such poor quality, the ingredients seemed "mashed together" Ms. Stanton said. The mixture of drugs and metal in each pill would vary depending on which portion was examined, she said.
The metal contaminants were likely part of the filler materials used to make the pills, the coroner's report said.
On Ms. Bergeron's computer, records showed she had been visiting websites from which medication could be purchased.
When U.S. Food and Drug Administration investigators examined her hard drive, it showed Ms. Bergeron bought Zolpidem - a powerful sedative available by prescription in the U.S. but not in Canada.
The website she used, which purported to be Canadian but has since gone offline, was previously flagged by the FDA concerning counterfeit Zolpidem.
Because of all these elements - computer records, e-mails, drugs found on scene and a subsequent autopsy - investigators were able to definitively link the online drugs to Ms. Bergeron's death.
It's an FDA first, Ms. Stanton said.
She said the website Ms. Bergeron used is one of thousands that claim to be reputable pharmacies.
"The site that she purchased from is one of a group of sites that the FDA says use the tactic of phoning people after they get the first order," she said. "They phone for the renewal so there isn't a computer record."
Marnie Mitchell, CEO of the B.C. Pharmacy Association said that Canada has a very regulated and monitored pharmacy system, and stepping away from it has risks.
"Online sources are very difficult to assess their legitimacy and their safety," she said. "This is a very tragic episode and illustration of the problems that stem from going to those kinds of places."
Cracking down on these websites, however, would be a difficult endeavour, she said, because they change and shift very quickly and are hard to trace.
Instead, she recommended the federal government launch a public-awareness campaign to warn people of the potential dangers.
Alain Desroches, spokesperson for Health Canada said the agency regularly flags counterfeit products and issues public advisories. It also works with RCMP in investigating counterfeit drugs. However, he could not comment on any policy changes that would stem from the coroner's findings.
"We welcome the report and it's going to be reviewed carefully," he said. Read More & Comment...
Here's the news from Canada's newspaper of record, the Toronto Globe & Mail.
ONLINE PHARMACIES
Counterfeit drugs caused woman's death, coroner concludes
ARMINA LIGAYA
July 6, 2007
VANCOUVER -- Shoddy pills from a bogus online pharmacy are to blame for the death of a 58-year-old woman from Vancouver Island, a coroner's report says.
Yesterday's conclusion makes Marcia Bergeron the first clear-cut case of a death stemming from counterfeit drugs bought on the Internet, but it likely won't be the last, said Rose Stanton, regional coroner for Vancouver Island.
"The quantity of seized counterfeit medication is huge," she said. "And so, what we have is the first person [for whom] we have all the facts, who we know died as a result of these drugs.
"But what we also know is lots of people are buying these drugs. So the potential for more deaths is high."
Ms. Bergeron was found by a friend on Dec. 28, 2006, in her bed in a normal sleeping position. Emergency services were called, but it was clear she had been dead for some time.
Three types of pills were found at Ms. Bergeron's home. One contained Zolpidem, a powerful hypnotic not available in Canada. Another contained the anti-anxiety medication Alprazolam, which is available with a prescription, and the third contained acetaminophen.
These drugs were later determined to be laced with extremely high quantities of metal. The acetaminophen pill had 15 times the amount of aluminum that would be fatal, Ms. Stanton said.
An autopsy showed that Ms. Bergeron died of cardiac arrhythmia stemming from metal toxicity.
In the weeks and months leading up to her death, she complained of flu-like symptoms. Ms. Bergeron said, in e-mails to a friend, that her hair was falling out, and she suffered from nausea, diarrhea, aching joints and blurry vision.
When the pills were tested, they were of such poor quality, the ingredients seemed "mashed together" Ms. Stanton said. The mixture of drugs and metal in each pill would vary depending on which portion was examined, she said.
The metal contaminants were likely part of the filler materials used to make the pills, the coroner's report said.
On Ms. Bergeron's computer, records showed she had been visiting websites from which medication could be purchased.
When U.S. Food and Drug Administration investigators examined her hard drive, it showed Ms. Bergeron bought Zolpidem - a powerful sedative available by prescription in the U.S. but not in Canada.
The website she used, which purported to be Canadian but has since gone offline, was previously flagged by the FDA concerning counterfeit Zolpidem.
Because of all these elements - computer records, e-mails, drugs found on scene and a subsequent autopsy - investigators were able to definitively link the online drugs to Ms. Bergeron's death.
It's an FDA first, Ms. Stanton said.
She said the website Ms. Bergeron used is one of thousands that claim to be reputable pharmacies.
"The site that she purchased from is one of a group of sites that the FDA says use the tactic of phoning people after they get the first order," she said. "They phone for the renewal so there isn't a computer record."
Marnie Mitchell, CEO of the B.C. Pharmacy Association said that Canada has a very regulated and monitored pharmacy system, and stepping away from it has risks.
"Online sources are very difficult to assess their legitimacy and their safety," she said. "This is a very tragic episode and illustration of the problems that stem from going to those kinds of places."
Cracking down on these websites, however, would be a difficult endeavour, she said, because they change and shift very quickly and are hard to trace.
Instead, she recommended the federal government launch a public-awareness campaign to warn people of the potential dangers.
Alain Desroches, spokesperson for Health Canada said the agency regularly flags counterfeit products and issues public advisories. It also works with RCMP in investigating counterfeit drugs. However, he could not comment on any policy changes that would stem from the coroner's findings.
"We welcome the report and it's going to be reviewed carefully," he said. Read More & Comment...
07/09/2007 09:23 AM |
In today's New York Times, Paul Krugman calls for universal health care in the United States, calls those who oppose it all sorts of nasty names, and points to SiCKO as his proof of concept.
Note to Paul: Read the ads for SiCKO in your own paper -- it's billed as a comedy.
To get a feel for his general position, consider this statement, "Medicare ... is being undermined by privatization."
What he doesn't say is that ... it's working. Every poll shows that seniors are very pleased with the Part D benefit-- and by huge margins. And every government report shows that the program is coming in significantly below cost projections.
Imagine that, a government program that people like and comes in under budget. Privatization may seem like a frightening concept to Mr. Krugman, but it sure works.
But why let facts get in the way when you've got an agenda to pursue?
And here's the agenda, summed up in one sentence:
"Universal health care would save thousands of American lives each year, while actually saving money."
Really? All the statistics from Europe and other nations with government-run health care say different. Having just returned from a conference of European health care experts, regulatory officials, and legislators, I can attest to the many problems European government are facing as they try to reinvent their own national systems for the 21st Century.
Paul -- come with me to Europe and let's film a documentary of not only care denied but care unavailable. I'm sure we could make it as "entertaining" as SiCKO. It's easy to prove an argument when you cherry-pick the facts. We can call our movie "MaLADE-O."
Ooh-la-la!
Mark Twain wrote, "For every complex problem there is a simple solution -- and it is usually wrong."
Alas, there is no perfect, easy solution to the American health care miasma. That only happens in the movies.
For a more balanced view of how to advance the cause of health care in America, read what HHS Secretary Mike Leavitt has to say ...
http://www.washingtontimes.com/article/20070709/EDITORIAL/107090020/1013
And -- see you at the movies. Read More & Comment...
Note to Paul: Read the ads for SiCKO in your own paper -- it's billed as a comedy.
To get a feel for his general position, consider this statement, "Medicare ... is being undermined by privatization."
What he doesn't say is that ... it's working. Every poll shows that seniors are very pleased with the Part D benefit-- and by huge margins. And every government report shows that the program is coming in significantly below cost projections.
Imagine that, a government program that people like and comes in under budget. Privatization may seem like a frightening concept to Mr. Krugman, but it sure works.
But why let facts get in the way when you've got an agenda to pursue?
And here's the agenda, summed up in one sentence:
"Universal health care would save thousands of American lives each year, while actually saving money."
Really? All the statistics from Europe and other nations with government-run health care say different. Having just returned from a conference of European health care experts, regulatory officials, and legislators, I can attest to the many problems European government are facing as they try to reinvent their own national systems for the 21st Century.
Paul -- come with me to Europe and let's film a documentary of not only care denied but care unavailable. I'm sure we could make it as "entertaining" as SiCKO. It's easy to prove an argument when you cherry-pick the facts. We can call our movie "MaLADE-O."
Ooh-la-la!
Mark Twain wrote, "For every complex problem there is a simple solution -- and it is usually wrong."
Alas, there is no perfect, easy solution to the American health care miasma. That only happens in the movies.
For a more balanced view of how to advance the cause of health care in America, read what HHS Secretary Mike Leavitt has to say ...
http://www.washingtontimes.com/article/20070709/EDITORIAL/107090020/1013
And -- see you at the movies. Read More & Comment...
07/09/2007 07:42 AM |
Word on the Hill is that Rahm Emanuel is going to try to tag sound FDA reform legislation with an unsound amendment on -- yes, you guessed it -- drug importation. Is anyone out there shocked? Probably not. After all, for Mr. Emanuel politics is more important than the public health.
Here's a new Chicago Tribune op-ed on why drug importation is a bad idea:
http://www.chicagotribune.com/news/opinion/chi-oped0708taintjul08,0,1697228.story?coll=chi-newsopinioncommentary-hed
You can't be for drug safety one day and against it the next. You can't rant against counterfeit tainted toothpaste and embrace the importation of foreign drugs. It's intellectually dishonest and contrary to the best interests of the public health. Read More & Comment...
Here's a new Chicago Tribune op-ed on why drug importation is a bad idea:
http://www.chicagotribune.com/news/opinion/chi-oped0708taintjul08,0,1697228.story?coll=chi-newsopinioncommentary-hed
You can't be for drug safety one day and against it the next. You can't rant against counterfeit tainted toothpaste and embrace the importation of foreign drugs. It's intellectually dishonest and contrary to the best interests of the public health. Read More & Comment...
07/08/2007 02:16 PM |
When Rezulin was removed from the market several years ago, the top endocrinologist I worked with was quite upset. Of course he knew about the few cases of severe liver failure and the rare death, but he also knew how many patients benefited directly from the drug. "Avandia will be next," he predicted.
Thiazolidinediones (TZDs) are a class of drugs which improve insulin receptor sensitivity and reverse the insulin resistance typically seen in type 2 diabetes. Since most type 2 diabetics have too few receptors per body surface area, the TZDs are very useful drugs.
The fact that patients ont he remaining two TZDs (Avandia and Actos) can gain weight on these drugs is not news. The question of whether they can cause or worsen heart failure has long been discussed. Unfortunately the current raging debate and targeting of the FDA and the drug manufacturers doesn't directly address this question. The existing information is based on mathematical analyses of previously published data and is weak.
Prospective randomized trials are necessary, but what should a clinician do? All too often, as the pendulum swings from panacea to panic, a perfectly good medication has its reputation damaged or destroyed based on limited or overblown results, all in the name of drug safety.
To give just one example as it relates to TZDs, it is clear that controlling blood sugar is important in preventing diabetic end organ damage. Among these crucial organs we try to protect is the heart. Everyone agrees that Avandia and Actos help to significantly lower blood sugar. But as their reputations are damaged in the media, how many safety-driven zealots have stopped to consider what uncontrolled sugars mean to the heart? Now that patients - and doctors - will be running from these drugs with their new "black box" warnings, what will be the clinical results? In other words, which will cause more heart damage; the drugs themselves, or stopping them? Read More & Comment...
Thiazolidinediones (TZDs) are a class of drugs which improve insulin receptor sensitivity and reverse the insulin resistance typically seen in type 2 diabetes. Since most type 2 diabetics have too few receptors per body surface area, the TZDs are very useful drugs.
The fact that patients ont he remaining two TZDs (Avandia and Actos) can gain weight on these drugs is not news. The question of whether they can cause or worsen heart failure has long been discussed. Unfortunately the current raging debate and targeting of the FDA and the drug manufacturers doesn't directly address this question. The existing information is based on mathematical analyses of previously published data and is weak.
Prospective randomized trials are necessary, but what should a clinician do? All too often, as the pendulum swings from panacea to panic, a perfectly good medication has its reputation damaged or destroyed based on limited or overblown results, all in the name of drug safety.
To give just one example as it relates to TZDs, it is clear that controlling blood sugar is important in preventing diabetic end organ damage. Among these crucial organs we try to protect is the heart. Everyone agrees that Avandia and Actos help to significantly lower blood sugar. But as their reputations are damaged in the media, how many safety-driven zealots have stopped to consider what uncontrolled sugars mean to the heart? Now that patients - and doctors - will be running from these drugs with their new "black box" warnings, what will be the clinical results? In other words, which will cause more heart damage; the drugs themselves, or stopping them? Read More & Comment...
07/06/2007 10:57 AM |
If you think it's easy for Al Gore III to score Vicodin and Aderall without a prescription, ask Zach Goldberg (aka his dad) just how quick and convenient it is to buy roids, Vicodin, ritalin, etc. online using his age (19) or any age for that matter. I did it, no problem using two different credit cards.
http://news.yahoo.com/s/ap/20070706/ap_on_he_me/gore_s_son_drugs;_ylt=AjKNKTx3L_N9zjupcFNwSgER.3QA
Note to Rahm Emanuel: Most fake drugs will come through the Web. They will be bought by kids who will use them recreationally or to resell them. Organized crime will profit and kids will suffer.
At what point will your concern for the welfare of kids overtake your politically motivated hatred of drug companies? Read More & Comment...
http://news.yahoo.com/s/ap/20070706/ap_on_he_me/gore_s_son_drugs;_ylt=AjKNKTx3L_N9zjupcFNwSgER.3QA
Note to Rahm Emanuel: Most fake drugs will come through the Web. They will be bought by kids who will use them recreationally or to resell them. Organized crime will profit and kids will suffer.
At what point will your concern for the welfare of kids overtake your politically motivated hatred of drug companies? Read More & Comment...
07/06/2007 08:00 AM |
From the American Spectator:
If iPhones Were Pharmaceuticals
Prescription drugs cost too much! Or at least that's what we hear, day-in and day-out, on television, in the news, and, of course, in Sicko.
Some health-care activists have rallied around high drug costs to agitate for more government regulation of the pharmaceutical industry and more government involvement in health care. Hoping to stoke public anxiety over prescription bills, these activists often point to "cheaper" foreign drug prices to garner support.
Fortunately, prescription drug price controls aren't coming to the United States. But now activists have turned to a new tactic: proposing to force American drug companies to sell their wares to foreign governments at whatever price and in whatever amounts those governments demand. American companies would also be unable to contractually bar those drugs from being imported back to the U.S. -- leading, in essence, to the imposition of foreign price controls and all their attendant safety complications.
Needless to say, this idea -- that the government should require an American industry to play cowering "yes-man" before the whims of foreign nations -- would be devastating to any of America's top industries. Imagine if a different sector of the economy -- say, a high-tech firm like Apple -- had to cope with such constraints.
Apple might schedule a meeting with a foreign distributor, but instead of haggling over bulk discounts and special deals on excess pink iPods, its representatives would find the terms of the sale already structured. The foreign buyer would be able to name its price and quantity, and it would demand permission to resell everything it purchases back to U.S. consumers.
In the background, the U.S. government would nod approvingly.
In other words, what used to be a process of negotiation would instead be a process of submission. Apple would have no way to protect its product or its revenues. It would certainly end up in deals that it would otherwise never agree to. And investment into the next generation of iPods, iPhones, and other products would decline.
Apple's domestic operations would suffer, too. Having just gotten a steal of a deal from Apple, the foreign distributors would be able to undersell domestic firms in the U.S. by reselling Apple products at a significant mark-up. Who benefits? The middlemen, of course. Consumers would only see a tiny price break and Apple and its domestic distributors would see a nosedive in sales. This isn't an example of market forces at work; it's the unfair exploitation of domestic firms.
Initially, Apple might find a way to adjust to forced sale. But in losing control over the terms of sale and distribution of its products, it's almost a certainty that the company's bottom line would take a massive hit.
In response to the loss in revenue, budgets would be slashed, with research and development into new products an early casualty. And with the threat of price controls destroying the prospect of new financial success, the next product would take longer to get to market and be far less innovative. Developing the next big computing device is a costly, time-intensive, and risky undertaking, so the stakes for a successful new product would be much higher.
With no margin for error, following up the iPod with the commercial equivalent of Betamax could be fatal. And that death would stand out as a blow not only to the American computing industry, but to broader American economic competitiveness as well.
Apple and the rest of the American high-tech industry may not have to worry about foreign governments dictating the prices they may charge while the U.S. government looks on approvingly. But advocates of forced sale are pushing for precisely this kind of absurd policy on pharmaceutical companies. The class of good may be different, but the effect is the same -- financial disaster and reduced innovation.
In fact, because drugs save our lives rather than simply entertain us, such stifling of the next round of research may be fatal not only to pharmaceutical companies, but to us as well.
Instituting a forced sale policy on any other industry would result in a great deal of outrage. It's high time that we treat such dressed up price controls on pharmaceuticals with similar looks of consternation.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former Associate Commissioner of the FDA. Read More & Comment...
If iPhones Were Pharmaceuticals
Prescription drugs cost too much! Or at least that's what we hear, day-in and day-out, on television, in the news, and, of course, in Sicko.
Some health-care activists have rallied around high drug costs to agitate for more government regulation of the pharmaceutical industry and more government involvement in health care. Hoping to stoke public anxiety over prescription bills, these activists often point to "cheaper" foreign drug prices to garner support.
Fortunately, prescription drug price controls aren't coming to the United States. But now activists have turned to a new tactic: proposing to force American drug companies to sell their wares to foreign governments at whatever price and in whatever amounts those governments demand. American companies would also be unable to contractually bar those drugs from being imported back to the U.S. -- leading, in essence, to the imposition of foreign price controls and all their attendant safety complications.
Needless to say, this idea -- that the government should require an American industry to play cowering "yes-man" before the whims of foreign nations -- would be devastating to any of America's top industries. Imagine if a different sector of the economy -- say, a high-tech firm like Apple -- had to cope with such constraints.
Apple might schedule a meeting with a foreign distributor, but instead of haggling over bulk discounts and special deals on excess pink iPods, its representatives would find the terms of the sale already structured. The foreign buyer would be able to name its price and quantity, and it would demand permission to resell everything it purchases back to U.S. consumers.
In the background, the U.S. government would nod approvingly.
In other words, what used to be a process of negotiation would instead be a process of submission. Apple would have no way to protect its product or its revenues. It would certainly end up in deals that it would otherwise never agree to. And investment into the next generation of iPods, iPhones, and other products would decline.
Apple's domestic operations would suffer, too. Having just gotten a steal of a deal from Apple, the foreign distributors would be able to undersell domestic firms in the U.S. by reselling Apple products at a significant mark-up. Who benefits? The middlemen, of course. Consumers would only see a tiny price break and Apple and its domestic distributors would see a nosedive in sales. This isn't an example of market forces at work; it's the unfair exploitation of domestic firms.
Initially, Apple might find a way to adjust to forced sale. But in losing control over the terms of sale and distribution of its products, it's almost a certainty that the company's bottom line would take a massive hit.
In response to the loss in revenue, budgets would be slashed, with research and development into new products an early casualty. And with the threat of price controls destroying the prospect of new financial success, the next product would take longer to get to market and be far less innovative. Developing the next big computing device is a costly, time-intensive, and risky undertaking, so the stakes for a successful new product would be much higher.
With no margin for error, following up the iPod with the commercial equivalent of Betamax could be fatal. And that death would stand out as a blow not only to the American computing industry, but to broader American economic competitiveness as well.
Apple and the rest of the American high-tech industry may not have to worry about foreign governments dictating the prices they may charge while the U.S. government looks on approvingly. But advocates of forced sale are pushing for precisely this kind of absurd policy on pharmaceutical companies. The class of good may be different, but the effect is the same -- financial disaster and reduced innovation.
In fact, because drugs save our lives rather than simply entertain us, such stifling of the next round of research may be fatal not only to pharmaceutical companies, but to us as well.
Instituting a forced sale policy on any other industry would result in a great deal of outrage. It's high time that we treat such dressed up price controls on pharmaceuticals with similar looks of consternation.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former Associate Commissioner of the FDA. Read More & Comment...
07/05/2007 09:17 AM |
According to Reuters, British drugmakers are launching a legal challenge to moves by the state-run National Health Service to switch large numbers of patients onto cheap generic prescription medicines.
The Association of the British Pharmaceutical Industry (ABPI) believes such schemes are potentially unsafe and primary care doctors are receiving additional payments to prescribe certain low-cost medicines in contravention of European law.
ABPI argues patients should have to give explicit consent for any switching rather than leaving them to object if they wish to do so.
A Department of Health spokesman said the government would rigorously defend the legal challenge.
We here at Drugwonks don't believe that doctors should be paid to prescribe anything. Their only incentive should be to do what's best for their patients. And that goes for any innovator company that would do the same thing for on-patent medicines.
But, somehow, when governments practice cost-based rather than patient-centric medicine they are called "good stewards." That's absurd -- and dangerous.
For an eloquent example of one doctor's frustration with the escalating generic switcheroo, please see CMPI senior fellow Dr. Marc Siegel's article, "The Unreal World." Here's a link:
http://cmpi.org/archives/2007/06/the_unreal_world.php
At a time when we are debating the issue of biosimilar interchangability, let's not forget to keep our eye on what's best for the patient, not what's cheapest for any given payor. Read More & Comment...
The Association of the British Pharmaceutical Industry (ABPI) believes such schemes are potentially unsafe and primary care doctors are receiving additional payments to prescribe certain low-cost medicines in contravention of European law.
ABPI argues patients should have to give explicit consent for any switching rather than leaving them to object if they wish to do so.
A Department of Health spokesman said the government would rigorously defend the legal challenge.
We here at Drugwonks don't believe that doctors should be paid to prescribe anything. Their only incentive should be to do what's best for their patients. And that goes for any innovator company that would do the same thing for on-patent medicines.
But, somehow, when governments practice cost-based rather than patient-centric medicine they are called "good stewards." That's absurd -- and dangerous.
For an eloquent example of one doctor's frustration with the escalating generic switcheroo, please see CMPI senior fellow Dr. Marc Siegel's article, "The Unreal World." Here's a link:
http://cmpi.org/archives/2007/06/the_unreal_world.php
At a time when we are debating the issue of biosimilar interchangability, let's not forget to keep our eye on what's best for the patient, not what's cheapest for any given payor. Read More & Comment...
07/05/2007 08:38 AM |
Balanced reporting or slanted coverage -- you be the judge.
Here are first three paragraphs from a story in today's Washington Post on PDUFA reauthorization:
"Three drugs -- Vioxx, Ketek and Avandia -- are casting long shadows over the congressional debate on how to update and revise the 15-year-old system that has dramatically sped up the process of bringing prescription medicines to American consumers.
All three ran into problems after the Food and Drug Administration approved them for use. The problems ranged from thousands of heart attacks partly attributable to the painkiller Vioxx to a few cases of liver failure caused by the antibiotic Ketek. And the hazards of the diabetes drug Avandia are only now emerging.
Together, the three drugs epitomize what can happen when a new pharmaceutical moves from the small and orderly world of scientific testing to the big and messy world of everyday use. Many experts now hope that efforts to do a better job of identifying the "unexpected toxicities" in drugs that have reached medicine cabinets will get a boost from an unexpected source -- the Prescription Drug User Fee Act."
Long shadows? The choice of phraseology certainly leads the reader in one direction. My favorite is when PDUFA is referred to as an "awkward acronym." As opposed to what, an elegant acronym? We all know that newspaper circulation is down, but does that explain why articles on serious subjects such as FDA reform should start sounding like dialouge from a Quentin Tarentino movie?
Here's a link to the entire article:
http://www.washingtonpost.com/wp-dyn/content/article/2007/07/04/AR20070704017.html
Let's get this guy a thesaurus and a better editor. Read More & Comment...
Here are first three paragraphs from a story in today's Washington Post on PDUFA reauthorization:
"Three drugs -- Vioxx, Ketek and Avandia -- are casting long shadows over the congressional debate on how to update and revise the 15-year-old system that has dramatically sped up the process of bringing prescription medicines to American consumers.
All three ran into problems after the Food and Drug Administration approved them for use. The problems ranged from thousands of heart attacks partly attributable to the painkiller Vioxx to a few cases of liver failure caused by the antibiotic Ketek. And the hazards of the diabetes drug Avandia are only now emerging.
Together, the three drugs epitomize what can happen when a new pharmaceutical moves from the small and orderly world of scientific testing to the big and messy world of everyday use. Many experts now hope that efforts to do a better job of identifying the "unexpected toxicities" in drugs that have reached medicine cabinets will get a boost from an unexpected source -- the Prescription Drug User Fee Act."
Long shadows? The choice of phraseology certainly leads the reader in one direction. My favorite is when PDUFA is referred to as an "awkward acronym." As opposed to what, an elegant acronym? We all know that newspaper circulation is down, but does that explain why articles on serious subjects such as FDA reform should start sounding like dialouge from a Quentin Tarentino movie?
Here's a link to the entire article:
http://www.washingtonpost.com/wp-dyn/content/article/2007/07/04/AR20070704017.html
Let's get this guy a thesaurus and a better editor. Read More & Comment...
07/04/2007 12:20 PM |
It is July 4th and am surfing the web to see what our freedoms hath wrought...
Danny Carlat, the self-styled independent shrink has a blog that lumps drugwonks into the pro pharma group and then has another grouping dubbed "Great Pharma Information."
http://www.carlatpsychiatryblogspot.com
Included are the whack jobs over at the Alliance for Human Research Protection who pushed the SSRI-suicide connection and was founded by Loren Mosher, who believed that manic depression has no biological basis. http://www.ahrp.org
Great pharma information?
And we also have the Prescription Access Litigation Project. That is a labor/Public Citizen/PIRG dragnet for lawsuits against drug companies that -- in combination with Trial Laywers, Inc. -- split the profits of settlements. No financial interest there of course. One of the law firms that is quarterbacking the PAL litigation is Hagens Berman Sobol and Shapiro which is famous for suing Apple for designing the Ipod for playing music too loud through earphones and possible causing deafness. (Volume conrtrol anyone?) Berman Sobol is also "investigating" Glaxo...as in: If you, or someone you love, took Avandia and suffered a heart attack or heart related death you may want to contact one of our attorneys in order to determine if your are entitled to compensation for your injuries. Please e-mail HBSS at info@hbsslaw.com or call 206-623-7292."
Great Pharma info indeed. Let Carlat ally himself with anti-science extremists and tort lawyers. In the wake of the SSRI-suicide debacle I will put my trust in the so-called pharma-academic complex any day..... Commercialization, carefully constructed and considered -- is the key to medical progress. The notion that purging capitalism from medical research will produce better medicine is not only a hypothesis that has been tested and rejected, it is dangerous.
Let freedom ring! Read More & Comment...
Danny Carlat, the self-styled independent shrink has a blog that lumps drugwonks into the pro pharma group and then has another grouping dubbed "Great Pharma Information."
http://www.carlatpsychiatryblogspot.com
Included are the whack jobs over at the Alliance for Human Research Protection who pushed the SSRI-suicide connection and was founded by Loren Mosher, who believed that manic depression has no biological basis. http://www.ahrp.org
Great pharma information?
And we also have the Prescription Access Litigation Project. That is a labor/Public Citizen/PIRG dragnet for lawsuits against drug companies that -- in combination with Trial Laywers, Inc. -- split the profits of settlements. No financial interest there of course. One of the law firms that is quarterbacking the PAL litigation is Hagens Berman Sobol and Shapiro which is famous for suing Apple for designing the Ipod for playing music too loud through earphones and possible causing deafness. (Volume conrtrol anyone?) Berman Sobol is also "investigating" Glaxo...as in: If you, or someone you love, took Avandia and suffered a heart attack or heart related death you may want to contact one of our attorneys in order to determine if your are entitled to compensation for your injuries. Please e-mail HBSS at info@hbsslaw.com or call 206-623-7292."
Great Pharma info indeed. Let Carlat ally himself with anti-science extremists and tort lawyers. In the wake of the SSRI-suicide debacle I will put my trust in the so-called pharma-academic complex any day..... Commercialization, carefully constructed and considered -- is the key to medical progress. The notion that purging capitalism from medical research will produce better medicine is not only a hypothesis that has been tested and rejected, it is dangerous.
Let freedom ring! Read More & Comment...
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