Latest Drugwonks' Blog
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?
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?
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?
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?
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.
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.
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.
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.
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.
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.
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!
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!
While we are on the subject of the Fear Factory (leftist academics, medical journals and journalists) the grudging coverage of the safety of anti-depressants and their value in reducing suicide should be noted. Last week it was the NEJM deciding to publish slowly and silently a study that pregnant women could use antidepressants will little risk to their infants and a media that barely reported the results. This week it was yet another large and careful observational study -- this time by Greg Simon from Group Heath of Puget Sound -- showing that far from causing suicide, antidepressants actually reduce the risk thereof.
Setting aside the abject coverage of these important studies, the attack on the safety of SSRIs needs to be re-examined from top to bottom. We have been told that for marketing purposes companies have buried the real dangers of drugs, that direct to consumer advertising pushes people to take medicines that they do not need but are unsafe, that industry sponsored research and medical conferences are corrupting and not informative.
But now the results of following the purists are clear. We did follow the sage counsel of the Jerry Avorns, Sid Wolfes, Marcia Angells, David Healys and Jerome Kassirers of the world. We ignored the studies showing clinical benefit of SSRIs and embraced their distrustful view of medicine which was based not on science but on the belief thata because drug companies are commercial enterprises neither their products or information cannot be trusted and that any relationship they enter into corrupts those who engage in them.
We have seen the results with SSRIs. The blog PurePedantry does an excellent job of laying out the human consequences of following a medical regimen “free†of industry involvement. They cite another article in the American Journal of Psychiatry that looked at the trends in the number of kids getting SSRIs in the wake of creating an industry free zone: A more sobering perspective on these data gives cause for concern.
An article -- also in the American Journal of Psychiatry - traced what happened to prescribing of SSRIs after the fear mongering and linked it to suicide rates:
"Pharmacoepidemiological studies examining the relationship between trends in sales or prescription fills of SSRIs have consistently shown a relationship between increases in SSRI prescription rates and declines in adolescent suicide rates. On the basis of those studies, one might expect that the adolescent suicide rate would begin increasing in the wake of the FDA advisory after a decade of steady decline."
Less marketing, less detailing, less CME. More regulation and warnings. But the void is filled by self promoting quacks like Gary Null, Scientology fronts, trial lawyers, and angry critics who use anecdotal material to rant about corporate influence. And the result? Fewer patients and more death. It happened with depression and it is happening with schizophrenia and manic depression. We need more corporate involvement, not less, to advance the public health and save lives.
http://scienceblogs.com/purepedantry/2007/07/the_fda_warning_on_antidepress.php
Setting aside the abject coverage of these important studies, the attack on the safety of SSRIs needs to be re-examined from top to bottom. We have been told that for marketing purposes companies have buried the real dangers of drugs, that direct to consumer advertising pushes people to take medicines that they do not need but are unsafe, that industry sponsored research and medical conferences are corrupting and not informative.
But now the results of following the purists are clear. We did follow the sage counsel of the Jerry Avorns, Sid Wolfes, Marcia Angells, David Healys and Jerome Kassirers of the world. We ignored the studies showing clinical benefit of SSRIs and embraced their distrustful view of medicine which was based not on science but on the belief thata because drug companies are commercial enterprises neither their products or information cannot be trusted and that any relationship they enter into corrupts those who engage in them.
We have seen the results with SSRIs. The blog PurePedantry does an excellent job of laying out the human consequences of following a medical regimen “free†of industry involvement. They cite another article in the American Journal of Psychiatry that looked at the trends in the number of kids getting SSRIs in the wake of creating an industry free zone: A more sobering perspective on these data gives cause for concern.
An article -- also in the American Journal of Psychiatry - traced what happened to prescribing of SSRIs after the fear mongering and linked it to suicide rates:
"Pharmacoepidemiological studies examining the relationship between trends in sales or prescription fills of SSRIs have consistently shown a relationship between increases in SSRI prescription rates and declines in adolescent suicide rates. On the basis of those studies, one might expect that the adolescent suicide rate would begin increasing in the wake of the FDA advisory after a decade of steady decline."
Less marketing, less detailing, less CME. More regulation and warnings. But the void is filled by self promoting quacks like Gary Null, Scientology fronts, trial lawyers, and angry critics who use anecdotal material to rant about corporate influence. And the result? Fewer patients and more death. It happened with depression and it is happening with schizophrenia and manic depression. We need more corporate involvement, not less, to advance the public health and save lives.
http://scienceblogs.com/purepedantry/2007/07/the_fda_warning_on_antidepress.php
The article today in the WSJ about a “link†between ALS and statin drugs underscores how much of epidemiology is nothing but statistical self-gratification that has grown exponentially in the hopes of seducing self-important medical journals who in turn seek to whet the appetite of journalists looking for peril in every pill.
The ALS-statin connection could have been addressed easily by asking if there was an overall increase in the incidence or prevalence in ALS since the widespread use of statin drugs beginning in the 1980s, particularly among the elderly. There are careful registry data in virtually every Western country in the world on ALS patients, some dating back to the 1920s that capture every new case of ALS and measure against increases in total populations and various demographic characteristics.
ALS incidence and prevalence is virtually unchanged since the beginning of the century. So if statins have a direct causative effect it would have shown up by now. Why no one, let alone the author of the WSJ article did not ask this simple question is beyond me.
Now more interesting is the fact that Beatrice Golomb, who is studying the evil effects of statins, claims to have found a link between low cholesterol levels and violence Indeed, there are a handful of articles that claim to have seen this association after doing some data dredging. (Uh, maybe they should control for age since most crime is committed by young people and most young people have...low cholesterol, duh.) And they NIH is giving her money?
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=11104842&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus
I can’t wait to the lawsuits flying around the claims that statins cause violent behavior. They WILL come.
Meanwhile, shame on WSJ's Jacob Goldstein and WHO's Ralph Edwards for even proposing that this is anything more than a coincidence. You give me four million data points and I will show you that there is a relationship between Jacob Goldstein and half the pregancies in Passaic, NJ.
http://blogs.wsj.com/health/2007/07/03/data-crunching-hints-at-risk-of-cholesterol-drugs/
The ALS-statin connection could have been addressed easily by asking if there was an overall increase in the incidence or prevalence in ALS since the widespread use of statin drugs beginning in the 1980s, particularly among the elderly. There are careful registry data in virtually every Western country in the world on ALS patients, some dating back to the 1920s that capture every new case of ALS and measure against increases in total populations and various demographic characteristics.
ALS incidence and prevalence is virtually unchanged since the beginning of the century. So if statins have a direct causative effect it would have shown up by now. Why no one, let alone the author of the WSJ article did not ask this simple question is beyond me.
Now more interesting is the fact that Beatrice Golomb, who is studying the evil effects of statins, claims to have found a link between low cholesterol levels and violence Indeed, there are a handful of articles that claim to have seen this association after doing some data dredging. (Uh, maybe they should control for age since most crime is committed by young people and most young people have...low cholesterol, duh.) And they NIH is giving her money?
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=11104842&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus
I can’t wait to the lawsuits flying around the claims that statins cause violent behavior. They WILL come.
Meanwhile, shame on WSJ's Jacob Goldstein and WHO's Ralph Edwards for even proposing that this is anything more than a coincidence. You give me four million data points and I will show you that there is a relationship between Jacob Goldstein and half the pregancies in Passaic, NJ.
http://blogs.wsj.com/health/2007/07/03/data-crunching-hints-at-risk-of-cholesterol-drugs/
NICE = the National Institute for Clinical Excellence -- the United Kingdom's center for deciding which medicines will be reimbursed. But more and more Britains are calling it by another, more descriptive acronym -- NASTY: Not Available So Treat Yourself.
To that end, allow us to recommend a new op-ed in the Journal of Life Sciences, "Strange Bedfellows."
Here's a taste:
"The politics of healthcare make strange bedfellows. Nearly 15 years ago, most health insurance plans opposed Hillary Clinton when she tried to give American healthcare a makeover in the image of the European and Canadian system. Back then, insurers blasted the Clinton plan as government takeover of medical decision-making based on cost considerations.
Last month, the presidential hopeful and the insurers stood shoulder-to-shoulder in support of giving the federal government the same power government agencies in single-payer systems have to determine what new medicines and services to pay for or not, based on what a government agency decides are cost-effective. In essence, both Clinton and the health care lobby want the government to engage in the practice of medicine.
What's changed? Clinton has always regarded government as the best arbiter of value for medicine. Health plans, now that they have a stake in Medicare, want the government to make across-the-board decisions about reimbursement. Now the Medicare Payment Advisory Commission, the independent federal body established to advise Congress on issues affecting Medicare, has endorsed a specific approach. It wants an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers and public and private payers.
The model, believe it or not, is Britain's National Institute for Clinical Excellence, which reviews comparative effectiveness of new and often expensive medicines in the way the Medicare Payment Advisory Commission and Senator Clinton envision. Steven Pearson, a senior fellow with the insurance industry lobbying group America's Health Insurance Plans, thinks that the British approach is an example of leadership and courage. As such, it's worth looking at the decision process our nation should follow in deciding how, whether and in what circumstances it will pay for a medicine."
Here's a link to the entire article:
http://cmpi.org/archives/2007/07/strange_bedfellows.php
And for those of you who like to read ahead, here's the article's concluding paragraph:
"Personalized medicine gives doctors and patients control over healthcare decisions while comparative effectiveness, as it is now defined, will increase government control over the choices doctors and patients make in the future. The battle over the value of medicine and who decides what is valuable will determine who controls healthcare in America over the next decade. That explains why Clinton and the insurance lobby are allies in the effort to give government more control over these important choices in the years ahead."
To that end, allow us to recommend a new op-ed in the Journal of Life Sciences, "Strange Bedfellows."
Here's a taste:
"The politics of healthcare make strange bedfellows. Nearly 15 years ago, most health insurance plans opposed Hillary Clinton when she tried to give American healthcare a makeover in the image of the European and Canadian system. Back then, insurers blasted the Clinton plan as government takeover of medical decision-making based on cost considerations.
Last month, the presidential hopeful and the insurers stood shoulder-to-shoulder in support of giving the federal government the same power government agencies in single-payer systems have to determine what new medicines and services to pay for or not, based on what a government agency decides are cost-effective. In essence, both Clinton and the health care lobby want the government to engage in the practice of medicine.
What's changed? Clinton has always regarded government as the best arbiter of value for medicine. Health plans, now that they have a stake in Medicare, want the government to make across-the-board decisions about reimbursement. Now the Medicare Payment Advisory Commission, the independent federal body established to advise Congress on issues affecting Medicare, has endorsed a specific approach. It wants an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers and public and private payers.
The model, believe it or not, is Britain's National Institute for Clinical Excellence, which reviews comparative effectiveness of new and often expensive medicines in the way the Medicare Payment Advisory Commission and Senator Clinton envision. Steven Pearson, a senior fellow with the insurance industry lobbying group America's Health Insurance Plans, thinks that the British approach is an example of leadership and courage. As such, it's worth looking at the decision process our nation should follow in deciding how, whether and in what circumstances it will pay for a medicine."
Here's a link to the entire article:
http://cmpi.org/archives/2007/07/strange_bedfellows.php
And for those of you who like to read ahead, here's the article's concluding paragraph:
"Personalized medicine gives doctors and patients control over healthcare decisions while comparative effectiveness, as it is now defined, will increase government control over the choices doctors and patients make in the future. The battle over the value of medicine and who decides what is valuable will determine who controls healthcare in America over the next decade. That explains why Clinton and the insurance lobby are allies in the effort to give government more control over these important choices in the years ahead."
You cannot escape the responsibility of tomorrow by evading it today.
-- Abraham Lincoln
When the government issues health care statistics there are usually two general responses from the constituencies that are influenced – “this shows a problem,†or “the study is flawed.†And what ensues is a blame game, a political, polemical battle of op-eds and spin. What rarely happens is that all sides consider the implications of the numbers and use them to advance the public health. There are many examples of this, perhaps the best known being the debate over the Part D drug benefit.
But a new study, just released by the Center for Medicare and Medicaid Services (CMS), is breaking the mold. And it’s about time. The report, based data on Medicare patients who died from heart failure between July 2005 and June 2006, ranks hospitals as to whether they fall above or below the average and the results are available and searchable on a federal Web site (www.hospitalcompare.hhs.gov) that compares mortality rates among the nation's more than 4,000 medical facilities.
Needless to say, those scoring well crowed and those falling below the national average started the spin cycle. Examples were not hard to find – that’s not news. What is important to discuss, on the other hand, is how some hospitals dealt with their below-average ranking. As I searched through the CMS database, I was surprised to find Baylor All Saints Medical Centers at Fort Worth Texas on the “below average†side. Having followed Baylor Health Care System over the years for a variety of reasons, I decided to look a little closer.
Here's the rest of the story:
Download file
The take-away?
"... if we want people to take more responsibility for their own health – those in the business of health care must as well. Do as I say, not as I do just doesn’t cut it when it comes to advancing America’s health."
The price of greatness is responsibility.
-- Winston Churchill
-- Abraham Lincoln
When the government issues health care statistics there are usually two general responses from the constituencies that are influenced – “this shows a problem,†or “the study is flawed.†And what ensues is a blame game, a political, polemical battle of op-eds and spin. What rarely happens is that all sides consider the implications of the numbers and use them to advance the public health. There are many examples of this, perhaps the best known being the debate over the Part D drug benefit.
But a new study, just released by the Center for Medicare and Medicaid Services (CMS), is breaking the mold. And it’s about time. The report, based data on Medicare patients who died from heart failure between July 2005 and June 2006, ranks hospitals as to whether they fall above or below the average and the results are available and searchable on a federal Web site (www.hospitalcompare.hhs.gov) that compares mortality rates among the nation's more than 4,000 medical facilities.
Needless to say, those scoring well crowed and those falling below the national average started the spin cycle. Examples were not hard to find – that’s not news. What is important to discuss, on the other hand, is how some hospitals dealt with their below-average ranking. As I searched through the CMS database, I was surprised to find Baylor All Saints Medical Centers at Fort Worth Texas on the “below average†side. Having followed Baylor Health Care System over the years for a variety of reasons, I decided to look a little closer.
Here's the rest of the story:
Download file
The take-away?
"... if we want people to take more responsibility for their own health – those in the business of health care must as well. Do as I say, not as I do just doesn’t cut it when it comes to advancing America’s health."
The price of greatness is responsibility.
-- Winston Churchill
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.
