There are a lot of problems with newspaper articles that are based, not on the fact, but on the perception of a problem that Tabloid medicine has created:
"…the Vioxx debacle, which sparked harsh criticism of both drug companies and their chief regulator, appears to have led to a climate shift. The drug industry largely has itself to blame for allegedly manipulating clinical data, concealing dangerous side effects and aggressively promoting risky products, which created widespread mistrust…."
online.wsj.com/article/SB121476772560213981.html
First, can one be blamed for alleged behavior. Second, where is the evidence of all these actions?
Well, it was largely generated by the same cast of characters:
“Outspoken scientists, watchdog groups, medical-journal editors and politicians have fanned worries about safety. The wave of post-Vioxx drug scares included concerns that GlaxoSmithKline PLC's widely used diabetes drug, Avandia, could raise heart-attack risk, and that Pfizer Inc.'s smoking-cessation drug, Chantix, may be connected to suicides. More than 80 U.S. deaths linked to contaminated heparin from China have further ratcheted up public anxiety. The FDA has been battered by criticism that it wasn't vigilant enough, including from Cleveland Clinic cardiologist Steven Nissen, Sen. Chuck Grassley of Iowa and Rep. John Dingell of Michigan.”
And when you want to keep fanning fears it helps not to be has vociferous in alerting the public when subsequent studies show Avandia has no heart attack risk or that multiple factors might associated Chantix to suicides (such as an increase in the number of addicts with mental illness taking the drug.) Ditto when drug safety vigilantes like Nissen and Grassley (I would not put Congressman Dingell in that camp) engage in fearmongering about Ritalin, SSRIs and Ketek because they know an unquestioning media fails to put the risks and reasons in context….
All of which begs the question, does any of this have any impact on drug approval rates and times?
The short answer: Sometimes it does but increasingly -- I hope – science-based regulation will not just shape drug development times but also who gets what drug, i.e. personalized medicine.
It is true that time is money, especially in drug discovery and development (same for devices and diagnostics). But the truth is the reaction to Vioxx could have been avoided with a post market system in place that could identify who was at greatest risk. Many of the product delays discussed – while in part due to the fact that the Office of New Drugs is overwhelmed and kicking everything back to the detriment of the public health -- would be overcome by the routine use of regulatory tools to speed up and improve the accuracy of toxicity screens, by wider use of combinations of drugs and diagnostics that measure and predict patient response to medicines and disease progression, etc.
To be sure, much of the information FDA reviewers are requesting could be obtained in the “real world.” But I believe that the questions they are asking are legitimate ones. Indeed, they are often the questions that companies themselves face but do not know the answer to or afraid to find out. To conduct an in-depth study of a safety issue absent large clinical trials and reliable assays would kill and drug and likely deny large number of patients who would benefit from a medicine access even as researchers were trying to establish the mechanism causing toxicity for a small percentage of people.
If we wait for drugs to be perfect and confer no risks, there will be no new drugs. No one wants that. Which is why we are developing predictive tools and should insist upon patient-centered real time updates of how well drugs and devices are performing.
I think rather than whining about how slow the FDA has become, pharma CEOs should demonstrate that they are putting their shoulder to the wheel to make better, safer medicines more quickly available. There are many such initiatives and partnerships focusing on these efforts. The recent efforts of the Predictive Safety Testing Consortium (PSTC) in developing safety biomarkers are great example. The PSTC, whose members consist of scientists from 16 institutions, including 13 major pharmaceutical companies, was organized and led by the Critical Path Institute (C-Path).
Talking about these programs and increasing support for them might not change the story line of reporters who want to write about “fast” and “slow”, “safe” and “dangerous”, drug safety “advocates” and Big Pharma, but it will change medicine for the better. Fast or slow will be replaced by what drug for which person.
"…the Vioxx debacle, which sparked harsh criticism of both drug companies and their chief regulator, appears to have led to a climate shift. The drug industry largely has itself to blame for allegedly manipulating clinical data, concealing dangerous side effects and aggressively promoting risky products, which created widespread mistrust…."
online.wsj.com/article/SB121476772560213981.html
First, can one be blamed for alleged behavior. Second, where is the evidence of all these actions?
Well, it was largely generated by the same cast of characters:
“Outspoken scientists, watchdog groups, medical-journal editors and politicians have fanned worries about safety. The wave of post-Vioxx drug scares included concerns that GlaxoSmithKline PLC's widely used diabetes drug, Avandia, could raise heart-attack risk, and that Pfizer Inc.'s smoking-cessation drug, Chantix, may be connected to suicides. More than 80 U.S. deaths linked to contaminated heparin from China have further ratcheted up public anxiety. The FDA has been battered by criticism that it wasn't vigilant enough, including from Cleveland Clinic cardiologist Steven Nissen, Sen. Chuck Grassley of Iowa and Rep. John Dingell of Michigan.”
And when you want to keep fanning fears it helps not to be has vociferous in alerting the public when subsequent studies show Avandia has no heart attack risk or that multiple factors might associated Chantix to suicides (such as an increase in the number of addicts with mental illness taking the drug.) Ditto when drug safety vigilantes like Nissen and Grassley (I would not put Congressman Dingell in that camp) engage in fearmongering about Ritalin, SSRIs and Ketek because they know an unquestioning media fails to put the risks and reasons in context….
All of which begs the question, does any of this have any impact on drug approval rates and times?
The short answer: Sometimes it does but increasingly -- I hope – science-based regulation will not just shape drug development times but also who gets what drug, i.e. personalized medicine.
It is true that time is money, especially in drug discovery and development (same for devices and diagnostics). But the truth is the reaction to Vioxx could have been avoided with a post market system in place that could identify who was at greatest risk. Many of the product delays discussed – while in part due to the fact that the Office of New Drugs is overwhelmed and kicking everything back to the detriment of the public health -- would be overcome by the routine use of regulatory tools to speed up and improve the accuracy of toxicity screens, by wider use of combinations of drugs and diagnostics that measure and predict patient response to medicines and disease progression, etc.
To be sure, much of the information FDA reviewers are requesting could be obtained in the “real world.” But I believe that the questions they are asking are legitimate ones. Indeed, they are often the questions that companies themselves face but do not know the answer to or afraid to find out. To conduct an in-depth study of a safety issue absent large clinical trials and reliable assays would kill and drug and likely deny large number of patients who would benefit from a medicine access even as researchers were trying to establish the mechanism causing toxicity for a small percentage of people.
If we wait for drugs to be perfect and confer no risks, there will be no new drugs. No one wants that. Which is why we are developing predictive tools and should insist upon patient-centered real time updates of how well drugs and devices are performing.
I think rather than whining about how slow the FDA has become, pharma CEOs should demonstrate that they are putting their shoulder to the wheel to make better, safer medicines more quickly available. There are many such initiatives and partnerships focusing on these efforts. The recent efforts of the Predictive Safety Testing Consortium (PSTC) in developing safety biomarkers are great example. The PSTC, whose members consist of scientists from 16 institutions, including 13 major pharmaceutical companies, was organized and led by the Critical Path Institute (C-Path).
Talking about these programs and increasing support for them might not change the story line of reporters who want to write about “fast” and “slow”, “safe” and “dangerous”, drug safety “advocates” and Big Pharma, but it will change medicine for the better. Fast or slow will be replaced by what drug for which person.
