Latest Drugwonks' Blog
"…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.
According to the NHS release:
“The first of its kind in the world, the Constitution follows extensive discussions with staff, patients and the public over the last year. It reaffirms the rights to NHS services, free of charge without discrimination of any kind. For the first time, it will bring together in one place and clarify for staff and patients their rights and responsibilities to ensure the NHS operates fairly and effectively.”
The draft Constitution can be found at www.dh.gov.uk/consultations
"measures that offer the opportunity to effect a seismic change in patients' right to access the best and most modern medicines based on clinical need."
Others disagree.
Antoine Clark, international editor of Pharma Marketletter, commented,
"Seismic? I don't feel the Earth move!"
Here’s his read on what “free of charge without discrimination of any kind” means in NHS parlance:
Health care except in the case of:
1) week-ends and Mondays;
2) smokers;
3) drinkers;
4) fat people;
5) grumpy old people;
6) people living in the wrong post code;
7) people living in England;
8) people who don't know how to make a noise and kick up a fuss;
9) people who require the latest medical care;
10) people who want to have dental care;
11) foreigners (except when it is politically inconvenient to deny them or they vote Labour; and
12) people who have the nerve to pay extra for private care, as in "Please Sir, can I have some more?
The Wall Street Journal reports that, “Last year, the FDA approved just 19 new medicines, the fewest in 24 years, and announced about 75 new or revised "black-box" warnings about potential side effects -- the agency's strongest -- twice the number in 2004.”
True. But numbers are just numbers. The story is somewhat different when you put those numbers in perspective.
According to the Journal story, “Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, denies that the agency has become "more conservative" about drug safety. Rather, she says, the industry's faltering research efforts are mostly to blame for the fewer product approvals. She says the agency continues to base its decisions on science, not outside pressures. New methods, she adds, have helped it become more vigilant about side effects. She attributed the increase in black-box warnings primarily to a few large groups of medicines that were relabeled."
Reality bites.
Bringing new drugs to market has always been a scientifically challenging and expensive proposition – and it remains so. But the big difference today isn’t (gasp!) politics – it’s that, while discovery and development embrace 21st century science, regulatory science lags behind. At present, the FDA is using 20th century tools to review 21st century medicines.
This is why the agency’s Critical Path Program and the Congressionally-mandated Reagan/Udall Foundation are so crucial to our 21st century healthcare future -- as well as to the future of the pharmaceutical industry.
The comments of Schering-Plough CEO Fred Hassan (courtesy of the Journal article) are instructive:
“Mr. Hassan believes an intensifying focus on safety and a diminished tolerance for side effects at the Food and Drug Administration have dramatically lowered the odds that the drugs would make it to market -- at least not without a lot of extra time and money.”
Not so fast. It is today as it has been in the past and must be in the future – the quest for appropriate risk/benefit balance. Side effects are “tolerated” insofar as the benefits are appropriate. As to the “extra time and money” comment – there’s no benefit from wishing for the “good old days.” Time marches on and so does science. Perhaps a better focus would be on more innovative clinical trial designs – and on the FDA’s promised guidance on adaptive clinical trial designs.
The past is prologue.
"What will it take to get new drugs approved?" Mr. Hassan asks. "The point is, we don't know."
Yes we do. Better development science and better regulatory tools for the FDA.
Here's the full Journal story:
According to an opinion piece in The Guardian newspaper, “If you suffer from epilepsy and you live in
Lourantos says: 'For example, there is a medicine called Lamictal for epilepsy which is imported to
Here’s a link to the complete story:
Whether you call it parallel trade in the EU or "drug importation," on the Presidential campaign trail -- it's still pharmaceutical imperialism.
This from the mind of Catherine D' Angelis, Editor D' Jefe of JAM, courtesy of Tom Sullivan's Policy and Medicine blog:
“Medical schools and professional medical associations have developed policies and guidelines in response to increasing concerns over potential conflicts of interest.
While many physicians agree with these concerns, some view conflict-of-interest policies as affronts to their integrity and an indictment of the ethical conduct of the profession as a whole. These individuals believe that their training as scientists and their devotion to professionalism protects them from external influences that might bias their opinions.
However, this view may be based on an incorrect understanding of human psychology. Conflicts of interest are problematic, not only because they are widespread but also because most people incorrectly think that succumbing to them is due to intentional corruption, a problem for only a few bad apples.
In this Commentary, we argue that succumbing to a conflict of interest is more likely to result from unintentional bias, something common in everyone. We review studies in neuropsychology, behavioral economics, cognitive psychology, and clinical epidemiology to illustrate this point."All of which means there is no escape from conflict and therefore no end to regulation or thought control. Which begs the question: if that's the case, what qualifies the equally corrupted D' Angelis and her ilk for ruling over the everyone else?
www.policymed.com/2008/06/jama-everyones.html
Have a look:
View video podcast here
According to the Wall Street Journal, “European Union investigators are widening a probe of the pharmaceutical industry as they look into whether drug companies have used unfair tactics to block competition and prop up prices.”
The EU sent questionnaires to drug wholesalers and trading firms, asking them about pharmaceutical companies' distribution methods and other practices.
That’s kind of like asking the Association of Hungry Foxes about chicken coop security regulations.
Specifically, the EU is asking about the distribution methods drug companies’ use in
Heinz Kobelt, secretary-general of the European Association of Euro-Pharmaceutical Companies, the trade group representing parallel traders, says EU investigators sent him a questionnaire in mid-May asking whether drug companies were using litigation or other tactics to thwart parallel trade.
So, Mr. Wylie E. Coyote, what do you think of the business practices of Mr. Roadrunner?
According to the Journal report, “Mr. Kobelt said the questionnaire asked for his group's views on so-called direct-to-pharmacy distribution channels, which Pfizer Inc. and AstraZeneca PLC have recently established in
Is this the debate then? Big Pharma trying to reduce fraud and counterfeiting versus parallel traders who want to protect their profits? What’s best for the consumer?
Relative to the value of parallel trade, consider the insights of. W. Neil Palmer of RTI Health Solutions. (By way of bona fides, Neil has served as a senior official with the Canadian Patented Medicine Prices Review Board -- the dreaded PMPRB -- as well as with the Health Division of Health
His take on the European experience with parallel trade:
* It is not the policy of EU governments to use parallel trade to deliver savings to their individual health care systems.
* Because savings are not passed on to consumers and payers.
* Patient care may be jeopardized because of quality, supply chain integrity and regulatory compliance issues -- as well as potential shortages occurring in exporting nations.
* Increased parallel trade results in decreased competitiveness of the pharmaceutical industry in local markets. And, since the profits of the parallel traders aren't reinvested into R&D, opportunities are lost for the patient, the local health care system, and the economy.
As far as safety goes, its been proven time and time again that parallel trade is the weak link in the European pharmaceutical chain of custody. Counterfeiters know it and so do national authorities across the EU.
For more on this issue, see here: www.drugwonks.com/blog_post/show/5362
Prescription use dropped about 17% after introduction of policy, Oregon study finds
THURSDAY, June 26 (HealthDay News) -- Adding small co-payments to Medicaid prescription drug plans reduces the use of medications by patients with chronic diseases, says a U.S. study.
Daniel M. Hartung, of Oregon Health & Science University, and his colleagues analyzed the effect of small co-payments -- $2 for generic and $3 for brand-name -- for prescription drugs introduced for Oregon Medicaid enrollees in 2003. The co-pay fees weren't required for patients who were unable to pay.
The researchers examined pharmacy claims data on about 117,000 Medicare enrollees with depression, schizophrenia, respiratory disease, cardiovascular disease and diabetes.
The patients' overall use of prescription drugs decreased by about 17 percent after introduction of the co-pay policy.
"Subjects with chronic diseases were less likely to reduce the use of drugs used for that disease compared with drugs not for that disease," the study authors wrote.
Most state Medicaid programs now use co-payments to help control prescription drug costs, but few studies have examined how these co-payments affect medication use, the researchers noted.
"This study suggests that in response to cost-sharing, patients discriminate what therapies they reduce based on the diseases they have," they wrote.
The study was published in the June issue of Medical Care.
In Oregon, co-payments for some outpatient services were introduced at the same time as the drug co-payments. But there were no significant changes in the use of those outpatient services, the study found.
This comes on the heels of other studies showing that decreased drug use is associated with a spike in illness...Where are those geniuses in Health Affairs who said Medicaid was the most efficient way to provide coverage for more people now? Along with the rest of the Left they are willing to sacrifice the quality of life of the people they "care" about to implement their program...
The same goes for those who see comparative effectiveness as a cost containment tool...
Read Article here
According to a report in the FT, “Leading pharmaceutical groups are cutting back on clinical research in the
Here's Brian telling his own story:
www.biggovhealth.org/testimonials/brian-turner/
And what about Dorothy "Dot" Griffiths (Stoke-on-Trent, United Kingdom), a breast cancer patient who, in July 2005, organized the advocay group "Fighting for Herceptin" and successfully lobbied the British Parliament after the NHS refused her request for the life-prolonging drug Herceptin because of ... cost of treatment.
Here's a link to Dot's story:
http://www.biggovhealth.org/testimonials/dorothy-griffiths/
Here’s a link to the complete story in today’s Financial Times:
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.
