Latest Drugwonks' Blog
Pleased to report that Peggy Hamburg has asked John Taylor (currently serving as counselor to the commissioner) to serve as acting FDA principal deputy commissioner.
I served with John at the FDA and he is a talented, devoted public servant – and a real stand-up guy.
John will serve in FDA's number two position for 60 days while the Commissioner conducts a review of the agency's organizational structure. John served with distinction at FDA for 14 years before resigning in 2005 as associate commissioner for regulatory affairs. He was VP for federal government affairs at Abbott from May 2005 to September 2007and EVP for health at BIO before returning to the FDA in October 2009.
Andrew Wakefield’s Lethal Legacy
Yesterday, The British Journal of Medicine http://www.bmj.com/ published the first of several articles detailing the systematic fraud Andrew Wakefield engaged in to show that the measles-mumps-rubella vaccine triggered autism in 12 children who, Wakefield claimed, were perfectly healthy before being immunized. The Lancet published Wakefield’s original article in 1998. Though the paper’s weaknesses were evident back then, it was also clear – to Wakefield and the law firm who paid him millions to concoct and falsify both the research and conclusions – that it would be enough, once published in a major medical journal, to spread a wildfire of fear about vaccine safety.
And indeed that was one hypothesis that Wakefield did prove correct. It took over a decade for The Lancet to retract the original publication and for Britain’s General Medical Council to strip Wakefield of his medical license. During that time, despite the substantive questions about Wakefield’s research, untested theories, lack of medical training and source of funding, there was no serious challenge to Wakefield. In spite of dozens of large studies showing no correlation – first between MMR and autism, then between thimerasol (a mercury-based vaccine preservative) and autism, and then the between whole array of childhood shots and autism — the myth that vaccines were permanently damaging kid’s brains persisted. Wakefield and the movement he helped spawn, thrived and does so today.
Focusing on Wakefield’s fraud misses the point. He succeeded because he created a narrative people wanted to believe. It goes beyond parents seeking a cause for their child’s autism and finding some comfort in blaming vaccines. Wakefield’s theories were published by mainstream medical journals and championed by major media outlets.
Wakefield was a ‘visionary’ because he realized that by churning out a series of small studies and quickly putting them on the Web he and others in the anti-vaccine movement could have a powerful impact on public perception of risks. Others used the Web to turn him into an ‘instant expert’ and characterize him as lonely crusader against evil drug companies on behalf of children with autism. The scientists who defended the value and safety of vaccines were – and are – discredited for their “conflicts of interest” – that is, helping develop vaccines.
The BMJ editorial’s on Wakefield notes that while he might be exposed: “Meanwhile, the damage to public health continues, fueled by unbalanced media reporting and an ineffective response from government, researchers, journals and the medical profession.”
Sadly, as I point out in my new book, Tabloid Medicine, the health damage is not confined to immunizations and the response is not only ineffective, it is shameful. To be sure, confidence in all manner of vaccines among certain groups of parents is decline. There is a corresponding spike in the number of kids killed and hospitalized by vaccine preventable diseases. But in the past decade other groups and individuals have followed the Wakefield formula of hijacking medical science by spreading flimsy fears through the Web where it is only a matter of time that unbalanced media reporting, biased researchers and publicity seeking medical professionals will spread panic for their own agenda.
Today, anyone willing to pay for newsfeeds that continually distribute and obtain prominent placement in Google searches can have their medical scare stories and their half-baked research virtually circle the globe ten times over before the truth takes its first step.
As a result, Wakefield’s imitators are many and are damaging the public health in equal measure. David Healy, another British physician doctor published a small study matching Wakefield’s 1998 research for shoddiness to spread panic about the link between suicide and a class of antidepressants called SSRIs. It lead to a decline in the use the drugs and an increase in teen suicide. David Graham, a Food and Drug Administration (FDA) researcher circulated an unpublished study through the Web claiming Vioxx was responsible for 100,000 deaths. The rest is history.
In 2007, Steve Nissen rushed a study into online publication through the New England Journal Medicine claiming the oral diabetes drug Avandia was linked to heart attacks (even though a government clinical trial found Avandia managed diabetes well and reduced heart risks). Overall use of oral diabetes drugs has declined. Millions of women are avoiding hormone replacement therapy and mammograms because of misleading claims about the dangers of both. As a result, the risk of breast cancer is higher than it should be. In some of these cases the switch to a ‘natural’ treatment, often promoted by those who foster fear, has done more harm than good.
Wakefield may be discredited. But as long as the Web is manipulated to discourage the use and development of medical innovations – and researchers, journalists and politicians – spread this misperception – his lethal legacy will endure.
As GOP takes aim at FDA, Sharfstein bows out
The FDA's point-man on prescription drugs, principal deputy commissioner Joshua Sharfstein, is leaving the agency to head up public health in his home state of Maryland.
Sharfstein, who presided over a crackdown on drug and device marketing at FDA, will serve as Maryland's secretary of health and mental hygiene. He headed health in Baltimore before joining FDA in 2009.
Sharfstein's resignation comes amid saber-rattling from the incoming head of the Congressional Committee on Oversight and Government Reform, who has vowed in recent days to investigate the FDA. Rep. Darrell Issa (R-CA) called FDA “a broken bureaucracy” and said he would hold hearings on FDA failures.
High-pressure hearings are a game Sharfstein knows well, having previously served as an investigator for another Committee on Oversight chairman from California – Democrat Henry Waxman, an inveterate critic of industry promotion.
“He knows what it's like to be under the gun, over and over and over again, by a chairman of a committee trying to help his party regain the White House,” said Coalition for Healthcare Communication head John Kamp, himself a former FCC legislative liaison who remembers his old boss comparing a root canal favorably to oversight hearings.
“It's also just a good career move for a public health official,” said Kamp. “Great job, good jumping-off point to later head FDA, CMS or HHS.”
Former FDA associate commissioner Peter Pitts said the resignation of Sharfstein, whom Republicans view as an overzealous regulator hostile to industry, will make life easier for FDA ahead of contentious PDUFA reauthorization hearings.
“When Sharfstein testified before the 111th Congress, he basically sat down and the members put leis around his neck,” said Pitts. “They were very congratulatory. Had he stuck around, he would have faced some very harsh questions. Putting him up before the 112th Congress would have been very difficult for the agency.”
Pitts called PDUFA reauthorization “an opportunity for the new Congress to make its wishes known to FDA and influence the way PDUFA is written and reauthorized.”
“It's an opportunity to get back to the first principles of PDUFA, which are clarity and predictability versus ambiguity.”
To liberty, and not to banishment."
1. More new drugs are being yanked well before they enter clinical trials. A good thing that can be chalked up to thinning revenues, higher standards, harder targets and better development tools.
2. The safety delta on all drugs is higher. Not a good sign. REMS and Safety First means approval times are slower or drugs are not approved on the first go round.
3. Clinical development is becoming more a legal battle and less a scientific one. If you don't believe me read this article from www.ft.com where the CEO of Watson Pharmaceuticals says generic lawsuits are causing drug companies to stop innovating. He calls it "eating their young." /tinyurl.com/259ko9q
4. Compared to previous years there are still fewer new drugs being introduced and those are being slowed down as these drugs are now considered less special or non priority. As Ed Silverman at Pharmalot notes:
"Overall, there was a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications, or NDAs. First-cycle reviews for priority NDAs were 47 percent in fiscal year 2003 and continued to climb to 70 percent in fiscal year 2007, but have since slipped back to 53 percent in fiscal year 2009."
Ed goes on to quote Paraxel consultants:
"As for priority designations for original NDAs, fiscal year 2005 marked a high of 30 percent after running as low as 10 percent four years earlier. However, that fell back to 13 percent in fiscal year 2009. Parexel says the decline has been “most stunning” in for antiviral and oncology NDAs, which are the two therapeutic areas that have driven overall rates at the FDA’s Center for Drug Evaluation and Research in previous years.
Priority designation rates for cancer NDAs have been declining consistently for several years, from 65 percent of the NDAs submitted between fiscal year 2003 and fiscal year 2005, to 18 percent in fiscal year 2009. The decline in AIDS and other antiviral therapies fell from 95 percent in fiscal year 2006 and fiscal year 2007 timeframe to just 8 percent among NDAs submitted in fiscal year 2009."
www.pharmalot.com/2010/10/the-fda-review-process-and-the-new-normal/
Is the bar being raised at the FDA for drugs that are truly innovative and targeted? It is not the FDA's business to determine whether one medication is better than another. Each treatment has to stand on it's own risks and benefits with respect to the people it treats.. But:
“The FDA’s 13 percent priority designation rate for 2009 new drug applications mirrors the low rate at which some health care plans and other payers are finding value in newly approved drugs. This illustrates the need for companies to take into account market-based clinical concerns in the product development process market-based clinical concerns in the product development process,” according to Charles A. Stevens, Vice President and General Manager, Reimbursement and Market Access, PAREXEL Consulting."
tinyurl.com/32ycdww
The question is whether the clinical development process is the appropriate mechanism to taking these concerns into account or whether it comes at the cost of true value. And innovation.
NEWS FLASH: Americans don’t understand drug labels.
The IOM estimates that 90 million Americans can’t fully understand and act upon health information.
U.S. Pharmacopeia to the rescue.
Proposed USP standards could make label information and instructions more comprehensible. For example, instructions to “Take two tablets twice daily” can raise confusion; saying “Take 2 tablets in the morning and 2 tablets in the evening” makes the numbers more explicit and also specifies exactly when to take the medications. The recommendations also suggest that if it’s okay with the patient, labels should include the purpose of the drug, and in plain language, i.e. “for high blood pressure” rather than “for hypertension.”
It's okay.
The proposed standards recommend formatting that can make labels easier to read, including using regular sentence structure, and laying out labels so users don’t have to rotate the container to read them.
The USP is taking comments at 17PrescriptionContainterLabeling@usp.org until the end of March. When finalized, they could be adopted by state pharmacy boards or other authorities.
It’s about time that we stop talking about health literacy, compliance and adherence and start doing something about.
I think this is the beginning of a beautiful friendship.
Okay, maybe not so simple -- but certainly exciting.
Researchers at Massachusetts General Hospital have already developed a prototype of a microchip that can detect tumor cells at extremely low levels in the bloodstream. The effort to be announced today intends to draw on the expertise of scientists familiar with how to bring such technologies to patients and doctors.
By detecting cancer cells through a blood test, doctors could better follow the disease’s course — looking to see whether the level of cancer cells circulating drops with treatment. It would also allow doctors to test the genetics of the cancer cells, considered by doctors to be critical because many cancer drugs are targeted treatments that work against a cancer with a particular mutation.
To detect the extremely rare cells, the new technology uses minuscule channels carved into a silicon chip, coated with a special glue-like substance. When the blood filters through the channels the technology is able to pick up, on average, about 10 cancer cells per milliliter of blood in patients with metastatic cancer, disease that has spread from a primary tumor to other parts of the body.
But will payers pay for it? Early diagnosis means earlier treatment and better chances for prolonged survival. Good for patients. But will payers (and particularly Uncle Sam, MD) see it that way?
From today’s Wall Street Journal:
FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."
From Albert Einstein:
Insanity: doing the same thing over and over again and expecting different results.
And onwards to PDUFA V.
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.
