Latest Drugwonks' Blog
The Supreme Court will decide whether states may prohibit the use of drug prescription records for marketing purposes.
By reviewing a Vermont law that restricts commercial use of prescription records, the court will settle a split in lower courts about whether such laws violate the First Amendment.
The U.S. Court of Appeals for the 2nd Circuit in New York struck down Vermont's law. The U.S. Court of Appeals for the 1st Circuit in Boston upheld similar legislation in Maine and New Hampshire. Both the states and the companies on the other side of the conflict asked the high court to decide the issue.
IMS Health and other companies collect data from pharmacies on the drug-prescribing practices and histories of doctors. The records do not include information that would identify patients.
Peek-a-boo -- ICU
The Food and Drug Administration is launching a website explaining its regulations to companies as part of a broader effort to rebrand itself as a more transparent, accessible agency.
The website, dubbed "FDA Basics for Industry," features answers to frequently asked questions about the regulation of food, drugs and medical devices. The FDA also pledged to respond to questions from manufacturers within five business days.
For more info, see here.
Those prescription drugs can be so gosh-darn expensive, but if you don’t buy them, you’ll just wind up paying more in medical bills down the road.
A new study in Health Affairs demonstrates that people with four common chronic illnesses saved themselves – and the healthcare system – significant dollars by taking being medication adherent.
The CVS Caremark-funded report, is based on an analysis of 135,000 patients with congestive heart failure, diabetes, hypertension and high cholesterol. The study found that people who took their meds made fewer visits to the emergency room and spent fewer days in the hospital. Specifically:
- Patients with congestive heart failure who took all their prescribed drugs saved $7,832 per year compared with those who didn’t.
- Patients with diabetes saved $3,756 by taking all of their meds.
- Patients with high blood pressure saved $3,908 when they filled all their prescriptions.
- Patients with high cholesterol saved $1,258 when they got the full benefit of pharmaceuticals.
A the study concludes:
“Our findings indicate that programs to improve medication adherence are worth consideration by insurers, government payers, and patients, as long as intervention costs do not exceed the estimated health care cost savings.”
Adding new meaning to the words "penny wise, pound foolish."
Words to the wise.
From something called medcitynews by someone called who plays a reporter there.
Sharfstein’s FDA replacement: Why not Cleveland Clinic’s Steven Nissen?
Dr. Steven Nissen
He’s a long shot. But Cleveland Clinic cardiologist Dr. Steven Nissen may be exactly what the troubled U.S. Food and Drug Administration agency needs.
Conventional wisdom is that the departure of FDA Deputy Commissioner Joshua Sharfstein represents an olive branch to newly empowered Congressional Republicans, who viewed Sharfstein as hostile to the industry. Sharfstein sought to crack down on drug and device companies and was once a staffer with a Democratic Congressman. So it could be that Sharfstein’s replacement will be someone who’s viewed as more industry friendly and therefore more palatable to Republicans.
Sharfstein is leaving the U.S. Food and Drug Administration to head Maryland’s health department. John Taylor, the FDA’s top lawyer, has been appointed as acting deputy commissioner for 60 days, and may very well be eventually chosen for the permanent post.
Tapping Nissen, who’s essentially hated by Big Pharma, would signal the exact opposite from President Obama. A Nissen nomination would symbolically show that Obama won’t back down from a fight with Republicans — and perhaps temporarily quiet a liberal base that sees him as at best too willing to cave to the GOP and at worst weak, ineffectual and just another opportunistic politician without any strong core beliefs.
Plus, Nissen’s affiliation with the prestigious Cleveland Clinic, recognized as the nation’s top heart hospital for 16 consecutive years, only adds to his cachet. Obama has praised the Clinic for providing high-quality care for a low cost (and Obama also bench-pressed 260 pounds during a visit to the hospital’s gym).
Nissen declined comment through a Cleveland Clinic spokesman. (My note: Nissen declining to comment? This was my clue that the article was a hoax.)
It’s not as if talk of Nissen joining the FDA is a new thing. Shortly after Obama’s election, industry insiders speculated that Nissen was among the leading candidates for the agency’s top job. “Big Pharma would go to the mat to stop Nissen, but he has plenty of cred on Capitol Hill after raising alarms about drugs, including GlaxoSmithKline’s Avandia, J&J’s Natrecor, and Pargluva, a diabetes medicine that Merck and Bristol-Myers Squibb failed to bring to market,” the Wall Street Journal reported at the time.
In particular, Nissen rose to national prominence as an early critic of Vioxx, a painkilling drug that Merck later pulled off the market. He also garnered attention by publishing a 2007 paper that argued that diabetes drug Avandia causes heart attacks. The FDA last year allowed Avandia to remain on the market, but with significant restrictions.
The public stands Nissen took against those drugs show he’s not afraid of a fight when he believes he’s right — something Obama’s critics on the left may not say about the president.
There’s at least one thing for Republicans to like about Nissen — like many GOPers, he’s been a harsh critic of the FDA. “I think the FDA has lost its way in terms of its mission,” he told the Plain Dealer two years ago. “It is truly a failed agency. We have to change the culture.”
And Nissen has been specific about some of the changes he’d like to see at FDA. He supports a fixed six-year term for the agency’s chief as a means of insulating the FDA from political pressure. He’d also like to see a change to the FDA’s funding mechanism. The FDA generates much of its budget through user fees imposed on drug companies that some critics believe give the industry too much influence.
And then there are the suggestions that really tick off Big Pharma. First, Nissen would like to see more transparency from the agency on its decision to approve or not approve drugs. He’s called on the FDA to publish the letters it sends to drugmakers that detail why a drug has or hasn’t been approved, as well as data from drugmakers’ clinical trials. Additionally, he supports giving the FDA the power to restrict direct-to-consumer advertising of drugs during their first two years on the market — a position that quite possibly may have resulted in his photo being placed on a few dartboards in Big Pharma boardrooms.
Alas, sadly for drug-industry critics, a Nissen nomination is likely not be. Taylor is already receiving support to be appointed Sharfstein’s permanent replacement, and with Taylor already holding down the spot on an interim basis, he appears the most logical and likely choice. And it certainly doesn’t hurt his case with Republicans that Taylor has worked in regulatory positions under both Bush administrations.
But if the Republicans are spoiling for a fight about the FDA, Obama shouldn’t balk from giving them one. Nissen has shown he isn’t afraid of a fight — and knows how to win them.
At least, it seems, for the time being.
U.S. Alters Rule on Paying for End-of-Life Planning
WASHINGTON — The Obama administration, reversing course, will revise a regulation to delete references to end-of-life planning as part of the annual physical examinations covered under the new health care law, administration officials said Tuesday.
The full New York Times story can be found here.
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."
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.
