Latest Drugwonks' Blog
Phase One of the FDA's Sentinel program for real-time monitoring of drug safety problems is now operational.
At a meeting in Washington and in a simultaneous online publication in the New England Journal of Medicine, program leaders drew back the curtain on Mini-Sentinel, a pilot program that accesses patient databases maintained by health plans and other organizations.
The FDA contracted with the Harvard Pilgrim Health Care Institute in Boston and the Brookings Institution's Engelberg Center for Health Care Reform to design the system, which is now capable of querying claims data on some 60 million individuals, without revealing identities of specific patients.
In the NEJM article, representatives of the three organizations reviewed the development of Mini-Sentinel and plans for its future. Authors of the paper are the agency’s Rachel Behrman (lead author), Janet Woodcock and former CMS Administrator and FDA Commissioner Mark McClellan (Engelberg Center).
"The FDA will soon begin to actively monitor the data, seeking answers to specific questions about the performance of medical products, such as the frequency of myocardial infarction among users of oral hypoglycemic agents …Using the Mini-Sentinel system, the FDA will also be able to obtain rapid responses to new questions about medical products and, eventually, to evaluate the health effects of its regulatory actions," they wrote.
Behrman and colleagues noted that the system could benefit agencies and organizations beyond the FDA, such as those concerned with quality measurement, public health surveillance, and comparative effectiveness.
"Healthcare data represent a precious resource that must be used to the fullest possible extent to promote the public health, while the rights of patients and consumers are protected.”
“Science is nothing but trained and organized common sense, differing from the latter only as a veteran may differ from a raw recruit: and the methods differ from those of common sense only as far as the guardsman’s cut and thrust differ from the manner in which a savage wields his club.”
Thomas Huxley
I wrote about the BMJ expose of Wakefield in a previous blog and in an oped I wrote for the that you can find here:
Here is what she wrote back in March of 2010:
The idea that vaccines are a primary cause of autism is not as crackpot as some might wish. Autism’s 60-fold rise in 30 years matches a tripling of the US vaccine schedule.
With so many kids with autism, the environment has to be to blame, and vaccines are an obvious culprit. Almost all kids get vaccines — injected toxins — very early in life, and our own government clearly acknowledges vaccines cause brain damage in certain vulnerable kids.
Take those simple facts, along with tens of thousands of parental reports of regression after vaccination, not to mention a growing list of court cases where our government paid claims to children with autism acknowledging vaccines as the trigger, and the case we Moms are making makes sense.
Yesterday she lamely tried to defend the flimsy pseudo science behind her anti-vaccine cause as NOT anti-vaccine. She claimed that Wakefield never claimed vaccines caused autism and then contradicts herself by claiming once again that lots of shots cause lots of autism.
Rebutting these silly claims takes up time and diverts resources from more important matters. Which is the point. Going forward the response to tabloid medicine has to be proactive and anticipatory. As I noted in my American Spectator article: Wakefield wannabes now overrun scientific discourse, dominate medical journals , flood the blogs, intimidate public health officials. They shape public perception of medical innovation’s risks and benefits and damage the public health.
The best defense is a good offense.In 2010 the FDA’s Drug Safety and Risk Management Advisory Committee held 13 days of meetings encompassing discussion of 10 drugs and two drug classes. In 2009 the committee held six days of meetings regarding four drugs and one class.
Discuss.
“Meetings are indispensable when you don’t want to do anything.”
-- John Kenneth Galbraith
Representatives Anna G. Eshoo (D, CA), Jan Inslee (D,WA), and Joe Barton (R,TX) have sent a letter to the FDA, explaining the "legislative intent" of the data exclusivity provisions of the bill.
Their letter states that P.L.111-148 does not provide a market exclusivity period. Instead, the bill provides 12 years of data exclusivity. The differences between these two types of exclusivity are "significant and critical," because the intent of these legislators was to "prohibit[] the FDA from allowing another manufacturer to rely on the data of an innovator to support approval of another product." The law was not intended to "prohibit or prevent another manufacturer from developing its own data to justify FDA approval of a similar of competitive product." This interpretation would encourage biologic drug competitors (presumably using the innovator's FDA submission as a roadmap) to submit their own data in support of an independent biologic license application (BLA) pursuant to Sec. 351 of the Public Health Service Act.
The letter also emphasizes that the bill prohibits "evergreening" by innovators, specifically that "no product, under any circumstances, can be granted 'bonus' years of data exclusivity for mere improvements on a product." New products, termed "next generation" by the letter's signatories, are not within the definition of evergreening -- such a new product (having "significant changes in safety, purity or potency") is considered a "new biologic [that] will receive its own 12-year period of data exclusivity" (emphasis in original). However the letter positively asserts that while its authors "care deeply about patient access to biologics," they "also care about the advancement of science and our ability to treat the most complex diseases." Thus, they warn that "[a]ny proposal to limit the definition of a 'new' product, and thus one which is entitled to its own period of data exclusivity has the potential to stifle innovation and negatively impact patient care," which they oppose.
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.
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.
