Latest Drugwonks' Blog
Avorn claims that academic detailing is "evidence based medicine" put to use. But their is very little evidence that anti-innovation detailing improves the health of patients. There are no large scale clinical trials to look at the effect on health outcomes. Or should we just take Avorn's word that his business model is better? A study last year seemed to suggest that doctors who were subject to marketing to use the guidelines from ALLHAT and prescriibe diuretics as the treatment of choice for high blood pressure were more likely to do so. Let's ignore the fact that the claim diuretics reduced death as well or better than other drugs is based on based on secondary endpoints and that the primary endpoint (fatal coronary heart disease and nonfatal myocardial infarction) was similar for the 3 drugs. ALLHAT guidelines also hurt minorities: ALLHAT steered African-Americans to a combination of an ACE inhibitor and a [beta]-blocker in black patients. Blacks randomized to an ACE-inhibitor had 40% excess stroke rate compared to whites which explains the overall benefit of diuretics found in ALLHAT.
So Avorn peddles a protocol whose design kills black patients. He also opposed the FDA approval of BIDil -- combination of two drugs that showed overwhelming reduction in death from heart failure among blacks until scientists conduct a study that tells us why white and black patients differ in response. In doing so he ignored 3 well-controlled trials suggesting or showing a mortality benefit in black patients. As the FDA noted in response to Avorn the was "apparently unimpressed by the 43% mortality risk reduction demonstrated.. and apparently believed that the racial difference hypothesis was based on a post hoc analysis of a single trial." www.annals.org/content/146/1/57.full#ref-list-1
Actually Avorn is not only not unimpressed, he doesn't care. He makes money pushing cheaper drugs and ignoring evidence that would undermine his racket. If it harms minorities in the process, well that's just a cost of doing business.
Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely.
And not just because of certain high profile LOE dates.
A new draft guidance (issued Sept. 16th) provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. The Pink sheet opines that “support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.”
“Some experts contend there are no more switches for conditions that are relatively easy to self-diagnose, meaning the bar to convince the agency that consumers can appropriately self-select for an Rx drug in an OTC setting has been raised.”
Can a patient self-diagnose and self-dose? Do symptoms hide another, potentially more serious, underlying condition? And what of safety concerns?
Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.
A BTC category would almost certainly reopen the conversation about the “statin quo.”
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.
At the September 8th meeting focused on efficacy data from the pivotal ROCKET AF study and whether the Factor Xa inhibitor was studied against an appropriate comparator. FDA sought the advisory committee’s input on whether warfarin or dabigatran was the appropriate comparator for rivaroxaban in light of a 1995 agency policy that requires new therapies be “as effective” as approved treatments when the disease at issue is life-threatening or capable of causing irreversible morbidity.
At a Sept. 8 meeting, the majority of panel members said Xarelto’s sponsors should not be required to directly show comparable efficacy to dabigatran, a drug approved 11 months ago.
According to the Pink Sheet, panelists commented that requiring drugs for serious or life-threatening diseases to be compared head-to-head against the newest treatment on the block could “throw a wrench in long-planned and ongoing clinical development programs that use a well-established standard of care as a comparator agent.”
Office of Drug Evaluation I Director Bob Temple on the question as to whether or not the ROCKET AF study population represented a sufficiently different group of patients from those in RE-LY as to render the “as effective” policy inapplicable to rivaroxaban:
“This was not my favorite question.” Dr, Temple then proceeded to point out the bigger issue inherent in applying FDA’s “as effective” policy in a dynamic development and regulatory environment.
“There is an interesting and provocative issue here. Suppose in the course of the study, something new and really hot comes along. Do we ever say, ‘I’m sorry, you compared it to a dog, we have something better now?’ We don’t usually do that, but I wouldn’t rule out the possibility. And this is a little bit about that possibility, but I don’t think we really meant to get too much into that discussion.”
PCORI Executive Director Joe Selby wants to be clear that while the institute's main focus will be on patient-centered activities, it will wants participation from all interested parties.
"We want a director of stakeholder engagement to engage providers, caregivers, employers, health plans, health systems, health services researchers and other researchers, government and industry," Selby said September 19th during the PCORI Board of Governors meeting in Seattle.
Good idea. And the selection process (and the selected candidate) should be carefully watched to see how Dr. Selby and the PCORI board defines “interested parties.”
Barak Obama is quickly becoming the anti-innovation President.
On Monday, the White House released its deficit reduction plan. Part of the President’s strategy is to impose new rebates on Medicare drugs, strengthen the Independent Payment Advisory Board, and reduce the exclusivity period for innovator biologic drugs.
It’s not class warfare – it’s no-class warfare. And it’s deleterious to the public health.
As the Old Perfessor used to say, let’s look at the record.
First, on the topic of Medicare rebates, why don’t we just call it what it is – a tax. More precisely, an excise tax imposed by Uncle Sam on drug sales.
But wait, it gets worse. The revenues from this tax don’t lower costs for a single patient. Not one. The cash would go into the general fund. It’s not a “rebate” – it’s a tax, plain and simple. A levy imposed on price.
And, hiding behind “deficit reduction,” it’s a tax with a hidden purpose – the introduction of backdoor price controls. And price controls equal cost controls – with or without IPAB.
Speaking of IPAB, the President's plan seeks to lower the threshold at which IPAB would impose Medicare spending cuts; however, the plan doesn't specify what the savings would be. So much for “specifics.” But, specifically speaking, a stronger IPAB further ices the slippery slope towards government price controls and (ultimately) a single payer system.
There’s already the very real risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the boardroom, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs. The President’s proposal makes this twice as bad.
And then there’s the anti-innovation codicil. The President wants to cut innovator biologics exclusivity to seven from the current 12 years.
It’s hugely disappointing that the same man who (as a United States Senator) once said that …
“Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."
… is now advocating a policy that would result in precisely the opposite.
After speaking (during the State of the Union and a widely quoted op-ed in the Wall Street Journal) about the need for America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.
Patent exclusivity funds an innovator company’s research and development efforts. If the President’s proposal becomes law, the US would provide less data protection for innovative biologics than Europe.
12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.
What’s next – an executive order instructing the FDA to approve biosimilars without clinical trials? Alas – this is unfortunately not a far-fetched idea considering the tone and substance of President’s speech on Wednesday.
If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”
As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."
L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning. Let’s keep our eye on the prize. No, not budget reduction – the real prize: better access to smarter healthcare for all Americans. Innovation that focuses on creating a chronic healthcare culture that embraces prevention and prophylactic care. Rather than wasting time on spin, let’s redouble our efforts on innovation. Then, when we succeed through brainpower and teamwork (and, hopefully some civil bipartisanship), the circus surrounding the President’s deficit reduction proposal will be but a footnote in the history of American healthcare.
According to the New York Times, “Hospira, based in Lake Forest, Ill., which has been selling cheaper versions of expensive biologic drugs in Europe for nearly four years, said on Monday that it would begin a final-stage clinical trial in the United States by the end of this year of its biosimilar version of Amgen’s brand-name Epogen in patients with renal dysfunction who have anemia.”
Good news, right? Well – yes. But ...
Yesterday at the 3rd annual Business of Biosimilars & Biobetters Conference in Boston, Naomi Pearce (Director of IP at Hospira) gave a brutally tactical presentation on how to move forward with biosimilars via the “3 C’s – Challenge, Circumvent, Create.” 99.9% of her remarks focused on how to challenge and circumvent patents. The remaining .1% (under the heading of “create”) was limited to “and create something new when it makes good commercial sense.”
Ms. Pearce is a patent attorney and, of course, when you have a hammer every problem looks like a nail. But it does point out many of those looking to enter the biosimilar space are looking at the opportunity as another “generics play.” It reminds me of the time that Israel Makov (the founder and “Big Abba” of Teva) said to me that “Teva isn’t in the pharmaceutical business, it is in the litigation business.”
That was then and this is now? Alas, not so fast.
Here are the links to the two performances.. I think I look better on radio than I do on TV.. But you decide.
minnesota.publicradio.org/display/web/2011/09/19/midmorning1/
www.nbc.com/the-tonight-show/video/michele-bachmann-part-2-91611/1355953/
www.nbc.com/the-tonight-show/video/michele-bachmann-part-1-91611/1355952/
A: When it's a super office.
FR: Janet Woodcock
TO: CDER Staff:
The Office of Medical Policy (OMP) has been reorganized into a Super Office. Within its organizational structure are the Office of Medical Policy Initiatives and the Office of Prescription Drug Promotion. Led by Rachel Sherman and her Deputy, Kathleen Uhl, OMP plays a critical role in directing medical policy programs and strategic initiatives.
This includes directing regulation of prescription drug promotion and advertising, providing leadership and scientific advice on clinical trial design, providing consultation and direction in policy issues related to human subject protection and good clinical practices, supporting the recent Health Care Reform Act that provides new legislation for Biosimilars, and developing regulation, guidance documents, and procedures related to medical policy issues.
· Rachel Sherman, Director, Office of Medical Policy
· Kathleen Uhl, Deputy Director, Office of Medical Policy
· Janet Norden, Associate Director for Regulatory Affairs
The Office of Prescription Drug Promotion
The Division of Drug Marketing, Advertising, and Communications has been reorganized and elevated into the Office of Prescription Drug Promotion (OPDP).
This reorganization will leverage OPDP’s resources and processes to provide for the highly effective oversight of prescription drug promotion.
ODPD consists of an Immediate Office, the Division of Professional Promotion (DPP), and the Division of Direct-to-Consumer Promotion (DDTCP). The new structure will help prevent misleading promotion about prescription drugs and enhance the quality of communications about prescription drugs and other health information developed by companies.
Thomas Abrams, Director, Office of Prescription Drug Promotion
Mark Askine, Associate Director, Office of Prescription Drug Promotion
Marci Kiester, Associate Director of Operations, Office of Prescription Drug Promotion
Catherine Gray, Acting Director, Division of Professional Promotion
Robert Dean, Acting Director, Division of Direct-to-Consumer Promotion
The Office of Medical Policy Initiatives
A newly created Office of Medical Policy Initiatives (OMPI) consists of an Immediate Office, the Division of Medical Policy Programs (DMPP), and the Division of Medical Policy Development (DMPD).
This office will develop and coordinate medical policy regulations and guidances that address the policy and program areas covered by the Super Office. The organization of the divisions supports the continued implementation and successful advancement of the Sentinel Initiative, the Clinical Trials Transformation Initiative (CTTI), and the Patient Medication Information (PMI) Initiative.
Within this reorganization, the Patient Labeling Team (PLT) will be moving from the Office of Surveillance and Epidemiology (OSE), Division of Risk Management (DRISK) to OMPI, Division of Medical Policy Programs. The goal of the Patient Labeling Team is to promote the safe and effective use of prescription medications by providing accurate and easily understood patient medication information. OMPI will reach out to affected offices with procedural details on the PLT's transfer.
Denise Hinton, Director, Office of Medical Policy Initiatives
Richardae Araojo, Deputy Director, Office of Medical Policy Initiatives & Acting Division Director, Division of Medical Policy Programs
Paula McKeever, Division Director, Division of Medical Policy Development
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.
