Latest Drugwonks' Blog
Embed head firmly in sand and repeat after me in your best Dorothy in Oz cadence, “Pens and Pizza and Biscuits. Oh my!”
Now consider this new British Medical Journal commentary piece by Iona Heath, the president, Royal College of General Practitioners” --
The politics of drug industry sponsorship
Earlier this month I received a letter from a senior politician inviting me to attend a meeting on a public health topic … I failed to notice that the letter included the sentence: "The meeting is being supported by the healthcare company, Bristol-Myers Squibb." However, when I arrived, the tabled agenda had a similar sentence across the bottom: "The logistical aspects of this meeting are being supported by Bristol-Myers Squibb (BMS)."
The usual round of introductions revealed that there were two representatives of the company in the room listening to everything that was being said … Although I welcome unreservedly the transparent disclosure, when I tried to express concern about the process, the said politician assured me, more than a little abruptly, that it was only the coffee and the biscuits … Not surprisingly, the biscuits were much more tempting than usual … Sadly the politician in question seemed not to be aware of the relevance of any of this to the coffee and biscuits.
Dr. Heath’s complete commentary can be found here.
Sadly Dr. Heath (while certainly entitled to her opinion and desire to tow the party line) seems unaware of the evidence to the contrary.
For example, in the January 2010 issue of Academic Medicine (Adad. med. 2010; 85:80-84), four researchers from the Cleveland Clinic published a paper entitled, "The Effect of Industry Support on Participants of Bias in Continuing Medical Education." The purpose of the study: "To obtain prospective evidence of whether industry support of continuing medical education affects perceptions of commercial bias in CME."
The method: "The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multi-specialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support."
The study's conclusion: "This large prospective analysis found no evidence that commercial support results in perceived bias in CME activities. Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present."
Further, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have adopted a new policy regarding the disclosure of conflicts of interest. Here's the key paragraph:
"There is no inherent conflict of interest in the working relationships of physicians with industry and government. Rather, there is a commonality of interest that is healthy, desirable, and beneficial. The collaborative relationship among physicians, government, and industry has resulted in many medical advances and improved health outcomes."
What a unique perspective -- a "commonality" rather than a "conflict" of interest.
And in a recent editorial in The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research, and the pharmaceutical industry are artificial at best—and dangerous at worst. They are dangerous, because all three constituencies are working towards the same goal—improved patient outcomes.
His point is that we must dismantle the battlements and embrace of philosophy of “symbiosis not schism.” It’s what’s in the best interest of the patient.
Nature Biotechnology puts it this way, “The great unspoken reality is that relationships between companies and researchers are not only becoming the norm, but they are also essential for medicine to progress.”
Suffice it to say that we disagree with Dr. Heath’s position – but we will certainly defend her right to have an opinion and express it.
Alas, the same cannot be said for another fellow traveler – Dr. Steve Nissan.
Recently my friend and co-conspirator Dr. Tom Stossel (the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women's Hospital) was invited to give a Grand Rounds lecture given at Case Western University. Here’s the verbatim e-mail that Dr. Nissen sent to his colleagues at Case Western:
“This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds. Your trainees deserve better.”
Talk about professional discourtesy!
The good news is that Tom’s lecture was standing room only.
Yesterday I was honored to attend and participate in the 2nd annual Galien Forum (part of the Prix Galien celebration). The topic under debate for my panel was, “What is value and how can it be measured and demonstrated in therapeutic innovations?”
I was joined on the dais by Jeff Berkowitz (SVP, Pharmaceutical Development and Market Access, Walgreens; Robert Epstein, Chief Clinical Research and Development Officer, Medco; Barry Gertz, SVP, Head of Clinical Research and Regulatory Affairs, Merck; and Roger Longman, CEO, Real Endpoints. Our moderator was Dick Pasternak, a former Merck VP, Harvard Medical School associate professor and past director of Preventive Cardiology at Mass General).
The combination of a meaty topic and a high-octane panel made for a robust conversation. When the video of the panel is available, I will post it.
The audience was engaged and one question was particularly thought provoking. Not surprisingly, it came from Nobel Laureate Dr. Michael Brown (Professor of Molecular Genetics and Internal Medicine at UT Southwestern Medical Center and a board member of Pfizer). Dr. Brown asked why innovative companies like Apple have such high public esteem while innovative pharmaceutical companies are at the other end of the spectrum of public opinion.
Perhaps the answer (or at least a piece of the answer) is that Apple defines itself in terms of innovation and the value it brings. How, in contrast, do pharmaceutical companies (and the people who populate it) define themselves? Too many see their jobs as “selling drugs.” And while that is certainly a part of it (and an important and worthy part at that) should that be how they define their jobs and their employers?
Until and unless pharmaceutical companies and their employees define themselves as being in the advancing healthcare business (as all their mottos proclaim), they will not be given the credit for the innovation that they truly deliver.
Many believe such image issues are the responsibility of PhRMA. And while the trade organization certainly has an important role to play, ask yourself this – does Apple rely on its trade association to promote its innovativeness?
Another panel featured (among others) Dr. Steve Nissen on the topic of “Perspectives on Innovation, Patient Safety and Global Access.” Here’s one direct quote from Dr. Nissen:
“No one should ever stop taking a medicine because of something they saw on television.”
Please pass the remote.
“Every time I put my line in the water I said a Hail Mary, and every time I said a Hail Mary I caught a fish.” Fredo Corleone
To use a pop culture metaphor, if IPAB is Michael, MedPac is Fredo.
The Medicare Payment Advisory Commission (aka – MedPac, the body that advises Congress on Medicare payment policy) is proposing to fix the Sustainable Growth Rate by sharing the cost of repealing the SGR among physicians, other health professionals, providers in other sectors and beneficiaries.
MedPAC’s draft plan suggests instituting a 10-year payment rate freeze for primary care physicians and three years of reduced payments at 5.9 percent each for specialists followed by a seven-year payment freeze. It also recommends offsets totaling about $235 billion. Those offsets would come from cuts to Medicare Part D drug plans (32 percent); post-acute care facilities (21 percent); Medicare benefits to seniors (14 percent); hospitals (11 percent); laboratories (9 percent); durable medical equipment (6 percent); Medicare Advantage (5 percent).
Not surprisingly, physicians are none too thrilled about the proposed cuts and freezes to their payment rates. In a statement, the American College of Surgeons said that, “The recommendations do not value the role all physicians have in the continuum of care and would have a devastating impact on access to surgical care.”
It certainly took long enough the physician community to stand up and speak out for patient care. Too bad it took the harsh realities of the bottom line to do it.
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.
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.
