For the last decade, as the biopharmaceutical industry has struggled — largely unsuccessfully — to live up to its anticipated potential, a litany of experts, analysts, participants, and commentators have offered up their diagnosis and treatment for pharma’s productivity problem.
The basic question they’re all trying to solve: how can it be that despite profound improvements in many aspects of drug discovery, actual productivity – measured by cost per new NME – seems to be declining?
That’s the problem that Jack Scannell (an industry analyst at Bernstein & Co.) and colleagues tackle in the latest issue of NRDD (here – abstract only), expanding upon a nice piece of work they did on this subject last year to now offer an even more comprehensive and thoughtful review of this important subject. While painfully depressing, the article is worth reading, as it cogently summarizes many years worth of hand-wringing and angst.
Having spent much of the last decade wrestling with many of the same issues (his topics will be familiar to regular readers of this column), I was perhaps most struck by the rather dismal take-away: there isn’t a clear unifying explanation for the R&D productivity problem; perhaps if each company examined its internal failures rigorously, new insight might emerge, but meanwhile, essentially, beatings will continue until morale improves.
More specifically: the payor environment is likely to make reimbursement increasingly difficult; regulators will always have an easier time tightening screws than loosening them; each success raises the bar higher; and the only immediate solution is likely to be continued R&D cuts.
Monday’s WSJ (online now) features an exceptionally important and courageous op-ed by Harvard professor (and frequent co-author of mine, although not in this case) Tom Stossel, discussing a rule within recently enacted healthcare legislation with the Orwellian title, “The Physician Payment Sunshine Act,” focused on physician/industry relationships.
Taking its name from the assertion that “sunshine is the best disinfectant,” the Act apparently aims to help disinfect physicians who might be contaminated by industry contact, an interaction the Act seems to assume is intrinsically corrupting — in stark contrast, one suspects, to the many other activities in which physicians engage, and the many other factors in their environment that might influence their behavior, as Stossel and I previously discussed here and here; see here and here as well.
To restore physicians to their baseline state of virginal professional purity, the Act mandates a stultifying series of reporting requirements, impacting amounts as little as $10. While such reports may be a Pharmascold’s wet dream, they are a logistical nightmare for the physicians involved, and serve to create an enormous compliance bureaucracy for everyone.
My recent experience at an innovation symposium at Duke University, as well as my frequent informal conversations with academic physicians at other leading institutes, suggest the increasing bureaucratic hurdles confronting university physicians seeking to strengthen the essential translational relationship between academia and industry are a particularly unfortunate problem, and are having the presumably intended effect of stifling these interactions. Young physicians worry that the burdensome requirements are overwhelming, while senior leaders seek desperately to avoid the inevitable media takedowns predictably led by the NYT, public radio, and the rest of the usual suspects. (Not infrequently, these stories seem to originate with material selectively provided to a sympathetic journalist by a plantiff attorney — but of course, nothing cozy or sketchy here….)
Payers, as with the rest of the healthcare industry, have a lot on their plate right now. Healthcare reform, via the Affordable Care Act (ACA) continues its march forward despite legal and political uncertainty. Struggling to define the payer role in Accountable Care Organizations (ACOs), understanding the impact of Health Insurance Exchanges (HIXs) on their business (McKinsey survey results likely have many payers wondering how to market to what may be an enormous uptick in individual purchasers of coverage – something that most are ill-prepared for), and how to better engage consumers/members in proactively managing their health are a few of the top issues that were addressed at the AHIP Institute last week.
But when one sits back and reflects on the AHIP Institute – all of the sessions, all the discussions, the chatter in the halls, underlying messages within the message, the exhibit hall – it boils down to three key themes that this sector of the healthcare industry is grappling with, which much like the three stages of meaningful use, build upon one another:Continue reading…
One of the big stories at the Health 2.0 Conference in San Diego is that Sermo is partnering with Janssen Global Services (part of J&J) to create tools for doctors to help them move their patients through the health care system. It’s the first time Sermo has explicitly both added a mobile app and moved into the transactional end of its physician community members’ businesses. Sermo’s figured out that a significant portion of their referrals never result in an actual appointment. So they’re going to be working with Jannsen to help close that loop, and we can assume that there’ll be a series of physician and consumer-aimed services to come from the partnership. Sermo says to expect the first product by end of spring. While new entrants like Doximity are aiming at the same market, Sermo’s marketing reach and J&J’s muscle makes them a formidable competitor.
And if you’re at the Health 2.0 Conference in San Diego, Dan Palestrant, Sermo’s CEO will be making an appearance to explain a tad more!
Many folks criticize pharmaceutical companies for providing physicians’ offices with free drug samples. They claim that this giveaway harms consumers because drug companies must raise their prices to cover the costs of these freebies. Of course, this is undeniable. Any business expense, such as payroll or advertising, has to be covered and is expectedly borne by the consumer. If a company chooses not to advertise, outsources manufacturing to a country with cheaper labor, offers limited benefits to its employees, then they can sell their product at a low price. In this hypothetical example, anemic sales may doom the company quickly.
Naturally, free samples are not really free. The rest of us pay for them. While this is true, I don’t think it is evil. Unlike the U.S. government, at least drug companies are covering their costs and not simply borrowing money every year to meet budget. Interesting concept.
Two of the community hospitals I work at have undergone transformations. One is owned by the dominant health care behemoth in Cleveland and has just completed a near $200 million renovation and expansion. The other smaller hospital is one of the few remaining Cleveland area hospitals that are still independent. I’d like to sneak there at night and hoist up a ‘Live Free or Die’ flag up the flagpole, to celebrate its independent streak, but I’m sure that there are video cameras everywhere and that I would be in violation of several bylaws. The apt punishment might be that I would have to spend a cold Cleveland night chained to the flagpole reading electronic medical record manuals out loud.Continue reading…
I want to digress from our recent focus on methods and talk a bit about conflict of interest (COI for short). There has been a lot in the press lately about doctors taking money from the biopharmaceutical manufacturers, and doctors inserting unnecessary hardware into patients’ hearts and spines. All of this has been happening against the background of a low hum of an ongoing discussion of what constitutes a COI, how much is too much and for what (for example, can a doc who takes research and education dollars from a manufacturer with an interest in anticoagulation sit on a committee that develops the guidelines for prevention of thromboembolic disease?), and how to mitigate these ubiquitous and pesky COIs.
In some ways watching this discussion has been amusing, while in others it has been downright sad. Medical journals, while insisting that advertising money is OK to take (presumably because the editorial and marketing offices are separated by some sort of a fire wall), though professional societies should not be able to take this tainted education money. Professional societies, on the other hand, are running away from the accusations by tightening their continuing medical education (CME) criteria and scrambling to replace the lavish budgets derived from pharma to develop their coveted evidence-based practice guidelines. And while all the pots are calling all the kettles black, academic researchers are being barred from collaborating with the industry on research projects, and industry researchers are being precluded from presenting their data at professional society meetings. While all the time the public is being whipped into lather about these alleged systematic transgressions, and forced to cheer for the ensuing retribution.
I met Billy Tauzin last summer in Aspen and you couldn’t help but love the guy. He had that amazing Louisiana charm, and was helping PhRMA walk a tightrope between being the bad guys, and giving away the store. Whether or not like Paul Krugman you’re appalled at his old school N’Awlins sense of ethics, he was clearly able to cross lines and get PhRMA to a place it hadn’t been before.
But now that reform is receding from likelihood, where does big pharma need to go now that Billy jumped (or was pushed)? At the Disruptive Women in Health Care blog, Robin Strongin suggests that pharma needs to get out of its box and really embrace the new type of patient—and appoint a leader who is on the technological cutting edge.
By KATHLEEN BOOZANG
Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for major substantive reforms in the financing and oversight of clinical research. In a White Paper entitled “ Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research.
Over 60% of testing of experimental drugs and medical devices now occurs in physicians’ private offices; unlike years past, industry funds a much higher percent of clinical trials than government, frequently paying researchers significantly more than government does. For some physician practices, conducting clinical trials represents a significant portion of their income.Continue reading…
The FDA has been widely criticized for not providing guidance for drug companies eager to promote their products on the internet. Earlier this year, the FDA expressed the view that the message was what was important, not the medium, meaning that companies should simply apply the rules governing prescription drug advertising in print media to the internet. On April 2, 2009 the agency issued Notice of Violation letters to 14 companies who sponsored links on internet search engines advertising their products; the links gave the name of the drug and, in some cases, its indicated use, without including the required “fair balance,” i.e., safety information such as contraindications and potential side effects. In reliance on the so-called “one-click rule” — which had never actually been adopted by the FDA — the companies had put the required safety information one click away on a separate page.
In recent months, the FDA has indicated that it is open to providing internet-specific marketing guidance. Yesterday and today (November 13th) the agency is holding a hearing on “Promotion of FDA–Regulated Medical Products Using the Internet and Social Media Tools.” Representatives from advertising agencies, consumer groups, health-related websites, pharmaceutical companies, and search engines are scheduled to testify.
I scan menus for keywords (fig, parsnips, salmon…) and it turns out I scan Twitter the same way, looking for anyone who is talking about my favorite topics (data, consumers, information quality…)
So when I saw Jonathan Richman‘s tweet the other night, I couldn’t resist it:
Anyone ever seen data on the overall accuracy of medical information found online? Need help for some final stats for #fdasm
Short answer: No. Long answer:
The Pew Research Center’s Internet & American Life Project has been reporting on the social impact of the internet since 2000, when “information quality” on health websites was a big part of the conversation. It was the era of wagging fingers, scolding patients for straying too far outside their boundaries, and Pew Internet data was ammunition.
We released our first report about the internet’s impact on health & health care in November 2000. The Medical Library Association (MLA) contacted us, asking for research looking at how consumers decide which sites/sources to trust. With their help we created a set of questions asking first if respondents went online for health info, then asking if they look for the source and date of the info they find (the two key quality indicators according to the MLA).