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Yesterday I was pleased to chair Day 1 of the Social Media for Pharma event in New York City.
First off, this and similar events can no longer (and should no longer) be identified as “pharma” events. Witnessing today’s attendance by and active participation of members of the medical technology (née “device”) community along with a full table of dietary supplement marketers, makes it pretty clear this and similar symposia are healthcare events.
And that’s a good thing.
A few memorable moments:
Greg Kueterman and Amy O’Connor of Eli Lilly & Company gave a splendid presentation on their health policy blog Lillypad (www.lillypad.lilly.com). One of their most important points (not rocket science, but rarely discussed) is that, when it comes to healthcare in the social media space – it can be about things other than product marketing and that metrics are more than about volume. It’s not about the top ten, but rather the right ten. Amen.
Greg asserted that he's “the Justin Bieber of healthcare social media.” Not sure what that means, but it does seem to be an off-label claim.
William Martino (Saatchi & Saatchi Wellness) and Shermon McMillan (Chattem) – henceforth forever known as Shermon/William – painted an interesting portrait of social media and the OTC launch (and subsequent marketing) of Allegra.
Ned Russell (Saatchi & Saatchi Wellness) pointed out that the oft-quoted FaceBook development maxim of “move fast and break things,” couldn’t be more antithetical to regulated healthcare communicators (note – not marketers, but communicators). My comment was that this might explain the tone deafness of the world’s largest social media platform has to issues such as moderated user-generated commentaries. (Also note that the FCC didn’t find FaceBook’s swiftness to cast aside privacy issues so kosher either.)
And, while we’re on the subject, why does FaceBook allow “drugs from Canada” pages. Did they not get the memo from Google and the DOJ?
Tai Spargo of NORD discussed their new social media efforts in creating a plentitude of orphan disease sites minus any participation of the biopharmaceutical industry. She also noted (and rightfully so) that there is no rare disease too small for social media. To illustrate her point she displayed the FaceBook page “Cats in Sweaters.” Meow.
Check it out if you are so inclined at http://www.facebook.com/pages/Cats-in-sweaters/183921988289175. Idle hands indeed do the devil’s work.
Sharon Landa (Johnson & Johnson) and Erica Wittes Schlack (Communispace) discussed the design and utility of private (read, “closed”) social media communities. Fascinating. Two comments to pass along, “Feedback is about the brand, but discovery is about the consumer” (utility) and “Diversity is for conversation but similarity is for cohesion (design).
There was also much chatter about how to make social media programs work along side of “traditional communications initiatives.”
Rather than calling them “traditional,” perhaps we should label them as “legacy” programs.
And we all know what happens to those.
America's Health Insurance Plans is out with a new report on the state of health savings accounts. Among the findings: Lower-income individuals open HSAs at a greater rate than do higher income groups - with an average income in the mid-$50,000 range - and the amount of money that individuals have accumulated in their accounts has grown over time, and the amount of money being rolled over from one year to the next also has increased.
Click here to read the report.
The New York Daily News (12/3, Pesce) reported, "A new FDA-approved hangover cure has hit the market." The over-the-counter medication, dubbed Blowfish, "combines 1,000 milligrams of aspirin, 120 milligrams of caffeine and a stomach-soothing agent into two effervescent tablets taken the morning after a night of heavy drinking." Blowfish "costs $2.99 for a single dose, or $11.99 for a six-pack" and "is currently available in Ricky's NYC stores or online at ForHangovers.com."
The website of WCBS-TV New York (12/5) reports, "Just in time for the holidays, the FDA approves a purported hangover remedy. Blowfish, created in the West Village, is promised to get rid of all your hangover symptoms within 15 to 30 minutes." FOX News Radio (12/4, Rappoport) added that that the drug "combines aspirin, caffeine and a stomach soother into two effervescent pills to be taken the morning after a night of partying." The remedy's creator Brenna Haysom "says the pill is only intended for people who had one too many, not binge drinkers."
At CMPI’s “PDUFA without the Politics” Capital Hill Briefing, Dr. Tim Franson (President, USP Convention, former Vice President, Global Regulatory Affairs, Eli Lilly & Co., and one of the “father’s of PDUFA”) mentioned the Hawthorne Effect – “that which is measured gets accomplished.”
Which begs the question – should more things in PDUFA V be measured or measured with more robust deliverables?
Are “meetings” sufficient promises – or are actions more desirable? Specifically – are meetings about a benefit/risk grid enough or should there be a date-certain for a regulatory instrument to be operational?
Should PDUFA V be exclusively about process? What about provision?
Speech is conveniently located midway between thought and action, where it often substitutes for both. – John Andrew Holmes
Always listen to the experts. They’ll tell you what can’t be done and why. Then they do it. – Robert Heinlein
On Tuesday the Center for Medicine in the Public Interest (www.cmpi.org ) hosted a Capitol Hill panel entitled, “PDUFA without the Politics.” I was the moderator and was honored to be joined by a panel of peerless nonpareils that included Vincent J. Ventimiglia, Jr (Former Assistant Secretary for Legislation at the US Department of Health and Human Services), Paul T. Kim (Former Deputy Staff Director for health policy for Senator Edward M. Kennedy), Michele J. Orza (Former Assistant Director of the Health Care Team at the Government Accountability Office), and Tim Franson (Former Vice President, Global Regulatory Affairs, Eli Lilly & Co., President, USP Convention). The Honorable Michael C. Burgess, M.D. (Vice-Chairman, Subcommittee on Health, U.S. House of Representatives) offered remarks as well.
The participants were pithy, poetic, and pragmatic.
We will shortly post videos of all the aforementioned presenters. In the meantime, here’s a short news story from Drug Information Daily:
Lawmakers Plan to Use PDUFA V Bill to Ease Conflict Rules for Advisory
Panels
Lawmakers plan to attach a bill easing financial conflict rules for FDA advisory panel members to legislation reauthorizing the Prescription Drug User Fee Act (PDUFA), a congressional leader says.
Rep. Michael Burgess (R-Texas) introduced H.R. 3206 last month and said Tuesday it would be attached to the measure authorizing PDUFA V, yet to be introduced to Congress. H.R. 3206 would eliminate the existing financial conflict rules for panelists, opening the door for committee members with greater expertise on the products they discuss.
Burgess, vice chair of the House Energy and Commerce Health Subcommittee, offered similar legislation during consideration of PDUFA IV in 2007, but it was voted down along party lines. With his Republican party now in control of the House, he may have an easier time gaining approval of the bill.
Speaking at a PDUFA V briefing for Capitol Hill staffers hosted by the Center for Medicine in the Public Interest (CMPI), Burgess said there are about 10 strong candidates for legislation to tack on to PDUFA V. One possibility is a bill addressing the issue of drug shortages, he said.
Another likely candidate is a bill to increase incentives for antibiotic makers, according to Foley Hoag lobbyist Paul Kim.
Proactive Lawmakers
Also at the briefing, Peter Pitts, former FDA associate commissioner and president of CMPI, urged Congress to be more proactive in changing the technical letter the FDA and drugmakers agreed to during PDUFA negotiations earlier this year. Specifically, Pitts called for more programs and agency action to address transparency and striking a better risk-benefit balance in product reviews.
Following these recommendations might mean altering the package the FDA and industry ratified, which has only happened once in the previous four PDUFA bills.
Recently, David Wheadon, PhRMA's senior vice president for scientific and regulatory affairs, said the package includes a "robust set of programs" to provide an objective measure of risk-benefit analysis at the agency.
http://www.cbsnews.com/8301-18560_162-57330802/hard-times-generation-families-living-in-cars/
EC proposes new research program
The European Commission proposed a new EU research and innovation program for 2014-20 called Horizon 2020, which would have a budget of EUR 80 billion ($107 billion). The proposal includes allocations of EUR 24.6 billion ($32.8 billion) for science research in Europe, including an increase in funding of 77% to EUR 13.2 billion ($17.6 billion) for the European Research Council (ERC); EUR $13.7 billion ($18.2 billion) for industrial technology development and small and medium-sized enterprises; and EUR 31.8 billion ($42.4 billion) to address societal concerns in areas such as climate change, energy and resource scarcity, and health and aging.
The EC said Horizon 2020 will have a simpler set of rules and procedures for obtaining funding than those of previous research programs, with the goal of reducing time to funding following a grant application by about 100 days. The European Parliament and EU Council will now review the proposal, with the goal of adopting it by year end 2013. The current research program, Framework Programme 7 (FP7), has a budget of EUR 54 billion and runs from 2007-13.
Here are a few key excerpts:
But above all, Mr. Lechleiter explains, "There's no better investment that we can make than in biomedical research and in our health. This is not something that we're trying to steal away from someone else. This is not a nascent industry." Pounding his desk on each word—"America leads the world, okay?"
"I believe this will be the biomedical century," he continues. "We'll look back a hundred years from now and say the 20th century was the century of chemistry and physics, and the 21st century was the century of biomedicine."
Mr. Lechleiter adds that "The challenge or the opportunity we have is that never before has the science and our knowledge base been riper for exploitation." For most of the pharmaceutical industry's existence—since Civil War veteran Col. Eli Lilly began to improve on the patent medicines of the day—"it was akin to feeling your way around a dark room and trying to make sense of what's what. Suddenly the lights are on and we can see, aha: In a cell, this pathway and that pathway both contribute to, say, tumor formation."
Not only is there an ongoing revolution in genomics and systems biology, Mr. Lechleiter continues, we increasingly have the tools to make use of this basic research and commercialize it. "A process that used to take years and years and rely too much on serendipity and conjecture can now be accomplished in a period of time that looks closer to months and months." Researchers are more "mission driven and deliberate" and, with a biological target, can "come up with a viable clinical candidate, something that we could hope to take into human testing" faster and with more confidence than ever before.
Read the full piece here.
To help shape thinking in this area, Beijing think tank the Cathay Institute for Public Affairs invited me to discuss with officials and experts how the system works in Britain at a symposium and workshop in Beijing, with additional comment from local policymakers and experts on general practice reform.
Britain presents a case study of how not to organise a health system. Since britain nationalised healthcare in 1947, subsequent governments have struggled to improve productivity, contain costs and improve the quality of care. Up until 1991, the system was mainly managed through central targets and control, with a chain of command going right up to the minister's office in Whitehall. By the late 80s, this system was beginning to look rather tired.
As part of the Thatcher government reforms, competition was introduced into the health service, in the form of an internal market. Providers and purchasers were split for the first time, and GPs were given the power and budget to buy care on behalf of their patients from any NHS provider. The aim was to use their market power to drive down costs and promote innovation. While this system achieved some success in reducing patient waiting times, Tony Blair’s government on election in 1997 decreed that this created a two tier system in which some received faster treatment than others.
This nascent market was therefore abolished and replaced with the old command and control system based on centrally-mandated targets. But by 2004, it was clear that this system was failing to manage an increasingly complex and massive health system, so the government reintroduced a diluted form of the internal market it had abolished, wherein GPs could form voluntary groups to commission care on behalf of patients. This time the budgets were notional instead of real, and any notional savings would be reimbursed by the ministry for spending on developing innovative services. Not surprisingly, few doctors found they had the time to engage with this new bureaucracy, so it has remained something of a sideshow to the main modus operandum of the NHS which is targets and central dictat.
Finally, the new government of David Cameron proposes reinvigorating the internal market by making it compulsory for GPs to commission care on behalf of their patients, and extending it to the majority of areas of care. This met with fierce opposition from opposing parliamentarians, as well as doctors unions and most of the medical profession, who fear that moves to a more market based system might undermine their not inconsiderable pay and generous employment conditions (as well as having ideological objections to the involvement of markets in healthcare). Pro reformers worry that the new bureaucratic apparatus required to manage this quasi market will work against physician autonomy, and could act as conduit for central government to reassert control - health civil servants are notorious jealous of their status as guardians of such a significant part of the body politic.
The key lesson for China, then, is that once they embark down a route in which central government is the primary provider and guarantor of care, it is very difficult to inject market force to tackle the problems that always arise from monopolies - interest groups, once entrenched, are very difficult to tackle. As a result of these failings, GP care in the UK is no way comparable to that in the US, as they have little incentive to develop the doctor patient relationship beyond responding to a narrow set of clinical and waiting time targets.
While things are bad in the UK, in China they are several orders worse. At our workshop Qin Jiangmei from the Ministry of Health outlined the major problems with the GP system, including the poor quality of doctors and service providers, and the fact that patients (especially in rural areas) normally have to pay out-of-pocket to poorly trained GPs. And as GPs derive most their income from sellling medicine or hosptial procedures, a visit to the doctor for even a mild ailment can end up with a huge bill as a result of over-prescribing. As a result, the majority of Chinese simply avoid the healthcare system altogether.
Professor Gu Yuan of the General Practictioner Association of Chinese Medical Association outllined her vision of the future system, which included training 300,000 extra doctors by 2020, and creating a new system of contract between patient and doctor that would inject some accountablity into the system. She also pointed out that General Practice is a very unpopular career choice for medical doctors, the majority of whom aim for a clinical specialism. This is hardly surprising when General Practitioners earn less than average civil servants. As a result, GPs are few and far between, particularly in rural areas, and they are often only in possession of a sketchy knowledge of medicine. In order to increase their wages to something reasonable, GPs routinely overprescribe, and make unnecessary use of expensive diagnostics (when for instance the patient may only have a cold). This is exacerbated by the fact that doctors receive a large proportion of their salary from profits they generate for the hospital, which leads to overprescribing, and not enough focus on preventative care and basic diagnostics (such as checking blood pressure).
Prof Wang Zhen on the Institute of Economics noted the problems inherent in expanding a system of coverage to a rapidly ageing population, in the face of rapidly changing technology and medical knowledge. The NHS experience shows that state-monopolies are not well-placed to foster innovation either in managerial techniques or the use of new medical technologies. China therefore needs to embrace choice and competition in its design of coverage systems if it is to avoid making the same mistakes as Britain. He noted that the government’s role should be restricted to supervision or the provision of additional services that cannot be provided by the market.
Excellent article in the always excellent RX Compliance Report on the Europe’s continuing debate over the dissemination of healthcare information.
European Commission proposal on patient information draws divergent views
The European Commission’s (EC) revised proposals on information to patients, released last month, drew divergent assessments across the Atlantic. The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents research-based pharma companies operating in Europe, cautiously welcomed the amendments, urging all member states to adopt a “pragmatic approach” to address what it calls “the existing inequality” of access to quality data. “The revised proposals put rights, interests and safety of patients first,” insisted John Dalli, European Commissioner for health and consumer policy.
However, former FDA Commissioner for External Relations, Peter Pitts, spoke for many on this side of the Atlantic when he said the proposals appear to slow what had been a movement on the part of the EC to liberalize the industry’s ability to provide information about prescription drugs to patients. “That effort was on the ‘slow track’ before last month’s announcement,” says Pitts, who heads the Center for Medicine in the Public Interest in New York. “Now it’s on the ‘super slow track.”
International compliance expert, Paul Woods, says he is hopeful that the revised proposal will eventually be enacted in a form that will enable citizens all across Europe to have equal access to high quality non-promotional information about their prescription medicines. “The outcome, however, remains uncertain,” he says.
The complete RX Compliance Report article can be found here.
And a happy Thanksgiving to all.
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.
