Editorial: Great minds think alike

One of the best outcomes of our ever-shrinking world is the opportunity to meet colleagues from other countries, to learn their best practices, share ‘war stories’ of failed attempts, and garner new ideas for solutions in our respective home countries. I often think back to the four years I spent living in France and England, and how it changed (and continues to do so, now 12 years later) the way I live my life, both personally and professionally.

The International Society for Pharmacoeconomics and Outcomes Research held its annual meeting in Paris, France last week and several of my colleagues from Rx Communications Ltd were lucky enough to attend. Our venerable (and venerated) CEO Ruth Whittington offers us her take home lessons from the meeting, in particular with regarding to health technology assessment (HTA) in several of Europe’s leading HTA agencies. As she notes, “If you’ve seen one HTA submission, you have seen just one HTA submission.” But the different processes provide important concepts for optimising HTA in other countries, especially for those who are just beginning this venture.

Abstract Submission Deadlines

Please note that dates were correct at time of sending this email; HOC cannot be responsible for any amendments.

“Moving and Improving Concepts and Evidence for Healthcare Decisions” – the latest ISPOR congress

Rx Communications has just returned triumphant from the 11th annual European Congress of ISPOR. ISPOR is a great place to meet old friends, find new ones, and discuss current issues with competitors, clients and collaborators. This year’s venue (Athens) provided an interesting reminder of how far we have moved in some respects from the beginnings of the civilised world, and yet how there is “nothing new under the sun”. Indeed, the ISPOR chairmen Uwe Siebert and John Yfantopolous quoted Pericles in 450 BC saying “We Athenians, as individuals, take our own decisions on policy and submit them to proper discussions; for we do not think that there is an incompatibility between words and deeds; the worse thing is to rush into action before the consequences have been properly debated”.

And debate there was. A recurring theme was the harmonisation or standardisation of HTA evaluations from agency to agency. One plenary session provoked a lively discussion of international guidelines for the evaluation of healthcare interventions, with the lead protagonists advocating the QALY (Mike Drummond) or the efficiency frontier (Jaime Caro), and with Milton Weinstein and Uwe Seibert inserting provocative questions regarding the applicability of standard approaches and the flaws in methodology.

Mike Drummond paraphrased Winston Churchill’s famous quote “democracy is a lousy form of government but it’s the best we have” by saying “QALY’s are a lousy form of measure but they are the best we have”. He added, somewhat cynically, that incremental cost per QALY is at least flexible enough to cope with the needs of politicians.

There are both methodological and political issues arising from the use of QALYs as the fundamental decision-making approach. For example, different measurement approaches for estimating the health state preference values for QALYs can give different answers, and if the concern is about the provision of social value, then equal weighting of QALYs won’t necessarily give it to us. As always, the “devil is in the detail” and in the eyes of decision-makers some QALYs are more equal than others.

On the other hand, using an efficiency frontier approach, where the value of the benefit is plotted against the total net cost, is a useful way of determining what role price plays in the estimation of value. A frontier is set depending on points specified by existing healthcare interventions, which enables one to plot what the current market sets as a reasonable return (benefit) for a given cost. However, this too has issues – it doesn’t provide a decision rule, or address societal preferences regarding the priority of various diseases.

It was an interesting debate, with no clear outcome. In some ways, it reminded me of the contentions regarding the peer-review process in publications – if you think of the QALY as a means of measuring value in healthcare, the peer review process in publications is the means of measuring value in a publication. And again, there are methodological issues and political issues in the peer review process. For example, reviewers’ opinions about the value of a manuscript can be strongly influenced by their own perceptions/positions in the therapeutic area, and in many cases the decision of the journal editor whether or not to accept the article is influenced by political considerations (the prestige of the lead author for example, or the likelihood of reprints) as much as they are influenced by the value of the research in the article.

So in my view both the QALY and peer review methods are deeply flawed – but they are the only ones we have for decision making. The question then becomes: do we “throw the baby out with the bathwater” as it were, and redesign the whole process of measuring value, or do we use these flawed measures as a guideline of value and apply commonsense and a little humanity in our decision-making?

The value of congresses such as ISPOR is that these issues are raised and debated, and with an open exchange of views and perceptions we gradually move forward in our thinking, and eventually find better ways of making decisions.

American Medical Writers Association (AMWA) Annual Conference 2008

Under the title “Setting the Pace,” the American Medical Writers Association (AMWA) held its 68th Annual Conference on October 23–25 in horse country, Louisville , Kentucky . More than 1000 medical communicators with a wide range of expertise and interests attended. This year, AMWA offered a full programme of 97 certificate and non-certificate workshops, as well as 38 open sessions in which panels of experts addressed issues of concern to present and potential medical writers.

The Walter C. Alvarez Award, for excellence in communicating healthcare developments and concepts to the public, went to T.L. (Tedd) Mitchell , MD , President and Medical Director, The Cooper Clinic, Dallas Texas . His witty and entertaining address was, “Move Yourself: Getting Americans Back on the Path to Good Health.” Mitchell tweaked the host state for the conference, noting that it has the highest tobacco consumption in the United States . In an illustration of absurdity, he showed a picture of men using the escalator rather than the stairs on their way to a gym, ostensibly for exercise. Another showed before-and-after pictures of Michelangelo’s David; “before” was the familiar slim young man, and “after” was an electronically altered image showing a chubby, middle-aged man with voluminous love handles. Mitchell presented a series of charts documenting the epidemic of obesity and other health problems. His message was clear: we all need to take individual action to maintain our physical fitness and reduce the risk of serious, preventable health problems.

AMWA’s highest award, the Harold Swanberg Distinguished Service Award, for major contributions to medical communication and the medical profession, went to Norman Grossblatt, the man behind the Board of Editors in the Life Sciences (BELS) exam for editors. Grossblatt’s speech was a reminiscence called, “A Life in the Day of a Manuscript Editor” (no, that’s not a typo!) that recounted the many technological changes that have advanced the editing process over recent decades. From the days of handwritten mark-ups of paper manuscripts he recalled the development of early copy machines yielding pages that were of questionable quality and quickly became brittle and discoloured. (And how many people remember the purple mimeograph?) Since those days, tremendous technological advances, such as the replacement of typewriters by computers, have eliminated much of the paper and speeded the review process, with reviewers able to review manuscripts entirely on screen and circulate their comments instantly via e-mail. The result is a process that is vastly different from that of a few decades ago. On the other hand, the current process still requires real human beings to do the actual editing.

Further information about AMWA can be found at www.amwa.org .

WHCC in Berlin: A glimpse into the future

The World Healthcare Congress, held March 10 – 13 in Berlin, always provides interesting insights on the ways governments, clinicians, and healthcare providers perceive healthcare delivery. In the same congress last year, held in Barcelona, two themes dominated the presentations and networking discussions.

The first was the concept of an electronic patient healthcare record – whether it was ethical, how it might be perceived by patients and clinicians, and how such a record might impinge upon such issues as cross-border healthcare provision within Europe. The second theme was chronic disease and how poorly healthcare providers deal with the handful of chronic diseases that account for more than 70% of all healthcare resources.

This year’s congress showed how far healthcare or at least the attitudes of the upper echelons of healthcare decision-makers progressed in a single year. Last year focussed on the concept and ethics of an electronic record; this year, the need for such a record was a given and instead, emphasis was on how best to implement such records and the integration of primary and secondary healthcare by using records to coordinate provision. Many countries are attempting to implement these records and the main issue they face is how to integrate all the existing data sources without undue changes in healthcare practice. The exhibition area of the congress abounded with systems aimed at capturing information, electronic diagnostic maps for patient care, and monitoring healthcare provision by use of guidelines and electronic record keeping. Ethics, apparently, have gone by the board.

Chronic disease management has undergone a similar transformation. Last year we were being alerted to the impact this had on healthcare; this year we were treated to advice and experiences in long term disease management systems, virtual wards for patients at risk, and systems to prevent chronic disease development. The shock of it all has evidently worn off; it seems now governments are knuckling down to deal with chronic diseases by as many new and innovative programs as they can devise. This year systems for prevention are in their infancy – what’s the bet that next year we will be assessing the impact of preventative programmes?

AMWA Annual Conference 2007

Under the title Legacy of Leadership, the American Medical Writers Association (AMWA) held its 67th Annual Conference on October 11–13 in Atlanta, Georgia. About 1000 medical communicators of all stripes attended. As always, AMWA offered a full programme of 95 certificate and non-certificate workshops, as well as 43 open sessions in which panels of experts addressed issues of concern to present and potential medical writers. Of note, AMWA launched its new science fundamentals certificate programme.

Formal banquets provided the setting for presenting key AMWA awards. The John P. McGovern Medal, for pre-eminent contributions to medical communication, was awarded to Julie L. Gerberding, MD, MPH, Director of the Centers for Disease Control and Prevention (CDC). In Dr. Gerberding’s absence, Steven L. Solomon, MD, Director of the Coordinating Center for Health Information and Service at CDC, accepted the award on her behalf. He then spoke of the challenges and opportunities of communicating science “in a flat world where information is perpetual, pan-global, participatory, personalised, and portable, as well as sometimes unedited, uncredentialled, unverified, untruthful, and unethical.”

The Walter C. Alvarez Award, for excellence in communicating healthcare developments and concepts to the public, went to Jeffrey P. Koplan, MD, MPH, Vice President for Academic Health Affairs at the Woodruff Health Sciences Center, Emory University in Atlanta. Dr. Koplan discussed major health challenges such as avian flu and obesity that threaten all nations and showed how working with people in other parts of the world is yielding solutions to common health problems.

AMWA’s highest award, the Harold Swanberg Distinguished Service Award, for major contributions to medical communication and the medical profession, went to Elliott Churchill, MS, MA, President of A World of Words. Churchill spoke of “mountains, molehills, and memories”, describing her long career as Senior Communications Officer at CDC, which included work with local physicians and other healthcare professionals in more than 90 countries.

Many of the workshops and open sessions focused on the nuts and bolts of medical writing and preparation of regulatory documents, training materials, and other types of documents. However, workshops also addressed principles of pharmacoeconomics, as well as ethical standards. Open sessions included public health challenges in an era of global connectivity and communication revolution; the twin epidemics of obesity and diabetes; predictive health (a novel paradigm for disease prevention); emergency health care: an emerging national crisis; health care on the margins: reaching out to the disenfranchised; and heart disease in women and AHA’s guidelines for cardiovascular disease prevention in women.

Further information about AMWA can be found at www.amwa.org.

Robert Hand is a former president of the Delaware Valley Chapter of AMWA.

Rx attracts strong interest at Dublin ISPOR Conference

The theme of this year’s ISPOR annual European Congress – the largest ever – was ‘Expanding Horizons’, and the Rx team took this very seriously, meeting almost every one of the 1700 delegates who visited our exhibition stand.

The programme featured multiple workshops, podium presentations and forums. The first plenary session, led by Drs Michael Barry and former ISPOR president Michael Drummond focused on recent challenges Ireland faces in adopting its own fourth hurdle; the foundation of the Health Information and Quality Authority and the Health Technology Assessments (HTAs) carried out so far.

Of the 33 evaluations conducted since January 2005, 15 submissions were accepted without modification, four were accepted with modifications, and 14 were rejected. Interestingly, the timelines for evaluations in Ireland put those of NICE to shame; they are aiming for – and, it seems, largely achieving – a decision within 90 days, provided there’s enough data. Single technology assessments at NICE take between three and six months, while multi-compound HTAs still average about 18 months.

Ross Hattaway, a New Zealander working for the Health Service Executive in Ireland, presented on the ‘not-NICE’ aspects of reimbursement assessment, and explained how a pre-application consultation with the product suppliers creates a simple, fast process that allows access for innovation. A system of supplier incentives will speed up the process to a mere 40 days if the necessary work is done ahead of the decision process. Another panel member, John McLaughlin, general manager of Sanofi-Aventis in Ireland, explained that a key advantage was a history of positive working relationships between government and industry. Ireland is one of the largest exporters of drugs in the EU with pharmaceutical products accounting for one sixth of all exports.

Other congress sessions focused on compliance and adherence issues; a topic we explore further in this issue of HOC. Patient-reported outcomes were also discussed at length, and featured in a number of the excellent posters on display.
We at Rx look forward to having a strong presence, meeting old friends, making new acquaintances – and expanding our own horizons – at next year’s ISPOR European Congress, to be held in Athens next November.

ASHE revisited

One year after its first conference, the American Society of Health Economists (ASHE) is clearly thriving. Its membership has grown to more than 800, planning for the next two biennial conferences has begun, an awards competition is in place, and many of the most prominent names in US health economics research have assumed leadership roles.

“There’s been tremendous evidence of a pent-up demand for this kind of association and meeting,” says Richard Arnould, PhD. of the University of Illinois Urbana-Champaign, executive director of ASHE.

More than 500 attendees came to the first ASHE conference held last June in Madison, Wisconsin, USA. The conference offered 330 papers in 107 sessions and 90 posters. Joseph Newhouse and David Cutler of Harvard and B. Douglas Bernheim of Stanford gave keynote presentations. “More than 80% of respondents rated the papers high or very high in quality,” said Arnould. “I believe it is safe to say the inaugural conference was a smashing success.”

The newly instituted ASHE awards generated much excitement. Two awards went to outstanding health economists under age 40 – David Cutler and Jonathan Gruber – and one award went to a doctoral student, Grant Miller.
“One benefit of ASHE compared to an international organisation is that at an international meeting, it would be almost impossible to give an award to a graduate student because doctoral programs differ so much in structure and content around the world,” says Arnould.

Founders of ASHE believe that the association brings other benefits to the health economics community that IHEA does not. In an interview published in the first issue of the Newsletter of the American Society of Health Economists, ASHE president Jody Sindelar, PhD of Yale University writes: “ASHE provides an opportunity to bring together a community of scholars who share an in-depth interest in a similar set of topics. I think you get a better sense of affinity and community with people who share a common set of issues and facts. Some of these issues that are so important to people in the United States are not of interest to people in the international community. IHEA is not interested in some of these topics because they are not as broadly appealing to people in other countries. Health economists from other countries don’t feel a need to learn all about Medicaid or SCHPs, HMOs, PSOs, and other institutions and policies that are specific to the United States.”

ASHE members, however, remain active participants of IHEA. At present, ASHE is under the IHEA umbrella, but by 2010 it will become an independent organisation. Biennial conferences are arranged so that they will not conflict with ASHE conferences scheduled for even-numbered years while IHEA conferences will take place on odd-numbered years. The second biennial ASHE conference will take place June 22–25, 2008 at Duke University. The call for papers will be issued soon after the IHEA meeting in Copenhagen.

Dr. Sindelar outlines some of the future plans for ASHE: “One of the things I’m working on is an ASHE web page. A really informative web page will be of great benefit to ASHE members and students. If someone is going to teach a new course in health economics or healthcare finance, or a newly-minted PhD student wants some help getting started, they can have access to syllabi, some problem sets, and other teaching materials. There can also be links to other material available on the web. The newsletter is also important because in addition to being informative, it will give a sense of community and purpose in the profession.” For more information visit the ASHE website.

ISPOR’s 12th annual international meeting

The theme of this year’s international ISPOR meeting – held on May 20–23 in Arlington, Virginia, USA – was “new tools, new audiences for health outcomes research.”

In his valedictory address, retiring ISPOR president Dr Michael Drummond told some of the 1600 registrants to the meeting that the organisation now has more than 3300 members in 80 countries. Forty nine percent of those come from the US and 35% from Europe, while industry accounts for 38% of the membership, he said, with healthcare research and academia each accounting for 28%.

This year’s meeting attracted 64 podium presentations and 524 posters. The organisation’s forward planning strategy – Impetus 2010 – includes research excellence, promoting education, reaching out to decision-makers, and international growth.

In a plenary session titled ‘How should the media convey information about new medical technologies?’ a former JAMA editor Drummond Rennie said that “while the drug industry does exceedingly good trials,” the press is often shrill in its Pharma bashing. Peter Littlejohns of NICE agreed, saying that the press too often sensationalises healthcare issues, takes a personalised angle, quotes from so-called experts, and often presents a negative slant.

Ex-national public radio journalist Snigda Prakash said that in the Vioxx case Merck had hidden adverse cardiovascular data, and, she said, an editor of the New England Journal of Medicine said he’d been ‘hoodwinked’ in connection with the journal’s Vioxx article. A pharmaceutical industry questioner from the floor noted that the media seldom report the great advantages of drugs and the good work done by the pharmaceutical industry. Ms. Prakash said the line between advertising and editorial has become blurred. And Dr. Rennie added that better ways need to be found to educate the public about adverse effects of drugs – a move that would also be helpful to the industry.

In a session on the economics of personalised medicine, a panellist defined this as “doctors customising medical care to a person’s genetic code for better diagnosis, more effective treatment and fewer side effects.” Another panellist spoke of raising the bar – the impact of heightened awareness of the need for health economics data in the absence of regulatory mandates. The managed-care revolution in the US created a demand for evidence-based formulary placement and the need to establish the value of a new medicine, said another. Applying evidence-based criteria to high technology, he said, if the answer is No to the questions of clinical effectiveness, safety, and improved value then the drug or the technology should not be adopted; if the answer is yes, and there is no comparable product, it should be adopted.

In a session on the relevance of cost-effectiveness information for clinicians, Dr. Alan Detsky said there’s a need to teach clinicians how to make decisions based upon rational thinking. Cost-effectiveness analysis is a linear programming technique developed to maximise good health outcomes, he said. Cost consequence analysis, he added, is the cost of the prescription, the cost of effects and the cost of side effects. Those doing such analyses may be biased, he said, and concluded “two economists debating is like watching the passive aggressive Olympics.”

In her inaugural address as ISPOR president, Diana L. Brixner, R.Ph, PhD, executive director of the University of Utah’s Pharmacotherapy Outcomes Research Center, said ISPOR “should glance back, reach outward, and press forward.” She noted the enormous growth, particularly internationally, of the organisation. Founding ISPOR Executive Director Marilyn Dix Smith, Ph.D., said the organisation’s revenue is more than $3 million with a net surplus of $700,000. She said she welcomes ideas for worthwhile projects for the organisation.

ISPOR’s flagship publication Value in Health attracted some 271 submissions in the past year, said its editor Dr Josephine Mauskopf… and the organisation’s website attracts some 1.5 million hits a month.

Next year’s international conference will be held in Toronto.

WHC and ISMMP congresses

By David Woods (dwoods@rxcomms.com)

HOC editor David Woods has just returned from attending two healthcare congresses. A full report of both can be found on the Rx website at www.rxcomms.com; here is just a taster.

Fourth Annual World Health Care Congress (WHC), Washington, DC, 22–24 April

A panel on competition, moderated by John Iglehart, the founding editor of Health Affairs, included Michael Porter, a Harvard professor and a leading authority on competitive strategy, who said that 21st-century medicine is being delivered with 19th-century organisation and management.

What’s called for, he said, is a fundamental restructuring of health systems rather than incremental improvement, and an emphasis on value and on health outcomes per dollar spent. True competition must be based on measurable results, not process, he said; and while information technology is an enabler, it’s not a solution. Restructuring must come from the bottom up and physicians have to ‘get out of the bunker’ to lead the change…

See the news page on www.rxcomms.com for David’s full report.

International Society for Healthcare Publication Professionals (ISMPP), Third annual meeting, Philadelphia, PA, 23–25 April

“Ensuring integrity in medical publications: conflicts, credibility and collaboration” was the conference theme, and the highlight was a panel discussion that featured all three of those in a sometimes heated but always engaging debate on conflict of interest.

Faith McLellan, North American senior editor of The Lancet, pointed out several examples of scientific fraud, including one perpetrated by a scientist who made up data on 960 patients – but gave them all the same date of birth. The lessons learned about conflict of interest, she said, are: slow down, develop more rigorous peer review and get a better handle on who the authors are and what they actually did…

See the news page on www.rxcomms.com for more.