Welcome to the October issue

By David Woods (david.woods@rxcomms.com)

After selling his travel company – the third largest in the US – to American Express for $6 billion, Hal Rosenbluth could have spent his time fishing, golfing, or globetrotting; instead, he co-founded Take Care Health Systems.

The company, of which he is chairman and cofounder Peter Miller is CEO, is principally dedicated to placing health delivery into the workplace. They call it, as Take Care's slogan puts it: “a better way to be well.” There are some 7,000 US companies with more than 1,000 employees, and Take Care is working with more than 100 of them.

Bringing healthcare services to the workplace is nothing new: bigger companies traditionally had a medical director, and perhaps some occupational health staff to speed injured workers back to fitness. But Take Care's Employer Solutions Group, responding to employers' concerns about rising healthcare costs and a growing shortage of primary care doctors, can bring comprehensive health services to the workplace. “In fact,” says Rosenbluth, “in many instances we bring a full range of care, including vision, dental, imaging, infusion, chronic care, and prevention.” In the town of Gillett , Wyoming , which has three mining companies but no physician, Take Care provides a complete health service.

The emphasis, says Rosenbluth, is on wellbeing – catching health problems before they escalate. For employers, this means reduced costs and a happier and more productive workplace. In fact, the happy workplace concept is central to Hal Rosenbluth's approach to management. His bestselling book, “The Customer Comes Second,” focuses on how to create a great service organisation by first focusing on your employees.

The whole idea of a strong service ethos – market driven healthcare – is appealing to employers. And it's what drives Rosenbluth who admits that he knew nothing about healthcare “but my whole life I've been in love with service.” Investment banking firms on Wall Street are especially enamoured of Take Care's 24-hour care that allows brokers to remain “on the floor”. The company has a sales force of consultants who engage in a “corporate conversation” with prospects. Says Rosenbluth: “Corporations are made up of human beings; but all too often we make things more difficult than they need to be. Our concept is a simple one.”

Do physicians see all this as a threat? Well, the American Medical Association's and the American Academy of Family Physicians' executives are apparently supportive although some individual physicians may perceive that their turf is being invaded. Yet Take Care's own doctors, relieved of onerous administrative duties and rising malpractice insurance premiums, seem happy enough. And anyway, how can you be against quality, affordable, comprehensive, and technologically up-to-date care? says Rosenbluth.

Asked about whether continuity of care might be a negative, he says that it's not an issue “if you believe in electronic medical records and medical homes”. And asked further what he brought to healthcare from the travel industry, he says that it's about improving the lifestyle of people – making things more convenient and easier by, for example, making airlines compete for business, making all facets of the operation electronic. Similarly, Take Care will negotiate payment and working arrangements with, say, ten cardiologists in a city.

In sum, Hal Rosenbluth wanted to find the biggest unsolved problem in the US and bring a private sector approach to solving it. Take Care seems to be a part of that solution.

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By Robert Hand (robert.hand@rxcomms.com)

The US Food and Drug Administration (FDA) in August proposed a new guideline asking the sponsors of clinical trials to submit annual development safety update reports (DSURs). The guideline, titled “E2F Development Safety Update Report,” is in draft form and describes the format, content, and timing of a DSUR. It specifies that a DSUR update the status of the clinical trial, summarise the sponsor's understanding and management of identified and potential risks, describe new safety concerns that could affect the protection of trial subjects, and examine whether the information collected in the previous year accords with current knowledge of the product's safety.

DSURs would be required for investigational drugs, including biologicals, with or without marketing approval, and whether or not the clinical trials are being conducted by commercial or non-commercial sponsors. A DSUR would have to be submitted within 60 days of the DSUR data lock-point, determined by the date of the sponsor's first authorisation to conduct a clinical trial in any country (the “Development International Birth Date”).

The guideline instructs sponsors to focus on data from interventional trials. However, it also advises the inclusion of other findings that may have a bearing on the safety of trial subjects. Such information could include findings of non-clinical trials, as well as clinical trials conducted by the sponsor's development partners and non-interventional or compassionate-use studies.

The FDA draft guideline matches one developed by the International Conference on Harmonisation (ICH).

Will DSURs create more work for the sponsors of clinical trials? Apparently not, at least in the long run. First, the guideline follows a standard format that has been developed for submission in the three ICH regulatory regions (the United States , the European Union, and Japan ). A report produced in accordance with the guideline could be submitted simultaneously in all three regions. Second, the DSUR would replace some reports that are currently required, such as the IND Annual Report. For already marketed products, some of the information required for the DSUR may be provided in the periodic safety update report (PSUR), on which the DSUR is patterned.

The draft guideline may be obtained online at http://www.regulations.gov or http://www.fda.gov/cber/guidelines.htm . The FDA has solicited comment on the draft. To be useful, comments should be submitted by 3 November.

“ No great discovery is ever made without a bold guess..”
Isaac Newton (1642–1727), English scientist

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By Laura Goldman (laura.goldman@rxcomms.com)

The Commonwealth Fund, a private New York foundation working for healthcare reform, commissioned polling firm Harris Interactive in May 2008 to conduct a public survey of adult attitudes towards healthcare. The 1004 respondents were asked about their own recent healthcare experiences, views on the administration and organisation of the healthcare system, and suggestions to improve healthcare.

More than 80% of those surveyed said that the healthcare system needs fundamental change or complete rebuilding. Conversely, only 16% said the healthcare system works well and only needs minor changes. Insured as well as uninsured, in almost the same percentages, called for change. Interestingly, there were no wide variations of opinion along either the income or the geographic spectrum.

Katherine Stoll, deputy executive director and health policy director of Families USA, was “not surprised” by the results of the survey. “With the economy in decline, the healthcare reform debate has moved from the theoretical and altruistic to the practical: will my coverage accommodate my own healthcare needs in the future?”

Dr. John Goodman, President and CEO of The National Center for Policy Analysis, is more sanguine. “If the same survey was done in Canada , Europe or anywhere in the developed world, you would get the same results. Like public education, everyone everywhere is unhappy with their healthcare.”

The primary concerns of those surveyed were cost, access and quality. The respondents wanted more timely access to doctors, better coordination among caregivers, an increased flow of information between doctor and patient, and a streamlining of the administrative and billing practices. Almost 9 out of 10 polled think that the next President should address healthcare reform.

Cathy Schoen, Senior Vice President of the Commonwealth Fund, said: “In view of the survey results, the Commonwealth Fund proposes realigning the incentives for primary care doctors. Instead of being paid by the visit, they should be paid by the outcome. The number of visits is not a harbinger of better health. Providers should be paid for each patient, not for each service.”

Dr. Goodman, the father of the health savings account, concurs with reordering the inducements but does not agree with a pay for performance methodology. “I want the healthcare providers to propose their own incentives. Geisinger Medical Center in Pennsylvania , for example, provides a 90-day warranty on their heart surgeries. If there is a need for additional surgery or care, Geisinger provides it at no additional cost.”

88% of those surveyed want to see the next President decrease the number of uninsured, currently an estimated 46 million, but health policy experts differ on how to reach that goal. “Families USA see healthcare reform as expanding coverage to the uninsured and helping the currently insured keep their coverage and out-of-pocket costs affordable,” said Ms. Stoll. “Being politically pragmatic, we advocate using a hybrid plan with a foundation of public coverage – Medicaid – for the very lowest income families and people with disabilities. Then you build on the existing framework of employer based coverage for other families who cannot afford their share of private insurance premiums.”

Dr. Goodman prefers to amend Federal tax policy to subsidise all purchases of insurance, not just employer paid insurance. “The Federal government “spends” approximately $250 billion a year on tax subsidies for private insurance because employer payments for employee healthcare are exempt from the employee's taxable income,” said Dr. Goodman. “Tax subsidies for the purchase of insurance should be provided uniformly, regardless of how the insurance is obtained.”

Almost all of those responding said technology should play a bigger role in healthcare. The United States lags behind the rest of the Western world in the adoption of healthcare information systems. While 98% of doctors in the Netherlands report accessing medical records electronically, the number falls to 28% in the United States .

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By Mary Gabb (mary.gabb@rxcomms.com )

The publication several years ago of Selling Sickness: How the World's Biggest Pharmaceutical Companies are Turning Us All into Patients by Ray Moynihan and Alan Cassels has brought the concept of disease-mongering into a global debate, and has introduced (or reintroduced) terms such as “medicalisation” and “lifestyle drugs” into today's lexicon. An entire issue of PLoS Medicine was devoted to the topic in 2006. The first international conference on disease-mongering took place in 2006 in Newcastle, Australia. Disease-mongering even has its own Wikipedia page.

Moynihan and colleagues define disease-mongering as “widening the boundaries of treatable illness to expand markets for those who sell and deliver treatments”. It “turns healthy people into patients, causes iatrogenic harm, and wastes precious resources”. In short, disease-mongering is purported to make us believe we are sick (or more sick than we really are) so that we will buy more drugs to cure what ails us (or at least make us happier). Iona Heath, MD* has said it exploits our deepest atavistic fears of suffering and death.

Those who say that pharmaceutical companies promote disease-mongering point to the recent upsurge in diagnoses and treatments for numerous conditions (see right) , asking whether some of these are even real conditions, or whether the stated prevalence is as broad as commonly stated by both medical professionals and the media.

In fact, disease-mongering proponents lay the blame for this alleged deception on several participants with Pharma affiliations: medical professionals (who are duped by Pharma via pharma-sponsored continuing education, especially in the United States), patient advocacy groups (also influenced by Pharma sponsorship to further their cause by “raising disease awareness”), and the mass media (who have a propensity to exaggerate a problem to sell their product and rely on lazy journalism in which facts such as prevalence statistics are never questioned). In fact, as Drs Steven Woloshin and Lisa M. Schwartz* note, disease-mongering stories have all the ingredients for what is considered “good journalism”: compelling personal anecdotes, public health crises, uncaring or ignorant doctors, and miracle cures. Much like the field of pharmacoeconomics, the pursuit of disease-mongering involves multiple disciplines (beyond medical science and economics) such as public health policy, sociology, psychology, anthropology, and patient advocacy.

The idea of questioning the diagnosis of conditions such as bipolar disorders, menopause, or erectile dysfunction (ED) is sure to ruffle some feathers. While the symptoms of menopause or ED may be a “troublesome inconvenience” for some, they can be debilitating and/or terribly embarrassing for others, affecting long-term personal relationships and self-esteem.

Is it disease mongering? NO

We live in an era in which each generation has lived longer and better than the preceding one. We expect the most out of quantity and quality of life, simply because it is possible. Is that wrong?

Second, let's be honest – Pharma products are addressing consumer needs, not medical science. Push-pull marketing has been around for ages, long before direct-to-consumer advertising. However, the danger is that Pharma is one of the few industries where profit-making activities have ethical overtones.

Third, the search for a biologic basis of disease and a reconsideration of what is normal has also led to some conditions being de medicalised, such as homosexuality.

Fourth, disease-mongering is not universally defined. Moynihan admits that the first step to studying possible disease-mongering is to create an operational definition.

Is it disease mongering? YES

The availability of so many pills and potions to address every ache, pain, and risk factor (which is treated as a disease state) runs the risk of removing the patient's responsibility for any lifestyle changes that would help to address the condition. The impetus to reduce risk factor exposure (such as stress, tobacco smoke) is removed so the condition may be treated but the underlying potential causes remain. And, as noted by Iona Heath, MD, the irony is that such profit-driven practices of Pharma marketing “poisons the present in the name of a better, or at least a longer, future”.

Note also the increasingly stringent definitions of what are considered to be optimal measures of health, for example blood pressure, cholesterol, and weight. Achieving these levels through diet and exercise alone may be possible only for the truly devoted, but “we do happen to have a pill that will reduce your______”.

As discussed by Dr Olavo B. Amaral**, the struggle over disease-mongering may force us (ie, those involved directly or indirectly in the practice of medicine and medical consumers) to consider diseases as spectra rather than binary states (i.e., sick or well), and patients can decide, by working with their physicians, if they are sick enough for treatment and whether the treatment is worth the risk of the adverse events.

*Drs Heath, Woloshin, and Schwartz were authors of two of the articles from the PLoS Medicine issue on disease-mongering. Dr Heath is a general practitioner in London , UK . Drs Woloshin and Schwartz are at the Veterans Affairs Outcomes Group in Vermont , USA , and the Center for the Evaluative Clinical Sciences at Dartmouth Medical School , New Hampshire , USA .

**In a Letter to the Editor in PLoS Medicine.

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