July2008

Is the NHS on its last legs?

Jul 26, 2008
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By Ruth Whittington (ruth.whittington@rxcomms.com)

With the NHS in the UK nearing its 60th birthday, there’s been considerable talk about whether the system should be put into retirement. At the recent European-based World Healthcare Congress in Berlin the Chief Executive Officer David Nicholson explained why he felt that there was plenty of life in the old girl yet.

Nicholson pointed out that the last 18 months have seen significant change in the NHS. One year ago, the NHS was in its third year of producing a deficit – averaging about £0.5 billion annually. In 2007 the organisation managed to turn this around so successfully that they created a surplus of £0.5 billion, and this year the surplus is projected to be 3 times that. Now, why, you may ask, is a surplus a good thing in a non-profit organisation? Simply because when you have money you have an element of control over what you do. Being constantly in debt leaves you on the back foot and leaves little room for manoeuvre. So it is with the NHS, Nicholson claims.

Thinking of the NHS as purely a system helps with the implementation of change, according to Nicholson. He described the changes that have happened in the NHS as a series of phases.

The first phase began in the post 1997 era with a focus on building capacity based on national targets. In this phase the NHS grew by almost a third, in staff buildings and all levels of healthcare provision.

Phase Two of the change was in providing reforms in healthcare delivery – setting up tariff systems and organisational models.

Phase Three, underway at the moment is the individualisation and personalisation of care – making patients partners in their own healthcare provision.

From the 1st of April (a somewhat unfortunate choice of date) patients will have free choice of their secondary healthcare. The NHS is hoping to introduce an element of choice and contestability into healthcare, and also to integrate primary and secondary care a little better with advanced IT systems. To that end, they are working closely with BT Health to develop electronic patient records.

A start of this phase is the ability for patients to interact with their own healthcare records via HealthSpace on the web. So it seems, with an exciting future ahead, the NHS is heading a second youth/swinging sixties/second wind.

‘Big box’ companies and public health

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

Whether it’s because of a shortage of primary care physicians, impatience at the length of time it takes to see one, or simply increasing costs, the so-called big-box companies are getting more involved in health issues. Steven Burd, CEO of Safeway, told attendees at the World Health Care Congress (WHCC) in March that 70% of healthcare costs are driven by behaviour and he called for introducing market forces into preventive medicine and drug compliance.

Safeway has attracted a coalition of more than 50 other companies in promoting healthful behaviours. At Jefferson Medical College ‘s Department of Health Policy’s 17th annual Dr. Raymond C. Grandon Lecture, Dr. John O. Agwunobi, a senior vice president at Wal-Mart, spoke about bridging the worlds of business and public health. And also at WHCC, Stanley B. Blaylock, president of Walgreens Health Services, described his company’s healthcare initiatives.

In an interview with HOC, Blaylock noted that Walgreens has more than 6200 retail pharmacies, and that 146 of these have “Take Care” in-store clinics that the company is adding to at the rate of one a day. In March, Walgreens became the exclusive specialty pharmacy provider for Prime Therapeutics, a pharmacy benefit manager collectively owned by 10 Blue Cross and Blue Shield plans, which together serve more than 20 million health plan members.

Medmark, a Walgreens specialtiy pharmacy of which Mr. Blaylock, a former investment banker, was a cofounder, will provide Prime Therapeutics with medication fulfilment and complement Prime’s existing patient education and clinical support services. Its pharmacists and nurses will counsel patients on the importance of medication adherence and on managing side effects.

Blaylock describes the company’s new employer on-site clinics as “Take Care on steroids.” He notes that in the US more than 7000 employers have over 1000 employees, and 200 of these, including Sprint, BMW, and Disney, are Walgreens clients. Taking healthcare to the workplace, he says, increases productivity and accessibility while decreasing absenteeism. It’s also more user-friendly, he believes. The next step for Walgreens, says, Blaylock, is to integrate the company’s health services more fully in an attempt to provide something closer to the so-called ‘medical homes’ – comprehensive, community based primary care.

While Safeway, Wal-Mart, and Walgreens may all serve different client bases and adopt differing strategies to serve them, there is clearly a growing trend towards store-and work based healthcare delivery as we try to come to grips with the increasing challenges of cost, access, quality, and efficiency.

The mean versus the gene: will national healthcare systems ever adopt personalised medicine?

Jul 26, 2008
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By John F P Bridges

While outcomes for any given treatment differ significantly among patients, national healthcare systems continue to take a top down population perspective in reviewing not only epidemiologic data but to evaluating the effectiveness and cost-effectiveness of new medicines.

This top down approach, coupled with a growing need for cost containment, has recently caused many governments to institutionalise these practices through health technology assessment institutions. The purpose of these agencies is to promote better quality or value for money in the healthcare system; but this has led to medicines and technologies either being considered good (in other words, good for all) or they are deemed bad and are blacklisted.

Whether it be data from a randomised control trial, a comparative effectiveness study or a cost-effectiveness study, the focus is on the average patient’s health outcomes, where all individuals are treated equally (or to be more correct, identically). Variation is something that we consider only when it comes to statistical inference, viz. does the average effect differ from zero.

This is a major over simplification since patients do vary: their needs vary; their preferences vary; their circumstances vary and, most important, their outcomes vary. Even if you wanted to treat individuals equally on ideological grounds, these top down approaches ignore the risks and uncertainties in medical decision making. For example, rather than understanding risk in clinical trials, we attempt to make it go away by demanding larger and larger trials (a movement away from the individual, towards the population).

As technology progresses, we are increasingly aware that the variation in benefits and adverse consequences of many healthcare interventions are predictable. As our knowledge of genetics and proteinomics expands, our ability to predict these events grows exponentially. This has prompted many healthcare innovators to develop diagnostics to tailor medicines for particular patients – in what is often referred to as personalised medicine. Governments everywhere have been eager to support these start-ups, almost to the point of frenzy and with little accountability.

One key problem exists, however, in that these new technologies are incompatible with the fundamental principles of many national healthcare systems and with the top down evaluation that has been implemented. Hence a bottleneck is occurring – ironically with government playing a dual role of promoting and rationing medical technology. In order to alleviate this bottleneck, we either have to address the funding crisis through personalised approaches to healthcare finance (The Netherlands and Switzerland have attempted this) or we need to stop wasting money on research and development of personalised medicine technologies that are unlikely to be funded in the future.

Essentially this means that healthcare systems need to decide whether they want to focus on the mean (the average effects of medicine) or on the gene (by accommodating personalised medicine.

John Bridges, PhD, is Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Senior Fellow at the Center for Medicine in the Public Interest and founding editor, The Patient: Patient-Centered Outcomes Research.

Regulating DTC ads – Are we attempting to herd cats?

Jul 26, 2008
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By Mary Gabb (mary.gabb@rxcomms.com)

129In a previous issue of HOC , we outlined some of the commonly expressed pros and cons of direct-to-consumer advertising (DTCA), which is currently allowed only in the United States (US) and New Zealand but under consideration for Europe .

On May 5, 2008, three executives, from Pfizer, Schering-Plough/Merck and Company, and Johnson & Johnson, appeared before the US Congress Subcommittee on Oversight and Investigation, to answer questions regarding three specific “potentially misleading and deceptive tactics” used in DTCA for Pfizer’s Lipitor, J&J’s Procrit, and Vytorin, which is sold by Merck and Schering-Plough. The congressional subcommittee asked whether the three companies would be willing to commit to six guidelines:

  • Follow the American Medical Association’s guidelines regarding the use of actors and health professionals in DTCA.
  • Not market products in DTCA until a valid outcomes study of the product is completed.
  • Place a 2-year DTCA moratorium on new prescription drug products, as recommended by the Institute of Medicine .
  • Not market off-label uses for prescription products in DTCA.
  • Add the FDA toll-free MedWatch phone number in all DTCA.
  • Include “black box” warnings in DTCA for products that contain such warnings.

All three companies agreed to only two of the six guidelines (following AMA guidelines on use of physicians in DTCA and placing a 6-month moratorium on DTCA for new products). Some of the companies also agreed to specific guidelines, or more often, agreed to work with FDA guidance or seek advice from the FDA on the proposed guidelines. The trade association for the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA), also participated in the congressional hearing. In 2005, PhRMA had developed its own guiding principles on DTCA.

DTCA are reviewed by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC). The reviews are for the most part voluntary, except for specific categories of drugs, such as cancer drugs, where the risk-to-benefit ratio may be weighted on the risk side. In the latter cases, the advertisement must be submitted ahead of time – but the pharmaceutical manufacturer does not have to heed the DDMAC advice nor even wait for the comments before it releases the ad.

Nonetheless, PhRMA maintains that DTCA is one of the most highly regulated forms of advertisement in the US . To date in 2008, the FDA DDMAC has issued 5 warning letters outlining regulation violations in promotional advertisements.

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The changing face of DTCA

The New England Journal of Medicine reports on a new form of DTCA of which we may be seeing more – for medical devices. (NEJM 2008;358:21). The article also describes the differences in DTCA requirements based on format – television ad, web site, and patient-education brochure. For example, the FDA requires that only “major risk information” be disclosed in broadcast DTCA, but these ads must direct viewers to other sources of information on associated risks.

Print advertisements, by contrast, must include all information about associated risks (ie, major side effects, contraindications, and precautions contained in the FDA’s label). As an example, a television ad for a drug-eluting coronary stent listed 4 potential adverse events related to use of stents in general, but none associated with the product. The web site listed 10 device-related adverse events, and 5 that were product-specific. The patient education brochure listed 31 device-related adverse events, and 13 product-specific adverse events. So, patients must do their homework, depending on the type of DTCA they see. A spokesperson from the FDA said that all ads – for devices and drugs – are required to not be false or misleading and to present information that is in accord with product label

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