Farmacovigilancia on line


The iHealth Alliance, a not-for-profit group operated by for-profit Medem, plans to launch a Web site that will e-mail physicians to notify them of significant label changes, warnings and recalls related to medications, the Wall Street Journal reports. Currently, physicians in most cases receive such notifications by regular mail.

In 2006, FDA issued a guidance that allowed pharmaceutical companies to send such notifications by e-mail, rather than by regular mail, as previous federal regulations required. Many pharmaceutical companies have continued to send such notifications by regular mail “because it has seemed like the surest way to reach doctors,” but physicians maintain that the notifications take “too long to arrive” and “often get buried in stacks of drug company marketing materials or thrown out with junk mail,” according to the Journal.

Pharmaceutical companies will pay to use the Health Care Notification Network, which will not include any marketing materials from the companies and will provide access at no cost for physicians who decide to participate. Physicians who decide to participate will receive e-mails that instruct them to visit the Web site for new notifications, with the e-mails focusing on the specialties of the physicians. The Web site will begin to send such e-mails in about two months.

After physicians visit the Web site, they will have the ability to send comments to FDA and pharmaceutical companies about patient reactions to medications. The Web site will record which physicians have viewed the notifications and will archive the notifications for one year. According to the Journal, the Web site also could “be used to send doctors information on major public health emergencies or bioterrorism alerts.”

Medem officials said that five large pharmaceutical companies have requested contracts to use the Web site, although they have not finalized any agreements. Johnson & Johnson officials have said that the company will use the Web site, and Alan Metz, North American medical director for GlaxoSmithKline, has said that the company likely will use the site (Rubenstein, Wall Street Journal, 3/25).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Does Preventive Care Save Money? Health Economics and the Presidential Candidates


With health care once again a leading issue in a presidential race, candidates have offered plans for controlling spiraling costs while enhancing the quality of care. A popular component of such plans involves greater promotion of preventive health measures. The first element in Hillary Clinton’s plan is to “focus on prevention: wellness not sickness.” John Edwards has stated that “study after study shows that primary and preventive care greatly reduces future health care costs, as well as increasing patients’ health.” Mike Huckabee has said that a focus on prevention “would save countless lives, pain and suffering by the victims of chronic conditions, and billions of dollars.” Barack Obama has argued that “too little is spent on prevention and public health.” Indeed, some evidence does suggest that there are opportunities to save money and improve health through prevention. Preventable causes of death, such as tobacco smoking, poor diet and physical inactivity, and misuse of alcohol have been estimated to be responsible for 900,000 deaths annually — nearly 40% of total yearly mortality in the United States.1 Moreover, some of the measures identified by the U.S. Preventive Services Task Force, such as counseling adults to quit smoking, screening for colorectal cancer, and providing influenza vaccination, reduce mortality either at low cost or at a cost savings.2

Sweeping statements about the cost-saving potential of prevention, however, are overreaching. Studies have concluded that preventing illness can in some cases save money but in other cases can add to health care costs.3 For example, screening costs will exceed the savings from avoided treatment in cases in which only a very small fraction of the population would have become ill in the absence of preventive measures. Preventive measures that do not save money may or may not represent cost-effective care (i.e., good value for the resources expended). Whether any preventive measure saves money or is a reasonable investment despite adding to costs depends entirely on the particular intervention and the specific population in question. For example, drugs used to treat high cholesterol yield much greater value for the money if the targeted population is at high risk for coronary heart disease, and the efficiency of cancer screening can depend heavily on both the frequency of the screening and the level of cancer risk in the screened population.4

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Market-Based Failure — A Second Opinion on U.S. Health Care Costs


U.S. health care expenditures rose 6.7% in 2006, the government recently reported. According to the Centers for Medicare and Medicaid Services, total health care expenditures exceeded $2.1 trillion, or more than $7,000 for every American man, woman, and child.1 Medicare costs jumped a record 18.7%, driven by the new privatized drug benefit. Total health care spending, now amounting to 16% of the gross domestic product, is projected to reach 20% in just 7 years. Relentless medical inflation has been attributed to many factors — the aging population, the proliferation of new technologies, poor diet and lack of exercise, the tendency of supply (physicians, hospitals, tests, pharmaceuticals, medical devices, and novel treatments) to generate its own demand, excessive litigation and defensive medicine, and tax-favored insurance coverage.

Here is a second opinion. Changing demographics and medical technology pose a cost challenge for every nation’s system, but ours is the outlier. The extreme failure of the United States to contain medical costs results primarily from our unique, pervasive commercialization. The dominance of for-profit insurance and pharmaceutical companies, a new wave of investor-owned specialty hospitals, and profit-maximizing behavior even by nonprofit players raise costs and distort resource allocation. Profits, billing, marketing, and the gratuitous costs of private bureaucracies siphon off $400 billion to $500 billion of the $2.1 trillion spent, but the more serious and less appreciated syndrome is the set of perverse incentives produced by commercial dominance of the system.

Markets are said to optimize efficiencies. But despite widespread belief that competition is the key to cost containment, medicine — with its third-party payers and its partly social mission — does not lend itself to market discipline. Why not?

The private insurance system’s main techniques for holding down costs are practicing risk selection, limiting the services covered, constraining payments to providers, and shifting costs to patients. But given the system’s fragmentation and perverse incentives, much cost-effective care is squeezed out, resources are increasingly allocated in response to profit opportunities rather than medical need, many attainable efficiencies are not achieved, unnecessary medical care is provided for profit, administrative expenses are high, and enormous sums are squandered in efforts to game the system. The result is a blend of overtreatment and undertreatment — and escalating costs. Researchers calculate that between one fifth and one third of medical outlays do nothing to improve health.

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