A Representative Survey of M.S. Patients on Attitudes toward the Benefits and Risks of Drug Therapy

Background: Although M.S. patients face significant trade-offs between risks and benefits of drug therapy, little is known of their attitudes toward these risks and benefits. Methods: A representative telephone survey of 200 patients with relapsing remitting M.S

A Representative Survey of M.S. Patients on Attitudes toward the Benefits and Risks of Drug Therapy

Background: Although M.S. patients face significant trade-offs between risks and benefits of drug therapy, little is known of their attitudes toward these risks and benefits. Methods: A representative telephone survey of 200 patients with relapsing remitting M.S. Results: Respondents suffered substantial disability, most of them requiring a wheel chair or support for walking any significant distance, and over half suffering relapses in the past year. All were on drug therapy; half had switched drugs; 1/3 had switched at least twice.Most patients had seen their neurologist at least 4 times in the previous two years and said they and their physician were equally involved in drug decisions. About 55% said they would definitely or probably use a drug that significantly reduces frequency of relapse or progression in disability even if the drug involves a 1-in-1,000 chance of a fatal side-effect.Willingness to tolerate risk bore little relationship with disability levels. A substantial majority agreed that the FDA should tightly control drugs with safety concerns, but a larger majority agreed that once the FDA has provided a warning, patients should be free to decide with their physician whether to use such drugs. Virtually all said they were willing to visit their neurologist more often in order to use risky drugs. Conclusions: M.S. patients are accustomed to playing a large role in their own drug therapy but do so in close collaboration with their physicians.After the FDA has reviewed drug safety and provided reasonable warnings, many M.S. patients wish to be free to choose to incur a 1-in-1,000 (or even greater) risk of a fatal side-effect in return for significantly more effective drugs, and are willing to work with the physicians in doing so.

An Exploratory Analysis of Pharmaceutical Price Disparities and Their Implications Among Six Developed Nations

In our study of 43 drugs, prescription drug prices in several wealthy nations (Australia, Canada, France, Germany, and the U.K.) were much lower than in the U.S. on average, well below relative per capita GDP. There was relatively little difference among the five foreign nations. All this is consistent with previous research. After separating less-unique from more unique drugs, however, important new findings emerged. Relative prices for less-unique drugs, which are subject to strong competition, were at about half the U.S. level. We suggest that this reflects the exercise of monopsony power that does not exist in the U.S., where buyers as well as sellers compete. On the other hand, relative prices for highly unique drugs tended to be approximately proportional to per capita GDP or higher. Remarkably, biotech drugs were priced at or above U.S. levels in Canada and France

An Exploratory Analysis of Pharmaceutical Price Disparities and Their Implications Among Six Developed Nations

In our study of 43 drugs, prescription drug prices in several wealthy nations (Australia, Canada, France, Germany, and the U.K.) were much lower than in the U.S. on average, well below relative per capita GDP. There was relatively little difference among the five foreign nations. All this is consistent with previous research. After separating less-unique from moreunique drugs, however, important new findings emerged. Relative prices for less-unique drugs, which are subject to strong competition, were at about half the U.S. level. We suggest that this reflects the exercise of monopsony power that does not exist in the U.S., where buyers as well as sellers compete. On the other hand, relative prices for highly unique drugs tended to be approximately proportional to per capita GDP or higher. Remarkably, biotech drugs were priced at or above U.S. levels in Canada and France. These results carry uneasy implications for the future of pharmaceutical research. The follow-on drugs that make therapeutic classes competitive also amplify the incentives to conduct new R&D within these classes even as R&D incentives for pioneer brands disappear with the approach of patent expiration. Our results suggest that price controls operate to blunt these incentives for follow-on drug research, leaving most of the burden to U.S. purchasers. Because these follow-on R&D results are often extremely valuable, the implications merit substantial concern. In contrast, biotech drug prices in foreign nations appear to be above profit-maximizing levels, which we suggest is caused by political forces in the U.S., while foreign revenues, as one would expect, are very low. This, too, undermines research incentives, especially for creating highly innovative drugs.

Public Policy Issues in Direct-to-consumer Advertising of Prescription Drugs. [i]Revised July 2002[/i]

In August 1997, the Food and Drug Administration announced a reinterpretation of its rules on DTC advertising, the effect of which was to permit branded broadcast ads and to increase the volume of DTC advertising several-fold. A substantial body of research, consisting primarily of consumer surveys, provides the basis for a preliminary assessment of the effects of DTC ads. The FDA's own assessment, that DTC ads provide substantial benefits and modest costs, is consistent with survey and other data. DTC ads appear to provide valuable information (including risk information), induce information-seeking (mainly from physicians), prompt patients to discuss conditions not previously discussed, and generate significant positive externalities including the possibility of improved patient compliance with drug therapy. The effects on drug consumption and on health care have yet to be assessed. The evidence to date suggests that a further relaxation of FDA rules would accelerate the dissemination of valuable information, with favorable consequences for drug development and consumer health.

The industry effects of information and regulation in the cigarette market: 1950-1965

The authors investigate the historical effects of information and advertising regulation in the cigarette market. Their method is a series of event analyses, which examines patterns of stock returns of major cigarette sellers during six crucial event periods in the years between 1950 and 1965. They find that the cancer scare of 1950, the episode offear advertising in 1953-54, and the 1962 report by the British Royal College of Physicians adversely affected the market valuations of the companies; however, the 1964 Surgeon General\u27s report and subsequent labeling laws had no significant effect on the stock returns. They also find that the cessation of fear advertising, coincident with FTC policy guides prohibiting such claims, and the FTC-engineered ban on tar and nicotine advertising brought recovery in stock returns, but favored large firms over small firms

Pharmaceuticals and the Worldwide HIV Epidemic: Can a Stakeholder Model Work?

The worldwide HIV-AIDS epidemic has generated intense criticism of pharmaceutical drug prices, a natural consequence of the industry's unique cost structure. A number of persons have proposed that the industry adopt what might be called a stakeholder model in place of the traditional profit-driven model. But the rapid drop in HIV drug prices, combined with generic entry and de facto abandonment of patent rights, has revealed the extremely limited role played by drug prices and access in the face of fundamental problems in infrastructure, prevention, and other essential elements in battling HIV-AIDS. Adoption of a stakeholder approach is likely to undermine essential R&D while doing little to curtail the HIV-AIDS epidemic.Health and Safety, Regulatory Reform, Other Topics

Regulating Access to Developmental Drugs for Terminally Ill Patients: Abigail Alliance v FDA

This amicus brief was filed in support of the Abigail Alliance for Better Access to Developmental Drugs in their lawsuit to force the Food and Drug Administration to provide patient access to drugs for cancer and other life-threatening illnesses after those drugs have passed through phase 1 clinical testing and have received FDA approval to enter additional clinical trials as a basis for eventual FDA approval for marketing. We make three arguments: (1) FDA staff face strong incentives to be too cautious in approving new drugs. As demonstrated by experience in cancer drug testing, patients often face a situation in which high-quality data from phase 1 clinical trials strongly indicate that a drug's benefits probably exceed its risks. (2) Permitting terminally-ill patients to access potentially life-saving post-phase-1 drugs still in testing will not unduly discourage patient participation in additional trials or inhibit post-phase- randomized clinical trials needed to obtain FDA approval. This is evident from the widespread and growing phenomenon of post-approval randomized clinical trials of approved drugs. (3) For similar reasons, it is clear that permitting terminally-ill patients to access potentially life-saving post-phase-1 drugs in testing will not discourage manufacturers from conducting additional randomized clinical trials.Health and Safety, Other Topics

Supreme Court Amicus Brief Regarding Wyeth v. Diana Levine

Prominent in arguments opposing preemption of state tort law liability for alleged inadequacies in prescription drug labeling is the argument that such liability can complement FDA regulation by improving on a regulatory scheme that fails to provide adequate deterrence against the marketing of unsafe or inadequately labeled drugs. The premise of this argument is faulty. Fundamental principles of economics and numerous studies of FDA drug regulation reveal that FDA in fact errs on the side of overregulation of prescription drugs. Product liability litigation focused solely on one side of the prescription drug public health equation leads to further distortions of the drug approval and labeling process and exacerbates FDA's inherent overly cautious approach. Preemption of state tort law where it conflicts with FDA requirements will minimize these distortions and thereby maximize public health.Health and Safety, Other Topics