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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 04-27-2005

TV Ads for Drugs Help Boost Prescriptions, Researchers Say
Los Angeles Times, 4-27-05

Editor’s Notes:

The Los Angeles Times today ran an article on a new study in the Journal of the American Medical Association. The article trumpets the finding that direct-to-consumer (DTC) advertising of prescription drugs can influence physician prescribing practices.

Since it was first allowed by the FDA in 1997, DTC advertising has been highly controversial. Pharmaceutical companies argue that it helps to encourage patient education and communication with physicians, especially for under-treated conditions like mental illness. Consumer groups, and some physicians, argue that it promotes over-treatment of minor ailments, driving up health-care costs, and that it may needlessly expose patients to potentially dangerous drug side-effects.

The debate heated up last fall with the withdrawal of Vioxx, a Cox-2 prescription painkiller, after it was linked in some patients to an increased risk of serious adverse cardiovascular events. Arguably, Vioxx was (and is) a very useful medicine that was given to millions of patients who might’ve done just as well on cheaper, older drugs.

The JAMA study cited by the Times was an unusual experiment, in which

actresses posed as patients, [and found that] doctors were five times more likely to write them prescriptions after the patients inquired about a specific antidepressant, Paxil. The actresses pretended to have [adjustment disorder, a mild form of depression], a condition that does not require antidepressants.

The study also found, however, that patients with major depression who made either a general request for “medicine” or Paxil were more likely to receive “minimally acceptable initial care” than patients who made no requests. The researchers discovered that

…patient requests [either for a general antidepressant or for Paxil] were an effective defense against initial undertreatment of major depression.

In short, mass media advertising helps patients with major depression receive better care.

So (taking the study at face value) with some patients getting better care, and others too much, is DTC advertising just a wash?

Without knowing more of the context, it’s hard to tell. The problem is that this study looks at DTC advertising in a vacuum, irrespective of other social factors that affect how doctors treat patients.

For instance, doctors operate in a nightmarish liability environment, exposing themselves to multi-million dollar malpractice claims anytime they withhold treatment. A patient who walks into a doctor’s office complaining of a headache might be referred to a neurologist to rule out a tumor because the doctor is worried about being sued. In this system, defensive medicine is the rule, not the exception, for every ailment, no matter how trivial.

Overtreatment is also encouraged by our third-party-payer system, where government and insurers foot the bill for minor and routine care. When physicians are presented with a patient request for care, they usually just shrug their shoulders and give it. After all, who gets hurt?

Blaming pharmaceutical companies for operating in this environment is like blaming physicians for defensive medicine. Both doctors and corporations are just responding to the financial incentives the system gives them.

Still, we should encourage better treatment for major depression, and less treatment for minor bumps and bruises that pass with time.

How can we do that? For starters, we can reform the medical liability system for doctors, and encourage more consumer-driven health plans, in which consumers pay for routine expenses. That would encourage more treatment with aspirin than Vioxx, and still retain financial incentives for companies to focus on serious ailments like major depression and heart disease.

Slapping new regulations on DTC advertising without considering these other problems is shortsighted. DTC advertising has real strengths and benefits, as the JAMA study shows. Any new federal regulations on DTC advertising are apt to be overbroad and undermine the incentives that push companies to compete in the marketplace to produce better, more effective medicines.

[permanent link]

Europe 'lagging further behind US on drugs'
Financial Times, 4-28-05

Editor’s Notes:

European pricing schemes, as we noted above, may be destructive in Europe but they remain popular in the U.S. On May 3, for instance, the D.C. City Council passed legislation

…that would make it illegal in the city to charge ‘excessive prices’ for prescription drugs and, in some cases, allow the District government to make its own arrangements to have drugs produced more cheaply.

As a benchmark for “reasonable” prices, the legislation cites prices charged in Europe, Canada, and Australia (among other places) where the governments impose drug price controls and ration access to new medicines.

The council member who sponsored the bill, David Catania, is probably unaware that the European Commission is awaiting the results of a study it commissioned on Europe’s declining pharmaceutical industry. Early data from the study were reported in the Financial Times last week. The study’s author, Fabio Pammolli, from the University of Florence, found that from 1996-2002:

  • 70 per cent of world drug research and development collaboration originated in the US against 25 per cent in Europe;
  • 70 per cent of "new chemical entities", the basis of innovative medicines, were launched first in the US - normally one to two years ahead of in Europe; and
  • More than half of total global pharmaceutical patents were registered in the US, and their influence was disproportionate, representing 70 per cent of academic citations.

Professor Pammolli recommended that Europe "introduce systems of co-payment and other private mechanisms to help supplement over-burdened state health systems in paying for medical expenses, in order to raise prices paid to drug developers towards levels almost twice as high in the U.S." [Ed.: emphasis added]

In other words, low European prices curtail investment and development of new medicines. The D.C. city council should order a copy of Professor Pammolli’s report and ready it carefully.

[permanent link]

New FDA office for drug safety is proposed; Two senators want it to have power to restrict marketing and pull approved drugs if new studies reveal risks.
The Philadelphia Inquirer, 4-28-05

Editor’s Notes:

As we noted, “custom cures” are in their infancy, and we are still far away from Star Trek style health care.

Getting significantly better data on drug safety, however, is within our reach - if we don’t burden the FDA and companies with expensive and redundant new regulatory requirements that will siphon scarce resources away from R&D.

New legislation, sponsored by Senators Grassley and Dodd, is designed to create a new Center for Postmarket Drug Evaluation and Research (CPMDER) at the FDA, which would report directly to the FDA Commissioner.

A new drug-safety office, with broad powers to fine pharmaceutical companies, restrict marketing of their medications, and in some instances pull drugs off the market would be established under legislation introduced yesterday by [Senators Dodd and Grassley].

Their legislation grew out of the conventional wisdom that the FDA was slow to remove Vioxx from market after suspicions were first raised about its risks. But the delay in action was not due to the lack of independence of the FDA’s drug safety office, but to its passive safety monitoring procedures and antiquated IT infrastructure.

Perhaps some new regulatory powers—and certainly more funding—might be considered for the FDA, but any changes should be carefully crafted and based on the best science available. The last thing the FDA needs is for the U.S. Congress to paste new bureaucratic boxes to its organizational chart that will inevitably create more red tape.

[permanent link]

Early-Warning Tool for Unsafe Drugs
Wall Street Journal, 4-28-05

Editor’s Notes:

As we mentioned above, the FDA sorely needs to update its IT infrastructure and use of datamining. Partly this can be accomplished by working with public and private insurers to access patient databases. For instance,

…UnitedHealth Group, Inc. plans to launch a drug registry that will use its vast database of health-plan members to find potential problems. The registry, which UnitedHealth…plans to market this summer to federal drug regulators, pharmaceutical companies and others, is part of a growing effort by health plans and health-care systems to create databases as resources for drug-safety research. …Once the UnitedHealth database has at least 1,000 people on a given drug, it will monitor that drug by comparing the group's claims experience to that of an equally sized and nearly identical group taking a similar drug, the company said. Over time, as more people take the drugs, the size of the groups will swell. Powerful computers will mine the data as they accumulate for unusual patterns, such as clusters of hospitalizations or higher-than-average reports of particular side effects.

This is no substitute for targeted medicines and diagnostic tests that can actively match patients to the right treatment—or avoid the wrong one. But, in the meantime, data-mining projects like this one are invaluable, and Congress should encourage the FDA’s own work in this area.

[permanent link]

Target Corp. redesigns the pill bottle, hoping to grab customers
Associated Press Newswires, 4-28-05

Editor’s Notes:

While talking about drug safety it’s easy to forget that many adverse events are caused by human error—for instance, doctors or nurses who inadvertently deliver the wrong drug to patients, or patients who fail to read a drug’s label and take it exactly as prescribed. In other words, we can’t forget that safety always requires consideration of the human element.

For instance, Target Corp. is redesigning prescription drug bottles to minimize the risk of human error.

Target pharmacies this month rolled out a flattened bottle with easier-to-read labels and plastic rings that can be color-coded for each family member…The name of the drug appears prominently on the spine, and a card with information about side-effects slips into a slot aimed at keeping it with the pills…Besides reducing the chance of errors with medications, Target is hoping the redesigned bottles will help it grab customers from other pharmacies.

Target’s new bottle, apparently, is the first redesign by a national pharmacy in about 40 years. Hopefully, consumers will be impressed by Target’s dedication to safety and other pharmacies will quickly follow suit.

[permanent link]



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