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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 08-09-2005

Guidelines May Fail to Meet Needs of Elderly Patients With Comorbidities
Medscape, 8-9-05

Editor’s Notes:

Evidence-based medicine is one of the hottest health care policy topics these days. Researchers and insurers (both private and public) hope that treatments that are validated through clinical research can provide reliable guidelines for physicians that, if followed consistently, would both improve quality and lower health care costs by avoiding drug side effects and ineffective treatments. The problem, however, is that patients’ health conditions can vary so widely that generalizing an “always do this” treatment regimen can be very difficult. For instance,

“Following clinical practice guidelines for single diseases in patients with multiple chronic conditions is very complex and costly and may lead to adverse consequences, including polypharmacy with its associated risks of adverse effects and drug interactions and even hospitalizations," lead investigator Dr. Cynthia M. Boyd told Reuters Health.
This is especially pertinent, she added, because pay-for-performance incentives may be based on quality of care standards created for the management of single diseases, whereas half of patients over age 65 have three or more chronic conditions. The care of these patients accounts for almost 90% of Medicare's annual budget. [Emphasis added]

Obviously, the stakes involved in creating effective evidence-based guidelines—in both financial and human terms—are enormous. Much more research is needed on patients with multiple chronic ailments, but in the meantime policymakers should remember that effective medicine is not about statistical constructs, but about getting the best possible care to individual patients.

[permanent link]

The Nation; For Generic Drugs, the Price Is Right in U.S. Plain-label medications can be 78% costlier in Canada, a survey finds. Many Americans are unaware of the savings potential at home.
Los Angeles Times, 8-9-05

Editor’s Notes:

Many vital drugs are cheaper in the U.S. than in Canada. The media, however, has focused so much attention on U.S. prices for brand name drugs that consumers can be forgiven for forgetting that we have the cheapest generic drug prices in the world. Generics, in fact, account for about 50% of all U.S. prescriptions. But the hype surrounding Canadian imports may mean that U.S. consumers are wasting “more than $100 million a year on Canadian generics.”

Americans know that brand-name drugs are cheaper in Canada because the government controls prices there. But many don't realize that Canadian policies have the opposite effect on prices for generic drugs. "We have a system of government favoritism toward generic companies," said Brett J. Skinner, director of pharmaceutical and health policy research for the Fraser Institute in Toronto. The public policy organization advocates free-market policies, including the repeal of price controls on brand-name drugs.

Earlier this year, the institute released a study by Skinner of the 100 top-selling generic drugs. It found that Canadian prices were, on average, 78% higher than in the U.S. The study estimated that Canadians could save $2 billion to $5 billion annually if their generic market was as competitive as it is here. (The study accounted for exchange rate differences, and the potential savings are in Canadian dollars.) A smaller study last year for the U.S. Department of Health and Human Services looked at five popular generics and found that U.S. prices were 32% lower.

More information on generic drug prices can be found on the FDA’s Web site. Policymakers should also remember that Canada’s policies reward copycat pharmaceutical companies at the expense of firms that conduct innovative research into new medicines.

Ironically, while some U.S. policymakers exhort Americans to shop for drugs in Canada, Canadians can’t take advantage of low-U.S. generic prices—importing generics is illegal under Canadian law.

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No New Cases in Tysabri Patient Screening
Associated Press Newswires, 8-9-05

Tysabri—a once promising new multiple sclerosis (MS) drug—has been shelved for months after a handful of patients taking it developed a rare, fatal viral infection called progressive multifocal leukoencephalopathy (PML). In an effort to clear the drug for its eventual return to the market, Biogen Idec and Elan (the drug’s sponsors) have screened thousands of patients (previously supplied with the drug) for any signs of PML. To date, those patients have tested negative.

The companies said they asked more than 2,000 MS sufferers who took Tysabri in clinical trials to be screened for signs of PML. They said 91 percent have complied so far, of whom 99 percent had a neurological exam and 98 percent had an MRI scan.
The screening produced "no new confirmed cases" of PML, the companies said. "Given the high unmet medical need in MS and the therapeutic benefit we have seen with Tysabri, we are encouraged by these safety findings," said Whaijen Soo, senior vice president of medical research at Biogen Idec in Cambridge, Massachusetts.

This represents good news for patients suffering from severe MS, who may be willing to accept the risks associated with the drug—provided that the FDA eventually allows it to return to the market.

[permanent link]

Pfizer will change how it markets drugs to public
Detroit Free Press, 8-12-05

Editor's Notes:

Critics of the pharmaceutical industry's recently released voluntary code regulating direct to consumer advertising argue that it is merely a sop designed to head-off federal legislation. But the industry’s leading firms seem to realize that producing popular drugs is not enough—advertising that promises the world, and delivers anything less than perfection, invites a backlash from consumers and Washington.

One company, Pfizer, has not only publicly embraced the voluntary code, but is going beyond it:

Amid growing public outcry about the way the drug industry advertises prescription drugs to consumers, Pfizer Inc., the world's largest pharmaceuticals company, said it's taking voluntary steps to change before the end of the year the way it markets its drugs to the general public. Among its new guidelines, Pfizer…said it will educate doctors about a drug at least six months before it advertises to consumers and will submit consumer ads to the U.S. Food and Drug Administration for preview before running them.

Pfizer…also said it plans to make ads clearer to understand, include suggestions of alternative treatments and better relay to consumers the potential risks associated with prescription-drug use and add information about drug-assistance programs. And starting next year, Pfizer also said, it will create more disease-awareness ads that won't mention a specific product. Additionally, Pfizer said, it will make sure ads reach age-appropriate target audiences. For instance, TV ads for its Viagra erectile-dysfunction drug will air during programs that have more than 90% adult viewership.

This is a welcome sign that the industry is refocusing on building confidence amongst consumers and physicians, and not just hitting Wall Street targets. In the long run, investors stand to benefit from this approach through increased customer loyalty and less interference from federal authorities.

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MEDICINE; IN THE LAB; Brain cancer in its sights; An experimental drug appears to home in on and destroy the malignant cells of deadly glioblastoma
Los Angeles Times, 8-15-05

Editor's Notes:

Policymakers who think that the biopharmaceutical industry is "too profitable" and want to impose price controls should spend some time studying cutting-edge cancer research. Investors and companies sink hundreds of millions of dollars into risky but promising treatments that may never pan out. Patients with rare diseases like brain cancer are particular beneficiaries of this calculated financial risk—and would be among the first ones hurt if government policies dry up investment capital.

While enormous strides have been made using targeted, less-toxic drugs in the fight against some cancers (breast, colorectal, leukemia), brain cancer remains as deadly today as it was decades ago. In fact, treatments remain "so limited that most people don't live more than 15 months after their initial diagnosis." The Times reports, however, that researchers are experimenting with one drug candidate from NeoPharm (IL13-PE38QQR) that attacks brain cancer cells while sparing healthy tissue:

The new drug singles out and destroys the malignant cells of…glioblastoma, similar to a heat-seeking missile locating a target. The chemical "is the next step toward making significant advances in battling this disease," says Dr. John S. Yu, a neurosurgeon at Cedars-Sinai Medical Center in Los Angeles who is testing the drug. About 60% of the 17,000 people diagnosed with brain cancer each year are stricken with glioblastoma. Although medical science has made great strides in the treatment of many other cancers, survival rates for this highly aggressive brain cancer have increased by only nine months since the 1960s. …

[IL13-PE38QQR] is programmed to home in only on glioblastoma cancer cells, and is surgically infused directly into the brain to deliver high concentrations of the medicine. … Early studies on 36 terminally ill patients have been encouraging. The participants had exhausted standard treatments—surgery to remove the tumors, radiation and the chemotherapy Temodar—and had had at least one recurrence. Typically, median survival rates for these patients are four to six months, and less than 5% live past 18 months. In contrast, the median survival rate for the study participants has been 45 weeks. Of the 36 patients in the original study, nine are alive one to four years later, and eight of them are cancer free.

Companies like NeoPharm depend on investors to bankroll them through the long, enormously expensive drug development and approval process—in return for a handsome profit. Even the specter of price controls would starve companies of working capital—and deny patients hope.

[permanent link]

South Carolina proposing to redefine Medicaid
The San Francisco Chronicle, 8-15-05

Editor's Notes:

Winston Churchill is said to have observed that Americans always try to do the right thing after they've tried everything else. This is certainly the case for the federal-state Medicaid entitlement, where states like South Carolina are finally trying to bring consumer discipline to the sprawling, $329 billion dollar program after decades of tinkering at the edges and nearly unbridled spending.

South Carolina is betting that poor, uninsured citizens can take more responsibility for their own health care, thus improving the quality of care and lowering costs. These reforms, which still have to be approved by the U.S. Department of Health and Human Services, are built around personal health accounts controlled by individuals, not bureaucrats:

The account would be used to purchase private health insurance, or pay for care directly. And the amount of money allocated to each account would depend on the person's age, sex and physical condition. That's much different from the way Medicaid operates. Now, those whose incomes are low enough and who meet other eligibility requirements are entitled to receive certain approved health care services regardless of costs.

South Carolina would cap how much it will spend on a recipient, and if health care costs more than the account will pay for, then the low-income people would have to make up the difference themselves or go without. States have to get waivers from the federal government whenever they want to use federal Medicaid funds in ways not authorized in federal law. But the implications of South Carolina's waiver request, contained in a 42-page document submitted to the Centers for Medicare and Medicaid Services in June, extend far beyond the Palmetto State. If South Carolina's plan is approved, analysts believe other states will seek similar changes.

To paraphrase Churchill again, this is not the end of Medicaid reform. It is not even the end of the beginning. But South Carolina, along with other states like Florida, have taken us a long way towards a new beginning.

[permanent link]



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