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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 07-10-2006

FDA Signals It's Open to Drug Trials That Shift Midcourse
Wall Street Journal, 7-10-06

Editor's Notes:

In a promising development at the FDA, agency officials have signaled their openness to allowing adaptive clinical trials for new drugs. Adaptive trials use Bayesian analysis, a type of complex statistical analysis, to determine which treatment may be succeeding or which drug combination offers the best result and allows researchers to adapt ongoing trials to home in on the best potential treatments. Drug companies and researchers hope that using adaptive trials will save both time and money, helping to accelerate the development of more effective Medicines.

The most ambitious adaptive designs would represent a big change from traditional clinical–trial practices, and the idea has sparked controversy among researchers. Now, once trials are set in motion, they are supposed to be left largely untouched until they are finished and the drug company finds out the results. One exception: The studies often have an independent data-monitoring board that has the power to shut a trial down for ethical or safety reasons.

Adaptive trials have aspects that are "fundamentally different from what we currently do," says Michael Krams, who joined Wyeth in April as assistant vice president for adaptive trials. The results of an ongoing study are watched closely, and changes to the design occur as it continues, guided by a complex plan developed in advance, typically through computer simulations. If one treatment looks more effective, a greater proportion of patients may be funneled to it. If one group of patients appears to be benefiting more, the trial might start adding a larger share of that type of person.

Pharmaceutical companies hope such approaches hold the potential for major savings, though so far they are largely focused on early–stage trials. Advocates of adaptive designs say they can involve a reduction of 30% or more in the number of patients needed in a trial, and can save time as well. They also say that adaptive trials carry major benefits for patients, who have reduced odds of getting a less–effective treatment.

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Patients With Rare Diseases Work to Jump-Start Research
Wall Street Journal, 7-11-06

Editor's Notes:

Patients with rare diseases face a number of hurdles in the search for effective treatments. Increasingly, these patients are banding together to spearhead research efforts and offer genetic materials that can help researchers plumb the origins of their disease.

Biospecimen banks, which may include tissue samples, blood, spinal fluid or other specimens along with clinical data about patients, are critical to medical research. They offer researchers a way to test new drugs and to study and better understand the biology of a disease. And they offer the best way of finding new targets for experimental drugs.

Major drug companies and medical centers often maintain such banks for a range of diseases. But specimens sometimes sit unused because there isn't money to study them. If a disease is rare, individual centers may not see enough patients to collect a critical mass of samples, and smaller drug companies often don't have the resources to find patients. Patient groups have also found that study results often aren't shared with other researchers, and legal fights have broken out over who owns the rights to potential therapies developed from tissue.

Out of frustration over all these issues, patient groups—especially ones focused on rare, underfunded diseases—are increasingly taking matters into their own hands. They are starting their own biospecimen banks in the hopes of accelerating research and gaining more control over the process.

Groups that include the Accelerated Cure Project for Multiple Sclerosis, the Joubert Syndrome Foundation, Cure Autism Now and the Inflammatory Breast Cancer Research Foundation have all started banks, leveraging their extensive patient databases and ability to raise funds. The Lance Armstrong Foundation recently awarded a grant to the Keck School of Medicine of the University of Southern California to establish the Los Angeles County Germ Cell Tumor and Tissue Bank Resource, which will collect, store and distribute testicular-cancer tissue specimens for cancer researchers all over the country in the hopes of finding new drug targets for that rare cancer.

Starting a bank "is becoming an obligate strategy for patient advocacy groups if you want to make really rapid progress, especially in a rare disease," says Jeffrey Trent, the president and scientific director of the Translational Genomics Research Institute, which along with the Eli and Edythe L. Broad Institute of MIT and Harvard, is working on the Multiple Myeloma Genomic Initiative. "We could not do this genomic project on multiple myeloma without the existence of the biospecimen bank."

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Medicare Part D Spending Projections Down Again, Part A and Part B Increases Highlight Need for Further Reforms
Centers for Medicare and Medicaid Services, 7-11-06

Editor's Notes:

In contrast to the New York Times article on the "windfall profits" that pharmaceutical companies are gaining from Part D Medicare recipients, a recent press release by the Centers for Medicare and Medicaid Services reports that the reformed Medicare Part D system appears to be cutting costs and tightening spending. However, CMS also reported that Part A and Part B spending increases would continue to strain the federal budget with high costs and called for more reform of the system.

Medicare Part D expenditures are now projected to be $34 billion lower over 5 years (2006–2010) than in the President's Budget, and $110 billion lower than in the Mid-Session Review one year ago. The average Part D premium is almost 40 percent lower than had been projected a year ago as a result of strong competition, and 90 percent of Medicare beneficiaries are receiving prescription drug coverage.

Medicare Part A and Part B expenditures are higher, primarily because of continuing rapid growth in the use of Medicare services. Part A projected expenditures over 5 years (2006–2010) are $17 billion higher and Part B projected expenditures over 5 years are $30 billion higher than in the President's Budget. Rapid growth in physician–related services and hospital outpatient services are the main factors responsible for a projected increase in the Medicare Part B premium of 11 percent for next year.

The continued rising costs in Medicare Part A and Part B highlight the need for reform of the original Medicare program to pay more accurately and especially to pay more for better care, not simply more services.

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FDA Clears Once–A–Day AIDS Drug
Washington Post, 7-13-06

Editor's Notes:

A new triple combination AIDS pill promises to make treatment for victims of the virus much simpler. The new drug, collaboration between Bristol–Myers Squibb and Gilead Sciences, combines three previously prescribed drugs into a single pill to be taken once daily.

"This is a landmark for those suffering with HIV and AIDS," said acting FDA Commissioner Andrew von Eschenbach. People will be more likely to take a single pill consistently than several of them, he said, and "compliance with therapy is as important as the therapy itself for a successful outcome."

Deputy FDA Commissioner Murray Lumpkin, who runs the agency's international and special programs, called approval of Atripla a major achievement. "A single, fixed–dose pill has long been seen as the holy grail of AIDS treatment," he said.

The combination pill will not only keep patients healthier, officials said, but also help slow the development of community–wide resistance to AIDS drugs. If patients do not take the drugs regularly, the human immunodeficiency virus has a better chance of mutating into new forms of AIDS that are not affected by the available medications, first in individual patients and later in others.

At a news conference yesterday, unusual in announcing a new drug approval, the agency officials said the combination pill will first be available in the United States, but the need is greatest in poor nations where AIDS treatment is often unavailable or inadequate. The sometimes confusing directions involved with taking many pills a day—some on a full stomach and some on an empty one—has kept effectiveness rates low.

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With Legislation in Limbo, CMS Launches HSA Demo
The Hill, 7-13-06

Editor's Notes:

Nothing worries defenders of large government programs like the introduction of market competition. And, this week, the Centers for Medicare and Medicaid Services gave them some new reasons to lose sleep.

CMS announced a modest new exploratory program this week to allow Medicare beneficiaries to choose their own health savings accounts offered by private insurance companies. CMS is hoping that this trial program will give political leaders the evidence needed to expand consumer–driven options for Medicare patients.

Conservative champions of HSAs and other so–called consumer–directed health plans also view the vehicles are part of a broader agenda to sever the ties between health coverage and employment or government entitlement programs.

Opponents, mostly on the Democratic side, maintain that HSAs—like the Social Security private accounts proposed by President Bush—are nothing more than part of what they view as the GOP’s goal of eliminating social–insurance programs.

"This is yet another attack on Medicare by this administration," Sen. Edward Kennedy (D-Mass.) said in a written statement. "The Bush administration tried to replace the guarantee of Social Security with chancy private accounts, and now they're attempting the same thing with Medicare. These private accounts are a tax giveaway to the wealthy that will leave millions of seniors behind."

Medicare law does not permit private insurers to offer HSAs to beneficiaries. A more limited precursor health–insurance product known as medical savings accounts (MSAs) has been allowed in Medicare for almost 10 years, but have never been offered to beneficiaries.

Health–insurance companies that provide benefits under the Medicare Advantage program would offer modified MSAs under the demonstration project.

The project announced Monday would springboard off the dormant MSA component of Medicare to create products that are more like HSAs. Private–sector HSAs permit higher annual contributions and have fewer restrictions on what the money in the account can be spent on.

Perhaps someone should remind Senator Kennedy that all federal employees, including U.S. Senators, can choose from a wide range of insurance programs offered through the Federal Employees Health Benefits Program—including HSAs. If this program is good enough for federal bureaucrats, what's wrong with giving Medicare recipients the same wide range of insurance options to choose from?

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