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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 06-29-2004

A New Approach to Fighting Alzheimer's: Major Clinical Trial Is Set To Begin, as Wave of Drugs Aims to Halt the Disease
Wall Street Journal, 6-29-04

Treating symptoms can control the progression of a disease - targeting the underlying disease mechanism offers hope of a cure. Neurochem, Inc. is soliciting patients for a large efficacy trial of its drug Alzemed, the first in a new line of treatments that offer hope to Alzheimer's patients by attacking what many researchers consider to be the roots of the disease - the formation of beta-amyloid plaques in the brain. By preventing the plague formation, researchers hope to halt the progression of the disease or even prevent it in the first place.

Several other treatments are in the pipeline, each taking a slightly different avenue of attack; Eli Lily is testing an enzyme that inhibits plaque formation, along with "vaccines" that can train the body to remove plaques even after they have formed. The proliferation of Alzheimer's drugs in development couldn't come at a more opportune time: with human lifespan's increasing, physicians expect the population at risk of developing Alzheimer's to mushroom, reaching as many as 16 million by 2050 (an estimated 4.5 million Americans suffer from the disease currently).

The few treatments that are on market now - Aricept, Exelon, and Reminyl - are all cholinesterase inhibitors, designed to boost a neurotransmitter that is important for memory and learning. Unfortunately, these treatments have shown mixed results at best, and doctors are anxious to bring new treatments online.

Besides new treatments, doctors are testing a wide range of currently available drugs as well - anti-inflammatories and statins - in response to new theories on how Alzehiemer's is triggered. The variety of treatments is in itself encrouraging, as stakeholder's all rush to bring new treatments to market, applying medicines to a variety of drug targets. This represents, in many ways, markets at their best, with investment underwriting a variety of treatments that can be eventually compared to each other in terms of cost, effectiveness, and suitability for indivdiual patients.

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Drug Companies Race To Develop Virus Vaccine
Wall Street Journal, 6-30-04

Over 600,000 children worldwide die from rotavirus infection, a disease that causes severe diarrhea and vomiting. Thanks to better treatment and infrastructure in the U.S., fewer than 40 children die a year, but it still sends nearly 500,000 children to their doctors' offices, incurring high medical costs and lost productivity from parents who stay home to nurse sick children. All things considered, producing a rotavirus vaccine makes good sense, and last year American Home Products produced a rotavirus Vaccine, Rotashield, that might have spared children at home and abroad from suffering from this potentially deadly infection.

Unfortunately, there was some early evidence that the vaccine caused a potentially fatal complication in a small number of cases and was withdrawn from the market as a result. Thankfully, several other companies have entered the race to produce a rotavirus vaccine, both for use in the developing world and in the U.S.

The trick is to overcome the enormous logistical and financial hurdles that inhibit vaccine development and distribution in less developed nations. In the U.S., success depends on being placed on the U.S. government's list of recommended childhood vaccines. But the problem is also that vaccines need to be tested in the individual regions where they may be administered, to see how different populations react to vaccination. The initial withdrawl of Rotashield was a blow to developing nations, who had been eargerly awaiting the vaccine. New formulations of the vaccine hope to avoid the earlier complications by finding different biological sources. The stakes are enormous: Glaxo estimates that it will spend $500 million on its vaccine, including testing on some 60,000 children; Merck's testing will include 70,000 infants in what may be "the biggest vaccine trial by a pharmaceutical company ever." Glaxo is hoping to defray the enormous costs by entering into partnerships with public agencies and foundations to help test and develop the vaccine in the poorest nations. In return, Glaxo will test the vaccine there and then offer the vaccine there at a cheaper cost. To date, Glaxo has worked with the WHO and the CDC to initiate early stage trials in South Africa and Bangladesh. More funding may be forthcoming from the Global Alliance for Vaccines and Immunization.

The reality is that the American market is still the most lucrative one for new medical treatments, and as a result, most medicines will be offered and tested there first. Overcoming that hurdle requires strategic relationships between public and private entities to offer new treatments in the places where they are needed first, with follow on availability where the manufactuerer can be expected to make a profit. It is also a lesson on how setting prices too low limits access to needed medications.

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