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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 08-23-2006

Discount Drug Deal Reached: Schwarzenegger, Democrats agree on plan to compel manufacturers to cut costs of medicines for lower–income residents
Los Angeles Times, 8-23-06

Editor's Notes:

In another California related story, Governor Schwarzenegger and the California legislature have reached an agreement on how to extend new health care entitlements to millions of moderate income Californians: Inflicting price controls on the pharmaceutical industry.

More than 5 million Californians with moderate incomes would receive substantial discounts on prescription medicines under a deal that Gov. Arnold Schwarzenegger and Democratic leaders reached over the opposition of the drug industry, negotiators said Tuesday.

The price–reduction effort, a showpiece for Schwarzenegger's re–election campaign, is an approach he rejected last year and one opposed by the drug industry and advocates for the poor and disabled.

The plan would give the drug industry three years to voluntarily negotiate discounts with the state on behalf of people who earn up to triple the federal poverty level, or about $60,000 a year for a family of four. An additional 400,000 people who earn somewhat more but face debilitating medical bills also would be eligible.

The discounts would take as much as 40% off brand–name drugs and up to 60% off generic medicines, according to lawmakers and Schwarzenegger administration officials.

In a major concession, Schwarzenegger agreed that companies that offer insufficient markdowns could be impeded from selling drugs through Medi–Cal, a $2–billion market that serves millions of Californians. In return, Democrats agreed to give the industry time to comply, and agreed to the income limit Schwarzenegger wanted...

"This is a huge victory for the needy," said Assembly Speaker Fabian Nuñez (D-Los Angeles). "This goes a long way toward correcting the wrong that was done at the ballot box in November."

It is hard to imagine calling families that earn three times the poverty level as "needy," but California policymakers seem up to the task. It also takes enormous chutzpah for a legislator to call the collective decision of California’s voters "wrong."

This plan will inevitably hurt the patients it was meant to help by reducing industry's incentives to create new medicines and leading them to slow the introduction of new drugs into California's market. A bad decision and a bad law all around.

[permanent link]

Group raps FDA panels as 'rubber stamps'
Bloomberg News, 8-28-06

Editor's Notes:

A new report from the National Research Center for Women and Families alleges that FDA advisory committees act as "rubber stamps" for companies seeking to market their products. But the question the study can't answer is: what is the right number of FDA approvals?

The U.S. Food and Drug Administration's outside advisory panels typically serve as "rubber stamps" for companies seeking approval of drugs and medical devices, according to a nonprofit research group.

Eleven randomly selected FDA advisory committees recommended approval in 79 percent of their votes on applications between 1998 and 2005, according to the study released Monday by the Washington–based National Research Center for Women & Families. The committees considered 89 products during that period.

"Some of the committees have never met a product they don't like," said Diana Zuckerman, president of the group, said in a telephone interview. "From a consumer point of view, this is not good news."

Actually, from a consumer point of view, this could be very good news. A high approval rate from the agency's advisory committees could be a sign that the FDA's stringent regulations ensure that only the best new products reach the stage when new drug or device applications are submitted for approval.

Since developing a single new product can take over a decade and cost $1 billion, companies have powerful incentives to weed out dangerous or unpromising candidates early on in the development process. And there is plenty of evidence that they do just that.

Of course, every marketed drug and device (and every medical procedure) comes with risks, some very serious. The need to balance risks and benefits means that the FDA and its committees are always vulnerable to Monday–morning quarterbacking from critics who think that the agency is too risk averse or too cavalier.

Reasonable observers of FDA approvals (or non approvals) can come to very different conclusions about the utility of these decisions. But calling the FDA or its advisory committees "rubber stamps" for industry is designed to inflame passions, not illuminate issues.

[permanent link]

Biotech's bright hope: Scientists are newly optimistic that gene therapy will help fight the most serious diseases
Los Angeles Times, 8-28-06

Editor's Notes:

This article provides a fascinating and detailed look into researchers' efforts to revitalize gene therapy after a series of failed efforts (and string of bad press) in recent years.

Gene therapy is making a comeback after a series of serious setbacks that threatened to permanently derail human tests. In recent years, European scientists have cured more than two dozen patients suffering from three rare, and in some cases lethal, immune disorders.

Spurred by this success, plus the development of new techniques aimed at making the therapy safer and more effective, more than 300 gene therapy trials, including the one for Parkinson's at UC San Francisco, are underway in the U.S. and abroad.

The approaches include what people traditionally think of as gene therapy: inserting functional genes to replace single, faulty ones to treat relatively rare genetic diseases such as muscular dystrophy, cystic fibrosis, sickle cell anemia, beta thalassemia and hemophilia. But, more and more, gene therapy is being studied as a treatment for lethal ills that are not inherited in any clear, simple way—cancer, hepatitis, AIDS, heart disease—and which also plague millions.

Today, scientists are injecting genes into people to try to block the formation of deadly cancerous tumors. They're implanting genes that stimulate cell growth in an attempt to regenerate heart muscle cells and grow blood vessels in patients with congestive heart failure; halt disease progression in people with macular degeneration; and slow the death of brain cells in Alzheimer's as well as Parkinson's patients.

Though most of these treatments are still in the early phases of human tests, a gene therapy drug to combat cancer could be available within the year.

[permanent link]

Assembly approves universal health care
Sacramento Bee, 8-29-06

Editor's Notes:

California, as usual, is trying to become Europe even as Europe is trying to become more like America. The Democratic–controlled Legislature is on the verge of sending Gov. Arnold Schwarzenegger a bill that would create a state–run universal health care system, testing him on an issue that voters rate as one of their top concerns in this election year.

On a largely party–line 43–30 vote, the Assembly approved a bill by state Sen. Sheila Kuehl, D–Santa Monica, that would eliminate private medical insurance plans and establish a statewide health insurance system that would provide coverage to all Californians. The state Senate has already approved the plan once and is expected this week to approve changes that the Assembly made to the bill.

Schwarzenegger has said he opposes a single–payer plan like the one Kuehl's bill would create, but the governor has not offered his own alternatives for fixing the state's health care system. As many as 7 million people are uninsured in the state, and spiraling costs have put pressure on business and consumers.

"We know the health care in place today is teetering on collapse," said Assembly Speaker Fabian Núñez, D–Los Angeles. "We need to do something to improve it, to reform it, and this is what we are bringing to the table."

Canada's single–payer health care system is in shambles, as is the National Health Service in the United Kingdom. Countries across Europe are trying to introduce more choice and competition into their state run health care systems to rein in costs and improve quality. California's legislature is doing just the reverse and appears to be on an ideological quest to emulate failure.

[permanent link]



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