NIH

Avastin-Lucentis trial may reshape pharma

Wed, 14 May 2008 06:59:56 -0400

We thought the head-to-head trial of Avastin and Lucentis for age-related macular degeneration was a big deal for Genentech, which makes both drugs. Now, IMS Health is saying that the trial could be "a Pandora's box" for the entire pharma industry.

Conducted by the National Eye Institute, part of the National Institutes of Health, the trial is designed to see whether the much cheaper Avastin, often used off-label to treat AMD, measures up to the AMD-specific--and very expensive--Lucentis. If Avastin passes muster, then prescribers may desert Lucentis completely. And if docs don't do so voluntarily, then insurers and other payers may nudge, cajole, incentivize, or downright push them to.

And there's the rub, IMS says. By taking the drugmaker out of the testing, this trial could fundamentally reshape relations between payers and pharma. Payers could sponsor comparative drug studies of their own or lobby the government to do so, IMS theorizes, especially as databases make those comparisons easier. There's plenty of time to worry about it, though: The Avastin-Lucentis trial won't wrap till 2010.

- see the story in the Financial Times

Seroquel researcher got cash from AZ

Tue, 08 Apr 2008 06:59:56 -0400

Sen. Charles Grassley's hall of shame: The chairman of the Senate Finance Committee, who's been trying to rally support for a bill requiring drug and device makers to disclose anything of value given to doctors, raised the case of Dr. Melissa DelBello, a psychiatrist who got hundreds of thousands of dollars in travel expenses, consulting fees, and lecture payments from AstraZeneca. DelBello also happened to be lead author of a study that concluded kids did well on AstraZeneca's antipsychotic med Seroquel.

Here's the timeline: DelBello authored the study, published in 2002. In 2003, she got $100,000 from the drugmaker, or so she told the University of Cincinnati. In 2004, she reported $80,000. AstraZeneca's figures total $238,000.

Grassley was pretty peeved not only about the apparent conflict of interest--which AstraZeneca denied; DelBello wasn't available for comment--but also by the fact that DelBello also got NIH funding during the same period. University of Cincinnati said it applauds Grassley's "looking into this very important issue."

- read the WSJ Health Blog item
- see Grassley's Physician Payment Sunshine bill

Related Articles:
AZ takes steps to shore up Seroquel. Report
AZ's Seroquel receives additional approval. Report

NIH launches Avastin-Lucentis trial

Mon, 25 Feb 2008 06:59:57 -0500

Gentlemen (and ladies), start your eye injections. In other Avastin news, the big trial pitting the cancer drug against Genentech sister med Lucentis is now underway. Sponsored by the National Institutes of Health, the independent trial is designed to show how the two meds stack up in treating age-related macular degeneration.

Lucentis has been FDA-approved for use against wet AMD. Though Avastin isn't, eye docs have commonly used it off-label, saying it's almost as effective as Lucentis, if not as effective. And Avastin costs much less: hundreds per treatment versus thousands.

The sticking point has been that, to use Avastin in the eye, it had to be repackaged by compounding pharmacists. Genentech moved last year to restrict supplies to those pharmacies, saying that the FDA was concerned about the repackaging. But Genentech had no plans to study Avastin for macular degeneration, preferring to push its already-approved and more expensive Lucentis.

So the NIH is doing it for them. After all, because macular degeneration tends to be a disease of the elderly, it's Medicare paying for much of the treatment. So the government has a vested interest in proving the cheaper treatment is a viable alternative.

- read the press release from the NIH
- see the story in the Wall Street Journal

Related Articles:
Genentech rethinks Avastin limits. Report
Eye docs confront Genentech exec. Report
Why should Medicare pay for Lucentis? Report
Genentech to curb Avastin sales. Report
Doctors balancing effects, costs of Lucentis and Avastin. Report

Canada to decide Lucentis' fate

Wed, 23 Jan 2008 06:59:56 -0500

The Lucentis versus Avastin match has moved to Canada. Officials there are arguing whether to pay the tens of thousands of dollars a year for Lucentis, the Genentech-made and Novartis-marketed drug that's approved to treat wet macular degeneration. Or should they instead reimburse for Avastin, another Genentech-made drug that's shown to be effective against WMD and is much cheaper to boot--but isn't approved by HealthCanada for that use.

Since Lucentis wasn't available in Canada until recently, eye specialists have been using Avastin against WMD. Many have reported success. But Genentech hasn't studied the drug in WMD, and a U.S. NIH study won't be complete until 2010. So provincial and federal health plans can't pay for the drug when it's used against WMD.

The federal panel responsible for deciding which drugs should be covered rejected Lucentis late last year. At Novartis' request, the group is reconsidering that application, and a decision may be announced as early as today. Novartis is pushing hard for the approval; alongside it is the Canadian National Institute for the Blind, which got a grant from the drugmaker and is using some of those funds to campaign for Lucentis.

You'll recall that a similar debate has been raging in the U.S. Genentech had tried to cut off Avastin supplies to the compounding pharmacies that repackage it for eye use, but ophthalmologists protested and the company agreed to keep some supply channels open to eye docs.

- read the The Globe and Mail report

Novartis drug cuts hip-fracture deaths

Tue, 18 Sep 2007 06:59:55 -0400

Big kudos to the Novartis osteoporosis drug Reclast: A New England Journal of Medicine study showed that patients with broken hips were more likely to survive if they were given a yearly dose of the drug. Twenty-eight percent fewer patients died, and Reclast reduced subsequent fractures by 35 percent, too.

Every year, some 300,000 patients 65 and older break their hips and, according to Boston Globe-sponsored research, 29 percent of them die within 12 months. In an editorial accompanying the new NEJM study, an NIH official called the reduction in death and fractures "striking" and said the study proved the need for "pharmacologic intervention" after hip fractures.

Sponsored by Novartis and headed by a researcher who has applied for two Reclast-related patents, the study data was independently reviewed by statisticians at the University of California.

- check out this press releaseﾠfrom Novartis
- read thisﾠarticle from the Boston Globe

Related Articles:
Novartis' Reclast gets FDA blessing. Report
Novartis options osteoporosis drug. Report
Cash-rich Novartis CEO mulls biotech buyouts. Report
Novartis touts pipeline. Report

Study: 86% of docs cut Zyprexa use

Tue, 18 Sep 2007 06:59:54 -0400

Whoever said there's no such thing as bad publicity never worked in pharma. The latest proof of bad news-related suffering: A new report on antipsychotic drugs finds Janssen's Risperdal and AstraZeneca's Seroquel overtaking Eli Lilly's Zyprexa.

Some 86 percent of doctors have cut their use of Zyprexa because of problems with weight gain and diabetes, the study found. These are the very side effects that captured so much attention late last year, when clinical trial data about them was leaked to The New York Times.

- read this releaseﾠfrom research firm Decision Resources

Related Articles:
Lilly ignored Zyprexa safety data on weight, blood sugar. Report
Lilly to pay $500M to settle Zyprexa claims. Report
NIH doctors slam Lilly's marketing tactics. Report

Stent-makers get more bad news

Tue, 28 Aug 2007 06:59:58 -0400

Go ahead, kick them while they're down. Britain's National Health Service may stop paying for drug-coated stents, products that already are suffering from safety-related fears. The National Institute for Health and Clinical Excellence (NICE) will meet next week to review the proposal, which cites the huge difference in price between drug-coated stents ($2,300) and the uncoated versions ($700). British cardiologists are fighting the measure, saying that drug-coated stents are still the best option for some patients.

Facing a market that's expected to shrink by $1 billion this year, leading makers of the drug-coated devices--Johnson & Johnson and Boston Scientific--have been retrenching by cutting costs and jobs. A NICE rejection? Insult to injury, especially for the thousands more who might get pink slips.

- read the report from the Boston Herald

Related Articles:
Tough times for stent market. Report
Congress spotlights J&J stent ops. Report
Decline in drug-coated stent use at cardiac centers. Report
Insurers may cut stent payouts. Report