Monthly Archives: November 2010

For a working vacation, try an NIH sabbatical

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Clinical psychiatrist Barbara Gracious had a month to spare over the summer while transitioning to her new job at Ohio State University in Columbus. But, instead of jetting off to a vacation spot, she packed her bags for Bethesda, Maryland, home of the US National Institutes of Health (NIH) Clinical Center, to go on sabbatical.

This past summer, Gracious, together with three other researchers, was part of a pilot training program in clinical trial management. The investigators took courses in introductory protocol writing, patient tracking and safety management, among other issues. They also met with program officers at the NIH and made contacts at the US Food and Drug Administration (FDA) to better understand regulatory issues associated with clinical research. (Click here to continue reading)

What can the lame duck US Congress do for biomedicine?

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lameduck.jpgWith Republicans set to take control of the US House of Representatives next year, the Democratic-led Congress has entered the awkward end of its life cycle — technically still in power, but lacking the clout to push forward any major initiatives. But even a lame duck can attempt a short flight, and the 111th Congress may still be able to pass legislation with implications for biomedical research.

One such bill is the Stem Cell Research Advancement Act, which authorizes the Secretary of Health and Human Services to ‘conduct and support research that utilizes human stem cells, including human embryonic stem cells’ — albeit only for projects that use stem cells derived from embryos obtained through in vitro fertilization (IVF) clinics that would otherwise have been discarded. Such a move could provide grounds for lifting a federal injunction against stem cell research that has been in place since late August (the injunction is technically still in effect, but has been stayed since 9 September). On Friday, the heads of dozens of American medical colleges sent a letter to Congressional leaders urging them to pass the act.

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Was the HHS secretary’s genetic advisory panel scrapped prematurely?

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By Kelly Rae Chi

In September, Steven Teutsch received word that the expert panel he chaired, which advised the US Department of Health and Human Services (HHS) on how genetic technologies could be best integrated into health care, was to be abruptly disbanded in two weeks’ time.

“We didn’t anticipate the committee would end,” says Teutsch, chief science officer of the Los Angeles County Health Department. “We were a bit surprised, because we had planned to continue this work that we had started.”

Since its inception in 2002, the US Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) helped push passage of the Genetic Information Nondiscrimination Act, which bars employers and health insurers from discriminating against individuals on the basis of their genetic information, and produced timely reports on gene patents and direct-to-consumer genetic testing, among other fractious topics. With the growing possibility of affordable whole-genome sequencing, many committee members and onlookers expected the panel to have an ongoing role in hashing out the clinical, ethical and legal implications of rapidly developing genomic technologies. But HHS Secretary Kathleen Sebelius, stating that the SACGHS had addressed all its “major topics,” decided not to renew the committee’s charter beyond 23 September. (Click here to continue reading)

Attention, drug companies — not all biosimilars are created equal

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By Stu Hutson

The Biologics Price Competition and Innovation Act, signed into US law last March, gave the country’s drug regulators the authority to establish a pathway to approving ‘generic versions’ of biologic drugs. Now the US Food and Drug Administration (FDA) must take the next step and set guidelines for evaluating these large, complex organic molecules that are almost—but not quite—copies of some of modern medicine’s most important drugs.

As the FDA held a public hearing about the abbreviated pathway for these biosimilars earlier this month, many industry analysts were examining the agency’s recent favorable decisions regarding generic versions of the biologic drugs Lovenox (Sanofi Aventis) and Neupogen (Amgen). Although these biosimilar versions might have received an easier pass than many suspected, some industry experts say that the drugs just represent low-hanging fruit.

DARPA thrill-seeker goes to the mountaintop to find COPD and altitude sickness treatments

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mountainclouds.jpgBy Brendan Borrell

New medications to fight the altitude sickness suffered by mountain climbers promise to aid peak performance. But the same drugs could also yield new treatments for people with breathing disorders. Brendan Borrell meets one man at DARPA, the US Defense Department’s research agency, who’s trying to move mountains for a new therapy.

Michael Callahan was racing south on California’s Highway 395 in a rented Chevy station wagon. It was early one morning in late August this year, and the night before he had faced down thunderstorms on his way back from Colorado’s Maroon Bells, two peaks that measure about 4,300 meters high. Now, he was cruising along the eastern side of the Sierra Nevada mountain range to Bridgeport. There, he would lead a joint training session at the US Marine Corps Mountain Warfare Training Center between the military and the legendary Yosemite Search and Rescue team, a group he had volunteered with as a lanky, long-haired climbing bum back in the summer of 1989.

“They are just over the mountain from each other, and they’ve never met!” Callahan says in disbelief. (Click here to continue reading)

Image by Cessna 206 via Flickr Creative Commons

Comparison of hepatitis drugs zeros in on null responders

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zero.jpgThe current standard-of-care treatment for hepatitis C is interferon treatments, which aim to inhibit the ability of cells to host the virus. Studies have shown that certain ethnic groups like African-Americans and Hispanics are less likely to respond to interferon treatments.

Drug giants Vertex and Merck are now jockeying to assume market supremacy in a new class of hepatitis drugs. Both companies are currently developing protease inhibitors that directly target the hepatitis C virus.

But when comparing the two companies’ compounds, the devil is in the details. An ‘apples and oranges’ problem was highlighted on the pharmaceutical blog In Vivo. In its RESPOND-2 study, Merck defines a null responding patient — someone who is faring the worst under the current standard of care — as a patient whose viral load decreased less than 1 log after four weeks of standard treatment. That’s a considerably different criteria from the US Food and Drug Administration, which defines null responders as ‘less than a 2 log10 reduction in HCV RNA at week 12’. Vertex used the FDA’s definition of null responder in its study, REALIZE. Since both companies are trying to show that their protease inhibitor works better for patients for whom current options have failed, there is a remote chance that Merck’s numbers might paint an artificially rosier picture.

Image via Wikimedia Commons

‘Secret’ rebates for Lucentis get a closer look

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greeneye.jpgToday, the New York Times reports on a secret rebate program that Genentech is using to apparently encourage doctors to prescribe Lucentis for macular degeneration instead of the less costly Avastin. The program, which started on 1 October, could potentially earn tens of thousands of dollars for participating practitioners. Lucentis, which recent studies have shown performs no better than Avastin at treating vision loss, costs about $2,000 per dose. Avastin, which was originally developed by Genentech to treat colon and lung cancers, costs less than $100 per dose.

The Times article says that Genentech is trying to spin the program as an effort to encourage doctors to prescribe Lucentis for retinal vein occlusion, a condition which the US Food and Drug Administration (FDA) approved the drug for in June. But the company has been investigated for Avastin-related chicanery before. In 2007, Herb Kohl, a US Senator from Wisconsin, asked the FDA to look into whether or not Genentech was artificially limiting the availability of Avastin to ophthalmologists to force them to prescribe the more expensive alternative.

While the (still unknown) details of the Lucentis rebate program may be contorted enough to not meet the legal definition of bribery, if it looks and walks like the proverbial duck, most people will be hard-pressed to call it a goose. And Genentech’s explanation for the program sounds all too much like quacking, particularly because recent studies have hinted that Avastin works to treat retinal vein occlusion.

Image by Karen Roe via Flickr Creative Commons

Mandatory limits on salt content could save lives, researchers say

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Governments should force companies to curb salt content in processed foods, rather than leaving it up to food manufacturers to voluntary regulate salt levels, according to a new study.

Researchers from the University of Queensland in Australia came to this conclusion after measuring the public health benefits and cost effectiveness of three different salt reduction strategies: dietary advice, voluntary incentives and mandatory limits. The first two interventions only had minimal impacts, according to the authors’ theoretical model, but forcing companies to reduce salt content cut ill-health from heart disease by 18%.

“If we rely on companies to voluntarily reduce salt content, there would be some benefit,” study author Linda Cobiac told Reuters. “But benefits from mandatory cuts would be 20 times greater.” The results were published online this week in the journal Heart.

One way to help food makers reduce salt levels in their bread, margarine, potato chips and other products while maintaining the same flavor is to use newer low-sodium alternatives. To read more about technological solutions for cutting back on the tabletop seasoning, be sure to check out our news feature ‘Parse the Salt’ from the August issue of Nature Medicine.

NIH to launch genetic testing registry next spring

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Cross posted from Nature’s The Great Beyond blog.

A public, online registry providing information on the hundreds of available genetic tests is set to launch this coming spring, US National Institutes of Health (NIH) officials said at a public meeting in Washington DC this afternoon. But many of the details — such as what information it will include — have yet to be determined.

The NIH first publicly announced plans to create such a registry in March, though the idea had been circulation for at least a year. Exactly what the agency will do has been an active topic of discussion in a growing industry.

NIH director Francis Collins began the meeting by outlining some things that the registry would not do. Many in the genetics community have pushed for the registry to be mandatory rather than voluntary, but Collins gave a definitive “no” to such hopes today. Also, he said, “to be honest, it would take resources beyond our means” to review data in the registry to ensure it is accurate.

Read the rest of the post on The Great Beyond.