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)

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.

By 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

The 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

Today, 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

US voters head to the polls today in a midterm contest that most number-crunchers believe will result in Republicans taking control of at least one house of Congress. Messages have been calibrated in order to snare that mythical election-season beast: the “swing voter”. But no amount of campaigning might sway some members of the electorate, because it turns out that how voters pull the lever today is written, in part, in their DNA.

According to research conducted by University of California–San Diego behavioral scientist James Fowler, certain genetic factors can predispose some people to be more liberal, provided that they’re social butterflies as well. Fowler’s previous work has found that alcoholism is contagious among social networks, and that researchers can track the spread of infectious diseases by monitoring people’s Facebook friends. His most recent study of 2,000 adults, published in the Journal of Politics, found that people who possessed the 7R variant of the DRD4 gene and had a lot of friends in adolescence were more likely to self-identify as liberal. DRD4, which codes for a dopamine receptor, has also been linked to attention deficit disorder, impulsivity, gambling and heroin addiction. The train of reasoning goes something like this: people with DRD4-7R are more likely to seek out new experiences and new friends, thus exposing them to lots of different lifestyles and making them more likely to hold opinions and support policies that are friendly to the poor, dispossessed, ethnic minorities, etc.

Continue reading →

On Friday, the US Department of Justice said that genes should not be patentable, a significant reversal of longstanding policy. The opinion was delivered in an amicus brief filed in an ongoing legal battle that kicked off when the American Civil Liberties Union (ACLU) challenged the validity of patents held by Salt Lake City-based Myriad Genetics and the University of Utah on the breast cancer-linked genes BRCA1 and BRCA2. (The ACLU won the first round when a federal court ruled in its favor in March.) The new brief opines that isolating a gene does not fundamentally change its nature, much like extracting coal from the earth does not change the material.

However the chips may eventually fall in the Myriad appeal, gene patenting is still standard operating procedure. The US Patent Office has issued more than 40,000 patents for the alleles of more than 2,000 human genes. Should these patents stand, there’s a host of legal, scientific, and philosophical issues to be resolved. For instance, if a patent is issued for a gene, does that mean that the RNA transcript and the protein are patented as well? And how much wiggle room is there on the DNA sequence itself? One could imagine enterprising competitors introducing silent mutations in order to make the sequence just different enough to avoid patent infringement. Can a company use portions of patented genes to create their own sequences, the way rap artists sample other musicians? The legal precedent for the latter question doesn’t look favorable, as US courts have ruled that even a sequence of 3 musical notes can be copyrighted.

Image by kevinspencer via Flickr Creative Commons

This weekend, clocks in the UK will ‘fall back’ one hour; a week later, the US will follow. This sudden change might leave you feeling slightly discombobulated, but chances are, your internal clock will soon adjust to compensate. Some people aren’t so lucky; perturbations of circadian rhythm are thought to be a factor in sleep disorders and some psychiatric conditions like bipolar disorder, according to a study published last month in PLoS One.

The master timekeeper of the body is in the suprachiasmatic nuclei (SCN), a tiny pair of neuron clusters located in the hypothalamus. But there are also peripheral body clocks, located in organs like the liver, and even within individual cells. Synchronizing these clocks means taking non-environmental cues, like feeding patterns, into account.

A recent paper in Cell described how an enzyme called poly (ADP-ribose) polymerase 1 (PARP1) coordinates the master clock of the SCN with circadian rhythmic gene expression in the liver. Mice deficient in PARP1 were slower to respond when their feeding regimen changed. The authors also found that PARP1 interacts with two key circadian rhythm regulators, CLOCK and BMAL-1. These transcription factors were also recently found to be involved in muscle maintenance by targeting MyoD, a master regulating protein of myogenesis.

Though researchers have been able to peer into the circadian clocks of model organisms like mice and fruit flies, it was unclear whether or not the nematode Caenorhabditis elegans had a circadian rhythm at all. A genome-wide analysis in PLoS Biology found the first evidence of gene expression patterns in C. elegans influenced by circadian rhythm. The authors found that temperature and light influenced the expression of up to 9% and 4% of all the genes in the organism.

Enjoy the extra hour of sleep!

Image by stevendepolo via Flickr Creative Commons

In July, reports of a successful anti-HIV vaginal gel wowed the the International AIDS Conference in Vienna. Now the US Food and Drug Administration is looking to speed the gel’s approval, according to the drug’s makers, who met with the agency last week.

Henry Gabelnick, the executive director of CONRAD, one of the groups developing the tenofovir gel, told Reuters that the gel has been fast-tracked, meaning that data can be submitted as it becomes available.

Results from the first study, involving 889 South African women, showed that the group of women using the gel had an infection rate 39% lower than the placebo group. And among women who used the gel most consistently, the rate of infection was lowered by 54%. But the FDA will want to see results from the VOICE trial, expected to conclude in 2013 or 2014, before seriously considering the gel for approval.

Yesterday, the New York Times reported that while items like acne creams and denture adhesive are eligible for tax breaks under the new US health care law, breast pumps are not. Breast-feeding boosters like La Leche League are, naturally, up in arms, but the US Internal Revenue Service says that the pumps do not fall under the umbrella of preventative medicine, since breast milk is primarily nutrition.

To counter the IRS, breast-feeding advocates point to research showing that breast-feeding transfers essential antibodies from mother to child. There’s also research suggesting that bacteria in mother’s milk plays a key role in building up a healthy community of intestinal microflora.

But in certain circumstances, breast-feeding can be a vector for harmful microbes as well. In February, the US Centers for Disease Control (CDC) reported the case of a mother in Brazil who, after she received a yellow fever vaccine, passed the virus to her infant through her milk. Hepatitis B virus (HBV) has been detected in the milk of HBV-positive mothers, though it’s unclear if the virus can actually be transmitted through breast-feeding; the most common method of mother-to-child HBV transmission is during delivery itself. If a Hepatitis C-positive mother has cracked or bleeding nipples, she runs a higher risk of transmitting the virus to her infant. UNICEF estimates that if an HIV-positive mother breast-feeds, she’ll pass the virus to her child 5 – 20% of the time.

It’s worth noting that another US government agency, the Transportation Security Administration, classifies breast milk as ‘liquid medication’, which is why mothers are allowed to bring more than three ounces of it on a plane.

Image by planet _oleary via Flickr Creative Commons