This year, the US Food and Drug Administration (FDA) has been tougher about approving new drugs based on non-inferiority trials &mdash and rightfully so, according to a report out this summer from the Government Accountability Office (GAO).

Non-inferiority trials pit an experimental drug against an established treatment in order to prove that the new drug does not perform any worse than its competitor. Some argue that, for conditions where there is already a drug available, this method is more ethical than placebo-controlled trials.

But the GAO report highlights the concern that non-inferiority trials lead to a phenomenon known as “biocreep”, where new drugs are approved that are slightly less effective than their predecessors, eventually leading to treatments that are no better than a placebo.

The FDA issued new guidelines in March of this year providing more specific suggestions to industry scientists on how to structure non-inferiority trials, including how best to select the drug control and what constitutes an acceptable margin of non-inferiority.

Last year, US President Barack Obama signed legislation that gave the Food and Drug Administration the power to regulate tobacco marketing. This past June, the FDA exercised its new authority by banning tobacco companies from sponsoring sporting events and prohibiting outdoor advertisements within 1,000 feet of a school or playground. But while restrictions on cigarette ads in print, TV, and radio have been in place for more than a decade, the Internet is a largely unfenced frontier where the Marlboro man could potentially roam free.

At least, that’s the thesis of a new study published in Tobacco Control, a British Medical Journal specialty publication. A group of New Zealand researchers searched YouTube for the most-viewed videos related to popular cigarette brands. They analyzed 163 videos and found that 71% offered pro-smoking messages, often using celebrities, sports, or music videos. While they did not find any videos posted officially by tobacco companies, the authors point out that the relative anonymity afforded by YouTube means companies could be acting through proxies.

“The Internet is an ideal forum for tobacco marketing, as it is largely unregulated and there is no global governing body for controlling content,” the authors write in the paper.

Continue reading →

The US National Institutes of Health (NIH) put a freeze today on all pending grant applications related to human embryonic stem cell research, although any ongoing stem cell projects funded by taxpayer-backed grants will be allowed to continue.

“Frankly, I was stunned,” said NIH director Francis Collins of yesterday’s court ruling. “The consequences of this decision are dramatic and far reaching.”

In the immediate term, many high scoring grants worth $15–20 million that were due to be funded will be put on hold; another 22 grants valued at $54 million scheduled for annual renewal next month have been frozen; and an additional 50 grants that were awaiting peer review are also being “pulled out of the stack,” Collins said in a press conference this afternoon. However, any money that has already gone out the door can continue to be spent.

The agency also canceled a meeting scheduled for today of the working group that evaluates whether to approve new human embryonic stem cell lines for federal funding.