Tag Archives: nih

A problem with precision medicine: It’s not quite precise – at least not yet

At a conference last year, Michael Laposata, M.D., Ph.D., one of the nation’s best known pathologists, explained how clinical laboratories could deliver more value to patients, physicians, and health insurers. To do so, pathologists and laboratory scientists need to provide more detailed explanations about lab test results because even physicians who order genetic and molecular tests are often confused about the results, said Laposata, chairman of the Department of Pathology at the University of Texas Medical Branch.

When he explains test results to ordering physicians, he frequently refers to an “allele” which is one of two or more versions of a gene, he said. When he does, physicians sometimes ask, “What’s an allele?”

His anecdote is telling following President Obama’s announcement last month that he recommended spending $215 million on the precision medicine initiative. The announcement was correctly hailed as an important and needed investment in medical technology. “Precision medicine” is described by the National Institutes of Health as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” Continue reading

POGO fears disclosure rule is in jeopardy

A database that would document the financial ties between researchers who are funded by the The National Institutes of Health and medical companies is in jeopardy, according to the Project on Government Oversight (POGO).

Under the proposed requirement, NIH-funded researchers at medical schools and universities would have to publicly disclose their financial ties to medical companies. In March, POGO sent a letter to Dr. Francis Collins, the Director of the NIH, urging him to implement this idea, which he had shown support for.

But POGO is concerned that the White House’s Office of Management
and Budget may weaken or block the rule. The organization has sent a letter to the OMB director in support of the rule.

Previously: NIH Proposes Rule to Shine Light on Potential Conflicts of Interest

Video, presentations from comparative effectiveness conference available online

Earlier this month, ECRI’s 17th annual conference tackled the thorniest detail of comparative effectiveness research, namely that it’s rarely a simple matter of A > B. Groups and individuals respond differently.

With a theme of “Comparative Effectiveness and Personalized Medicine,” the nonprofit and its partners at NIH and Health Affairs, among others, sought to better understand how big research ideas will interface with the person-by-person decisions through which such work will ultimately be implemented.

The conference has a detailed postmortem online, including two days of video (Fair warning: Together, they’re a good 700+ minutes of conference) and slides from a number of the presentations. I strongly recommend using the conference schedule listed on the slides page as a rough guide to finding the most relevant bits of video.

In case you’re looking for a place to start, here are two of the most relevant presentations:

The online Q and A is also interesting, though there are only a handful of answers up at present. The most relevant one so far comes from Vivian Coates (Vice President, Information Services and Health Technology Assessment, ECRI Institute), in response to a query about a central listing of comparative effectiveness projects.

The CER inventory contract was awarded to the Lewin Group Center for Comparative Effectiveness Research (CER) in June, 2010. Over the 27 month period of the contract, Lewin will design, build and launch a web-based inventory that catalogs CER outputs and activity, including research studies, relevant research methods, training of researchers, data infrastructure and approaches for dissemination and translation of comparative effectiveness research to health care providers and patients.

$95 million to figure out proper doses for kids

On The Wall Street Journal’s Health Blog, Katherine Hobson profiles the Pediatric Trials Network, a seven-year, NIH-funded effort to determine pediatric dosing information for things like hypertension drugs and antibiotics. The $95-million initiative will fund 16 clinical trials, most of which will enroll 100 to 200 participants, Hobson reports.

Photo by woodleywonderworks via Flickr

Even then, Hobson said, the new study will only make a “dent” in the larger problem. She found that, at present, “virtually all” pediatric drug use is off-label, and that physicians get pediatric dosing wrong about a third of the time. The FDA already does some baseline work to make sure drugs are kid-safe, but the PTN represents a large step beyond present efforts.

Some brand-name drugs do get scrutinized under a program that gives drug makers an extra 6 months of patent protection for conducting FDA-requested studies in kids. And experimental drugs up for FDA approval must assess the effects in kids if they’re likely to use them. But that leaves a big knowledge gap for the host of generic drugs used to treat everything from infectious diseases to cancer.

Gays excluded from clinical trials

Thanks to an awards announcement from the National Lesbian & Gay Journalists Association, we just noticed Jen Colletta’s story in the Philadelphia Gay News about the exclusion of gays from clinical trials. Colletta won an Excellence in News Writing Award. The exclusion of gays in clinical trials is an issue that hasn’t received much mainstream attention, apart from a letter from Colletta’s sources in NEJM, a write-up by Ed Silverman and a story in The Philadelphia Inquirer.

According to Colletta, the data behind the story grew out of a chance discovery by researchers at the Fox Chase Cancer Center in Philadelphia.

“We review all the different trials that are proposed here, and they don’t necessarily open here, but a lot of them are multi-center trials so we do look at them. And I saw that we had been looking at a number of clinical trials that explicitly excluded gay people, and they didn’t necessarily open at Fox Chase, but I started to become more attuned to this and realized that this is a bigger, national issue,” (Brian Egleston, assistant research professor of biostatistics at the center) said.

The researchers analyzed trials listed in the ClinicalTrials.gov database, maintained by the National Institutes of Health and the Food and Drug Administration.

In particular, Colletta reported, homosexuals are excluded from studies about couples, especially those dealing with erectile dysfunction, which are often related to treatments for prostate cancer. It’s entirely normal for a drug trial to have exclusion criteria, but an oversight in NIH regulations mean that the exclusion of homosexuals, unlike exclusion along racial lines, can be implemented arbitrarily.

In the mid-1990s, Congress mandated that NIH establish a set of guidelines that would prevent it from excluding minorities, such as women and African Americans, from federally funded clinical trials unless there was a significant reason. There are currently no such rules regulating the inclusion of LGBT individuals.

The distribution of exclusionary studies is particularly interesting. To put it in perspective, here’s a quick visualization of the data put forth in the NEJM letter: