Wednesday, November 10, 2010

XMRV On Everyone’s Mind at a Chronic Fatigue Syndrome Meeting

The Chronic Fatigue Syndrome Advisory Committee — which advises the head of HHS on policy and scientific issues related to CFS — just wrapped up its latest meeting. During three days of presentations and debate (you can watch it all here), it was hard to avoid talking or thinking about XMRV.

That?s the retrovirus that was linked to CFS in a study published last year in the journal Science. Scientists have been debating the finding ever since, with some labs finding the virus in a majority of CFS patients and other labs not finding XMRV in a single case.

At the meeting’s public comment period, CFS patients pressed for more funding to study XMRV and to launch clinical trials. Many of the patients wore shirts with “NIH: What have you done for ME/CFS today?” emblazoned on the front. And some held up “Act Now” placards. (”ME” refers to myalgic encephalomyelitis/encephalopathy, another term used to describe the condition.)

For the first time, an extra day was added to the advisory committee meeting to focus solely on scientific developments; XMRV got prominent billing. In its final recommendations to HHS, the committee called for the creation of a national clinical trials network. “When [the science behind] XMRV gets sorted out, we?ll be ready to jump,” advisory committee member Nancy Klimas, a University of Miami professor who runs a CFS clinic and researches the condition, tells the Health Blog.

The idea, Klimas says, is to set up a network of at least five centers to serve as a kind of hub for research, clinical care and education. Doctors would start collecting standardized clinical and research data from patients at the sites, and teams of investigators would work together to develop common clinical trial protocols to start pushing drug development for CFS.

Yet a number of scientists at the meeting expressed caution about XMRV. Stuart LeGrice, who has helped lead XMRV efforts at NCI, gave the scientific talk on the virus and urged patients to wait until more is known before taking anti-retroviral medications. (Some are already taking the meds, as the WSJ reported recently.) “We?re not far from a controlled clinical trial,” he told participants during a Q&A session.

And while XMRV is a hot topic, Christopher Snell, the chair of the advisory committee, said at the meeting that research on XMRV has “overshadowed” other possible CFS research avenues. Klimas tells the Health Blog that research in CFS is finally yielding a number of possible therapeutic strategies that spring from other hypotheses unrelated to XMRV.

However, for patients like Robert Miller — who testified at the meeting — it’s clear what’s providing the momentum in CFS research. “This all started because of XMRV,” he said.

Image: iStockphoto


View the original article here

Tuesday, November 9, 2010

What Happens to Screening Rates When the Deductible Disappears?

You can see why insurers and employers would want to encourage people to take advantage of preventive care — in theory, it will cut the chances of later developing potentially costly diseases and conditions. (In practice, prevention may improve individual health, but there’s evidence that at least some of it doesn’t save the system money.)

As we’ve written, many companies pick up all or part of the costs of tests and procedures considered to fall under the preventive-care umbrella, including some cancer screening tests, annual physicals and flu shots.

Researchers funded by the government, Rand Corp.’s Bing Center for Health Economics and Merck wanted to see if that kind of incentive works. So they looked at whether screening rates changed at all when an employer eliminated the deductible for preventive tests and routine physical exams. (People still had to pay between 20% and 30% of the cost, in the form of co-insurance.) They analyzed data covering three different groups: people in high- and low-deductible plans, before and after the preventive care deductible was eliminated; and a control group from another employer where the deductible for preventive care didn’t change. Their findings were published in Health Services Research.

Scrapping the deductible “modestly” improved screening rates for blood-cholesterol tests, Pap smears, mammograms and fecal-occult blood tests, the researchers conclude. After adjusting for demographics and the overall trend of the test’s use, “there were between 23 and 78 additional uses per 1,000 eligible patients of covered preventive screens.”

But they recommend that “patients’ predisposing characteristics merit attention.” They’re referring to the finding that the expanded prevention coverage had a smaller effect on screening rates among people with high-deductible plans — perhaps because those folks are less risk-averse than the people who opt for low-deductible plans, or prefer to interact less with the health-care system. Or they could just be different in some other way that wasn’t controlled for by the study — such as income. (We wonder if they’re more skeptical about the value of some screening tests whose risk-benefit ratio isn’t so clear, such as mammograms for women in their 40s.)

The point is, though, that not everyone will respond in the same way to an incentive that would seem to work in a pretty straightforward way, i.e. lowering the out-of-pocket costs of a certain test or office visit. If the goal is to increase screening rates among the people who opt for high-deductible plans, other approaches — like patient or physician reminders or education — should also be studied, the researchers conclude.

Further reading:

Image: iStockphoto


View the original article here

XMRV On Everyone’s Mind at a Chronic Fatigue Syndrome Meeting

The Chronic Fatigue Syndrome Advisory Committee — which advises the head of HHS on policy and scientific issues related to CFS — just wrapped up its latest meeting. During three days of presentations and debate (you can watch it all here), it was hard to avoid talking or thinking about XMRV.

That?s the retrovirus that was linked to CFS in a study published last year in the journal Science. Scientists have been debating the finding ever since, with some labs finding the virus in a majority of CFS patients and other labs not finding XMRV in a single case.

At the meeting’s public comment period, CFS patients pressed for more funding to study XMRV and to launch clinical trials. Many of the patients wore shirts with “NIH: What have you done for ME/CFS today?” emblazoned on the front. And some held up “Act Now” placards. (”ME” refers to myalgic encephalomyelitis/encephalopathy, another term used to describe the condition.)

For the first time, an extra day was added to the advisory committee meeting to focus solely on scientific developments; XMRV got prominent billing. In its final recommendations to HHS, the committee called for the creation of a national clinical trials network. “When [the science behind] XMRV gets sorted out, we?ll be ready to jump,” advisory committee member Nancy Klimas, a University of Miami professor who runs a CFS clinic and researches the condition, tells the Health Blog.

The idea, Klimas says, is to set up a network of at least five centers to serve as a kind of hub for research, clinical care and education. Doctors would start collecting standardized clinical and research data from patients at the sites, and teams of investigators would work together to develop common clinical trial protocols to start pushing drug development for CFS.

Yet a number of scientists at the meeting expressed caution about XMRV. Stuart LeGrice, who has helped lead XMRV efforts at NCI, gave the scientific talk on the virus and urged patients to wait until more is known before taking anti-retroviral medications. (Some are already taking the meds, as the WSJ reported recently.) “We?re not far from a controlled clinical trial,” he told participants during a Q&A session.

And while XMRV is a hot topic, Christopher Snell, the chair of the advisory committee, said at the meeting that research on XMRV has “overshadowed” other possible CFS research avenues. Klimas tells the Health Blog that research in CFS is finally yielding a number of possible therapeutic strategies that spring from other hypotheses unrelated to XMRV.

However, for patients like Robert Miller — who testified at the meeting — it’s clear what’s providing the momentum in CFS research. “This all started because of XMRV,” he said.

Image: iStockphoto


View the original article here

Author Rick Riordan’s Ideas For Helping ADHD Kids Enjoy Reading

Rick Riordan’s latest book, which kicks off a new series.

We at the Health Blog are not afraid to admit that we devoured Rick Riordan’s blockbuster “Percy Jackson and the Olympians” series of kids’ books, despite being a few decades older than the target demographic.

So we were intrigued to read that the series sprang from the bedtime stories the author used to tell his son Haley, who — like Percy — has dyslexia and ADHD. And as Riordan writes today on WSJ’s Speakeasy blog, Haley, now 16, has become an avid reader.

(We’ve written about the drug treatments for ADHD, which are a big driver of increased spending on kids’ meds.)

Riordan offers up four tips he’s gleaned from being a dad and a classroom teacher for encouraging a reading habit among kids with ADHD, dyslexia or other learning “differences,” as he says. We think they sound like good advice for any parent trying to get any kid — ADHD or not –to put down the Nintendo Game Boy and pick up a book.

First, Riordan recommends parents model reading at home to give children the “sense that it is a valuable part of your daily routine.” He continues:

Sometimes the Riordan family will read books together. Sometimes we?re all reading different things. But we value books, and we have great conversations about our favorite authors and stories.

To read all of Riordan’s suggestions, check out the Speakeasy post.


View the original article here

FDA Sniffing Around Pfizer’s Doggy Weight-Loss Drug Slentrol

Not only have we in the U.S. made ourselves fat, we’ve dragged our dogs along with us. Hence, Slentrol, Pfizer’s FDA-approved drug to help pudgy pugs lose a neck roll or three.

But the FDA says a preliminary analysis suggests a “potential correlation” between the breed of the dog and certain side effects of the drug, Dow Jones Newswires reports, citing an agency document. The FDA is planning to study genetic data on dogs that have taken Slentrol to see if certain breeds are more susceptible to problems. It didn’t specify which adverse events it’s tracking.

Pfizer disagrees with this plan, DJN reports. The company says side effects listed on the label, including vomiting, diarrhea and lethargy, are usually mild, and that specific breeds don’t seem to be disproportionately affected.

The breeds most commonly associated with adverse events with Slentrol — Labrador retriever, beagle, golden retriever, dachshund, pug and Chihuahua — are also very common, and some are predisposed to obesity, Pfizer says.

Meantime, there’s been lots of action on the diet-drugs-for-humans front. Last week Abbott pulled Meridia from the market at the FDA’s behest, on concerns of cardiovascular side effects. Three experimental drugs are up for FDA consideration; an advisory panel has voted not to recommend two of them, Arena’s lorcaserin and Vivus’s Qnexa. Orexigen’s Contrave comes before the panel late this year. (The FDA doesn’t have to follow the advice of its advisory panel, though it often does.)

Humans on the hunt for new options shouldn’t steal Fido’s Slentrol, however. The FDA has said that Pfizer tested the drug in a small number of people and it produced swollen abdomens, stomach pain, diarrhea, flatulence, nausea and vomiting.

Further reading:

Photo by dboy via Flickr


View the original article here

Study Suggests Electronic Medical Records Improve Adverse-Event Reporting

Digitized medical records and systems have been proposed as a remedy for a lot of problems, from the difficulty of deciphering a doctor’s handwriting to decentralized and inaccessible patient medical information to long ER wait times. (Whether electronic records can live up to all the hype is, of course, not clear.)

Now a new Pfizer-sponsored study suggests digitized records may improve the reporting of adverse events associated with prescription drugs, the WSJ reports. (The paper also wrote about this project when it was in progress.)

Research suggests the vast majority of harmful drug-related side effects go unreported to the FDA. This small study — covering 26 physicians at two Boston hospitals over a five-month period — set out to see if incorporating reporting into the electronic medical record system could help change that. As the WSJ describes it: “When one of the doctors in the study recorded discontinuing a medicine because a patient experienced an adverse event, the hospital’s electronic patient record system generated an alert. The system asked the doctor whether the side effect was serious and submitted a report to regulators.”

The physicians in the study reported 217 side effects to regulators during the study period, compared to none the year before.

Only about 20% of the flagged side effects were serious, and the Brigham and Women’s Hospital internist who led the study tells the paper the system may need some rejiggering to reduce the number of reports of non-serious issues. A common complaint of physicians who use electronic medical records is that they issue so many automated alerts for things such as drug interactions that doctors end up ignoring many of the messages.

Further reading:

Image: iStockphoto


View the original article here

Survey: Plenty of Uncertainty on Impact of Health-Care Overhaul

Almost half of private-company CEOs and CTOs surveyed by PricewaterhouseCoopers say health-care overhaul legislation may affect their business financially, while another 31% say it’s too soon to assess the impact.

The uncertainty isn’t totally surprising, since most of the provisions of the bill haven’t kicked in yet. But employers are still sussing out even the provisions that took effect Sept. 23 — or will in the next plan year.

Take the requirement that plans cover dependents until age 26, for example: 28% say they’re not certain of the impact (or didn’t answer the question). Another 29% said it would likely have no impact, and 43% said it would have either a slight or moderate/significant impact.

The executives surveyed said the increase in Medicare tax on high-income individuals would have the biggest financial impact — 31% reported it would have a moderate or significant impact. (Then again, 27% said it would likely have no impact.) The provision getting the greatest proportion of “no impact” votes — 66% –? was the penalty for companies with 50 or more employers that fail to provide minimal affordable coverage.

The new PwC survey covers the views of 224 CEOs and CTOs representing private companies averaging $257 million in annual sales.

Even without knowing the full financial impact of the law, some 70% say they’ll reevaluate their company’s overall benefit strategy and 60% plan to change benefits to comply with the law. More than half — 52% — say they’re likely to change employee contributions for medical coverage. That’s not too far off from a recent National Business Group on Health survey reporting 63% of big employers plan to increase the proportion of premiums paid by workers.

Further reading:


View the original article here