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.

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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:

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A.M. Vitals: Case Claiming Individual Mandate is Unconstitutional to Proceed

Case to Proceed: A federal judge says the assertion by 20 states that the health-care overhaul law’s individual coverage mandate is unconstitutional is “a plausible claim,” the WSJ reports. Judge Roger Vinson of U.S. District Court for the Northern District of Florida is permitting the states’ case to go forward. He was more skeptical about the claim that the expansion of Medicaid included in the bill is also unconstitutional, but permitted it to go forward as well. The case is likely to make it to the Supreme Court, the WSJ says.

Offering Suggestions: UnitedHealth Group suggests that to save money, health benefits for the nine million people eligible for both Medicare and Medicaid should be administered via managed-care plans, Bloomberg News reports. The insurer issued a report proposing several measures for Medicare and Medicaid it says can save $3.5 trillion over the next 25 years.

FDA Reversal: The FDA said it shouldn’t have allowed the Menaflex knee implant to reach the market because political influence affected the approval process, and is now revoking its approval of the device, the WSJ reports. As the paper wrote in 2009, the implant, made by ReGen Biologics, was approved following a lobbying campaign by four members of Congress — even after FDA staff questioned its safety and efficacy. ReGen says it’s weighing its options, which include an appeal of the decision.

Fighting Bacteria?: Chiquita Brands’ Fresh Express, which makes bagged salad mixes, says washing greens in a mixture of two organic acids — rather than the usual chlorine — is a more effective way to kill off potentially dangerous bacteria, the New York Times reports. The company will switch to the FreshRinse wash and will also license it to other producers; food-safety experts tell the NYT that without published data, it’s impossible to verify the wash’s effectiveness. Fresh Express has recalled packaged greens three times this year over bacterial contamination worries, the NYT says.

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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

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

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CVS Will Pay $75 Million After ‘Smurfers’ Bought Meth Ingredients

If you’d been in a CVS in Los Angeles during 2008, you might have witnessed people coming into the store and clearing the store’s shelves of cough and cold medicines. It also might have occurred to you that they weren’t just facing a bad case of the sniffles.

According to federal prosecutors in L.A., those folks were “smurfing”: making “multiple purchases of pseudoephedrine in small amounts with the intent to aggregate the purchases for use in the illegal production of methamphetamine.” And CVS became smurfing central as those folks discovered that those stores, “unlike other large chain retail pharmacies, allowed customers to make repeated purchases of pseudoephedrine that exceeded federal daily and monthly sales limits,” the U.S. Attorney’s Office for the Central District of California says.

That big whoopsy-daisy is costing CVS $75 million in civil fines (and the estimated $2.6 million it made on the medications).

As the Associated Press reports, CVS was supposed to be monitoring and limiting how much pseudoephedrine its customers purchased. It had an automated “Meth Tracker” electronic logbook to record purchases, but did nothing to stop the smurfers (we can’t stop saying that word!) from making multiple purchases in a day.

CVS Caremark CEO Thomas Ryan said that the chain violated its own policies. “To make certain this kind of lapse never takes place again, we have strengthened our internal controls and compliance measures and made substantial investments to improve our handling and monitoring of [pseudoephedrine] by implementing enhanced technology and making other improvements in our stores and distribution centers,” he said in a statement.

The AP says CVS declined to comment on the government’s allegation that the company failed to follow up on reports from employees and store managers about the repeat purchases.

Prosecutors say the violations occurred in Nevada and elsewhere, too; this settlement covers liability in 25 states. As part of the deal, the government won’t seek criminal charges against CVS.

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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:

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