Feeling Heat Over Financial Conflicts, NIH Mulls New Rules for Grantees

The NIH, under fire from Congress for failing to crack down on unreported financial conflicts of interest among academic researchers receiving federal grants, came out with a plan to do something about the problem on Friday. But it’s going to take a while.

Under current NIH rules, researchers are required to inform their universities about any “significant financial interests” they hold in research financed by the NIH. The threshold for income is $10,000. In turn universities are obliged to inform the NIH of the steps they’ve taken to manage, reduce or eliminate conflicts of interest.

Critics charge the NIH hasn’t being policing the university researchers closely enough. In October, the NIH suspended a five-year, $9.3 million grant to Emory, after Senator Chuck Grassley (R., Iowa) raised questions about drug industry payments to the chair of the med school’s psychiatry department.

At a Friday meeting of a committee advising the head of NIH, Sally Rockey, the NIH’s acting deputy director for extramural research, highlighted parts of the regulations under review. Among the questions being asked? Should researchers be required to disclose all their sources of income if they get an NIH grant? Does the definition of “significant financial interests” need to be changed? And should universities be required to disclose the nature of the conflicts of interest in their reports to the NIH? At present they don’t.

We watched a webcast of the event and the opinions differed among committee members. One way to get a clearer picture of the sources of researchers’ income could be to take a peek their tax returns, suggested one member — apparently in jest. “Do you want us to go there?” he asked. Such a requirement would be “nuts” and create more bureaucracy without solving any problems, he added.

Still, there seemed to be a consensus more needs to be done — at the very least to avoid the perception by Congress and general public that the NIH is ducking the issue.

For starters the NIH will tell the world that is proposing to make some changes. Outside parties, including researchers, universities, companies and individuals will have sixty days to chime in. Armed with the feedback, the NIH can then start drafting new regulations.

“It’ll be six months to a year before we can act on this,” said Raynard Kington, the NIH’s acting director. In the meantime, Kington said the NIH would be “aggressive” in cracking down on research institutions found flouting the existing rules.

Tests of New Drugs for Developing World Need $1 Billion a Year

When it comes to finding drugs for diseases of the developing world, the most expensive work is about to begin.

Charitable groups, academics and a few drugmakers have made some progress on experimental medicines and vaccines to fight tuberculosis, malaria and Dengue fever. But taking the drugs beyond early tests is going to require a whole lot of money.

Paul Herrling, head of Novartis’s research into diseases of the developing world, told the Health Blog that it will take about $1 billion a year for the foreseeable future to put the experimental treatments and vaccines through large human trials and file them with regulators. That’s far more money than is currently available from donors.

So Herrling has a plan that calls for governments and donor groups, like the Gates Foundation and WellcomeTrust, to prioritize this work by chucking a bunch of money into a new fund. A group of independent scientists and medical experts would then dole out the cash to the best projects, sort of like an NIH grant committee. Herrling has laid out his analysis and proposal in more detail here.

But what about the drugmakers? We know Big Pharma has its problems, but wouldn’t the companies still be able to kick in some cash? Companies would also be welcome to donate, Herrling told us, but because many “have already contributed to the pipeline” through their early-stage investments, he hasn’t counted on them as a potential donors for the new fund.

Groups taking money from the new fund would pledge to make the drugs available free (or a least profit-free) to poor people. Inventors would retain patent rights and would be free to sell a drug for other illnesses in rich countries. But inventors would give the fund the exclusive license for specific indications in the developing world.

In a report issued this week, Oxfam expressed concern about the lack of new medicines for the developing world, noting that less than 10% of all medical research funding is being spent on diseases affecting more than 90% of the world’s population. Oxfam recommended a new funding model of its own, calling on the World Health Organization to establish a Global Fund for Research and Development into which all countries would contribute according to their GDP. Charitable groups would also contribute. Drug companies could contribute by relaxing their inclination to patent every innovation, Oxfam said, arguing that patents often hinder development of drugs for poor people. (Herrling, for his part, hotly disputes this point, saying that patents are an essential part of inspiring innovation.)

Gardasil Vaccine Not Linked to Serious Side Effects

The feds gave Merck’s Gardasil a clean bill of health yesterday, after reviewing data from some 375,000 women and girls who received the vaccine, which protects against several strains of the virus that causes cervical cancer.

The agency has received reports of more than 10,000 cases of possible side effects associated with the drug. Most of those were issues that are relatively mild and short-lived, such as nausea and fever.

After mining a large data set drawn from several managed care organizations, officials determined that several serious side effects — including stroke, bood clots and Guillain-Barre Syndrome, a disorder that causes muscle weakness — were no more common among women and girls who received the vaccine than among those who did not.

Here’s the update the CDC published yesterday; here’s a story from the WSJ.

The CDC also noted that there have been 26 reports of death in girls and women who received Gardasil. But “there was not a common pattern to the deaths that would suggest they were caused by the vaccine,” this FAQ says. “In cases where there was an autopsy, death certificate, or medical records, the cause of death was explained by factors other than the vaccine.”

How Defensive Medicine Puts Patients At Risk

To reduce the risks of being sued, doctors often give patients tests they don’t really need and send them off to specialists that could probably be avoided. What doc wants to wind up in court answering questions about why he didn’t order a CT scan, “just to be sure?”

But — one of the many ironies of modern health care — when doctors practice medicine to defend against being sued, they can raise risks for patients.

Defensive medicine is actually aggressive medicine. And there are plenty of situations where a patient would be better off doing nothing than getting a test, taking a pill or undergoing a procedure.

As family doc and WSJ.com columnist points out in his column today, patients who want doctors to practice defensive medicine can usually get it. But, he writes, “make sure to factor in the extra doses of radiation from scans, the extra medication you might be allergic to, and the extra procedures the specialist is likely to recommend.” (Those procedures, by the way, carry their own set of risks.)

If you think a doctor is ordering a test or giving you a referral just to play defense — and if you’re not happy about it — speak up. “The defensive among us will document your informed refusal and our estimation that your lack of compliance might hurt you,” Brewer writes. “The rest of us would probably agree with you.”

Report: Medicare Drug Fraud May Go Unnoticed

Seems like every time we turn around there’s a new report on Medicare’s ability — or lack thereof — to monitor for fraud.

Last week, there was a hubbub over a draft report that said Medicare directed an auditor to use improper methods in an anti-fraud audit related to durable medical equipment. That came on the heels of a GAO report about equipment fraud. There were also scams involvingdead doctors, AIDS care and some guy who bilked a bunch of money from Medicare and bought a Rolls Royce.

Now, the fraud issue du jour: the Medicare drug benefit. The Government Accountability Office came out with a report today that says some insurers sponsoring Medicare drug plans haven’t put in place all the fraud controls they’re supposed to. For instance, some haven’t met requirements for employee training and internal monitoring and auditing. Click on the icon below to read the report.

Medicare’s oversight has been “limited,” and the agency hasn’t audited the plans to make sure their controls are up to snuff, the GAO said. A lack of oversight “risks significant misuse of funds in this $39 billion program.”

Medicare’s acting administrator, Kerry Weems, disagreed with the finding that its oversight had been limited, pointing out in a letter that the agency has monitored fraud and abuse complaints, taken action in response, provided detailed guidance to the plans on fraud control and gathered information from them on their programs. But Weems added that inadequate funding has stymied heavy oversight. A Medicare Integrity Program funding cap has “seriously degraded [Medicare's] ability to meet its responsibilities in combating fraud and abuse,” he wrote.

Medical ‘Wikipedia’ Is Looking For a Few Good Doctors

An online medical encyclopedia launching later this year aims to have have the open-source, ever-evolving, comprehensive nature of Wikipedia. But — in a key departure from Wikipedia’s all-comers sensibility — the new encyclopedia will be edited only by those with advanced degrees in medicine and biomedical science.

The site, Medpedia, launched a preview this week (see image at right) and said it’s taking online applications from would-be volunteer editors. The site says Medpedia is looking for “M.D.s, biomedical research Ph.D.s, and clinicians” who will be screened in a “rigorous internal review process.”

The site is backed by an incubator called Ooga Labs (whose Silicon Valley cred is detailed at TechCrunch) and will run text ads.

A lot of heavy hitters from the biomedical world will be contributing, the site says. Harvard Medical School is giving the site some seed content. And Medpedia’s advisers include current and former deans from the med schools at Harvard, Stanford and Michigan and the school of public health at UC Berkeley. And the site will pull in public domain content from the likes of the CDC, NIH and FDA.

Health Insurance: Extreme Matrimony Edition

How far would you go to land or keep affordable health insurance?

Some couples, straight and gay, are finagling wedding dates to quickly get both spouses on a company plan. Other married couples cruising for a breakup can at least agree on postponing divorce to keep both people on the existing health plan of one of them. And some self-employed people are hiring workers just to qualify for group insurance, Dow Jones Newswires’ Victoria E. Knight reports.

The rub is basic. Under federal law, insurers have charge the same for premiums for everybody in an employer-sponsored insurance plan–no matter their health. But try buying health insurance on the open market, and you may face high prices or rejection, depending on your medical history.

One planner told Knight about a client, a woman in her mid-50s, who moved up her wedding so that her fiance, would also become eligible for health benefits offered to workers and spouses as part of a corporate buyout package at her job.

A business owner in California, covered under a small group plan, put her husband on the payroll largely for insurance reasons. “I hired my husband to run my office and manage the IT,” the woman told Dow Jones, who asked not to be named for fear of drawing the attention of insurers.

Seven percent of Americans said that in the past year they or someone in their household decided to tie the knot mainly so one spouse would be eligible for the other’s health coverage,according to a survey by the Kaiser Family Foundation. We were a little skeptical about the figure, which by our calculation seemed a bit high, but have little doubt that insurance worries weigh heavily on millions, married or otherwise.