Right off the bat let’s just note that the promised cures from stem cells have been slow in coming.
Science is hard. But many researchers trying to harness embryonic stem cells, which have the potential to produce any kind of cell in the human body, say restrictions on the cells that qualify for federal funding have made the work even harder. (AHCJ article – Covering stem cells: Background on science, politics and global competition)
When stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell. Photo: National Institutes of Health
Earlier this year the Obama administration rolled back limits from the Bush era that restricted federal funding to only a few cell lines. But it still hasn’t been clear which stem cells are OK and which are verboten.
The National Institutes of Health has waded in with clarifying guidelines that take effect today. The upshot: if the old cell lines were created ethically, then they should be good to go. The main issue is whether researchers got the appropriate consent of donors.
Next up, an NIH committee will pass judgment on existing cells and produce a Web site itemizing the ones that are legit.
“Every institution shouldn’t have to rediscover which cell lines are eligible for NIH funding, so having a registry is very practical,” George Q. Daley, a stem-cell researcher at Children’s Hospital Boston told The New York Times.
You can’t tell the health-care lobbyists without a program. So The Washington Post, working with data from the Center for Responsive Politics, has come up with one just in time for the next round of health-reform negotiations on Capitol Hill.
More than 350 former congressmen, committee staffers and federal bigwigs are busily advancing the interests of drugmakers, insurers, hospitals and medical groups, the Post reports.
Buying influence is easy but it ain’t cheap. The Post calculates the “record-breaking” campaign is costing the health-care industry more than $1.4 million a day.
What does it get for the money? A seat at the table, for starters, and maybe much more. For their part, the ex-government employees get a pretty rich payday.
“For people like me who are on the outside and used to be on the inside, this is great, because there is a level of trust in these relationships, and I know the policy rationale that is required,” Richard Tarplin, a lobbyist working for the American Medical Association, told the Post. Tarplin used to work for Health and Human Services and Sen. Chris Dodd (D-Conn.), who’s a key player in the health debate.
From The Washington Post
If you do nothing else, check out the slick graphic showing the influence of ex-staffers from the Senate Finance Committee.
Quitting smoking, always nerve-racking, may prove even tougher in the wake of a Food and Drug Administration decision to require its strongest warnings for some drugs popular with folks trying to kick the habit.
Pfizer’s Chantix, GlaxoSmithKline’s Zyban, and Zyban’s generic equivalents will now carry a lengthy “boxed warning” about risks of some pretty serious changes in behavior, including hostility and suicidal thoughts, that could dissuade people from using the drugs.
But a “boxed warning?” Hey, FDA, don’t you mean “black box warning?” That’s the way the agency has long been proud to talk about the toughest warning at its disposal. Well, maybe not so much anymore.
CNBC’s Mike Huckman tweeted during an agency call with reporters about the rowback: “FDA official wants media to stop using term ‘Black Box’ & just say ‘Boxed Warning.’ ‘Black Box carries implication ‘Don’t u dare use this.””
Forbes’s Matt Herper wrote that during the call Robert Temple, director of the FDA’s drug evaluation office said the beefed-up boxed warnings on Chantx and Zyban aren’t meant to stop people from using smoking-cessation drugs. “Smoking is really bad for you,” Temple said. “What you want is that people don’t [use the drugs] casually.”
What’s a reporter to do? U.S. News and World Report health writer Katherine Hobson poked FDA on Twitter, “What’s a better substitute for ‘black box warning’? Gentle reminder?”
How about, “Whoa! You sure you really wanna take this pill?”
The august Institute of Medicine is out with academic medicine’s answer to the Billboard Hot 100. A panel of experts has come up with a list of the top 100 health topics that deserve a rigorous comparison of options to determine which are best.
The recommendations, part of a larger report that lays out a blueprint for research, are organized by quartile, and the top 25 would be the ones with a bullet, to stretch the pop music analogy.
Some of the high priorities:
- What are the best strategies to reduce infections spread in health-care settings?
- What’s the best way to use expensive biotech drugs – like Remicade, Enbrel and Humira – to treat inflammatory diseases, such as rheumatoid arthritis?
- How should dental care be delivered to children to most effectively prevent cavities?
Comparing effectiveness is suddenly an idea whose time has come. “Health care decisions too often are a matter of guesswork, because we lack good evidence to inform them,” said Harold C. Sox, editor of The Annals of Internal Medicine, and panel co-chairman, according to The New York Times.
In legislation to boost the economy, Congress set aside more than $1 billion to fund comparisons that would pick health winners and losers. It was the IOM’s job to come up with recommendations on where to start.
For a little peek into how the priorities were chosen, Consumer Reports‘ Health Blog has a Q&A with Consumer Union President Jim Guest, who was a member of the Federal Coordinating Council for Comparative Effectiveness Research that came up with the recommendations.
The New England Journal of Medicine weighed in with a “Perspective” piece on implications of the report. For more about comparative effectiveness, see this piece from AHCJ board member Andrew Holtz, M.P.H.
When it comes to acute liver damage, acetaminophen, the painkilling ingredient in Tylenol, is a bigger hazard than alcohol.
Some 56,000 Americans end up in the ER each year as a result of the drug, a ubiquitous ingredient in over-the-counter cough and cold remedies and also one half of the most prescribed medicine in the United States – hydrocodone-APAP.
So the Food and Drug Administration, which has ratcheted up warnings about acetaminophen’s risk in recent years, is holding a two-day meeting seeking advice on what to do next.
For consumers, a big part of the problem is that taking even a little more than the highest recommended daily dose (4 grams for adults) can lead to serious liver damage.
About half the nearly 500 annual cases of liver failure linked to acetaminophen are accidental. It’s easy to overlook the total dose of acetaminophen when taking a pain pill and a combination medicine, for instance.
One option would be a ban on combination drugs, like Theraflu and NyQuil. Makers of over-the-counter drugs say prescription-strength medicines containing acetaminophen account for most of the problems.
The outcome of the meeting will be “an important first test of the FDA’s new power to impose risk evaluation and mitigation strategies on manufacturers of widely used drugs that pose a small but distinct public health threat when misused or abused,” writes FDA-watcher Merrill Goozner on the blog GoozNews.
Sometimes it takes a celebrity to draw attention to something we should have noticed long ago. Though the exact cause of pop icon Michael Jackson’s death remains undetermined, reports of his heavy use of prescription medicines remain at the center of attention.
Cardiologist and blogger Westby Fisher draws a lesson from the Jackson case and his own experience closer to home. “We have become a pill culture,” he writes, gobbling medicines “with barely a thought about their side effects.” That’s a mistake.
Fisher got to thinking about the commonplace but risky combinations of drugs many Americans consume after watching his mother-in-law casually count out a mountain of daily meds then swallow them “like a pelican downing an oversized fish.”
Doctors can be as “pill-obsessed” as patients, he writes, and too often turn to a prescription as a “quick fix” without considering the alternatives – or consequences. At the hospital where Fisher works, he’s noticed more and more side effects – especially abnormal heart rhythms – in patients taking multiple drugs.
Fisher urges patients to disclose all the medicines they’re taking to their doctors. Physicians, for their part, should be more careful when prescribing drugs to patients already on oodles of them.