FDA weighs tougher warnings for acetaminophen
When it comes to acute liver damage, acetaminophen, the painkilling ingredient in Tylenol, is a bigger hazard than alcohol.
Photo by sun dazed via Flickr
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.
More pills mean more risk
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.
NY stem cell researchers can pay egg donors
The ethical thicket that is stem cell research just got a little more complex. New York became the first state to allow taxpayer-funded researchers to pay women to donate eggs specifically for stem cell experiments.
"Stripped" human oocyte; granulosa cells that had surrounded this oocyte have been removed. Courtesy: RWJMS IVF Laboratory via Wikimedia Commons
The compensation could run as high as $10,000. Supporters argue it will spur better, quicker research results. Opponents say paying for eggs crosses an ethical line.
The state board that made the new policy says it’s just like compensating women for donating eggs for reproductive purposes. But the National Academy of Sciences doesn’t see it that way, saying in its guidelines for stem cell research that payment to donors for eggs is a no-no.
Some scientists in the field say the main source now — eggs left over from in vitro fertilization procedures — hasn’t been adequate. (New York won’t pay for those eggs under the new policy anyway.)
Scientists outside New York are already envious. Harvard stem cell researcher George Q. Daley, told The New York Times, the payment policy “will mean a tremendous advantage” for labs in New York.
Health insurance exec becomes hostile witness
You know your industry is in a real jam with Congress when the nosy legislators call an ex-spinmeister to testify about how his old employers give consumers the shaft.
Enter Wendell Potter, until last year the top PR guy at Cigna, one of the nation’s largest health insurers. Potter, now an activist on health issues, testified before a Senate committee about how “a cartel of large for-profit insurers” that dominates health care deliberately confuses customers and dumps the sick and unprofitable ones. (Read his prepared testimony here.)
Wendell Potter
Photo: Center for Media and Democracy
Potter told the Philadelphia Inquirer, that he has no “ax to grind with Cigna.” His beef is bigger: “It’s the system. Cigna is part of a system that is not functional, that does not serve the needs of the American people.”
If you’re interested in Potter’s conversion to insurance critic, check out his blog, where he describes his “road to Damascus,” a stretch of highway in rural Virginia. A few years back, he saw hundreds of people flocking there for free medical and dental care from a group that got its start aiding remote villages in South America.
Cigna disputed Potter’s charges, saying in a statement to The Wall Street Journal Health Blog, “…we strongly disagree with the suggestion that, motivated by profits, the insurance industry has deliberately attempted to confuse or unfairly treat covered individuals.”
Trudy Lieberman, president of AHCJ’s board of directors, interviewed Potter for her “Excluded Voices” series in the Columbia Journalism Review. The interview provides a window into how insurance companies control the message and what questions reporters should ask, but don’t. Potter make some predictions about how insurers will react as health reform moves forward and how they will mount “duplicitous PR campaigns.”
Memphis hospital confirms liver transplant for Jobs
Apple CEO Steve Jobs still isn’t talking about his health. But a Tennessee hospital confirmed a Wall Street Journal scoop over the weekend that said the secretive exec had a liver transplant.
Jobs has been ill and took a leave from the company early this year. But his statements, and those of the company, have been vague – at best. The front-page Journal story saying he’d had a liver transplant was nearly as vague, lacking attribution for the claim.
Well, Methodist Hospital of Memphis, with Jobs’ permission, has ended the speculation on the veracity of the transplant report. In a statement, the hospital said he got a new liver because he was “the sickest patient on the waiting list at the time a donor organ became available.” Tennessee has shorter waiting times than most states.
Jobs’ outlook is good, the hospital said. Wonder what Apple and Jobs have to say on that score?
It’s especially curious that Methodist, operating under patient privacy rules, was more inclined to get the news out than Apple, a publicly traded company obligated by securities regulations to disclose material information.
There’s plenty of wiggle room in those regs. Still, as Columbia University law prof John Coffee tells Business Week, “Apple is probably an extreme example where the CEO’s health is very material. Walt Disney in 1950 would have been an equivalent.”
Update: A Reuters reporter spotted Jobs at the Apple campus on Monday, adding to speculation that the CEO may have returned to work.
Earlier: Jobs’ letter too vague for meaningful reporting
An ounce of prevention will cost you
Prevention is no panacea. If the country expects to keep people well by catching and treating disease early, better health won’t come cheap.
Stanford med school prof Abraham Verghese explains in a critique of Obama’s health plan in The Wall Street Journal. The gist: health reform won’t pay for itself.
Photo by digicla via Flickr
“Counting on the ’savings’ that will come as a result of investing in preventive care and investing in the electronic medical record among other things,” he writes, is “a dangerous and probably an incorrect projection.”
Sure, losing weight and exercising more don’t cost much. But Verghese says screening, testing and treating patients early is expensive. “Prevention is a good thing to do,” he says, “but why equate it with saving money when it won’t?”
The bottom line, Verghese writes, is that fundamental reform and an expansion of coverage can’t happen without cutting costs. That means drug prices, doctors’ fees and hospital charges are all in line to get whacked.
Related
In the Columbia Journalism Review, Trudy Lieberman, president of AHCJ’s board of directors, interviewed Rutgers researcher Louise Russell about the potential for preventive care to curb health care costs. Russell (bio page) said that, in many cases, preventive care may actually add to overall health care costs because, for such care to be effective, it needs to be employed on a large scale.
Russell says studies that claim savings based on prevention are not only calculating medical expense, but also figuring in potential future earnings of those whose lives are saved by prevention. She also encourages a stronger focus on more cost-effective preventive measures, like flu shots, over more expensive options like annual pap smears.
In the final third of the interview, Russell specifically addresses reporting on preventive care and provides guidance and recommendations.
Consumer group challenges selenium claim
It’s put up or shut up time for Bayer Healthcare. The Center for Science in the Public Interest is threatening to sue the maker of One-A-Day multivitamins if the company doesn’t cease claiming that selenium, a mineral in the pills, may cut men’s risk of prostate cancer.
Researchers halted a federally funded study of selenium’s ability to protect against prostate cancer last year when the mineral showed no effect and some men taking it developed diabetes.
Yet Bayer claims in ads, including this Web site for its Men’s Health Formula multivitamin, that “emerging research suggests Selenium may reduce the risk of prostate cancer.” Indeed, CPSI also asked the Federal Trade Commission to require Bayer to run corrective ads, given the impression made by at least 11 television ads and nine radio ads touting prostate protection.
A Bayer spokeswoman told the Associated Press that the company stands “behind all claims made in support of our products.”
Tough talk and rough road for health reform
Filed under: Health care reform, Hot Health Headline
Speechmaking has given way to lawmaking. Now that the complex task of making health reform real is under way, it’s shaping up as a pretty tough slog.
The Senate Health Committee began its public deliberations over a draft bill with some testy sparring between Republicans and Democrats. Pick your winner in the soundbite battle over the legislation.
In the Republican corner, Sen. Judd Gregg of New Hampshire: “I don’t know who wrote it, but if it had been Rube Goldberg, Ira Magaziner, and Karl Marx you might have gotten this product.”
Counterpunching for the Democrats, Sen. Barbara Mikulski of Maryland: “Our current system is a combination of Adam Smith, Darth Vader, and ‘Invasion of the Body Snatchers’ .”
A sobering financial challenge lies behind the sniping – cost estimates have ballooned to $1.6 trillion. Democrats “privately acknowledged” to the Washington Post that finding a way to pay for an expansion of health coverage without blowing up the federal budget “is proving excruciatingly difficult.”
Indeed, the powerful Senate Finance Committee postponed the release of its draft amid worries about cost and a push for at least a little bipartisan support. “We’re not there yet,” said Chairman Max Baucus (D.-Mont.), The Wall Street Journal reported.
VA hospitals faulted for lax infection control
The Veterans Affairs health system may be a model for electronic medical records and savvy drug purchasing, but all bets are off when it comes to the disinfection of equipment for colonoscopies.
After reports of problems piled up, the VA inspector general did some surprise inspections at the government-run hospitals and found they weren’t doing a good enough job sterilizing endoscopes. Yesterday, congressmen blasted the VA for not fixing the problems even after it became aware of them.
“The failure of medical facilities to comply on such a large scale with repeated alerts and
directives suggests fundamental defects in organizational structure,” said the report by the VA OIG. Inadequate cleaning of the equipment may have exposed more than 10,000 vets to hepatitis B, hepatitis C or HIV.
In all, more than 40 facilities got the once-over by investigators, including three which have been “the subject of considerable media attention.” Those are the Bruce W. Carter VAMC in Miami, the Tennessee Valley Healthcare System-Murfreesboro campus, and the Charlie Norwood VA Medical Center in Augusta, Ga.
The Tennessean has a handy chronology of the colonoscopy controversy and a recent story with reactions from affected patients. “There’s nothing they can say,” said Thomas Mayo, a 58-year-old Vietnam vet who learned in February that he has hepatitis C. “They’ve given me something that may kill me.”
For more, see testimony by the VA in this Associated Press video.
Where’s the money for health reform?
If there ever was a time to remind health journalists to follow the money, it’s now.
President Obama is back in campaign mode, barnstorming the country to win support for health-care reform. The details and fate of the overhaul remain uncertain, but it’s clear any steps toward universal coverage will mean big bucks — at least $1 trillion over 10 years.
How to pay the bill without increasing the federal deficit, as Obama has pledged? A combination of tax hikes and cost cuts.
Team Obama is already planning for reductions in payments to hospitals, private insurers and drugmakers. For more details, see the video below and the White House blog’s post on Obama’s weekly radio address.
But the real action is looming over how to get more cash into the health system. A federal tax on employer-sponsored health benefits, opposed by Obama during his run for president, is under serious consideration in the Senate, the Washington Post reports.
That approach, supported by some economists as a way to manage health costs, could be political suicide. “Taxing benefits would be a disaster,” Democratic pollster Celinda Lake tells the Post. “You have no idea how strongly this is going to backfire if we do it.”
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