Thursday, June 18, 2009
ADHD drug study swerves way off course
Recently, parents of children with ADHD were subjected to some alarming headlines warning of a possible association between the use of stimulant medications for the disorder and sudden cardiac death.
The study, published in the American Journal of Psychiatry, seemed to carry some weight and even prompted a communication from the FDA (who provided funding, along with the National Institute of Mental Health), but pay close attention to the study's many limitations. Consider the unusual design of the study: researchers compared two groups of healthy children using stimulant medications. Half died suddenly in car accidents while the other half died suddenly from other causes. Because fewer kids in the car accident group died than in the other causes group (10 vs. 2), while taking the drugs, researchers surmised that there may be an association betwen the drugs and sudden death in healthy children. Huh?
And how did the researchers determine whether the deceased children were taking stimulants at time of death? They simply asked the grief-stricken parents, often years after the fact -- that's one of the "limitations" mentioned by the FDA. Another is the very real possibility that a child's death from unexplained causes prompted an autopsy investigating medication use. According tothe FDA, "the low frequency of stimulant use in both groups, as well as possible differences in the type of post-mortem inquiry, could have a profound biasing effect on the results." No kidding.
It's bewildering as to how this study even got funded. With so many problems with the methodology and possibilities for biases, the only effect of publicizing the results appears to be stirring up needless panic in the many parents whose children are being treated for ADHD.
posted by Janet Colwell at
1:48 PM
2 Comments
Thursday, March 5, 2009
Let them eat drugs: An update
An official tip of the hat today to the CDC.
Back in January, we wrote about how grocery store pharmacies were handing out free generic antibiotics....and how this might not be such a great way to curb the spread of antibiotic resistance.
Today, the New York Times reports that the CDC has sent letters to these places, asking them to dole out their medi-candy carefully. Of particular concern, says the article, is the fact that the stores are linking the drug giveaways to cold and flu season, thus intimating that antibiotics can cure these viral conditions. So the CDC basically said "Hey. Cut it out."
True, the CDC took a couple months to get around to doing this. And cold and flu season is already winding down. But if this had been in the hands of certain other three-lettered government agencies, it might not have happened till next Halloween.
Labels: antibiotics, CDC, FDA
posted by Jessica Berthold at
5:14 PM
2 Comments
Tuesday, February 3, 2009
Redefining "organic"
Organic: Characteristic of, pertaining to, or derived from living organisms.
--Random House Dictionary, 2006
Every day when I come to work, my email inbox is flooded with more product recalls from the FDA, thanks to those darn salmonella-tainted peanuts. The vast number of products supplied by the Peanut Corp of America plant amazes me: they range from store-brand ice cream to high-end "organic" protein bars.
Huh. I never realized the "organic" label referred to animal feces. Though I suppose that is just about as organic as it gets.
Labels: FDA, peanuts, salmonella
posted by Jessica Berthold at
10:38 AM
0 Comments
Tuesday, January 27, 2009
A company that makes Enron look good
I just listened to an FDA/CDC conference call about the salmonella outbreak. It turns out that Peanut Corporation of America, the company which supplied the tainted peanut butter and paste, detected salmonella in its own plant twelve times in 2007 and 2008 ...and shipped out its product anyway. Then the company failed to take mitigating steps to make sure it didn't happen again.
Whoever was in charge of that little operation should be glad he or she doesn't live in China.
CDC/FDA also said to expect more recalls as they continue to link the supplier to various products (A big job: FDA said it has already visited nearly 1,000 firms which got supplies from PCA). The illness toll to date: 501 sick, 108 hospitalized, and 8 dead. Twenty-one percent of the sick cases were in kids age five and under.
Full report from the investigation on FDA's Web site tomorrow.
Labels: FDA, peanut butter, salmonella
posted by Jessica Berthold at
4:30 PM
0 Comments
Tuesday, December 9, 2008
Wrong agency, buddy
It seems the FDA knows it's got enough on its plate. Yesterday the agency decided not to get into the business of approving firearms, the AP reports.
A New Jersey man tried to get approval for an easy-to-use "Palm Pistol" for folks with disabling conditions who might find it hard to pull a trigger. He registered the palm-sized gun-- which discharges at the press of a button-- with the FDA as a medical device last week, the AP said.
The FDA wisely pulled the plug on the idea yesterday, which the inventor reportedly chalked up to "political pressure" (and not the fact that guns are nowhere near an "F" or a "D").
Labels: FDA
posted by Jessica Berthold at
3:59 PM
0 Comments
Monday, August 4, 2008
FDA's new conflict-of-interest guidelines
Seems like everyone is getting on the conflict-of-interest bandwagon when it comes to drug companies.
New FDA guidelines prohibit the experts who advise during committee meetings to participate if they, their spouse or minor child have more than $50K financial interest in the companies that will be affected by their actions at the meeting.
Below $50K, the expert may get a waiver by the FDA to participate, but only if his or her input is deemed essential. The number of waivers given will be limited, and FDA will post on its Web site, in advance of the meeting, the reasons for each waiver.
Other changes:
-Advisory committee members must now vote all at once, insted of one-at-a-time. the aim is to avoid "momentum" that could sway people to vote in line with those who preceded them.
-Votes will be immediately announced at the meeting.
-Committee member votes will be posted on the FDA Web site.
-FDA will post the background materials it gives to committee members on its Web site at least 48 hours before the meeting starts.
What do you think of these guidelines? Is $50K a reasonable cutoff? How difficult is it to find experts who have little or no financial interest-- as from consulting or speaking fees-- in these companies? Do the voting and waiver rules go far enough to ensure transparency?
Labels: conflict-of-interest, drug companies, FDA
posted by Jessica Berthold at
5:00 PM
0 Comments
Friday, May 30, 2008
Get drug alerts, warnings and recalls fast
More than 100,000 doctors have registered to receive emails about safety alerts and drug recalls. Are you one of them?
The service is provided for free by the nonprofit iHealth Alliance, and you can sign up here.
The alerts are tailored to your specialty, and are limited mostly to the "Dear Doctor" letters that drug manufacturers send out about label changes, recalls and warnings.
According to the Wall Street Journal:
"After receiving email notifications, doctors will get updates by going to a Web site called the Health Care Notification Network, which will archive alerts for a year, and will record that the doctors have gone to the site to see the notices. The network will provide suggested language that doctors can forward to their patients....The network may also be used to send doctors information on major public-health emergencies or bioterrorism alerts. "
If you haven't already, you can also sign up for the FDA's MedWatch safety alert and recall emails. It's always good to cover your bases.
Also, your patients can be sent alerts about drugs they are taking by setting up an online personal-health record here.
posted by Jessica Berthold at
2:59 PM
0 Comments
ACP Internist hosted Grand Rounds on June 16, wrapping up the best of the medical blogosphere. Click here for the complete wrap-up.
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