Tag Archives: food and drug administration

Propofol abuse a concern in medical profession

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Alicia Mundy of The Wall Street Journal reports that abuse of the common anesthetic propofol has become a problem the medical profession, where the drug is plentiful and easy to access. The powerful, fast-acting drug enters the bloodstream quickly and makes the user unconscious.

Mundy does note that “The number of people with a propofol problem is small, and there is little data tracking addictions or death.”

The FDA is considering whether to classify propofol as a controlled substance, which professionals say might be problematic because the sedative, which is suspected to have contributed to Michael Jackson’s death, needs to be readily available during emergencies. If it were to become a controlled substance, hospitals would have to “track inventory, account for all vials, list users, and lock it up with narcotics.”

Mundy cites another concern: “Tighter regulation might impede doctors and nurses from seeking help for addiction, because abusing a DEA-controlled drug is more likely to cost them their licenses and lead to criminal charges.”

Hensley: New FDA chief looks to be tough

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

According to NPR Health Blog’s Scott Hensley, newly confirmed FDA Commissioner Margaret Hamburg sounds like she means business.hamburg-speech

Hamburg vowed to speed things up around FDA headquarters, calling the agency’s processing times for some routine tasks “unacceptable.” She also proposed a new system of publishing “close-out letters” on the FDA Web site when companies resolve a problem about which they had been formally warned by the FDA, presumably in the hopes that violators with clean up their act faster with the added motivation of a publicized clean bill of health.

AHCJ speaker writes about physiology of eating

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The New York Times‘s Tara Parker-Pope reviewed former FDA chief Dr. David Kessler’s new book, The End of Overeating: Taking Control of the Insatiable American Appetite. In it, Kessler seems to paint Americans as victims of a carefully calibrated gustatory assault, explaining that the food industry has perfected the art of creating food that “taps into our brain circuitry and stimulates our desire for more.” Though he did not write a diet book, Parker-Pope says, Kessler does try to help folks enter “food rehab,” where they can use their new awareness of food science to “take back control of our eating habits.”

Kessler will be a spotlight speaker at AHCJ’s Aging in the 21st Century Workshop, set for Oct. 16 and 17 in Miami. Tapping into the expertise and understanding of human psychology and physiology he showed in his book, Kessler will discuss nutrition and aging at the workshop.

Wrestling with the FDA recall e-mail avalanche

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

NPR’s April Fulton recently blogged about a phenomenon familiar to anyone with a subscription to the FDA’s recall e-mail list, or their RSS feed, or their Twitter account: a late rush of random recall messages that would require a prohibitive amount of time to sort and research. fda-recallsFor example, in a two-minute span on June 15, @FDArecalls on Twitter buzzed with messages about multivitamin labels, fish, organic chocolate peanuts, white peppers and soy sprouts. Fulton also notes that many of the notices come out late in the day.

She proposes some sort of flagging or rating system to make it easier to figure out which stories are big deals and which aren’t. She may be on to something. The FDA could make these releases more accessible and useful for journalists and consumers. At the very least, it should be possible to explain the location and magnitude of the public health danger in a way that could be understood at a glance.

What other tips or tricks help you figure out which recalls are relevant to your readers? Do you have suggestions as to how the FDA could makes its releases more accessible or useful? Let us know.

FDA dropped ball on sketchy syringes

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

According to a report by Christina Jewett of ProPublica and Deborah L. Shelton of the Chicago Tribune, the U.S. Food and Drug Administration — understaffed, overworked and increasingly reliant upon the cooperation and assistance of the industries it’s expected to oversee — allowed a North Carolina plant to ship tainted syringes which have “been linked to at least 4 deaths and 162 illnesses nationwide.”

The reporters chronicle the, the series of FDA internal safeguards that failed to catch the syringes before they were shipped.

  • In October 2007, an inspector visited the plant after reports of specks of debris in fluid-filled syringes. She reported that management had a plan to deal with the problem, not noting that their sterilization method was unreliable.
  • The company, AM2PAT, announced a recall a week later. This should have triggered an automatic FDA review but the overloaded agency ignores that particular fail-safe unless it judges lives to be on the line.
  • In late 2007, as folks started getting sick, the FDA finally gave the plant a detailed inspection, finding a gummy brown substance on the syringe filler and brown water coming from the taps. It was closed in January 2008, but the damage had already been done.

The reporters found the regulatory failures were the cumulative effect of overwork and an increasingly heavy reliance on industry to police itself.

For this article, Gordon Harnack, a consultant who helps medical device companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant dating to 2005. He said inspectors didn’t look deep enough, and FDA managers were too tolerant.

“Time after time, the evidence was there that [AM2PAT] management had little intent of complying with adequate FDA regulations,” Harnack said. “In 2005, [the FDA] might have caught it. In 2007, they should have caught it. And finally when reports of deaths came in, it all became evident.”

The Propublica/Tribune report exhaustively chronicles AM2PAT’s fraud and manipulation of the system, a history of deception which the FDA failed to act on until it was too late.