Tampilkan postingan dengan label FDA. Tampilkan semua postingan
Tampilkan postingan dengan label FDA. Tampilkan semua postingan

Minggu, 05 Juni 2011

Were bean sprouts the vehicle for E. coli O104:H4?

Some new developments today in the enormous enterohemorrhagic E. coli (EHEC) outbreak in Germany, an outbreak that has sickened at least 1600, caused over 600 cases of hemolytic uremic syndrome (HUS), and killed 22 so far. Daily updates can be found at the European CDC site, here.

Eli has blogged several times about the FDA Food Safety Modernization Act, which was passed several months ago. That law will do little to protect U.S. consumers from foodborne illness, however, if the FDA is not provided sufficient funding to implement it. Perhaps they should serve a delicious bean sprout salad at the next House Appropriations subcommittee meeting--we'll find out if our representatives are confident enough in U.S. food safety systems to eat it.

Jumat, 22 April 2011

FDA Warns: OTC products caught making false MRSA claims

Today, I was off searching the interweb for news at sites not named The New York Times, when I came across this piece in the LA Times. Apparently, the FDA has issued four warning letters to companies making false claims that their products prevent MRSA infection.  These products, which include some 'natural' hand sanitizers, had little data to back up these claims.  The companies/products include:
  • Tec Laboratories for Staphaseptic First Aid Antiseptic/Pain Relieving Gel;
  • JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant;
  • Dr. G.H. Tichenor Antiseptic Co. for Dr. Tichenor’s Antiseptic Gel;
  • Oh So Clean, Inc dba CleanWell Company for CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap
My recommendation:  stick with alcohol hand rub or just plain-olde soap-n-water (TM)

Source: FDA News Release 4/20

Senin, 03 Januari 2011

80% of antibiotics given in US go to animals

Just catching up on things after my long winter nap...  Three weeks ago, FDA reported that 29 millions pounds of antibiotics were used in livestock production in the US.  How does that compare to human use?  A new estimate for human use is 7 million pounds.  Thus, almost 80% of antibiotic use is in food production.  One caveat, it appears this estimate was derived from IMS sales data for selected antibacterial drugs and I'm not sure how accurate those figures are. Early estimates were closer to 70%.

With all of the antibiotic stewardship efforts both in hospital and through education of primary care physicians and patients, you wonder how effective these efforts could possibly be?  If by magic, we could reduce antibiotic exposure in human populations by 50% that would still leave 90% of the actual antibiotic exposure burden untouched.  The funny thing is, bacteria don't care if the antibiotic they are exposed to was ingested by a human or an animal...

link: Maryn McKenna Superbug Blog

Minggu, 12 Desember 2010

Deadly Medicine

The January issue of Vanity Fair has a very interesting investigative piece entitled Deadly Medicine (free full text here) by Donald Bartlett and James Steele, which explores the globalization of the pharmaceutical industry and the effect that has had on the drug approval process. The majority of data used in the new drug approval process now comes from other countries where regulatory oversight is scant. Moreover, they describe co-opting of the FDA by industry. In some countries, doctors enrolling patients in clinical trials can earn 25-fold more money from enrolling one patient than from their monthly salary. This creates huge conflicts of interest. And then there is the exploitation of patients who may not even understand the trial they have been enrolled in and the risks they are bearing. It's a sobering and scary piece, but well worth reading.

Minggu, 21 November 2010

Listeria: Safety-based date labels, cheese and the FDA

As I've written before, I spent several years on the USDA's National Advisory Committee on Microbiological Criteria For Foods (NACMCF).  We spent several years writing scientific briefs on a variety of topics. During 2002-2004, I worked on a subcommittee looking at "Criteria for Refrigerated Shelf-life Based on Safety."  For someone who didn't spend 100% of my time on food-safety issues, I was initially surprised that the dates on foods were not at all related to safety.  Dates on that yogurt you are about to eat are based on palatability, FYI.

The document we produced and then published in 2005 in the Journal of Food Protection was predominately a Listeria control document even though we considered four psychrotrophic pathogens: L. monocytogenes, nonproteolytic C. botulinum, Y. enterocolitica, and B. cereus. The hope was that a safety-date on refrigerated foods, when combined with education about proper storage and handling of these foods, could reduce the health risk in the very young, very old, immunocompromised and pregnant women, who are at increased risk for miscarriages and stillbirths after Listeria infection.  Of course, any safety-based date label would have little impact if the food is highly contaminated during production. 

One thing I noticed serving on NACMCF was the hard work and honest efforts of the others on the committee. Even though some members worked for industry, some worked for the government and some had worked for both, they all tried hard to produce a good document. There was no evidence of some conspiracy to harm the public.  Outbreaks of foodborne illness are bad for everybody. Producers looked to government to set standards and then helped determine the best ways to meet those standards.

With that background, I was shocked to read recently in the NY Times about an artisanal cheese producer from Washington state who was defying a recall order from the FDA. Her cheeses were found to be contaminated with Listeria.  She and others are claiming that the FDA is going after the little producers - a David vs Goliath story.  Senators and others are rallying to modify the food safety bill in the Senate that I blogged about last week, in an effort to exempt these types of small producers.  They suggest that the real risk is in the big producers since they make the most foods, but I think they are making a very poor decision.  If you had the choice to buy cheese that was subject to regulation and unlikely to be contaminated or some cheese that wasn't tested for safety, which would you buy?  I agree with William Marler, a Seattle food safety lawyer, who said he just doesn't "know how they make the leap from the government trying to do the right thing for public health to ‘they’re food Nazis in the pocket of big agribusiness.’ ”

What if we had that situation in HAI prevention? What if big hospitals had to publicly report CLABSIs and follow Joint Commission standards and small hospitals got a free pass? Wouldn't that be the quickest path for bankruptcy for small hospitals? It would be hard to imagine small hospitals claiming that they only take care of a few patients so a few excess deaths don't matter, but that is exactly what the small food producers are claiming in the NY Times article.

Falsum in uno, falsum in omnibus
It seems that we currently live under a logical fallacy, where the government is evil and people claim that the government is bad at everything. Sure, government has its faults and could improve its efficiency, but when we get to a point where we are saying that small food producers shouldn't have to be regulated and thus produce safe food, we have gone too far. I would love to support local producers and serve fresh produce in my home, but I won't do it if they get a free pass on safety.  I hope they can work out a compromise where the FDA and small producers can work together.

NY Times article: Small Cheesemaker Defies F.D.A. Over Recall - November 19, 2010

Kamis, 18 November 2010

Food Safety Modernization Act

Senator Durbin (D IL)

Not hospital infection prevention, but still infection prevention.  I won't go into too much detail, but the Senate may "pass" the FSMA - S. 510 tonight - this would change how the FDA regulates what it regulates, which is to say, not all foods.  You can read Michael Pollen's take on the bill here.  From what I gather, this won't impact USDA, CDC, and NOAA's NMFS etc.  Will be interesting to see what happens and also how the 'spinmeisters' treat this.  There has been surprisingly little mentioned about this given how important food safety is.

Rabu, 04 Agustus 2010

FDA releases a "Dear ICP" letter for positive displacement needleless connectors

Similar to a "Dear Doctor" letter, the FDA just sent out a "Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors" and addressed it to "Dear Infection Control Professional." My first thought was that there are no more ICPs, so someone should alert the FDA.

On a serious note, the FDA is requiring nine companies to conduct postmarketing surveillance of positive displacement needleless connectors as they have been associated with higher CLABSI rates. However, while the FDA is not recommending changing the use of these devices, they refer people to the SHEA/IDSA HAI Prevention Compendium. Since the Compendium states to "not routinely use positive‐pressure needleless connectors with mechanical valves before a thorough assessment of risks, benefits, and education regarding proper use," it appears that FDA has taken a risk-averse stance. The studies, which are expected to take up to 3 years, have to answer the following two questions:

1) What is the rate of bloodstream infections for subjects receiving your positive displacement connector for central line access and is it statistically non-inferior to the rates seen in subjects receiving other needleless connectors (e.g. negative, neutral, or split-septum connectors) for central line access, given comparable patient populations?

2) Are there patient demographics, comorbidities/severity of illness, or device cleaning practices for which placement of your positive displacement connector for central line access increases subjects’ risk of bloodstream infections compared with other needleless connectors?

Full FDA letter is here.
SHEA/IDSA HAI Prevention Compendium
Image from Edgar K. Infect Control Hosp Epidemiol, April 2009