QDIS Blog

Maybe it is just coincidence but we’ve now had three major outbreaks of e.coli O157:H7 since Sept 2006.

1. Bagged Spinach in western states killed 3 and sickened at least 199
2. Taco Bell on East Coast in NY, NJ, and PA from green onions/scallions: 62 sick, 49 hospitalized
3. John’s Taco in Iowa 14 hospital, 36 sickened and this is still developing

Here are the FDA press releases on the first two incidents:

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach–Update October 4, 2006
FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach–Update October 12, 2006
FDA Investigating E. Coli O157 Infections Associated with Taco Bell Restaurants in Northeast
UPDATE: FDA Investigates E. Coli O157 Cases Associated with Taco Bell Restaurants

The most recent is from a Taco Johns (not associated with Taco Bell) in Iowa and the source of the problem has not yet been identified. I would not surprise me though if it ends up being green onions also and maybe from the same source.

14 hospitalized after dining at Iowa restaurant; E. coli suspected - CNN.com

This brings the total to almost 200 sickened and more than 63 hospitalized in the past four months due to e. coli. The CDC states that 61 deaths occur each year due to e coli. I think just about anyone would come to the conclusion that there is likely a problem and some changes need to happen.

I should point out that e. coli is found in the human gut and is normally present and does not normally cause problems. However, this particular strain O157:H7 is particularly virulent and affects people but the worst effects are seen mainly in the elderly or the young. This strain comes primarily from cattle and is found in cattle feces. This can get into water supplies and if that water is used for irrigation, it can lead to contamination. Another problem is that bacteria can form biofilms which are practically impossible to wash off.

There are estimates that tens of thousands of people are sickened each year due to food based illness but the problem is very much under estimated mainly due to sickness not being reported.

The authority for foods can be broken down into meat and poultry which is inspected by the US Dept. of Agriculture (USDA) and other foods which fall into the jurisdiction of the Food and Drug Administration (FDA). A major problem is that the FDA not set up to do field testing and monitoring.like the USDA does with meats. For example, the USDA has 7,000 inspectors inspecting 6,000 plants daily whereas the FDA has only 800 for food. Inspections of food processing plants which fall within the FDA’s jurisdiction are inspected only about once every five years!

While I’m focusing on e coli here, but there are other concerns such as salmonela, hepatitis and other food-borne illnesses.

All of this has lead to the call for a new agency. I’m not sure if that is a good idea, but I do think increasing the cooperation between the food and meat/poultry inspectors would be useful. I think again that the problem is not that the FDA does not understand its mission but that they are not funded adequately to do the functions they have been assigned.

Calls for new agency
Chemical & Engineering News: Government & Policy - Food Safety System
ScienceDaily: Calls For A New Food Safety Regulatory Agency Follow Spinach Tragedy

Here is a quote from the Chemical & Engineering News article that supports my position.

According to Michael R. Taylor, an epidemiologist at the University of Maryland School of Medicine, the primary missing element is resources. FDA does not have the resources to do inspections and set up testing systems, nor does it have a mandate “to drive primary prevention at the point of production,” he says. Another problem, he says, is no one—not the head of CDC, FDA, or USDA or California officials—is in charge of preventing the next outbreak of E. coli in spinach or lettuce. When it comes to food, Taylor says, “all play a role, but no one is in charge, and no one fairly can be held accountable.”

If food safety is an issue, then the FDA should be funded adequately in order to bring this expectation into reality.

I would point out though that there other daily risks that are much more hazardous such as driving your car or even death from the flu. However, this does not mean that steps should not be taken to minimize the risks regarding foods.

Other Resources

E. coli infection, disease information, NCID, CDC

Disease Listing, Escherichia coli O157:H7, Gen Info | CDC Bacterial, Mycotic Diseases

The Cincinnati Post - Death by dining: excellent article

US FDA/CFSAN - Nationwide E. Coli O157:H7 Outbreak: Questions and Answers (last updated Oct 20, 2006) only reall covers the spinach incident.
CFSAN Video Library: Dr. X and the Quest for Food Safety (Real Media and Windows Media files)

Recent Science Friday programs on food safety
September 22, 2006, Hour Two: Tracking Food Safety / Solar Energy
November 24, 2006, Hour One: Food

Do our fears add up? - Town Online: good article on everyday risks.

Technorati Tags: e coli, FDA, food safety

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I have had some thought on the situation of drugs being sold over the counter and prescription drugs. I couple of years ago I was taking Claritin for my allergies and it worked well. When it went OTC, it ended up costing me more because my insurance co-pay was less than the cost of the drug as an over-the-counter product. In my case, I switched to Flonase (and eventually its generic equivalent) sinc my doctor thought it was better to treat my symptoms locally with a nasal spray rather than systemically with pills. I know of other people who switched from Claritin to either Zyrtec or Allegra since these were covered by their insurance.

The problem of cost is made difficult because in many cases, it is cheaper for an individual with medical insurance which covers drugs to get a prescription drug rather than buying an over-the-counter medicine, even though the overall cost may be lower for the OTC product.

Drug pricing is a complex issue and one that will be only continue to grow in the coming years.

Technorati Tags: drug cost, drug price

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This stem cell article appeared in the Washington Post about a week ago and I am just now getting around to commenting on it.

Democrats Plan to Revive Stem Cell Bill - washingtonpost.com:

I really think there are other things I’d like to see at the top of congresses agenda. While I think this is important, I doubt there would be enough votes in congress to override a certain presidential veto. The president has already veto it once and there is no reason whatsoever to expect it not to happen again. However, there could be consideration beyond just getting the bill passed as is common in politics. This may be a way for Democrats to benefit from the debate and ensuing media attention after a second veto and would certainly bring the issue to the forefront for the presidential elections in 2008.

My impression is that the majority of people think there should be funding for such research. It brings to my mind the times when the church and other groups felt that cutting up human bodies to understand the various system such the the respiratory system or the circulatory system was unconscionable and an abomination. I don’t know of anyone today who would say that was wrong given the enormous impact of such knowledge on medicine today.

I truly hope stem cell research can be funded and continued in order to keep the US at the forefront for such research.

Technorati Tags: stem cells

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I always get concerned when I see drug imports touted as a way to achieve lower drug prices.

Congress seen pushing for imported drugs:

The main point brought up by the pharmaceutical industry and the FDA is safety. While I think safety is a concern, it is something that could be overcome and the proper procedures put into place to ensure safety. The safety concerns are important especially with regard to companies that set up websites that appear to be Canadian based but are really getting the “drugs” from questionable sources.

The more important point from my perspective is that if even if a low percentage of Americans start this, there simply are not enough drugs in Canada to supply even a small percentage of the US. Also, the Canadian government has considered and are still considering a ban on sales into the US. Also, it is interesting as to how you word the question. If you ask simply about importing cheaper drugs then the majority are for it. If you change the question to be should we have price controls on drugs similar to Canada’s then the majority are not in favor. They are basically the same thing just worded differently.

Also, not all drugs from Canada are cheaper. Primarily it is the brand name drugs that are cheaper. Generic drugs in general tend to be more expensive when purchased form Canada. The US has chosen a different approach than the rest of the world with regard to generics ever since the Generic Drug Act.

The main problem is that prescription drugs are like energy, it is something you basically can not do without. With other products, the consumer can decide whether or not to purchase say a car or even how much they want to spend on a car. With energy and medicines, this isn’t the case. The choice of a generic can save money but it is not always the case that generics are available.

It is a trouble-some issue and the main point to be kept in mind is that on an international scale, the drug and biotech industry are not a free market. In most of the rest of the world, the government is the sole purchaser and the companies must negotiate with the governments. This basically means that the US subsidizes drug costs for the rest of the world.

Technorati Tags: drug cost, drug imports, FDA

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I finally got around to watching the latest episode (Nov 21, 2006) and found segment on the 1918 flu pandemic and the bird flu to be very informative for the average person. It does a great job of describing many of the issues in a way that everyone can comprehend. You can watch the segment at the link below. THe file is in Quicktime, Real Video and Microsoft Media formats.

NOVA | scienceNOW | 1918 Flu | PBS:

I highly recommend it and think just about everyone in the general public will find it informative.

Technorati Tags: avian flu, bird flu, sciencenow

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Tamiflu is back in the news.

FDA Posts New Tamiflu Warning

WLBZ2.com - Prescription Flu Drug Can Trigger Bizarre Behavior

Tamiflu (oseltamivir phosphate) Information page (FDA page)

IMPORTANT PRESCRIBING INFORMATION (pdf)

There are reports that use of Tamiflu MAY, and I emphasize MAY, be associated with some side effects such as delirium. There have been 103 reports with 95 of those came from Japan, 3 from the US and 6 from other countries. It should be noted this is primarily in Japan and it is well known that the Japanese population can have some difference in how they respond to drugs that differ from other ethnic groups or geographic areas.

One of the problems is it is almost impossible to determine if the cause is Tamiflu. It is also rare having only 105 cases out of 24.5 million prescriptions in Japan and 6.5 million in the US. So the rate for US and Japan is 98 out of 31 million or 0.00025%.

I personally think this is the media getting out of hand. I looked though many reports and very few even mention how few cases there are given the number of prescriptions that have been filled. Remember that it is the odd or bizarre that attracts attention in the media gets written about. THe commonplace is considered boring.

Other Resources

• Yahoo! News Search Results for new tamiflu
• tamiflu - Google News

Technorati Tags: oseltamivir phosphate, Roche, Tamiflu

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As if the pharmaceutical industry needed more bad news. Seems Perrigo has recalled their 500 mg acetominophen caplets due to traces of metal in the product. Only the 500 mg caplets are affected, but that is still 11 million bottles.

Perrigo recalls 11 mln bottles of acetaminophen | News One | Reuters.com

At least Perrigo have made the announcement of the recall right on their home page. It should be pointed that no illness or injuries have resulted from this. It appears the metal came from a tabletting machine that the company noted was wearing prematurely.

The FDA has issued a statement on the matter and here is the list of recalled lots from the FDA website as well a list of places where the product is sold.

Technorati Tags: acetominophen, FDA, Perrigo, recall

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This is old news by now but I did want to post about it. Chinese scientists are believed to have located a gene in the H5N1 virus that makes it virulent in poultry.

Chinese scientists identify deadly gene in H5N1 - Yahoo! News:

They achieved this by analyzing the difference in two strains, one which caused the disease and another which is harmless. These differences were contained in four genes. They then designed four genetically modified viruses and discovered that only one of these modified viruses caused death in birds. This gene is called NS1.

This should allow for production of better, more efficient vaccines since it is now know what gene to target.

Technorati Tags: avian flu, bird flu

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I recent report from the Harvard Medical School and the National Institute on Aging shows that resveratrol found in red wine can keep fat mice healthy.

Wine extract keeps fat mice healthy - Yahoo! News

Resveratrol is chemically known as 5-[(E)-2-(4-hydroxyphenyl)-ethenyl]benzene-1,3-diol [501-36-0] and the structure is shown below.

It is found mainly in the skins of red grapes as well as peanuts and berries such as blueberries, and cranberries.

The report states that although the mice are fat, their internal organs looked fine and they did not appear to suffer abnormal effects normally associated with obesity. death was down 31% from a control group. It is way too early though to make any conclusions for humans and the does to see this effect were quite high. A person would have to drink ~100 bottles of red wine per day to get the levels of resveratrol they used in these animal studies.. At least Sirtris Pharmaceuticals will be doing trials and intend to file a drug application through the FDA.

It should be pointed out that resveratol is also sold as a non-regulated supplements but that little safety studies have been performed on it to date.

Other Resources

• Therapeutic potential of resveratrol: the in vivo evidence : Nature Reviews Drug Discovery
• A methoxy derivative of resveratrol analogue selectively induced activation of the mitochondrial apoptotic pathway in transformed fibroblasts
• Redistribution of CD95, DR4 and DR5 in rafts accounts for the synergistic toxicity of resveratrol and death receptor ligands in colon carcinoma cells
• resveratrol information from Linus Pauling Institute at Oregon State University (great source of information)

• resveratrol - Yahoo! Search Results
• resveratrol - Google Search

• Resveratrol (from quackwatch.org; lots of references)
• Resveratrol - Wikipedia, the free encyclopedia

Technorati Tags: resveratrol

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The World Health Organization (WHO) has issued a report critical of the Chinese government for not cooperating on the issue of bird flu.

WHO blasts Chinese gov’t on bird flu - Yahoo! News

The Chinese government evidently did not share information and samples of a new strain of the bird flu. It seems this strain has been spreading in poultry and some humans in China for about a year. It wasn’t until it spread to Hong Kong, Malaysia, Laos and Thailand that is was brought to WHO’s attention.

While I understand the possible reasons for the Chinese government not wanting to make this sort of information available, the fact that viruses don’t respect artificial country boundaries makes it the world’s problem. The same thing happen with SARS. I’m not sure how to convince a country to be more forthcoming with this sort of information.

Convincing the Chinese it is in everyone’s best interest to be forthcoming is a challenge. They don’t want to look weak or like they can’t handle the situation but then the rest of the world can’t wait until they situation is so bad that they can no longer keep a lid on the situation. For now, I think the only thing that can be done is to have an active surveillance program in adjacent countries to see when it appears there. It may not give as much advance notice as desired but it appears to be the only viable option it this time.

Technorati Tags: avian flu, bird flu, World Health Organization

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