QDIS Blog

The AP had a nice report this week related to food safety and the FDA.

FDA cuts food inspections by half

They report that over the last three years, food safety inspections have dropped in half! Here are some other startling facts from their investigation:

- There are 12 percent fewer FDA employees in field offices who concentrate on food issues.
- Safety tests for U.S.-produced food have dropped nearly 75 percent, from 9,748 in 2003 to 2,455 last year, according to the agency’s own statistics.

After Sept 11, 2001 the FDA urged increasing food inspection and that did indeed happen and peaked in 2003 but have fallen back and erased those gains.

I have stated before that given the number of high profile cases in the last year, there will be increased scrutiny in this area, especially from Congress. I would not at all be surprised by a hearing on this sometime before the summer. The problem is, there are many other areas of higher priority now such as the war in Iraq.

The budget for next year does include modest gains for food safety of $10.6 million, but most critics agree this is only a very small portion of what is really needed to do their job properly. Some claim that as much as ten times that amount would be necessary.

The FDA Commissioner had his to say.

“We’re applying resources to targeted areas. So in a way, it’s not a matter of ‘Are you inspecting one out of 100 or 10 out of 100?’ The real issue is if you can define risk. Are you applying the 10 inspectors to the 10 areas of concern? Then it’s essentially you’re covering 100 percent of your problem, which is not covering 100 percent of the universe,” FDA commissioner Dr. Andrew von Eschenbach said.

While this is a good goal and I am a advocate of risk based assessment, it ignores the fact that some risks exist that we do not know about. In the case of the lettuce e.coli problems it may be that a feral pig defecated in the field and that was the source of the contamination. I doubt anyone would have had that on their list of criteria for risk assessment.

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Seems they knew what they was doing when Shire purchased New River Pharmaceuticals. Now, the FDA has approved Vyvanse for treatment of Attention Deficit Hyperactivity Disorder (ADHD).

FDA approves Shire’s ADHD drug Vyvanse - Yahoo! News:

Here’s the Shire press release. This is big for them and for anyone suffering from ADHD. This drug seems to be better tolerated and longer lasting than other stimulates used to treat this disorder.

Other Resources

lisdexamfetamine dimesylate - Yahoo! Search Results
lisdexamfetamine dimesylate - Google Search
Google Blog Search: lisdexamfetamine dimesylate

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I’ve been meaning to comment on this article for quite some time. The LA Times is reporting that a virus may be responsible for Mad Cow disease (aka bovine spongiform encephalopathy or BSE).

Virus may be the cause of mad cow - Los Angeles Times:

For a long time, scientists have thought prions, misshaped proteins were the cause but according to these new results from Lead author Dr. Laura Manuelidis of Yale University, the prions occur late in the development of the disease in mice. It remains to be proven that these isolated virus particles cause the disease but work is underway to prove just that. They did stimulate the product of the prions fivefold and this did not increase the level of infection. If this does prove to be the case, it is certainly a major turn of events for Mad Cow disease. Other scientists are highly skeptical of this idea.

I personally have always had some doubts about prions being the cause but am really not an expert on the subject. A virus seems to me to be much reasonable explanation. It is curious is to why no one had seen these sorts of particles in previous research. It will be interesting to see if they can prove that these viruses actually cause the disease.

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With all of these new reports of problems with food safety, I think it is now inevitable that some sort of major reform will occur in the 110th Congress. This time it is not only the FDA but also the USDA since the latest report is of chicken. I’m not sure what will come out of this but there will certainly be changes proposed. My bet is the proposed solution will be to move all the food related problems to a new agency combining the F part of FDA and the USDA as well as maybe parts of CDC. I’m not sure where I come down on that. Until now, I didn’t think the creation f a new agency was needed but I am willing to wait and see what is proposed.

Cooked Chicken Breasts Join Tainted-Food Recalls - Forbes.com

The article has the particulars but it involves Oscar Meyer/Louis Rich chicken breast with rib meat, which is fully cooker and ready to eat. The problem is bacterial contamination, Listeria monocytogenes, which can cause listeriosis, a rare but serious infection.

As the article points out this is the fourth problem within a week. The others were fresh cantaloups, organic baby food and the peanut butter.

Some jars of Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast baby food were recalled because they may be contaminated with Clostridium botulinum,, which can cause a life-threatening illness.

FDA Warns Consumers Not to Use Certain Jars of Earth’s Best: “Organic 2 Apple Peach Barley Wholesome Breakfast Baby Food”

The FDA has a web page devoted to the other major food safety problem last week related to Peter Pan brand peanut butter. This has involved more than 290 people in 39 states. At least 46 people were hospitalized. Seems the peanut butter from both Peter Pan brand and Great Value are contaminated with salmonella.

Update on Salmonella Outbreak and Peter Pan Peanut Butter

The cantaloupe info was harder to find but it is also on the FDA website.

Recall of Cantaloupes Due to Potential Health Concerns (FDA web page)

For cat owners the FDA has also warned consumers not to use certain cat foods due to possible salmonella contamination.

FDA Warns Consumers Not to Use Wild Kitty Cat Food Due to Salmonella Contamination

Other Sources

South Carolina Firm Recalls Chicken Breast Strips For Possible Listeria Contamination (USDA web page)

FDA Recalls, Market Withdrawals and Safety Alerts
FSIS Recalls (Meat, Poultry & Egg Products)

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Wow, this is a major mixup. Seems some people who order drugs over the internet got the wrong drugs! In most cases they were ordering a sleeping pill or an anti-anxiety medication and instead received the schizophrenia drug, haloperidol. Some people actually went to the ER because of complaints such as difficulty breathing, muscles spasms and stffness. It is unclear how many people were affected.

FDA Warns of Dangers of Internet Drugs - Forbes.com:

Seems these were all purchased from commercial websites and the FDA is investigating. It will be interesting to see if and when the web site names come out. The shipments had Greek postmarks and came in clear plastic bags.

Here is the FDA news on the internet drug mixup. Here is the most interesting paragraph to me.

Although the involved consumers have named several Internet Web sites where the products were purchased, identifying the vendors is difficult because of the deceptive practices of many commercial outlets on the Internet. FDA is investigating this illicit trade and plans to release appropriate information when it is available.

If you do have any reports along this line use the FDA’s MedWatch Online Voluntary Reporting Form.
Technorati Tags: drug price, drug safety, FDA

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Wow, I go to a conference for a week and all kinds of things happened. Here are some of the headlines that caught my attention.

FDA

‘Accelerated Enforcement’ Now Against Unapproved Drugs: FDA will be accelerating enforcing regulations against unapproved and unregulated drugs and are having weekly meetings to discuss priorities.
Killing the Goose That Lays the Golden Drugs: An article stating that there is a need to balance drug safety with access to new therapies.
Press Release: Sanofi-Aventis Announces Update To U.S. Prescribing Information For Ketek - FierceBiotech: More on the Ketek fiasco.
PharmaLive: FDA Announces Label and Indication Changes for the Antibiotic Ketek
Sanofi shares slide as FDA delays Acomplia–again - FierceBiotech: More delays for Acomplia in the US; decision to be made by July.
FDA deny drug application from Advancis - Washington Business Journal: Another antibiotic has hit a snag; Advancis NDA is said to be incomplete and unable to be approved.
US warns Abraxis BioScience about plant problems | Health | Reuters
Abraxis Bioscience, Inc., Warning Letter: From the FDA website.

Government and Congress

GAO warns of Medicare drug overcharging - Boston.com: The GAO is worried about schemes to overcharge the US government for the Medicare Part D Prescription Benefit. The basis is that the complex set of rules makes it difficult to verify the accuracy of drug prices.
Biotech trade group warns of price controls - MarketWatch: The leader of BIO warned against the HHS being able to negotiate drug prices and calls them defacto price controls.
Democrats plan bill for generic biologics - washingtonpost.com: This could be big and I’ve posted before about biogenerics.
Generic Biotech Drugs Could Save $71B - washingtonpost.com: Another article on biogenerics and what impact it may have.
Lawmakers unveil bill to create clear pathway for generic biologic drugs
Newsvine - Texas Gov., Lawmakers in Vaccine Dispute: more about the Gardasil vaccine being required by the govenor for girls in Texas.
Pfizer’s AIDS drug to get faster review - Yahoo! Finance

Pharma News

PharmaLive: Lovenox Patent Infringement Suit Decided Against Sanofi-Aventis
PharmaLive: New Campaign Champions Changes in Medical Prescribing to End Conflicts of Interest
Bayer to file for Nexavar approval for liver cancer - Boston.com: I know folks at Onyx and am glad to see this drug proceeding so well.
Thailand threatens to produce more copycat drugs | Science | Reuters
Thailand plans to break patents on 14 drugs: firms - Yahoo! News
British pharmacy pilots over-the-counter Viagra - International Herald Tribune: Brings new meaning to the question, What’s Up? PharmaLive: Merck Settles Tax Dispute with Internal Revenue Service
Eli Lilly Regains Leaked Papers - washingtonpost.com: A judge orders papers related to Zyprexa to be returned to Eli illy.
PharmaLive: Telik Announces Corporate Restructuring: More lay-offs.
Ariad says close to cancer drug partnership deal | Health | Reuters
PharmaLive: Ranbaxy: Press Statement: Federal officals conducted a suprise search of Ranbaxy’s NJ offices.

Biofuels

Philadelphia Inquirer | 02/12/2007 | Oil firms speak up on alternative fuels: Major oil companies now want a seat at the table for discussing alternative fuels.
New theme heard at oil gathering - Los Angeles Times: Another article on big oil and their interest now in biofuels.
Big Oil says biofuels won’t meet U.S. energy demands - Feb. 15, 2007: more on the big oil views of biofuels.

Biotech

United Press International - Health Business - Seattle Genetics’ drugs get orphan status: I know people at Seattle Genetics and think they have a good business model and am glad to see these products get orphan drug status.
Wired News: Pharm Animals Crank Out Drugs: Another article on pharming, using animals to produce drugs. Covers GTC Biotherapeutics who I’ve mentioned before here and here.
Biotech posts fastest growth globally: Article on the double digit growth (35%) in India’s biotech industry.
Hawaii has more biotech bills - Pacific Business News (Honolulu): The Hawai’i state government had 44 bills before it relating to biotech in 2006.

Other
Refusing to share samples ‘may cause a vaccine delay’-News-World-Asia-TimesOnline: GSK has attacked the Indonesian government for refusing to supply bird flu samples to other companies for research to develop vaccines.
Technology Review: Discovering Drugs with Bubbles: I’ll share my views on this in a later post.
I’ll try to comment on some of these in more detail later this week if I can get some spare time.

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The FDA approved the diet drug Xenical which has only been available by prescription for over the counter distribution. The new name for the lower dose OTC version will be Alli.

FDA Approves Orlistat for Over-the-Counter Use (FDA.gov)

The following Medical News Today article has more information.

FDA Approves Over The Counter Weight Loss Pills (Medical News Today)

I have mixed feelings about this. The article makes clear that this should be used in conjunction with diet and exercise but I think too many people may view it as an easy way to loss weight without any effort on their part. I think it appears to be useful for people in conjunction with diet and exercise and I am all for helping people become healthier. Bit it also seems to play into the American obsession with losing weight without putting forth any effort on their own part. It will be very interesting to see how Roche (the makers of Alli) what kind of advertising they use to promote this drug.

This is the first time the FDA has approved an over-the-conter weight loss drug.

Other Resources
Yahoo! News Search Results for xenical FDA over the counter
xenical FD over the counter - Google News

Google Blog Search: xenical FDA over the counter
IceRocket Blog Search: xenical FDA over the counter

Technorati Tags: Ali, FDA, weight loss, Xenical

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Seems the presidents budget for fiscal 2008 will contain massive cuts in domestic programs to pay for the war in Iraq. Bloomberg is reporting the cuts will be over $78 billion over five years.

Bush Seeks $78 Billion in Health Cuts Over Five Years

This will certainly lead to some interesting discussions in the Democratic controlled congress. Take a look at the article to see what programs will potentially be affected.

Technorati Tags: healthcare

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I found this report from the BBC to be interesting and an example of what I call thinking outside the box. By that I mean approaching a problem from a different perspective than normal.

BBC NEWS | UK | England | London | Anti-MRSA silver pyjamas trialled:

It describes research being done in England with sheets and clothing )pajamas) made with silver in the them to combat methicillin-resistant staphylococcus areus (MRSA) infection. These infections are the so-called superbugs that are resistant to most common antibiotics. Usually these sorts of infections only respond to Vancomycin and if strains develop a resistance to that and then become prevalent, the world could be back to the equivalent time when all we had were sulfa drugs to treat infections.

This approach is interesting since it . It is known that silver can be an effective anti-microbial and if this proves effect could be a wonderful way to prevent infections in hospitals.

I can say that I know first hand how devastating these infections can be as my wife developed a life threatening MRSA infection last summer and was in intensive care for about a week followed by another week in a regular hospital room and eight more weeks of daily IV Vancomycin therapy after that!! THese infections can come on very quickly and are very serious.

I will definitely keep an eye on this and am interested to see if it works. It certainly is a new way of thinking about preventing hospital infections.

Technorati Tags: MRSA, superbugs, silver cloth

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As long time readers know, I’ve posted quite a bit about flu pandemics and now the Center for Disease Control (CDC) today issued a guide for communities on preparing for a flu pandemic. The Washington Post had a story on it.

CDC Issues Guide on How to Fight Flu Pandemic - washingtonpost.com

The emphasis is on dealing with situations before a vaccine or drug is available. They call it “non-pharmaceutical interventions”. The Post article does point out that one of the areas that is not addressed is the use of face masks. These were extremely popular in Asian countries during the SARS outbreak a year or so ago. It seems the CDC is still evaluating that doing their own research as well as looking at historic data. I’m sure that as soon as they complete their evaluation they will release their recommendations.

Here is the actual pdf (106 pages).

Community Strategy for Pandemic Influenza Mitigation (PDF - 2.51 MB)

Other Resources
PandemicFlu.gov

Technorati Tags: CDC, Center for Disease Control, flu, flu pandemic, CDC

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