QDIS Blog

I have always believed in admitting when you are wrong or have made unjustified assumptions and that appears to be the case in my post about the illness at the Castleton Olive Garden in Indianapolis. I stated that it to may be related to the recent outbreaks of e. coli but now news reports are saying the prime suspect is norovirus (aka Norwalk virus). I made some assumptions that were not valid and I apologize for that.

Norovirus virus that caused problems on cruise ships a few years ago. This virus tends to be very hardy and can survive for quite some time on many different surfaces such as doorknobs and railings. The best advice for individuals is to wash heir hands frequently and thoroughly especially before eating. THis is also something restaurants should keep in mind; having a sick worker is a potential liability.

Indy Restaurant Closed As Illness Reports Reach 300 - Local News:

It appears some workers at the Olive Garden who came to work will sick may have been the source. The reports are that at least six workers called in sick. I should state it is not yet known and the first test results should be released. The restaurant was closed until at least today.

This also hits close to home as my mother had been visiting my sister who lives in the area and they ate at that exact restaurant just two days before people started getting sick.

Other Resources
Centers for Disease Control and Prevention: Respiratory and Enteric Viruses Branch

Norovirus Summary Document
Norwalk virus group - Wikipedia, the free encyclopedia

Technorati Tags: food safety, Olive Garden, norovirus

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

As regular readers know, I’ve been following the issues surrounding Ketek (telithromycin) an antibiotic from Sanofi-aventis and reports that it has caused some liver problems.

UPDATE 3-Studies support Sanofi antibiotic, say FDA staff | Reuters.com:

The FDA has had meetings Dec 14-15 on this product as a joint meeting involving both the anti-infective drug advisory committee and the drug safety and risk management advisory committee. It will be interesting to see what comes out of this meeting. We may know later today but most likely early next week.

If you want to know the background as well as key dates in the approval history of Ketek then I recommend the Brief documetn listed below which has a lot of good background material on the product.

Once transcripts are available, i’ll post links to them.

Other Resources
FDA Completes Safety Assessment of Ketek New Safety Information to be Added to Product Labeling (press release of June 29, 2006)
Advisory Committees: CDER 2006 Meeting Documents

BRIEFING DOCUMENT AVAILABLE FOR PUBLIC DISCLOSURE: KETEK® (telithromycin)
Technorati Tags: drug safety, FDA, Ketek, Sanofi, Sanofi-Aventis, telithromycin

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

This report again highlights that something is wrong with food safety in this country.

Over 250 sick after eating at Indiana Olive Garden - Yahoo! News

Evidently about 250 people in Indiana have become sickened and three people hospitalized after eating at an Olive Garden in Indianapolis. Interestingly, their is nothing on their website yet in the press release area. Although the exact restaurant has not been identified it is most likely this one on 82nd St in Indianapolis near Castleton Square.

If this is indeed caused by e. coli then I think there is very likely some sort of connection between these seemingly unrelated events. According to the report, it will be about 48 hours before any results are know as to what may be the problem.

It could be that the problems at Taco Bell, Taco Johns and Olive Garden all come from a common source. It would not surprise me if it is all the same ingredient (likely lettuce) and that it came from the same geographic source probably in California. This is all just a guess on my part but I certainly hope there is some sort of coordination in this to hopefully trace it back to it origin.

I think this will just add more impetus to Democrats wanting to reform the food safety part of the FDA. I only hope that it doesn’t involve creating a new government agency combining the food aspects of the FDA with the US Dept. of Agriculture’s inspection of meats. AI better solution that I have expressed in the past is to give an adequate budget to the FDA in order to allow them to do their job properly. It may be that the mission of the food safety group needs to be redefined. I would like to see them beef up their inspection force on the food side.

I lived in Indiana for quite a few years so I was interested in what the local TV stations were reporting on this. I’ve listed their reports below. I may even haven eaten at this restaurant at one time. That’s how I know which restaurant it is. There is really only one located in the northeast side of Indianapolis in the Castleton area.

Other Resources

WISH-TV - Indianapolis News and Weather - Update: More than 200 Claim Illness from Restaurant
2 Hospitalized, 200 Report Illness After Eating At Restaurant - Local News

Technorati Tags: FDA, food safety, Olive Garden, Taco Bell, Taco Johns

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

The FDA earlier this week ordered several companies to stop selling quinine as a treatment for leg cramps. Many of these companies

FDA halts sales of some quinine drugs - Yahoo! News

Quinine is a useful drug for its intended purpose of treating malaria although this has become less useful recently due to the emergence of resistant strains. Mutual Pharmaceutical Company Inc. is approved to sell Qualaquin for the treatment of malaria. What is interesting to me is that this was just approved on Aug 12, 2005.

This drug has serious side effects and its use for malaria is justified since malaria can be life threatening. However, leg cramps are not life-threatening and therefore the benefit does not outweigh its potential down-side in this situation.

Here is the actual release from the FDA

FDA Advances Effort Against Marketed Unapproved Drugs

This touches on a subject I have posted about before that is off-label use. I think it should be left to doctors to decide a drugs use but in some cases such as this, its use really isn’t justified. The problem is quinine has a narrow therapeutic window. This means the difference between an effective dose and a dose that causes serious side effects is quite small.

There are some drugs out there that have been used in medicine prior to some of the current drug regulations and have not been tested to the current standards. The FDA estimates are that several hundred drugs that are un-approved account for about 2% of all prescriptions written each year.

I have tried to find the companies involved as some articles mention as many as eight companies but the only one currently identified are:

Watson Pharmaceuticals
Ivax (now part of Teva)

These companies have 60 days to stop selling quinine. I would be interested if someone else know the other companies involved.

Other Resource

Questions and Answers About FDA’s Enforcement Action Against Quinine Sulfate Drug Products

Final Rules for Drug Products Containing Quinine for Treatment and/or Prevention of Malaria for Over-the-Counter Human Use (pdf)

Technorati Tags: drug safety, unapproved drugs, quinine

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

I did want to clarify something I reported on earlier. I had said that the Taco Bell e. coli problem was likely caused by green onions but it now seems that may not have been the case.

Lettuce May Have Caused Taco Bell E. Coli Outbreak

Now the likely culprit is lettuce. Cheese has been ruled out because all the cheese use is pasteurized and therefore it is unlikely to be the source of the contamination.

Being as there is no clear answer, this may lead to lingering problems for Taco Bell.

Technorati Tags: e coli, food safety, Taco Bell

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

I’ve seen many articles come across my desk in the last few months and they all seem to focus on high throughput experimentation being THE ASNWER to the pharmaceutical industry’s productivity problems. The latest was from Chemical Processing on Oct 2006.

Process Engineering | R&D takes the fast track | Chemical Processing

Many of these articles focus on automated systems working overnight and lowering labor costs. While I don’t dispute that, I think there needs to be more thought put into what you can learn from this and how it can be used effectively. In some ways, it reminds me of when desktop publishing first came to personal computers and people used dozens of fonts, formatting and colors simply because they were could. After a while, people realized that using these indiscriminately just because you could, did not result in better communication of ideas. The same holds true with automated high throughput experimentation. Just because you can perform thousands of experiments in a week doesn’t mean you should or that you are getting the best answer. Doing 1,000 reactions in two weeks isn’t as productive as 200 carefully chosen and designed experiments done in three days.

Here are my basic points.

1. There is a need to work smarter not faster.
2. Better use needs to be made of the data generated.

First, I am a firm believer in spending time up front thinking about the problem before starting to do experimentation. This avoids the “Ready, Fire Aim” mentality that seems to be so pervasive in some R&D departments. I understand this tendency and fell into that trap myself early in my career. However, taking the time to think through the possible variables that could have an impact is a worthwhile exercise.

One of the most important aspects of this thinking ahead before performing experiments involves, design of experiments. This is a way of running reactions to get the greatest amount of information from the smallest number of experiments. While it may not be as imperative as it was in the past to run a small number of experiments, it still is valuable to run the best set of experiments possible. Using advanced software, it is possible to get the best set of experiments regardless of how many variables there may be or whether or not those variables are discrete in nature (such as which catalyst to use) or non-continueous (where only a given set of of conditions can be ran). I would point out that QD Information Services has the capability to design experiments specifically for your situation.

The second point involves better use of the data generated. I have come across too many situations where the approach was to run hundred or thousands of experiments and then sort those in a spreadsheet and go forward with the top one or two choices. At a major process development conference last year, one of the top ten pharmaceutical process development directors made a point of listing all the reactions they had run to find the “best results”. At the end I stood up and asked what they did with the data and got the reply that basically they had solved the problem and moved on to the next problem.

The problems with this approach is it does not take advantage of all the experiments that have been performed. Why invest the amount of time into setting up that many experiments and collect that much data and not try to get as much information as possible out of it? Also, how do you know you have found the “best answer”? Too many times, it is settling for what is acceptable instead of what is best. This leads to openings for your competitors to come in, find the true optimum and possibly patenting that and preventing you from using the best possible conditions.

The best approach is to design the experiments up front but even if that doesn’t occur it is possible to do data mining and possibly find meaning in the data. It continues to amaze me the number of large and mid-sized pharmaceutical companies that don’t take advantage of all the data generated to get the most out of their investment. And too many times, the answer I get is they don’t have time to do more and must move on to the next problem. I often offer to do this data mining for them but they still fail to see any value in this activity. To me, I think this is poor decision making and not getting the most out of your investment and it could come back to haunt you.

I just want to remind folks that QD Information Services can help in these sorts of situation so if you have a need for this, please feel free to contact me and I’ll help you understand how you can get the most out of your data.

Technorati Tags: data mining, design of experiments, high throughput

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

I just wanted to alert my readers that I was recently a guest on a podcast that I listen to and have contributed to before. It’s the Bicyclemark Communique and I was interviewed in bm172 entitled Pharma and You: Part 1 - The Researchers

It is always a pleasure to talk with someone about this topic and hopefully people find it helpful in understanding the world of pharmaceuticals. We talked about drug pricing, Medicare, patents and the world wide situation with regard to pharmaceuticals. He also interviews a friend os his who works for a small biotech company and I always like to hear what others have to say about this topic.

Give it a listen and please feel free to contribute to the conversation on his blog or to leave me comments here.

Technorati Tags: pharmaceutical companies, podcast, prescription drugs

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

There has been a lot of talk about what effect the Democratically controlled congress will have on the pharmaceutical industry particularly with regard to Medicare.

Dems take middle ground on drug plan - Yahoo! News:

The new plan seems to steer away from a totally government run program and instead concentrate on government-negotiated prices. This is indeed on the Democratic agenda but no real details have been offered yet.

While this may be a better idea than their previous position, it still might be divisive enough to cause a ruckus. I tend to think their are other issues of more importance than getting caught up in this debate at this time.

Mark Senak at Eye on the FDA blog had a link to a great article by Kip Piper entitled “Should Federal Government Negotiate Prescription Drug Prices in Medicare: Emotions versus Economics; Politics versus Facts”. Kip Piper is indeed a leading authority on health care with a focus on Medicare and Medicaid unlike other bloggers who have no background in public healthcare policy (and I include myself in this category). I found this article quite enlightening and it has moved me away from government negotiation. I’m still waiting until the programs has been around long enough to see how much of an impact it will have and come to a more informed position. A recent poll I saw said that 80% of those enrolled in Medicare part D are happy with the program so it’s hard to justify any major changes. There is more of a danger in angeingr folks than there is in increasing the percent who are pleased with the program.

Technorati Tags: drug price, Medicare

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

Seems Gilead may be in trouble over off-label marketing of its HIV drugs. The practice of prescribing drugs for off-label use is legal but the marketing of drugs to doctors for off-label use is prohibited.

MercuryNews.com | 12/07/2006 | Gilead gets subpoena over HIV drug marketing:

Recently Intermune agreed to pay $36.9 million to settle charges related to off-label marketing efforts related to its drug Actimmune. It is reported they were touting its use in a fatal lung disorder and it is only approved for treatment of a bone disorder. Scios a division of Johnson & Johnson is also under investigation related to their drug Natrecor.

I know some folks who think that it should be illegal to prescribe drugs for off-label use. I tend to think the present system works but there is a need to make sure drug companies aren’t pushing the limits in terms of what their rugs can be used for. I don’t want to take away the ability of doctors to prescribe what they deem best for their patients and this is particularly true in the area of oncology.

One line of defense that needs to be worked on is doctors reporting of improper marketing efforts by companies. I have a suspicion that it occurs more often than many think and that it is just ignored by doctors instead of being brought to light. I know this comes up on occasions and is talked about in corporate meeting rooms but only behind closed doors and usually in the content of how far can we push this without getting caught. This problem is one of those “dirty little secrets” that exists and needs to be dealt with.

Other Resources

Drug Injury Watch: Off-label Use / Prescribing

Off-Label Imbroglio Latest Concern for Drugmakers

Genentech gets subpoena regarding drug marketing | The San Diego Union-Tribune
When Doctors Go Off-Label - Forbes.com

Technorati Tags: Gilead, off label use

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

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

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |