QDIS Blog

I did want to relate an email exchange I had recently with a reader who was having problems finding a pharmacy carrying Gardasil. She had seen a doctor and they did not have the vaccine so he wrote her a prescription. The vaccine comes is in a pref-illed syringe according to the prescribing information. Her normal pharmacy, CVS said it was “backordered” and they would not get it for some time. She was asking me for recommendations, I gave her some suggestion such as calling the Merck number for information about the vaccine but she finally tracked it down on her own at her local Walmart.

This sort of situation isn’t uncommon for newly approved drugs or vaccines. It takes a wile for the supply chain to fill and for the drugs to make it to your local pharmacy. If you are looking for a new drug, call you local pharmacy and ask about the availability and when they think they will have it in stock. Also larger corporations such as Walgreens or Walart are likely to have it sooner since they buy in large quantities. Hopefully, this will help someone else who may be in a similar situation.

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Seems the problems with 80 people getting sick at Taco Johns in Iowa and Minnesota were indeed sickened by e. coli and that the strain has been tracked back to a dairy farm near lettuce fields.

Officials track E. coli strain to Calif. - Yahoo! News

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This article from about a week ago cuaght my eye on Yahoo. It is about the need for collecting long term safety data for two approved diet drugs in the US and another one tat is under review by the FDA. THe three drugs are Xenical (orlistat), Meridia (sibutramine) which are approved and Acomplia (rimonabant) which is under review. The article mentions an article in journal Lancet.

Long-term data needed on anti-obesity drugs - Yahoo! News:

I tend to agree especially since they all seem to have the potential for serious side effects which show up even with just short term use. As I have said here many times, they risk and reward need to be weighed for the use of any drug. There may be cases where the potential benefits outweighs the negative. However, my concern with drugs such as diet drug are the potential for misuse and over-prescribing of such drugs. Given Americans obsession with dieting and weight loss, these drugs have a huge potential for problems and I agree that more long term safety data is needed.

Long term safety data will likely be one of the primary topics for FDA reform this year from the Democrats in Congress especially in the House of Representatives.

Other Resources

XENICAL.com Home
Meridia (Sibutramine HCl)
Accomplia: The New Weight Loss Drug (Rimonabant)

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Reducing cholesterol with the use of statin drugs is a goal that the medical community has agreed can have a major impact on health. Now, with Zocor coming off patent, there are more choices and the cost should drop significantly.

Regulators Clear 6 More Companies to Sell Generic Zocor - New York Times:

Although Teva and Ranbaxy were approved in June of 2006, they had six months exclusivity which meant that they were selling the drug for only 8% less then Merck was selling Zocor. Now there are six more companies and the prices will likely drop significantly; perhaps by 50% or more.

Current generic approvals

In June
Teva Pharmaceuticals
Ranbaxy Laboratories

This month
Cobalt Pharmaceuticals of Ontario
Aurobindo Pharma
Zydus Pharmaceuticals
Dr. Reddy’s Laboratories of India
Sandoz unit of the Swiss drug maker Novartis
Perrigo Company of Allegan, Mich

This could have an impact on other brand name statin drugs particularly Lipitor from Pfizer, the best selling of all the statin class of drugs. Many health insurance companies are certainly going to recommend that their patients ask their doctor about switching to simvastatin as a means for not only controlling cholesterol but also controlling cost. It will be interesting to see how much of an impact it does have on the sales of LIpitor. Pfizer will certainly fight this in any way they can since Lipitor is a $10 billion per year product and the patent will not expire until March of 201 and June of 2011 (depending on the crystalline form). It will definitely be interesting to see how this develops in the coming years. I don’t look for Lipitor to reach $10 billiob in sales this year.

Other Resources
FDA Approves First Generic Simvastatin

simvastatin - Yahoo! Search Results
simvastatin - Google Search
Google Blog Search: simvastatin

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Given the fact that there have been flu vaccine shortages the past couple of years, it is disturbing to see that there way well be unused flu vaccine this year.

After Shortage, Vaccine for Flu Goes Unused - New York Times:

I encourage everyone to get a flu shot and it isn’t too late. If you are at risk or will be traveling a lot this year you should certainly get vaccinated. If there is a significant amount of unused vaccine this year, it could have a negatively impact in the future. Companies will be less likely to make as much vaccine in the future if it goes unused this year.

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It seems 2006 will be the year of finding out all kinds of things about drugs once though safe.
From Vioxx to everyday over-the-counter pain relievers we have seen unintended consequences raise its ugly head. The latest is the proton pump inhibitor class of compounds including Prilosec, Nexium, Prevacid, Aciphex and Protonix.

Heartburn drugs raise risk of hip fractures: study | Health | Reuters.com

The study is fairly large; 150,000 Britons over the age of 50. It found they had 13,556 hip fractures which is higher than expected. There was also a correlation to fractures with how long the drug was used and how high of a dose was taken. This is likely due to the drugs inhibiting calcium absorption. The good news is that by increasing calcium consumption these side effects can likely be overcome although studies would need to be done to prove that.

Here is a quote from the article.

“At this point, physicians should be aware of this potential association when considering (proton pump inhibitor) therapy and should use the lowest effective dose for patients with appropriate indications,” said study author Yu-Xiao Yang.

The report on the study, published in this week’s issue of the Journal of the American Medical Association, also said that elderly patients requiring long-term and high-dose drug therapy should consider increasing calcium intake.

I have always said that some of this problem is that pharma companies do not want to find out potentially negative information and avoiding doing studies that have a potential for a large downside but little to no upside. While I understand this from a business perspective, I think if there is any data that there could be unintended consequences, they should be investigated.

Technorati Tags: Aciphex, drug safety, Nexium, Prevacid, Prilosec, proton pump inhobitor, Protonix

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I’m late on posting this but still wanted to comment on this. An FDA advisory committee came to the conclusion that drug coated stents are not problematic.

ABC News: FDA Panel Finds Drug-Coated Stents ‘Not Detrimental’:

However, there is concern about the massive use of drug coated stents for indications outside of the approval. As many as 66% of the stents are used “off-label”. This is the category that the panel had great concerns over the use.

Here are the summaries from this meeting.

Summary from the Circulatory System Devices Panel Meeting - December 7 & 8, 2006

Again, I think off-label use is valid however I think that there needs to be some sort of check on this. Too many times the off-label use of a drug or in this case a device, accounts for the vast majority of its use. There was a drug at a company I use to work for where ~80% of the sales were for off-label use.

Many times, pharmaceutical and biotech companies will turn to the easiest indication to get approval and hope to get further sales from these other indications for which it is not yet approved. In some cases, there are actually plans to do more studies and get approval for other indications. This is common practice in oncology but I think in other areas there needs to be some sort of regulation. I would suggest that when the off-label use constitutes a certain percentage, the drug companies should be required to get approval for that indication. Now this could have other consequences and one of the biggest concerns would be how do you determine the percentage of off-label use, that is whose’ data do you use. If you rely on the drug companies there may be under-reporting in order to avoid doing further costly studies. However, I think in non-life threatening situations, this could be justified.

Other Resources
FDA Statement on Coronary Drug-Eluting Stents
FDA Heart Health Online - Questions and Answers on Coronary Drug-Eluting Stents
fda drug-eluting stents - Yahoo! Search Results
fda drug-eluting stents - Google Search

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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

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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

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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

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