1. There has been a 4,000% increase in diagnosis of psychiatric problems in young children over the last ten years

2. Although doctors do not agree about bipolar in young children many kids are being diagnosed as being bipolar at ages as young as four years old.

3. There is a growing number of strip mall places offering “brain scans” looking at blood flow to the brain to give a diagnosis. The company featured was co-founded by a social worker and she was the one featured giving the family the diagnosis of the problem. To me this edges on the verge of giving medical advice but not being a medical doctor.

4. In one case they highlighted it was teachers who told the parents their child had ADHD. I know teachers and I do not envy their job but I think suggesting an actual diagnosis is inappropriate.

5. Another big problem mentioned only in passing on the program was that many of these children are being treated by family pediatricians and not by child psychiatrists.

I’m not always a fan of highlighting individual cases which may or may not be typical. However, these do pull on our heart strings and it does highlight how desperate these families become when dealing with “the problem child”. I truly feel for these parents who are trying everything to help their child but nothing seems to work. Just take a look at the discussion page and read what some of these folks have gone through. This situation is what leads to some of these snake oil salesmen mentioned in point 3 above.

Part of the problem is the whole quick fix attitude especially in the US and the resulting expectation (re-inforced by the pharmaceutical industry) that a few pills can solve all your problems. I have always believed that in the case of mental issues that medication and therapy together are much more beneficial than drugs along.

I really liked the program and highly recommend it. You can watch it for free online and they also have lot of information and further interviews with experts here. There is also a Parents Guide.

I personally look forward to the day when we can run a blood test or do a brain scan and come up with a definitive diagnosis and be able to confidently prescribe medications that will solve the problem >90% of the time. Unfortunately, I don’t know if this will occur in my lifetime. This is one situation where I truly hope I am wrong.

Technorati Tags: medicated child

Dr. Reddy’s Gets Generic Ambien Approval - Forbes.com:

I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription since they did not recognize the name. The pharmacist explained that it was the generic version of Ambien. This could be a big blow to Sanofi-Aventis since they had sales of $1.2 billion in the last year.

While Dr. Reddy’s Lab is the first, there will be several others and the competition will bring down the price. At least 10 other companies have approved generic versions.

Both my wife and I use it on occasion and I love it. I especially use it when traveling to get my body in sync with the local time. I should note that it has recently come under scrutiny and the labeling has been strengthened to warn about possible side effects.

Technorati Tags: Ambien, Sanofi-Aventis, zolpidem tartrate

Novartis Buys Right to Experimental Drug - Forbes.com:

It will be interesting to watch and see how NicQb comes along. Currently it is in phase II studies but if successful could be a huge success. To my knowledge, this is the only vaccine being developed to combat nicotine addition.

Technorati Tags: anti-smoking vaccine, Cytos Biotechnology, NicQb, Novartis

Dr. Reddy’s Gets Generic Ambien Approval - Forbes.com:

I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription since they did not recognize the name. The pharmacist explained that it was the generic version of Ambien. This could be a big blow to Sanofi-Aventis since they had sales of $1.2 billion in the last year.

While Dr. Reddy’s Lab is the first, there will be several others and the competition will bring down the price. At least 10 other companies have approved generic versions.

Both my wife and I use it on occasion and I love it. I especially use it when traveling to get my body in sync with the local time. I should note that it has recently come under scrutiny and the labeling has been strengthened to warn about possible side effects.

Technorati Tags: Ambien, zolpidem tartrate, Sanofi-Aventis

Proper Disposal of Prescription Drugs

The most important point is that you should NOT flush drugs down the toilet unless the accompanying direction specifically say to do so. Municipal waste water treatment plats are not set up to handle this and it can cause environmental problems. In general, the unused or old medication should be placed in the trash in nondescript containers.

Vaccine May Treat Many Bird Flu Strains - Forbes.com:

The vaccine measurably increased the levels of antibodies in 400 adults after they were given two shots. THe levels were high enough to give presumed protection against the strain of bird flu it was designed to work against. The more promising result is that it may protect against other strains. Other companies such as Novartis and Sanofi-Aventis has also seen cross-protection in their vaccines. What is interesting is the GSK is using a proprietary adjunct which can increase the number of doses by 10-fold. This would be vital if there were an epidemic.

Technorati Tags: avian flu, bird flu, GlaxoSmithKline, H5N1, Novartis, Sanofi-Aventis, vaccine

Indonesia refuses to share bird flu samples with WHO without legally binding agreement - International Herald Tribune

While I understand that Indonesia does not want to have pay high prices for a vaccine that may be developed in the future, this seems short sighted. Indonesia is not the only source of the samples and if a major pharma companies wants to get samples, I’m am sure there are other options and other countries. The only reason Indonesia is important is because they seem to have more cases and those cases need to be tracked to determine how the virus may be mutating.

This is a major change from previous understandings where nations share information for public health purposes. One of the reasons WHO has an interest there is Indonesia is a likely center for any future pandemic since it is heavily populated and many people live in close proximity to birds. THis refusal to share seems to put the Indonesian people at even more risk if something should occur.

Technorati Tags: avian flu, bird flu, Indonesia, WHO

State OKs Plan Against E. Coli Outbreaks - Forbes.com:

Seems California as instituting a voluntary program for produce shippers and handlers where they agree to only work with other companies who are taking preventative steps to stop e. coli and other contamination. Among the proposals are fencing fields to prevent ingress of wildlife and routine testing of irrigation water for bacteria.

I think these are good ideas but it will be interesting to see how successful it is.

Technorati Tags: e coli, food safety

H5N1 bird flu outbreak confirmed on English farm - health - 03 February 2007

About a month ago there was an outbreak of Bird flu on a turkey farm in England. The interesting thing in this article is the timing of the outbreak. It occurred when birds are not migrating and so it was not immediately obvious how this started.

New ScientistPandemic flu may be only two mutations away - health - 01 February 2007 - New Scientist

Interesting article concerning work on how much change needs to occur for H5N1 to have the potential for creating a pandemic. The researchers compared the 1918 flu with the H5N1 bird flu and determined it may only take changes at two amino acids. Unfortunately, they don’t comment on the probabilities of each of these happening and I would note that you have to multiply the percentages to arrive at an overall probability. If one has a probability of 10% and the second also is 10% then the overall probability (assuming both are necessary) is 1%.

World moves closer to having bird flu vaccine: WHO | Top News | Reuters.com

Article about developing a vaccine for bird flu. Mentions CSL Ltd in Australia has developed a vaccine that brins about a strong immune response. Also mentions the GlaxoSmithKline is working on this as well as

World Crises | Reuters.co.uk

The above article concerns Baxter having an agreement with Indonesia and that the Indonesia is no longer sharing samples. They are interested in the IP rights surrounding the H5N1 strain.

PharmaLive: Baxter Continues Collaborations With Global Health Authorities to Advance Pandemic Preparedness

An article further clarifying the situation with regard to sharing samples of bird flu from humans.

Flu Preparedness Still Lags Globally - Forbes.com

Report about the World Health Organization report that the world as a whole is poorly prepared for dealing with any sort of word-wide flu pandemic.

Technorati Tags: bird flu, flu, flu pandemic, flu vaccine

Report: FDA Eyes Kids’ Cold Drugs - Forbes.com
Warnings sought on kids’ cold medicine - Yahoo! News

The cause of this was a filing by Baltimore health authorities and others yesterday (Mar 1, 2007). A recent report from the Center for Disease Control that noted 1,500 toddlers and babies had been taken to the emergency room because of over the counter cough and cold remedies over a two year period. And the medical examiner in Baltimore noted that at least four children under the age of four have had their deaths linked to these products over a five year period.

None of these products are recommended for children younger than two and all state that it should not be used except under the advice of your doctor. But the report says that many products contain the name “infant” or “baby” such as “baby aspirin”. These along with pictures of mothers holding infants and other children much younger than two are shown in the packaging.

I personally think the warnings are adequate but that some of the pictures and wordings in the packaging should be changed so as to not be misleading. I’d like to see the OTC industry do this voluntarily but I don’t think that will happen. And I don’t think the FDA is likely to step in and require that. It is much more likely in my opinion for the FDA to issue a statement saying that these products should not be used in children younger than two without instruction from their doctor.

This does bring up the bigger issue of how do you determining the proper dosing of these OTC products in children? Most data is from extrapolation of adult data and may not be appropriate to children. THis is really the bigger question and one for which there is no answer currently.

Technorati Tags: drug safety, pediatric drugs

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.

Technorati Tags: FDA inspection, food safety

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

Technorati Tags: lisdexamfetamine dimesylate, Vyvanse

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.

Technorati Tags: BSE, Mad Cow disease, bovine spongiform encephalopathy

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)

Technorati Tags: FDA, food safety

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

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.

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

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

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

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

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.

Technorati Tags: Gardasil

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

Technorati Tags: e coli, Taco Johns

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)

Technorati Tags: Acomplia, Meridia, orlistat, Rimonabant, sibutramine, Xenical

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

Technorati Tags: simvastatin, Zocor

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.

Technorati Tags: flu, flu vaccine, flu shot

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

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

Technorati Tags: drug coated stents, FDA, stents, tag

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

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

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

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.