QDIS Blog

I discover this article originally from Mark Senak over at Eye On FDA blog. This FDA proposal would allow for greater access to experimental drugs as reported in the New York Times.

FDA Proposes Broadening Access to Drugs - New York Times

I am a backer of allowing greater access to experimental drugs but feel that the key in this is the word “appropriate”. While no one would object to this with regard to life threatening conditions such as cancer it is unclear how other situations would be dealt with. One of the point in the proposed rule states that:

modernize applicable regulations to include all circumstances under which access to experimental drugs is permitted.

This seems to be a little overly optimistic to me. I find it hard to believe they could define ALL CIRCUMSTANCES in which this may be appropriate. What about someone who has a respiratory ailment that makes breathing difficult and they have tried all approved therapies without positive results? Maybe it keeps them from being mobile and getting out of their home. If there is an experimental drug that could significantly improve their quality of life would this be allowed? The question basically boils down to what is appropriate and this could indeed vary with regard to aliment and even for given patients having a certain condition. I think rather than trying to state all conditions it might be better to define the process allowing for the use of experimental drugs.

One of my other concerns in this involves the fact that our society today seems to be very litigious. Seems anytime something goes wrong, we look for someone else to hold responsible or to sue. I firmly believe that if a company deliberately withholds information concerning dangers or concerns then they should be held liable. However, in the case of an experimental drug, little may be known and opening it to what use to be called compassionate use may be opening a can of words. I firmly believe individuals should be held accountable for their decisions provided it is an informed decision. I’m not sure how this would be worked out, but I’m sure that this will be an item for discussion.

Technorati Tags: drug safety, FDA, experimental drugs

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I’ve reported on the Lilly Icos merger previously and although this news is not unexpected it is interesting.

Lilly Buyout to Cut All Icos Jobs | Chron.com - Houston Chronicle:

Lilly will cut all jobs from Icos meaning they basically just bought Icos to avoid the payment of royalties on Cialis. I have a friend who works for Icos and it looks like they will have to be looking for a new job in the New Year. Some in the manufacturing group will be kept on through 2007 to meet commitments to other companies for making their product.

Technorati Tags: Eli Lilly, Icos, pharma M&A, pharmaceutical deals

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As regular readers know, I’ve been following the developments related to Ketek all year. Now, it seems the FDA advisory committee has recommended that Ketek only be used for certain life-threatening indications.

FDA Panel Hits Antibiotic For Bronchitis, Sinusitis - Forbes.com:

Basically, the committee recommended a black box warning on Ketek for its use in community acquired pneumonia which can be potentially life-threatening. The vote on this aspect was 16 to 3 that for community-acquired infections that Ketek should still be available.

They voted 17 to 2 that the the benefits did not outweigh risks for other indications such as sinusitis and bronchitis. These indications are not as serious and can be treated with other drugs. It will be interesting to see if the FDA rescinds the approval of Ketek for these indications. I think that is very likely to happen. For those out there interested in the chemical structure here it is.

Bottom line was that the drug is effective and can be used in certain indications but that physicians and the patient should be aware of the potential problems. Again, I applauded this recommendation; the risks vs reward must be weighed not for the drug itself but based on the exact indication.

Other Resources

FDA Search Results: ketek (sorted by date with most recent at the top)
Aventis Pharmaceuticals -Ketek - June 2006 prescribing information
Patient Information Sheet: Telithromycin (marketed as Ketek) (from FDA.gov)
ketek - Yahoo! Search Results
ketek - Google Searchimage

Technorati Tags: antibiotics, drug safety, FDA, Ketek, Sanofi-Aventis, telithromycin

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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

Technorati Tags: food safety, Olive Garden, norovirus

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