QDIS Blog

The FDA requested the Institute of Medicine conduct a yearlong review of the U.S. drug safety system in the wake of the Vioxx controversy, but agency officials supposedly are unhappy with reports of the committee’s deliberations. The final report is expected to be released in July, which could impact congressional action on an important funding bill for the FDA or spark calls for widespread reforms that could hurt the drug industry.

Assessment of the U. S. Drug Safety System - Institute of Medicine

Can the Institute of Medicine review the FDA? - Nature Medicine

Keep an eye out for this report in about a month.

Technorati Tags: drug safety, FDA

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I’ve posted previously about the US plan to deal with a potential bird flu pandemic and how it seems inadequate in many ways. It is interesting to note the level of detail and thought that went into the World Health Organization (WHO) plan.

WHO issues plan to limit bird flu outbreak in humans - Bird Flu - MSNBC.com

If WHO can come up with a plan such as this and give out such a level of detail to re-enforce the view that they are prepared, why doesn’t the United Stated do like-wise?. They’ve done mathematical modeling and have in place a process to communicate with Roche about deliveries of drug if needed and the process appears to work since Roche was put on alert recently to be prepared to ship part of the stockpile if needed to Indonesia. It just seems that emergency preparedness in the US has fallen off dramatically in recent years (just look at the response to hurricane Katrina) and it gives me cause for concern.

Now, I definitely don’t expect the government to take care of me in case of some emergency, but it would be nice to know they cared enough to give out good advice on how to be prepared. I think the US has blown a lot of citizen trust by making some recommendations that appear pitiful to the person on the street. These include such advice as staying three feet from all people to avoid sneezes (ignoring the fact that viruses can survive for quite some time on some surfaces) and stockpiling duct tape and plastic in case of a terrorist attack. I’d really like to see a plan that shows elected officials and the folks working in government have at least thought through various scenarios and have consulted recognized experts and then effectively communicate how they arrived at the recommendations without stirring up fear. Now I realize this isn’t easy, but it I think it could be accomplished without undue expense and effort. Right now, parts of the plan looks pretty pathetic. I will say that in general, the government Pandemic Flu site especially the page on Individuals & Families Planning has some good advice. The individual and families page has advice that applies to any natural disaster and something anyone in an area where such event occur should definitely plan for.

Technorati Tags: bird flu, flu pandemic, H5N1

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Seems a Wyeth plant in Puerto Rico that makes several popular medications, has had problems during a recent FDA inspection.
All the complaints had to do with quality control (more precisely, the lack thereof).

FDA warns Wyeth on quality at Puerto Rico plant | Reuters.com

Some of the products mentioned include Advil, Prempo, Caltrate, and Effexor

Here is the FDA warning letter.

The main point appears to be that no corrective actions have ben determined and implemented so the problems do not happen again. Anytime an incident of any type occurs, an investigation is suppose to be initiated and a set of recommendations develop with a focus on preventing this from re-occuring. While this sounds simple, sometimes , it can be more complicated. It is not always possible to determine why something happened, especially if the process is looked at as finding s scapegoat. This leads to situations where the details that may be vital to solving the issue, never emerge for fear of losing a job.

Outsourcing pharma has more details. It seems there was also an unknown substance in the birth control pill Triphasil and that Wyeth has changed their story a couple of times and has issued a voluntary recall of 20 lots of this product from wholesale distributors.

It should be noted that the company states that none of these problems had any impact on patient safety or product efficacy.

It will be interesting to see how quickly Wyeth responds to this warning letter. They had 15 working days (until May 29) to respond in writing and another 15 days to implement a corrective action (until June 20).

Here is a whole list of news articles:

• Yahoo News Results
• Google News Results

Technorati Tags: drug safety, FDA, Wyeth

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Although I’ve not directly mentioned the Sanofi antibiotic Ketek (telithromycin), I did mention it in my post State of the Pharmaceutical Industry. Back on May 01, 2006, some in Congress raised concerns about it due to liver toxicity. It is interesting to note that the FDA turned down the new drug application not once, but twice (in 2001 and 2003) before approving it, ironically on April 1st, 2004. There are also questions surrounding one of the clinical trials and one doctor in Alabama pleaded guilty of fraud and served time in jail.

Now, in this article of May 19, the FDA is looking at changing the labeling for Ketek and may add a “black box” warning. This is the most serious of the various possibilities.

Sanofi, FDA in talks on Ketek label after concerns | Reuters.com

The drug has been linked to 12 cases of liver failure and 4 deaths and the FDA is in talks with Sanofi concerning changes to the label. It should be noted that the FDA is recommending changing the labeling and NOT product withdrawal so they must feel it has some usefulness. Accroding to Sanofi, these talks have been underway for “some months”. Here’s the FDA Q&A page on Ketek:

Telithromycin (marketed as Ketek) Questions and Answers
Here is the current labeling:

Ketek approved label (from the FDA website)
Ketek labeling from Sanofi’s website

Interestingly, the chemical structure is missing from the FDA pdf file but is in the Sanofi version which is why I’ve included both. It is in the class of macrolide antibiotics of which there are several on the market.

This brings us to the topic of how drugs get their labeling. It is interesting to note that these sorts of issues can sometimes lead to long drawn out “talks” before an agreement is worked out. The problem is, the FDA can’t force manufacturers to add certain words to the label and the process usually involves a lot of negotiation. I can understand the concern for medicines where an alternative may not be available or where there is only one alternative, but in instances where there a number of alternatives and all or most appear to be considerably safer, I fail to see why there should be long delays that may result in more deaths or injuries. I think a true assessment of risk vs reward for the public at large gets overlooked in the process.

Technorati Tags: antibiotics, FDA

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