QDIS Blog

I wake up this morning and it seems all of a sudden, Plan B is making progress towards becoming approved for over-the counter use!

FDA weighs over-the-counter Plan B sales - Yahoo! News:

You may ask why all of a sudden is this happening now? I think this quote shows why:

Asked why the FDA was moving forward now, 11 months after delaying a decision, FDA spokeswoman Susan Bro said von Eschenbach wanted to spend Tuesday’s hearing less on this contentious issue and more on his own plans for the agency if confirmed as its chief.

“He knew it was critical that he be able to provide tomorrow a thoughtful approach to resolving what has been one of the most divisive issues the agency has faced in order for him to present his broad and ambitious vision for the FDA,” Bro said.

I truly hope this is indeed the case. I am very much looking forward to hearing what exactly his vision is and hope he is able to clearly explain what he wants to accomplish.

I would point out that Mark over at Eye on FDA has a good post about the upcoming confirmation hearings tomorrow (Tuesday, Aug 1, 2006). I think he definitely has a point about the possibility of a recess appointment and I seriously think that’s why the FDA made the announcement just the day before the confirmations. It doesn’t give much time to absorb what exactly the FDA means by this. It may be a play to get Dr. Eschenbach approved without committing to a decision on Plan B. The announcement only says the FDA wants to meet with Barr Labs to have further discussions. That’s a good positive step forward as long as it isn’t just another delaying tactic to get Dr. Eschenbach approved. The FDA could still have reservations and prevent it at a later date.

Bottom line, (and I’l admit this is somewhat cynical) I bet the announcements was made in order to get senators to go along and approve Dr. Eschenbach but that the FDA won’t do anything with Plan B after the nomination goes through. Here’s one case where I sincerely hope I am wrong.

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I haven’t had time to read the report in its entirety but did want to post some of my thoughts on the main points.

Report finds drug errors hurt 1.5 million - Yahoo! News:

Here’s one quote:

Perhaps the most stunning finding of the report was that, on average, a hospitalized patient is subject to at least one medication error per day, despite intense efforts to improve hospital care in the six years since the institute began focusing attention on medical mistakes of all kinds.

I must say I thought this was high. I’d like to see this broken down by say size of hospital. Based on a recent experience of having a family member hospitalized in intensive care and then in a regular hospital room, I must say they did a great job. This was at a smaller regional hospital and not in a large major metropolitan area. My guess is that at some of the larger busies hospitals you are going to see an increase in the medication errors. Another interesting stat would be the nurse to patient ratio.

One of the recommendations from the report is to go to all electronic prescriptions by 2010. First, I think this is a great idea, however, I don’t think it will happen. The biggest reason is that most physicians are very busy and many don’t want to learn a new system. This is a major problem; whatever system is used needs to be easy to use and even easier to learn. It should be designed from scratch with the ned use in mind and the goals. Too many times, it is made to be easy to maintain the software or to be easy to be install and not a lot of thought is given into the doctors that will be using the system. Another problem is recruiting tech savvy physicians to test the system, working on it, an then wondering why is doesn’t work when rolled out to a larger audience. This is because in all such testing for use-ability, you need to make sure you have a wide range of abilities in your test group.

I truly think that electronic prescribing is the way to go, but I can’t say I’m confident on how well it will be implemented

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I wanted to mention that Chmoogle, due to pressure from Google’s legal department has changed their name back to eMolucules. The Chmoogle address will now redirect you to the eMolecules site. For those of you not familiar with it, it allows you to do chemical structure, substructure, and name searching via the web. It is not nearly as large as Chemical Abstracts but it is free and does a very good job in my opinion. I like it because they have direct links to suppliers for chemicals so you can use it to find suppliers. You can also use the substructure search to find related molecules.

If you have a need for chemical name and structure searching, then eMolecules is the palce for you.

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MeTHF is an interesting solvent and a useful alternative to THF. One of the primary differences is that MeTHF is not miscible with water whereas THF is. This means that at the end of a reaction, you can add an aqueous quench and work up the reaction without having to add another solvent. MeTHF also gives clean phase splits whereas THF mixed solvents can give problems with emulsions and long sitting times to get clean phase splits.

MeTHF has some other interesting properties as well. Bromo derived Grignards are more soluble in MeTHF than in THF itself. It is also more easily dried. Not only can it serve as a replacement for THF, but it also has been used as a replacement for dichloromethane (pdf) which is a big advantage.

The main drawback currently is price. I quick check of Aldrich gives a 2L bottle of 2-mehyltetrahydrofuran for $165. By contrast, a 2L bottle of THF is only $88.90. I think the price will come down if more people start using it. After all, it comes from furfural which comes from corn and is renewable. Also with ethanol being considered as a fuel alternative, the ability to increase capacity for 2-methyltetreahydrofuran can be increased and the price will certainly come down.

Here is the page from Penn Speciality Chemicals with a lot more information on MeTHF.

For a reference on MeTHF for replacing dichloromethane: David H. Brown Ripin, Synlett 2003, No. 15, p 2353.

Technorati Tags: THF, solvent change, solvents

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This article reports on significant advances reported by GlalxoSmithKline on their work with a potential bird flu vaccine.

GSK Reports Significant Advance in H5N1 Pandemic Flu Vaccine Program

The main point is that they have managed to get a very good immune response from a low dose level. Here’s the key qoute from the press release.

The vaccine, which uses a proprietary adjuvant, enabled over 80% of subjects who received 3.8 micrograms of antigen to demonstrate a strong seroprotective immune response. This level of seroprotection meets or exceeds target criteria set by regulatory agencies for registration of influenza vaccines. Efficacy results at these levels of antigen dosage have also not been reported for any other H5N1 vaccine in development to date, including those using other adjuvants such as alum.

This is truly a breakthrough since getting enough vaccine to treat enough people has long been a major concern.

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I continue to be concerned about some of the reports coming out about the FDA. The following article is one of the recent ones.

Some FDA scientists claim interference | Top News | Reuters.com:

One thing I would point out is people who feel they have a gripe or have been ignored are much more likely to respond to these sorts of surveys (995 out of 6,000 responded but that is a good return rate). Also, the percentage of scientists saying they felt pressured to change decisions was down 5% (from 20% in a Dept. of Health and Human Services inspector general in 2002). Still, even if the number is only 5% accounting for bias, it is too high in my opinion.

Here is a quote from the FDA spokesperson:
FDA spokeswoman Susan Bro called the survey a “counter-productive exercise based on leading questions and innuendo.”

It would have been much more productive if she could have given examples of the questions that were used in order to allow the reader to see for themselves if the questions were indeed leading.

I do know that the way questions are worded can have a great impact on the results. This means one has to taken into account whomever is running the study. In this case, the study was co-sponsored by Public Employees for Environmental Responsibility. They are more typically involved in environmental issues so it is interesting to note their interest in this area.

The Union for Concerned Scientists (UCS also has been critical of the FDA of late. While not mentioned on the PEER site or in the Reuters article, the UCS website states they were the co-sponsors along with PEER. The actual survey is on the Union of Concerned Scientists website. Click on the link entitled “FDA survey: Questions and findings (pdf)”. They have unfortunately made it very difficult to link directly to the survey itself.

Here is the first two question and I leave it to you to decide if it is leading.

MISSION
1. FDA has sufficient resources to effectively perform its mission of “protecting the public health and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” [Excerpt from full FDA mission statement]
strongly agree agree no opinion disagree strongly disagree

2. The Center/Office of the Commissioner/Office of Regulatory Affairs where I work has the resources it needs to meet its role in fulfilling the mission of FDA.
strongly agree agree no opinion disagree strongly disagree

I do think though that some of this has to do with a lot of media attention and the fact that it is a midterms election year. Everyone seems to be making the FDA their favorite whipping boy. But, I also fault the FDA themselves for not doing more to deflect the criticism. They seem reactive and defensive instead of proactive in this regard.

Here also is the 2002 Dept. of Health and Human Services inspector general survey in pdf format. And here is the report.

I know it is almost impossible to get a group of scientists to agree on all aspects of a given research project. However, it is also important to acknowledge and forthrightly deal with those who have legitimate concerns. Sometimes, if a dissenter feels there views have been acknowledged and weighed in the decision making process, even though they might not agree with the outcome, they will support it. However, being dismissive and ignoring others concerns is a sure fire recipe for trouble.

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The US Senate has now proposed legislation that would allow the FDA to fine pharmaceutical companies for failure to complete post-marketing studies that are agreed to when a drug is approved.

Key senators unveil bill to bolster drug safety

Currently, the FDA has no recourse except to remove a drug from the market, something which does damage by denying consumer drugs that may be vitally needed. This legislation would allow the FDA to fine companies not complying with the agreements. I should note that this is only in the Senate and I’m not aware of anything similar in the US House. I also have my doubts about whether or not such legislation would actually pass.

I have often wondered why the FDA has no power to fine when companies don’t comply with post-marketing agreements. I never really made sense to me but then politics rarely makes sense to me. I have always thought that the FDA should have the ability to fine for failure to follow through on agreements.

BTW, if you want a great book about how the FDA developed and issues they have dealt with read “Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation” (Philip J. Hilts)

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Roche continues to add additional manufacturers of Tamiflu world-wide. The latest addition is Chugai Pharmaceuticals in Japan.

Chugai to make modified version of Tamiflu dry syrup - International

It is expected they will be in production for the 2009-2010 flu season and they will be making a syrup formulation instead of the typical capsule form.

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I figured it was going to happen and yet it still isn’t comprehendible. After Congress passed a bi-partisan bill allowing for federal money for stem cell research, Bush vetoed it. I tend to try to stay away from politics on this blog but sometimes science and politics collide and unfortunately, especially lately, politics trumps science. However, it is beyond me as to why, when so many people in the US (76%) back stem cell research mainly because they have loved ones who might benefit from such research.

I’ve never quite understood the mindset: stem cell research bad; death penalty good. Killing civilians for democracy building in the Middle East, good; contributing to medical breakthroughs for diseases ranging from Alzheimer’s, diabetes, and many other diseases, bad. I could go on with even more examples such as Sen James Inhofe saying that global warming is the biggest hoax ever perpetrated by scientists on the world, but I suggest you read “The Republican War on Science” by Chris Mooney for a long, long list of politics trumping science.

If you are interested in this topic, I highly recommend Chris Mooney’s blog “The Intersection“.

Art Caplan on the MSNBC site also had a scathing article. Here is part of it.

An administration that has shown itself over and over again to have trouble telling the truth is now telling Americans in wheelchairs, those with damaged hearts, babies who are diabetic and those left immobile by Parkinsonism not to worry. The president, whose grasp of science left him unable to identify creationism as a fundamentally religious idea, and his trusty sidekick Karl Rove, rarely seen in a white lab coat but who knows something about rats, having been in Washington for some time now, claim to know best which medical research is most likely to benefit diseased Americans in the future.

I will admit that I have family members who might benefit from such research. I also know that in the past, religious leaders were strongly against cutting open bodies to understand how the body works. This today has led to organ transplants and medical knowledge that saves many lives. It is a shame to see the US fall behind the rest of the developed world when it comes to research that may help many people in the future.

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I’ve posted about Exelon several times before but today comes news that it may be available in a patch the would be absorbed through the skin.

Alzheimer’s patients may get skin patch - Yahoo! News:

I should note that this has not yet been approved but will likely be considered by the FDA before the end of this year. This would be very beneficial for patient compliance since some elderly have trouble swallowing pills. Also, as I have stated before Exelon is not a cure, it just slows the progression of the disease.

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