QDIS Blog

Here is a recent article in the Boston Globe. They report that European regulators testified to a congressional panel that some biological products can fairly easily be produced such as insulin and human growth hormone. Others are too complicated to be safely duplicated.

Caution urged on biologic drugs - The Boston Globe

Europe has had biogenerics for the last four years but European regulators have required human clinical trials for these products. I think there is need for talking about what process may be in the best interest of patients and is safe. I’d like to see criteria developed for biologics that would allow it to be determined which can be safely approved in a fashion similar to the current generics model based on bioequivalence, and which would have to undergo human trials. I don’t fall into the trap that some do of insisting it is either one or the other. However I think it may be difficult to draw up guidelines for determining which track a given product should follow that a majority will agree with. That doesn’t mean it can’t happen, but it will be contentious.

Technorati Tags: biogenerics, FDA

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Seems the FDA started podcasting in Feb 06 on drug safety. Only two have been made so far and they are very short (two minutes and seven minutes)

FDA Drug Safety Podcasts

While I find it refreshing that they would do these (and they also provide transcript by the way) it seems that only a few minutes is too short to convey any really useful information. Also, they have a lot to learn about how to do podcasting and making it successful.

It sounds unnatural and stilted. I’m sure they are just reading a script as there in no intonation or dynamics at all. They also need to learn proper mic technique to get rid of popping p’s and hissing s’s. I could barely get through the seven minutes without nodding off due to the monotone nature of the podcast.

While I find it promising they are taking advantage of a new technology, I certainly wish they would have done more to learn about it before putting together such as poorly produced product.

Technorati Tags: drug safety, FDA, podcast

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There have been many reports today, most saying basically the same thing, Here are two that cover the issue.

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

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Seems the external panel of experts has recommended approval of Sanofi’s H5N1 bird flu vaccine. While the FDA doesn’t have to follow the panels advice, they typically do. This despite the fact that the vaccine only showed antibodies in approximately 50% of the people vaccinated.

Sanofi Gets Nod From FDA Panel:
Sanofi Bird-Flu Shot’s Benefit Isn’t Clear, FDA Says

I would comment that vaccination are not 100% effective in all cases. I know from painful experience that this is the case. When I was young I was given a attenuated live vaccine for measles along with gamma globulin. Then as an adolescent, I developed full blown measles.

However to help prevent a pandemic, 100% effectiveness is not necessary. It is only necessary to vaccine a critical number of folks that will help prevent the spread of the disease. Right now, I think that this particular vaccine is not worth the risk unless you happen to be a chicken farmer. No one in the US has ever developed bird flu and right now it is difficult to spread from human to human. There have only been 270 cases in 10 countries world-wide. An interesting comment in the article is that this vaccine will NOT be commercially available and that governments will likely stockpile it to protect first responders and healthcare workers if needed.

Technorati Tags: bird flu, vaccine

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The AP had a nice report this week related to food safety and the FDA.

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

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CNN Money reported yesterday that the sentencing of Dr. Lester Crawford, the former FDA commissioner was completed yesterday. He ended up being fined $89,377 and three years of probation as well a 50 hours of community service.

Former FDA chief fined $89,377 - Feb. 27, 2007

Boy did I get this wrong. You may remember I made a prediction back in October that said he would be fined $10,000 and given 2-3 months probation. This was based upon my pessimistic view of high level officials ever being truly held accountable. I am glad to see that the judge thought this was worthy of more punishment than that. It is interesting that the fine is much larger than the agreed amount of $50,000 between Crawford and the prosecutor, but still lower than what could have been handed down.

I personally would like to have seen more hours of community service given out. Fifty hours is just slightly more than one work week.

Technorati Tags: FDA, FDA Commissioner

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LIlly received additional approvals for Cymbalta for treatment of generalized anxiety disorder.

Press Release: FDA Approves Eli Lilly and Company Cymbalta - FierceBiotech:

This brings to three the number of indications for this drug. The others include depression and diabetic neuropathy.

Technorati Tags: drug approval, Eli Lilly, Cymbalta

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Seems they knew what they was doing when Shire purchased New River Pharmaceuticals. Now, the FDA has approved Vyvanse for treatment of Attention Deficit Hyperactivity Disorder (ADHD).

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

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Tomorrow, an expert panel of outside advisors will give their recommendation on a Sanofi-Aventis bird flu vaccine.

FDA experts to vote on America’s first bird flu vaccine - Feb. 23, 2007:

It will be interesting to see what comes out of this meeting. I still think that the concerns over bird flu are currently overstated. Many more will die this year from the standard flu than from bird flu.

As the article point out though, it is impossible to develop a precise vaccine against bird flu unless it actually mutates into a pandemic strain. It is a difficult decision to stockpile a vaccine that may likely do no good whatsoever. However, it is also unconscionable to do nothing. I think the best spending of money would be on technologies that get away from using chicken eggs to produce vaccines. The way the pharmaceutical industry produces vaccines has not changes in many, many years. If bird flu should become epidemic within the chicken population and not affect humans directly, it could still have a major impact on humans since ALL vaccines are made using chicken eggs. This would inhibit the ability to produce any other vaccines. These technologies, if they allowed rapid ramp up of production, could easily be used for other vaccines in the future.

Technorati Tags: bird flu, FDA, Sanofi-Aventis, vaccine

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I’ve always said that pharmaceutical companies that are truly looking at improving their image (and heading off further regulations) with the public, should do better at completing agreed upon post-marketing studies. A recent article shows that 71% of agreed upon post-marketing studies (899 studies) have not yet even been started.

Prescription Drugs | Prescription Drug Makers Have Not Begun Many Pending Post-Market Studies on Newly Approved Drugs, FDA Says - Kaisernetwork.org:

Here is the latest numbers for 2006 from the FDA: Postmarketing Study Commitments 2006 [HTML] [PDF ]

These are studies that pharmaceutical companies agree to as a condition for approval of the drug. The problem is, the FDA has no authority to do anything if companies do not comply. Their only true recourse is to withdrawal approval but that is something they have never done for failure to complete post-marketig studies. It isn’t something I would recommend either as it would hurt too many patients who may truly need a specific drug.

Some in the industry complain that it is hard to recruit patients for some drugs. That may very well be the case, but that doesn’t mean they should not even start trials. It means it may take longer to get them completed. However, that reasoning does not address the extremely high percentage of studies that have not even been started! Also, if there will be a problem getting patients for these studies, then the companies should discuss that with the FDA at the approval and agree to start them but state that it will likely take longer to complete them. It would be interesting to try and determine how many drugs pharmaceutical companies make this sort of claim for and look at how many prescriptions are written for those drugs. One of the problems is, someone in a phase IV study (aka post-marketing studies) will not be generating revenue for the company.

At the heart is the fact that these studies tend to be large and costly and in most cases, the companies will not be achieving anything substantial from them (i.e. a competitive or marketing advantage). They are mainly studies to give the FDA better confidence in the safety of the drug. Therefore, from a strictly business perspective (ignoring safety), it makes sense to put off these trials as long as possible since they are costly and are not likely to bring any benefit for the companies. Also, if there are no consequences than why do them? I would argue that sort of mentality is very shortsighted and not including the potential costs of later legal problems if the drug should have some unintended consequences (i.e. Vioxx).

Also, if this sort of trend continues, there will certainly be more power given to the FDA. I have always found it interesting that the EPA can fine companies in order to protect the environment (and the potential human consequences) but the FDA has no such power to fine companies for failing to complete required pot-marketing studies that have a larger potential to do harm.

Fro another view see Opinion | Delayed FDA Post-Marketing Study Statistics ‘Misrepresented,’ Opinion Piece Says - Kaisernetwork.org

Other Resources (note: some are from 2005)

FDA says too many drug studies delayed - Boston.com
FDA Accused of Dropping the Ball on Post-Marketing Studies of Fast Track Drugs - CME Teaching Brief® - MedPage Today
FDA To Drug Firms: You Promised, Where Are The Post-Marketing Studies? - CBS News
Postmarketing Study Commitments Database (FDA website)
Postmarketing Study Commitments: Introduction (FDA website)

Technorati Tags: FDA, post-marketing studies, phase IV studies

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