FDA decision on Avandia

So this is a follow up to the post a couple months ago on the fate of Avandia.  In short, the manufacturer of the drug hid data about its safety.  It turns out the drug increases your risk for heart attack.  In light of the danger and the obfuscation by the drug company, the FDA put Avandia back under review. Last week the FDA finally released their decision, which was to change the status of Avandia to only be prescribed for diabetics who do not respond to safer drugs on the market.  Now, while I admit I would have liked the FDA to have removed the drug completely from the market, the fact that the drug does help some diabetics does make it worthwhile to keep around.  I do wish, however, the FDA would have taking a much harder stance on the drug company itself.  Sadly, the current state of the FDA, both its dependence on corporate money, and its lack of true regulatory power, would have made that option highly unlikely.

A Cancer Vaccine Shows Promise

I'm sure most everyone reading this blog has dealt with personally, or has had a close family member or friend that has been diagnosed with cancer.  While detection and treatment of cancer has greatly improved over the past two decades, it still is one of the most devastating diagnoses a doctor might have to give.  This is even more so the case with malignant forms of brain cancers as surgery and/or drug treatment typically only delays progression of the disease for a short time, in part, due to difficulty in operating on the brain, but also the fact that our bodies do a very good job of preventing many proteins and chemicals from reaching the brain (aka the blood-brain barrier) including many potentially helpful drugs.

Now, one of the holy grails of fighting cancer has been to make a vaccine to fight it.  The concept of making such a vaccine has been around for as long as I can remember.  In fact, my uncle, who died of kidney cancer, was asked by his doctors at the VA if he wanted to participate in a trial to make a vaccine for his cancer over a decade ago (he opted to not take part).  Unfortunately, the idea of a cancer vaccine has proven difficult to turn into reality.  There are a few reasons for this, but I want to highlight just a couple.  First, vaccines for infectious diseases (what we normally associate vaccines with) rely on the fact that the virus and/or bacteria looks very different than the cells in your body.  The immune system uses these differences to kill the bad stuff and leave our bodies in tact.  Cancer, however, doesn't look all that different from the rest of the body to the immune system, making it difficult to elicit a robust immune response.  Second, almost every cancer from every patient is slightly different, so making a single vaccine for more than one person is not really feasible.  For that reason, most attempts to make a cancer vaccine has required removing part of the cancerous material, growing it up in the lab, grinding it up with some adjuvants (think Red Bull for your immune system) and injecting it back into the patient.  Sadly, for most cases it hasn't really worked....well with the exception of a new study centered on glioblastomas (very deadly forms of brain cancer).

The new study, led by Dr. Parsa at UCSF, has used individual vaccines to treat glioblastomas in 8 patients.  While the usual prognosis of glioblastoma is measured in months, all 8 of the patients in the study are alive and well, all a full year after receiving the vaccine.  Is this a cure for glioblastoma?  No, probably not, but it is a huge step forward.  It will be very interesting to see how these patients fair as time marches on but we can hope that the continued use of this vaccine will extend the lives of many more cancer patients in the future.

More information on Human CMV

I managed to run across a very good website for women who are or who are thinking about getting pregnant.  It has many statistics about CMV transmission during pregnancy as well as stories of women who have endured through it.  I highly recommend checking it out it out.


http://www.stopcmv.org/

Writing hell is temporarily over

Hello again.  Long time no see.  My apologies again for my absence but I have a good excuse.  I have been working on a paper to submit for publication the past month and it has drained much of my mental capital.  I'm happy to report that the paper was sent to the Journal of Virology on Thursday and will be out of my hands for at least a month as it is reviewed.  I also see this is a great time to briefly explain what I do in the lab.

As mentioned in my last blog entry, I am working on new vaccine approaches to prevent transmission of the Human Cytomegalovirus, or HCMV.  Now, HCMV is something that 90% of the US population is exposed to by the time they hit their mid life crises.  Fortunately, it is very rare for HCMV to cause disease in healthy individuals, which is most of us.  It only really becomes a problem if you were to become immune compromised, or, if you were to happen to get infected while pregnant.  Even then, the virus would do very little to you, but could have devastating affects on the fetus.  In fact, infection of pregnant women is the leading cause of deafness due to infectious disease in the US and the developmental defects due to uteran infection of a fetus costs billions of dollars a year to treat.  Due to the morbidity and cost associated with HCMV infection, the Institutes of Medicine has given developing an HCMV vaccine "priority one" status, its top rating, and many labs over the past 30 years have been working towards a vaccine.  Sadly, none have really worked.

One of the reasons making an HCMV vaccine has been problematic is that the virus only infects humans, making an animal model to study vaccine efficacy unavailable.  No animal model means no pre-testing of vaccine candidates before going into actual humans and getting approval to inject humans with anything with out some sort of safety and efficacy testing in animals is very very difficult.  In lieu of this, I am working with a closely related virus, Rhesus CMV, in the hopes that our studies with it will translate into similar results with HCMV.  While not great, Rhesus monkeys are the closest thing we have to an acceptable animal model.  Fortunately for the monkeys and my own conscious, Rhesus CMV is endemic in the monkey population and, like HCMV, does not result in morbidity in healthy animals.  We are developing a vaccine that makes use of viruses that are unable to grow outside of the lab.  Ideally, this will generate a very strong immune response in the monkeys and prevent them getting the real virus when challenged.  If all goes well, we will then adapt the system for a human vaccine...granted that could be decades away.