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Small Pox in the Us

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Submitted By ambermehg
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Current Event Article In the article titled “Costly drug for smallpox questioned” published in the Los Angeles Times on November 13, 2011 the antiviral vaccine for smallpox was looked at. This vaccine was developed by Siga Technologies Inc. as a treatment for people who are diagnosed with smallpox too late to use the current vaccine that the government has stockpiled in case of a bioterrorism attack. The drug is controversial as it is not known if it will work in humans due to testing only being allowed in animals. As there are no current smallpox outbreaks to test on, animals are the only test subjects at this time. Also it comes with a large price tag, around $255.00 a dose, this for 1.7 million doses per the contract to be stockpiled. This high price tag and the governments’ apparent favoritism to Siga has caused outrage by some. The disease which causes pustules and a 30% death rate was eradicated worldwide in 1978. The only strains known to exist are in Russian and US freezers. To date there is no credible evidence that any terrorist group or county has the virus and can attack the US with it. However, the government feels that it is important to have not only our current vaccine stockpile, enough to vaccinate the entire US population, but a backup for those not vaccinated or diagnosed in time. The new drug, ST-246, is said to have $115 million in federal support, not including the contract for manufacture and development, which is estimated to be around $433 million. One issue expressed is that according to some the FDA does not see a foreseeable path to licensure. The FDA must approve the drug for human use in order for the US to administer the drug in the event it is needed. Another concern is that unlike the older vaccine for smallpox which has a decade’s long shelf life, the ST-246 vaccine is only guaranteed for 38 months. The government who awarded the contract to SIga, under much criticism for not opening it up to other contenders, has dropped the exclusivity provision allowing other companies to replenish or expand the stockpile. While the threat does not appear to be severe or to some even viable, the idea is to plan for the worst case scenario. Americans stopped being vaccinated against smallpox in 1972. This means that millions of Americans no longer have any immunity to smallpox and exposure would be detrimental. In light of September 11th and the new U.S. Biodefense policy the key is to plan for attacks like these now to prevent epidemics later (William, 2011). What exactly is ST-246? This is a new oral antiviral drug to treat orthopoxvirus infections, including smallpox (Jordan, 2008). The vaccine is also effective against Cowpox, although there was some resistance to ST-246 in some cowpox variants. In a recent phase I double blind study the ST-246 was tested in healthy volunteers. It was found that the drug was generally well tolerated with no serious adverse effects (Jordan, 2008). So how does ST-246 work? Based on the resistance found in the cowpox strains it was found that there was a single amino acid change in the V061 gene (Yang, 2005). When this gene was reengineered to the normal genome the virus was not resistant to ST-246. This shows that the drug is acting on the a specific gene, V061, in this case one that codes for a major envelope protein (Yang). This is homologous to the vaccinia virus F13L. Since this protein codes for the extracellular virus envelope and is being inhibited the virus can not complete replication. In a cell culture the ST-246 inhibited plaque formation and virus-induced cytopathic effects (Yang, 2005). In single-cycle growth assays the ST-246 drug reduced extracellular virus formation by 10 fold when compared to untreated controls. However it has little effect on the production of intracellular virus, again pointing to ST-246 as being an inhibitor of extracellular virus formation. With inhibition of the extracellular virus the systemic spread in the host in prevented, a key step in a viruses virulence (Yang, 2005). ST-246 targets a specific viral enzyme. There is no known human equivalent to this enzyme making it highly specific for othopoxvirus replication (Yang, 2005). As ST-246 does not prevent viral replication but prevents viral spread, this does make dosing duration longer. The longer dosing will prevent spread while the human immune system can mount immune defenses against the intracellular replication. The ST-246 targets a virulence factor, therefore it doesn’t diminish our protective immunity. What is a Phase I double-blind study? According to the medical dictionary a double blind study is an experiment designed to test the effect of a treatment or substance by using groups of experimental and control subjects in which neither the subjects nor the investigators know which treatment or substance is being administered to which group. The purpose of a double blind study is to eliminate the risk of prejudgment by the participants so as not to distort the results (Elsevier, 2008). The addition of Phase I indicates that this is an initial study to determine the metabolism and pharmacologic actions of the drug in humans. This includes the side effects associated with an increase in the dose. A Phase I study is done to gain early evidence of effectiveness and may include healthy participants and/or patients (ClinicalTrials.gov, 2008). In the study on ST-246 both of these are applied and it is thus called a Phase I Double-Blind Study. This then is an initial study where the participants and researchers were not aware of who was getting the ST-246 drug and who was receiving the placebo drug. Further studies could then be performed and would be noted as Phase II, Phase III or Phase IV studies.
As the world changes and bioterrorist attacks are more of a threat the development of vaccines such as these will be needed. While the price tag is high, the life saving benefits will outweigh the cost. However, after reading the articles I do feel that there should be more of an open platform for labs to research and develop these types of drugs. I feel that the governments favoritism in only allowing Siga to compete for the contract will prevent progress in the race to find new treatments for not only this disease but others.

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