By Dr. Mercola
The U.S. government has awarded a $433-million contract to pharmaceutical company Siga Technologies for 1.7 million doses of an experimental smallpox drug called ST-246 (Tecovirimat).
In this time of limited resources and heavy budget deficits, the decision to spend nearly half a billion dollars to stockpile a drug of questionable safety and effectiveness, for a strictly theoretical danger, is puzzling -- and that is an extreme understatement.
Smallpox Drug Given FDA "Fast-Track" Status, Despite No Imminent Risk
Siga's ST-246, which reportedly works by blocking the ability of the smallpox viruses to spread to other cells, has been granted "fast-track" status by the U.S. Food and Drug Administration (FDA).
Under this accelerated approval process, experimental drugs are brought to market sooner, even though they've only been tested on a small number of people and their effects and safety risks are not clearly understood.
Unfortunately, there are serious, and sometimes fatal consequences of bringing drugs to market without adequate safety testing -- and it is unclear why there is an urgent need for this drug that would warrant "fast-track" approval.
Even Siga's Web site notes smallpox is "no longer found in the natural environment."
The U.S. government is claiming the need to stockpile the drug in order to strengthen U.S. preparedness should the virus be used as a biological weapon in a terrorist attack.
But, reportedly, smallpox is not in the hands of a terrorist group; in all probability, only the U.S. government and a Russian science institute have the virus.
As reported by the Los Angeles Times:
"Once feared for its grotesque pustules and 30% death rate, smallpox was eradicated worldwide as of 1978 and is known to exist only in the locked freezers of a Russian scientific institute and the U.S. government. There is no credible evidence that any other country or a terrorist group possesses smallpox."
The U.S. Government Already Has $1-Billion Stash of Smallpox Vaccine
The U.S. government began stockpiling vaccines and drugs, ostensibly to protect Americans from potential bioterrorist attacks in 2004, when Project BioShield was signed into law by then President Bush.
This includes about 300 million doses of smallpox vaccine, one of the major selling points of which is that it can supposedly protect against smallpox even if given up to 7 days after infection.
There are many complications associated with the smallpox vaccine, which uses a live virus, not the least of which is the possibility of infecting those around you after vaccination. So its use for anything other than a full-fledged attack is extremely concerning (and even this is questionable).
But the question that comes to mind is "Why is the U.S. government investing in an unproven smallpox drug when it has has already spent $1 billion to stockpile a vaccine against smallpox?" Last year, Randall Larsen, CEO of the non-profit Weapons of Mass Destruction Center, told USA Today in regard to the smallpox vaccine stockpile:
"In effect, we have eliminated smallpox from the category of weapons of mass destruction …"
Again, why then is the government now insisting it is necessary to double-up on a drug for the same purpose, in the name of smallpox preparedness?
What's more, Siga's ST-246 only has a "guaranteed effective" shelf life of 38 months, which means if it's not used in just over three years, it will be worthless. Of course, I use the term "effective" loosely, since no one actually knows if it will work in humans -- and because researchers cannot ethically infect test participants with smallpox, there's no real way to find out. As recently as May 2011, the Los Angeles Times reported that FDA officials stated "there was "no clear regulatory path" for approving antiviral drugs for smallpox" — again because of the uncertainty surrounding proof of safety and effectiveness.
The Government Eliminated All Competitors, Gave Siga a No-Bid Contract
Siga was the only company that the U.S. government asked to submit a proposal for the antiviral smallpox drug, even though its price of $255 per dose is far higher than what Department of Health and Human Service negotiators wanted to pay.
The LA Times noted:
"Negotiations over the price of the drug and Siga's profit margin were contentious. In an internal memo in March, Dr. Richard J. Hatchett, chief medical officer for HHS' biodefense preparedness unit, said Siga's projected profit at that point was 180%, which he called "outrageous.""
Rather than allowing companies to compete for the contract, government officials "completed a required 'justification for other than full and open competition,' which said an antiviral against smallpox was needed within five years and Siga was the only company able to meet that timetable," the LA Times reported.
Siga's most prominent shareholder is Ronald O. Perelman, a billionaire who donates to the Democratic party. Siga also counts as its chief executive, Dr. Eric A. Rose, who served on the U.S. National Biodefense Science Board advising on such matters as how to respond to biological terrorism.The company has also spent $800,000 on lobbying efforts over the years, focused on Project BioShield and, according to the LA Times, "'issues related to homeland security and HHS,' along with 'government procurement of vaccines.'"
"In June 2010, Siga further heightened its presence in Washington by naming to its board Andrew Stern, former head of the Service Employees International Union and a frequent visitor to the Obama White House. The union is a wellspring of campaign money and volunteers for Democratic candidates."
The federal government has already invested a reported $115 million in the development ST-246, and that's without the $433-million contract.
Be Aware of the Problem-Reaction-Solution Process …
There is a process that some refer to as Problem-Reaction-Solution, in which you create or manufacture a problem, which is followed by a public reaction, and then you provide an answer designed to further your own agenda.
With respect to ST-246, the problem created was the imminent threat of "bioterrorism" using the smallpox virus. Similar Problem-Reaction-Solutions have been created in recent history, such as anthrax and the anthrax vaccine. Predictably, people react to the implied threat of further attacks with widespread panic, and the solution offered up in response to these threats is, ultimately, a drug or vaccine.
This obviously creates a massive opportunity for drug and vaccine makers, as it allows them to produce highly profitable new products, that are approved with little testing due to fast-track status, under the guise of protecting homeland security and public health.