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  • The U.S. government has awarded a nearly half a billion dollar contract to pharmaceutical company Siga Technologies for 1.7 million doses of an experimental smallpox drug called ST-246 (Tecovirimat).
  • The drug has been granted fast-track approval status by the FDA, without proper testing -- because testing a smallpox drug in human subjects is unethical, as it would require participants to be infected with smallpox.
  • The U.S. government has already stockpiled 300 million doses of potentially dangerous smallpox vaccine, which in addition to providing protection before exposure, is said to protect against smallpox after exposure --, in essence fulfilling the same (redundant) purpose as new ST-246 drug.
  • The U.S. government is claiming the need to stockpile the drug in order to strengthen U.S. preparedness against a hypothetical terrorist attack using weaponized smallpox. In reality, only the U.S. government and a Russian science institute are known to have the virus, which means that there is no reason to believe smallpox is in the hands of any terrorist group, or an imminent threat.
  • Siga was the only company 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.
  • Siga board members and shareholders have donated heavily to political campaigns and its chief executive served on the U.S. National Biodefense Science Board advising on such matters as how to respond to biological terrorism.
 

Why is the U.S. Doubling Its Protection Against this Non-existent Health Enemy?

December 24, 2011 | 60,388 views
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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.'"

The LA Times continued:

"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.

Protect Your Right to Informed Consent and Defend Vaccine Exemptions

With all the uncertainty surrounding the safety and efficacy of vaccines, it's critical to protect your right to make independent health choices and exercise voluntary informed consent to vaccination. It is urgent that everyone in America stand up and fight to protect and expand vaccine informed consent protections in state public health and employment laws. The best way to do this is to get personally involved with your state legislators and educating the leaders in your community.

THINK GLOBALLY, ACT LOCALLY.

National vaccine policy recommendations are made at the federal level but vaccine laws are made at the state level. It is at the state level where your action to protect your vaccine choice rights can have the greatest impact. It is critical for EVERYONE to get involved now in standing up for the legal right to make voluntary vaccine choices in America because those choices are being threatened by lobbyists representing drug companies, medical trade associations, and public health officials, who are trying to persuade legislators to strip all vaccine exemptions from public health laws.

Signing up for NVIC's free Advocacy Portal at www.NVICAdvocacy.org gives you immediate, easy access to your own state legislators on your Smart Phone or computer so you can make your voice heard. You will be kept up-to-date on the latest state bills threatening your vaccine choice rights and get practical, useful information to help you become an effective vaccine choice advocate in your own community. Also, when national vaccine issues come up, you will have the up-to-date information and call to action items you need at your fingertips.

So please, as your first step, sign up for the NVIC Advocacy Portal.

Share Your Story with the Media and People You Know

If you or a family member has suffered a serious vaccine reaction, injury, or death, please talk about it. If we don't share information and experiences with one another, everybody feels alone and afraid to speak up. Write a letter to the editor if you have a different perspective on a vaccine story that appears in your local newspaper. Make a call in to a radio talk show that is only presenting one side of the vaccine story.

I must be frank with you; you have to be brave because you might be strongly criticized for daring to talk about the "other side" of the vaccine story. Be prepared for it and have the courage to not back down. Only by sharing our perspective and what we know to be true about vaccination will the public conversation about vaccination open up so people are not afraid to talk about it.

We cannot allow the drug companies and medical trade associations funded by drug companies or public health officials promoting forced use of a growing list of vaccines to dominate the conversation about vaccination. The vaccine injured cannot be swept under the carpet and treated like nothing more than "statistically acceptable collateral damage" of national one-size-fits-all mandatory vaccination policies that put way too many people at risk for injury and death. We shouldn't be treating people like guinea pigs instead of human beings.

Internet Resources Where You Can Learn More

I encourage you to visit the website of the non-profit charity, the National Vaccine Information Center (NVIC), at www.NVIC.org:

  • NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries, and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
  • If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
  • Vaccine Freedom Wall: View or post descriptions of harassment and sanctions by doctors, employers, and school and health officials for making independent vaccine choices.

Connect with Your Doctor or Find a New One That Will Listen and Care

If your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don't want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to stop the change in attitude of many parents about vaccinations after they become truly educated about health and vaccination.

However, there is hope.

At least 15 percent of young doctors recently polled admit that they're starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents. It is good news that there is a growing number of smart young doctors, who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families, who decline use of one or more vaccines.

So take the time to locate a doctor, who treats you with compassion and respect and is willing to work with you to do what is right for your child.

[+] Sources and References

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