Friday, December 09, 2011

These Bush Era projects were never cheap, were they?

...McCaskill, (click title to entry - thank you) in a letter this week to health Inspector General Daniel J. Levinson, said that Siga's product "is reported to be more expensive and has a shorter shelf-life" than the nation's standard smallpox vaccine. McCaskill's letter referred to a report by the Los Angeles Times on Nov. 13, which revealed unusual steps taken in awarding the biodefense contract to Siga, whose controlling shareholder is Ronald O. Perelman, a longtime Democratic Party donor...

I take it this Bush Era Project is about a product that is similar to Tamiflu in its development.  I don't know that Tamiflu is all that effective.  I know it was a product viewed as important during the Swine Flu outbreak, but, I don't recall it being important enough for everyone to have some in their medicine cabinet.  It sure didn't help in saving lives, maybe prevention.

Girl infected with smallpox. Bangladesh, 1973.
In ordinary type smallpox the bumps are filled with a thick, opaque fluid and often have a depression or dimple in the center. This is a major distinguishing characteristic of smallpox

I know I am grateful to have been spared such a disease when I received a vaccination.  The new drug is being developed as a Bush Era concern for an outbreak in the USA, but, if it sincerely is effective the use can be global.  I don't know off hand if the UN has a worldwide vaccination program, my guess is no.

But, McCaskill is correct, the program needs to be addressed before it is ever implimented.  The initial project is $433 million, so before all that awarded to a company or companies to put into production the effectiveness needs to be looked into.  I hope the drug is what it is supposed to be.  It would be a minor miracle drug for many people.  There are hearings next week by an FDA Advisory Panel to take testimony about it.

The really unfortunate part is if this medication is all it is supposed to be now politics is entering the scene as to the composition of the Board of Directors or something.  It is better to know the facts before the money is spent, but, my guess is this is not an empty promise.  The FDA has its responsibility to determine the benevolence and effectiveness of the drug.  Senator McCaskill was correct in bring it before the public so it receives the scrutiny it should.

In all honesty when a company is encouraged to spend development dollars on a cutting edge technology and then abandoned by the USA government after it is perfected, that is hardly a prudent policy.  The USA is experiencing a sincere shortage of vital IV drugs and if the industry is insulted further by denied success of a viable treatment for smallpox, it will discourage the industry all the more to venture into development in the first place.  I hope the investigation and the FDA hearing places the R&D in a good light for the effort put forth, but, it needs to be known to work before manufacturing begins on a large scale.

It is not unusual for the USA Government to stockpile medications in case of a national emergency.  I think Potassium Iodide is one the government keeps handy.  The military has more stuff they inject into bodies than Carter has little liver pills.

Eighty percent of children that contract the disease die from it.  Smallpox also causes blindness.  There are several variants of the virus as well.  The medication may not work on all of them.  The virus is airborne and more or less a communicable disease.

...In 1967, (click here) when WHO launched an intensified plan to eradicate smallpox, the "ancient scourge" threatened 60% of the world's population, killed every fourth victim, scarred or blinded most survivors, and eluded any form of treatment....

See that, it has been so long since Smallpox was even discussed I had forgotten the darn stuff was once eradicated.


...Through the success of the global eradication campaign, smallpox was finally pushed back to the horn of Africa and then to a single last natural case, which occurred in Somalia in 1977. A fatal laboratory-acquired case occurred in the United Kingdom in 1978. The global eradication of smallpox was certified, based on intense verification activities in countries, by a commission of eminent scientists in December 1979 and subsequently endorsed by the World Health Assembly in 1980....

So, I guess there is good reason to reconsider the expenditure of the production of the medication, but, there is the disincentive of having companies respond to requests of the USA government when asked to do so.

Surveillance of smallpox infection is probably easier than for any other infectious disease. A distinctive rash is produced (see above) which is wholly characteristic in the great majority of cases. The rash is most dense over the face and hands – unclothed and readily visible portions of the body.

How many more of these projects exist?  They all seem to run somewhere in the neighborhood of a half a billion to carry out.  Interesting number, but, then Bush/Cheney sent something like $68 billion to Baghdad in case on a air transport for the first infusion.  So, the billion number became common place during that administration.  I just find it odd there is this chronic dollar value attached to these programs.

Duration of protection following vaccination

Vaccination usually prevents smallpox infection for at least ten years.
If symptoms appear, they are milder and mortality is less in vaccinated than in nonvaccinated persons.
Even when immunity has waned, vaccinated persons shed less virus and are less likely to transmit the disease.

So, the 'concept' behind this medication development is that if there is WMD of Smallpox released into the USA there would be a treatment for it because people are no longer vaccinated for it.  Hm.  I guess it was necessary to explore this possibility.