Cost, need questioned in $433-million smallpox drug deal; Obama tackles drug shortages

At a cost of $433M, the US Government is buying an experimental smallpox drug while at the same time time we are experiencing a shortage of drugs to fight cancer and other illness?  Why are we spending $433M on a sole source contact for the smallpox drug when the only two sources for smallpox are locked up in very secured areas in the US and Russia?  It is not an imminent threat plus this drug is experimental.

Once again a major donor of the Democrats and Obama, Ron Perelman, gets this sole source award who is the controlling shareholder of Siga and whose people convinced the Obama Administration how important it was to invest in this experimental drug.  Wonder if he spent too much time watching James Bond movies?  The way this sole source contract was awarded should set off alarms, but then it is an election season for President so would expect more sole source contracts to be awarded.  Our taxpayer dollars at work which will end up back in Obama and the Democrats campaign coffers. How does it feel to know that with such a huge deficit that Obama has not quit playing politics with our tax dollars?  It irritates me to no end as it keeps happening over and over again.

There should be no sole contracts awarded unless it is an emergency and then they should have to jump through every hoop there is.  To not ask other pharmaceutical companies to bid is ludicrous and shows once again a sole source contract as been steered to a company for political purposes.  That is no way to run Government period.  Make contractors compete and you will get a lower price and a better product in most cases.

Cost, need questioned in $433-million smallpox drug deal

A company controlled by a longtime political donor gets a no-bid contract to supply an experimental remedy for a threat that may not exist. 

By David Willman, Los Angeles TimesNovember 13, 2011Reporting from Washington— 

Over the last year, the Obama administration has aggressively pushed a $433-million plan to buy an experimental smallpox drug, despite uncertainty over whether it is needed or will work.
Senior officials have taken unusual steps to secure the contract for New York-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world's richest men and a longtime Democratic Party donor. 

When Siga complained that contracting specialists at the Department of Health and Human Services were resisting the company's financial demands, senior officials replaced the government's lead negotiator for the deal, interviews and documents show. 

When Siga was in danger of losing its grip on the contract a year ago, the officials blocked other firms from competing. 

Siga was awarded the final contract in May through a "sole-source" procurement in which it was the only company asked to submit a proposal. The contract calls for Siga to deliver 1.7 million doses of the drug for the nation's biodefense stockpile. The price of approximately $255 per dose is well above what the government's specialists had earlier said was reasonable, according to internal documents and interviews. 

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. 

If there were an attack, the government could draw on $1 billion worth of smallpox vaccine it already owns to inoculate the entire U.S. population and quickly treat people exposed to the virus. The vaccine, which costs the government $3 per dose, can reliably prevent death when given within four days of exposure. 

Siga's drug, an antiviral pill called ST-246, would be used to treat people who were diagnosed with smallpox too late for the vaccine to help. Yet the new drug cannot be tested for effectiveness in people because of ethical constraints — and no one knows whether animal testing could prove it would work in humans. 

The government's pursuit of Siga's product raises the question: Should the U.S. buy an unproven drug for such a nebulous threat?   

Excerpt:  Read more at LA Times

Now the Obama is tackling the current drug shortages after awarding $433M for an experimental smallpox drug -- maybe if the pharmaceutical companies had been given part of the $433-million in order to concentrate on manufacturing drugs that are necessary for people to keep living like cancer drugs, we wouldn't have a shortage right.  First I thought this was a manufactured story but then I heard the report that will be upcoming on our local news detailing the shortages after they did an investigation.

How could this happen in America?   Congress has been trying to do something like this since February and to date nothing has been done.  Will someone please tell us why Congress continues to go on recess and vacations with bills left hanging that affect the lives of Americans?  There is way too much political grandstanding in Congress and not enough working together for the American people.  These drugs affect people's lives and they cannot put partisan bickering aside to get the job done?

These are the kind of drugs we are talking about -- not something new on the horizon but basic drugs:

amid mounting alarm among physicians, patients and others about the unavailability of some drugs to treat cancer, to control infections, even to provide basic electrolytes to patients who need intravenous feeding

This is frankly frightening that hospitals could be and some are facing a shortage of these drugs.  The biggest question is WHY?  We are not sure the whole story is out there since some pharmaceutical firms have been accused of price gouging on top of everything else.  How has threats of price gouging charges by the DOJ or discontinuing various drugs due to costs affected the shortage?  Frankly we don't know but will be looking into this further and watching the investigation by a local TV reporter this week.

One thing we do know for sure is that the former Governor of Kansas, Kathlyn Sebelius is most likely the wrong person to be in charge of this as Secretary of Health and Human Services.  Her degree is in political science and was executive director and chief lobbyist for the Kansas Trial Lawyers Association before serving as a member of the Kansas Legislature, Insurance Commissioner, and Governor of Kansas.  When you appoint someone for political purposes instead of experience, you end up with a Secretary who seems to be over her head most of the time.

Obama tackles drug shortages

An executive order directs the FDA to press companies to more quickly report shortages, among other measures.

By Noam N. Levey, Washington BureauOctober 31, 2011, 8:54 p.m.Reporting from Washington— 

President Obama is pushing federal regulators to do more to address dangerous shortages of crucial medicines, sidestepping a deadlocked Congress that has not dealt with the problem.
In an executive order signed Monday, the president directed the Food and Drug Administration to press drug companies to more quickly report shortages to federal regulators, an early warning that advocates say can help mitigate shortages. 

The order, which administration officials concede does not give the FDA any new authority, also told the agency to expedite reviews of new manufacturing facilities. 

And it directed the FDA to work with the Justice Department to step up investigation of price gouging in the pharmaceuticals market. 

"Congress has been trying since February to do something about this," Obama said at the White House. "It has not yet been able to get it done. … We can't wait for action on the Hill."
The White House action comes amid mounting alarm among physicians, patients and others about the unavailability of some drugs to treat cancer, to control infections, even to provide basic electrolytes to patients who need intravenous feeding. 

There were 178 drug shortages reported to the FDA in 2010, the agency said. And this year, federal regulators have seen a continuing surge in reported shortfalls. 

Some shortages have resulted from quality problems in manufacturing. But others have been caused by drug makers' decisions to stop making some products and by an increase in demand for some drugs that outstrips supply. 

"That's not something we can control," Health and Human Services Secretary Kathleen Sebelius said Monday. "We can't fix the capacity issue." 

Excerpt:  Read More at LA Times

Cannot believe there is not a federal rule that pharmaceutical companies are not required to report when they discontinue a drug or when production disruptions might create shortages.

In detailing their plans, officials said the government would use existing authority to require drug makers to more regularly report when medications are discontinued, and when production disruptions might create shortages. 

There are so many reports required by the Federal Government but this isn't one of them?  What am I missing?  Have the pharmaceutical companies been allowed to do what they want over the years since they are such large donors to political parties and candidates?  In some cases, millions of dollars are donated to Super PACS and 527's for parties and PACs.

This is an example of what is wrong in politics today from both sides.