Remember Dr. Kent Brantly and Nancy Writebol, the Americans who contracted Ebola while helping the needy in West Africa and were saved through the use of the still-unapproved drug ZMapp?
Now, the U.S. Food and Drug Administration has refused to provide information about how officials determined that the drug could be used.
The Goldwater Institute, which is campaigning for the “Right to Try” drugs still in the testing process, has filed a Freedom of Information Act request seeking information about the internal approval process that was used.
ZMapp is considered to have been a life-saver in the patients’ cases.
Goldwater wanted to know if the doctors complied with the FDA’s standard “compassionate use” process that other Americans need to follow when seeking to use experimental medications.
The institute reported the average compassionate-use request takes 300 hours to complete.
“If these doctors were allowed access to experimental medication without following the FDA’s normal process, we want to know why and how other sick or dying Americans can also get an exception,” said Jon Riches, an attorney at the Goldwater Institute.
“When time is of the essence, as it was in these two Ebola cases, we can all agree that the government shouldn’t stand in the way of a potentially life-saving treatment. But every sick American should be treated the same by the government; and if the FDA is willing to forgo its own process for some, it should do it for everyone. All we want to know is whether or not the FDA followed its own procedures when dealing with these doctors,” said Riches.
When WND contacted the FDA about the process, spokeswoman Stephanie Yao said: “We can’t comment on specific products. Federal law and FDA regulations prohibit us from disclosing information about drugs in development as the information is considered confidential.”
However, Yao added: “Even though a drug is not approved right now, the FDA can still provide access to potential products through other mechanisms, such as through an emergency Investigational New Drug (IND) application. In order for an experimental treatment to be administered in the U.S., a request must be submitted to and approved by the FDA. The FDA stands ready to work with companies and investigators treating these patients who are in dire need of treatment.”
Goldwater is leading a nationwide move to have states adopt “Right to Try” laws, which would give terminally ill patients the right to access even investigational drugs or other treatments.
These are drugs or other chemicals that have passed the first phase of FDA approval but still may be years away from being available to consumers.
It already is law in Missouri, Louisiana and Colorado, and is in the process of approval in Michigan and Arizona.
Riches said his organization will appeal the denial of the FOIA request.
And the institute has released a video promoting access to the treatments:
[jwplayer OZNidmj8]
WND columnist Walter Williams recently noted the campaign.
“There’s no denying that there’s risk in taking a drug or medical procedure that hasn’t completed clinical trials. The question is: Who has the right to decide how much risk a person will take – he or some faceless Washington bureaucrat? In my opinion, the answer depends upon the answer to the question: Who owns you? If one owns himself, then it is he who decides how much risk he takes. If government owns you, then you don’t have the right to unilaterally decide how much risk you’ll take.”
WND reported that fewer than 1,200 patients across the U.S. qualified for “compassionate use” in 2011, and the number dropped to 940 in 2012.
The figure contrasts with the 1,529,560 new cancer cases in 2010 alone.
The Goldwater Institute’s model legislation gives terminal patients under a doctor’s care the right to go directly to pharmaceutical firms to obtain drugs in clinical trials.
