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The Federal Government’s Inconsistent Ebola Story

The federal government denies having any significant involvement in helping two sick American aid workers in West Africa obtain an unapproved Ebola drug from a U.S. company, but the stories coming from the relevant agencies are murky and inconsistent.

Experts say the non-transparent, strained telling of the government’s involvement, and the passive, anything-goes approach to treating the outbreak, is evidence the U.S. needs to review its experimental drug laws. They also say it’s evidence the country is unprepared to deal with potentially more dangerous contagions at home or abroad.

In late July, two Americans in Liberia – Kent Brantley, a doctor with Samaritan’s Purse, and Nancy Writebol, a missionary for another charitable organization, SIM – were diagnosed with Ebola and received treatments of ZMapp, a highly experimental medication made by tiny San Diego-based Mapp Biopharmaceutical, Inc. The drug was designed with the support of the U.S. military. It’s expensive, difficult to transport, exists only in a limited supply, and before it’s arrival in Liberia, had only been tested on a handful of monkeys.

Brantley and Writebol arrived back in the U.S. in early August. Their return and steady improvement attracted a media frenzy, which in part forced the federal government to detail how the patients obtained the rare, early-stage drug while overseas.

But the government’s explanation has at every point been murky, and at times, conflicted with the stories coming from the private companies involved. All three federal agencies —the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and National Institutes of Health (NIH) —say they played little or no role in the decision-making or drug procurement process.

This seems unlikely, according to Ford Vox, a physician at Atlanta’s Shepherd Center hospital who has written critically about the government’s Ebola response “If [Mapp] did this on their own, they must have had unbelievable confidence in the product and lawyers who know this up and down,” Vox said. “If they went this alone, their investors should be worried, because that’s reckless. A team of scientists could get in a lot of trouble doing that, and I can’t imagine they run their company that way, especially considering they have support from the Department of Defense.”

According to the CDC, it was Samaritan’s Purse, the private humanitarian organization that employs Dr. Brantley, who reached out to them in an attempt to find an experimental Ebola drug. The CDC says it passed Samaritan’s Purse along to NIH, who referred them to contacts within Mapp.

“This experimental treatment was arranged privately by Samaritan’s Purse,” the CDC said. “Samaritan’s Purse contacted the Centers for Disease Control and Prevention (CDC), who referred them to the National Institutes of Health (NIH). NIH was able to provide the organization with the appropriate contacts at the private company developing this treatment. The NIH was not involved with procuring, transporting, approving, or administering the experimental treatments.”

The New York Times first reported this version of events on Aug. 6, and the statement was posted on the CDC’s website a few days later, where it remains.

But the NIH told Morning Consult one of its scientists on the ground in West Africa approached the charity before the group had even decided to pursue an experimental alternative.

“The NIH scientist who was in West Africa referred Samaritan’s Purse to company contacts because they were best equipped to answer questions about the status of their experimental treatment,” the agency said in an email to Morning Consult. “This occurred before Samaritan’s Purse decided to pursue an experimental therapy.”

A statement from Samaritan’s Purse also conflicts with the CDC’s telling of events, and indicates the NIH and other government agencies may have played an active role in procuring the drugs.

“The experimental medication given to Dr. Brantley was recommended to us,” the group said. “We didn’t seek it out, but worked with the National Institutes of Health and other government agencies to obtain this medication.”

NIH did not answer repeated questions on how the agency decides it is appropriate to refer sick patients directly to a private company, how often it does so, and what criteria is considered. In an interview, Dr. Arthur Caplan, the head of bioethics division at New York University, said such referrals are an “ethical call” that he deals with frequently and occasionally struggles with.

The CDC also did not respond to multiple requests for clarification, and when presented with this confusing string of events, the NIH merely reiterated the CDC statement.

The Food and Drug Administration has also sought to diminish its involvement in the transaction.

“In some cases, when a U.S.-based drug company may be pursuing approval of a drug and that drug will be shipped from the United States for investigational use prior to its approval, that shipment will be covered by an Investigational New Drug (IND) [approval pathway],” the agency said in an email. “FDA has procedures in place to permit, in appropriate circumstances, emergency use in individual patients under an emergency IND. In other cases, exports of investigational drugs may be permitted without an IND as long as they meet the export requirements under the law.”

“However, FDA was not involved in the shipment of this experimental treatment to West Africa or the administration of the experimental treatment there,” they added.

But a statement from drugmaker Mapp implies that the process followed FDA guidelines.

“Any decision to use an experimental drug in a patient would be a decision made by the treating physician under the regulatory guidelines of the FDA,” the company says in a statement posted on its website.

The FDA’s jurisdiction here is difficult to decipher. The agency doesn’t govern non-commercial transactions and has limited international influence. And while the IND approval process is one way a patient could obtain an experimental drug, private individuals and companies sometimes operate outside of the regulatory process – and it’s not necessarily illegal to do so. But in these cases, drugmakers usually have little reason to comply with patient’s request. That’s because they take on enormous liability in giving out an unapproved drug, and most patients can’t pay for those drugs out of pocket anyway. In general, it’s safer for the drugmaker to go through the clinical trials process, rather than to openly test its product on a random patient.

In this case, it seems the stars aligned in favor of the American aid workers.

The FDA did not respond to a follow-up question from Morning Consult requesting clarification about how the transaction could be described as having taken place in accordance with their guidelines, and Mapp did not return a phone call or email requesting comment.

In addition to these inconsistencies, many questions remain unanswered because the events transpired hidden from public view. For instance, it’s unclear how the ZMapp, which requires delicate handling in a cold environment, was delivered to Africa.

While nobody is arguing the sick Americans should have been denied the treatment they received, and indeed, everyone Morning Consult spoke with agreed that getting the aid workers ZMapp was the right thing to do, experts say that by claiming to have not been involved, the government set a real-world precedent that raises questions about how the U.S. might handle another, more serious threat.

They also say the disorganized and secretive nature of the endeavor, in which no federal agency has stepped forward to claim responsibility, is a concern.

“An ethical case can surely be made for an organization that puts health-care workers in harm’s way to acquire access to experimental drugs and bring staff home to get the best possible care,” Caplan wrote in a recent Washington Post op-ed. “But that is neither a fair nor just policy for deciding what to do when an emergency arises and rationing is the only option.”

It also raises questions about U.S. compassionate use laws. In June, Morning Consult reported on so-called ‘right-to-try’ laws, which a number of states have passed in an effort to make it easier for dying patients to obtain experimental early-stage medications. The idea is that the federal government shouldn’t tell a dying patient what to do. Despite the inherent conflicts with federal law, the state laws have gained traction on the strength of this emotionally compelling argument.

At the time of that story, medical experts and the federal government stood in almost unanimous opposition to the laws, arguing, among other things, that they’d turn the U.S. drug market into the Wild West. However, it’s difficult now to distinguish between the way in which the American aid workers obtained the drug, and how a private citizen or group in the U.S. might obtain an unapproved medication under right-to-try laws.

“It looks like we haven’t done any planning whatsoever,” Vox said. “There’s no consistency here – it’s left to the market, what connections you have, whether you have money and the media behind you, whether you know who to call…there’s been no planning, despite the fact we’ve been working with these outbreaks for decades…there’s apparently no process and no person tasked with making these decisions.”

Caplan is a fierce critic of right-to-try laws – like many, he believes the laws are thinly written to appeal to emotional, not scientific reasoning, and he argues they do nothing to help patients connect with private companies or pay for the drugs that may be able to help them. But he also acknowledges that the Ebola outbreak exposed the present system as inadequate.

“I think it alerts us to the need for a transparent public policy debate about compassionate use that goes beyond the window dressing of right-to-try laws,” he said. “It would be good if that debate were convened by the FDA, because this comes up in all sorts of situations.”

Vox noted that ZMapp was developed with the military, making it taxpayer property. He left the conversation with a simple matter of concern.

“Who are we going to leave these questions up to?” he asked.

 

25 Responses

Leave a Reply
  1. Drew
    Aug 15, 2014 - 02:32 PM

    Wait, the Federal Government is giving inconsistent stories? So the reports of Ebola are not a result of a youtube video?

    Reply
    • FortSteve
      Aug 15, 2014 - 03:54 PM

      I guess we need to believe that Ebola is a disease of peace.

      Reply
      • Filbert
        Aug 15, 2014 - 06:49 PM

        Brilliant, Sir! I hereby award you the keys to the Internets. Use them wisely…

        Reply
  2. FortSteve
    Aug 15, 2014 - 03:53 PM

    How can anyone expect any federal agency to have transparency and be forthcoming with information when the administration is incapable of doing the same? Most of these federal agencies need defunded and disbanded.

    Reply
    • Darknlovely
      Aug 16, 2014 - 11:12 AM

      I totally agree!

      Reply
  3. mke
    Aug 15, 2014 - 04:06 PM

    You’d have to be a fool to believe anything the federal government says.

    Reply
    • Filbert
      Aug 15, 2014 - 06:52 PM

      You’re right there. I know a former nurse who said she used to get lots of warnings about illnesses and outbreaks that were not to be released to the public. I don’t believe for a minute they’ll tell us the truth if there’s a real epidemic here. I assume they would rather we march into the ICU and drop dead, rather than avoid contact with people and stay at home, not consuming, during an outbreak. If they tell me it’s sunny, I look out the window, first thing.

      Reply
  4. KissMyAmericanFlag
    Aug 15, 2014 - 04:32 PM

    What concerns me is the mention of cloudy connection the US govt and any of its agencies — including USmil — had in ‘developing’ and possibly delivering the strain. Private rules, private procedures, private and “tiny” SanDiego-based entity: Potentially quite diabolical.

    Reply
  5. Sandy
    Aug 15, 2014 - 04:39 PM

    When the information was released that it was Mapp Biopharaceuticals that produced the drug coctail used on the 2 American missionaries, I looked at their website. If you read the research articles posted there you will see that they have been working on an Ebola drug for a decade. In 2012 they posted an article in which they claim that working with the Kentucky tobacco plant, they can produce a new lot every 2 weeks. The drug MB-003, or ZMapp, appears to have been set for clinical trials this August, with a up and running manufacturing goal set for July of this year. They had the experimental doses available to use on the Rhesus monkey’s during the research period. It seems hard to believe that they would not have had more doses available in time to start the clinical trials. It appears that the 2 American missionaries may have been the first humans to be administered the drug cocktail. Yes, the American taxpayers paid for the years of research and development. Leaf Bio was just licensed in July to act as the sales arm of Mapp Bio.

    http://www.mappbio.com/news.html

    Click on the tabs to the right. As you click through them they add additional areas to view.

    Reply
    • Tammy
      Aug 16, 2014 - 02:25 PM

      U are right. I said the samething. This is bullshit. The government is a bunch of liars. If u really want to no what i think i am pretty sure they new about this for a minute and are trying to use it against us. This is crazy. Thanks for web site. Tammy

      Reply
  6. Colleen
    Aug 15, 2014 - 05:50 PM

    Speaking of “murky” I hope the test to determine he is clear of infection is not “murky” and it is full proof

    Reply
    • Tammy
      Aug 16, 2014 - 02:11 PM

      For sure or we all might be in trouble. Huh. T

      Reply
  7. suibne
    Aug 15, 2014 - 06:47 PM

    We don’t have a government….we have a clown college with a campus in dc.

    Reply
  8. Elizabeth
    Aug 15, 2014 - 09:08 PM

    Anyone with two brain cells to rub together knows that this wonder drug was developed and tested as a classified DOD project. We have weaponized ebola on the shelf and ready to deploy in the field. We can’t maintain that capability if we don’t have a cure or vaccine.

    The real kicker is that we didn’t use it to cure the epidemic. We only pulled it out when Americans got infected. That’s a d-ck move DOD.

    Reply
    • Tammy
      Aug 16, 2014 - 01:51 PM

      I agree. We have known about Ebola for years, so why dont they have a vaccine. The government is a buch of liars.

      Reply
  9. ben
    Aug 15, 2014 - 10:31 PM

    If these people could afford to pay for a cure there would be a cure. Not saying we should or should not pay for their cure. Just saying that the fda are scum who have no interest in anything that does not make money.

    Reply
  10. Justin
    Aug 15, 2014 - 10:42 PM

    Original reports said the one doctor was getting a blood transfusion from a patient who survived earlier. Then the report changed to “healed by experimental drug”.

    I mean, how else do you convince everyone this super expensive drug is worthwhile to invest in? I personally believe the original reports based on past research in using antibodies in a blood transfusion from a survivor of the same strain of the virus.

    Reply
    • Tammy
      Aug 16, 2014 - 02:01 PM

      The thing is there trying to say this is a new strain. Do we believe that huh. Tammy

      Reply
  11. Jasonn
    Aug 16, 2014 - 12:19 AM

    Old habits are tough to break, eh?

    Reply
  12. Robert Fallin
    Aug 16, 2014 - 02:49 AM

    The US government has known that certain forms of Ebola can be transmitted by breath since 1989. This was dramatized in the book “The Hot Zone”. Transporting infected patients when so many health care workers practicing infection control have already become victims is either incredibly stupid or incredibly evil.

    Reply
    • Tammy
      Aug 16, 2014 - 02:04 PM

      There are evil. They are all for there self. We are nothing to the government. T

      Reply
  13. James
    Aug 16, 2014 - 07:13 AM

    I think Vox nailed it on the head when he said it was a matter of money, media and connections that was the deciding factor in how this went down. It seems reasonable to ‘follow the money’ as to who could benefit when the Company’s stock price went up, as it must have given the success of the treatment. Look for paid Board Positions and stock purchases of those involved. Unfortunately, it is not dissimilar as to how drugs get approved at the official level. The FDA approved a ‘super Vicodin’ recently even after their advisory process said it wasn’t necessary. I wonder who at the Pharmaceutical ccompany had the connections to get a highly addictive and unnecessary narcotic approved when prescription drug abuse in this country is out of control?

    Hey, it’s only paranoid if it isn’t true!

    Reply
    • Tammy
      Aug 16, 2014 - 02:09 PM

      Thats crazy, because they are taking away everybodys pain meds, so why would they want to make another pain drug. Dosent make sense. Thats the damn government for ya. T

      Reply
  14. Barb
    Aug 16, 2014 - 10:24 AM

    We need to realize that our government is filled with people whose only interest is in preserving their own jobs at the expense of the rest of us peons.

    Reply
  15. Tammy
    Aug 16, 2014 - 01:38 PM

    Hi, This is very serious situation . I think it’s bullshit on the other hand. We are not even ready for a disaster at all. That is scary. The government better get there shit together. Or they are waiting to take us to one of there camps. Yea i said it. Concentration camps. I’m surprised i did not hear fema through this hole story. They usually have a hand in the bullshit to. I think that they all are liars anyway. They Will say anything to get out of telling there secrets. The government, military, cdc, fda, obama, fema. I don’t trust any of them. Things are getting really crazy lately. This outbreak just happens to happen just when we are having a currency collapse, problems with war all this shit is just not a coincidence no way. Anyone to believe that needs to have there head examined. Wel i hope well for everyone and stand up for ur right’s. Thanks for listening. Tammy

    Reply

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