GSK and the Ebola vaccine: drug approval, ethics, corporate citizenship and regulatory strategy

Is the Ebola vaccine taking too long to get to market or is it being rushed too quickly? 

In spite of the World Health Organization (WHO) recommending that vaccines jump straight to phase III efficacy tests in Liberia, Guinea, and Sierra Leone, questions have been raised about the ethics of the process including the design of clinical trials, how to determine priority amongst prospective patients, and when to begin mass production.

Ebola vaccines are now very effective in monkeys, but deciding how to extend vaccines to humans is ethically challenging.  For example, one placebo-controlled vaccination study planned for Liberia had called for volunteers to be randomly injected with either one of the two candidate vaccines, or with a placebo.  The lead NGO on the ground in West Africa, MSF or Doctors without Borders, strongly opposed the random trial arguing:  “Our health workers would not accept this… imagine.. giving sugar pills to someone who is fighting death.”  Instead, success rates will be compared to the background level of roughly 50% survival, so if survival reaches, say, 75% in a trial then this will be considered evidence of a successful test.  Experts, including the head of the London School for Hygiene and Tropical Medicine, produced a report supporting this approach: “We accept that RCTs can generate strong evidence in ordinary circumstances; not, however, in the midst of the worst Ebola epidemic in history,”

Over the summer there were discussions about various alternative Ebola vaccines and BusinessWeek has a richly detailed piece describing just how complicated it was to get a vaccine through the US regulatory process (including what is meant by ’emergency’ and which agencies have a say in the process).  It had become clear by the end of the summer that the company best positioned to roll out an Ebola vaccine at scale is the ‘British’ firm GSK.  In mid-August there was optimism that a vaccine would be ready for 2015.  As recently as a month ago though, GSK was warning that a vaccine would not be ready in time to deal to deal with the current outbreak and that production would not start until 2016 because testing would not be complete until the end of 2015 (according to one GSK official, “in retrospect we should have pulled the trigger earlier” although they also had been discouraged in the spring by WHO from moving too quickly).

Then, last week the New England Journal of Medicine released a report that the GSK vaccine had produced ‘promising’ results.  GSK reaffirmed that cost should not be a barrier and that it would be working with partners in the Global Alliance for Vaccines and Immunization and others to find a way to make the vaccine available.

Sounds like standard corporate good citizenship and the ‘right’ response to a public health emergency, but is there a potential regulatory strategy angle? Some commentators have already begun to argue that the agencies such as the “FDA should be in Ebola-Mode all the time” pointing to cases such as Sanofi’s Lemtrada, a multiple sclerosis drug and Bexsero, a vaccine against Meningitis B from Novartis, where the US FDA still had not granted permission even long after it was in regular use in other major economics including the EU, Australia, Canada, etc. Even the New York Post (the US equivalent of The Sun) has piled on to complain about ‘the feds’.

In spite of the hundreds of outlets providing coverage of the positive clinical trial results, the only place I can find a bit more insight was in the BBC interview of Sir Andrew Witty, the CEO of GSK, with some incisive questions by Kamal Ahmed. In response to questions about liability and the economics of vaccines, Witty claimed “we have taken financial risks, have taken decisions without being asked and we’ve made decisions without any guarantee of compensation, I think that is the right human response…I think it is obvious that there are some risks here that companies shouldn’t be expected to take on their own, there are inevitably risks that need to be incorporated into some sort of indemnification agreement… and we can reassure our shareholders at that point… but we are not holding anything up in anticipation of that. It sounds trite, but you simply have to do the right thing…. “

So that leaves much fodder for discussion:

  1. One might always challenge the ‘ethics’ of RCTs, how is this case different?
  2. Is this simply a welcome chance for a bit of good PR for GSK after the past years of bad PR including a $3B fine from US authorities to settle a host of civil and criminal charges and the more recent $490M fine from China (plus deportation for bribery)?  More generally how should companies make calculations of how and when and where they can ‘afford’ corporate social responsibility? Or is that question too cynical and one should simply expect companies to ‘do the right thing’?
  3. Is Ebola a good opportunity for advocates of reforming the drug approvals process proving that one should ‘never let a good crisis go to waste’?  Do you think that this crisis provides one of Kingdon’s policy windows? Does it satisfy all the requirements, that is, do you think that change is likely?