Emergency Donation of hydroxychloroquine and chloroquine phosphate; what does compassionate use mean?

Last night the Department of Health and Human Services (HHS) was given 30 million doses of hydroxychloroquine by Sandoz pharmaceuticals (Novartis) and 1 million doses of chloroquine phosphate by Bayer pharmaceuticals. These were donated to the US Strategic National Stockpile (SNS) for potential use in treating patients hospitalized with COVID-19, and for use in clinical trials.

Having this many millions of doses in the HHS SNS assures that there is adequate amounts of this drug available to treat all currently approved diseases, mainly malaria and rheumatic disorders. Also, while there is no formal data supporting the use of these drugs in treating COVID–19, they are being used widely and there have been reports of shortages. 

The FDA also issued an Emergency Use Authorization (EUA) to allow these drugs to be distributed and legally used by physicians. It also allows the shipment of these drugs by the government, as currently the government had no legal approval to stockpile or distribute these anti-malarial drugs.

There are a number of important points to take away from this announcement.

• This does not mean that the drugs are either safe or effective in treating COVID–19. There clearly need to be clinical trials to provide scientific evidence that these treatments are effective. As I have stated before while there is anecdotal data suggest the drugs may offer some benefit, the actual doses, time of use and adverse events are not known.

• It does assure there is an adequate supply of these drugs and provides legal coverage to physicians who prescribed the drugs for this purpose. 

• Most importantly it gives information to doctors about the use of both chloroquine phosphate and hydroxychloroquine in treating COVID-19. This provides important limitations on using these drugs in COVID-19 including the potential risk associated with this therapy, along with interactions between these drugs and other medications the patient may be using.

Until clinical trials are performed the drugs remain under compassionate use. In other words, a unproven, desperation play that physicians can use to treat patients in the direst of situations.