By email to [email protected]
Susan Shurin, M.D.
National Heart, Lung, and Blood Institute
National Institutes of Health
Dear Dr. Shurin:
We are writing to continue our correspondence on the possible use of statins to prevent influenza deaths. The two previous letters are posted online: our letter of November 13, 2009, to Secretary Kathleen Sebelius and your letter of reply of May 24, 2010.
Soon after Secretary Sebelius took office we wrote her about a broader subject: a lack of transparency in the pandemic flu vaccine program and the risk that serious defects in the program, undisclosed and thus uncorrected, might lead to vaccine shortages in a pandemic. Since its inception in 1981, the Project On Government Oversight has advocated greater transparency in government. A vaccine shortage actually occurred, but the pandemic proved to be a mild one. Thus the public health suffered relatively little from the inaction of senior members of the Department of Health and Human Services and their failure to deal more openly with the nation's insufficient capacity for rapid vaccine production.
Research on statins and other immunomodulatory drugs for possible use in a flu pandemic would also benefit from a more open discussion. We think that clinical and nonclinical research on this issue deserves more attention within DHHS. If department officials have reasons not to encourage and invite research on this issue, we think these reasons should be discussed more openly.
Statins for treatment of influenza
In the present letter we urge NHLBI to encourage and support studies on the possible use of statins and other immunomodulatory drugs to prevent influenza deaths or mitigate the course of the illness – studies like STIP ("Statin Trial for Influenza Patients").
Your May 2020 letter mentioned an ARDSnet trial ("Statins for Acutely Injured Lungs from Sepsis (SAILS)"). Although you said the trial was ready to start, it had apparently started a few months earlier, in January 2010, according to ClinicalTrials.gov. The SAILS trial will likely include very few patients with seasonal influenza or pH1N1.
When we wrote to Secretary Sebelius in November 2009, we urged her to fund the STIP trial without delay by exercising her enhanced powers as Secretary in the public health emergency that had been declared. The STIP protocol had already received FDA approval when the trial began in October 2009, and soon afterwards most of the participating institutions had received IRB approval. However, in mid‑November 2009, when we wrote Secretary Sebelius, it was not clear that the 2009 pandemic would be as mild as it proved to be. Now STIP is in a holding pattern until the next flu pandemic.
For this reason we urge you and other NHLBI leaders to encourage clinical research on seasonal flu with goals similar to those of STIP. One possibility suggested to us by Dr. Gordon Bernard would be a trial of statins and similar agents conducted with outpatients during annual outbreaks of seasonal flu.
In addition, NHLBI should encourage laboratory studies of statins and other agents for the treatment of influenza . These studies, in animal models, would be much less expensive than clinical trials and would be much quicker. The results would provide critical guidance for choosing which specific agents (statins, glitazones, fibrates) or combinations of agents to test in clinical trials.
The value of statins and other agents for patients with cardiovascular diseases is well known and undeniable – demonstrated safety and effectiveness and extremely low cost. What is not known is whether some of these agents would also be useful for treating influenza.
We'd all wince if we saw notices or advertisements like this in the next flu pandemic – people gulping statins because they they had heard from a friend that this untested remedy might be useful if they got sick. In a pandemic, NHLBI should be ready to announce what was found when a particular statin or other drug was given to a group of severely ill, hospitalized flu patients. The public will surely look to the NHLBI for such a statement.
This August, soon after WHO announced that the H1N1 pandemic had mainly run its course, The Lancet noted that the pandemic "largely caught the research community unawares" and that "few patients were entered into randomised trials, and thus solid data to inform treatment decisions for future pandemics are lacking." It was an opportunity that need not have been lost. Five years ago the federal government's National Vaccine Advisory Committee (NVAC) recommended that classes of drugs such as statins should be investigated for their impact on influenza during a pandemic (see here, page D-29, and here, page 6).
Possibly you and your colleagues in NHLBI and NIAID and in the office of the Secretary of HHS are satisfied that this area of research – the possible use of statins for those severely ill with influenza – is receiving sufficient attention and support. If so we ask that you justify your position more openly. The public interest will benefit from from greater transparency on this point as on many others.
We would appreciate having your comments on these issues.
Project On Government Oversight
Ned Feder, M.D.
Project On Government Oversight
1100 G Street, NW
Washington, DC 20005
cc: Kathleen Sebelius, Secretary, Department of Health and Human Services
Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, NIH
Dr. Robin Robinson, Biomedical Advanced Research & Development Authority, DHHS
Dr. Bruce Gellin, Director, National Vaccine Program Office, DHHS
Dr. Gordon Bernard, Professor of Medicine, Vanderbilt University Medical School