A dramatic rise in flu deaths this year due to the return of the H1N1 virus could be much worse if policy efforts had not begun years ago to ensure that health systems were adequately prepared for an onslaught of infectious disease.
These efforts can be traced to the Department of Health and Human Services under the direction of former Utah Gov. Michael Leavitt. In 2007, the then-HHS secretary launched a plan to ensure that vaccinations were stockpiled and public awareness sufficient to combat a flu epidemic.
The prescience of this action is now clear. At the time, Secretary Leavitt wrote, “current domestic manufacturing capacity is insufficient to provide pandemic vaccine for all Americans in advance of a possible (many experts would say ‘likely’) second pandemic wave.”
That wave did indeed arrive. After a global H1N1 pandemic in 2009, the virus has returned this flu season. So far in Utah, rates have been thankfully low, but other parts of the country are significantly impacted. In California, there have been at least 245 deaths among people under 65 years of age, compared to 26 deaths among the same age group during the 2012-13 flu season. In San Francisco, clinics have been so inundated with cases of the so-called swine flu that triage tents have been built on hospital lawns.
In this case, the increase in mortality is not the result of a shortage of vaccine, though perhaps it is evidence of its underuse, particularly among young and middle-age adults.
A key component of Leavitt’s battle against the threat of pandemic was recognition that America’s capacity to manufacture vaccines and anti-viral drugs was inadequate. Seven years later, it is even less adequate.
A panel of health care experts on Wednesday told a congressional committee that as much as 80 percent of medicines taken by Americans are produced in foreign countries, and may not meet quality standards set by the Food and Drug Administration.
These are not just drugs that would be effective against flu viruses. Nearly all generic drugs prescribed by U.S. doctors are made overseas, mostly in India and China. The FDA is struggling to ensure that quality control is not lost in the outsourcing of pharmaceutical production, but has acknowledged difficulty in achieving such assurance.
Following the terrorist attacks on Sept. 11, 2001, the Bush administration was concerned that infectious agents might be unleashed in metropolitan areas, and those concerns led to an examination of the American supply chain for antibiotics and other drugs.2 comments on this story
That concern continues under the Obama administration. A 2011 survey of drug companies documented a continuing trend toward the foreign outsourcing of pharmaceutical production. This perpetuates the concerns raised in 2007 about America’s inability to guarantee against disruptions in supply, whether by economic factors or by acts of malevolence.
While we support a default rule for free trade in goods and services, the return of H1N1 speaks to the need to account for both national security and public health concerns as our nation prepares for more virulent strands of the flu virus.