The Adenovirus Vaccine, Wyeth Labs, and the Defense Department

Here’s another drug company scandal caused, in part, by the profit motive as exercised by Wyeth Labs.  Many years ago, the government developed an oral adenovirus vaccine for military trainees that it licensed to Wyeth.  The vaccine was astoundingly successful, nearly eliminating adenovirus infections in recruits.  But then, the FDA stepped in and told Wyeth that it had to upgrade its manufacturing facility for producing the vaccine.  The cost?  Between $5 and $15 million.  Wyeth told the military it would have to pay, because the military was the only customer and the profitability of the vaccine was virtually nil.  This is the same situation that holds for many vaccines as well as drugs that are needed by small numbers of patients and that are normally cheap to manufacture, known as “orphan” drugs.

The military refused to pay, and Wyeth stopped making the vaccine.  At that point, DoD was forced to consider licensing another manufacturer– but that was impossible.  No one wanted to produce the vaccine at the rates DoD was willing to pay.  So they did another study that proved the cost-effectiveness of this vaccine (no surprise there) and decided to encourage frequent hand-washing instead.  Soldiers in formation were given permission to break formation in order to cover their noses when they sneezed.

Therefore, in approximately 2001, recruits stopped getting the vaccine.  The rates of adenovirus infections skyrocketed, and some recruits died.  The reasons for this are simple: military recruits are put through overwhelming stress during basic training, and many drop out or are forced to postpone training for infections or accidents that would be considered trivial in a less stressful environment.  This lesson was taught, but not learned, during the influenza pandemic at the end of WWI: recruits fell sick and died in huge numbers, while most of the civilian population was little affected.  Some observers thought that this phenomenon was unique to the epidemic strain of influenza, but that simply wasn’t true.  Every infection that would be minor to a civilian is potentially deadly to a stressed out trainee undergoing the extreme physical conditioning typical of boot camp.

Over ten years later, the vaccine is finally coming back into production and is being used in trainees again.  The irony here is that, at the same time, the military was forcing trainees to submit to anthrax vaccination, an even more stressful procedure than boot camp.  Anthrax infections are extremely rare except in occupational exposures (people who treat hides for further use, for example.) The vaccine against anthrax is itself quite toxic, and not all that effective.  The reason for the vaccinations was that someone feared that anthrax would be used as a bioweapon in a coordinated “weapon of mass destruction” attack.

The fact that the US and Russia are the only countries to possess “weaponized” anthrax didn’t deter military planners.  Perhaps they thought that we would be the ones to use this barbaric bioweapon and our troops needed protection from our own weapons.  Perhaps.

The failure of Wyeth to step up to the plate and produce adenovirus vaccine for the military, even at a small financial loss, is an excellent argument for the government to step in and nationalize drug development and production.   This vaccine is only one example of the consistent behavior of every private drug company when it makes a decision about “orphan” drug production.  Considering profit as the main factor in deciding whether, and how, to produce a drug leads to egregious errors such as this.  The behavior of Wyeth (and every other drug company) when it is faced with a profit or loss decision on a vitally needed drug, regardless of the number of people who need the drug, makes it clear that the profit motive must be removed from decisions about drug development and production.