We have a major drug problem here in the US.  No, I am not talking about illicit street drugs.  I am referring to prescription medications that are supposed to help people.  In the US every year, more people die from taking prescription medication than illegal drugs; by as much as a factor of ten.   In fact, drug deaths, primarily from prescription medications, outnumber deaths from traffic accidents (LA Times).  Who is protecting us from this public health crisis?  Is the FDA negligent or merely ineffective?

Prescription drug spending in the US has increased from $40 billion in 1990 to $320 billion in 2011.  Along with that increase in pharmaceutical revenue has been a significant increase in monetary fines.  The Public Citizen’s Health Research Group authored a study showing that fines against the pharmaceutical industry represented the largest monetary fines levied by the government in the last 20 years.  But is that enough?

There has been public outcry from citizens and lawmakers about the horrible conditions at a Massachusetts compounding pharmacy that led to several hundred recent deaths from fungal meningitis.  This seems to be a case of pure neglect and/ or incompetence.  Criminal charges have yet to be made but there are calls for tighter regulations of that industry, citing the pharmaceutical industry as an example.

Curiously, the FDA regulations of the pharmaceutical industry have done little to protect US citizens.  Two widely published cases illustrate the point.  Merck’s painkiller, Vioxx was pulled from the market due to increased heart attack rates among users.  It is estimated that over 50,000 people died from taking it.  Merck was found guilty of suppressing negative research on the drug prior to its release and paid billions in fines.  Any criminal indictments?  No.

More recently, Glaxo suppressed research for over ten years documenting increased heart attack risks for people taking their diabetes drug Avandia resulting in 47,000 deaths.  Glaxo just agreed to pay $3 billion in fines to settle claims that “Glaxo misled consumers about whether Avandia caused heart attacks and strokes to pump up sales.”  Although there were internal company emails with instructions to suppress the data, company officials were allowed to plead guilty to misdemeanor charges.  Anyone go to jail?  No.

Billions of dollars sounds like a lot of money until you realize that these two drugs sold $2.5 and $3.5 billion per year, respectively.  Sadly, Arizona Attorney General Tom Horne said: “This Consent Judgment is tough, fair and it holds GlaxoSmithKline accountable for how the company marketed Avandia.”  Accountable? Really?  What are tens of thousands of deaths worth, anyway?