Friday, December 2, 2011


A problem that seems to be growing and to be continually getting worse is the issue of shortages and the unavailability of critically needed pharmaceuticals. This is an issue that has been around for quite some time, for example see this overview that I penned back in 2002. However, over the past few years the frequency and length of the shortages, the critical nature of the drugs involved, and their negative impact have been growing and have approached alarming levels.

One result is that the visibility of the issue has greatly increased - stories and articles about drug shortages (both in general and related to specific drugs) have migrated from mainly being covered by the 'trade' press to appearing in national and local news outlets (newspapers, radio, television, etc.). Their frequency has also increased, and shortage-related stories now appear as a weekly, if not daily, staple of the news. Additionally, coverage has spread from 'hard news' outlets to a myriad of other outlets - general magazines (e.g. Wired), blogs, etc.

Perusing the various articles and reviewing the hundreds and thousands of readers' comments, it is interesting to note that most reactions seem to fall into two polar camps. One group blames the government, red tape, and over-regulation for the problem, while the other blames 'greed' (mostly pharmaceutical company greed, but also healthcare provider greed) and sees government intervention as the answer. See below for a very few examples:

So, is it possible that drug shortages are now some sort of Rorschach test, in which one's reaction to the issue can be considered "projective" i.e. the issue allows one to project his or her real biases into the issue via his/her interpretation of the causes and the steps that need to be taken to resolve the issue?

A common characteristic of most of the coverage and the readers' comments is that they boil down what is a very complex issue to simple (and usually simplistic) answers: One answer, the problem is caused by the greed of the pharmaceutical companies, who are actually deliberately causing the shortages. Presumably the thought here is that the shortages will lead to increased prices, and thus higher profits. A minor variation on this theme is that the manufacturers cause the problems by under-investing in their facilities. Again, the cause is greed, the deliberate under-investment being to fatten margins. However, drug pricing is not elastic, and when a manufacturing line shuts down the pharma company loses money as it has no sales income while it still has the cost of the plant. Additionally, its contracts often contain "failure to supply" clauses, obligating the pharma company to reimburse providers if they incur additional costs sourcing alternate, higher-priced product (assuming an alternative exists). Thus causing manufacturing problems (either deliberately or inadvertently) hardly seems to be a viable strategy. The opposite answer, the problem is caused by the government via unnecessary burdens including onerous legislation, red tape, price controls, and other government inspections, controls and regulations... If only the government got off the pharma companies' backs, all would be well. This too is overly simplistic, the inspections, controls, and regulations are there to protect the public, and we have seen what happens when these do not work (e.g. the recent heparin problems). Those decrying them are often the first to call for someone's head when a failure does occur and products get through that hurt consumers!

Another characteristic of the proponents of each answer is a willingness to believe the worst about the motives of those who they hold as responsible. Thus "greedy" pharma companies put money and profits ahead of the health of the population, indeed ahead of their very lives; faceless bureaucrats live to stifle businesses that seek to better the national good... Rapacious providers put their margins and profits ahead of the needs of their patients; while pencil-pushers use mindless regulations and red tape to stifle innovation and the operations of those striving to produce life-saving drugs...

The size and scope of the problem is such that it is difficult to see a solution. However, everyone agrees that "something needs to be done" this usually by someone else. At a recent FDA public meeting to discuss drug shortages, presenter after presenter came up to provide stories of shortages and how they adversely affect one group or another - Oncologists testified how shortages of life-saving chemotherapy drugs put the lives of their patients at risk; pharmacists testified how shortages of drugs have affected their patients, including the cancellation of necessary surgeries due to shortages of anesthesia drugs; patients with esoteric diseases testified how shortages of simple electrolytes and parenteral nutrition drugs threaten their survival; pediatricians told stories of kids at risk because needed therapeutic drugs were unavailable; and researchers testified how research studies and protocols for future drug breakthroughs are put at risk due to difficulties in the procurement of some of the drugs involved. Each had multiple, excellent reasons why their patients needed the drugs, all were unanimous that the situation was unconscionable and that action was needed, but few (if any) had concrete suggestions for solutions to the problem! The FDA representatives present were at pains to spell out all that they do and to take credit that the situation would have been worse had they not succeeded in averting a number of shortages, but even they had few answers! Add "something needs to be done" to what seems like a huge and insoluble problem and many automatically turn their thoughts to legislation and a governmental role in the solution!

With such a huge and escalating issue, naturally politicians are increasingly involved, be that in response to the concerns of their constituents or because this is an area of interest/concern for them. However, often they too cast this as a one-dimensional issue and put themselves on one side or the other (as described above). Thus we get generalized denunciations of 'excessive regulation' on one side, and suggestions that additional requirements and mandates be placed on drug manufacturers on the other. These start off with a fairly uncontroversial (if most likely ineffective) requirement that pharma manufacturers provide advance notice (when possible) of availability problems. However, not content with this, the talk turns to instituting a system of significant fines and penalties to enforce these notification provisions ("civil fines for noncompliance that could reach $1.8 million under the House version" see here), and then imposing additional requirements....

President Obama issued an Executive Order "directing the FDA and Department of Justice to take action to help further reduce and prevent drug shortages, protect consumers, and prevent price gouging." A mostly symbolic act, this generated multiple headlines which act to reinforce both sides' preconceptions that this is an issue amenable to a political solution. Also, by using language such as "... reminding them of their legal responsibility...", and "... illegally hoarding medications or raising prices to gouge consumers...", the order appeared to reinforce those believing in the "greed" version of the issue (especially when magnified by news headlines picking up on this language.) This also may have had the effect of confusing people to believe that a symptom of the shortages (the grey market) is actually one of the causes of the shortage...

So, finally, a quick recap of what the 'drug shortage ink blot test' reveals about the public's reaction to and discourse on this problem:
  • An apparently unquenchable thirst for simple, one dimensional answers.
  • A willingness to ascribe the worst motives to others.
  • A "something needs to be done" reflex that, allied with a feeling that the problem is so much bigger than one can handle, can inexorably lead to a 'government action is the only viable option, and legislation - generally coercive - is the main answer' response.
  • With all of the above reinforced by shoddy reporting, and the best efforts of the political classes (on a bicameral and bipartisan basis) to implement band-aids and/or ill-considered solutions!
This paradigm mirrors numerous other problems/areas in which there is very little in the "middle" and in which most seem to choose to exist on the extremes... In general the extent of this polarization seems to be expanding, at least at present. Why this should be is beyond the scope of this blog entry; however the increased polarization is clearly illustrated by the 'drug shortage ink blot test.'

Previous blog entries on drug shortages:
Help on the way? - July 31st, 2011
Random charts - April 6th, 2011
The why's of drug shortages - March 30th, 2011 (update of a 3/03/2002 oped)


Rx Drug Shortages Hit All-Time High
Drug Shortages Increasingly Take Toll on Care
Drug Shortages Are Mostly Generic Injectables
The Number Of Drug Recalls Is Rising How Fast?
Drug Shortages: Endangering Human Lives and Pets, Too
DeGette on drug shortages: ‘It’s a problem that’s crept up on us.'
Drug Hoarders, Manufacturing Cuts Exacerbate Shortage of Key Medications
Navigating Drug Shortages in American Healthcare: A Premier healthcare alliance analysis

Vital Drugs in Short Supply
Obama Tackles Rx Drug Shortages
Obama Tries to Speed Response to Shortages in Vital Medicines
Obama Calls on FDA to Reduce Drug Shortages, Stop ‘Gouging’ by Resellers
Fact Sheet: Obama Administration Takes Action to Reduce Prescription Drug Shortages in the U.S.

FDA: Letter to industry
FDA: A Review of FDA's Approach to Medical Product Shortages

Drug Shortages
The Bush-Obama Rx Shortages
Shortage of cancer drugs tied to simple economics, experts say
The Shortage of Essential Chemotherapy Drugs in the United States

FDA charts on drug shortages:

The answer:
Since the current drug shortages have multiple causes and do not result from a unique set of circumstances, the answer of necessity needs to be multifaceted, addressing and mitigating as many of the potential causes as is possible. This would include the following and much more:

The identification and remediation of many market-distorting rules and regulations (example: cost reimbursement methodologies that may distort/influence prescribing patterns); closer cooperation, even integration, between the FDA and pharma manufacturers; increased flexibility on both sides (e.g. pharma ramping up production where possible to mitigate shortages; the FDA expediting reviews and approvals, looking at extending expiration dating where feasible, perhaps non-recall actions (e.g. 'dear Doctor' letters) in response to some non-product issues with labeling and/or 'paperwork', expedited product specification changes, etc.); improved transparency on all sides; increased collaboration in developing responses to raw material availability issues or to natural disasters effecting production; and many more.

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