We are at a most unusual juncture. The US Congress is the most polarized ever, with Democrats and Republicans unable to agree on the day of the week. The most divisive issue of all is healthcare. Healthcare is also the greatest problem with costs rising toward 20% of GDP and threatening to sink the economy. If the money were producing better outcomes, there might be less controversy but there is a widespread perception that health is getting worse rather than better.
The only thing both sides agree on is paradoxically a healthcare issue, speedier access to medical drugs and devices. There is currently a Bill before Congress to speed this up and to get FDA to take into account not just the efficacy and safety of drugs but also the fact that drug manufacturing leads to jobs in the United States. In the face of our mounting healthcare crisis, better and more efficacious drugs not unreasonably seem like a possible path to salvation.
In the UK, meanwhile a recent edition of New Internationalist, a Marxist publication, comes with a diagram that is found in everything from Marxist publications through to brochures for PharMA suggesting that 15-20% of us are mentally ill and in need of efficient access to treatment. The issue of access is a recurring theme across healthcare, not just mental healthcare, for stakeholders from both the Right and extreme Left of the political spectrum. All fifty shades of left and right agree we are awash in a sea of unmet need.
But it seems the more we meet these unmet needs, the worse rather than better health gets. Life expectancy in the most advanced countries, those that consume the greatest amount of the most recently developed medicines, is falling relative to other countries. There is no reason to think that meeting even more needs with more of the latest medicines will do anything other than aggravate this trend.
This raises the prospect that for some reason the market in healthcare may not be working. If this is the case, there are two questions. One is why not? The second is whether there is any way in which we can assert an unmet need not to have unmet needs met until normal market service is resumed.
The usual liberal-social democratic response to market failures is to call for more regulation. In this case, as will become clear, while the answer might be smarter regulation, it cannot be more regulation. Regulation has caused or greatly shaped the problem. The usual conservative response is to call for a freeing of the market. Conservatives have a preference for solutions delivered by private enterprise rather than government. In this case those most resistant to and most likely to object to a freeing of the market are private enterprises.
Solving this problem is not only economically necessary but is likely to cut a political Gordian knot that will have long-term political consequences.
In the late nineteenth and early twentieth century, in the face of a widespread and dangerous exploitation of patients with mark ups on drugs of the order of 400 and 500 per cent, the creation of an advertising industry that sold beauty rather than health, product labeling that was grossly fraudulent, and a lack of effective treatments, there was a push to regulate the pharmaceutical industry.
Industry protested but the first regulations were put in place in the United States in 1906 and a series of regulations followed in other countries. It is now clear that a predictable consequence of regulation is to foster a growth in company size as the companies that survive put an apparatus in place to manage their regulatory requirements and this is built into the cost of drugs while other companies go to the wall.
This much is a simple story about a predictable and manageable consequence of regulation that is not unique to the market in drugs. Since then we have had the development of a unique market that was not predictable – or at least has not been predicted or discussed in detail elsewhere.
The initial thrust behind the regulation of drugs was patient safety. The first call was for an accurate labeling of the contents of products, aimed at empowering consumers. During the 20th century there was a steady push towards some specification of the efficacy of drugs. This interest in efficacy was originally a safety issue. If a drug didn’t have efficacy it couldn’t be safe.
The emergence of the randomized controlled trial (RCT) bolstered the argument that demonstrating efficacy was important and a requirement for controlled trials was built into the last set of regulations we have had, the1962 Food and Drugs Act. But far from improving comparative safety, this development has led to a comparative efficacy market that has had adverse consequences for safety.
As with all other regulatory developments, in 1962 the changes followed on a drug safety crisis, involving the sleeping pill thalidomide. This crisis fed into more general concerns about the pharmaceutical industry. The upshot was a series of changes. One involved the incorporation of controlled trials to determine efficacy. A second lay in a decision taken about the patent status of pharmaceuticals. The third development lay in making new medications available on prescription only.
Just as earlier regulations led to company complaints but also a predictable increase in company size and the emergence of the pharmaceutical companies we know today, so there has been a predictable set of consequences to the 1962 regulations. But there has also been a confluence of changes that created a unique market that few have noticed and none has taken fully into account.
These distinct regulatory elements have shaped the pharmaceutical market, the practice of medicine and global consciousness to this day. They have also produced the perfect raw material, the perfect product and the perfect consumer. But if the outcome being sought is an increase in personal health and national wealth the market has produced an unimaginably bad outcome.
In this election year in the US, one of the candidates has the chance to rise to the occasion and sort things out. A series of 6 further posts in the next few weeks covering different dances and ending with a Dance with Python will lay out the elements of the problem and how to solve it.