Following Louis Appleby’s, Dan Troy’s and FDA’s logic (see Platonic Lies and Pla(u)to) the greatest public health benefit would come from getting the greatest number of people on the greatest amount of medications to ward off all conceivable risks. This clearly isn’t going to work out well.
This isn’t going to work out well.
Let’s say we appointed someone to look after people rather than suicide rates or bone densities or lipid levels. The first thing such a person would immediately say is that having large numbers of people on multiple medications is a much greater risk than leaving a few lipid levels elevated or failing to pick up all people who rate highly on a depression rating scale.
Once people are on more than 5 medicines a day the risks of something going wrong increase dramatically – we might lower suicide rates but partly by killing off people through heart attacks or other medical mishaps instead. This brings to mind Tom Lehrer’s famous quip:
“Once the rockets go up, who cares where they come down,
that’s not my department says Werner von Braun”.
If there is a limit to what can be treated safely someone is going to have to exercise discretion but a doctor cannot exercise discretion or engage a patient properly if she doesn’t have all the information. But how does the government now tell her that companies and FDA have conceded for close to 30 years that antidepressants cause suicide but have decided to play down these risks? It’s difficult to avoid the impression that it’s the health of drug companies that regulators and others have been most concerned about.
There is an intriguing parallel between drugs and medical devices. A string of scandals recently about faulty hips, breast implants and other devices have put pressure on politicians. The Institute of Medicine reviewed the issue and came to the conclusion that the device approval process needed to be tougher. But instead Congress is considering a bill to speed the approval process (see http://www.startribune.com/business/140360593.html).
Rules to create an identification system for medical devices to help recall unsafe products are stalled and may never be published. AdvaMed, the device equivalent of PhRMA, say their discussions with FDA have become more constructive lately and now look at the role of regulation in the context of innovation, investment, economic growth and global competitiveness.
A public health brief to look after the health of drug companies?
The so called public health mission of FDA which was formerly portrayed as one of avoiding risks has been reframed by Troy, Appleby and others in terms of giving as many patients as possible early access to medicines and devices (see Pla(u)to).
But in fact FDA has never had a public health brief. The 1962 Act that governs FDA makes it clear FDA has no role in the practice of medicine. In as far as they can, their role in public health is to ensure that the claims made by the makers of healthcare goods are honest.
What was going on in 1990 when concerns blew up about Prozac and suicide? Companies and regulators had compelling data that SSRIs caused suicide. FDA turned a blind eye to a miscoding of suicides that breached regulations; company documents conceding a link to suicide; and a series of stratagems to hide the risk. Is it too fanciful to suggest that FDA were primarily concerned about the health of Eli Lilly who were on the ropes after a drug disaster with Oraflex (Opren)? Keeping Lilly in business was part of keeping the pharmaceutical sector healthy – at a time when the US was keen to build up its pharmaceutical sector.
Soon afterwards, following a UK model, an FDA Modernization Act led to FDA being part funded by industry and encouraged to partner industry. We could note that George H Bush had been on the board of Lilly. That Mitch Daniels, later the Governor of Indiana, ran the public relations around Prozac and suicide, coming up with the key concept – it’s the disease not the drug.
Beyond conspiracy theories … innuendo is not enough
Adding details like this just seem to invite allegations of unfounded conspiracy theories. Innuendo is not enough. The case needs something in black and white and more specific than suggestions of partnership.
What about this. On December 8th 2011, Dan Coats, the Republican Senator for Indiana introduced an FDA Mission Reform Act with the following statement:
“The current regulatory environment created by the FDA has forced American companies to eliminate jobs and move operations overseas,” said Coats.“Unpredictable and burdensome regulations from this agency have severely impacted medical device manufacturing, an important industry in Indiana’s economy. These are tough economic times, and we need to support, not punish, our job creators so they can innovate and expand. This legislation will encourage the development of innovative products and protect American jobs.”
Coats’ wants to establish a regulatory system that:
- Advances medical innovation by incorporating modern scientific tools, standards, and approaches to ensure the predictable, consistent and efficient review, clearance, approval and licensing of innovative products (including drugs, devices and biological products);
- Protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness and job creation among the industries regulated by the FDA;
- Identifies and uses the most innovative and least burdensome tools for achieving regulatory ends; and
- Incorporates a patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance.
One question must be: Is the Bill just aimed at doing what FDA in the US and MHRA in the UK have been doing for the better part of three decades? A second is what have the experiments of recent years taught our rulers about our risk tolerance?
Have they calculated how many Margaret’s, Anne-Marie’s, and Millie Kieve’s they can get away with in the UK, and how many Vera Sharav’s and David Graham’s in the US, in much the way you’d think that someone in China has made a calculation about many Tibetan monks can immolate themselves without causing a real problem.
It seems too despairing to say nothing can be done to change things. There is money and there are jobs in safety. In other areas of the economy its the value-added elements that distinguish the West from elsewhere. Why not boutique, artisanal and organic as opposed to factory medicine.
Having a George Bernard Shaw to update Arms and the Man to Pills and the Man would help. He would have to take two differences into account. In this War its the elderly and the young being sacrificed rather than young men. He would also have to come up with a plausible scenario to account for the mysterious behavior of doctors who sit on the sidelines while their profession is taken over by industrialists and bureacrats and their jobs are outsourced.