Why we can trust Medsafe
The drug agency may have its flaws, but we should be grateful for its existence, argues Ben Gray.
The pharmaceutical industry is rich, powerful and difficult to deal with because the stakes are high.
The costs of developing a drug are enormous and only a small proportion of researched drugs makes it to market. At best, there is a risk of interpreting evidence of safety and efficacy optimistically because of these costs. At worst, information relating to safety and efficacy is hidden to enable marketing.
The costs of releasing a drug that has not been adequately researched can be disastrous. Thalidomide caused thousands of children to be born with severe deformities.
New Zealand suffered an epidemic of asthma deaths from the use of the Berotec inhaler in the 1970s and 80s. The safety of this drug had not been adequately established by the drug company, and this came to light only as a result of independent researchers proving a correlation.
Once something is approved, the companies tend to stop doing quality research on the product. The pharmaceutical industry has a long history of behaving in an untrustworthy manner, with many court cases settled for billions of dollars.
There are risks to approving drugs that are not safe or effective, but also costs if a drug is safe and effective yet its release is delayed because of the time and effort taken to investigate it.
We therefore need regulators to examine the evidence available on risk, benefit and cost-benefit to help us make decisions on what to make available. In New Zealand we rely on Medsafe to decide which drugs are safe to be released and Pharmac to decide which drugs should be funded.
This is difficult work, sifting through large amounts of information, some of which has been deliberately written to be misleading.
It requires an understanding of all the evidence available on the drug and not just the exciting positive findings. An important feature of regulators is that they are accountable through Parliament to the public.
So why do we not rely on agencies from other countries with larger resources than ours to do this work for us? The history of the United States Federal Drug Administration (FDA) provides an important reason.
The FDA has an appalling recent history of regulating pharmaceuticals in the US. It completely failed to address the prescription opioid epidemic that has led to 400,000 deaths and counting. This happened because of systemic problems in the US, including inappropriate influence of the manufacturing companies over the FDA regulators.
The rate of opiate prescribing at the height of the epidemic was 100 times higher than in New Zealand.
The FDA approved the use of hydroxychloroquine for the treatment of Covid-19 in the absence of reliable evidence and against the advice of its advisory panel, because of pressure from President Trump. This resulted in the drug not being available for many rheumatology patients who depended upon it, people being exposed to significant side-effects, and a scrambled effort by researchers to provide definitive data that it did not help to treat Covid.
Drugs should be approved only if we know they work and are safe.
It was reported in late June that the FDA has finally banned JUUL vape devices, seven years after they were first introduced, and after they managed to addict a large proportion of US teenagers in the process of making billions of dollars for the company selling them.
The costs of approving drugs that don’t work or have nasty side-effects are borne by the patients and the limited drug budget, and flow directly into the pockets of the pharmaceutical industry.
We need a trustworthy regulator. There are many reasons not to trust the FDA. The pharmaceutical industry is probably the last industry for which it would be sensible to lessen regulation.
Medsafe is inevitably constrained in what it can do by the size of our population and there is a possibility that there are some delays in its processes for approving medicines, but at least it is accountable to us and trustworthy.