Ben Gray is an associate professor of primary care and family medicine at the University of Otago, Wellington
OPINION: The pharmaceutical industry is rich, powerful and difficult to deal with because the stakes are high.
The costs of developing a drug are very high and only a small proportion of the drugs studied reach the market. At best, there is a risk that evidence of safety and efficacy will be interpreted optimistically because of these costs. At worst, information related to safety and efficacy is hidden to allow marketing.
The cost of releasing a drug that hasn’t been adequately researched can be disastrous. thalidomide thousands of children were born with severe deformities.
New Zealand has suffered an epidemic of deaths from asthma of the use of the Berotec inhaler in the 1970s and 80s. The safety of this drug had not been sufficiently established by the drug company, and this only came to light when independent researchers showed a link.
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Once something is approved, the companies tend to stop doing quality research on the product. The pharmaceutical industry has a long history of unreliable behavior, with many lawsuits settled for billions of dollars†
There are risks to approving drugs that are not safe or effective, as well as cost if a drug is safe and effective, but delayed because of the time and effort it takes to research it.
We therefore need regulators to examine the available evidence on risks, benefits and cost-benefits to help us make decisions about what to make available. In New Zealand, we rely on Medsafe to decide which drugs to release safely and Pharmac to decide which drugs to fund.
ROBERT KITCHEN/Things
Medsafe Group Manager Chris James spoke to the media early last year following the decision to provisionally approve the Pfizer/BioNTech vaccine.
This is difficult work, sifting through vast amounts of information, some of which is deliberately written as misleading. It requires an understanding of all the available evidence on the drug and not just the exciting positive findings. A key feature of regulators is that they are accountable to the New Zealand public through Parliament.
So why not rely on agencies from other countries with greater resources than our own to do this work for us? The history of the US Federal Drug Administration (FDA) gives an important reason.
The FDA has an appalling recent history of regulating drugs in the US. Completely failed to tackle the prescription opioid epidemic that has led to 400,000 deaths and counting. This happened because of systemic issues in the US, including undue influence by the manufacturing companies on FDA regulators. The number of opiates prescribed at the peak of the epidemic was 100 times higher than in New Zealand.
Joe Rondone/AP
The FDA has approved the use of hydroxychloroquine to treat Covid-19 “in the absence of reliable evidence and against the advice of its advisory panel under pressure from President Trump,” Ben Gray wrote.
The FDA cleared use of hydroxychloroquine to treat Covid-19 in the absence of reliable evidence and against the advice of his advisory panel under pressure from President Trump. This resulted in the drug being unavailable to many rheumatology patients who depended on it, people exposed to significant side effects, and a distorted effort by researchers to provide definitive data that it didn’t help. Medicines should only be approved if we know they work and are safe.
At the end of June it was reported that the FDA has finally banned JUUL vape devicesseven years after they were first introduced, and after they managed to get a good portion of American teens addicted while making billions of dollars for the company that sold them.
The costs of approving drugs that do not work or have unpleasant side effects are borne by the patients and the limited drug budget, and flow directly into the pockets of the pharmaceutical industry.
Delivered
Ben Gray: “The pharmaceutical industry is probably the last industry where it would be wise to reduce regulation.”
We need a reliable regulator. There are many reasons not to trust the FDA. The pharmaceutical industry is probably the last industry for which it would be wise to reduce regulation.
Medsafe is inevitably limited in what it can do by the size of our population and there is a possibility that there will be some delay in the drug approval processes, but at least it is accountable to us and reliable.