Dec 6, 2020

Pfizer’s miracle should speed up Big Pharma

written by Lisa Eason

Reactions by governments and scientific advisers to Covid-19 fall largely into two categories. The first set of interventions — lockdowns and physical distancing — are medieval, and almost certainly lead to a greater toll of net harm caused than benefits gained. The second — developing new vaccines at breakneck speed — is a 21st-century solution and likely to produce minimal collateral damage, assuming that they are safe.

Of course, the latter response takes time. However, despite the fears of many (including me) that an effective, safe vaccine available in sufficient quantities would take years, the Pfizer/BioNTech vaccine has been approved by the UK regulator and will soon be dispensed.

The pharmaceutical industry, drug regulators and the world’s scientific laboratories have worked at unprecedented pace to invent, produce and approve novel vaccines for hundreds of millions of people.

Prior to this pandemic, the fastest-ever vaccine developed was Merck’s Ervebo, an anti-Ebola medicine. It took five years from initial trials to approval in 2019. In the past 25 years, only seven genuinely new vaccines have been approved by America’s Food and Drug Administration (FDA). In 2020-21, it is likely that at least five new vaccines will be approved for the coronavirus alone.

My experience at the Institute of Cancer Research, where we have one of the most successful cancer drug discovery programmes of any academic centre, is that it can take typically 14 years from a patented compound in the lab to treating patients. Monoclonal antibodies took 25 years from their discovery to being used in cancer treatments. This has always struck me as incredibly slow. Somehow, biomedical science should go faster. The sector needs to maintain the sense of urgency that has been apparent during 2020.

I had always assumed that delays in licensing drugs were mainly due to fears about their safety. The horror of awful birth defects suffered by children of women who were taking thalidomide in the early 1960s prompted regulators and drug companies everywhere to adopt a precautionary approach to novel medicines. But the timescales are now too drawn out. This means patients are dying because they cannot receive drug treatments, and the delays mean drugs cost too much to invent and launch.

Often a drug takes so long to come to market that the patent has only a short time left before it expires — so pharma companies feel obliged to charge very high prices to recoup their investment. Drug patents last 20 years in the US and 15.5 years in the EU — so if a drug takes, say, 12 years from first patenting to launch, there may be only a few years of intellectual property protection to exploit those many years of work.

No doubt various governments giving drug companies blanket indemnities from patient litigation has helped accelerate the development of the coronavirus vaccines. In normal times, this ability to avoid claims for severe adverse side effects would not be possible. In recent years, companies such as Glaxo Smith Kline and Pfizer have paid billions to settle lawsuits for unapproved off-label use of drugs. Societies — companies and governments — have thrown huge sums at coronavirus vaccines, committing to all clinical trial phases at the outset. Moreover, the FDA is likely to grant “emergency use authorisation” for these vaccines.

Some drugs take a long time to develop because the technology has not matured. In other cases, the funding is not available to carry out expensive phase one, two and three clinical trials. Sometimes actually manufacturing the drug can present significant obstacles. The potential of an innovative compound can be overlooked for years — or it might fail against an initial disease target but prove effective in another context only appreciated much later.

The rapidity of the clinical trials and approvals from regulators such as Britain’s MHRA for coronavirus vaccines mean procedures that would typically take years have been conducted in a few months. Like everyone, I hope that no one has cut any corners. Assuming that the scientists, doctors, civil servants and pharma executives have taken care, why can’t such streamlined methods be used every time?

Creating pioneering drug therapies is a risky and complex undertaking. The journey typically involves academic research (often government or charity-funded), smaller drug firms and then large pharmaceutical firms. If the system can be made more efficient, and important medicines can reach sick patients more quickly and cheaply as a result, this might be a wonderful by-product of this grim era.