After the 1968 Medicines Act, people assumed new drugs were properly tested and safe. Doctors were asked to report side effects through the Yellow Card scheme, but because reporting is voluntary and time‑consuming, most problems – then and today – were not recorded.

This meant early warning signs were often missed. Some experts suggested stronger safety measures, like testing new drugs on a larger group of real patients before full release, but the pharmaceutical industry pushed back because it said it would slow down sales. As a result, these safety ideas were dropped, leaving the public relying on a weak monitoring system that still misses large amounts of harm.

The below is an extract from a document called Pharma and the NHS 1948-2008. A pdf of this document is at the bottom of this blog.

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After the Medicines Act in 1968, doctors and patients in the NHS were confident that new drugs were tested for safety and efficacy in controlled clinical trials and animal studies, though the interpretation and enforcement of scientific standards by industry and U.K. regulators for such testing were not as rigorous as they could have been – permitting some patients to be exposed to unnecessarily toxic drugs (Abraham and Davis 2007).

In addition, doctors were brought into the drug regulatory system via the “Yellow Card” scheme, which asked prescribing doctors to voluntarily report to the regulatory authorities all suspected adverse drug reactions (ADRs) they observed in clinical practice.

The scheme was supposed to track complications associated with each new drug on the market. It was intended to provide an early warning system about dangerous drugs that had slipped through the battery of premarket safety testing and regulatory review.

However, doctors reported, and continue to report, only between 1 and 10 percent of adverse reactions / complications (Lumley et al. 1986; Medawar and Hardon 2004: 154; Millar 2001; Pirmohamed et al. 1998; Walker and Lumley 1987).

Corporate bias ensured that much stronger regulatory interventions that would have been more effective in protecting public safety (but contrary to industry interests), such as more rigorous premarket regulatory review and restricted release of new drugs to the market, were dismissed.

For example, in 1976 the Committee on the Safety of Medicines (CSM) established a working party to consider ways of supplementing the Yellow Card system to improve safety regulation and a scheme of “registered release” was proposed to the working party that would require pharmaceutical companies to complete a quota of (five to ten thousand) patient registrations for a new drug before it went on widespread sale (Dollery and Rawlins 1977).

Registered patients’ results would then be followed in detail. This countervailing intervention by some expert scientists would have formally slowed the market release of new drugs and would have provided more time and evidence for assessment of complications before marketing to a potentially huge patient population.

The Association of British Pharmaceutical Industries ABPI made it publicly known that it was opposed to such a scheme of restricted release for new drugs because it would “unnecessarily inhibit the freedom of doctors to prescribe a new medicine” (Wilson 1977).

However, an article in the industry journal Scrip suggested that an important reason for industry opposition was that such a scheme would have inevitably reduced sales in the initial period of new drug marketing (CSM Interested in Computerised Monitoring 1976). Significantly, the National Economic Development Council’s “sector working party” on the pharmaceutical industry concluded in 1976 that, in order for the pharmaceutical sector to maximise its contribution to a positive balance of payments through expansion of direct export and import substitution, the Department of Health should seek to minimize its interference with the industry’s economic performance (News and Notes 1976).

In this context, the industry resisted curtailment of its sales by measures such as restricted release, and the CSM was asked by the government to look at ways of helping the industry (PSGB 1976).

By the end of 1978, the CSM had abandoned its plans for restricted release of new medicines as being “not practicable” (Range of Post-Marketing Surveillance Schemes 1978). Several members of the CSM and senior regulators at the time have confirmed that the CSM abandoned restricted release largely because of industry opposition (Abraham and Davis 2006: 141–142).