Healthy Skepticism Library item: 20528

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Badwe R, Baum M
London Perspective: British medicines wrapped in fog
The Lancet 1992 Jan 4; 339:47

Abstract:

Secrecy enshrouds almost every aspect of British life. It starts at the top with the Government, but seeps down to the most mundane level: details about compensation for cancelled trains or waiting times in post offices are both closely guarded “secrets”. Mrs Thatcher increased the central control over information through changes to the Official Secrets Act, a new Contempt of Court Act, and the Law of Confidentiality. Long before she came to power, however, the secrecy culture had enveloped every aspect of medicine – licensing, regulation, and the control of drug marketing. Now this secrecy is being seriously challenged.

In a report published last month (Pharmaceuticals, a Consumer Prescription), the National Consumer Council (NCC) looked at, among other things, the damaging effects of secrecy on public access to crucial medical information. Compare, for example, the UK with the USA, where patients have a right to know why a new medicine has been licensed, the sorts of clinical studies undertaken (including “lethal dose” studies), and detailed information on side-effects such as dependency effects or potential interference with reproduction. In the UK all information supplied to the Medicines Control Agency (MCA) is strictly confidential, as is the advice that ministers receive from the agency and the other medicine advisory bodies. Patients are not permitted to know in what circumstances their medicine are licensed. They cannot see any information on adverse drug reaction. They cannot learn why a medicine has been withdrawn from sale. And no member of the MCA may divulge the ingredients of any drug formulation. Section 118 of the 1968 Medicines Act, which sets out present framework, creates a catch-all to end all catch-alls: staff are prohibited from saying anything about anything.

If British patients want more facts about the drugs they are taking, they have to seek them out in the USA, where the Food and Drug Administration has to publish summaries of the basis on which approval has been granted. In the words of the NCC: “It is ironic and insulting that UK consumers can get more detailed information about the medicines they take from information published in another country, than from their own regulatory and professionals agencies. This must be changed”.

The ludicrous nature of existing British procedures for controlling the misleading promotion of drugs has drawn comment from Dr Joe Collier, a clinical pharmacologist at St George’s Medical School, London. Collier, who is due to take over as editor of the Drug and Therapeutics Bulletin in April, was shown an advertisement for ‘Lederfen’ (fenbufen), an anti-arthritis drug taken daily by thousands of British patients, by a general practitioner who had seen it in one of seven medical journals where it had been placed. Lederle Laboratories, the manufacturers, claimed in the advertisement that the drug’s effectiveness was “uncompromised by serious gastrointestinal side-effects”. In reality at least 4 people have died from gastrointestinal bleeding after taking it, and another 72 have had haemorrhages and perforations of the gut. Yet, even after the manufacturer had been told by the MCA to withdraw and redraft its advertisement, officials were not allowed to say what had taken place.

Three weeks after sending the advertisement to the MCA, saying it was clearly misleading and in breach of the 1968 Medicines Act, Collier received a letter of thanks from the agency. It went on to inform him in the most obscure manner that “You should find that in future, the promotional material for Lederfen is more balanced and consistent with the prescribing information”. This was all the officials were able to tell him. When he telephoned for further information, they were unable to elaborate. Collier said this week: “I do not blame the officials, who are required to follow the law, but I do blame the system. Here was a breach as mischievous as you could find, as it is being brushed under the carpet by the secrecy of the procedure. This is a quite inadequate sanction. By then, the advertisement may have already achieved its end: more prescriptions. It only increases the temptation to drug companies to make misleading claims”.

There has been, in fact, only one prosecution of a major pharmaceutical company for misleading claims about a drug. It happened in 1986 when Roussel Laboratories were fined £200,000 (and ordered to pay the prosecution costs of £120,000) for falsely claiming that their anti-arthritis drug ‘Surgam’ (tiaprofenic acid), caused fewer serious gastrointestinal side-effects than competing drugs. The company’s medical director was also fined £1000. This was seen at the time as a step forward, because by making the medical director of the drug accountable it increased the incentive for other directors to exert their influence in an industry where they had previously been overshadowed by marketing departments. The optimistic predictions, however, were not borne out.

Real reform should start at the top with a Freedom of Information Act, which would open up British government and make policy-making much more democratic than today’s closed circle. Sweden has had such a law for 200 years. The US passed its FOI Act in 1968, and France followed suit in 1978 with its Law on Access to Administrative Documents. The Commonwealth (Australia, Canada, and New Zealand) with Westminster-style parliaments all passed FOI laws in the same year, 1982. But Britian’s Conservative Government has continued to resist the idea, although the two main opposition parties both support reform. The NCC declares in its report that it will be pressing for a more open system of drug regulation. It wants the UK to follow the road pioneered by the US, Sweden and Germany in giving consumers more independent guidance on medicines and their effectiveness, and to adopt the French comparative test whereby newly licensed drugs must be an improvement on existing products. European harmonisation will eventually lead operation”, without the support of clinical trials, should be treated with caution. Chapters on resection of hepatic and pulmonary metastases include very critical comment about adjuvant and therapeutic chemotherapy, with a clear bias towards surgery for control of metastasis in selected patients – an opinion largely based on comparison with historical, unmatched controls. By contrast, the chapter on liver transplantation discusses experiences with this procedure but modestly stresses its experimental nature.

Orthopaedic oncology has harnessed hi-tech engineering with stunning results in the management of bone and soft tissue sarcoma, although these accounts might sound more convincing if statistics for overall survival, relapse-free survival, time to ambulation, duration of hospital stay, and cost of treatment were included. The chapters on breast cancer, melanoma, ovarian cancer, and reconstructive surgery are brief, to the point, and bring the relevant facts to the intended postgraduate and specialist readership. These are the only parts of the book to express a healthy criticism of all available data and conclusions based on them. The views expressed in “Pallative Adjuncts” seem personal and based on retrospective data: indeed, the very word palliation has subjective components, and surely there are no descriptions of controlled trials to assess true gains in the quality and quantity of life. Adjuvant radiotherapy and systemic therapy is dealt with judiciously, covering the results of most published randomised trials, although the recommedations made at the end of the chapter are perhaps more dogmatic than one might expect from the evidence available. Novelty is not necessarily progress, and acceptance of a new approach should be decided not by availability but by efficacy. Many novel techniques for delivery of radiation, chemotherapy, and immunotherapy are exciting but as yet unproven and experimental.

With the present explosion of information and the development of new (and, to many clinicians, mysterious) statistical techniques to interpret data, it is good to see such helpful chapters on computers and biostatistics. And it is only humane to accept defeat and not to show an unyielding and unbounded enthusiasm in the management of metastatic disease. Here the role of oncologist is incomplete without an understanding of treatment of pain, and of nutritional and psychological support for the terminally ill. Relief of pain is exhaustively dealt with, and the details of pharmacology, side-effects, nursing responsibilities, and patient-controlled analgesia would also make good reading for any family physician. The hospice principle and its scope in cancer and allied diseases is well highlighted.

Adjuncts to Cancer Surgery will be valuable for any oncologists who want an update on all topics useful in the management of patients with cancer – but they may be well advised to keep patients out of the hands of the megasurgeon.

Raj Badwe
Micheal Baum

Academic Department of Surgery
Royal Marsden Hospital,
London SW3 6JJ, UK