We think the extent of secrecy in the present system of medicines control in Britain is a disgrace. The public is routinely denied access to all specific information relating to the basis on which approval for specific medicines is either given or denied. Virtually nothing is communicated to the public about the decisions and activities of a variety of committees and expert advisory bodies concerned with drugs.
No information is published about the volumes and costs of different medicines prescribed under the NHS; and there is very little systematic information published about the reported incidence of suspected adverse reactions to those drugs. The extent of the secrecy is such that the public has even been refused information about the consultancies with drug companies held by members of the Committee on Safety of Medicines.The importance of openness is underlined by the fact that the DHSS acts both as the Drug Licensing Authority and as "sponsor" of the pharmaceutical industry. Unless the medicines' control system is open, there must always be suspicion that the government's own vested interest in the wealth of the industry interferes with its duties in approving drugs and in promoting safe, rational and economic drug use.
We think there should be changes in some of the main procedures involved in drug approval and registration. First, all companies should be required to submit with each application for drug registration a "Basis of Application for Approval" statement. In this, the company would be required to set out under the appropriate headings summaries of the main evidence provided.
The responsibilities of drug companies seeking product licenses are at present assumed to be mainly discharged by submitting large masses of fragmented data which the authorities are then expected to assess. This is very unsatisfactory because it means that the scientific evidence cannot be evaluated in relation to the claims of the drug that will be based upon it.
Secondly, we think that the regulatory authorities should prepare a "Summary Basis of Approval" statement a monograph which summarizes, so far as possible, what is known about the safety and effectiveness of the drug, identifying how the assessment was made. Such summary basis of approval (SBA) documents are already routinely published in more open countries; and should be published here too.
Thirdly, we think the authorities should accept only such evidence as is claimed to be of real scientific merit, within the meaning suggested in the code of international marketing practices of the International Federation of Pharmaceutical Manufacturers Federations.
Manufacturers must "provide scientific information with objectivity and good taste, with scrupulous regard for truth, and with clear statements with respect to indications, contraindications, tolerance and toxicity". Many applications for drug approval are supported by data of very little scientific merit, and often of limited relevance to clinical practice. We believe that the DHSS/CSM has been in the habit of accepting clinical trials and other studies whose express and implied conclusions have been totally unwarranted by the evidence given for them. Some scandalous practices continue to go unchallenged. It stands to reason that more openness and public participation; higher standards for drug approval; and greater emphasis on personal responsibility in the assessment of claims made for drugs, would all help to make the drug control system more efficient and effective than it is now. For the same reasons, the present system of medicines control is ineffective; and likely to remain inadequate until it is greatly changed.