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Category Archives: Regulators

Homeopathy and Pharmacy

22-Feb-10

The House of Commons select committee on science and technology has been examining homeopathy, and their report has been just been released. The main focus will be on the committee’s view that both NHS funding and MHRA licencing should be withdrawn. I’ll focus on the parts related more directly to Pharmacy and the Royal Pharmaceutical [...]

Short but effective

26-Jun-09

Stephen J Evans, Professor of Pharmacoepidemiology, on the recent licensing of a homeopathy preparation in this weeks BMJ:
It is tragic that we now have a respected body, the Medicines and Healthcare products Regulatory Agency (MHRA), granting a licence for a product for which there is not only no evidence of efficacy but good evidence against [...]

Homeopathic victory?

02-May-09

About three years ago there was considerable concern about the Medicines and Healthcare products Regulatory Agency (MHRA) becoming associated with homeopathy.
The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing rules to allow remedies to specify the ailments for which they can be used.
But critics argue the treatments will not be rigorously tested as they [...]

Chinese scapegoats

22-Jan-09

The Chinese government are executing two individuals in the melamine milk scandal. The contaminated milk killed six babies. Many people’s instinctive reaction might be to welcome this punishment, but the punishment deflects attention away from the failure of the Chinese authorities to properly regulate industry. As I have written here, the unregulated capitalism in China [...]

Long-acting beta agonists in asthma under scrutiny

13-Dec-08

The Washington Post reports on an FDA decision on long-acting beta agonists (LABAs) in asthma:
The risks of two widely used asthma drugs outweigh their benefits for both children and adults, a U.S. Food and Drug Administration advisory panel said Thursday.
The health panel targeted GlaxoSmithKline’s Serevent [salmeterol] and Foradil [formoterol], made jointly by Novartis AG and [...]

Rimonabant withdrawal and conflicts of interest

23-Oct-08

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) have pulled the marketing authorisation for rimonabant (Acomplia) [PDF]. This isn’t much of a surprise. What is interesting in this case is the reasoning, which not only addresses safety concerns, but also concerns about effectiveness in clinical practice (as opposed to clinical trials). Effectiveness, rather [...]

Regulators, the public, and blogs

18-Sep-08

In times gone by regulatory bodies concerned with drugs were a black box. Decisions were made and conveyed to the public, with little explanation. Other concerns, that were preliminary and yet to be confirmed by further evidence might be delayed. Public engagement with regulators was minimal. For a number of years things have been changing.
The [...]

Seeding trials and missed opportunities

23-Aug-08

There is an excellent paper at the Archives of Internal Medicine describing a seeding trial. The authors of the paper helpfully provide a useful and concise description of a such a trial:
Seeding trials are clinical trials designed by pharmaceutical companies to promote the use of pharmacotherapies that were recently approved or are under review by [...]

Homeopathy and malaria prophylaxis

17-Apr-08

Homeopathy is not only a fake pseudo-scientific faith-based treatment, it is extremely dangerous when practiced by people whose belief in it is so great that they are willing to extend its role outside of minor self-limiting conditions (which would surely make them enough money). This blog has already noted some cases of malaria in the [...]