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'One I prepared earlier' award ?

March 2005

'Worlds' worst drug safety catastrophe'

The subject could not be more serious. The answer could hardly be more vacuous. Oral questions are designed to give MPs a chance to cross-examine ministers. If only.

This sublime 'Answer I prepared earlier' example was delivered in the Commons on Tuesday 22nd March. There is a prize for anyone who can find any connection, of even protozoan proportions, between the question and the answer. A bigger prize for any answer that is even more Delphic.

Paul Flynn (Newport, West) (Lab): What new proposals she has to improve the safety of medicines.

The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson): We believe in putting patients first, and, in accordance with that the Medicines and Healthcare products Regulatory Agency has today published a consultation document on proposals for implementing a number of changes to the law in the UK designed to strengthen regulation. Copies have been placed in the Libraries.

Paul Flynn: Last Thursday, the head of drug safety in the United States said that Vioxx was the single greatest drug safety catastrophe in the history of the world, afflicting up to 140,000 Americans with strokes or heart attacks. In this country, we have 4.5 million prescriptions for COX-2 inhibitors, yet our own defective yellow card system failed to find a significant adverse reaction here. Is it not time that we banned the prescription of all COX-2 inhibitors and had a thorough safety appraisal?

Miss Johnson: As my hon. Friend is aware, the changes to UK legislation that we have put in place, those that we have proposed and the ones that I have just announced will further strengthen drug safety monitoring, by requiring risk management plans at the time of licensing new medicines, and by reinforcing the obligations on the industry to keep regulators informed of any issue that might impact on the safety of marketed medicine. We have reviewed the legislation. The National Audit Office has given the MHRA a clean bill of health, and we are taking all the steps that I have outlined and others to improve transparency and protection for patients.

The facts are: Merck withdrew their painkiller, Vioxx, after public disclosure that a study found that it increased the risk of heart attack and stroke by more than 100%. Yet, Pfizer is hanging tough even as a study showed that patients given high doses of Celebrex had a 240% increase in heart problems, including death.

Industry's control of how the trials are conducted and what is reported to the public has put the public health at increased risk of harm inasmuch as the true risks have not been disclosed either to the public or to physicians. Through its lavish advertising campaigns, the drug industry has encouraged the use of expensive new drugs whose lethal risks remain in company vaults. Dr. David Graham's courageous public alert warning in testimony before the Senate Finance Committee: "I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx," has been more than validated by a spate of recent revelations about widely marketed drugs whose hazardous effects have not been previously disclosed: The makers of Celebrex, Bextra, Aleve (naproxen), Strattera (widely promoted for the treatment of children loosely diagnosed with ADHD) have announced hazardous side effects.

To follow up the campaign, I have tabled a string of oral questions and this Early Day Motion.

That this House is alarmed at the statement by Dr David Graham, associate safety director of the US Food and Drug Administration, that the COX-2 inhibitor drug Vioxx is the `single greatest drug safety catastrophe in the history of the world', resulting in up to 140,000 strokes and heart attacks in the US; notes that there were 4,500,000 prescriptions for COX-2 inhibitors in the UK in 2003 but regrets that the UK's defective yellow card system failed to detect significant adverse reactions; and calls for an immediate halt to the prescription of COX-2 inhibitors and a thorough safety appraisal.