October 26

Integrity of Medical Regulators

Integrity of Medical Regulators

Wed, 8 Jun 2005

The UK MHRA (equivalent of US FDA) has been caught in flat out public deception. The MHRA–which is entirely funded by the pharmaceutical industry–had claimed that two thirds of professional organizations it consulted favored selling a heart medication (Zocor Heart-Pro) without a physician’s prescription.

But, the Guardian reports: “after a battle with the consumer publication Drug and Therapeutics Bulletin, [the MHRA] conceded that the figures were wrong. Only one third of those who responded agreed unequivocally with the change of status of the drug, one third did not agree and the rest had reservations.”

The MHRA deemed the deception “an administrative error.” Others, however, are calling “for a massive overhaul of the MHRA.” Dr Ike Iheanacho, the editor of the consumer publication, Drug and Therapeutics Bulletin, said: “Their job is to protect people but this latest episode totally undermines faith in their decision-making process.”

Indeed this example of MHRA’s bad-faith, validates the scathing report by the Health Committee of the British House of Commons, “The Influence of the Pharmaceutical Industry,” (April 2005). See: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf

Thanks to the alertness of the consumer publication, tragedies have been averted in this instance. However, other deceptions–such as the deception surrounding mercury laced vaccines, which regulators and “expert” advisory panels on both sides of the Atlantic have engaged in for decades–have caused neurological damage to thousands of babies.

The best that consumers can do is to be very skeptical about all medical products and pronouncements about those products–much as they are when considering purchasing a used car.

The following excerpt from a report by the US Centers for Disease Control, Office of the Director, Office of the Chief Science Officer Blue Ribbon Panel Meeting, Summary Report, June 3 and 4, 2004, raises the possibility (likelihood?) that many of the chronic diseases afflicting millions of people in the industrialized world, may have been caused by prescrbed drugs and vaccines:

“Additional questions focused on the perceived increase in national morbidity from chronic diseases-and the role, if any, that vaccines may play regarding such conditions as asthma, neuro-developmental and learning disabilities, diabetes and autoimmune disorders.

While CDC does conduct research on chronic diseases, it was not completely clear what the roles are for the agencies in conducting research on chronic diseases that could be linked to a vaccine and/or drug (i.e. product/drug-induced disease) and whether this type of research should fall only within the purview of FDA, since it is a regulatory agency. The challenge of determining whether a chronic disease is product-induced was recognized.

There is great difficulty in determining whether a valid signal exists for a relationship between vaccines and chronic conditions. Some participants questioned the sensitivity of existing vaccine safety tools, such as VAERS and VSD in picking up signals around chronic diseases.”


“However, concern was expressed that most monitoring/surveillance systems are not specific to a particular vaccine and there are not enough studies of possible adverse effects of new vaccines in combination with existing vaccines. Therefore, as the number of vaccines increases, the number of unresolved hypotheses which need new studies might also increase. Who will be responsible for prioritizing and doing these studies? Another point raised was that post-marketing research results may not necessarily be included in the vaccine package insert unless they are submitted for FDA review by the manufacturer.”

See: http://www.cdc.gov/od/ads/brpr/brprsumm.htm

Unlike other consumer products, medicine is a two edged sword–its benefcial side depends on the integrity of the profession and the regulatory system. Medicine without integrity is a lethal weapon.

Contact: Vera Hassner Sharav

The Guardian
Watchdog accused over heart drug sales
Sarah Boseley, health editor
Wednesday June 08 2005

A government agency misled the public over the results of a consultation exercise, which it claimed had come out in favour of letting a heart drug be sold by high street chemists without a prescription.

The move to change the status of Zocor Heart-Pro, a statin which can help lower cholesterol, was so controversial that the Medicines and Healthcare Products Regulatory Authority (MHRA) launched a public consultation in December 2003. Around 100 organisations and individuals responded, including medical royal colleges and pharmacists’ organisations.

Allowing people to buy the drug without seeing a doctor was a world first. The government was in favour, hoping it would reduce heart attacks and cut NHS bills since some people would buy the drug rather than get it on prescription. But there was concern about side-effects of the drug, generically known as simvastatin, and also that some people who need stronger medication would buy it rather than see a doctor.

The MHRA last year announced that two-thirds of those consulted were in favour of the drug being sold in pharmacies. Yesterday, however, after a battle with the consumer publication Drug and Therapeutics Bulletin, it conceded that the figures were wrong. Only one third of those who responded agreed unequivocally with the change of status of the drug, one third did not agree and the rest had reservations. The MHRA said there had been “an administrative error”.

But the editor of the Bulletin, published by Which?, said yesterday that the episode cast doubt on the entire decision-making process at the MHRA.

“This has got to be the killer argument for a massive overhaul of the MHRA,” said Dr Ike Iheanacho. “Their job is to protect people but this latest episode totally undermines faith in their decision-making process.”

Dr Iheanacho said that even now, after a highly critical report earlier this year by the Commons health select committee, which objected to a lack of openness by the MHRA and its closeness to the pharmaceutical industry, too many decisions were being made behind closed doors.

“The MHRA has stated that it has made an ‘administrative error’ but there must be concerns that it dressed up the consultation responses to support its own decision to make simvastatin available over the counter,” he said. “The MHRA displayed a mixture of arrogance and carelessness which is certainly not ideal in a body supposed to protect the public.”

In April, after the Bulletin scrutinised those responses to the consultation which had been made public and told the MHRA the figure of two-thirds could not be right, the agency issued a robust denial.

Yesterday the MHRA did a u-turn and apologised “for any confusion caused by this error”.

But the final count is still in question, said Dr Iheanacho. Among responses now categorised as “not opposed but raised issues to be considered” are letters which appear entirely critical of the proposal.

The National Patient Safety Agency’s letter said: “If there is no direct or indirect danger to health when simvastatin is used without medical supervision, the question begs why have other countries not reclassified the drug as safe to use OTC [over the counter]?”

The Royal College of Paediatrics and Child Health expressed concern about potential long-term side-effects and worried that neither GPs nor pharmacists would know what drugs a patient was on.

The MHRA said in a statement that the full and correct facts had been put in front of the Committee on the Safety of Medicines, the experts which made the final decision.

Copyright Guardian Newspapers Limited

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