The Thalidomide Tragedy and the Need for a Regulator
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The casual process of manufacturing and marketing medicines in the UK and across Europe changed dramatically following the Thalidomide tragedy in the 1950s. The drug was discovered by the German firm Grünenthal, which had a record of rushing drugs to market and withdrawing medicines due to safety concerns.[6] However, it insisted Thalidomide was a ‘wonder drug’ which was even safe if used in suicide attempts.[7] Distillers marketed Thalidomide in the UK as Distaval in April 1958 after its chief medical officer declared: ‘If all the details of this are true, then it is a most remarkable drug. In short, it is impossible to give a toxic dose.’[8] Thalidomide was enthusiastically prescribed to treat nausea and insomnia in pregnant women, until thousands of mothers who had taken the drug in the early stages of pregnancy gave birth to deformed babies. The drug, which was initially marketed as having no side effects, caused blindness; cleft palates; bowel problems; and severe deformities in newborns. Some babies were born with trunks instead of limbs.[9] Prescribers and patients blamed one of the biggest medical disasters of the 20th century on lack of legislation and the absence of a regulator in the licensing process of drugs.[10] America, however, escaped the worst effects of Thalidomide, because the country’s regulator, the Food and Drug Administration (FDA), deemed the drug’s licensing application inadequate: the animal studies were not reported in sufficient detail by the manufacturers and the study on the absorption of the drug in rats was not supported by evidence; the company had failed to report the clinical studies in full detail and studied an insufficient number of cases; chronic toxicity data were incomplete leading to the obvious conclusion that no evaluation could be made of the safety of the drug when used for a prolonged period of time; the application contained limited information about the drug’s stability; and side effects were passed over lightly.[11]
The drug was eventually withdrawn from the market in the UK in 1961, prompting major changes in the way drugs were marketed and licensed.[12] Less than two years later, the government set up the Committee on Safety of Drugs (CSD), which would later become the Committee for Safety in Medicines (CSM). [13]‘It advises the UK Licensing Authority – the Medicines and Healthcare products Regulatory Agency (MHRA) - on the quality, efficacy and safety of medicines in order to ensure that appropriate public health standards are met and maintained.’[14] With the creation of a regulator and a committee dedicated to safety, patients should rest assured that the drugs they are prescribed are not harmful. But fifty years after Thalidomide was launched, several other drugs are making headlines for all the wrong reasons. The controversial antidepressant, Seroxat, which was licensed by the MHRA in 2000, may very well be the mental health, 21st century equivalent of Thalidomide.[15] The arthritis drug, Vioxx, has been withdrawn from the market after being licensed in 1999.[16] The diabetes drug, Avandia, is still on the market even though clinical trials have shown patients on it have died from heart attacks.[17]These cases illustrate that the regulators are failing the public, but the reason for this failure is not immediately apparent. They could be incompetent, negligent or alternatively, working hand-in-hand with the pharmaceutical industry during the licensing process.
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How Drugs are Licensed in the UK
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Drug companies are faced with high costs when developing new drugs, so it is in their best interest to recoup expenses as quickly as possible after licensing. The time a drug takes to move from licence to launch in the UK is one of the fastest in the world [18], but pharmaceutical companies hoping to achieve marketing authorisation still have to go through one of two relatively lengthy processes: they can apply through MHRA; or go through the European Union’s (EU) established organisation, the EMEA. If a drug is licensed by the EMEA, it is valid in all countries of the EU. While the MHRA supports the European process as part of the EMEA, it also acts as the sole agent for drug companies who only want to licence a drug in the UK. [19]. As the pharmaceutical industry is a business with obligations to its shareholders, it is up these regulators to ensure that companies looking to market new drugs and benefit from drug approval are met with a set of rigorous standards. The MHRA’s activities however, are 60 per cent funded through licensing fees paid by those seeking marketing approvals (pharmaceutical companies) and 40 per cent through an annual service fee, also paid by the industry.[20]
Theoretically, a new drug needs to go through a strict and extensive procedure to find itself on the market, passing three phases of clinical trials before being granted a licence.[21] Laboratory research is followed by clinical trials, where healthy volunteers take the drug so that the effects on the body can be studied and understood. The medicine is then used to treat a few hundred people suffering from the disease it is designed to treat, so that any side-effects can be spotted. Finally, the third phase of trials sees up to 3000 patients taking the drug under medical supervision for a certain period of time. [22] Drug companies anticipating responses for non-generic products should expect to wait for 30 working days for their licences to be approved by the MHRA; approximately a month for the regulatory body to assess the safety, quality, efficacy and overall balance of benefit to risk of the drug before it is marketed for human consumption.[23] When deciding whether or not to licence a drug, the MHRA considers company data summarised in a series of detailed assessment reports and hardly ever analyses raw data.[24] However, ‘drug companies are required by law to provide all data on the drug, published and unpublished, to the regulatory authorities when applying for a licence.’[25] Any company failing to do so is breaking the law and committing an act of fraud.
In 2005, the Health Select Committee (HSC) carried out its first enquiry since 1914 into the influence of the Pharmaceutical Industry in the UK.[26] It concluded that industry self-regulation was not effective, as the activities of drug companies failed to be fully transparent and effectively audited. It accused the MHRA of secrecy and condemned the closeness between the regulatory agency and the industry. It called for a new system of random audits of the raw trial data collected by drug manufacturers. However, it stopped short of accusing manufacturers, regulators and the government itself of being fraudulent, despite extensively examining at least two clear cases of scientific misconduct: Vioxx and Seroxat.[27]
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Pharma Analysis in the Mainstream Media
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The Independent
The Wall Street Journal
The Guardian
The New York Times
The Washington Post
The Scotsman
New Scientist
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References
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- ↑ House of Commons, Health Committee The Influence of the Pharmaceutical Industry Accessed on May, 20, 2008
- ↑ Chauhan, S.Mighty Pharmaceutical Giants Under Attack The Guardian, Accessed on May, 25, 2008
- ↑ Duffy, J.Safe Hands? The Sunday Herald, Accessed on June, 25, 2008
- ↑ Fagin, D., Lavelle, M., and the Center for Public Integrity. (1996) Toxic Deception: How the Chemical Industry Manipulates Science, Bends the Law, and Endangers Your Health. Birch Lane Press, New Jersey.
- ↑ Ibid., p. xix.
- ↑ Stephens T, Bryner R. (2001) Dark Remedy: The impact of thalidomide and its revival as a vital medicine. Perseus Publishing, Massachusetts.
- ↑ Stephens T, Bryner R. (2001) Dark Remedy: The impact of thalidomide and its revival as a vital medicine. Perseus Publishing, Massachusetts.
- ↑ Cox, A.Fifty Years Ago This Month Thalidomide was Launched Black Triangle, Accessed on June, 14, 2008
- ↑ BBC News Why We Needed to Regulate Accessed on June,25, 2008
- ↑ Ibid.
- ↑ Potter, E. and The Insight Team of The Sunday Times. (1979) Suffer the Children: The Story of Thalidomide. Andre Deutsch Limited, London.
- ↑ BBC News Why We Needed to Regulate Accessed on June,25, 2008
- ↑ BBC News Why We Needed to Regulate Accessed on June,25, 2008
- ↑ Ibid.
- ↑ Hodgson, M. and Watt, N.Drugs firms face new laws on test resultsThe GuardianAccessed on May,26,2008
- ↑ Frith, M.Exposed: how drugs giant pushed Vioxx painkiller The Independent Accessed on May,24,2008
- ↑ Foley, S.Is Avandia set to be Glaxo’s Vioxx? The Independent Accessed on May,8, 2008
- ↑ Cancer Research UK How are Drugs Licensed in the UK? Accessed on April,7, 2008
- ↑ Cancer Research UK How are Drugs Licensed in the UK? Accessed on April,7, 2008
- ↑ House of Commons, Health Committee, Op Cit.
- ↑ Duffy, J., Op Cit.
- ↑ Duffy, J., Op Cit.
- ↑ House of Commons, Health Committee, Op Cit.
- ↑ Ibid., p.31.
- ↑ Chauhan, S., Op Cit.
- ↑ House of Commons, Health Committee, Op Cit.
- ↑ Ibid.
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