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Petitioning Home Office, Department of Health, the National Institute of Clinical Excellence (NICE)

To publish all drug trial test results.

I have started a petition to the HOME OFFICE, DEPARTMENT OF HEALTH and the National Institute of Clinical Excellence (NICE) to publish all drug trial test results and one in particular. It should be mandatory. The publication of all drug trial test results is a matter of public interest to protect the health and safety of all patients.

In 2010 I made two Freedom of Information requests to the Home Office and the Department of Health to see a copy of the test results of an animal statin drug trial carried out on 145 rats over a period of 5 years (2006-2011) but was refused permission. All the correspondence is published on the WhatDoTheyKnow.com website.

"STATIN EFFECTS ON HEART AND SKELETAL MUSCLE/HOME OFFICE  In addition, statins do have some side-effects (including muscle pain and fatigue)…of anaesthesia, malignant hyperthermia (MH) has also been reported... (scienceandresearch/homeoffice.gov.uk)" 

On 6 March 2008 I reported a near fatal statin-induced adverse drug reaction (ADR) after taking Lipitor for 2 years and almost died from polyneuropathy and heart failure due to muscle wasting caused by the toxic/chemical poisoning. All the GPs involved in my case closed ranks and failed to report the incident under the Yellow Card Scheme to the regulatory body - the Medicines and Healthcare products Regulatory Agency (MHRA) - to conceal the truth about what happened. I have yet to be told and understand the reason why.

According to an NHS National Patient Safety Agency (NPSA) report the MHRA receives approximately 20,000 ADR reports a year from GPs. But this figure fails to take into account the additional reporting from other health professionals such as dentists and patient self-reporting under the Yellow Card Scheme. The MHRA does admit: “There is limited research to quantify actual harm arising from medication errors” so the number of ADRs that go unreported is unknown and that is of considerable public concern. And even more worrying is the scant data statistics collected by the NPSA and MHRA on the reported ADRs shown here:

 “Evidence of harm to patients

Researchers conducted a study in two large hospitals in Merseyside to determine the current burden of ADRs in the NHS. The study found that of 18,820 patients over 16 years admitted to hospital over a six-month period, there were 1,225 admissions thought to be related to an ADR, giving a prevalence of 6.5%. Of these 1,225, the ADR was judged to have led directly to the admission in 80% of cases. The majority (72%) of ADR-related admissions were judged as avoidable, including medication errors. The median bed stay was eight days, accounting for 4% of the hospital bed capacity. The projected annual cost of such admissions to the NHS was £466 million. In a review of medication error incidents reported over six years between the years 2005-2010 there were 525,186 incidents reported. Of these, 86,821 (16%) of medication incidents reported actual patient harm, 822 (0.09%) resulted in death or severe harm.

Costs to the NHS

Medication errors cause unnecessary pain and harm to patients and can even lead to death. Such errors account for a substantial amount of NHS resources and the annual cost of avoidable hospital admissions across the NHS in England is estimated to be £410 million.”

This research covered just two NHS hospitals. Therefore the actual cost and the true scale of the harm done to patients from prescribed drugs in all of the NHS England hospitals is unknown. According to a Guardian report in April 2008 adverse drug reactions cost the NHS £2bn a year treating patients.

I conclude that this is an unacceptable and alarming state of affairs that has to change.

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  • Home Office, Department of Health, the National Institute of Clinical Excellence (NICE)

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