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LOW LEVEL OF REPORTING OF ADVERSE DRUG REACTIONS
There have been 100s of media reports of bribery fraud and corruption in the pharmaceutical industry and medical profession with the odd reports of low level reporting of adverse drug reactions (ADRs). Without quoting from these countless reports I give here details just three reports of low level reporting of ADRs from sources which those in the drug industry and medical profession will not want to dispute or discuss.
1 Report in his book of 1972 by the world famous Australian haematologist Professor G.C. de Gruchy “Drug Induced Blood Disorders” page 28. 2 Oxford University Textbook on Adverse drug Reactions 1984 page 60.. 3 The Pharmaceutical Journal of the UK 2.11.1996 page 631.
The report in his book “Drug Induced Blood Disorders” by Professor G.C. de Gruchy in 1972, now withdrawn from circulation but available from the UK National Lending Library at Thorpe Arch, notes on page 28 on the chapter “Diagnosis, reporting and prevention” that it is probable that less than 10% of serious reactions are reported. He also notes that with voluntary reporting there will inevitably be significant under-reporting. Researching dozens of cases of blood disorders after suffering aplastic anaemia, in my case caused by exposurer to toxic chemicals not prescribed drugs, I agree with Professor de Gruchy. I found as he did that at least 50% of cases of aplastic anaemia and other blood dyscrasias ( dyscrasias meaning blood disorders connected to disorders of the bone marrow like aplastic anaemia and leukaemia) were caused by prescribed drugs and that reporting in these cases was well under 10%. In fact of the many cases I investigated only two said it was admitted by the medical profession that their condition was caused by drugs. With no investigation by the medical profession the vast majority of us were not even told there are documented causes of these disorders. In every case I investigated there had been substantial exposure to a known causative agent. Answers to questions I had asked in Parliament on 11.1.1989 listed nearly 200 prescribed drugs associated with causing aplastic anaemia as well as many toxic chemicals, pesticides and radiation.
The Oxford University Textbook on Adverse Drug Reactions 1984 notes that during the 1960s there was an epidemic of nearly 3,500 young asthmatics deaths caused by pressurized aerosol bronchodilators for asthma and that only 6 doctors had suspected and reported a possible association between the over-use of aerosols and sudden deaths. This level of reporting amounts to only about 0.17% of deaths due this adverse reaction. This near zero level of reporting of ADRs seems nearer to my own findings with reporting of ADRs. The book observes that the level of deaths after the effects were recognized and a circular leaflet published by the Committee of Safety of Medicines warning of the dangers, showed that deaths due to the asthma aerosols was reduced to near the level of that before the aerosols were introduced. The book also notes that this episode does not qualify as a success story for the reporting of adverse drug reactions.
A report in the Pharmaceutical Journal dated 2nd November, 1996 was on a survey that was carried out between April 1990 to March 1993, into the causes of acute hospital admissions of over 20,000 patients by the John Radcliffe hospital, Oxford. Of those admitted because of ADRs only 6.3% of these had been reported on the yellow cards provided for doctors to report ADRs. There has been some attempt in recent years to introduce a system whereby, because doctors do not report ADRs patients can report themselves direct to the drug control agencies. From reports I had and the odd media reports about this new reporting system, which was little advertised, most doctors, patients and pharmacists seem to have no idea that such a system of reporting ADRs is in place, The reporting cards can be obtained from GPs surgeries and pharmacists. I have a letter from The Pharmaceutical Journal dated 20.1.1997 which includes a comment from them “I am sure you are right to show a degree of skepticism towards the medical profession’s use of drugs”. I have had contact by letter, several times, with the UK Committee of Safety of medicine about the non or low reporting of ADRs and each time they reply saying they will answer me soon but they never have. One issue connected with this correspondence is why is the drug manufacturer’s safety recommendation of regular blood checks for those prescribed Ritalin not being carried out? Ritalin is documented to cause serious and fatal blood disorders of the bone marrow like thrombocytopenia and leucopenia. Another report in The Pharmaceutical Journal 16th October, 1993 by Dr. P. Roberts, senior clinical pharmacist, Mersey Academic Pharmacy Unit, was headed Adverse Drug Reactions Dr. Roberts said patients did present to community pharmacists with symptoms which could be ADR’s and The Committee of Safety of Medicines (CSM) did not invite pharmacists to report ADR’s direct via the yellow cards system. The CSM was concerned about the level of under reporting from doctors, dentists and coroners. Dr. Roberts said pharmacists preferred a scheme that involved working in collaboration with locals doctors but if co-operation was not forthcoming pharmacists could act alone.
The British National Formulary (BNF) by the Royal Pharmaceutical Society of Great Britain and the British Medical Association, the book doctors in the UK prescribe from, warns that drugs should only be prescribed if necessary and that side-effects including long term effects like cancer should be reported. A report in The Times 26th May 2006 headed “Sleaze Curbs to Prevent Firms from ‘Buying’ MPs” reported on the pharmaceutical industry funding activities of MPs and even writing policy reports. The Royal Pharmaceutical Society issued another warning in September, 2006 on the dangerous cocktail of drugs being prescribed to the elderly in residential homes and hospitals, who along with the very young are particularly susceptible to drug side-effects. They note the interactions of these drugs can prove lethal. The Independent on 10th September, 2001 in an article “Drug Firms Accused of Distorting Research said 13 of the worlds leading medical journals including The Lancet mount an outspoken attack on the rich and powerful drug companies, accusing them of distorting scientific research for the sake of profits. The giant drug companies were accused of using their money – or threat of its removal –to tie up academic researchers so they were unable to report freely and fairly on the results of drug trials. The American economist J. J. Galbraith in his book The Good Society (The Humane Agenda) 1996 notes one regulation as a well recognized necessity that there must be protection against damaging drug and medical use and intervention.
An article in The Guardian dated 3rd April, 2008 by Sarah Boseley “Adverse Drug Reactions Cost NHS £2 Billion” a figure given by Health Minister Dawn Primarola as the cost of treating 6.5% of hospital admissions which result from bad reactions to medical drugs. As so few adverse drug reactions are ever reported this figure will be underestimated. The Health Minister also said that drug campanies were often aware of drug side-effects but chose not to accept their responsibility. No matter how much publicity there is, or reports of vast numbers being killed and injured by drug side-effects and drugs regularly being withdrawn as too dangerous after having been declared safe when being launched, little or nothing is actually ever done about regulation or to increase the level of reporting of ADRs.
We can only assume by this lack of action the government, the drug regulatory bodies, the medical profession and drug industry want as many people sick as possible for drug industry profits.
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