Pharma: Side Effects Killed 'Magic Bullet'

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Pharma

Are we not all looking for that magic bullet when we are sick, or even just suffering from some ache or pain? "Here, take that pill and your headache will be gone in no time" or "this drug will make your acne go away". Let's not even speak of "prevention" of heart trouble by use of cholesterol lowering drugs or blood thinners. We are told what the pill will do for our condition, but not what damage it will do to our health in general. Side effects these days almost seem to have the status of a state secret.

With a real jungle of drug side effects "out there" I see little willingness by health authorities to even confront the thought of drug induced illness and death, much less do something about it. Why? Health has become a business model. Pharma's business model. Today’s Sunday Times (UK) contains a truly excellent article from Rose Shepherd about the death toll from pharmaceutical medicines. Death of the magic bullet describes how reporting of side effects and evaluating the data meets a lackluster attitude by health officials ... compared with getting drugs approved and on the market.

The business model requires there be "a market" for drugs. It also requires that competing intervention and prevention be impeded. We see this in international legislation to "control" vitamins and minerals, and in efforts to keep any alternatives firmly confined to the periphery of medical practice. Perhaps more people will gradually begin to connect the dots between the issues raised in the Sunday Times article and the growing moves to ban natural therapies that she described in her equally impressive “Nil by mouth” article in the Observer (UK) in February 2004.

(Thanks to Paul Taylor for the links.)

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Death of the magic bullet

The Sunday Times
(see original here)

July 31, 2005

We have learnt to place our faith in pills. But at what cost? As more and more prescription drugs are withdrawn because of adverse side effects, new figures suggest that the medicines we take are killing up to 20,000 people a year in the UK — six times as many as die on Britain's roads. Rose Shepherd reports

Mark's death in March 2004 was horrific. He'd been feeling low and losing sleep, and his doctor had prescribed promazine, an antipsychotic, although Mark, 49, had no symptoms of psychosis — until he took the drug. After two tablets he started to act oddly, saying he felt he could control things with his mind. After a third tablet, James, his partner of six years, saw him stepping agitatedly from foot to foot as he talked strangely on the phone, and then he fell. "He said he was okay," recalls James, "but I went with him to the surgery and we saw a different GP, who took the tablets off us and said Mark should be all right."

That evening, as James tried to go into the kitchen, Mark blocked his way and scuffled with him in the hall. James pushed him out of the front door, and Mark, "the quietest person", lobbed a paving slab through the window.

"He calmed down, so I let him in, then phoned 999. The police and ambulance came and asked Mark if he was okay, and left us to it. When Mark had gone to bed, I phoned the duty doctor, who said some people react that way to medication. He didn't feel a need to come out. I fell asleep but was woken by Mark screaming. He had locked himself in the bedroom. I called and he came to the door. He was trying to say something, but the words weren't coming. Then he fell on his back, really screaming. It looked like he was having an electric shock." James was on the phone to the emergency services when the screaming stopped. He found Mark lying on the stairs. There was blood in his mouth. The paramedics arrived promptly, but too late.

James was summoned to the police station, not to talk about the drug that might have killed Mark, but to raise the possibility that he had. "The inquest seemed mainly about establishing it was an accident. They said they believed Mark died of postural asphyxia after falling downstairs. Promazine was mentioned, but they never went into what caused him to have a fit. It is just my opinion that the promazine killed him."

According to the mental-health charity Mind's booklet Making Sense of Antipsychotics, adverse drug reactions (ADRs) to these drugs can include restlessness, unease, rocking from foot to foot, muscle spasms, aggression and, rarely, potentially fatal neuroleptic malignant syndrome, characterised by "sweating or fever... rigidity or loss of movement, difficulty in speaking or swallowing, changes in consciousness from lethargy and confusion to stupor or coma". Who knows, then, if it was the promazine, or perhaps an interaction between the promazine and other medication Mark had had? But shouldn't the possibility have been countenanced? There is a system in place for logging suspected ADRs.

The fact is, if someone you know is suffering from ADRs, you and they may not know it, and it may not be immediately obvious to your GP or even to a hospital consultant.

Allopathic medicine is founded on the belief that drugs are, all in all, a good thing; but we are now in a society awash with medications, and we have ushered in a killer. In a report in July 2004, the department of pharmacology and therapeutics at Liverpool University suggested ADRs account for 5,700 deaths a year on admission to hospital. If adverse reactions after admission were added, this could suggest a total of 10,000 deaths, while deaths from ADRs among those not admitted to hospital could be as many again. To put this in perspective, 3,221 people were killed on Britain's roads in 2004, and six times as many were killed by a legally prescribed drug, according to this study's conservative reckoning.

It has always been accepted that medicines can have dangerous side effects — hence the so-called "risk-benefit" trade-off. Even drugs in long and common use can cause ill in a susceptible few. And, with an industry under economic pressure to produce new drugs, these are prescribed without knowledge of their long-term side effects. It may take years for unwanted consequences to be known. They could even show up a generation later, as was the case with the synthetic oestrogen DES (diethylstilbestrol), prescribed to prevent miscarriage from around 1950 until 1975 in the UK, when it was found to cause a rare form of vaginal cancer in one in 1,000 girls exposed to it in the womb.

Most of us take pills at times, and we need clear information as to possible side effects. Yet packet inserts are skimped, small-print affairs, while in medical schools there is a paucity of teaching of clinical pharmacology and therapeutics. Much of doctors' knowledge comes from advertisements, sales reps' spiel, industry-sponsored seminars, and a medical press seeded with ghosted articles that emphasise the positive.

The need to monitor drugs more closely became evident after the thalidomide debacle in 1964. Here in Britain, Sir Derrick Dunlop, chairman of the new Committee on Safety of Drugs (CSD), circulated a letter to doctors asking them to report promptly "any untoward condition in any patient that might be the result of drug treatment". Thus began the yellow-card scheme, implemented by Bill Inman, formerly with the medical department of the pharmaceuticals division of ICI. Under this voluntary reporting scheme, doctors were to notify the committee of suspected ADRs.

The Medicines and Healthcare products Regulatory Agency (MHRA) now collects yellow cards — submitted by health-care professionals and coroners, and by pharmaceutical companies under statutory obligations — assisted by the Committee on Safety of Medicines (CSM) and the Medicines Commission within the Department of Health. It is funded entirely by the pharmaceutical industry, and how it goes about its business is not for us to know. The Medicines Act, 1968, prohibits the disclosure of any information "obtained by or furnished in pursuance of this act". Professor Inman demurred. "I believe," he has written, "that all information about the effects of drugs should be available to any bona fide research worker from the first moment that the first dose is taken by a human being."

In 1965, Inman took home nearly 1,000 yellow cards relating to ADRs among women on the contraceptive pill. He arranged and rearranged them on his living-room floor, sorting and resorting them according to age, time on the pill, and whether or not the patient had died, until it became "glaringly obvious" that certain preparations of the pill caused thrombosis. Inman spent hours performing analyses that, he noted, "I would now have completed in minutes on a home computer".

The MHRA, under the chairman Professor Sir Alasdair Breckenridge (formerly of Glaxo's scientific advisory committee), enters yellow-card reports onto its Adverse Drug Reactions On-Line Information Tracking (Adroit) database. Doctors, pharmacists and scientists within the Pharmacovigilance Group of the Post-Licensing Division use this information and other sources to assess causal links between drugs and reported reactions. But is the authority performing any more effectively than did Inman, grubbing around on his carpet 40 years ago?

Not to judge by a recent inquiry by the Commons health select committee into the influence of the pharmaceutical industry, which describes a "lack of effective discipline and regulation", a "pervasive and persistent" industry, a "failing system of pharmacovigilance" and an "extremely passive" process of drug surveillance. The MHRA is, says the inquiry report, "oblivious to the critical views of outsiders and unable to accept that it has any obvious shortcomings... [its] attitude to its public health responsibilities suggested some complacency and a lack of requisite competency".

Charles Medawar, the founder-director of Social Audit, an offshoot of Ralph Nader's Public Citizen network in the US, with the pharmacologist Dr Andrew Herxheimer, carried out "probably the only independent analysis of what yellow cards say", to see if, in the case of the antid