October 26

Time to put drug giants on trial – Scotsman (UK)

Time to put drug giants on trial – Scotsman (UK)

Fri, 20 Jun 2003

The UK media-including BBC, the Guardian, the Scotsman, the London Times, and others–have been informing the British public about the hidden health hazards underlying the industry-controlled drug approval and drug marketing process. Current practices have led doctors to prescribe drugs– to adults and children–without their knowledge of the hazardous side effects.

One of the issues that has come into view is that children are unconscionably exposed to drugs whose potential to harm them is greater than any possible benefit.

It was public outcry following a BBC series disclosing the hazards of the anti-depressant, Seroxat (PAXIL), that led the UK government to ban PAXIL for children. That action brought a host of drug-related problems to public notice. For example, children are being prescribed powerful psychotropic drugs that have both known and hidden severe adverse side effects. These drugs are often prescribed for ‘conditions’ that may not be medical in nature–therefore the drugs are prescribed without medical justification.

Many drugs have serious adverse effects that are magnified in children. Claims have been made that early clinical trials by GlaxoSmithKline showed a ten-times greater risk of suicide on Seroxat than on placebo. What were the adverse findings in trials testing the other anti-depressants such as Prozac and Zoloft, known collectively as selective serotonin reuptake inhibitors (SSRIs)?

As Margaret Cook notes in an excellent overview in the UK Scotsman, from a business viewpoint, the Nuremberg Code and its mandatory principle of voluntary, informed consent, and oversight committee procedures are an “inconvenient” “interference with access to test subjects and speed of the process.”

Indeed, in the US and in underdeveloped countries, children – who are precluded from exercising the human right to informed consent — are being made to bear health risks for the financial benefit of others. Children are being increasingly enrolled in medical experiments that are against their best interest — because others make decisions on their behalf.

Furthermore, it is a fallacy to suppose that by conducting 6 to 8 week clinical trials in children the safety of other children will be enhanced. Clinical trials are not designed to elicit adverse effects, and they do not reveal even lethal effects for a minority because these effects often surface when the drugs are taken over a longer period of time than the duration of a clinical trial — which is usually 6-8 weeks. And most importantly, whose children will serve as human guinea pigs for the presumed good of others?

Two articles by Tom Curtis, medical correspondent of the Scotsman, focus on the specious claim that “children are set to lose vital drugs.” Why would the banning of a drug that induces suicidal behavior prompt anyone to deny children with life-threatening conditions drugs whose safety has been established in adult trials? The argument is meant to scare the public, powerful groups that have a stake in the drug industry – among them doctors — hope to use the opportunity to legitimize the unethical use of helpless children in drug trials. See: http://news.scotsman.com/index.cfm?id=661332003 and http://news.scotsman.com/index.cfm?id=660502003

As Cook notes, the public is amazingly ignorant about adverse drug side effects because the potential problems “are soft-pedalled, described in emollient terms.” She also notes that “Strict procedures regulating the testing of drugs are being circumvented by Western organisations in the pursuit of wider profit margins. ”

Two examples demonstrate the hazards involved for children: A drug for treating thalassaemia was tested in a children’s hospital in Toronto, Canada. Initially, the results led to euphoria. However, when Dr Nancy Olivieri, the principle investigator who is a world expert on this disease, found that some of her data showed a few patients deteriorating, the trial sponsor, Apotex, prevented her from publishing negative findings.

Another case involved Nigerian children who were the subjects of a Pfizer trial testing their new, untested antibiotic Trovafloxacin during a meningitis outbreak. The children used in this life-and-death natural disaster were malnourished and not suitable subjects for oral treatment. According to the Scotsman, Pfizer’s own child specialist objected vociferously to the trial organization and was sacked. Since then, the drug has not been approved because of a poor safety profile. The case will be heard in a court of law.

For an examination of 13 other cases demonstrating the plight of children in US clinical trials, see: http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf

Mon 19 May 2003
Time to put drug giants on trial
Margaret Cook

SOME years ago, I looked after a patient, a young man in his teens with the serious blood disorder thalassaemia, who begged me to use him as a guinea pig. He had read of a new tablet called L1 which was being tested, and wanted to try it even if it made him trial fodder.

Kept alive by regular blood transfusions, he also needed medication to leech surplus iron from his tissues. The only treatment then available was desferal, which had to be injected over 12 hours several times a week; painful, inconvenient and cumbersome.

I was not in a position to put him in a trial, and in any case, dangers for volunteers are often greater than benefits, so advised him to wait till L1 passed safety and other hurdles.

Now L1 – the trade name for which is Ferriprox – has reached the markets in Europe, where it has been licensed in 24 countries, including the UK. The story of how Apotex, the manufacturing company, has introduced it here – described in detail by Channel 4 documentary Dying for Drugs – makes uncomfortable reading.

Much of the research was carried out in a children’s hospital in Toronto, Canada, and was supervised by Dr Nancy Olivieri, a world expert in thalassaemia. After initial euphoria, some of her data showed a few patients deteriorating. Then, more worryingly, there emerged some evidence of rapid liver damage.

On voicing these concerns to Apotex, Dr Olivieri claims that the trial, and her leadership of it, were abruptly terminated, her concerns labelled “misinterpretations” and her work rubbished.

When other colleagues waded in to support her, they were reportedly also treated to intimidating tactics, even poison pen letters.

This scarifying battle, which almost ruined Dr Olivieri’s professional life, is now in the public arena, and the European Commission is currently being charged in court with premature licensing. The jury is still out. Meanwhile, children keep taking the tablets.

Dr Olivieri received letters from hundreds of research doctors bearing witness to thuggish techniques, even intrusions into personal lives by private investigators hired by drug companies.

Many will no doubt have preferred to give in for the sake of a quiet life and a swift backhander, lacking Dr Olivieri’s courage. Editors of the American Journal of Medicine and the Lancet also admit to pressures – of a more gentlemanly kind – to change results.

Where huge profits are at stake, it seems global companies behave as if they are beyond the rules – or else they bind other heavyweight interest groups to change or bend those rules.

One of these groups, I fear, is doctors. Their sins may be individually tiny, and often are of omission rather than commission, but collectively, they have a huge impact.

The side effects of drugs, until recently, were not shared with patients at all and the public is still amazingly ignorant. Even now, potential problems are soft-pedalled, described in emollient terms.

Monitoring is so ineffectual as to be culpably neglectful. All doctors have a duty to report problems to the Committee on Safety of Medicines using a yellow card system, even on suspicion. But few perform this voluntary duty. It seems unscientific, anecdotal, ineffective – if our discretionary points systems were based on the number of reports we made, you would see a stratospheric response.

Yet the recent Panorama television programme on Seroxat, an antidepressant, revealed to the experts just how this should be done. Here is a riveting programme, to which thousands responded, and immediately patterns can be recognised.

The repeated description of nightmares, often about blood, suicides – attempted and achieved – emotional turmoil, personality changes and violence cannot be ignored. Similarly, the terrifying electric-shock sensations in the head on withdrawal was beamed in from many sources.

Of course, doctors don’t recognise problem-patterns when they come singly. In these days of sophisticated IT, it is not beyond the imagination to collect data straight from patients, who are far more motivated to report than their doctors.

Certainly, the manufacturing company is not motivated to draw attention to side effects. “My heart goes out to anybody…,” gushed the oily GlaxoSmithKline captive doctor, dripping with insincerity and contorted with body language.

And serious questions should be asked about claims that early clinical trials by GlaxoSmithKline showed a ten-times greater risk of suicide on Seroxat than on placebo.

Equally penetrating queries should be directed at how, in the UK, a review committee of the Medical Controls Agency to investigate Seroxat had to be disbanded because half its members were share-holders of GlaxoSmithKline. The name of the Medical Controls Agency was changed; but the government should jettison the entire organisation and recreate a new, motivated, independent and listening organisation.

The Chancellor, Gordon Brown, clings to the Keynesian tenet that a nation’s economy depends most strategically on its business investments. Thus are governments worldwide at the beck and call of big business, of which, globally, pharmaceuticals top the chart.

Donald Rumsfeld, the United States defence secretary, is a former Pharma chief executive. When countries signed up to a World Trade Organisation ruling to protect poor countries in getting access to cheap generic drugs (especially for AIDS and infectious diseases), Mr Rumsfeld, loyal to his tribal trade roots, disagreed. The agreement was killed by the US veto.

Under world trade rules, a company has exclusive rights to the patent of a new drug for 20 years. Thus the price is set by the company, and governments can do little to interfere. Glivec, a genuinely innovative new drug for chronic myeloid leukaemia, is blisteringly costly, yet the price of $19 a tablet is not justified by the research costs.

Some third world countries have created a strong generic drug sector, notably India, where active ingredients of much-needed medications (for AIDS and cancer, for instance), can be put together at a fraction of the patented cost.

Dr Hamied, of Cipla, an Indian pharmaceutical company, talks of humanitarian values which can be reconciled with business. “Do you want reasonable profits or do you want obscene profits?” he asks. When you see the plight of sick people in poor countries, the threshold for obscenity is at rock bottom.

In Korea, the minister of health delivered to his government an application for a compulsory licence to sidetrack the high cost of Glivec. Korean patient volunteers had helped develop the drug but could not afford it thereafter. The minister was warned by the US secretary for trade not to meddle with drug prices. Continuing to campaign, he was sacked.

It seems his government had been threatened with crippling trade sanctions by the US and Europe unless he was silenced. The US has likewise threatened Thailand with tariffs on wood and jewel exports (30 per cent of their US trade) if they persist in making generic drugs.

Now, World Trade Organisation rules mean that cheap generics will soon no longer see the light of day, even in India. Money and markets rule OK. Yet there are regulations which in western countries are not so easily evaded, such as those controlling research and human rights.

Ever since Nuremberg, the principle of voluntary, informed consent by individuals has been paramount, and the details of any proposed trial must be scrutinised by a watchdog ethical committee.

From a business viewpoint, this is inconvenient; it interferes with access to test subjects and speed of the process to the summation of, hopefully, billion dollar returns.

Increasingly, pharmaceutical companies have found ways to bypass these formalities by taking trials to inarticulate third world countries from where events tend to go unreported in the West.

It is claimed that Pfizer did this in Kano, Nigeria, during a meningitis outbreak, using their new, untested antibiotic Trovafloxacin. Children used in this life-and-death natural disaster were malnourished and not suitable subjects for oral treatment. Since then, the drug has not been approved because of a poor safety profile.

Pfizer’s own child specialist objected vociferously to the trial organisation and was sacked.

Yet the Nigerians’ voice has been heard, and the Kano story will be tested in court, if the lawyers involved have a measure of compassion and can detach themselves from deference to might instead of right.

Now I do not want to put anyone off taking essential medications. However, it is time for patient empowerment.

If you need treatment, it is far better to be taking something that has stood the test of time and long experience, something which has long passed its patent time, and is no longer the vehicle of massive profits.

Do not be seduced into thinking the newest is the brightest and best. Know about side-effects, and insist on your doctor reporting any new ones, even – or especially – if they seem bizarre. Lobby your MP about trade sanctions with third world countries. And don’t buy shares in pharmaceutical companies.

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