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Children Were 'in Danger' After Taking Asthma Drug Steroid Concerns Revealed in Doctor's Study

Posted on: Tuesday, 31 May 2005, 09:00 CDT

SIX more children have suffered life-threatening reactions after taking high doses of a steroid marketed as the best way to treat childhood asthma.

Their cases are highlighted in a new research paper which underlines the dangers of overuse of fluticasone, made by GlaxoSmithKline (GSK), the pharmaceutical giant.

A sheriff ruled last week that excessive use of the inhaled steroid had killed five-year-old Emma Frame, from Lanarkshire. Her brother, Calum, also nearly died from "adrenal suppression" linked to the steroid.

Dr Malcolm Donaldson, an endocrinologist at the Royal Hospital for Sick Children at Yorkhill, Glasgow, is about to submit the results of his research to a leading medical journal.

He identified 190 young people, aged two to 19 and treated at Yorkhill, who had been taking high doses of fluticasone, and found close to half (81) showed adrenal impairment.

Six children showed severe impairment, similar to the symptoms suffered by Emma and Calum, then aged seven, who recovered after being taken off the drug.

Of the six, aged between six and 11, two have since changed to a different steroid and the others had their levels reduced where possible.

The steroid was previously branded as Flixotide, and marketed with slogans such as "Putting a Smile on the Face of Asthma", but is now sold in an amended formula as Seretide.

Dr Donaldson, also a senior lecturer in child health at Glasgow University, gave evidence at the fatal accident inquiry into Emma's death.

He said: "As medics, I think we were lulled into a false sense of security and thought that, in theory, it was the safest treatment available. In practice, nobody really believed that somebody could get into serious trouble."

However, he added: "I think it's important to stress that some boys and girls genuinely do need high doses of Flixotide outwith licence."

Experts agree that asthma sufferers must not suddenly stop taking fluticasone medication, as this can be more dangerous than excessive dosages.

Emma was taking five times the amount recommended by GSK when she died, following advice by her own GP. Her parents, Stewart and Karen Frame, have told The Herald they now suspect their daughter may never have had asthma in the first place.

Mrs Frame said: "We wonder if some children are being misdiagnosed. Asthma can be a serious condition but we would urge parents presented with such a diagnosis to ask lots of questions and make sure the doctor explains any likely side-effects of the treatments proposed."

The study by Dr Donaldson comes after allegations by Dr Geoff Todd, another expert witness in the Frame case, that the multi- million-pound drug companies wield too much influence over the products doctors prescribe.

There have been calls within the medical profession for an independent register, in which doctors declare their links with the pharmaceutical industry. A website could enable patients to find out whether their doctor has attended a conference at a company's expense, or been paid to give a lecture on a certain product.

Dr Todd, a chest consultant who helped GSK promote Flixotide when it first came on the market, now believes the company exaggerated the safety of the drug. He said: "I believe a lot of responsibility must be borne by both the drugs companies and the people who are supposed to be protecting doctors from the drugs companies.

"The relationship between the regulatory bodies, the doctors and the drug companies is far, far too cosy. There is a price to be paid for that."

The Medicines and Healthcare products Regulatory Agency (MHRA) is the only regulatory body to be fully funded by the industry it exists to police. Meetings between its officials and firms such as GSK are kept secret because of "commercial sensitivity".

Dr Todd first warned of the potentially fatal side-effects from Flixotide in 1996, the year Emma was born, and went on to conduct his own national survey.

His warnings were published in both the Lancet and the Archives of Childhood Disease, after he discovered 40 cases of adrenal suppression linked to high dosages of Flixotide. Thirty-three were children and, of those, 25 nearly died after suffering coma and convulsions, like Calum Frame.

Dr Todd said: "Of those 40 cases, there have been two deaths and a number of nearmisses. And these numbers are an underestimation as adrenal crisis is hard to diagnose.

"There is no medical evidence that this drug is any safer or any better than the other existing inhaled steroids used to treat asthma. The claims of greater safety are wrong, in my opinion. We found out the hard way that it had life-threatening side effects.Why did they have to wait until Emma died?"

A third doctor, who was involved in the latest study at Yorkhill, has backed the idea of an independent register declaring doctors' links with the pharmaceutical industry. Dr Jimmy Paton, a respiratory consultant, said a public register would force medical professionals and companies like GSK to be open about their interdependence.

He said: "If that was all made public, like MPs declaring their interests, it would be more transparent. There are some safeguards there, but whether they are the right safeguards and strong enough is a matter of debate and reflection."

A spokesman for GSK said the company had followed all advertising and ethical guidelines in its promotion of the drug.

He said: "The safety profile of fluticasone within licensed doses is well established. The safety of our medicines . . . is regularly reviewed and where appropriate, reported to the Medicines and Healthcare products Regulatory Agency."

A spokeswoman for the regulator said: "The MHRA is committed to carrying out its functions in an open and transparent manner."

Source: Herald, The; Glasgow (UK)

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