Warning This Medicine May Make you Ill

posted on:
September 18, 2007

author:
Staff

 Bob Bowen had been diabetic for 18 years when his doctor switched him to a newly licensed drug called Avandia. The effect was devastating. 

"After a month, my feet, legs and thighs suddenly swelled to twice their normal size and I was diagnosed with heart failure," he says. "The doctor told me to keep taking the Avandia. Two months later, I passed out."

Bob spent 10 days in hospital and was diagnosed with heart valve damage, a heart blockage, fluid on the lungs and kidney failure. Neither Bob nor any of his family has a history of heart problems and his doctors now believe these were triggered by the drug.

Avandia is used to treat people with type-2 diabetes. It helps lower blood sugar levels by increasing the sensitivity of the liver, fat and muscle cells to insulin.

The drug hit the headlines in May when a U.S. study found it made patients 40 per cent more likely to suffer heart attacks. In America, Avandia is likely soon to carry a 'black box' warning that it could cause cardiovascular problems. This is the highest level of warning to doctors and patients that this drug may have serious side-effects.

Here in the UK, the only response of our drug watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), has been to say that leaflets that come with the drug already contain warnings about heart problems.

In recent months, two more diabetes drugs, Actos and Januvia, as well as the weight-loss drug Acomplia, have come under scrutiny in America. The American government drugs watchdog, the are planned.

Food and Drug Administration, has called for the same high risk warning to be put on Actos, while another committee has recommended that Acomplia should not be licensed in America because of links with depression and suicide. All these drugs are available in the UK, but no extra warnings on them are planned.

It's a familiar pattern. American consumers are made far more aware of possible drug dangers than their British counterparts. Labour MP Paul Flynn believes we are not being properly protected. "For too long the British authorities have just followed the U.S. lead in issuing warnings about drug safety," he says.

"What happened with the anti-inflammatory drug Vioxx was a classic example." Vioxx was withdrawn in 2004 in America after reports that it doubled the risk of cardiovascular problems. Only after its American withdrawal was it removed from the UK market.

"The system the MHRA uses to pick up the number of side-effects a drug is causing gave absolutely no indication of the scale of the problem," says Flynn, a long-time campaigner for improved drug safety.

American safety experts reckoned that up to 100,000 people had been harmed by the drug over there. Do you know how many reports of problems with Vioxx the MHRA received on average every year? Six.

If it hadn't been for the American action, we would still be taking that drug and suffering all the damage that went with it. As it is, we still have no idea of how many people were affected in the UK because there has never been any investigation.

The system that the MHRA relies on to discover if a drug is causing problems once it has been licensed has been heavily criticised. Known as the 'yellow card' system, it depends on doctors and patients filling in details about a suspected adverse reaction caused by a drug and sending it to the agency.

However, it has long been recognized that most adverse reactions are never reported – expert estimates range between 1 per cent and 10 per cent – and there are claims that even when reports do come in, they aren't properly followed up.

A House of Commons report on the agency two years ago complained that reports are 'not always investigated or pursued with sufficient robustness'.

Dr Dhruv Kazi, an expert in medical statistics at the London School of Economics, said: Just how many people in the UK are being affected by a drug is the key question that the system is just not able to answer at all well at the moment. Like Flynn, Dr Kazi is worried UK, but no extra warnings on them that not enough attention is paid to the effect of drugs once they have been licensed.

"The system needs to be fixed," he wrote in a recent article about Avandia in the British Medical Journal.

The European Medicines Agency that passed Avandia only spends 10 per cent of its budget on post-marketing (monitoring a drug's performance after it has been licensed). That is not nearly enough to do the job properly. It should be the main function of drug agencies.

The MHRA also spends much more of its £65 million budget – which all comes from drug companies – on checking applications by drug companies for a licence than on checking what effects the drugs are having afterwards. Like the MHRA, the FDA relies on doctors reporting adverse events and, as in the UK, the number it receives is only a small fraction of the total.

What makes the American system different is that the FDA's decisions are much more open.

Recently, a number of its own officials have gone public about their worries about a drug – virtually unheard of in the UK – and some key hearings have been open to the press and the public. Data from those hearings has been used to highlight FDA failings. This has led to greater pressure on the organisation. Adding to this pressure has been the more litigious culture. In the UK there are virtually no court cases against drug companies, but in the States there are tens of thousands.

There is much more of a debate about these matters in America, prompted by bodies such as the charity Public Citizen – which has a good record for spotting problems – calling for the withdrawal of Vioxx two years before it came.

The Patients' Association is concerned about the current system.

"It relies on reports, and there aren't enough being sent in," says Roger Odd, a pharmacist and trustee of the Association. "For the sake of patient safety, there should be a review of how the reporting system can be improved."

The MHRA itself admits that there is a problem with underreporting.

"We have a robust and focused surveillance system. What we need is more help from healthcare professionals and the public to report when they have an adverse reaction," said a spokesperson.

But critics are not convinced.

"What's happened with Avandia shows up what is wrong," says Dr Kazi. 'It comes from a family of drugs known to adversely affect the cardiovascular system.

Yet, after seven years on the market in Europe and the UK, the only information about how people were responding to it came from a patchwork of different studies all run by the manufacturers, many of which weren't even published.

The solution may lie with following the American model. At the moment, new laws are being drawn up to reform the FDA, giving it greater powers to uncover side effects and act to reduce them.

"We badly need the kind of changes being proposed for the FDA," says Kazi.

Drug agencies are largely funded by drug companies, so their main focus is getting drugs licensed as fast as possible. Checking up on what happens comes a very poor second.

Long-time drug safety campaigner Charles Medawar says: "The average person on the average drug is unlikely to get a bad reaction." But if road safety was treated in the same way as drug safety is at the moment, we would be driving without seat belts, with few traffic lights, no white lines or street lighting, and crashes would never be investigated.'

A spokesperson from The Association of the British Pharmaceutical Industry says: 'The system of licensing in this country is robust and working well. All drugs are scrutinized very carefully after they are first introduced, and we strongly encourage doctors to report any adverse side-effects.'

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