Tuesday, March 10, 2009

Black box panic

If a drug has no side-effects, it will also have no main effects

President Barack Obama has designated overhauling American health care as a priority of his administration, and he has indicated that whomever he appoints to head the U.S. Food and Drug Administration (FDA) must implement "a stricter regulatory structure" and redouble the agency's focus on food and drug safety. With mounting pressure for the incoming FDA Commissioner to dramatically reform the agency, it is worth noting that when regulators are pushed to err on the side of safety, they often make society less safe, not more. A good example is the FDA's recent crackdown on prescription antidepressants, which has led to a drop in their use and a corresponding increase in suicides among teenagers and young adults.

Critics in Congress and in the news media often accuse agency regulators of having too cozy a relationship with the drug industry and favoring industry profits over patient safety. This chorus has grown in the past few years, as the agency has come under increasing scrutiny for a host of perceived blunders in approving new medicines and for being too slow to withdraw dangerous ones from the market. FDA regulates products representing approximately one-quarter of the American economy, so even small mistakes can have huge consequences.

The problem, which many critics fail to understand, is that no drug is absolutely safe. Even the most important life-saving medicines will often have potentially dangerous side effects that are not discovered until after the drugs have been approved. And many drugs later found to be dangerous provide tremendous health benefits to the vast majority of patients who use them. So, when deciding whether any given drug should be approved in the first place, or pulled from the market once potentially harmful side effects begin to emerge, the FDA must carefully balance its benefits against its risks.

Still, as early evidence of negative side effects begins to arise, politicians and the news media demand that the FDA "err on the side of caution." The agency is often called upon to issue warnings or withdraw a drug based solely on preliminary and highly suspect information. When faced with this mounting political pressure, there is a real danger that the FDA will overreact-either by warning doctors and patients away from beneficial treatments or by withdrawing a drug from the market too quickly.


Father died after NHS doctors failed three times to diagnose stroke

A father died after doctors and paramedics misdiagnosed his stroke three times. Jeffery Wingrove, 48, collapsed on a Saturday with severe vomiting and crippling headaches. His wife Isabelle, 52, rang an out-of-hours GP service but doctors twice refused to make a home visit. Instead they offered to fax her local pharmacy a prescription for painkillers for her to collect.

But Mr Wingrove's condition worsened and despite emergency surgery at hospital he died less than 48 hours after falling ill. His family last month won a six-figure sum in an out-of-court settlement over his treatment.

Mrs Wingrove said: 'If he had been ill on a weekday he would still be alive today. 'They held a gun to his head and they pulled the trigger. He was never given a chance of survival. 'All they had to do was come and see him, which my usual GP would have done at the drop of a hat. But it was too much trouble for them.'

Mr Wingrove, a dustcart driver from Braintree in Essex, fell ill at around 10am on December 9, 2006. The former marathon runner crawled to the bedroom with a severe headache and was unable to move his right side easily. He began sweating and vomiting. Not knowing he was already showing clear signs of a stroke his wife, who works at the local college, contacted the family GP. But because it was a Saturday she was directed to an out-of-hours service run for Mid Essex Hospital Services NHS Trust by the private firm Primecare.

A doctor called her back at 11.35am and told her to take Mr Wingrove to hospital that afternoon for anti-sickness tablets. Mrs Wingrove pleaded for a home visit, explaining he was too ill even to lift his head from the pillow and she could not move his 6ft frame herself, but she was refused. Not satisfied, she phoned the helpline NHS Direct and a nurse told her to demand a home visit from a doctor as soon as possible. At 12.20pm she called Primecare but was again refused a home visit.

By 9pm she called paramedics, who arrived but told her Mr Wingrove had vertigo and gave him paracetamol. After a sleepless night and in major pain, he fell out of bed at 2.30pm the following afternoon and began hallucinating. He was taken to Broomfield Hospital before being transferred to the neurosurgical ward at Queen's Hospital in Romford. He died the next day despite surgery.

David Kerry, the lawyer who handled the claim of clinical negligence against East of England Ambulance Service and the GP involved, said: 'Mr Wingrove was showing all the symptoms of a stroke, whereas the current TV advertising campaign to alert the public insists that a doctor should be called if the sufferer only has one. 'Yet the NHS itself actually failed to recognise any of them, and on three separate occasions. 'It's an outrageous travesty of professional care and the public have a right to wonder, when they see the warnings of strokes on TV, whether the NHS might do better spending that money on training its own staff.'

The family - Mrs Wingrove and her sons Marc, 14, and Danny, 23 - intend to make a complaint to the General Medical Council about the GP, who has not been named. It is understood the GP no longer works for Primecare.


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