Sunday, May 17, 2009

NHS GP told family of meningitis death mother to 'stop fussing' three days before she died

Rushed consultation means that obvious syndrome was missed. People are just cattle to government doctors

A mother-of-two died from meningitis three days after a GP told her worried family to 'stop fussing' and she would soon be 'right as rain.' Two doctors put Karen Finan's symptoms down to a nasty stomach bug when they were called out to see her on successive days. But she became so ill she was rushed to hospital by ambulance and admitted to intensive care. Despite carrying out tests and scans, hospital doctors also couldn't correctly diagnose the problem, said husband Darren Finan.

The 37-year-old mother's brain became swollen and her life support machine was switched off after doctors said nothing more could be done for her. A post mortem later revealed she died from meningitis of the brain and septicaemia.

Mechanic Mr Finan, 44, of Wakefield, West Yorkshire, said:'We feel angry at the doctors because they dismissed Karen's condition and didn't seem to have the time to examine her properly - she could have been saved. 'We were given a card for the Meningitis Trust that lists the symptoms. Every single one Karen had on that first visit from the doctor - fever, vomiting, drowsiness, confusion, and severe muscle pain. It was just a string of errors from start to finish. 'They say with meningitis that every hour is critical - the longer they misdiagnosed Karen the more she was slipping away from us. We have been robbed.'

Mrs Finan fell ill on April 14 suffering from sickness, diarrhoea and stomach cramps. Mr Finan said they weren't too concerned at first and his wife tried to 'carry on as normal.' But she began complaining of a painful headache and the next morning he called the doctor's surgery.

On April 15 a GP from their health centre in Stanley came to the house and diagnosed gastroenteritis. 'The doctor who came to see her didn't examine her at all, he took one look at her and said it was gastroenteritis. Not even Karen's temperature or blood pressure was taken,' he said. By the evening her condition had deteriorated further.

Mr Finan said:'She kept saying "I'm red hot" but when I touched her skin it was cold, I put a fan on full blast to try and cool her down, I touched her back and she was dripping wet.' Within 24 hours she could not speak and her eyes were rolling to the back of her head.

On the Thursday another GP came out and confirmed gastroenteritis. 'The doctor was saying Karen just needed to go to bed, we needed to stop fussing and she'd be right as rain by the weekend. It took me 35 minutes to get Karen up to bed, she couldn't walk or stand on her feet - she was like a dead weight.

'When the doctor left that day I told Karen I loved her. She looked at me and was able to mouth the words "I love you more" and went to sleep. That was it.' By the next morning Mrs Finan was so ill her family dialled 999 and she was taken to Pinderfield's Hospital in Wakfield.

Tests were inconclusive and doctors said she may have had a stroke, a blood clot or a bleed on the brain. Sadly her condition deteriorated and her brain became badly swollen and she died on April 19 with her family at her bedside. The couple have two children, Stacey, 18, and Fletcher, 12.

NHS Wakefield district medical director, Mark Napper, said:'We offer our sincere sympathies to Mrs Finan's family for their loss. 'We are very concerned to hear they are unhappy with Mrs Finan's care and, although the family have not contacted us with their concerns, we take this very seriously, which is why we are initiating an investigation.'


Why would FDA approval cause a stock to increase ten-fold?

In the news: Vanda Pharmaceuticals won U.S. approval for its first product, a drug to treat schizophrenia, the Food and Drug Administration said. ... Vanda, which closed at $1.08 in regular trading yesterday, soared to $9.98 in extended Nasdaq trading.

It would appear, going by the jump in price, that prior to the FDA's decision, investors gave the drug at most a 1 in 10 chance of being approved. If Vanda's case is typical, then, even moments before the actual decision is made, it is hard to predict what drugs the FDA will approve.

I can understand it being difficult to predict whether a new chemical will turn out to be a useful drug when all the testing is done five or ten years down the road. But once the testing has been done, at the very least the results of those tests are fully known. There is no uncertainty about the results that have already been observed. And the FDA decision is, necessarily, based entirely on the results available at the time the decision is made.

If the FDA's decisionmaking process is

a) not arbitrary, and
b) based on the available results,

then the FDA's decision should be highly replicable, and therefore highly predictable, by any independent entity with access to the same results. And yet the FDA's decision is, apparently, hard to predict. Two possible alternative explanations are:

1) The results that the FDA bases its decision on are extremely well-guarded right up until the very moment that the FDA makes its decision. I doubt this is possible.
2) The FDA's decisionmaking process is highly arbitrary. This is my tentative conclusion.

A few anticipated objections and responses.

Objection: Vanda's case is not typical.

Answer: Could be. However, this seems not all that atypical. When I read the story it didn't really stand out as atypical.

Objection: The typical investor doesn't know how to interpret the data, doesn't know what the data is, etc.

Answer: This is true of most investors in most publicly traded companies. If it were a significant problem the efficient market hypothesis (EMH) would be not only wrong, but wildly wrong, all the time, and Vanda's case would provide a model for disproving the EMH.

Objection: Pharmaceutical companies really keep a tight lid on their results.

Answer: I have a hard time believing that. A tremendous number of people are involved in any study that gets to this stage. Even partial information should give a sense of how well a drug is working and what its side-effects are.

Objection: The cause of the unpredictability isn't that the FDA is arbitrary, but that the drug is borderline useful, and even the most predictable decision-making process will be unpredictable when it comes to borderline cases.

Answer: But surely the typical drug is not borderline.

Objection: The FDA can hardly be blamed because it is fundamentally hard to judge whether a drug is useful or not. It is unclear and/or subjective whether a given drug is useful or not.

Answer: Then why is the FDA making a decision for all of us?


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