Drug companies fed up with blundering British bureaucracy

So Brits don't get new drugs

One of the world’s leading drug companies is threatening to withdraw some of its new cancer treatments from the process by which they are approved for use in the National Health Service. Cancer patients in Britain will consequently be denied more effective drugs that are available to sufferers in other countries.

Roche, the Swiss pharmaceutical giant, has already refused to supply economic data on its drug Avastin for treatment of lung and breast cancer to the National Institute for Health and Clinical Excellence (Nice), the authority that evaluates the cost-effectiveness of medicines for the NHS. This means Avastin will not be available on the NHS for those diseases. Avastin is said to double the time a breast cancer patient’s condition remains stable when compared with existing treatments. Studies have also shown improved survival rates for lung cancer victims.

Roche said last week it will consider withdrawing from other evaluations rather than submit products only for them to be rejected by Nice as too expensive. The statement is the latest twist in the growing row over decisions by Nice. Earlier this month Nice caused an outcry in a preliminary decision when it rejected the use of Avastin (also known as bevacizumab), Sutent (sunitinib), Nexavar (sorafenib) and Torisel (temsirolimus) as too expensive to treat kidney cancer.

“The alternative to these drugs for many patients is death,” said Jonathan Waxman, professor of oncology at Imperial College, London. “Nice is making terrible mistakes.” The survival rates for cancer in Britain are already among the lowest in Europe — on a par with Poland, Slovenia and the Czech Republic, according to data published last year. However, cancer charities acknowledge there has been significant improvement in rates since the government made the issue a priority with its NHS Cancer Plan, first launched in 2000. Some consultants argue, however, that Britain already spends less on cancer drugs than many other European countries and that it is “crazy” to reject drugs proven to prolong life.

Richard Barker, director- general of the Association of the British Pharmaceutical Industry, which represents the drug companies, said: “Nice does a tough and necessary job, but is making errors because of a very mechanistic approach. It relies too much on arithmetic and not enough on clinical judgment.”

Nice was created in 1999 with the aim of ensuring that decisions on the best and most cost-effective drugs for the NHS were made at a national level, were transparent and could be challenged. When the drug companies scrutinised the economic modelling used by Nice, they realised that the estimated costs of their drugs and effectiveness could vary widely. Even more seriously, some of the calculations were wrong. There was an outcry in the medical community in February 2006 when Nice stated that Temodal (temozolomide) — declared as the biggest breakthrough in treating brain tumours for decades — did not offer value for money. Temodal had won approval from the European regulator in 2004, but many British patients were denied treatment as Nice wrangled over costs.

Peter Davison, 48, a manager for Cambridge University Press, was among the few British patients who received the drug — because he was diagnosed with a brain tumour while working in Singapore. “I was lucky to be abroad,” said Davison, who is now in remission. “Four months after I had the operation to remove the tumour, I was running and climbing mountains.” When Schering-Plough — the pharmaceutical company which markets Temodal — prepared its appeal against the Nice decision, it identified an error in the modelling. Once corrected, the model showed the drug was cost-effective — and as a result it was ultimately approved for NHS use.

Not surprisingly, the drugs companies now want full access to the economic models, with the chance to check the accuracy of the calculations. In May, the High Court ruled that Pfizer and Esai, the companies which market the Alzheimer drug Aricept, should be given full access to these models. “We believe this modelling might not be fit for purpose and we want to check it,” said a Pfizer spokesman last week. Nice said it was seeking leave to appeal to the House of Lords after the High Court decision.

Even where the models are correct, consultants and patients’ groups say Nice fails to give proper weight to the evidence from clinicians and patients’ groups. The Sunday Times has highlighted the fact that NHS patients do not even have the option of paying for the drugs privately because of government ban on “co-payments”. The government has said it will review the issue.

Professor Sir Michael Rawlins, chairman of Nice, said the evaluation process was recognised internationally and Nice had been commended by the World Health Organisation for the quality of its work. He said: “We have a finite amount of money to spend on healthcare and we have to divide it up in as fair and as equitable a way as we can. We can’t say to yes to everything. It’s awkward, it’s difficult, it’s unpleasant.”

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Arrogant Australian drug regulator to cause taxpayers MORE pain

And the crooked bitch mainly responsible is still in her job! Australia's version of the FDA shows how badly such organizations can go off the rails

A class action against the federal Government is set to be launched next week after the $55million payout to Pan Pharmaceuticals founder Jim Selim. The Government could be liable for another multi-million-dollar payout because of the action taken by the Therapeutic Goods Administration in 2003 to cancel Pan's licence. The Weekend Australian has also uncovered further evidence of what occurred in the lead-up to the decision to cancel Pan's licence - including a senior TGA officer shredding notes taken at a crucial meeting.

Mr Selim claimed the government had breached its duty and abused its power of public office, and his Federal Court case was settled on Thursday in his favour. More than 300 people lost their jobs, shareholders lost tens of millions of dollars and hundreds of businesses were affected by Pan's closure in 2003.

In January that year, people reported hallucinations and vomiting as a result of taking travel sickness drug Travacalm. The TGA then investigated Pan and meetings were held to decide what action to take. On April 23, 2003, the TGA organised for an expert advisory group to decide whether the public was at "imminent risk" of death, serious injury or serious illness from Pan's products. It was a statutory requirement that the government believed this "imminent risk" existed before it could take the action to cancel Pan's licence. The EAG was later to report back to the TGA that there was no "imminent risk", although it did find there was a lack of confidence in the quality of Pan's products.

Pages of notes taken by the members of the EAG were later taken by the TGA and destroyed at the direction of senior bureaucrat Fiona Cumming. Dr Cumming is the director of the office of complementary medicines. At the same time, the EAG was meeting at the Qantas Club at Sydney Airport to discuss the risks of Pan's products, media officer Kay McNeice was in the TGA's Canberra office putting the finishing touches to a media release - announcing the cancellation of Pan's licence.

Although the notes of the EAG's deliberations were destroyed, lawyers were able to unearth a transcript of the meeting, which had been recorded at the behest of the TGA. "We don't have much evidence do we," one member noted. "We're having trouble getting to 'imminent risk'," said another. The findings of the EAG did not justify an immediate suspension of Pan's licence, a proposition agreed to in court by the TGA's director of the office of devices, blood and tissues Rita Maclachlan, who spent several days being cross-examined by Mr Selim's barristers. Immediate suspension meant Pan could not dispute the issue in the courts, a fact the TGA was aware of.

Ms Maclachlan, second in command at the TGA, was also present when then health minister Kay Patterson and prime minister John Howard were briefed in late April. "Why didn't you speak up and say, 'Look, even though it's not my call ... we are about to implement the largest recall in the history of the Western world, unlawfully, because we are going to deny the company its statutory requirement to natural justice'. Why didn't you say that?" Mr Selim's barrister, Justin Gleeson SC, asked. "I don't have a recollection, Mr Gleeson" Ms Maclachlan replied.

When Ms Maclachlan gave evidence that she was concerned that one batch of Pan products - manufactured in August 2000 and not part of the 2003 recall - could cause severe allergic reactions in the public, the judge hearing the case, Arthur Emmett asked a few questions of his own. "You weren't prepared to recall this product back then but that was the reason you were going to call the other 6000 products back (in 2003)?" "I don't have a particular recollection as to what happened with this product," Ms Maclachlan replied.

"But you've just told me ... that you were concerned that this product was still out in the community," Justice Emmett said. "You didn't take any steps to have it recalled? I just find that quite unbelievable." Ms Maclachlan declined to comment yesterday.

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