FDA madness

#1: FDA experts have voted to ban the drugs Serevent and Foradil for asthma patients. The vote isn't binding, but the FDA generally follows such recommendations. And yet . . . One-third of these experts disagreed with banning these drugs for adult patients. The leading rationale was that many patients used them incorrectly by not pairing them with a steroid. But what about patients who took the drugs responsibly and correctly? The total cost of these drugs plus steroids is still cheaper than that of two other asthma drugs, Advair and Symbicort, which were approved. In other words, the panel voted to limit the clinical options of doctors and increase the costs for patients.

Even so, it could have been worse. Some FDA safety experts wanted to ban all four drugs because they may cause one death in "somewhere between 700 and 4,000 patients." They apparently didn't listen to Dr. Richard Gower, President of the American College of Allergy, Asthma, and Immunology, who said, "We live in an imperfect world. All drugs have potential benefits and side effects."

#2: The FDA has also banned the use of chlorofluorocarbon (CFC) inhalers (MDIs) beginning this year. CFC products are believed to cause ozone depletion, and most of them were banned internationally by the Montreal Protocol of 1987. However, Medically essential products, such as CFC MDIs, have been exempt. Medical products account for, at most, 0.5% of CFC consumption, meaning the ban is not environmentally necessary. Replacement inhalers (HFAs) are still patent-protected, and no generics can be made until 2010. HFA MDIs are 2-3 times the price of CFC MDIs, and require more diligence to clean and maintain.

The poor, who are already more likely to suffer asthma, are paying a tax on their health for the sake of a symbolic environmental gesture. There is no medical justification for banning CFC MDI's....

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British cancer victim confronts drugs chiefs

Nothing can hasten the glacial pace of bureaucracy

Seventy-year old David Basey is planning to spend his life savings on a drug that could give him a few months of extra life - in the hope that the NHS will step in before it is too late. And yesterday, he and his wife confronted the group which makes drugs decisions for the NHS to ask why it has taken so long to make up its mind on four life-extending drugs for advanced kidney cancer. Mr and Mrs Basey, from Gorleston, went to the public question time held by the National Institute of Health and Clinical Excellence (Nice), the independent body which provides national health guidance.

The retired bricklayer and electricity board worker was diagnosed last February and was given one to two years to live. He has had his kidney removed but the cancer has spread to his spine. His only hope is one of the latest cancer drugs, Sutent, which could double his life expectancy and his time with his wife Ann, to whom he has been married less than a year.

But the drug is not recommended for use on the NHS apart from exceptional cases. Nice is reviewing its guidance and met to make a decision last week, but will not publish it until late March. Until then, Mr Basey has decided to spend his life savings on the 3,000 pounds-a-month drugs in the hope that the NHS will pay for them before his money runs out.

Mrs Basey, 60, asked Nice bosses why there had been such a delay - and chief executive Andrew Dillon admitted that they should have started the process much earlier. She asked: "Bearing in mind that the process has already taken years, can you tell me why there is such a delay between the meeting last week and the announcement in March? Do you realise how many kidney cancer patients are dying for the want of these drugs, or are spending their savings in the hope that it will help them? If the drugs are approved, why do PCTs [primary care trusts] then have three months to implement that guidance?"

Mr Dillon said: "We started work on assessing these drugs far too late. The guilty parties there are Nice and the Department of Health." He said that, once work started, committees had to look at all the evidence, hold a consultation, and look at new evidence. Primary care trusts are given three months to help with financial planning, although some are ready to implement it more quickly. He added: "I know it is tedious, and not just tedious, but distressing. I do sympathise with you."

Nice has been looking at Sutent, Nexavar, Torisel and Avastin since 2007. The drugs could help up to 1,700 people in Britain with advanced kidney cancer each year. It is due to publish its guidance, or final appraisal determination (FAD), in late February, followed by a 28-day chance to appeal, so if there is no appeal it will become official in March. But its new guidance on end-of-life treatments, which was published earlier this month, said it can only publish an appraisal consultation document - in which case the wait will last much longer.

Mr Basey said: "Sutent might double my lifespan. We can afford to pay for it until June and I hope by then the guidance will have changed. I hope something in medicine will come along in the time I have got left. That is my only hope."

Ian Small, deputy head of prescribing for NHS Norfolk, said: "NHS Norfolk welcomes definitive answers on the funding of drugs by Nice. This means that NHS Norfolk would pay for a drug, should it be recommended clinically appropriate for a patient by their consultant. "Nice gives guidance to all primary care trusts to say that processes should be in place to be able to prescribe to appropriate patients within a three-month window and NHS Norfolk would work in line with this."

Fellow kidney cancer sufferer Alan Martin, from Lowestoft, has been campaigning for Sutent to be widely available on the NHS. And David Blackett, from Attleborough, is one of the few to receive Sutent on the NHS as an "exceptional case" after battling to receive it.

Also at the meeting, held at the Norfolk and Norwich University Hospital, was Deborah Browne, the chairman of the N&N's drugs and therapeutics committee. She asked why there had to be a gap between the FAD and the guidance becoming official. She said afterwards: "Once the FAD is published, the patients' expectation is that it will be available. The patients are kept in limbo. That is difficult, when there is a whole group of patients that are waiting."

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