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Author Topic: It's not just in the US that drug companies screw people over  (Read 1304 times)

Dissident

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Drugs firm blocks cheap blindness cure
Company will only seek licence for medicine that costs 100 times more
Saturday June 17, 2006
Guardian

A major drug company is blocking access to a medicine that is cheaply and effectively saving thousands of people from going blind because it wants to launch a more expensive product on the market.

Ophthalmologists around the world, on their own initiative, are injecting tiny quantities of a colon cancer drug called Avastin into the eyes of patients with wet macular degeneration, a common condition of older age that can lead to severely impaired eyesight and blindness. They report remarkable success at very low cost because one phial can be split and used for dozens of patients.

But Genentech, the company that invented Avastin, does not want it used in this way. Instead it is applying to license a fragment of Avastin, called Lucentis, which is packaged in the tiny quantities suitable for eyes at a higher cost. Speculation in the US suggests it could cost £1,000 per dose instead of less than £10. The company says Lucentis is specifically designed for eyes, with modifications over Avastin, and has been through 10 years of testing to prove it is safe.

Unless Avastin is approved in the UK by the National Institute for Clinical Excellence (Nice) it will not be universally available within the NHS. But because Genentech declines to apply for a licence for this use of Avastin, Nice cannot consider it. In spite of the growing drugs bill of the NHS, it will appraise, and probably approve, Lucentis next year.

Although Nice's role is to look at cost-effectiveness, it says it cannot appraise a drug and pass it for use in the NHS unless the drug is referred to it by the Department of Health. The department says its hands are tied.

"The drug company hasn't applied for it to be licensed for this use. It wouldn't be referred to Nice until they have made the first move," said a Department of Health spokeswoman. "They need to step up and get a licence. If they are not getting it licensed, why aren't they?"

New drugs for the condition are badly needed: those we have now only slow the progression to blindness. With Avastin, many patients get their sight back with just one or two injections.

Avastin was first used on human eyes by Philip Rosenfeld, an ophthalmologist in the US, who was aware of animal studies carried out by Genentech that showed potential in eye conditions. This unlicensed use of Avastin has spread across continents entirely by word of mouth from one doctor to another. It has now been injected into 7,000 eyes, with considerable success.

Professor Rosenfeld has published his results and a website has been launched in the US to collate the experiences of doctors from around the world. But although the evidence is good, regulators require randomised controlled trials before they grant licences, which generally only the drug companies can afford to carry out.

Prof Rosenfeld said the real issue was drug company profits. "This truly is a wonder drug," he said. "This shows both how good they [the drug companies] are and on the flip side, how greedy they are." He would like to see governments fund clinical trials of drugs such as Avastin in the public interest.

Rising drug bills are a big problem on both sides of the Atlantic. In the UK, said David Wong, chairman of the scientific committee of the Royal College of Ophthalmologists, doctors are fighting battles to persuade primary care trusts to pay for drugs to stop their patients going blind while they wait for Nice to decide on Lucentis and another expensive drug called Macugen. That decision is not expected before the end of next year.

About 20,000 people are diagnosed with age-related macular degeneration in the UK each year. "From the patient's point of view, if they have an eye condition that deteriorates very quickly, there is no question of waiting," said Professor Wong. "We're talking about days and weeks, rather than months. The question is should we do nothing and say there is no randomised controlled trial to prove Avastin is of value?" He called for primary care trusts to agree to pay for the planned phasing-in of new drugs for the condition.

Last night Genentech said its main concern over the use of Avastin to treat eye conditions was patient safety. "While there are some small, single-centre, uncontrolled studies of Avastin being performed, safety data on patients who are treated with Avastin off-label is not being collected in a standard or organised fashion," said a spokeswoman for the company.

Pharmaceutical firms say they need to launch drugs at high prices because of the hundreds of millions of pounds spent on developing them. Critics point out that the company's calculations also include the marketing budget.

 
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kitten

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Since Avastin has already been researched and developed, why are they dragging their heel on this?  To say that the high price for individual doses reflects the cost of development is an outright lie and they know it.  That is both greedy and cruel.  Blindness is a horrible affliction  and anything that will prevent it should be made available immediately.  Since they have already shown that it works, there should be no excuse for tardiness.  Governments should step in and crack down on tactics by big business like this that threaten the health of their citizens.  And doctors should order large quantities of Avastin and keep it handy for the victims of age-related macular degeneration bot here and abroad.  I seem to recall reading that this ailment can be caused by deficiencies in peoples diet, among other things.  They should be ashamed!
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Dissident

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 I'm from a medical family, and have seen what the drug companies have done to the whole health care industry, but I have to admit that this example is one of the most craven I've seen since the original patenting and distribution of AIDS drugs in the 80s and 90s.  

Fortunately Avastin is available in other forms—and with other legitimate applications hopefully ophthalmologists can continue using it in some "off list" manner.  If there were a political agenda behind it (like with misopristol) I wouldn't exactly understand it but I wouldn't be so shocked.  What will happen, unfortunately, is evidently without NHS licensing, patients would have to go to private clinics for treatment.  To me, that's the worst part—people with disabling eye diseases usually aren't in an economic position to pay for costly treatments.

Hopefully, the social backlash will force Genentech to back off on this blatant attempt at money-grubbing—after all, it did work with the developers of AZT.
   
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kitten

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It seems that the poorest and neediest are always at the end of the line in medical treatment, unless they volunteer to be guinea pigs for trials of new medicines.
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Dissident

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 kitten wrote:
It seems that the poorest and neediest are always at the end of the line in medical treatment, unless they volunteer to be guinea pigs for trials of new medicines.

What saddens me is that this is happening in the UK, which had a "single-payer" system like in Canada and the rest of Europe, but thanks to all the Thatcherist privatisation in the past few decades, so many private clinics and hospitals have sprung up that there's a de facto "two-tier" health system.  Harper's pushing for it here, too.  At least under the old system there was at least the pretence of egalitarianism in health-care delivery.

As a clinical professor at a major medical research centre, my mother once had to sit on a committee rationing a life-saving procedure (that had just been developed) amongst applicants.  She said that it was the most difficult thing she had ever had to do—this coming from someone who had many chronically and often critically ill patients whose care often required deciding when to cease "heroic measures" (the "quality of life" criteria come into play in these decisions).  She got off that committee as soon as she could.

Can you imagine being a doctor who has to tell a patient that they will have to accept going blind because the government won't pay for their treatment?  When you think of it, the doctors are employed by the government that their patients are paying for.  Their real employer isn't the NHS, but the taxpaying patients they are bound in their professional ethics to serve.  They have to be cognisant of the incredible injustice of the circumstances.  I feel for the doctors as well as the real victims of this situation.
 
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