Drugs firm blocks cheap blindness cure(to seek license for more expensive)

Drugs firm blocks cheap blindness cure
http://www.guardian.co.uk/medicine/story/0,,1799772,00.html
Company will only seek licence for medicine that costs 100 times more
Sarah Boseley, health editor
Saturday June 17, 2006

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.

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God, don't you just love profit-seeking capitalists?

someone else's suffering and or financial debasement.

if Ophthalmologists are taking doses of Avastin from one vial - they could be putting unsuspecting patients in danger. They are essentially using the vial as a MDV - multiple dose vial. The problem is that the more times one enters a vial - depending on the technique of drawing the dose out of the vial - the more chance you have of contaminating the solution in the vial and incorporating bacteria. Injecting contaminated drug into the eye could cause severe infection and potentially the loss of an eye if not worse.

I could understand if Genentech repackages the drug into what would be called an SDV - single dose vial. This allows for the Ophthalmologist to only be able to withdraw one dose from the vial and one dose only. This reduces the potential for incorporating pathogens that could cause infection. This is the safe way to proceed.

Also - if Avastin was not approved for use in the eye - the physician is taking on an additional liability for using a product for an off-label use. If Genentech has since tested the drug in the eye and applied to the FDA for an indication for the product to be used for wet macular degeneration - this makes the Lucentis product more desirable to use from a liability standpoint.

Both repackaging from a MDV to an SDV and testing the product for use in the eye and applying for that indication cost the drug company considerable about of money to do - hence they will try to recover that sunk cost by raising the price of the product. Overall - they did make the product safer for both the MD and patient and should be able to make a buck on that fact.

Whether the dose should go up in price a hundred fold is questionable though. It is one thing to make a profit and recover your investment - it is another thing to take advantage of the situation and price gouge.

Remember pharmaceutical companies like oil companies are friends of George W. Bush.

or impaired vision whereas usage of it slows down or prevents vision impairment/blindness in most patients. Especially in the developing world, cost is a huge issue - if the price is 100 times, or even 20 times, fewer patients would be treated.

If the government decided to run the studies, I don't see why it couldn't, although the cost would probably be higher (because of the cost of obtaining the drug). If the patent hasn't run out on Avastin, one would think it would soon, so a generic version could be tested. (The patent expiration is probably the real reason Genentech tweaked the drug to produce a slightly different version ... with a new patent).

http://www.lef.org/protocols/prtcl-071.shtml

* Lutein Plus with lutein, zeaxanthin is suggested at a dosage of 1 tbsp daily with a fatty meal
* Super Zeaxanthin with Lutein; 5 mg of zeaxanthin and 10 mg of lutein per capsule, 1 or 2 capsules daily
* Life Extension’s Solarshield sunglasses
* Lipoic acid, 150-300 mg per day
* Selenium, 200-300 mcg per day
* Riboflavin, 50-150 mg per day
* Taurine is suggested at a daily dosage of 1,000 mg
* Coenzyme Q10 – 100 to 300 mg per day
* Life Extension Mix, 9 tablets, 14 capsules, or 3 scoops per day in divided doses
* Life Extension Booster, suggested dosage of 1 capsule daily
* Brite Eyes II eye drops (N-acetyl-carnosine) is suggested at 1-2 drops in each eye daily
* Super EPA/DHA with Sesame Lignans, two soft gels daily (for the dry and wet types).
* Ginkgo biloba extract, 120 mg per day.
* Grape seed-skin extract, 200-300 mg per day
* Bilberry extract, 150 mg per day
* Super Absorbable Soy Isoflavones for genistein: 1 capsule twice per day.
* Hydergine, 4-5 mg per day (prescription only)

The Age-Related Eye Disease Study (AREDS) recommended recipe consists of the following dosages:

* Vitamin A (Beta Carotene), 25,000 IU daily
* Vitamin C, 500 mg daily
* Vitamin E, 400 mg daily
* Zinc, 80 mg daily
* Copper, 2 mg daily

worked, do the studies and prove it.

If a specific combination together is an improvement over a placebo, you could PATENT and sell the drug.