Who here thinks drug companies (pharmaceuticals) are altruistic...

[NNadir]

42. Perhaps the scientists at Genentech, rather than be thought greedy, shouldn't have done...

...the clinical trials.

That would have saved them embarrassment and you $2000 a shot. Everybody wins, right?

One of the the things that someone has to do for an ocular drug is to bioanalysis in aqueous humor. To do this, one needs to built a calibration curve in a blank, quality control samples in a blank. How many people do you know who donate aqueous humor by tolerating an injection in their eyes? As a practical matter, one needs cadaver aqueous humor, and it can take years to accumulate enough to develop and validate a bioanalytical method. Or else one has to justify using bovine aqueous humor or rabbit aqueous humor, which involves analyzing all of the components in various species and submitting an argument to regulatory that they are "close enough." (This is, by the way, what almost always happens but...

...Have you ever tried to buy human aqueous humor? What do you think it costs?)

Avastin is an engineered protein. There are three ways to do bioanalysis in a protein, one by digestion, another by a technique known as ELISA, which involves raising antibodies in animals, isolating them, purifying them qualifying them and storing them until they're needed - the latter being no small issues - and the latter being intact high resolution mass spec.

A high resolution mass spec runs between half a million dollars and over a million dollars - these instruments are sensitive enough to measure billionths of a gram. For more than half a century, hundreds of thousands of professors, grad students, electrical engineers, materials scientists, physicists, computer scientists, biochemists have worked to make these instruments work. They are not run by high school students, and the data isn't interpreted by game show hosts.

Now, once Genentech, that greedy company filled with rapacious executives who live to rip you off, decided to "invest" in making the anti-angiogenic drug Avastin approved for ocular injections, they just didn't write in on the label, "Oh yeah, you can inject in an eye too!"

They would have faced fines of tens, if not hundreds of millions of dollars for doing so.

They had to do animal studies, probably with rabbits, including bioanalysis, and perhaps with monkeys. What do you think it costs to maintain a colony of monkeys? Cheap? Easy? They had to have highly trained veterinarians administer the drug to the eyes of rabbits and monkeys. They had to design a syringe with a narrow enough bore to inject eyes - no small feat for a viscous protein solution, in fact a major problem for every protein drug. They had to make sure that the materials in that syringe did not leach any polymer antioxidants that destroyed the activity of the drug, and conduct stability trials lasting three to four years, paying chemists to analyze (with mass specs and/or HPLC) samples stored under rigorously controlled conditions involving back up generators, all kinds of sensors to continuously record temperature and humidity, using multiple methods that required weeks of high level scientists work to develop, and weeks more to validate.

While all this is going on, they needed to get to a point, after multiple meetings with regulatory authorities at the FDA, EMA, Health Canada, etc, etc, at which they could recruit people willing to have their eyes injected with an experimental drug. These people are paid of course, to be subjects, but it's only a small part of the costs. A clinical trial research organization employs nurses, pharmacists, statisticians, and physicians to continuously monitor all events associated with the trial.

After all of this a report is issued - a book length report - and returned to the regulatory authorities for review.

If everything fits together, if the drug is safe, and effective for the treatment of macular degeneration, then, and only then, can the greedy executives at Genentech begin to rape their customers by charging them to save their eyesight.

And let's be clear about something OK? Genentech executives know damned well that the injection can be achieved by cowboy doctors using approved Avastin for cancer treatments off label.

Nevertheless, they were willing to try to get the drug approved for a small population whose eyesight might be saved.

For all this, they wanted to (gasp) make some money. You know, I think my mechanic should fix my car at a loss because, well, damned, I need to get to work, don't I?

Greedy bastards.