| HN Mirror

The way things currently are, people are dying without access to drugs that are known to work. The approval process is painfully slow.

As a concrete example, there's a new class of immune therapy drugs used in the treatment of melanoma, among them PD-1 inhibitors and Ipilimumab. The data for these has been around for years, they are known to offer some kind of response in about a quarter of patients. In a small percentage of patients, there has been complete response and they've been disease free for years. This is unheard of in metastatic melanoma (stage IV has a 10% 5-year survival rate).

Dying of melanoma, by the way, is not a pretty death, there's nothing dignified or natural about how melanoma kills. It's something out of a horror movie. Dying early of liver failure would is a walk in the park compared to what a terminal patient has to look forward to.

In any case, the point is moot, because not only are PD-1 and its ilk more effective, but the side effects in trial patients have been minimal compared to the destructive known effects of chemo and radiation (or golf-ball sized bleeding tumors cropping up in your intestines).

I invite you to visit any melanoma forum and read the backlogs. You can read through years of people going through horrific treatments, all of which, again, are known to not be effective (biochemo, interferon, surgeries, whole brain radiation once the cancer spreads to the brain), while desperately applying for studies for drugs that are out there and already showing positive results. Then they suffer. A lot. Then they die.

The boards are filled with stories like these: http://abcnews.go.com/Health/dad-pleading-unapproved-cancer-... - "Dad Pleading for Unapproved Cancer Drug Dies".

Trials often have very strict exclusionary criteria, leaving many people out - often those who need it most:

> Auden said he was told that in order to be accepted into a clinical trial for the anti-PD-1 drug, he would need to have either no brain tumors or brain tumors that were at least no longer growing.

Even once they are approved, they might not be immediately approved as first-line treatment, meaning you still have to go through the old standard of treatment, wait until it doesn't work (meaning: put your body through the wringer, then wait for the cancer to come back again -- hopefully nowhere important like your brain or your lungs), and only then you have access to the new miracle drugs.

It's easy to make internet comments over some theoretical "gotcha" if you've never been on the receiving end of the stick. But the current system is broken and real people are suffering needlessly.

How in any way does it negate the scientific process to allow people who have nothing but months of pain and suffering ahead of them to give an experimental drug a shot?