It’s possible that the next FDA chief will be Jim O’Neill. O’Neill has publicly supported proposals to do away with the FDA’s requirement for phase 2 and 3 trials, instead favoring “progressive approval” of drugs and other medical technologies and if the job does indeed become his, he could implement progressive approval for drugs.

Our current flawed system

As it stands right now, big pharma really is king. They reap a great deal of rewards from the fact that most small biotechs can’t fund phase 2 or 3 trials so they end up giving up significant ownership of their biotech to the giants in exchange for financial help.

Still, other organizations get paid billions each year for services related to those phase 2 and 3 clinical trials and doing away with those trials would mean a loss of income. Oh, and it would endanger patients, they argue.

While that’s true, it’s also true that patients often get sicker, and sometimes die, waiting for access to unapproved but effective drugs.

And then there are the drugs that never leave the lab. Often times drugs could effectively treat serious illnesses but aren’t worth the cost of approval. So they sit.

It really is all about money. It’s not about people or illness. It’s all about money.

Hope on the horizon

There are currently two important areas of research that have been stalled: geroprotectors and induced tissue regeneration (ITR).

From the article:

“Geroprotectors are compounds that repair the systems that accelerate aging and age-related disease. Major universities and research organizations have found at least half a dozen molecules that could slow aging and extend health spans… even in older people.

Induced Tissue Regeneration (ITR) has even greater potential. ITR is an emerging technology that could reactivate the embryonic healing powers hidden deep in your DNA. It could restore lost limbs, broken spinal cords, or any other body part to youthful function. Eyes, hearts, joints, skin, and livers could be taken back in time using relatively simple compounds.”

ITR, which may be the biggest breakthrough in the history of medicine, took OVER 20 years to get approved. This isn’t medicine. This isn’t regulation. This isn’t safety. This is a maze. And people are dying.

So, regardless of how you feel about President-Elect Trump maybe Jim O’Neill is just the person we need.

Source: Forbes