A Bill that directs the FDA to speed up the drug and treatment approval process was passed by Congress and President Obama says he will sign it intermediately..The Bill also provides money for some major cancer research...

It has been pointed out that many potentially lifesaving drugs get hung up in needless red tape and extensive clinical trials that are not really needed..The FDA has been directed to develop faster more efficient methods to move promising new drugs and therapies into the marketplace sooner...

/www.washingtonpost.com/news/powerpost/wp/2016/12/07/congress-passes-21st-century-cures-act-boosting-research-and-easing-drug-approvals/?utm_term=.050ff7877fb0

It should not take 10 years to determine whether a drug is safe to use or not and whether it is effective or not...In the case of cancer drugs, many, many patients do not have ten years to wait...I'm not advocating we just give Big Pharma Carte Blanche but I think safety and efficiency standards can be maintained while at the same time speeding up the approval process from where it is today...

In a rare display of "class," Congress named a portion of the bill for Beau Biden. Salute!

Fairwind has mis-stated the bill's intent and purpose...the clinical trials are both needed and beneficial, but with a greater sharing of data across the cancer researchers, it is likely that the net processes may be sped up. There is no intent on shortcutting the clinical trial process for approvals.

Just as a sidebar, in 1953, Jonas Salk announced he had developed what he hoped would be a successful vaccine to prevent Polio..50,000 people contracted Polio that year, mostly children, many died or were paralyzed for life..Trials began immediately, using selected groups of school children..The trials were a huge success..By 1955, mass inoculations began in schools across the country at low or no cost as Dr. Salk did not seek a patent on his vaccine, allowing mass production by multiple sources..By 1961, there were only 161 cases of Polio reported in the United States. Today, the disease has been virtually eliminated around the globe. The vaccine went from the laboratory to distribution in 2.5 years. In 7 years, Polio was a fading memory in America and soon, the world.

Had Salk developed his Vaccine today, it would still be in clinical trials 7 years down the road.. It would be patented and very expensive..Times have changed........

(Maybe this is getting a little OT, but some may find it interesting).

Here's a sidebar to Fairwind's sidebar about polio vaccination.

I still remember the day (but not the year, as it was so long ago, but sometime in the early 1960s I believe) when I was in line with other kids, at school as I recall, waiting to get, one by one, our polio vaccinations.

The interesting thing about it was that we didn’t get shots that day, but sugar cubes! Yes, the line we were in passed by a large metal tray with dozens of little sugar cubes on it, each of which had gotten a drop of vaccine plopped on it by a nurse who was moving from cube to cube with a syringe.

As the line moved along, passing the tray, we were each instructed to take a cube, put it in our mouths, chew it up and swallow it. That was it! Polio immunity without even a needle prick! Just a sweet treat!

Makes one wonder if the sugar cube method could be brought back for use in vaccinations today!

My two cents. If someone is dying from a fatal disease, then any drug therapy should be allowed. It should be up to the individual to make the final decision. But if a new drug for a chronic condition comes about, it should be thoroughly tested in phase I, II, and III. Now if there are bureaucratic delays, then something should be done to speed the process.

Fairwind said...
I agree 100% Lapilot....Once your Oncologist writes "Metatastic Prostate Cancer, Terminal" into your medical records, then any drug or treatment your doctor and you want to try should be available to you and your insurance (within reason) should pay for it...

There are quite a number of mis-guided "Right-to-try" (RTT) laws recently passed at the state level which have created a new dawn of false hope...it's passed in something like 30 states now. The basis of those laws, all of which have been sponsored by the libertarian Goldwater Institute, allows terminally ill patients to access investigational treatments that have passed basic safety testing (Phase 1) with the FDA, but are not yet available on pharmacy shelves. Under the RTT laws, patients are responsible for costs of their investigational treatments.

The access to drug candidates that have completed no more than a Phase 1 clinical trial is the worst form of false hope that threatens to cost those most vulnerable everything. Because most drug candidates enter Phase 2 (70% pass Phase 1), a proposed cancer drug that kills normal cells too fast or causes side effects that kill a patient more quickly than the cancer will likely progress through at least Phase 2 trials before being dropped from the pipeline. In fact, a patient is far more likely to receive a drug candidate that will have significant adverse side effects beyond the symptoms caused by the disease. Insurance companies are exempt under the RTT laws from paying for medical problems, complications or side-effects...and nobody, not even the lawmakers who passed these laws, believes insurance should be held accountable for the costs of the RTT drugs or the cost of complications.

So, these laws seek to make experimental drugs available on an unbalanced scale to those who can afford anything, but will bankrupt many of those who cannot afford any cost.

In a nod to autonomy and the power of hope, perhaps a more reasonable approach would be to allow patients the right to try drug candidates that have entered into Phase 3 clinical trials. While many of the problems with cost, insurance and liability would remain, perhaps the most toxic and least effective drug candidates may have been screened from the pool of drug candidates. The current RTT laws are, in my opinion, mis-guided.


NOTE: The RTT laws are completely outside of the Biden "moonshot" efforts.

alephnull said...
I don't believe those laws to be mis-guided at all.

If you have a TERMINAL disease any treatment that is in the works, what ever stage of testing, ought to be allowed if it shows some promise.

No chance for treatment for a terminally ill patient means NO hope.
Some treatment that has been marginally tested does provide SOME hope at least.

Don't misunderstand...I would like to see the process of being able to seek to use an investigational medicine to treat a terminally ill patient under a compassion use protocol simplified, but I don't agree that it is any sort of absolute "right" which would completely fly in the face of the existing "rights" of the investigational drug owner.

alephnull, you didn't address my key two points: i) Phase 1 isn't far enough along, and will likely result in a high level of complications; Phase 3 is the place we should push this initiative; and ii) insurance does not pay for the drug, the administration or the subsequent complications/side effects under any of the 30-some existing RTT laws, and nobody (except Fairwind; not even the Goldwater Institute) thinks they should...which makes this a solution for the rich. Unfortunately, the laws have been passed by pushing the emotional aspect of this without addressing these key points. As they exist today, I think they are mis-guided.


Also, reiterating again this NOTE: The RTT laws are completely outside of the Biden "moonshot" efforts.

Post Edited (JackH) : 12/12/2016 3:31:23 PM (GMT-7)

Bololidat said...
Barry Goldwater was not a libertarian...but a solid republican conservative...

I can't say that the historic facts back that up, Bozo. Probably the greatest example:

Conservative or Libertarian: Goldwater viewed abortion as a matter of personal choice and as such voted consistently to uphold legalized abortion.



[Tread lightly here Bozo; you are not among the favored few who can talk religion or politics]

I will defer to your wisdom on both matters JackH

So newbie do not castigate JackH ( or applaud him) Bozo is an acceptable appellation from a galaxy far far away and JackH is a nostalgic kine guy...I like that in a human being...

The best part of that bill, after reading the Washington Post article (thank you Faitwind), is the 4.8 billion going to the NIH. More NS more, I've been told in my conversations with multiple doctors, clinical trials are being funded by big pharma. I'd be much more comfortable with studies funded by NIH.

Tony Crispino said...
Prato,
I am currently working on a couple NIH trials. They tend to be the trials comparing efficacy of older drugs in new settings or comparing where big Pharma has no stake holding. Big Pharma must fund their own trials for new drugs. And I think that's fine. After all they are the ones that want to go to market with new drugs they should have to pay for the research that brings them to market.

"Investigational drugs are almost always “owned” by someone — a research center, a university, a pharmaceutical company, a biotech company, etc. Occasionally, they may be “owned” by the government (i.e., taxpayers) through the National Institutes of Heath — but that is a very rare situation indeed."
/prostatecancerinfolink.net/2014/08/22/the-right-to-investigational-drug-therapy-to-save-your-life/