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Trump Cures Cancer, Trump Is Pretty Sure

POTUS


Did you hear? Presidente Naranja is going to force the big bad pharma companies to let sick folks get access to their life saving meds, even before the drugs are approved by the FDA. This is the "Right to Try" legislation he signed into law last week.

We will be saving — I don’t even want to say thousands, because I think it’s going to be much more. Thousands and thousands. Hundreds of thousands. We’re going to be saving tremendous numbers of lives," said man who never exaggerates. Not about crowd size, hand size or anything.

What a bold move by a guy everyone thinks only does things that benefit himself or his chromosomally challenged brood. See! Pharma lobbying doesn’t matter to him. He just wants babies to be healthy and happy. He’s for the people. Or is he? Let’s dig into the legislation a bit shall we?

First off, where did this idea come from? Well, it came from the Goldwater Institute, a libertarian think tank based in Arizona and funded by Sith Lords (Koch Brothers). Warning bells yet? Critics of the law (and state versions that were already on the books before the federal one) believe that the motivation for the institute pushing the legislation is really to bypass the FDA. Makes sense, since libertarians dislike regulations like Trump dislikes a natural skin tone.

The new law actually does very little. Before the law, a terminally ill patient could ask the FDA to contact a pharma company and request access to an experimental drug that could potentially benefit them. This would be in a case where the drug was already in human clinical trials, but for some reason, the patient didn’t qualify for a trial. In rare cases (~1% of the time), the FDA declines to ask the company because of safety concerns. Sometimes the pharma companies agree, and sometimes they don’t, as it’s a complicated issue. Point is, they aren’t obligated at all to provide the drug. More on that shortly. So, what changes with the law? Are they now obligated to do so? As Kanye would day, nopety, nopety, nope, scope, nope. All the law does is allow patients or family members to petition the drug company directly without going through the FDA. Remember, libertarians hate regulations so sidestepping the FDA gives them Ayn-Randian-mini-boners.

But Carlos, why wouldn’t pharma companies want to give their lifesaving drugs to terminally ill patients who have no other options? Thank you for asking. It’s because the industry I work in is evil and only cares about profit. NOOOO! That’s not why, but when you have my old employer, Novartis, paying $1.2 MM to get access to Trump, well that doesn’t help our image much. Most of you know, but in case you don’t, to get a drug approved it typically goes through three phases of clinical development, cleverly named “phase 1,” “phase 2,” and “phase 3.” Sometimes we use Roman numerals if we’re feeling fancy. This is after all the early research and animal work is finished. In a nutshell, phase 1 is safety testing where you slowly increase the dose of the drug, looking for side effects. If the drug passes this phase, and only 10 percent do, then it goes to phase II (felt a little fancy) where it’s tested for signs of efficacy. Usually, but not always, phase 1 is done with normal human subjects and phase 2 with the actual patients you hope to treat. Phase 3 follows and is basically similar to phase 2 but with bigger patient numbers and designed so that if the drug works how it’s envisioned, the statistics will bear that out.

“Right to Try” lets patients ask for experimental drugs after phase 1 and safety has been “established.” Why the quotes there? Because safety isn’t fully established in phase 1. There can be rare and life-threatening side effects that don’t show up until the drug is dosed in a larger population. Often times, the request for an experimental drug is to treat a child and phase 1 is almost always done on adults with pediatric trials following later in development. So what, you say? A terminally ill patient doesn’t care about potential side effects since they have no options! Well, sometimes that’s true, but if the drug isn’t going to help and only makes the patient’s last few months of life even more agonizing and painful, that’s a bad thing. Of course, that’s a personal choice.

There are other reasons why it can be a problem to provide experimental drugs outside of clinical trials. Patients in trials are very well-monitored and all data about them and how the drug is working (or isn’t) is captured. In a compassionate use setting, that’s more difficult. Again, the safety thing, but also potentially a public relations fiasco for the pharma company. Imagine a situation where a child gets an experimental drug and dies from some unknown cause NOT related to the underlying disease. If the patient had been in a monitored study, it would be easier to judge if the adverse event was related to the drug or not. It’s less easy in the compassionate use setting. Regardless, now the news is out there that a patient died while taking the drug. Situations like this have led to the FDA putting a clinical trial on hold until an investigation is completed. Slowing down development of a potentially life saving drug is obviously a bad thing.

I was involved in a situation where we were just kicking off phase II (feeling fancy again) of an oncology drug that had potential use in some rare cancers. We got a request from a family via the FDA to get access. Ultimately, we did provide the drug, but it was a tough decision. We were having manufacturing issues (it was a tough molecule to make!) and were already nervous about having enough drug for the clinical study, let alone requests outside of that. We also considered the ethical question of providing drugs to this request but potentially not others if the supply became tight. In the end things worked out and we didn’t have any shortages. The terminally ill patient got access and we completed the study. Unfortunately, as is often the case, the drug didn’t show efficacy in the study and that was the end of the program. Did the compassionate use patient get benefit? Hard to say.

So, back to the legislation. Trump signed a law that allows him and Congress to take a bow for pure window dressing. Terminally ill patients already had a way to ask and often get access to experimental drugs. Nothing changes other than the FDA can be bypassed (bad idea) and some swampers wearing ties get to do photo ops with sick kids. If they care so much about kids, how about not separating the brown ones from their families and putting them in holding cells? How about a “Right to Try” legislation focused on helping immigrant kids and their families try the supposedly great American way of life?

Carlos Sagan

I am a biochemist MexiCAN. I also write screenplays, ever hoping to get one made.

email me at: carlossagan2018@gmail.com

follow me at: @RealCarlosSagan

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Once upon a time... about ten years ago, a group of entirely ridiculous men burst onto the scene wearing stupid hats and telling men that wearing stupid hats and telling men that walking up to women in bars and insulting ("negging") them would get them laid. This did not last long, as women also had televisions and computers and were completely aware of these tricks as well, so when some ass came up to us in a bar and said "Hey, nice nails, are they real?" we would laugh and laugh and loudly announce "Oh my god, this guy just tried to neg me! Can you believe that shit? HEY EVERYONE, THIS GUY JUST TRIED TO NEG ME!" and then refer to him as "Mystery" the whole night.

Most of the men who tried that shit only did so a few times before realizing that it wasn't going to work, and thus moved on to other things. Perhaps things that did not involve furry hats and coming off as a huge creep. We may never know, because I would assume that those who tried it are now extremely embarrassed and would never, ever admit to this to us.

Still, there were a few men willing to eat that shit up, as well as some grifters willing to take advantage of that. Said grifters tended to be extremely misogynistic and seemed more like they were teaching men how to be as despised by women as they were than teaching them how to actually be liked by women.

Some of them, like Roosh V, a creepy weirdo who actually does live in his mom's basement, actively encouraged men to rape women who were intoxicated to the point of being obviously unable to consent.

However, even that branch of the PUA tree is wilting away. Many "self-help" style PUA forums like Nextasf and RSDnation are shutting down or have already shut down. In March, Chateau Heartiste, a batshit crazy PUA turned White Nationalist/Alt-Right blog was shut down by Wordpress. This week, rape advocate Roosh V (whom you may recall once called yours truly a "Wonkette typist/clown face, would not bang") announced that he was renouncing his PUA ways and devoting himself to Jesus. He explained to the forum he manages that he would no longer be allowing anyone to discuss premarital "fornication."

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'Baby Geniuses' star Jon Voight took to Twitter early this morning to proclaim his undying love for Donald Trump, probably because there is no one left in his life who will listen to him talk about this, or anything else, in person. In this video rant, Voight encouraged members of the Republican Party, whom he apparently thinks are the only real citizens of the United States, to stand by Donald Trump and "acknowledge the truth" that he is the best President since Abraham Lincoln.


Part ONE:

People of the Republican Party, I know you will agree with me when I say our president has our utmost respect and our love. This job is not easy. For he's battling the left and their absurd words of destruction. I've said this once and I'll say this again. That our nation has been built on the solid ground from our forefathers, and there is a moral code of duty that has been passed on from President Lincoln. I'm here today to acknowledge the truth, and I'm here today to tell you my fellow Americans that our country…

Oh no, not our absurd words of destruction!

Part DEUX:

is stronger, safer, and with more jobs because our President has made his every move correct. Don't be fooled by the political left, because we are the people of this nation that is witnessing triumph. So let us stand with our president. Let us stand up for this truth, that President Trump is the greatest president since President Lincoln.

Does Jon Voight not know there have been... other presidents? Can he name them? Because really, it does not sound like it. Does he also not know that a very big chunk of the Republican Party actually does not care very much for Abraham Lincoln? Namely those defenders of Confederate statues that Trump called "very fine people?" Also, did he intentionally diss their beloved Ronald Reagan?

Who can know? Who can even tell what he is trying to say or why he is trying to say it. He doesn't appear to have tweeted much since 2016, so I'm guessing whoever's job it was to keep him from tanking his career quit. Either that... or after filming the seventh season of Ray Donovan, he found out it's going to be canceled or his character is getting killed off or something and he is now free to be a jackass? I don't know, I haven't watched the show, although my parents are very into it and mad that I haven't watched it. Literally all I know about it is that it has something to do with Boston, because they keep mentioning that to me like it's a selling point.

It seems useless at this point to note that the people who scream their faces off about how bad it is for Hollywood celebs to support liberal causes, and how they should keep their politics to themselves, etc. etc. make a way bigger deal than normal people do whenever a Big Time Hollywood Celebrity like Jon Voight or, uh, Scott Baio, supports their cause. Mostly because they're the only ones who have elected a reality TV star and the star of Bedtime for Bonzo (who by the way, also once practically ruined a perfectly good Bette Davis movie with his bad acting. Which is not to say that Dark Victory is not fantastic and probably the best thing to watch if you want to sob your face off, but he was very bad in it.) to run the country.

But we might as well do that anyway, because it actually never stops being funny.

[Jon Voight Twitter]

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