happiness

Statutorily, a preparation of cells qualifies as “drug” subject to FDA regulation if the cells are “more than minimally manipulated.” The specific treatment I need calls for a patient's stem cells to be isolated from his bone marrow and culture-expanded to grow them to multiplicity. The expanded cells are then implanted into an arthritic joint, where, if the process is performed by skilled hands, they are well-documented to be capable of exerting reparative effects. In 2010, the FDA sued the company that pioneered this procedure on the grounds that the expanded cells are "more than minimally manipulated" (see ARI's commentary). The FDA prevailed, and it is now illegal for any doctor to administer culture-expanded stem cells in the US without obtaining a biologics license, the cost of which is so burdensome that it renders the procedure economically unviable in today’s regulatory environment. The cause also seems obstructed by parties with serious conflicts of interest. The former FDA commissioner said this: “When I was commissioner of the Food and Drug Administration (FDA) from 2005 to 2009, I saw firsthand how regenerative medicine offered a cure for kidney and heart failure and other chronic conditions like diabetes. Researchers used stem cells to grow cells and tissues to replace failing organs, eliminating the need for expensive supportive treatments like dialysis and organ transplants… For example, in August 2010, the FDA filed suit against a company called Regenerative Sciences. Three years earlier, the company had begun marketing a process it called Regenexx to repair damaged joints by injecting them with a patient’s own stem cells. The FDA alleged that the cells the firm used had been manipulated to the point that they should be regulated as drugs. A resulting court injunction halting use of the technique has cast a pall over the future of regenerative medicine.“ I don’t think it’s unreasonable to project that, by the end of the ensuing decade, the FDA vs. Regenerative Sciences decision will probably have resulted in millions of preventable deaths.

I have Google alerts set up to send me articles on regulatory policy pertaining to adult stem cell therapy. While not a popular issue, there is a battle raging on among interested parties on the internet, in the media, and in the legislatures, where there have been a few credible attempts at deregulation. The odds have always been stacked against patient freedom, and the progress has mostly reflected that, but there have been a few positive developments, most notably a Texas law that makes federally prohibited adult stem cell therapies legal at the state level starting in the near future—it remains to be seen whether the FDA will interfere. In the last two years there has also been an explosion of clinics offering a legal kind of stem cell treatment that doesn't meet the FDA's ever-changing definition of a "drug," and this has provoked much negative press, always outrageously biased and clearly intended to fearmonger, spread misinformation, and drum up public support for regulators to stamp these treatments out of existence. So, I have to stay abreast of what's happening on the regulatory front since it has such important implications for me. I wish it was easy to set it aside when I'm done processing the latest news.

no more* dismissive

It’s crazy that I’ve been following Peter Schiff for 10 years and his predicted economic collapse hasn’t played out, yet all along I’ve felt as if the threat has been imminent, and even hoarded a small fortune (by my standards) in gold. I’m actually no less dismissive of the collapse scenario than I’ve ever been, and still holding tightly to my gold, but at this point I do at least grant the possibility that the Schiffs of the world could turn out to be completely wrong. If this is the case, what flaws in my general thinking could have contributed to the formation of this erroneous belief that, five years ago, I held with certainlty? Over-pessimism? Some degree of emotionalism? Lack of understanding of economics? Maybe just being out of my depth?

Thanks. I haven’t take taken anything stated here as snide, though.

With the Govt spying, there are many reasons you can’t be assured it’s safe to do this. I’m not sure that America comparing favorably to other counties means much, as the rest of the world sets the bar pretty low. Status quo FDA policy is morally equivalent to the mass murder of sick people. Regardless of how it’s rationalized, cutting off a person’s access to a needed medicine is no different than slaughtering him by any other means. I don’t know what percentage of voters have any awareness of this issue, but the overwhelmingly negative response to the Right to Try bill I’ve observed shows that the majority of people who understand what the FDA does are clearly apologists for mass murder. That’s pretty evil. I’m not terminally ill, so this bill doesn’t affect me, but I’m in the same boat with a chronic disease which is highly treatable with an advanced therapy that the FDA will probably never let happen in US, so the issue is deeply personal to me. I’ve tried to deal with the issue constructively by presenting the pro-freedom side wherever I could, but found that pretty much every time I’ve either been downvoted into oblivion or treated to the most banal displays of irrationality one could ever hope to come across. The other side’s arguments always follow same pattern: they focus solely on the possibility of harm caused by unregulated medicines, cherry-pick the negative as evidence, treat the priestly bureaucrats as omniscient and incorruptible without any justification and against all evidence to the contrary, and use inane buzzwords like “snake oil” as substitutes for facts. I have argued with MDs who ardently support the FDA and never seen anyone muster anything more intelligent than “BUT BUT BUT THALIDOMIDE!!!” Trying go educate others on this is simply a gigantic waste of time. So what are my options? Try to find a more effective way to communicate the issue even though the prospect of positive change anytime soon seems impossible. Avoid debate and try to block out current events. Focus on my life and generating enough funds for more offshore treatments. Say the Hell with it all, it’s been fun. Most of the time I’m in mode #2, but sometimes read an article like the one I posted, and my blood just boils over.

Is there a reason it would be less likely to pass the House when it’s already passed the Senate? If it passes the House it’s as good as law.

I cannot stand that I live in a country where the majority of people even tolerate these views , much less one where biggest media outlets and allegedly scientific publications promote this utter filth as the voice of science and reason. All the "Right to Try" legislation does is is give people a chance to live when they have no other chance, and only after the drugs have passed the phase of testing that allegedly proves safety. What kind of foaming-at-the mouth animal would oppose that? Physicians, ethicists urge Congress not to pass ‘right-to-try’ legislation Science Feb 3, 2018 4:15 PM EST WASHINGTON — Dozens of doctors, medical ethicists, and lawyers are warning Congress that legislation to allow Americans with life-threatening conditions access to unapproved, experimental drugs risks harming patients’ health. The letter was drafted by Alison Bateman-House, associate professor of medical ethics at NYU Langone Health, along with some of her colleagues. It is addressed to the leaders of the House Committee on Energy and Commerce, the committee currently considering a so-called “right-to-try” bill. The letter was circulated for online signatures on Thursday, and organizers said they planned to send the letter on Feb. 5. In August the Senate passed a right-to-try bill sponsored by Sen. Ron Johnson, which is now sitting in a House committee. The bill would allow patients with life-threatening conditions access to drugs that have not been approved by the Food and Drug Administration. FDA Commissioner Scott Gottlieb has expressed reservations about the bill, but President Trump seems to support it. The 40-plus signatories of the draft letter, however, say they are strongly opposed. “This legislation sells vulnerable patients and families false hope at the expense of weakening the FDA’s critical role in making sure that all Americans can have confidence in the safety and effectiveness of our medical products,” the draft letter read on Thursday afternoon. The FDA already has a pathway for patients to be able to use experimental treatments outside of clinical trials, which is called “expanded access” or “compassionate use.” According to an FDA study, 99 percent of requests made from 2005 to 2014 for these experimental drugs were approved. But a right-to-try bill would allow doctors and patients to skirt around the FDA, leaving them more vulnerable if something goes wrong. “Patients with terminal conditions who access unapproved therapies outside of clinical trials may be at risk of hastened death or reduced quality of the life that they have left, and deserve protections similar to patients taking part in clinical trials,” the authors wrote. Andrew Powaleny, a spokesperson for the pharmaceutical industry organization PhRMA, which hasn’t taken a firm stance on the legislation, said, “It is crucial that any right-to-try policy proposals protect patient safety and the integrity of the clinical trial process along with U.S. Food and Drug Administration oversight. PhRMA appreciated the opportunity last fall to work with Sen. Johnson on his proposal and is engaged in an ongoing dialogue with his office and Energy and Commerce Committee Chairman Walden.” Trump doubles down Meanwhile, in a speech to Republican lawmakers on Thursday, Trump reiterated his support for congressional action on the subject. He first spokepublicly in favor of right-to-try legislation in his State of the Union address on Tuesday. “I hope you folks can approve it, and I hope you agree with it,” Trump told Republican members of Congress at a Thursday retreat in Greenbrier, West Virginia. Trump’s remarks implied that FDA Commissioner Scott Gottlieb was on his side, saying that Gottlieb was “heading it up.” However, Gottlieb has actually expressed concern about the current bill that the House is considering, testifying at an October hearing that it would undercut the agency’s authority to protect patients from unsafe drugs. The FDA declined to comment Thursday. Bateman-House testified at the October hearing alongside Gottlieb. She said that she has not been in touch with the committee since the hearing, and that she thought after the hearing the bill had “more or less died.” But Vice President Pence has been vocal recently on the issue, proclaiming his support in January. He signed a similar bill in Indiana as governor in 2015. Thirty-eight states now have such laws. “I think his heart’s probably in the right place,” Bateman-House said of Pence. “I just wish he would put all this time and energy [into legislation] that was actually going to help patients.” This article is reproduced with permission from STAT. It was first published on Feb. 1, 2018. Find the original story here.

I'm not sure how I would define rudeness exactly, but it is a type of communication that could justifiably offend and cause emotional distress. Say you're calling a customer service line with a legitimate reason to be angry—is it OK to yell at the person and use expletives? Or is this kind of conduct always gratuitous?

The free state project is pretty nutty IMO. These people are talking about making drastic life changes in the name of a completely hopeless cause. Even if a fraction of the people who gave them a signature actually followed through on their alleged commitment to move there, what would 20,000 people accomplish on a state scale?

I imagine that, probably over a long period of time, either a lot of Objectivists would move to a given area or that a lot of people in a given place would become Objectists, resulting in a large Objectivist population whose members would eventually become influential in local politics. Yes, they would still be subject to the laws of external governments, but they could still accomplish things like abolishing the property taxes used to fund public schools and answering the cliche "who will build the roads?" (if not the government).

I'm not talking about the creation of a mico-nation, just a significant population of Objectivists setting somewhere within an established country. They wouldn't presume the right to banish people. Maybe they could shoot down the local school levies.

Obviously, this isn't in the near term future, but if the Objectivist movement was to grow to, say, a few hundred thousand, would there be any incentive for them to band together and settle in a common area? Would this even be desirable?

Could it very likely be only a few years away? The thought is frightening. And what will it look like? Will there be a new tax on everyone to fund it?

The purpose of medicine is to restore health, not simply the process of dying. Getting healthy is exactly what today's shit governments, including that if the US are making impossible.

I think art is better because it's a product of the mind. While sport has a strategic element, it's mostly genetically gifted specimens flexing physical abilities—that has a place, but it's below art.

Given the current alternatives, I'm better off with the US government in my life than I would be without it. But I want it all, a country whose government protects my rights from both street thugs and politicians and bureaucrats.

If I say no, do I admit that the Federal government in its present form isn't a complete abomination? I don't think so. It only does a reasonable job by world standards of protecting us from violent criminals who are not among its own ranks.

It's my own personal example. The FDA prohibits any doctor in the U.S. from administering a legitimately promising treatment derived from my body's own stem cells to treat the arthritis that is gradually robbing me of everything that makes life worth living. Earlier this year I traveled out of the country and paid $33,000 cash plus travel expenses to get this treatment in a jurisdiction that allows it—it's working great, but I only treated 1/3 of the joints that need it, and I need additional treatments in those joints. It took me a year and a half to save enough money to do that much and the reality is I will never be able to afford to get the improvements I need under today's laws. I just paid my self-employment taxes and they took a fifth of everything I was putting toward the next round of treatment to pay my share of Medicare recipients' medical expenses, to say nothing of the $3000+ in premiums I had to pay for a health insurance policy that covers my 33/M self for any medical expenses I might incur related to pregnancy complications and altzheimer's disease, but that the government won't let pay a dime for the only treatment in existence that can make any meaningful difference in my own condition. What a great country.

I think you're setting the bar too low and my beef with the U.S. isn't that the police arrest people for pot. Today's government, in the name of "protecting" people, imposes real hardship on many, and in some cases actually makes it impossible to even have a chance of survival.

Strike back by comparing them to people who are yet more successful.

I think the bad outweighs the good. I don't know what to say about the U.S. military; I don't watch or read the news and the only commentary on foreign affairs I pay attention to is Yaron Brook's and even then I feel pretty much nothing but contempt and revulsion for the stuff he talks about. The police and especially court system are worse than mixed bags and those of us who have been on the wrong side of either at some point in our histories, either for some victimless non-crime or just doing what we needed to do to live, know they regularly do a lot of bad.

Though it may still be better than most other countries, as I hold the present-day United States in low esteem due to its rampant violations my rights. Does the U.S. flag mean anything anymore? Should one who has lost all respect for the U.S. as a political entity respect the flag and only detest the voters who have corrupted the government? Am I justified in not wanting to salute the flag or stand for the national anthem, and wanting to remove the flag from the front of my residence?

Obviously there should't be different sets of laws for men of different races. But what should be done about Indian Reservations? Should the laws recognizing them be repealed altogether? Should Objectivists support their existence in the context of the status quo since they provide some refuge from state and federal government?

Is there any good reason to want to learn about ancestors you never knew and whose lifetimes didn't overlap with your own? Is it a form of tribalism?