Friday, March 21, 2014

Mom Takes On FDA and Saves Her Son's Life

CNN reports:
After just three doses of an experimental drug, Josh Hardy -- whose parents had to launch a media campaign to get him the medicine -- is sitting up, doing homework and playing board games with his brothers, his mother said.

Just last week, Josh was so sick he could barely get out even a few words. He was in heart and kidney failure, and vomited blood several times an hour as his family held a vigil in the intensive care unit of a Memphis hospital.

Josh received doses of the drug brincidofovir Wednesday, Saturday, and Tuesday, and tests showed the level of adenovirus in his blood went down from 250,000 copies per milliliter to 367 copies per milliter...Before receiving brincidofovir, Josh was fighting for his life. The adenovirus was ravaging his immune system, left vulnerable by treatment for cancer, and the only available antiviral drug to treat it wasn't working.

In early February, Chimerix, the company that makes brincidofovir, refused to give Josh its experimental drug. But after reports by CNN and intense pressure from social media, Chimerix and the Food and Drug Administration came up with a plan to get the medicine to Josh and other patients who request it.
In many ways, the FDA is one of the most evil government agencies in operation. Someone should do a study of how many obvious deaths the FDA is responsible for. It's really time to shut then down and return research freedom and product analysis to the private sector.


  1. "In many ways, the FDA is one of the most evil government agencies in operation."

    Couldn't agree more, but it's difficult to get the sheeple to feel comfortable controlling their own health.

    Andre Marrou once told me that he and another libertarian activist approached a group of gay protesters -- I believe they were protesting for more AIDS research funding. Marrou broached the subject of eliminating the FDA, and the protesters were horrified. "Who would make sure our medicine was safe???"

    Here, we had a group of people -- many of whom were terminally ill, and certainly all of them personally knew people who were terminally ill -- being denied drugs that represented their only hope for life, and they STILL defended the agency that was killing them. It's pretty shocking what decades of indoctrination has done to people.

  2. "It's really time to shut then down and return research freedom and product analysis to the private sector."

    I don't believe anything like that will happen in isolation. I suspect it will be more like a systemic collapse (and nothing short of that) that triggers a questioning of the overall state of things with the level of government being what it is in our society now. But the question is will the U.S. be even salvegable because the only people really having kids now are Latinos and they love the government and hate capitalism. I think those of us who want to be free are going to have to come together and break away at some point like maybe in New Hampshire or something.

    1. Latinos love the government and hate capitalism?

  3. Unknown

    That's why it's so awesome that "homophobic" and "racist" libertarians have embraced "Dallas Buyers Club" as the best movie of the last year. It shows how incompetent, ignorant and evil the FDA really is.

    When many regular columnists at LRC tout it as their favorite movie of the year (and I'm just glad my childhood crush Jordan Catalano won an Oscar!) then you know it's doing something right.

    Can you imagine the tools at FOX News or Sarah Palin saying their favorite movie was about gay people and transsexuals with AIDS?

  4. "It's pretty shocking what decades of indoctrination has done to people."

    Thats the kicker right there, government control of education has made all this statism possibly. As Jacob Hornerberger said there has to be a complete separation of school and state.

  5. As a pharmacist of 17 years who has kept an eye on the FDA, I echo all the statements and can verify that the FDA is a corrupt, inept, and incompetent organization.

  6. Yeah right. How about all the hokum the FDA keeps out of mainstream that Libertarian natural-living types want to class as medicine? Or for that matter the crazies who refuse to believe things such as vaccines cause autism even the only "link" is that Andrew Wakefield hack?

    1. People have the right to have their own opinions, without experts with guns enforcing the profitable version of "truth". The mainstream medicine has its own series of hokums, most of which are way more dangerous than hokums of "natual" kind.

    2. Gil: Major TROLL.

    3. Translation: people have the right to have their own opinion in a way they can poison and/or swindle others (caveat emptor, right?). It's laughable that you accuse modern medicine of hokum when it quite clearly removed the scourges of the past whereas natural hokum are often big fat (expensive) placebos.

      Just as well-fed people today can't imagine going hungry for lack of modern agriculture so too people with access of modern medicine can romanticise that people were dying en masse from infectious diseases or worse that cancer actually preceded the 20th century.

    4. Gil: learn what "liability" means, will you? If somebody sells a poison claiming it to be a medicine, he is guilty of murder, or attempted murder. Now, how many people Vioxx killed? 50000? See any pharma execs in jail for life? Oh, sorry, that poison was FDA approved. You must live in a cave if you think FDA exists to protect you rather than pharmas.

    5. Oh wow life must have been good to you and your people until the 20th century when the FDA and Big Pharma appeared on the scene. So them medical folks can't be sued eh? :

      On the other hand, I would definitely assert the "natural/alternative/homeopathic" groups (a.k.a. Big Placebo/Poison) most definitely do not have anyone else's interests at heart as they push their gimmicks onto the gullible I-hate-gubmint/science sheeple. Strange how they accuse medical science of daring to make a profit while they are quite happy to fleece the pocket of their vic-, er, patients.

    6. Gil, we don't hate government or science. It is the monopoly on providing government that we want to change. Why should there only be one FDA? And why the animosity toward the placebo effect? Why not use science to study the placebo and use it to cure 100% rather than the lucky 15%? Not sure why you mention profit. Profits are market signals used in economic calculation. BTW, You are my people too.

  7. Ironically, the chemo was weakening him to the point where adeno was killing him. Everyone looks to the purveyers of chemo poisons for a drug to save him from adeno? Sad.

  8. Think about it.....if they cured diseases instead of treating them....they would kill the game.

    What's the game?

    All of the beneficiaries from the constant flow of money into medical buildings, medical boards of research institutions, charities, foundations, universities, drug companies, medical equipment companies, infusion centers, care facilities, etc.....

    The patients are the platform...the reason for their existence.....cure them and then what???????

    What we they all do?.....If ever a system was built on's the medical industry.

    1. If there were a better system for profit it's the natural industry - they just offer placebos and some cases poisons. Since they do absolutely nothing in return for money means they're far more insidious.

    2. ...but you have a choice....and the above story is about life or death and no choice.

  9. There was also an intriguing talk by former CEO of Intel, Andy Grove.

    Grove’s central argument today was that the way we as a country handle
    the development of new drugs is in serious need of a transformation, a
    real transformation. He argued that the FDA should go back to what he
    called its original mission of approving new drugs that are proven
    safe, and leave the tests of efficacy to a process that is post-FDA.

  10. The great stem cell dilemma

    Finally, I visit someone who's even more familiar with how game-changing industries are born: Andy Grove, one of the godfathers of the semiconductor industry. He has invested in four biotech funds, is involved in a clinical trial of a drug for Parkinson's disease, has pledged as much as $40 million to the Michael J. Fox Foundation, and has been thinking a lot about the promise of stem cells lately. And yet, at his own foundation's office in Los Altos, I find him to be surprisingly full of doom and gloom. He rejects any comparison of stem cells to transistors. "The sun shone on that industry. The government had a stake, the consumer had a stake, and the telecommunications industry had a stake," he says. "This industry is just as important, but after that the similarities are gone."

    For close to two hours, Grove argues passionately about how the FDA is enabling predatory offshore industries by impeding progress and the many reasons financiers want no part of stem cells. "VCs aren't interested because it's a shitty business," he says. Big Pharma? Forget it. CIRM? "There are gleaming fucking buildings everywhere. That wasn't necessary." When I press him to be constructive, he wearily offers one possible solution. Rather than courting billionaires to put their names on buildings, we need a system of targeted philanthropy in which the 99% can sponsor the individual stem cell lines that matter to them.

    Even suffering from Parkinson's at 76 years old, Grove has plenty of fire in him. On this issue he seems particularly zealous, and clearly frustrated. He argues until he's exhausted, and politely asks if we may conclude. On parting, he looks me in the eye, shakes my hand, and offers one final thought. "What you're trying to do is extremely difficult, but also extremely worthy," he says. "I don't envy you. But you'll be a better man for it when it's done."
    It was clear during our talk that Grove wants an economic model for stem cell research and development to emerge, even if he's not willing to bet money on its happening. And that puts him in good company. According to a recent Gallup poll, 62% of Americans now consider embryonic stem cell research to be morally acceptable, and that attitude is pretty consistent across all age groups. It's a healthy sign that public sentiment is strengthening in the way it often does with scientific breakthroughs. First we fear the different or unknown. Then we realize how much it may help us or the ones we love. It's hard to imagine that there was once moral outrage over in vitro fertilization now that it's become fodder for reality television.

    Keirstead also has progressive ideas about how to lower development costs. He wants to offshore clinical trials in the same way corporate America has outsourced business processes. Many stem cell scientists worry about the U.S. losing a stem cell arms race to China. But Keirstead wants to drag the industry there on his terms. He recently founded China Stem Cell in Shanghai, and expects to start conducting trials there before long. "If you look at the old companies, with all their ups and downs and tiring out investors, they just have so much internal baggage," he says. "Running trials in China would be cheaper. I'm not advocating that people skirt FDA quality. Take the standards with you. You can do 100 or 1,000 patients there and be 20% of the cost of an American trial."

    There's a theory in evolutionary biology called punctuated equilibrium. It proposes that things don't happen gradually. We go through vast periods of stasis in which the status quo rules, and then, once in a great while, profound disruption occurs.