A Miracle Drug Cured Ed Levitt of Stage IV Lung Cancer. Then the FDA Withdrew it From the Market.

 

I have a new video out today (click above) that I made for the Manhattan Institute, which tells the story of Ed Levitt, who in 2004 was diagnosed with terminal lung cancer. Unable to get out of bed and covered in tumors from head to toe, Levitt's doctors advised him to start making funeral arrangements.

Levitt’s nurse suggested he try a new experimental drug called Iressa that could make his radiation treatments more effective. The goal was strictly palliative; Levitt was told that his best hope was that the radiation augmented with Iressa could save him from spending his final days in sheer agony.

A few weeks later, all signs of Ed Levitt's cancer had disappeared. Nine years later, he's still in almost perfect health. It turns out that Iressa effectively eliminated Levitt's cancer because has a genetic mutation affecting what's called the epidermal growth factor receptor in his cells. The following year, the FDA withdrew Iressa from the market. Those who were already taking it, like Levitt, could continue, but no new patients could start.Ed Levitt and his wife Linda |||

The FDA's decision to take Iressa of the market is indicative of how the agency is out of touch with the emerging paradigm of personalized medicine. The FDA's method of conducting clinical trials is designed to identify drugs that work for the typical or average patient, "but you're not wholesale, and neither am I," says Peter Huber, a senior fellow at the Manhattan Institute, and the author of The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine. The war on cancer, Huber argues, will be won using cocktails of drugs tailored to the unique biology of each patient and his or her variant of the disease. Only if the FDA abandons its outdated one-size-fits-all approach to drug regulation will there be more patients like Ed Levitt.

For more on how the new era of personalized medicine threatens the FDA's command and control approach to drug regulation, read Nick Gillespie and Ron Bailey on the agency's recent efforts to get the genetic testing company 23andme to stop selling its genotype screening test.

For more on how the FDA keeps life-saving treatments out of the hands of patients, watch Nick Gillespie's Reason TV interview with Peter Huber:

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  • sarcasmic||

    If it doesn't work for everyone, then no one can use it! Anything else would be unfair!

  • Will Nonya||

    You wouldn't want those patients without genetic mutations to be discriminated against...

  • Rasilio||

    "The war on cancer, Huber argues, will be won using cocktails of drugs tailored to the unique biology of each patient and his or her variant of the disease. Only if the FDA abandons its outdated one-size-fits-all approach to drug regulation will there be more patients like Ed Levitt."

    This is incorrect. There are enough rich old people with these diseases that if the FDA doesn't get the hell out of the way medical toursim will take over and fill the gap.

    As long as they are just making drugs more expensive or a little slower to market the FDA will be tolerated, once people realize effective cures are available but just illegal for them to purchase they'll find a way around the bureaucracy.

    The treatments might performed be in India or Costa Rica or a cruise ship in the middle of the ocean but there is no way a multi millionaires will sit bye and just die because the government said they can't have the drugs they want.

  • AlmightyJB||

    Drones

  • waffles||

    The answer is always drones with you. Sheesh!

  • Agammamon||

    To be fair, our Top Men in the Obama administration consider drones to be the first (and last) solution to all problems.

  • Leigh||

    You know, I'm actually surprised we haven't heard of drones invading out borders delivering/dropping off drugs from the cartels. If Amazon has been tinkering with it, I'm sure the cartels are investing heavily in this area. Drones can fly close to the ground, launched anywhere, evading or making radar tracking difficult, and land anywhere. Plus, if they were shot down captured - no big deal, just a cost of business. Genius!

  • robc||

    I think we havent heard of it because the border patrol hasnt figured out they are doing it yet.

  • Dweebston||

    Shh! SHH! Don't give our regulators ideas. We'll see drone manufacturing as an avenue for innovation shot down in the name of DRUG WARZ.

  • dinkster||

    They fly rc airplanes back and forth all the time.

  • Dweebston||

    Hilariously, I only ever hear from the diehard single-payer crowd that fully privatizing healthcare provision ensures only the wealthiest are adequately cared for. It's the zero-sum mantra again and again with the anticapitalists.

  • Adam330||

    There is a second order effect to the regulatory regime though- pharmas don't invest in the technology in the first place because they know it's a waste of time.

  • Andrew S.||

    I work with a company that's spending tens of millions of dollars to test a drug for approval to the FDA's satisfaction. A drug that's already approved, and has been used for years, in Europe and other areas.

    (and people wonder why drugs cost so much money...)

  • Brett L||

    Thalidomide?

    SLD, fuck the FDA.

  • Ted S.||

    Doesn't thalidomide have efficacy for leprosy patients?

  • BakedPenguin||

    It actually seems to have a few uses. Furthermore, what reason was there to ever not give it to men, or women past childbearing years?

  • Brett L||

    Godammit, I haven't slept in like 3 fucking days and I'm in a hospital surrounded by babies. Cut me some slack. I can't wait to go back to work on Monday so I can nap at my desk.

  • Game of Gnomes||

    I am temping for a pharm, and sat in for some class about regulations. The FDA is just a government sanctioned extortionist. They charge annual fees, fees for making changes, fees for reviewing proposed drugs. The worst part is the company rep said the FDA charges these fees because otherwise it wouldn't be funded with a straight face.

    The left moans about how evil korporationz only want money even to the point of killing people yet the FDA (an arm of the all feeling compassionate government) won't even touch the report for a proposed drug unless all fees are paid. At least in theory people could be dying in beds due to a money craving government.

  • sarcasmic||

    The FDA is just a government sanctioned extortionist.

    Government at every level exists on extortion.

  • tarran||

    When I worked in a pharmaceutical co, our division's flagship drug was a treatment for Hunter Syndrome, which dooms kids to die around the age of 15. Given our treatment, the kids could have a normal life and evade the mental retardation and tissue damage that otherwise doomed them to a painful, short life.

    And because my predecessors had fucked up a bunch of paperwork, we could sell it anywhere in the world but not in the U.S.

    So if you had the disease in the U.S. you were going to die because god forbid the Batch Records of how the drug was produced for several months hadn't been properly reviewed by the chain of management.

    The one aspect of that job that I struggled most with was the visits by the FDA. I had to be nice and shake hands with those murderers instead of sucker punching them and stomping their skulls flat which is what they deserved.

  • Dweebston||

    This seems appropriate.

  • hickory||

    When I worked in R&D for Pfizer, that was their mantra, but oddly enough, reading their annual report, they were spending more on direct to consumer advertising than R&D and FDA filings. So, yes, people wonder why drugs are so expensive, and if they ask the FDA makes a fine whipping boy, but it's a lie. Those annoying Viagra ads on TV, and the disincentivizing effect on comparison shopping of the third-party-payer system are why drugs cost so much money.

  • ||

    But without the FDA, evil pharmaceutical companies would be selling us rat poison!

    That was an actual argument a college professor once made to me when I questioned if the FDA regulation of drugs is really beneficial to people.

  • sarcasmic||

    But without the FDA, evil pharmaceutical companies would be selling us rat poison!

    Not just Big Pharma, but Big Agra and everything else! All food would be poison! All drinks would be poison! Everything would be poison! We'd all be dead if not for the FDA!

    (I've had liberals make that argument to me with a straight face. They actually believe it.)

  • ||

    Like I said, an actual professor, who gets paid to educate people, made the argument that a panel of FDA bureaucrats are more trustworthy and responsive than an evil corporation that has to compete for customers.

    It didn't seem to occur to her that poisoning all your customers was not a good way to do business and would have consequences.

  • sarcasmic||

    These people seem to feel that because government is us and we are government (false premise, so whatever follows is a fallacy), anything government does is with our consent because it's us who are doing it because government is us.

    On the other hand they feel that those evil corporations are forcing you to buy their products.

    They've got voluntary and force completely flipped.

    Not surprising, considering that they feel tolerance means being intolerant of anyone with a disagreement, inclusiveness means excluding anyone with a disagreement, and equality means they are superior to anyone with a disagreement.

    It's no surprise then that they feel that when you voluntarily purchase something you're being forced by the corporation, and when you're compelled by government you're doing it of your own free will.

    It's a mental disorder.

  • Rasilio||

    "Not surprising, considering that they feel tolerance means being intolerant of anyone with a disagreement, inclusiveness means excluding anyone with a disagreement, and equality means they are superior to anyone with a disagreement."

    You forgot diversity was everyone thinking the exact same way

  • Will Nonya||

    Freedom is slavery. War is peace.

  • Juice||

    (I've had liberals make that argument to me with a straight face. They actually believe it.)

    And there's no arguing with them after they release this rationalization. They consider that the end of the dispute. Case closed. QED.

  • Invisible Finger||

    I stopped reading at "professor".

  • Fist of Etiquette||

    Have we reached the point where the FDA cost more lives than it's protected?

  • Agammamon||

    Hmm, I think that calls for a series of multi-year studies through animal testing and double blind testing in human trials, submitted to the FDA so they can review the efficacy and safety of the FDA.

    Don't forget to pay the review fees.

  • NoVAHockey||

    and the lobbyists you'll need.

  • Adamsmith1776||

    Way past that time. Pick any drug that saves any person from any disease, and count how many died from that disease in the time between submission for approval and actual approval. Add those up over the last 20 years, and I bet the number is bigger than all of the Americans in wars fought since the Revolution.

  • robc||

    ^^^This.

    My understanding is that the delay in approving beta blockers killed more people than the FDA can probably ever hope to save.

  • Paul.||

    "but you're not wholesale, and neither am I," says Peter Huber,

    Yes you are. You are a product which produces revenue and GDP for a government office, nothing more.

  • Sam Grove||

    It turns out that Iressa effectively eliminated Levitt's cancer because has a genetic mutation affecting what's called the epidermal growth factor receptor in his cells.

    ?

  • Death Rock and Skull||

    because HE has.

  • Death Rock and Skull||

    My friend showed me this documentary he picked up at Family Video about some chemical that was extremely effective in treating cancers, but was not approved by the FDA. Some Austrian sounding doctor was defying laws to give it to people. Anyone know what I'm thinking of?

  • Will Nonya||

    Marijuana?

  • Plopper||

    Dr. Burzynski?

    I saw that documentary, but it didn't convince me if he was a quack or not...

    Although it did convince me the FDA probably should have given up after the nth time.

  • Plopper||

    I'm thinking he's a quack though honestly, but who knows.

  • Death Rock and Skull||

    I was pretty high when the documentary was on, and wasn't paying that much attention, so I can't really recall the details. But my perception at the time was that he was dead sincere in what he was talking about.

  • RickCaird||

    The FDA is dedicated to killing more people than they save.

    On a more serious note, the FDA should be abolished.

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