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  • #3
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    Don't blame the drug company. They're following FDA regulations to the letter in order to bring a drug to market to benefit many people. Giving the drug to ONE boy, while laudable, would kill more people down the line by causing a delay. If you don't like that fact, change the law, change the FDA, or START YOUR OWN DRUG COMPANY.
  • #13
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    @Knightkore I once received a drug under the auspices of this program. The extension of the drug trial because of the program conditions means that it's not on the market yet. It gave me a couple of years of relief, but now that I'd like to be able to get it again, I CAN'T. The FDA paused the human trials because of the early releases outside of a controlled program, and I'm stuck for years, at least, using much less effective medicines. The extra costs may mean it NEVER comes to market.
    http://pharmatimes.com/Article/13-10-27/Celge...
  • #19
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    @Knightkore Just what I suggested. Harping on a drug company for FOLLOWING the law seems pretty stupid to me, but that's what this thread will devolve into. They'll be corporate thieves, immoral, racist, nazis, you name it. People who haven't been part of a drug trial and gotten involved with the politics just don't know how screwed up our system can be. Thank the AMA, ABA and trial lawyers for it.
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  • #48
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    Sure blame the drug maker over the government that sets the laws and regulations they must follow.Thats a nice twist on your part Greg congrats.
  • #46
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    Instead of pressuring the drug company for following FDA rules, we should be pressuring congress to change those rules.
  • #131
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    What rule in particular? That companies have to test drugs and submit the results to the FDA? Or that they have to pay for the tests, rather than the cost come out of tax revenue as a stimulus for research?
    Don't just tantalize us with your deeply thought out opinions, you small government types.
  • #138
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    @gzuckier
    Yep. Those rules. The company was forced to make a choice, give out their product for free or procede with the long, expensive process of getting FDA approval. In other words, helping a few or helping many. That's the same decision Obamacare will be forcing upon the entire medical industry. Fortunately for this poor little boy a charity has offered to pay for his medication and the company will be providing it to him. So the boy gets help and thousands of others will not have a longer wait for the same help, a win-win without governmental interference.
    Except for that excessively long, expensive approval process!
  • #169
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    @galt45 They are highly regimented in certain areas and very much the victims of legal abuse which is why most are off shore. It was big pharm and the government that allowed loser testing so that HIV meds could be distributed.
  • #40
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    I don't think people realize just how corrupt the FDA and these drug companies are. Many of these medicines are mostly developed by tax payer funding and then the FDA lets the drug companies sell them at an insane mark up as well as sole rights to manufacture.

    If you really want to be pissed off read: http://healthland.time.com/2011/03/10/can-pat...

    Premature birth prevention drug price raised from $10 to $1500 after the FDA gives sole manufacturing rights of a common manufactured drug to KV Pharmaceutical Company. If you REALLY want to be pissed off read that KV Pharmaceutical Company spent $2,500,00 lobbying that same year.

    https://www.opensecrets.org/lobby/clientsum.p...
  • #67
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    This is a good case not only for free healthcare but for government mandated manufacture of pharmaceuticals.

    If we could spend tax dollars to make more of this drug then they could grant compassionate use to everyone who needs it and still have enough of it left to go through clinical trials.

    Chances are this company could easily afford to pay for the increased production itself but that would mean lower profits. They would be only somewhat rich instead of filthy rich.
  • #73
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    mandated manufacture?
    also just like Keyjo below you didn't read enough to understand the process.
    The FDA will not allow the approval process to go on while they are giving it away.
  • #92
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    All the article says is that they chose to focus resources on obtaining FDA approval. It doesn't say the FDA won't allow clinical trials at the same time as compassionate use. In the link to the Fox article it even says "they can not afford it" not that it isn't allowed.

    This whole case makes me sick. Why aren't our laws to protect people in this case? Nobody should have to die because a drug isn't approved yet or because they don't have money.

    The government itself should pay for more to be manufactured in cases like this.
  • #101
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    Oh yeah, cause god of liberal does everything else so well, we should turn over all drug development to them. Good god.
  • #140
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    @CommonSense This is very much like the early days of the AIDS crisis, when drugs were being developed but weren't yet approved. So much public pressure was brought that they allowed compassionate use, and guess what? Many drugs did NOTHING, and others made the patients worse. Until AZT came along, using a drug was an act of desperation, not an act of healing. What if this kid doesn't get better, or if the drug harms--or kills--him?
  • #143
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    @ cpeter133

    If nothing is given to him then he will die for sure.

    If this treatment is given to him then he has a chance to live.

    It's a no-brainer. He should get the drug. He should get a chance to live.

    Same with those people with AIDS you mention. The treatment may have worked based on what they knew then. Had they not had the treatment they would've died. Getting these uncertain treatments most still died, but at least they were given a chance. And some had AZT before it was certain that it was a good treatment, and those lived. Would you have had them die just because the treatment wasn't sure yet?

    If there's a chance at life people deserve the right to have that chance.
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  • #38
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    Kathleen Sebelius: "...someone lives and someone dies.”

    When our own government officials, who have the power and authority to apply a signature and save a life, decide that a child's life is not worth the effort...

    ...you can hardly hold a company with an untested, unlicensed drug which has yet to be approved by the FDA to use that drug to save a child's life.

    As horrific and sad as it is, this is the government we have made...and the regulations we have allowed them to place into action...and the agencies that have the power over our children's lives.

    When Sebelius and the FDA sign off against prosecution of the maker of the drug...I am certain it will be available.

    But don't hold your breath.

    Good luck, Josh. I am so sorry for what you are going through.
  • #81
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    @AntiPorcheria
    And in that case, letting the girl jump to the top of the organ donor waiting list DID cause somebody else to die.

    In this case, on the other hand, giving the boy the medicine he needs would not cause somebody else to die in his place. This is sheer unadultrated greed.
  • #100
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    @Cal maybe you should read and learn. God of liberal will not give approval of the drug if the company does not pull it. THAT will delay release of the drug, causing other people to die. If you and your leftist friends don't like the laws your god made, call them. But no. A liberal cannot bring themselves to blame their god for problems.
  • #108
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    @Cal - My friend, the world and the circumstances we have allowed to evolve mean life and death decisions must be made on an minute by minute basis...and hopefully we, as people, make the best decisions for the greatest number of people.

    In the case of the lung transplant, that should have been the doctors call. The child, while under 12, was physically developed enough to accept an adult lung. It was simple bureaucracy that kept her off the list. After getting common sense to cut through the red tape, she received an adult lung from a donor family that lost an adult in a motor vehicle wreck.

    Her getting the adult lung did not "cause" someone to die. No one has died as a result of the exception to allow her to live.

    On the other hand...

    When a drug finishes clinical trials (the period of time when it can be used experimentally), the drug company that wishes to make it available must subject it to rigorous testing through the FDA with input from the AMA. The testing then suspends the clinical trials by law and, based on the various compounds and their associated side effects, the drug may not be used again until the testing is complete. That period of time varies from 3 - 8 years depending on anticipated, possible side effects.

    These are the laws set by our government.

    Using the drug again will now set back the testing and results by more than two years.

    How many other children will then be effected because we wanted an exception to use this drug just this once just for this one child?

    You may look at it as greed.

    I look at it as the greater good for the greater number.

    My heart genuinely goes out to young Josh and his family...but unless we get the law changed to allow for continued clinical testing while a drug is under the testing phase...these situations are going to continue to happen.
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  • #34
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    I can not blame the company uinless they get a written release from all liabilty both criminal and civil if they administer the drug to him. This is exactly the type of thing that can get the company run at by the Feds and the civil courts should something go wrong. The drug is not approved for general use yet so the company has every right to not take that chance.
    Look at all the commercials on TV about this drug or that having had bad side effects and now even though those drugs were fully licensed by the FDA the companies are being sued.
  • #9
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    This is one of those, do you help this kid and he live and slow down the process to actually get it in the hands of doctors and hospitols widely. Or do you sacrifice countless lives of the many for this kid? Its a bad scenario all the way around. I think Jon Luc Picard said it best.

    " The needs of the many outweight the needs of the feW"
  • #27
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    @methinks Yes but i am going on a general consensus that most people on this site are lucky enough to have been fans of TNG let alone the Star Trek Movies ( Pre-Chris Pine) etc.
  • #39
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    @Arumizy The majority of the posters on this site are more than old enough to remember TNG and a large number certainly remember ToS.
    FYI, to be a Trek fan and not be a liberal, you must have missed something along the way.
  • #49
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    @TRex84 I don't see how being a Trek fan has to mean you have to be a liberal. Its science fiction, not science faction.
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  • #159
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    Some of the folks who opposed this probably still don't see the light of this being the right thing, and always was. That's what is scary, knowing there are people like that.
  • #15
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    This seems like the story that showed up awhile ago where people wanted the rules dismissed to allow a girl to recieve lungs that she normally wouldn't. I remember how the majority wanted that girl to get those lungs regardless of the rules in place and damn the consequences it would have on others.

    Now those same people are wanting this kid to NOT get the medicine (which is manufactured, unlike lungs) because of the rules and because it might impact others negatively.

    Damn hypocrites.
  • #21
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    Different situations. She was considered too young to be on the adult donor list. The first set failed, but the second set worked. That's part of the organ donor program.

    This is different, and the FDA needs to bend IT'S rules, not the pharmaceutical company. Apparently, administering the drug outside of the control group puts a delay on the approval of the drug for use by the general public. It shouldn't and these are mutually exclusive events.

    @GregZeman: How about the contact information for the FDA, which ultimately controls the fate of the drug?
  • #23
    Editorial Assistant
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    @methinks Sure, why not?

    1-888-INFO-FDA (1-888-463-6332)—main FDA Phone Number

    Thanks for reading and commenting.
  • #37
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    @methinks same situation. The only difference is that the girl needed lungs and the boy needs a medication. Nobody has to die for this kid to get medication and apparently two people had to die for the girl to be ok.
  • #44
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    Really? Did you keep track so you can honestly say that these exact people were in favor of breaking the rules in one instance and not in favor of breaking the rules in this instance?
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  • #14
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    For to positive publicity they should provide it, if allowed by the FDA. Since it is not a market drug it would be considered as further testing.
  • #4
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    The problem is with the FDA and its rules. It is easy to blame the company, but, it has a choice of getting the drug approved for distribution which will probably take a couple of years or not. The FDA could and should make an exception in cases like these, but, they rarely if ever do. The FDA is responsible for many unnecessary deaths in this country by refusing drugs proven to work elsewhere but not by them to patients that would be cured by the drugs. The law establishing and responsible for this should be amended by making the FDA an advisory service instead of a regulatory agency. They can list all drugs the have tested and approved but allow a Doctor to prescribe other drugs that are available and proven in other countries.
  • #16
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    That would be a nightmare medically considering companies could push out utter crap that's cheaper and less effective than the stuff they make now to save a buck and the doctors would have to prescribe it. Not to mention what company would bother with lengthy and expensive trials when they don't need the drug to meet any standard to go on the market?
  • #61
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    @fraps Well, maybe other developed countries...

    Drugs approved in some African country with bad water... might not be so safe
  • #75
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    @BobSmith Yes, other well developed countries. I do not know if many African companies have the equivalent of an FDA. Germany, France, etc. all do. They get drugs to the marked much faster than we do. Those drugs are even proved by use of the regular population while we go through years of tests. Foolish.
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  • #176
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    treat the boy & fight to change the fda regulations simultaneously. everyone can send emails to your reps, congressmen,senators, obama,( he says he will sign whatever he wants regardless of protocol). the head of the fda, health & human svcs. it takes 15 minutes to do & you may change lives.
  • #167
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    Bending like a Willow is appropriate on occasion and the FDA should allow for this. However, the FDA is not a willow or even close to it. There should be guidelines developed that prevent liability issues for the company.
  • #166
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    My standard still remains: "When having to choose between seemingly all-wrong options, ALWAYS chose the one that causes the least harm and/or promotes the best outcome. Period. Simple as that.
  • #164
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    Actually, the correct answer is "No."

    The drug companies don't "give" drugs away..

    The problem with Chimerix is that it can't donate, give, provide any thing to any one that isn't approved.

    The work around is easy enough.
    Give the the medication in whatever state of development it is in to the government, then let the government issue it to the family.
    That resolves approval issues - and, any potential liabilities back on the company.

    Considering the state of the patient, it might not be a good idea to put him into a clinical study.
    He may be too aberrant to provide useable data.
    But, that is up to the company.
    If they feel that the kid can be of use to the study - it's their call.
  • #162
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    just like other "life saving drugs" that should be legalized to the sick & people in need of help, not drugs that make you sicker.

    sending + thoughts to all who are suffering without help or hope.
  • #161
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    I can't imagine if my sons had been denied IVIG! Without it they would have died horrible painful deaths. But it's use before and after my sons had bone marrow transplants made their BMT's a success. Sadly my younger son died of a pulmonary embolism not long before he was to be released to go home. My older son had his BMT after and ended up in ICU on life support 4 months after his BMT. He needed a drug not approved by the FDA and not used in this country. A doctor flew to D.C. To plead his case and got immediate approval. The doctor flew overseas that day to get enough of that drug for my son and flew straight back to the hospital. My son started receiving the drug in the wee hours. This doctor had pulled this off in less than 24 hours. My son recuperated. He was in ICU on life support for a little over a month. He graduated from Vanderbilt not long ago. I'm glad it was a congressional committee the doctor had to convince instead of an American drug company. This determined and swift acting, committed doctor saved my sons life! The FDA, the congressional committee, and drug companies should always act if there is a drug capable of saving a life! It's a very good thing this drug company is doing to save this boy. My younger son first had cancer when he was 3. The anti-nausea medicine they gave him was not FDA approved, but chemo never made him vomit. I knew it as ondancetron, now everyone knows it as Zofran. I know the pain of loosing your child. I don't want any parent to feel that pain. I nearly lost my only other child, but swift action was taken by all involved! He may be grown now, but I now have two perfectly healthy little girls. A completely different experience all the way around!
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