The problem is the responsibility of cost/benefit, risk/reward decisions vested in a regulatory body rather than the individual or family whose interests are at stake. The regulatory body's primary interest is minimizing risk to themselves.
I agree with you. We shouldn't force them to do it, but from a moral standpoint, if I'm in a decision making role in that company, I do it. If anybody is in the wrong here, it would be the FDA for using holding this against the company. Honestly, if I were in a decision making role in that company, I'd give it to them under the table and bust out the old Alberto Gonzales and "not recall" anything.
This is sort of like that story about the school that forced the girl from Minnesota to stand outside in freezing weather to comply with their fire drill rules. Yes, the followed the rules, but the girl ended up with frostbite. Except in this case, the stakes are life and death, and the perpetrator is the FDA. The FDA's rule here is incentivizing moral hazard.
What I don't like about all these cases is that, where's the media coverage, grassroots movement, random donations from small foundations, people chartering buses to protest to help provide clean water & cheap immunization to 3rd world countries? Look this kid had cancer 5 time + 1 heart failure already in his short 7 years, it's pretty obvious that he has a genetic predisposition for cancer. Even if he somehow survive this bout it's overwhelming likely he'll get it again in the near future and will most likely not have a long lifespan. People get all incensed & worked up over the possibility of trying to save a kid that'll most likely die soon anyways but instead ignores the fact if the same $$ and efforts was redirected into providing clean water, cheap immunizations etc to 3rd world countries they WILL save thousands.
I'm not an expert on this but I suspect that the condition of the patient and cause of death would be considered in the results reported.
As I said I didn't feel the problems cited by the company were insurmountable and glad to see this situation has worked out. I just hope that this hasn't come to late for Josh Hardy. http://www.cnn.com/2014/03/11/health/josh-hardy-drug-study/ Drug company will give ailing 7-year-old medicine that could save him (CNN) -- After days of pleading with drug company executives, Josh Hardy's parents got what they'd been praying for: a chance to get medicine that could help their son survive. The Chimerix pharmaceutical company said Tuesday that the ailing 7-year-old will receive medicine that doctors hope will help him when he becomes the first patient in a new trial set to start Wednesday. Todd Hardy, Josh's father, said he got the call from Chimerix president Kenneth Moch about a half hour before the public announcement was made. "It was wonderful," Hardy said. "Truly wonderful. It was overwhelming." In an emotional Facebook post, mother Aimee Hardy praised the company's decision. "Glory to GOD!" she wrote. "They are releasing the drug for Josh!!!!!!!!!" Over the years, cancer turned up in Josh Hardy's thymus, lung, and bone marrow. Mom's desperate plea to drug company The company had previously denied calls from the 7-year-old's family to give him the drug, brincidofovir, arguing that spending the time to help Josh and others like him would slow down efforts to get the drug on the market. Josh's story drew national attention as his parents and supporters pushed the company to change its mind in online and media campaigns. CNN told Josh's story Sunday night, describing his parents' desperate pleas for help from Chimerix. Josh's journey began when he was diagnosed with a rare form of kidney cancer at 9 months old. Over the years, cancer turned up in his thymus, lung, and bone marrow, and each time Josh beat it. But a bone marrow transplant left Josh without much of an immune system, and in February doctors diagnosed him with an adenovirus that spread through his body. Now he's in critical condition in an intensive care unit as the virus ravages his body. Josh is in heart and kidney failure. He vomits blood several times an hour as his family gathers in vigil. His doctors at St. Jude Children's Research Hospital in Memphis had also been pushing for the company to provide the drug. In a statement Tuesday, the hospital said it expected to receive the medication within 48 hours, but noted that its safety and effectiveness has not yet been established for use in children. "It is also important to understand that this remains a critical and complex medical situation," the hospital said. "St. Jude will continue to pursue state-of-the-art treatment for Josh and all of our patients. We are grateful for the efforts of Chimerix, the FDA and many others who worked to achieve this outcome. We ask that you continue to keep Josh and his family in your thoughts." An FDA policy known as "compassionate use" allows someone with a serious or life-threatening disease to ask a drug company for an experimental drug. Though it's called compassionate use, sometimes it feels anything but compassionate. Companies often say yes: The FDA approved 974 compassionate use arrangements in fiscal year 2013. But pharmaceutical companies often say no, as Chimerix did at first to Josh Hardy. Moch previously told CNN he wouldn't back down from his decision not to give Josh the drug. He said Tuesday that he hopes the new FDA-approved study will help other patients as well. "I'm happy for Josh and I'm happy for many patients," Moch said. "We've come up with a way of helping not just Josh, but helping other patients in need, and there are many." Over the past two years, the company has received more than 80 requests for compassionate use of brincidofovir from patients like Hardy, according to Moch. Todd Hardy hailed Moch as a hero. "He's a super man. He worked diligently on behalf of everybody," Hardy said. "His integrity was unquestioned. He was utterly professional." A Facebook page dedicated to the online campaign to help Josh get the medicine posted a thank-you message to supporters Tuesday night. "Thank you to every member of Josh's Army. The world has heard you and because of you Josh and many others will have the opportunity to receive CMX001 (Brincidofovir) the life saving antiviral drug made by Chimerix."
No. Take responsibility for your own damn decision (and i stated previously I side with the company just not their reasoning on it's for none or for all) and stop blaming anyone else, including any regulatory body. Christ, what a cop out with you folks.
Are you comparing what a few random people on the internet said about a basketball player to loving parents who are begging for a chance to save the life of their child? You are a freaking sick person.
But it's the regulatory body creating the disincentive to provide the drug (and also driving up the cost).
Yes, with respect to people talking about how to spend other people's money. I find it ironic that the people who asked the company to donate the drug didn't bother to offer to pay for it the same way as the LOFs asked Les to buy out Lin.
No matter how you slice it, either you are trolling or you are sick in the head to make the comparison between these parents who are begging for the life of their son to a few cyber forum screen names who talk about a basketball player. And it is obvious that you are using this tragic incident to take a shot at the so-called LOFs that you personally hate (Perhaps you got bashed so badly in the other thread that you are still mad?). Look into the mirror in your bathroom if you want to see the face of a hypocrite.
There is a point of comparison; which you haven't provided an argument for the invalidity of. And, actually, I'm not exclusively referring to the parents in that comparison but to everyone who asked the company for the drug. I take every opportunity to bash the LOFs. You're reaching with the comment about me being mad. Hypocrite about what? Did I espouse some virtue that I'm not following?
Your very first post in this thread. "They're a reasonably small company..." You are talking about Chimerix being a reasonably small company. No? But now you are saying that you did not refer to this particular incident when making the comparison? You are spinning and lying through your teeth.
. Similar to the cases where interest groups force and cajole a corporation to act through public pressure (Imus, Paula Dean, et al. racists), will there be a similar, though misguided, Conservative-libertarian backlash of the death of <s>First Amendment</s> private property rights in America? Just checkin' the ol' consistency meter.
