Josh has been fighting and winning his battle against cancer, along with heart and kidney issues, since he was less than a year old. Now, his mother, Aimee Hardy, says he will die if the curable virus is not treated soon.

 

Doctors believe the adenovirus can be cured with a drug named Brincidofovir, which is in the trial stage and has not been approved by the FDA. Doctors say the drug has been used successfully on kids with Josh's infection.

 

Aimee says the drug maker, Chimerix, has so far refused their urgent pleas to give doctors the drug on "compassionate use" grounds. Kenneth Moch, the company’s president and CEO, said Friday that the company cannot approve "compassionate use" of the drug right now because it is in phase-three of the clinical development process.

 

Drug Maker Chimerix Refuses to Release Drug as 7-Year-Old Josh Hardy Struggles Against Curable Virus | Fox News Insider

I couldn't imagine being the parents in this situation. Wow.

The compassionate bureaucracy.

 

Yes - "compassionate bureaucracy" is an oxymoron.

There was not enough information for me to determine if the company is not releasing the drug because the clinical trials are not done; and without the clinical trials being completed, the drug cannot achieve FDA approval; and, without FDA approval, the drug cannot be legally administered in the US.

There was not enough information for me to determine if the company is not releasing the drug because the clinical trials are not done; and without the clinical trials being completed, the drug cannot achieve FDA approval; and, without FDA approval, the drug cannot be legally administered in the US.

100% agree

For almost every process in business there is a waiver or bypass method. If there is no alternative - and this is not real clear in article or story - then a waiver process should be available.

 

Does the FDA not grant waivers? Even if they did does the company have a responsbility to provide the drug if a waiver is granted?

 

Of course, the company may not want a waiver due to sales implication should the drug fail the situation and the publicity this one case already has.

 

I hate to see autocratic and inflexible 'processes' prevent the right thing from happening.

Drug company refuses to give lifesaving medication to 7-year-old boy | Fox News

 

I read about this in the linked article and they stated below why they will not give him the medication. So, which is it?

 

Chimerix, the company that manufactures Brincidofovir, has given hundreds of patients emergency access to the medication in the past, but they have since stopped this practice saying ‘they cannot afford it,’ according to Johnson Jr. However, Chimerix has received more than $72 million in federal funding to develop Brincidofovir.

Cant afford it, how much does it cost to make a medicine for a company? What goes into making a medicine that has already been made multiple times.

So is it the cost/revenue or is the FDA approval process? The article certainly makes it should like former.

 

Is this drug like a transplant organ? Are there are only so many or so much and they HAVE to make money now after giving "hundreds of patients emergency access"?

 

I guess ACHA did not fix this situation.

If it's a financial deal, then I agree with the sentiment.

Let's conference call the CEO so we can decide how we feel about this. :lol2:

From Market Watch

 

"Doctors think Chimerix’s /quotes/zigman/14956180/delayed /quotes/nls/cmrx CMRX +1.12% Brincidofovir, a drug now in the testing stage, could help the child but the company needs to go through an elaborate process with the U.S. Food and Drug Administration to get the drug to him under the FDA’s “compassionate use” guidelines. Companies are allowed to offer experimental drugs for compassionate use if patients have no other recourse.

 

Chimerix officials, however, say they can’t spare the manpower needed at their 50-person company based in Durham, N.C., in order to properly process a compassionate use case and are concerned it would open the floodgates for many more such requests. Complying with these requests, company officials told CNN and other news agencies, would hamper its ability to get the drug to market. Brincidofovir is not expected to be approved for sale until at least 2016.

 

Chimerix Chief Executive Kenneth Moch says he would feel “horrible” if Josh were to die, but says if he helps the boy, it could hamper his ability to help many more patients down the road."

 

Tough, tough situation. Help him now and chance losing many more in the future due to delays? What if it doesn't work and still delays or prevents more future successful treatments?

Maybe if they weren't spending so much advertising vanity drugs they could afford helping out someone who truly needs it. That goes for all pharmaceutical companies.

Looks like they got it done.

 

Chimerix approves drug for Josh Hardy | The News Desk

Maybe if they weren't spending so much advertising vanity drugs they could afford helping out someone who truly needs it. That goes for all pharmaceutical companies.

 

Those vanity drugs generate a lot of cash for pharmaceuticals. That's cash that is used for R&D for drugs like this one. Also the profits the advertising creates more then pays for the advertising.