The dying child vs. the biotech: Everybody loses
Anyone in the industry who knows Ken Moch, the CEO of a little biotech in Durham, NC, named Chimerix, is likely to describe him as personable, chronically cheerful and an outspoken champion of all things Chimerix ($CMRX).
Today, though, to anyone who listens to the mainstream media, Moch is a villain. He's the head of a company that "denies drug to dying child" (CNN) and "refuses to give life-saving medication to 7-year-old boy" (Fox News) as "thousands beg company" to fork it over (Detroit Free Press). He and his staff are getting death threats.
There are plenty more juicy headlines to pick from. Big media groups can really rack up audience traffic when they can profile a dying child and his desperate parents' fight against a drug company; even if the "drug company" in question doesn't have any products, works with a small staff of 54 and is trying its best to get an approval so it can start making some money.
Chimerix is doing this on a budget, mind you, that is as far from the Big Pharma world as your local bank is from Wall Street. In the last quarter the biotech lost $8.2 million as it worked on an experimental therapy for lethal viral infections dubbed brincidofovir (CMX001).
Josh Hardy, the 7-year-old kid at the heart of this story, is impossible not to like. He's been fighting cancer for years and now his parents say that his only chance of surviving the virus that threatens his life is with Chimerix's experimental, unapproved therapy.
The problem for Chimerix, as Moch has been trying to explain, is that if they give the drug to Hardy, they'd have to set up a program for hundreds of more such patients. And they would have to pay for this philanthropic program and administer it while they're working on clinical trials.
But reason isn't going to make a dent in public opinion. Not when you have a dying child in the story. But this situation occurs too often for biotechs, which inevitably come out looking like hard-hearted corporations putting profits ahead of lives.
I routinely get emails looking for some back door to a clinical trial or advice on obtaining a Phase III therapy. Occasionally, desperate patients hire PR firms to take their cases public. But Chimerix and the other biotechs that find themselves in the spotlight aren't the villains. Caught between a rock and a hard place, biotechs can't sacrifice common sense or veer from their development path. The best they can do is finish their work as quickly as possible, so doctors and patients will know for certain whether the product they've been developing can actually help.
That's the business model this country and much of the world depends on for developing new drugs. It may be deeply flawed, but it cannot be ignored by a company like Chimerix or any other small biotech.
Perhaps there is some other way for biotechs to handle compassionate use programs. Perhaps the bigger CROs, industry leaders and regulators could coordinate a compassionate use program for the most needy patients that could be paid for from multiple sources. But the heat needs to come off the small biotechs. They follow a risky enough path as it is. Suddenly being confronted with a phalanx of cable news shows and USA Today and other major news groups which feed on raw emotion shouldn't be one of the threats they face. -- John Carroll, editor-in-chief (email | Twitter)
Editor's Note: As we reported Tuesday night, Chimerix came up with a special pilot study that planned to treat Josh Hardy Wednesday morning, saying the FDA was open to expanding it into a Phase III trial at a later date. Also, USA Today's writer, Kim Painter, contacted us to say she felt that this piece unfairly lumped her story--"Thousands beg company...."--in with the cable news reports. To be fair, she included comments from the CEO as well as a bioethicist who sympathized with the company's position, pointing out some of the complexities of this case. It was the lurid headline that attracted my attention primarily, perhaps unfairly, to the writer. Stories are more than a headline, as I often point out to my own critics.