AUSTIN (KXAN) - Top executives of the drug-making company, BioMarin, explained to shareholders Tuesday why they have not granted Andrea Sloan access to the experimental cancer-fighting drug that might prolong her life.
“Hope sometimes gets unfulfilled in the course of clinical trials and things that we think work don't actually end up working so we stick to the clinical trials process,” BioMarin Chief Medical Officer Henry Fuchs said in response to a question at the shareholder's meeting in New York about how the decision might affect stock prices.
Sloan, who has battled ovarian cancer for seven years and is running out of treatment options, is seeking access to BioMarin's BMN 673 under a compassionate-use exemption while the drug remains in the clinic trial phase.
The company has declined to make BMN 673 available, but Tuesday was the first time top executives commented publicly on the matter. The comments came during BioMarin's research and development presentation that was made available online.
Sloan's campaign has attracted national headlines since KXAN began covering her efforts three weeks ago. An online petition seeking to persuade BioMarin to grant access has gained more than 136,000 signatures and lawmakers from Texas and California have also called on the drugmaker to revisit its decision.
BioMarin CEO Jean-Jacques Bienaime said the company is adhering to its policies.
We believe that everybody, all the patients that we try to serve should have access to the drug in an absolutely equal way,” Bienaime said. “No one has priority over anybody else and consequently we will continue to stay true to that purpose.”
But many drug companies do allow for compassionate use of their experimental drugs. KXAN has learned that 3,170 requests to the FDA for compassionate-use exemptions over the last three years. Of those, 3,149 were granted.
“Our objective is to get the drugs we are developing to the maximum number of patients in the minimum amount of time and that's what we are focusing on,” Bienaime told shareholders.
But an email obtained by KXAN shows BioMarin may be focused on more than that. Bienaime appears to have accidentally replied to all, instead of only BioMarin executives, in a response to an Andrea Sloan supporter.
In his email, Bienaime wrote to Fuchs and other executives:
“Hank, As you said it is time to refocus the message on competitive PARP's available. Although is the assertion that there are no trials of PARP inhibitors currently enrolling in ovarian cancer correct? Debra, Have you engaged the PR agency? JJ”
“Debra,” is Biomarin's Media Spokesperson, Debra Charlesworth.
Asked to authenticate the email, Charlesworth replied, "We don't have any further comment."
KXAN also asked BioMarin how many times the company has requested single patient compassionate use access from the FDA and how many times it was granted. BioMarin told us the company doesn’t provide that information publicly.
Sloan said, “I do think there is a moral imperative that we do whatever we can to make lifesaving medications that have already been developed, available to the people who need them.”
Sloan said she isn't asking for special treatment, but she does want a chance to take advantage of a system already in place for people just like her.
“No life is worth more than the other,” said Sloan. “No one person deserves this drug more than the other. I just happen to be the person who is asking for it right now.”
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