Lawmaker joins ‘Andi’s Army’ in battle with drugmaker

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AUSTIN (KXAN) – A state lawmaker has joined the ranks of “Andi’s Army,” and as they grow each day, the battle continues to persuade a pharmaceutical company to provide an Austin woman with a potentially lifesaving drug.

State Rep. Eddie Rodriguez said he is writing a letter to the leaders of the California-based drug company, BioMarin, urging them to allow Andrea Sloan to take a promising new medicine called BMN 673 to help her battle the ovarian cancer that has resisted all other treatments.

“Andi is a longtime friend of mine,” the Austin Democrat told KXAN.  “She’s also a constituent. So it makes her real special to me.”

Sloan is an attorney and the executive director for the Texas Advocacy Project where she fights for victims of domestic violence

Rodriguez, who plans to ask California lawmakers to endorse his letter, is among some 20,000 people urging BioMarin to allow Sloan to use the drug under the federal compassionate-use policy. The drug is in the trial stage, but compassionate use allows drug companies to make such medicine available to people who have exhausted all other treatment options.

KXAN reported last week that the FDA and doctors at Houston’s MD Anderson Cancer Center have said Sloan is a candidate for the compassionate use of BMN 673.

“Andrea has a lot of friends in the Texas House and Texas Senate,” Rodriguez said. “And I’m sure we’ll get a lot of both Democrats and Republicans signing on to this letter encouraging my colleagues in California to do the right thing,” said Rep. Rodriguez.

Rodriguez said he already has several Texas legislators on board.  He also believes it’s time to start a national conversation about compassionate use of experimental drugs not yet approved by the FDA.
Andi’s Army in the “War Room”

A group of Sloan’s friends who call themselves Andi’s Army gathered in their “war room” Tuesday night in the hours before she was to head to MD Anderson in Houston yet again.

“She means that much to every single one of us,” said Michelle Wittenburg, one of Sloan’s closest friends. “So many people are compelled toward her and toward the movement she has started.”

Wittenburg is a “general” in Andi’s Army where the troops’ savvy use of social media including Facebook andTwitter has caught the attention of thousands of supporters, including country music singer Wynonna Judd.

An online petition at Change.org has garnered more than 23,000 signatures of support over the last week.

“I have to fight for this drug because I need it to save my life,” Sloan told KXAN.

Since her diagnosis of Stage 3c ovarian cancer seven years ago, when she was 37 years old,  Andrea has been through two full rounds of chemo-therapy, five surgeries, a stem cell transplant, a bone marrow transplant, and went through her last round of radiation in February.

Through its online campaign, “Andi’s Army” has tried vigorously to get BioMarin to help Sloan.

“We’ve tried and are trying to have a dialog and communication with them that leads to the only right result, which is giving her the drug and giving her the drug timely because if it’s not timely, its meaningless,” said Wittenburg.

Sloan, meanwhile, has wrote an open letter to BioMarin asking the company to reconsider her situation and her need for its investigational drug.

“There’s people that just don’t have the time,” said Rodriguez.  “They can’t wait. So whatever we can do in the law to make that more accessible, we need to do that. I think it’s time to do that.”

While Sloan is at MD Anderson the latter part of this week, members of her “Army” continue their life-saving mission.

“None of our lives — and they’ll all tell you — will be the same without her,” Wittenburg said. “She needs sainthood and not martyrdom and we’re going to get it because of who she is as a person and her doctors’ commitment and who I think BioMarin will show themselves to be.”
Looking for answers

KXAN asked BioMarin for an updated statement regarding whether or not the company will allow Andrea access to BMN 673.  The company did not respond but instead had the CEO of the California Healthcare Institute, David Gollaher call.

Gollaher told KXAN the company is concerned the portrayal of this case “could damage the clinical trial process and could set poor precedent in breaking open clinical trials, as well as damage the integrity of the trial.”

Gollaher also said his organization supports compassionate-use policy the appropriate guidelines and added that the medical community “needs to follow the science and follow the data even when doing so is a difficult decision.”

KXAN received another call on BioMarin’s behalf from Gail Maderis, CEO of BayBio, an association of scientific companies and institutions based in San Francisco.

“It really comes down to the needs of individuals versus the greater good of all patients,” Maderis told KXAN.

“Everyone’s goal is to get new treatments approved by the FDA as quickly as possible so they can help the greatest number of patients and sometimes that means not being able to help every patient in an expanded use situation,” said Mederis.

Then, KXAN received a call-back from Debra Charlesworth, spokeswoman for BioMarin.  Charlesworth said she could not speak about any specific patient but told KXAN:

“At this point in the development at the drug it is such an early stage that it is premature to implement any expanded use program. …

“We need to make sure that what we’re putting out there is safe first.  We have to go for the greater good.  We are working towards the greatest good for the greatest number of patients.”

On Wednesday, Sloan’s doctors at MD Anderson performed tests to evaluate the progress of her cancer.  Sloan and her doctors still hope to get approval from BioMarin and administer BMN 673 as soon as possible.

If BioMarin ultimately does not agree, as indicated in its phone call to KXAN, Andrea’s support team says she and her doctors will have to have a challenging conversation about how to proceed with her treatment.

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