Andrea Sloan is a 45 year old lawyer who has spent most of her adult life helping others as executive director of the
Sloan told CBS News that she has had multiple rounds of traditional chemotherapy, two different rounds of radiation treatment and five surgeries in the past five years in order to eradicate the cancer but she keeps having recurrences.
Treatments using the drugs currently available are no longer effective on Sloan’s cancer. She needs something different, she needs something better.
Sloan’s oncologist, Dr. Charles Levenback from MD Anderson cancer center, a hospital which is widely considered the best in the nation for cancer care, explained during the CBS report that he knew of a new drug to help Sloan. The drug has not finished receiving FDA approval, but he believes it is Sloan’s best chance for survival.
This new drug called BMN 673 is manufactured by BioMarin Pharmaceuticals.
The FDA requires strict adherence to the clinical trial phases before a company can distribute a drug to the public. They have an extensive education program through their website and brochures describing the steps every medication went through before ending up in one’s home in order to provide a sense of security and confidence in the medicine a doctor has prescribed.
Each phase lasts several years and is treated as a separate trial. If a drug successfully passes through phases 1-3, it will usually be made available to the general public.
On Monday September 9, the Chief Financial Officer of BioMarin, Dan Spiegelman told investors at a conference in
Andrea Sloan is not eligible to join the phase III trial, but she still has another chance to get access to the medication prior to the FDA’s approval which is still years away.
The FDA allows “compassionate” drug use for people who are desperately ill. Perspective patients must meet four criteria to qualify for compassionate use.
- A patient’s physician must certify that a patient is no longer benefiting from traditional treatment and is in critical condition.
- A patient must certify that they accept any side effects that might come from the drug and not hold the company or FDA responsible.
- The FDA must certify that the patient is an appropriate candidate for compassionate use of a specific drug.
- The drug manufacturer must approve the use.
Sloan told Huffington Post Live that the first three criteria have been met and approved but the last step was not. BioMarin will not approve the use by Sloan.
BioMarin’s explanation for their refusal to permit Sloan to have the medication before the FDA approval came in the form of a letter which Sloan and her supporters have posted on several social media sites. The letter states that although they support compassionate use policies, they were denying her request because it is still unknown how well BMN 673 will work and who will be best served by the drug.
The irony that the pharmaceutical company would not give Sloan an experimental drug because they do not want any harm to come to her when she is facing almost certain death without it has caused Andrea and her supporters to start an online campaign with the laser focus to getting access to the drug and soon.
Kristin Nelson, a cancer survivor who spent two years undergoing chemotherapy, radiation treatments and surgeries to beat her aggressive form of cancer cannot understand why a company in the business of helping people would refuse to do so, “I don’t know why a drug would be denied to someone in need, other than cost or safety. But what is the risk if you sign a statement saying you won’t sue the drug company? Patients depend on these drugs.”
Nelson’s sentiments are the same as many in “Andi’s Army”, “Shame on the drug company. It appears profit over quality of life is more important.”
At www.change.org an online petition that is directed to the CEO of BioMarin currently has signatures from 128,213 supporters, including Kathy Bates, Ally Sheedy and Wynonna Judd. Sloan is hoping to reach 150,000 signatures before presenting the petition to the pharmaceutical executives.
There are also Facebook pages and twitter accounts with thousands of followers that are working overtime getting the message out, hoping people will join the fight and help put pressure on BioMarin in any way they can.
Some of Sloan’s twitter followers have gone so far as to post the phone number of BioMarin so supporters can personally call to advocate for Sloan.
Andrea Sloan and some of her “army” came to
After meeting with Sloan, Newt Gingrich has agreed to help the cause and is currently using his own blog to bring her plight to a larger audience and to push for anyone qualifying for compassionate use of a medication to be able to get it.
In a public statement released by Andrea Sloan, she pleads her case to BioMarin saying, “I recognize the importance of weighing the risk and the myriad of considerations they face as a company. However, this is a risk worth taking. I will thank them. My family will thank them. An amazing army of loyal supporters, to whom I owe a debt of gratitude, will thank them.”
Andrea Sloan is hoping BioMarin will institute a compassionate use policy soon because she knows every day that goes by without taking the drug, is one step closer to it being too late for her life to be saved.
BioMarin has refused to provide any additional comment on the Sloan case.
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