Brantly and Whitebol justify use of experimental drugs by critically ill

Andrea Sloan died after being refused access to non-approved drug
Andrea Sloan died after being refused access to non-approved drug

WASHINGTON, August 5, 2014 — Granting access to experimental drugs is in the headlines with Dr. Kent Brantly and Nurse Nancy Whitebol receiving the ZMAPP serum, which at this time is being credited with saving their lives after the contracted Ebola in Liberia, Africa.

The serum had previously not been tested on humans and was not approved by the FDA.

Not every person, dying from incurable disease is as fortunate.

Andrea Sloan, diagnosed with Ovarian Cancer, turned to social media last summer with the hopes that she could pressure a pharmaceutical company to give her access to a cancer drug that could save her life.

Unfortunately she lost her fight with BioMarin Pharmaceuticals and cancer, dying on January 1, 2014 (b. January 23, 1968).

Andrea Sloan was a 45 year old lawyer who has spent most of her adult life helping others as executive director of the Texas advocacy project, an organization that provides free legal services to low income victims of domestic or sexual abuse. But over the past seven years, her focus has been turned inward and her energy has been spent trying to overcome late stage ovarian cancer.

Before her death, 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, BMN 673 is manufactured by BioMarin Pharmaceutical, and had not finished receiving FDA approval. Sloan’s doctor felt it was her best chance for survival  but he believes it is Sloan’s best chance for survival.

In October of last year, Sloan was given access to a drug, not the BioMarin drug but from another manufacturer, similar to BMN 673, but it was too late to save her life.

“The drug I am receiving is from the same class of breakthrough therapies I was initially pursuing and my world-renown doctors are confident in its ability to be effective,” Sloan said in a press release. “I began this quest for compassionate use because my life matters to me and to the people I love. I owed it to myself to fight for my life, and I owed it to them.”

“It has not been easy to confront my own mortality, and certainly in such a public way,” Sloan said in her press release. “I want to offer a heartfelt thank you to the thousands of people who have signed the petition, tweeted their support, joined Andi’s Army on Facebook and made immeasurable personal sacrifices. I do believe our collective efforts have been in furtherance of a greater good.

“We have started a national dialogue about the need to institute meaningful change not only in the way that individual pharmaceutical companies implement and grant compassionate use of pre-approved medications in rare circumstances, but also in the way that the system works to get drugs to market as quickly as possible while ensuring that they are safe.”

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.

The FDA allows “compassionate” drug use for people who are desperately ill. Perspective patients must meet four criteria to qualify for compassionate use.

  1. A patient’s physician must certify that a patient is no longer benefiting from traditional treatment and is in critical condition.
  2. A patient must certify that they accept any side effects that might come from the drug and not hold the company or FDA responsible.
  3. The FDA must certify that the patient is an appropriate candidate for compassionate use of a specific drug.
  4. 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 would not approve the use by Sloan.

BioMarin’s explanation for their refusal to permit Sloan is 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 is that the pharmaceutical company would not give Sloan an experimental drug because they do not want any harm to come to her when she was facing almost certain death.

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.”

In their quest to get access to the drug, Andrea Sloan and some of her “army” came to Washington D.C. to sit down with any member of congress who would make the time to meet with her to hear her story. After meeting with Sloan, Newt Gingrich has agreed to help the cause.

A Washington D.C. based oncologist, who asked that his name not be used out of concern of backlash from the large pharmaceutical companies, said that the corporations reaction was not a surprise, “They don’t come in here every day and see the faces, get to know the people who are fighting for their lives. I wonder how many of these executives could look this woman in the eyes and tell her that they are choosing to not save her life due to corporate policy?”

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