FDA Allows NH Girl To Try Controversial Brain Tumor Drug
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MANCHESTER, N.H. (CBS) — McKenzie Lowe is looking great and feeling well.
“Sometimes I have little headaches but they’re really little. They don’t bother me that much,” she says.
“Oh I started crying,” says the girl’s grandfather Frank LaFountain.
But the good news was quickly tempered because there’s a new fight for the family. They have to find a doctor willing to administer the unapproved drug and so far, no luck.
“We need a doctor is what we basically need right now,” said LaFountain. “Anywhere in the country doesn’t matter where. We’re going to go.”
The family says doctors are reluctant because the drug therapy McKenzie would like to undergo has been spearheaded by Texas physician Stanislaw Burzynski who’s been criticized by many in the medical community.
“They simply know nothing about the treatment,” said Dr. Burzynski in a phone interview with WBZ-TV in response to his critics.
McKenzie’s family and friends believe the drug is a risk worth taking.
“You know it’s a chance,” said family friend Kim Frenette. “And any chance is better than zero.”
In a statement to WBZ-TV, the FDA said:
“The FDA has a statutory responsibility to ensure that the rights, safety and welfare of patients who take experimental therapies are protected. This reflects a societal judgment that all patients, including those who are terminally ill, deserve this protection when taking a product that has not been found to be safe and effective. Patients who are suffering from serious diseases, including diseases that are life-threatening, have an understandable interest in accessing investigational drugs. We recognize that there is a range of opinion about the extent to which individuals should be able to decide for themselves how much risk they are willing to tolerate from an experimental therapy. The FDA recognizes its important role in assisting patients and their physicians regarding appropriate treatment access to investigational drugs, while at the same time recognizing the need to protect the public health by carrying out its statutory mandate to ensure that drugs are safe and effective before they are approved and marketed to the American people. The FDA applies the process and criteria set forth in its statute, as well as its regulations, when it receives requests for access to experimental therapies.”
For now, McKenzie’s family and friends say they have found some doctors willing to help but the doctors are having a tough time with the FDA’s stipulations.
“I mean it’s great they’re saying the drug is available,” said Frenette. “It does us no good if the kids aren’t able to get on it.”
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