Public Testimony: Mary Vargas, JD

Release Date: May 27, 2009

FDA Public Meeting on Risk Evaluation and Mitigation Strategies (REMS) for Certian Opioids

Good morning. My name is Mary Vargas. I am a lawyer specializing in disability discrimination and access to health care. Twelve years ago, my car was struck from behind, leaving me with persistent pain caused by injuries to my head and neck. For four years, I struggled to find a doctor who could treat me, a medication that would allow me to function, and a treatment that would bring hope to my life even as my life was being swallowed by pain.

It took 16 doctors, countless procedures and surgeries before I broke even in my battle against chronic pain. Oxycontin, fentanyl patches, and an implantable medical device – gave me back a life, and allowed me to have a family.

When the FDA considers implementing REMS for certain opioid medications, the agency is talking about the medications I take, the doctors who treat me, and the pharmacists who fill my prescriptions. Yet, when I read the call for public comment, some of the extreme policies proposed – requiring patient registration, dispensing medications only in certain settings, patient monitoring, providing access to medications only when prescriber, pharmacist, and patient are all enrolled in a program - the assumptions about the current state of pain care in the United States underlying these extreme proposals are so divorced from the reality experienced by patients and doctors that they left my mouth hanging open.

The FDAAA requires that elements of REMS enacted to ensure safe use must not be unduly burdensome on patient access to medication. When you consider requiring one more safeguard, one more certification, one more agreement that patients must sign, one more form of monitoring to which people living with pain must submit….these “one mores” must be considered in the context of the incredible and unprecedented scrutiny that legitimate pain patients already face. Our access to pain care is already unduly burdened – don’t let anyone tell you otherwise. Unlike any other kind of patients, we are required to submit to urine tox screens, we sign treatment contracts, we are turned away from doctors who are afraid to treat us because of the kinds of medications that lessen our suffering. We face a kind of legitimized discrimination that is based on fear.

It is clear from the call for public comment that the FDA is not considering implementation of REMS in my interests. I say this understanding it may be impolitic, but individuals living with pain can no longer stand by while concern for those who break the law trumps their right to care.

In 2001, I stood with the Commissioner of the DEA and called for balance – balancing the moral imperative to ease suffering with concerns over illegal use.

Again and again those living with pain have been asked to do just one more thing in the name of balance – another contract, another form of monitoring – but already we cannot find doctors to treat us, we cannot find pharmacies to fill our prescriptions, – and now we are here talking about implementing strategies that are all about law enforcement and nothing to do with healthcare or compassion and, quite frankly, I’ve had all the “balance” I can take.

The truth is that the “balance” we have all talked about is a euphemism, if the only actions taken restrict access or depress prescribing practices. We tie the hands of legitimate patients and doctors in the name of balance and still it isn’t enough, because no matter how many barriers you put in front of my access to pain care, there will always be those who misuse or abuse drugs – if not pain medication, something else.

To the parents who are here asking the FDA to make it more difficult for me to obtain care: I know what it feels like to lose a child. I know how it feels to want to make your child’s death not be in vain – to find meaning, to prevent another family from suffering like you have. But I ask you to consider whether restricting my access to needed medications will give meaning to your loss? Will making it more difficult for me to obtain the healthcare I need – asking me to suffer in your child’s name – will that diminish your grief? Does the loss of a child or a spouse give any one person the moral authority to deny me healthcare, and privacy, and dignity?

Today we will undoubtedly see life-size photos of loved ones who illegally used and abused prescription medication and left behind a devastating wake of grief. For each one of those photos, there are thousands upon thousands of other stories we aren’t hearing – stories like mine that aren’t flashy or illicit – stories of people who do everything right and still cannot get treatment. Consideration of REMS must be grounded in the reality of people who live with pain. Our suffering matters, too.