The FDA, A Drug Company, and One Patient’s Life

By Christopher Medrano

Andrea Sloan, a 45 year old Texas Lawyer, works with a nonprofit group where she provides legal assistance for those who cannot otherwise afford it.  For seven years, she’s been battling stage three ovarian cancer, which has taken a severe toll on her life.

Now, in her time of need, Sloan is being denied the human compassion she has always given to others.  While she has successfully gone through rigorous chemotherapies before, these debilitating treatments haven’t been able to eradicate the disease since its recent return.  “I’ve had three rounds of chemotherapy, I’ve had a stem cell transplant, I’ve had two rounds of radiation, I’ve had five major surgeries, I have lost my hair twice. I have run the gamut of traditional therapy,” Sloan said.

Her physicians have concluded that her only hope of survival is a new drug produced by the pharmaceutical company BioMarin.  Although, it hasn’t reached the market, PARP inhibitor BMN 673 is a promising medication for those suffering from genetic ovarian and breast cancer.  It is an efficient treatment that targets cancer cells without causing detrimental damage to the body, a beneficial component for those whose bone marrow cannot withstand the effects of further traditional treatments.

Of course, like most other things in this world, it is seemingly too good to be true.  Unfortunately, the new drug hasn’t been approved by the Food and Drug Administration.  A drug company must obtain approval from the FDA’s Center for Drug Evaluation and Research (CDER), a department that ensures safe and effective distribution of new medications.  When a company submits a new drug application, it must provide evidence that the drug has been tested thoroughly for both safety and effectiveness.

Occasionally, patients meeting strict conditions are permitted “compassionate use,” which is the prescribing of a drug that isn’t yet approved by the FDA, when there are no other possible treatments for the patient, and the use of a risky medication literally means the difference between life and death.  This must also be approved by the FDA, especially for those not involved in a clinical trial.  This single patient access has been granted by the FDA to Sloan, but must also be approved by the pharmaceutical company involved.  BioMarin refuses to grant Sloan the approval, since they haven’t processed their phase three trials.  They claim that they are wary of prescribing the drug because they aren’t sure whether it could be hazardous to her health.  Debra Charlesworth, a spokeswoman for BioMarin, has stated, “Giving experimental therapies outside of the clinical trial process slows down the drug development and delays the potential to deliver a treatment to thousands of patients.”

Here is where the politics of a money-driven industry veer away from its original purpose, which is to help the ill.  Americans can sleep tight knowing that the pharmaceutical producers aren’t swayed by their ailing patients, but by the almighty dollar.  Rather than potentially saving this woman’s life, the company chooses to let her die to avoid delaying the launch of their new drug.  While they claim that they are attempting to form a clinical trial to involve Sloan, they’ll be unable to medicate her for at least 40 days, while Sloan’s physicians insist that she receive the treatment within the next two weeks.  Time is running out for this innocent citizen, and justice is dragging its feet.  At the end of the day, it has been proven again that the field of healthcare has evolved into something that knows only profit and refuses to see patients as individuals, but rather customers.

This is a grave sign of what our generation has to face in the future.  The last humane field in our society, founded on the precedent of man healing its fellow man and striving to discover better cures for the future, has become another corporate empire, whose decisions know no rules and whose corruption knows no limits.  The day the FDA condones a corporation’s choice to allow a sick woman to die for the purpose of yielding profit a little sooner is the day medicine turns its back on the Hippocratic Oath.

Editor’s Response: I don’t usually comment on my writers’ articles, but I think it’s important to do so here. First of all, the case of Andrea Sloan has a happy ending, at least for now. An anonymous  pharmaceutical company working on a drug similar to the one BioMarin was working on has agreed to supply Sloan with the drug under the compassionate use exemption, so even if BioMarin’s actions here are to be condemned, this does not mean that they are representative of all drug companies, or the way in which a free market health care system would work. In fact, apparently BioMarin’s CEO has actually attacked Sloan personally, calling her a “spoiled petulant brat,” which is certainly not something CEO’s of drug companies usually do.

Second of all, it’s important to discuss the problems inherent in the FDA. When it comes to its role in regulating drugs, there are two mistakes that the FDA can make. The first is that it approves a drug which has such severe side effects that they obscure any benefits. Such mistakes are very public and the people who make them would probably be fired. The second kind of mistake is if the FDA doesn’t approve or delays approving a drug with beneficial effects. Such a mistake wouldn’t receive a huge amount of press coverage, and the only people who would object to it are the patients that it would help, who may not have much longer to live, and the drug companies, who are just greedy capitalist entities anyway, right? So, bottom line, if you’re a bureaucrat, it’s always in your interest to err on the side of caution and delay approving good drugs if there’s even the slightest amount of doubt. This is obviously problematic, and ought to be reformed. -DM

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