Roy Exum: My Pimples And Andrea Sloan

Monday, September 30, 2013 - by Roy Exum
Roy Exum
Roy Exum

A real long time ago I was having a fit with acne. I was a lovelorn teenager, infatuated with pretty girls in a dizzy game where pimples can really become cumbersome. It seemed like nothing was working and, after I grew a pimple large enough for its own zip code, I finally found a genius doctor who quickly became my lifelong hero when he came up with a marvelous idea.

At the time there was a new “super drug”  that was languishing through years of “clinical trials” in the United States and nobody could get any, despite the fact the revolutionary medicine was already available in Germany. My hero called up a close friend who was a German doctor and – presto! – the first 250 pills came flying across the ocean.

I had to promise that I would not sue anybody if I grew an extra set of ears, developed female breasts, or my eyes turned yellow, but, honestly, I would have dyed my hair green to get the American-made medicine. After I took a course of what was then identified by only a strange laboratory number, my pimples and my acne were gone forever. I had Clark Gable looks and never looked back. That’s a true story (except the Gable part.)

Other fellow Americans had to wait for many months. I don’t believe that's right. Since this occurred in my formative years, I have cursed the federal Food and Drug Administration for much of my adult life because the “clinical trials” process we use is horribly dysfunctional and in critical need of an overhaul.

To illustrate my point, allow me to introduce a beautiful Texas lawyer, Andrea Sloan. Yes, she is quite pretty but “beautiful” because her career has been as the executive director of a Texas advocacy project that provides free legal services to low-income victims of domestic or sexual abuse.

Andrea is a victim herself, not just of stage 3c ovarian cancer but a horribly-tangled FDA system. Her doctors have exhausted every known method to save her life. Six years of surgery, radiation, and chemotherapy haven’t worked. She’s still very much a patient at the world-famous M.D. Anderson Medical Center and her oncologist believes an experimental drug called “BMN 673” might well save Andrea’s life.

M.D. Anderson has a good supply of BMN 673 on hand but with millions of dollars at stake, the manufacturer, BioMarin in California, has said no. “It would be unethical and reckless to provide end-stage refractory ovarian cancer patients outside clinical trial with BMN 673 at this early stage of development,” said spokesperson Debra Charlesworth.

“If we did,” Charlesworth explained to CNN, “we would be exposing the experimental drug to a large group without adequate testing. There have been previous circumstances where early access to large groups has resulted in adverse consequences that were worse than the course of the disease.”

I am certain no scientist can hardly wait for somebody to try to explain to me what “adverse consequences” could possibly be worse than what Andrea Sloan is facing without BMN 673. Andrea is pleading for the drug – let the petals of the flower fall where they may – and probably understands the risks as much as anyone involved. She knows what will happen if she fails to get BMN 673 better than anyone else, too.

Here is what she wrote in a statement to the drug company: “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. In America we do not leave our wounded warriors on the battleground. BioMarin, please be the Calvary that saves me.”

Her M.D. Anderson doctors believe Andrea is a great candidate. Further, the FDA itself has just announced Ms. Sloan qualifies for a “compassionate care” waiver in the rules but the manufacturer, BioMarin, still says no. The word is BioMarin stands to make about $500 million on the drug and, even though they say they plan to give away 10 percent of the medicine to charity, they refuse to face the ethical dilemma.

As of Sunday afternoon Andrea had almost 170,000 supporters on her Change.org webpage and politician Newt Gingrich, co-host of CNN’s “Crossfire” program, is irate at “a corporation protecting its wallet at the expense on Andrea’s possibly dying. If you want to know why big companies often get bad names, it’s explaining that clerical support to fill out FDA paperwork is too difficult when you can save a life.”

Dr. Charles Levenback, Andrea’s doctor, is disappointed at BioMarin’s stance but, as a man who sees the fight against cancer every day, he told CNN reporters, “My own belief is that the drug companies, the manufacturers, the insurance companies, the providers like my hospital M.D. Anderson, the individual medical professionals, the investigators, the patients -- everybody wants the same things. Safe, effect, novel therapies for as many people as it's appropriate for. Even BioMarin, I believe. I don't think this is like 'Let the masses eat cake.' I think they're on the same mission. But the whole system is giving this dysfunctional result."

On Andrea Sloan’s Facebook page there is a picture that tells of “Three Simple Rules.” The text reads, “If you don’t go after what you want in life, you will never have it. If you don’t ask, the answer will always be No. If you don’t step forward, you’ll always be in the same place.”

Those three rules got rid of my pimples but all we can do is pray for Andrea Sloan. She needs it right now.

royexum@aol.com


Send Your Opinions To Chattanoogan.com; Include Your Full Name, Address, Phone Number For Verification

We welcome your opinions at Chattanoogan.com. Email to  news@chattanoogan.com . We require your real first and last name and contact information. This includes your home address and phone number. We do not post the contact information, but need it for verification. There is no word limit, but if your article is too long you may lose your reader. Please focus more ... (click for more)

Teachers Have Good Compensation Compared To Other Taxpayers

Hamilton County experienced a property tax increase of about 10.7 percent in 2017. By law the reappraisal of property shall not increase tax revenue. So after the reappraisal the state certified millage rate for Hamilton County was 2.4976 per hundred dollars assessed value. The county commission voted to raise the millage rate to 2.7652 per hundred. That's about a 10.7 percent increase ... (click for more)

Mayor Berke Plans Affordable Housing Fund, Expansion Of Innovation District; Creation Of Council Against Extremism

Mayor Andy Berke, in his annual State of the City Address on Thursday, said he plans to establishing the city’s first Affordable Housing Fund. He said the city plans to commit $1 million to the fund "that will be used exclusively to aid the creation of affordable and workforce housing throughout Chattanooga. These funds will be used to supplement federal funding, various ... (click for more)

Chattanooga Man Who Was Recently Charged With Murder Is Accused In Another Earlier Shooting

Chattanooga Police have charged Britian Crutcher with the September 2017 shooting of LaSandra Burdette. Ms. Burdette, 26, was shot just after 3 a.m. in the 2000 block of Ocoee Street in Avondale. Her vehicle was involved in a minor wreck just before the shooting. The shooter was in another vehicle. Police recently charged Crutcher in the homicide of 28-year-old ... (click for more)

Tankersley One-Hitter Leads Silverdale Past CCS

Silverdale had beaten Chattanooga Christian by a 7-0 final in a   softball game at CCS a few weeks ago, but the Lady Chargers were hoping to turn the tide after allowing just two earned runs in that earlier game. Things didn’t turn out as planned for the Lady Chargers Thursday evening at Silverdale. The Lady Seahawks are a really good hitting team and they showed it ... (click for more)

Fulmer Gets 4-Year Contract As Vols Athletic Director

University of Tennessee Chancellor Beverly Davenport announced Thursday that Director of Athletics Phil Fulmer has signed a four-year contract. Fulmer took over as UT's Director of Athletics on Dec. 1, 2017.   "Phillip has been a great partner over the last four months and I commend him for the work he has done with our student-athletes, coaches and staff," Davenport ... (click for more)