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


Chattanooga Is Mired Down - And Response

As an avid Chattanoogan reader, especially the opinion and also latest booking reports, from afar Chattanooga is mired down.  I can't exactly put my finger on it, really.  I have studied it and thought it over and don't even have a great description. The school board is a mess with special interests like CSLA wanting to be "special". I lived on Signal Mountain and went ... (click for more)

Change Is Needed In District 2 - Vote Mickey

I am ready for a change in District 2.  Over the past year, I’ve emailed Jerry Mitchell about several concerns I have for District 2, my emails have gone unanswered.  Now a few days before Election Day, March 7, 2017, I’ve received three calls asking me to vote for Jerry;  I explained that I would not vote for him due to my experience of him not responding to my emails ... (click for more)

Chattanooga Area Under Tornado Watch Until 7 PM, Severe Thunderstorm Warning Until 3 PM

Severe Thunderstorm Warning Weather Updated: Mar 01 1:59PM Issued by the National Weather Service SEVERE THUNDERSTORM WARNING FROM 1:58PM EST WED UNTIL 3PM EST WED THE NATIONAL WEATHER SERVICE IN MORRISTOWN HAS ISSUED A * SEVERE THUNDERSTORM WARNING FOR... RHEA COUNTY IN EASTERN TENNESSEE... SEQUATCHIE COUNTY IN EASTERN TENNESSEE... SOUTHWESTERN MEIGS COUNTY IN EASTERN ... (click for more)

Boyd Says Visitors Bureau Spending $25,000 A Month On Travel; Doak Agrees To Meeting

County Commission Finance Committee Chairman Tim Boyd on Wednesday said the Chattanooga Visitors Bureau regularly spends about $25,000 per month on travel. He said that was "one of the first items that caught my eye" after he said he got "an inch thick" packet from Auditor Jenneth Randall about CVB finances. He said spending he picked out "just on the first few pages was incredible."  ... (click for more)

Region 3-3A Girls Title Game Postponed To Thursday At Bradley

The Region 3-3A tournament championship basketball game pitting Cumberland County and Bradley Central scheduled for Wednesday night has been postponed until Thursday at 7 p.m. at Jim Smiddy Arena on the campus of Bradley Central High School. The delay was necessitated by the threat of severe storms in the area that caused the closing of several school systems, including Bradley ... (click for more)

Tyner, Brainerd Boys Advance In 3-AA Hoops

ATHENS, Tenn. – Round Five is set for 7:30 Thursday night here at McMinn County High School. We’re referring to the fifth time that Tyner and Brainerd will meet on the basketball court this season after both advanced to the Region 3-AA championship game with wins here in the semifinals Tuesday night. So far, both teams have won twice as they won in the other gym during the ... (click for more)