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


Become An Official, Stay Connected To High School Sports

They don’t make the headlines, their names are not in the box scores and they don’t make the allstar teams, but perhaps the most important individuals in high school sports are the contest officials.  These individuals are so important that, in fact, there would be no organized competitive sports at the high school level without the men and women who officiate these contests ... (click for more)

General Bell: This Government Shutdown Is Outrageous - And Response (5)

The day before yesterday two Army Apache Attack Helicopter pilots were killed in a crash during training at Fort Irwin, Ca.  The pilots and their unit were preparing for a future deployment to combat operations.    As a result of the government shutdown, none of the spouses or families of these pilots will receive a dime from the United States Government in immediate ... (click for more)

City's Top Traffic Reconstruction Expert: "Man, This Truck Just Creamed A Dozen Cars"

The Chattanooga Police Department's top traffic reconstruction expert testified Tuesday that when he first viewed the scene of an horrific crash at the Ooltewah exit he thought "Man, this truck just creamed a dozen cars." Officer Joe Warren told a jury from Nashville that, according to his calculations, Benjamin Scott Brewer was traveling at 81-82 miles per hour when he struck ... (click for more)

Taji Webb, 26, Shot And Killed Monday Night; Shooter Will Not Be Charged

Taji Webb, 26, was shot and killed Monday night. Police said they have determined that the shooting was justified and the unidentified shooter would not be charged.   The Chattanooga Police Department responded at 10:43 p.m. to a person shot call in the 1500 block of Ryan Street .  Upon arrival, officers located Webb lying on the ground suffering from a gunshot ... (click for more)

East Hamilton's English Suspended For Tonight's Bradley Game

(Story will be updated) East Hamilton boys’ basketball coach Rodney English has been suspended from his coaching duties and will not accompany the team to Cleveland for tonight’s District 5-3A game against Bradley Central. English, who guided the Hurricanes to the 2017 boys’ state tournament in the program’s best season since the school opened in 2009, was suspended by ... (click for more)

Ooltewah's Second-Half Rally Dumps East Ridge, 66-54

East Ridge launched an all-out 3-point blitz against Ooltewah on Monday night at Catherine Neely Gymnasium. The Owls, who trailed 2-0 before the game even started due to Cam Chambers’ technical foul because of dunking in warmups, weathered that storm. They whittled an 18-6 first-quarter deficit down to 27-23 at halftime. Ooltewah took its first lead at 31-30 on Kobe Smith’s ... (click for more)