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


Gays Get 7 Percent Marriage Licenses In Hamilton County, 2 Percent Elsewhere - And Response

More than a hundred people in a homosexual relationship have received marriage licenses from Hamilton County clerk Bill Knowles.  The licenses were issued from June 26 through Feb. 3, according to a county spreadsheet.  The rush to homosexual nuptials was the U.S. supreme court’s publication of the Obergefell v. Hodges opinion, which is generally said to have ... (click for more)

Vouchers Are Not The Solution

Although the Republican legislators who represent Hamilton County are not willing to fully fund the BEP 2.0, they have endorsed sending thousands of your and my tax dollars to private schools. The voucher bill (HB1049) provides the promise of a private school education to students currently enrolled in low-performing schools.   Vouchers may provide financial resources; however, ... (click for more)

Hamilton County Principals Say Part 1 Of TN Ready Testing Should Be Cut Due To Online System Failure

Hamilton County principals are asking that Part 1 of the TN Ready Assessment be dropped this year due to the recent crash of the online system for the program. The principals also asked that any Part 1 TN Ready test results  not be applied to students’ grades or to evaluations and rankings for school personnel and school districts. The local principals also ... (click for more)

Allan Walsh Named New Bradley County Workhouse Superintendent

Sheriff Eric Watson announced the appointment of Allan Walsh as superintendent of the new Bradley County Workhouse, which will begin construction soon and be opened this year.  Plans are for the new facility, to be adjacent to the Bradley County Sheriff’s Office, Jail and Courts complex, to hold up to 128 non-violent, low security inmates. A graduate of Bradley ... (click for more)

District 5-3A Hoops Haunted By The Owls' Absence

ATHENS, Tenn. – District 5-3A basketball coaches gathered here on Wednesday to set up brackets and choose regular season All-District teams. In terms of all-district selections, the coaches did that fairly simple matter of voting and tabulating the numbers in short order. Bradley Central swept the top player honors when Cole Copeland and Rhyne Howard were selected to the ... (click for more)

Red Bank Picked To Win Region 2-A/AA Wrestling

It appears that the Red Bank Lions will be the target for teams involved in the Region 2-A/AA wrestling tournament being held at Hixson Middle School this weekend. The Lions, fresh off Saturday's A-AA State Duals title, are the early favorites for the upcoming tournament after claiming six number-one seeds in the 14 weight classes during the seeding meeting held Wednesday at ... (click for more)