God Bless Andrea Sloan as she not only battles for her life but also BioMarin. My 19-year old nephew died after battling cancer for 3 years. He was granted the use of compassionate drugs and one of his legacies is that he helped advance science to help those that come behind him. This is not a selfish request by Andrea, it is a sign of love for other human beings that she does not even know. BioMarin Pharmaceutical is being selfish in my opinion, if you have something that may help a willing patient I think ethically you have the responsibility to share it.   (Facebook Post with Link, Andy Reistetter, 9/28/13)

William Hudson’s article is below and below that is Andrea’s obituary. She passed on January 1, 2014 as an inspiration to all. There has not been a more beautiful tribute written, don’t miss it. I am sad that I was unable to meet her as I passed through Texas on my Journey to Olympic Golf but somehow I think I did and her inspiration inside me will surely never die.

In Cancer Drug Battle, Both Sides Appeal to Ethics

By William Hudson, CNN

All Credit given to William Hudson with gratitude!

Updated 5:38 PM ET, Sat September 28, 2013

Story Highlights

Andrea Sloan, 45, has ovarian cancer

She is seeking “compassionate use” of a new drug that’s not FDA-approved

Sloan says she’s willing to accept the risks

Andrea Sloan is dying of ovarian cancer. Having exhausted all standard treatment options, her doctors say her best hope now is a new class of cancer drugs called PARP inhibitors.

The California pharmaceutical company BioMarin makes one version of these drugs called BMN 673. Earlier this year, the company presented very early data on this experimental drug at a large cancer conference. Initial results in women with breast and ovarian cancer were encouraging.

Sloan says there are doses of BMN 673 sitting on shelves in the same hospital where she’s seeking treatment: M.D. Anderson Cancer Center.

But she’s not getting the treatment because the company is refusing to give it to her. That’s because this drug she wants is still in clinical trials, and the company says hasn’t been proven effective.

Sloan is a 45 year-old attorney in Austin, Texas, who has ovarian cancer.

Sloan is a 45 year-old attorney in Austin, Texas, who has ovarian cancer.

BioMarin points out that to date their drug has been tested in fewer than 30 patients with ovarian cancer like Sloan.

“It would be unethical and reckless to provide end-stage refractory ovarian cancer patients outside a clinical trial with BMN 673 at this early stage of development,” says company spokesperson Debra Charlesworth.

“If we did, we would be exposing an 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.”

But Sloan says she’s willing to accept the risks — to roll the dice now that her doctors have tried everything else they can to save her life, including multiple rounds of surgery, chemotherapy, and radiation since she was first diagnosed with cancer in 2007.

And her doctor supports her.

She has the help of a PR firm, working pro bono, to bring attention to her case, and a change.org petition for her cause has collected more than 150,000 supporters. It will likely be years before BMN 673 is on the market, but Andrea says she does not have that long to wait.

PARP inhibitors work by preventing DNA repair in cancer cells, and are thought to work especially well in patients with a particular gene mutation.

“One of the reasons she’s such a great candidate for PARP inhibitors specifically is because she has a BRCA mutation,” says Dr. Charles Levenback, Sloan’s oncologist at M.D. Anderson Cancer Center.

“She has a hereditary form of ovarian cancer, so we believe she has a much better chance of responding to PARP inhibitors than patients with a nonhereditary type of ovarian cancer.”

Levenback says Sloan doesn’t meet the eligibility requirements for any open clinical trials to the best of his knowledge. If she did, he would not be seeking compassionate use for his patient in the first place, he says.

BioMarin is conducting more clinical trials, but in breast cancer only, not ovarian cancer.

The standoff between Sloan and BioMarin raises the question: When should patients get access to experimental drugs?

Under “Compassionate Use” or “Expanded Access”, the Food and Drug Administration allows an unapproved drug still in development to go to a patient with few alternatives remaining, also absolving the drug maker of liability should the drug not work or cause harm.

The FDA has said Sloan qualifies to seek compassionate use of BMN 673, but BioMarin won’t provide it and they don’t have to.

“You have the FDA saying, ‘Look we’ll approve compassionate care.’ You have the doctor who is the specialist saying: ‘This is the right thing to do.’ And you have a corporation protecting its wallet at the expense of Andrea possibly dying,” says Newt Gingrich, co-host of CNN’s “Crossfire,” who has been gathering support for Sloan’s case.

“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.”

BioMarin says it does provide “expanded access” to patients for another drug which is further along in the clinical trial process, and that the company expects to spend $50 million or approximately 10% of its revenue in 2013 on providing free drugs to patients.

BioMarin also notes that other drug companies are developing PARP inhibitors too, so they’re not the only potential source for Sloan.

The company points to an AstraZeneca clinical trial currently enrolling ovarian cancer patients, but Sloan’s doctor says she doesn’t qualify.

“We’re focused on BioMarin because initially that is the one that one of my doctors had the most direct experience with and recommended,” says Sloan, whose doctors at M.D. Anderson also participate in BioMarin’s clinical testing.

“The compassionate use policy exists for exactly this situation, and this is how patients lose: I lose if BioMarin is able to say ‘Well you need to go ask for it from one of the other three’,” says Sloan.

Art Caplan, professor of Bioethics at NYU Langone Medical Center, says the scatter-shot way in which individual patients are left to petitioning drug companies for access to experimental drugs creates an unfair process.

“One problem in this country is we haven’t set up a system. Right now what we’ve got is a squeaky-wheel lottery; if you can figure out what your options are, if you know how to use social media, if you know how to have a bake sale, if you can hire a PR firm — you can have a shot at an unapproved drug,” says Caplan.

“But that’s all obviously inequitable relative to the number of people who might want to seek compassionate use.”

Caplan says that without more safety and efficacy data on BioMarin’s drug, it’s too early in the process for a compassionate use exception for a different form of cancer than the one BioMarin is targeting. There’s still a big risk that the drug could harm Sloan, speeding her death, as much as it helps her, he says.

Sloan’s doctor agrees the system needs changing.

“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,” says Levenback.

“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.”

Levenback says the window for Sloan is closing. If it’s going to be effective, she will need the new drug soon. Knowledge of that fact has put Sloan on a mission, and she says she’s not giving up.

 

SLOAN, Andrea (Obituary)

Andrea Sloan completed a life abundantly well-lived on January 1, 2014. This beloved woman was known to her multitude of family, friends, admirers and supporters as a spitfire of generous, loving exuberance.

Though her years in this world were fewer than we hoped, let it be known the reason: Most all mundane hours and periods of sour spirit or wasteful failure of character were intentionally carved out of Andrea’s life, resulting in such a concentration of zestful eagerness, sincerity, character, strength, passion, kindness and luminosity that only the most courageous and determined soul could possibly have owned it. And she did.

Andrea was born January 23, 1968 and grew up on the trail of her parents’ teaching careers, which took the family to some of America’s most beautiful places including Durango, Colorado; Park City, Utah; California; and Wyoming.

She competed on the swim and soccer teams in grade school; at Robert E. Lee High School in Tyler, she was a member of the National Honor Society, participated in the gifted program in all academic areas, competed with the debate team and was chosen for both Girls State and Presidential Classroom. She earned a B.A. in Government from the University of Texas at Austin, where she also earned her law degree in 1997.

Andrea started her career around the Capitol as a page and quickly advanced to serve as a Legislative Aide for Rep. James Hury and Rep. Jim McReynolds, then as a junior lobbyist for Louis Bacarisse & Associates. She worked for eight years at Haynes & Boone law firm, where she practiced construction litigation while also serving meaningful causes including the Texas Freedom Network, the Texas Hill Country Ride for AIDS and United Way of Central Texas. She served on and chaired the City of Austin’s HIV Planning Council.

In 2005, she was named Executive Director and General Counsel for the Texas Advocacy Project, where she oversaw a staff of attorneys providing free legal services to victims of domestic violence and sexual assault.

She spoke of her passion in life as ‘serving up a bowl of justice’ because she was driven to use her law degree to help inject an increased level of fairness into all aspects of our world. Andrea was a zealous and effective advocate for her clients but always in the context of being a thoughtful, ethical officer of the court.

Andrea was a ‘foodie.’ Topping her list was the white queso at Zocalo. She loved the mac & cheese and brussel sprouts at Perla’s, the migas at South Congress Café, the fresh pastas at Becco’s in New York’s Hell’s Kitchen, her mother’s ravioli at home, the salsa bar and cheese enchiladas at Polvos, the Mezza platter at Phara’s, Italian cream cake, Kalamata olives and, of course, thin and crispy crust pizza!

A committed vegetarian, she had a huge heart for all animals. She treasured the many German Shepherd and Belgian Malinois dogs she had adopted over time, and in recent years she spent many hours with her beloved Quarter Horse, Heathen.

Andrea loved having fun. She put on vampire teeth to pass out Halloween candy. She held Christmas cookie parties that became sleepovers because no one wanted to leave. She loved trips to Bandera, and her friends dubbed her ‘Bandrea’ because of her love of the town and its cowboy culture.

Music fueled her Rock Star life. If there was a concert within 300 miles, it was fair game for a road trip. She was a dedicated Bon Jovi fan and loved ‘hair bands’ from the ’80s as well as The Bellamy Brothers and Luke Bryan.

Andrea learned that she had ovarian cancer in 2006, but she did not let that change the way she lived her life outside of treatments. Her love for adventure only grew as she traveled more often and to farther-flung places. This petite blonde loved to ride her Harley Davidson, but she traded it for the serenity and adventure offered by time spent with her faithful steed, Heathen.

She loved adventure and was at home in nature. She cycled across Alaska for an AIDS fundraiser, hiked the Narrows at Zion National Park and whitewater rafted in the Grand Canyon. She had entertained the idea of someday becoming a National Park Ranger, and the National Park Service awarded Andrea an honorary membership last year.

Andrea was a faithful blogger who loved words. She was a careful speaker and a great listener. She admired strength of character in people who do the right thing even when it’s hard. She always made time for the people she loved.

She loved her family: her parents and sister; her niece, nephews and brother-in-law; her cousins; and her ‘framily’ of friends. She was passionate about being Aunt Andi. She cared deeply for the children and often engaged her friends in planning new ways to spoil them.

She was a strong believer in God, a Christian who greatly respected the right of others to practice their beliefs in their own personal way. Her faith gave her great strength and courage to fight cancer and to accept her destiny with grace and gratitude.

She loved and appreciated her life, blogging that she would not choose to rewrite any part of her story. While she did not choose her battle with cancer, she certainly chose the means by which she would face it with faith, humor and the will to summon new courage every day.

In this, and in her advocacy on behalf of all cancer patients, she inspired people across Texas, the nation and the world who logged in daily to read her quips of wisdom, progress reports and enlist themselves in ‘Andi’s Army’ to advocate alongside her for Compassionate Use Reform.

Andrea was preceded in death by her maternal grandfather, Fay Livers of Longview, Texas; paternal grandmother Grace Daluiso Santolucito of San Bernardino, Calif.; paternal grandfather Gordon Sloan of San Bernardino, Calif.; aunt Rebecca Livers Oliver of Longview, Texas; and aunt Marilyn Donovan of Salt Lake City, Utah.

She is survived by the most phenomenal parents on the planet, John Harmon Sloan and Karen Livers Sloan of Tyler, Texas; sister Ashley Sloan Harrison, brother-in-law Andrew Harrison, niece Anne-Marie, and nephews Pike and Price, all of Round Rock, Texas; maternal grandmother Elsie Albin Livers of Longview, Texas; aunt Jan Sloan of Salt Lake City, Utah; uncles Gordon Sloan of West Jordan, Utah; Michael Sloan of Dayton, Ohio, and Donald Oliver of Longview, Texas; and many first and second cousins. She is survived by her BFFs Michelle Wittenburg of Austin, Mary Smith of Tyler, Blair Hodgkins of Austin, and by countless more friends everywhere.

 

The family extends its most sincere gratitude to Andrea’s beloved and committed oncologist and lifesaver, Dr. Charles Levenback at MD Anderson, and to her extraordinary medical team: Drs. Robert Coleman, John Meroney, Yago Nieto, Anuja Jhingran, Carol Lewis and nurse Celine Chacko.

 

A celebration of her life will be held Friday, Jan. 31 at 4:30 p.m. at Camp Lucy, 3509 Creek Road, in Dripping Springs.

 

Andrea asked for any gifts in her name to benefit one or more of the following: MD Anderson’s Ovarian Moon Shots Program (https://gifts.mdanderson.org/), be sure to select “in memory of” Andrea Sloan or mail to MD Anderson Center, Andrea Sloan Memorial Fund, PO Box 4486, Houston, TX 77210-4486; the KK125 Ovarian Cancer Research Foundation (www.kk125.org or PO Box 12581, Austin, TX 78711); or the Texas Advocacy Project (https://www.texasadvocacyproject.org/donate.php or 1524 S. IH 35, Box 19, Austin, TX 78704).

Published in Austin American-Statesman from Jan. 25 to Jan. 26, 2014

 

If you think about it, all of us, men and women, lived in a Women’s World very early in our lives. A woman helped us even before we could breathe, gave us the nourishment we needed and provided a comfortable place for us to rest and sleep. Though we did kick back a little, we were safe, nurtured and happy for the most part in those days of gestation.

What the heck happened? It was only a three or four inch trip down the birth canal from complete happiness to the real world. At that moment in time, we did not think a mother or any women knew what was best for us. After all it led us to a man’s world or at least what most men think is still a man’s world.

I grew up with three sisters and a mother for the most part. Dad was a fireman who lived part time at the firehouse back in the days of 24-hour shifts. We had quality time together golfing, fishing and watching Johnny Carson on TV but it was my mother who ran the household. My two older brothers were off to college before I was in fourth grade. One thing I learned from my mom and remember to this day is that I should treat a girl the same way I would want another other boy to treat my sisters.    

How did I come to attend the Generation W Women’s Leadership Conference? Anybody who knows me knows the answer to that question—golf. Normally a freelance golf writer, the fairway I took to get there made sense, at least, in my own mind. I met Donna Orender, the founder and CEO of Generation W at TPC Sawgrass last fall. I knew she had previously worked for the PGA TOUR and ran the WNBA. I heard of the inaugural Gen W Conference last year but was out of town that week and missed it. I asked her if I could attend this year’s event and write an article about the experience. Her response was yes, please join us. It seemed to me as easy and fun as joining up with another golfer on the first tee at the golf course.

While I am comfortable playing golf with women I was a little out of my comfort zone arriving at what was advertised as a women’s conference. About a thousand woman of the Generation W converged on the campus of the University of North Florida in Jacksonville, Florida. Once I found my seat and the conference began, I felt somewhat comfortable being the minor minority if gender is considered a minority at all these days.

Was this going to be a women’s rally or a parley of leadership principles? The answer came in the very first presentation about transformational leadership. The presenters were newlyweds Carolyn Buck Luce and Rob Evans. This was going to be a marriage encounter weekend. Just kidding, their shared presentation about mountain climbing on their recent honeymoon was right on message and was a guide to reference my own journey through a day of presentations and networking functions.   

Here are some of my lasting thoughts, impressions and hopefully learning from that day at the Generation W conference:

1.   Woman tend to find the center versus find the top. Maybe I would be happier and more fulfilled in the center?

2.   In a world of ME, in a world of increasing isolation despite technology, let’s choose to connect. I want and need to connect with other human beings.

 

3.   Most issues of Women’s Rights are not woman issues, they are human issues. I am human, these are my issues too even if I am a guy. It’s all part of living life in the center and being connected. Makes sense to me.

4.   Do we let other people define who we are? Who are you right now? I like Carolyn and Rob’s description: “I am the one who knows how to do this.” I can use that whether climbing a mountain, making a four foot putt to win or closing that sale at work. I am good at being Andy Reistetter. I bet you are good at being you too.

5.   This is a guy’s conference too. Yes there are cross-over role models in women but there were several other male speakers including Florida Governor Rick Scott and Pat Geraghty, the CEO of Florida Blue. The keynote speaker was Dr. Nancy Snyderman, Chief Medical Editor for NBC News who has a lot to say about the health of both men and women on the NBC Nightly News with Brian Williams.    

6.   “There is a special place in hell for women who don’t help other women.” This is a quote from Madeleine Albright from her keynote speech at the Celebrating Inspiration luncheon with the WNBA’s All-Decade Team in 2006. Maybe a bit of a rallying cry but in reality there is a place in hell for any person who doesn’t help another person in life and it is not a special place to be.

I witnessed something pretty spectacular on tour earlier in the year at TPC Scottsdale. There were 179,022 spectators who came to the golf course on Saturday for the third round of the Waste Management Phoenix Open. The most ever I have seen and the most in history to witness a golfing competition for sure.

In a different context I had the same feeling of awe, amazement and inspiration at the Gen W event of 1,000 on the UNF campus. Orender is on to something different and meaningful here. It wasn’t a gathering of political and corporate female titans and wannabes. This is the full heart and soul of cupcake makers, scientists, athletes and leaders who happen to be female. That is where they start in life but not where they will end. One can easily see the impact of today’s Gen W movement 20 years down the road.

Whether you are female or male, it doesn’t matter. Young or old, it doesn’t matter. Married or single, it doesn’t matter. Gay or straight, it doesn’t matter. What does matter is that we ourselves and every other person in this world have a choice.

Generation W is making a difference, not only in the lives of women but men too. All around the world, too; there is no telling where the little ripples that originated at the University of North Florida will travel to and make an impact.

Back in the days when we were confined to a Women’s World we weren’t just safe, nurtured and happy. We were growing. Life is growth and change and if you don’t want to die just keep growing.

Embracing a woman in the sense of understanding how they see the world is “not simply a matter of emotion or altruism,” as Hilary Clinton stated. “A growing body of research tells us that supporting a woman is a high yield investment resulting in stronger economies, more vibrant civil societies, healthier communities and greater peace and stability.”

But you already knew that, right? After all you were not born yesterday.

Check out the Generation W website and I look forward to seeing you at next year’s conference!

 

Andy Reistetter is a freelance golf writer and a broadcast assistant for the various golf networks. He spends time on all four major American golf tours- the PGA TOUR, Champions, Web.com and LPGA.

Reistetter resides within two miles of the PGA TOUR headquarters and the home of The PLAYERS Championship at TPC Sawgrass in Ponte Vedra Beach.

A lifetime golfer, Andy enjoys volunteering at the World Golf Hall of Fame and THE PLAYERS while pursuing his passion for the game of golf and everything associated with it.

Embark on a “Journey to Olympic Golf” with Reistetter in the Fall of 2013 as he travels from St. Louis, Missouri where golf was played in the 1904 Olympics to Rio de Janeiro where it will be played again in the 2016 Olympics.

Original Journey to Olympic Golf in October 2013.

Follow-Up Journey to Witness Olympic Golf in August 2016.

Friend Andy Reistetter on Facebook or touch base with him by e-mail at AndyReistetter@gmail.com