FDA protects Big Pharma profits while new super bug runs rampant

If anyone told me that I might one day mix up a concoction of my own poo with saline in a blender and use it to make a medicinal enema to save my daughter’s life I would have called them crazy.

Something about seeing your child suffer while doctors stand by a cure with their hands tied elevates desperation to unimaginable heights. So that’s what happened when my daughter suffered for more than six months with clostridium difficile, more commonly known as c-diff, a healthcare associated infection (HAI) surpassing MRSA as the most pervasive hospital super bug in the nation.

From the day she was born seven weeks prematurely twenty-two years ago my girl has been a fighter overcoming physical, emotional and social challenges. All the while I’ve been a pit bull mom doing what comes naturally for me.

God help the punk who picked on her, the school system that ignored her, or the hospital that tried to give her substandard care. I became by necessity a feared and revered advocate.

But nothing prepared me for c-diff now at historically high levels, it kills 14,000 Americans a year while the Big Pharma bully stands in the way of an obvious solution.

I used to believe the gun lobby was the worst, most short sighted and greed driven gang of cretins on earth. But actually, they are only a close second to Big Pharma. Similarly they both care not how many must die to protect their billions in profits and have enough money to guarantee nothing gets in their way. But the pharmaceutical industry is supposed to be saving our lives, not killing us.

My daughter contracted the bacterial infection associated antibiotic treatment in hospitals and nursing homes as she was treated for an ulcerative colitis flare in the summer of 2012. At the time it never occurred to me to question the standard cure, high doses of and antibiotic called Vancomycin even while she was taking immune suppressant medication to treat colitis.

It was the start of a vicious cycle. She would finish a course of antibiotics, feel better for a week or two then become sick again more intensely than before. She suffered extreme weight loss, was gaunt, depressed and defeated when I learned there was an alternative that was not only more effective but less likely to encourage a recurrence. Massive doses of antibiotics don’t just attack pathogens, they wipe out all bacteria, good and bad, leaving an intestinal host for festering spores of c-diff to repopulate.

I found a study touting the success of fecal microbiota therapy—repopulating a sick colon with the fecal matter of a healthy person—curing c-diff in 90 percent of patients resistant to antibiotic treatment. The study was published in the January 2013 New England Journalof Medicine and featured on the website of the hospital where my daughter was being treated. 

“Please doc,” I begged, “Sounds like this is what she needs.”

While doc agreed, hospital protocol required my daughter be diagnosed three times before employing FMT.  She had been consistently symptomatic for months but only two blood tests had been drawn confirming c-diff.

Three times, really? So we give the nasty pharmaceutical solution three strikes while my daughter’s colon is being destroyed? Hmmm…

I felt helpless as they threw the medicine cabinet at her one more time prescribing high doses of Cipro, Flagyl, and Vancomycin all at once. Within weeks of finishing that round of treatment the demon was back and so was bully mom demanding the FMT. Even her doctor was waving the flag and started the process to schedule the procedure in the hospital.

Unfortunately at the same time the Food and Drug Administration raised the flag on fecal transplants and at an April 2013 meeting where they put a halt to FMT establishing a cumbersome regulation until further studies could be achieved and protocol established.

A decision I'm sure was quietly applauded by pharmaceutical companies which stand to loose billions if shit replaces drugs like Vancomycin. From September through January my insurance company paid more than $17,000 for the drug. No extra zeros my pharmacist insisted.

Dr. Ben Goldacre, author of Bad Pharma, describes a very unhealthy relationship between the FDA and pharmaceutical companies where exiting FDA employees are hired quicker than Ivy League scholars. Goldacre describes the FDA as ripe with corruption with a history of routinely banning supplements and substances that compete with Big Pharma's gravy train. So people are prevented from even hearing about supplemental treatments that are safer and less costly then drugs.

Now the FDA wants to regulate our shit like a drug.
Hmmm....

FMT has been performed in a medical setting since 1958 and all of the sudden the FDA decision blindsided doctors and clinics with a requirement for an "investigational permit" that can be acquired in a cumbersome bureaucratic process that takes at a minimum 30 days to approve. The decision also discourages research by applying an increased cost burden.

As the number of c-diff patients becoming resistant to antibiotic treatment grew last year from 20 percent to 30 to 40 percent, the decision issued with no mandate or funding for study stranded thousands of patients desperate for a cure, including my daughter.

Go figure.

So as the FDA cracked down on the real cure, what were those people supposed to do?

I found an online Facebook community and website, the Power of Poop, that walked me through the do it yourself in home fecal transplant process. That's when desperation and common sense overwhelmed the ick factor. Turns out it’s not rocket science. Requires a healthy donor, some saline, disposable enema bottles, a dedicated blender, and an ability to suppress the gag reflex. I had just had a physical and was in excellent health to be the donor. The risk was zero and cost minimal. I purchased a six pack of disposable enema bottles, a bottle of saline from the pharmacy, and a funnel, strainer and individual style blender all dedicated to the treatment. Total cost, less than $50.

So I cured her. It wasn’t pretty, but after months of pure hell, the c-diff was gone and didn’t come back.

But it was too little too late. Months of illness had already destroyed my daughter’s colon. Six months later it had to be removed. Something I’m pretty sure could have been avoided if FMT was a first line of defense instead of the last resort. It also prevented her from entering an FMT study group like the ones where positive results have been documented for people with inflammatory bowel disease including remission for patients with ulcerative colitis.

Several studies have been conducted using FMT to treat autistic children commonly afflicted with an inflammatory bowel disease, clostridium bolteae that causes symptoms similar to c-diff. Not only do they achieve remission with the fecal transplant but their emotional well-being is dramatically improved as well. For too long we have been ignoring that instinct we are always referring to, that gut feeling that is apparently a critical indicator of physical and emotional well being.

            But this viable treatment is literally flushed down the toilet every day while the FDA scrambles to loosen restrictions on pharmaceutical research and ease the approval process to develop new antibiotics even after everything we have learned about how vulnerable they make us.

What the hell is wrong with people?!

I shouldn’t be surprised because we are the same Americans who sit on our hands while 28 people have been killed in 44 school shootings since Sandy Hook and we are still hostage to the National Rifle Association and Gun Lobby.

            As long as shit has the potential to cut into pharmaceutical profits we wont see much change in how antibiotics are over prescribed and wrongly prescribed.                

I now avoid hand sanitizers like the plague and will never take another antibiotic as long as I live if I can help it.

A balance of germs in the environment and bacteria in our bodies is not only healthy but necessary and the over use of antibiotics not only by doctors, but in livestock raised as food has been linked to the rise in allergies and illnesses like Crohn’s and ulcerative colitis.

Trust me, no one in my generation went to school with a kid who had a peanut allergy. A kid with gas ate beans and didn't have IBD. Does anyone else over 50 find that strange?

Hmmm…

And the winner is...

Since when is coming in third in the world devastating? Especially for a young woman who already proved her medal ascending to the top of the podium in the 2010 Olympics in the women’s mogul free style skiing event…

Hmmm…

This is why I was never a sports reporter. A bronze medal at the winter Olympics would never occur to me as the “second place loser” award. It would also never occur to me to exploit the athlete’s initial disappointment to tears on her local news station. I’m sure that momentary grief at ending her Olympic career with a bronze and not the gold she had hoped for is the last thing she wants to be remembered for. Thank goodness for the integrity of the national news that acknowledged she was disappointed, but spared the tears footage and gave her well deserved kudos. 

As did her fans at home like *Norwich Inn owner Joe Lavin who said, “for us Hannah’s a champion no matter what the color of the medal.”
          Sure, I was rooting for Hannah to do well. The free style skier raised in Norwich, Vermont is a junior at Dartmouth College where my daughter is a freshman. So was there something wrong with me because I was like, “good job Hannah!”? Bring that bronze you just won in Sochi home and hang it proudly right next to the gold medal you earned in Vancouver. You did an outstanding job just getting to the Olympics and now you get to represent your country on the podium today.
         Just before leaving for Russia Hannah described the mogul event as one that requires a strong acrobatic component, power, speed and agility but is “endlessly satisfying.”

“You only do it if you love it,” she said. I hope she is still feeling the love.

I guess the Olympics and competitive sports in general naturally bring out fierceness in competition, chest thumping egos and an aggressive drive to be first or nobody. That will always be disturbing to me.

Athletes with that kind of drive and determination are already winners in the confidence arena that fans and news stations driven by sensationalism should never devalue.

No one knows that better than two time Olympic moguls skiier Shannon Bahrke who took the silver medal in 2002 and bronze in 2010 while no doubt looking up at Kearney at the top of the podium.

Among the tidbits of advice for success the Olympic champion turned entrepreneur told Reuters last week is one that I think will ease Hannah’s pain, “don’t get so caught up with achieving the end goal that you disregard the journey. Trust me, when the goal has been achieved or not, it’s the journey you will tell the most stories about!” said Bahrke.

Recovering from a ski injury in 2007 Bahrke channeled her confidence in the direction of the business she founded with her husband, Silver Bean Coffee in Salt Lake City, Utah. Not only is their earth friendly coffee business a great success, they support a number of charities including the U.S. Olympic Ski Team that went to Sochi and my favorite, the Best Friends Blends that contribute $5 of the proceeds of every bag sold to the Best Friends Animal Society. Bahrke gets a gold medal from me for that initiative.

I’m sure there are lots more third place success stories, my personal favorite Nicholas David who rocked the 2012 season of the Voice. The multi-talented soulful and dynamic singer and

songwriter may have lacked the pop star looks and appeal to the youthful audience that drives the show but he was unmistakably the most talented performer I've seen on any of these reality television rocket to stardom shows. Nonetheless, that third place push launched the Minnesota based musician’s career across the country. He even turned up in Massachusetts last summer as the headliner at the 2013 Martha’s Vineyard Jazz and Blues Summerfest.
          Just curious, who are your third place heroes? I’d love to hear about them.

*Not sure if they have won any medals but if you are ever in Norwich, this is my favorite place to be. 

Fall from grace

“I have to ask you this,” a nurse looked down at me lying on a gurney, peering over her half frame cheaters, “do you feel safe at home?”

I must have looked quizzical.

“I mean would anyone there hurt you?” she continued.

“Oh,” I said still in a concussion-induced haze. But I was sure I had done this to myself so I answered, “No… I mean yes I’m safe at home, and no, no one hurt me.”

I guess it is pretty standard now in an emergency room to throw that question out there for the potentially battered and abused women, men too, that present with the kind of injuries I had. And then there was the circumstance, how exactly I ended up in the ER with a potential concussion, three knots on my head and a fat, bruised and split lower lip that would make anyone question the validity of my story. Flu like symptoms and a predisposition to Vertigo not withstanding, it was a pretty bizarre story.

Honestly I was feeling fine up until about 10 o’clock the night before. Lounging on the sectional with my husband watching a plot confused, post apocalyptic Tom Cruise science fiction flick, the first sign things were not quite as they should have been was when I reached for my guilty pleasure—a bag of Pepperidge Farm goldfish crackers, Parmesan flavored. On any given day I can eat half a bag in one sitting fooling myself all the while that they have very few calories because they are just tiny little fish. After a few handfuls my husband, the perpetual killjoy, snatches the bag from me and tells me I’ve had enough. But this time after eating only three or four fish I pushed the bag away feeling a bit squeamish.

The movie ended with about as much satisfaction as the goldfish and my husband went to bed. I stayed on the sofa watching late night comedic pundits. My drooping eyelids briefly alerted to the sound of blaring horns and the caw of the swooping eagle announcing The Colbert Report, and then I drifted off.

It wasn’t long before my slumber was interrupted by sharp stomach pain and an urgent need to go to the bathroom. No sooner was I on the commode and the gushing from my hind parts began with the force of a fire hose, a condition that became the mantra of my next five hours.

I was desperately tired and wanting to go to bed but from my spot on the couch there was a straight shot to the downstairs bathroom. The abrupt necessity to vacate my bowels was occurring every 15 to 20 minutes with only intermittent excuses to vomit, which I would have gratefully preferred.

At about 4 am I sat in the darkened downstairs bathroom, long since having bypassed flipping the light switch saving valuable seconds to launch, when the diarrheal urge was competing with the urge to vomit. In a state of exhaustion, dehydration and delirium the last thing I remember was that I must somehow switch positions to avoid puking on the floor.

Black out.

“The next thing I know,” I tell the doctor, “I’m thrashing around on the tile floor. I’m tugging at the scatter rugs trying to pull them over my body like they are my blankets. And only as my bare bottom is scratched by the torn rubber underside of the floor mat do I realize I’m not in my bed and this is not my comforter and my damn pants are twisted around my ankles. Not only that, but my head hurts and my mouth is swollen.”

Then I explained how I felt my way around the small still unfamiliar room, grabbing hold of the toilet seat to leverage myself to stand. Only then did I realize where I was. One hand to the wall for steadiness, I yanked up my pajama pants. With my head pounding and the taste of blood in my mouth I flipped the light switch and in the mirror met a horrible sight that was apparently me. Hair flattened to the left side of my head with a vomit and blood infused gel, one round red lump was displayed on my forehead and I plowed my fingers through my hair to find two others burgeoning on my crown. Then there was what looked like red lip liner applied neatly and exclusively to the left side of my mouth as if drawn on by a neurotic bisectional cross dresser. It was blood dried to the edge of my lips, a forensic state of cosmetology indicating I had been unconscious on that cold hard floor a good 10 minutes. With a finger I pulled my lower lip down exposing a mouth full of blood and a puncture wound neatly aligned with an upper incisor.

All this happened in the bathroom, alone? Hmmm. What kind of person gets a stomach bug and ends up looking like a prizefighter after falling off the toilet? I think you can see where the skepticism comes in. My injuries just didn’t jibe with a simple fall to a tile floor. But I was quick to dispel any idea that my clueless husband who dumped me off in a virtual ER drive by had anything to do with it.

Well sure doc, I told him. It’s just like I’m telling you. I swear. I must have rolled around on the floor or something.

As it turns out a key piece of evidence had gone unnoticed as I staggered out of the bathroom and up the stairs to report the drama to my husband who rolled over and told me to get some sleep. After explaining I might die for want of a nap he eventually dropped me off at the ER and turned back home directly as he too was feeling a bit woozy. (Karma is a bitch)

But what I had yet to discover back at the scene of the fall was that a small antique wood table suitable for bathroom reading material and strategically placed in front of the toilet was also a casualty of my early morning tumble. Only after being discharged from the ER did I discover its structural integrity had been completely compromised being struck by a large heavy free falling object – my head.

Upon further examination the lower shelf of the table was completely split in half, legs splayed outward and securing screws dangling from the force of the trauma. It seems the only thing keeping it standing was a dated Consumer Report wedged into the opening of the splayed legs. When I removed the magazine the table fell to pieces like a Tetris tower with its vital tile removed.

Only then could I reasonably account for exactly three lumps where my head thrust into the legs beneath the table top apparently only missing one, and a punctured lip that must have smacked the lower supporting shelf before I landed on the floor.

A perfectly reasonable explanation that would have gone a long way to satisfy the ER staff who reluctantly allowed me to go home after pumping me with several pints of saline fluids and performing an EKG and Cat Scan revealing nothing abnormal.

So back to the question, do I feel safe at home?

As it turns out falls are the number one cause of accidental injury in the home in America resulting in about 6000 deaths a year. Go figure. Could have happened to any naturally clumsy person with Vertigo compromised by a fast moving stomach virus and one very kitschy albeit poorly placed antique table.

I guess I’m as safe as I will ever be.

All I ask is that there be no bathroom memorials.