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…