URL Pharma Price-Gouging of Colcrys Is a Pain in the Foot

When I had my first gout attacks as a result of my Polycythemia Vera, the doctor prescribed colchicine to provide relief.  Colchicine is a generic drug that is 1,500 years old (it comes from the seeds of the autumn crocus) and was used by the ancient Egyptians and others to reduce inflammation and other pains.   

In 2010, my $10 prescription co-pay priced the pills at $0.16 each.

Last month, my rheumatologist prescribed colchicine again -- this time for extremely painful and inflammed joints and tissue inflammation (erythromelalgia).  

Bring back the colchicine!

I went to pick up the medicine and the pharmacy tech asked, "Are you sure you want this Colcrys?  It's $328.75."

"What?  I want the generic version, colchicine.  I don't need the name brand version." was my reply.
She went back to the pharmacist to ask about this.

How could a single pill go from costing $0.16 to $5.48?   What the heck?  

Here's what I learned:

In 1962, the FDA began a drug testing and approval process to make sure that new medications on the market are safe, effective, and accompanied with helpful information for physicians, pharmacists, and patients.  

In 2006, the FDA began the "Unapproved Drug Initiative" to get old medicines that have not gone through the FDA approval process off the market.  These old drugs were about 2% of the prescriptions written at that time.  The intent is good:  protect us from bad drugs and potential dangerous side effects and interactions of medications. 

It turns out that in 2009, URL Pharma agreed to take Colchicine through the FDA's review and approval process.  In return, it gets three (3) years of exclusive rights to sell the Colcrys for gout and seven (7) years to sell for Familial Mediterranean Fever (through the Orphan Drug Act).  

It also can price it however it chooses.  The FDA does not regulate pricing of drugs.
But how much is too much???   
I believe increasing the price by 34 times higher is beyond greedy... it is downright cruel to people who are ill and in significant pain.

So here's the practical rub:  

The study with 1,000 patients conducted by URL Pharma met FDA requirements, and it did not provide any new insights about the drug, contraindications, or interactions that were previously unknown to the medical community.

We are no safer today with colchicine (aka Colcrys) than before URL Pharma came along.  What was a generic drug (and quite affordable) has become a brand-name drug owned and sold in a monopolistic, predatory manner.

A rheumatologist told me that in a few years, it will go back to the $0.16 per pill.

I double-checked with my rheumatologist about this medicine, given my sticker shock.  
We decided that I would bite the bullet and get the colcrys.

Today, I went for my refill and learned that the price dropped a whopping $4.00 for 60 pills.  So this month, each pill costs me $5.41.  That's still predatory pricing in my book.

This drug that costs $5.41 per pill used to cost me $0.16 per pill.

The pharmacy tech that dispensed the Colcrys to me said, "Wow!  I couldn't afford to take this medicine if I had to.  You're lucky you can afford it."

I asked him if he sees a lot of patients who leave prescriptions at the counter because they are too expensive.  "Several times a day," he replied.  "Some people ask for a week's worth of a prescription because that's all they can afford this week or this month."  


His words really hit home... I am indeed lucky.  

I am married to a wonderful guy who has a great job with excellent health insurance coverage.  I have not been able to work in a meaningful way since struck by illness and that has taken a huge toll on me mentally and emotionally.  (We miss the earnings in our household budget, too).

If dear hubby lost his job and health insurance, I would be among the millions of "Un-insurables" with serious pre-existing conditions. 

The State of Georgia defers to the federal government's High Risk Insurance Program for people like me.  To qualify for the federal program, I would have to be uninsured for 6 months.  I'm pretty sure we wouldn't be able to afford 6 months of specialist visits and all my medications (we'd likely make too much money to qualify for patient assistance programs).  I would likely experience thromboses again and maybe a stroke out before I could access the medications again.

It's no wonder that medical bills are the #1 cause of personal bankruptcies in the United States.  People will do anything they can to ease the pain of their loved ones.

My parents taught us this maxim:  Just because you can, doesn't mean you should. 

This concept applies to many aspects of life, including price gouging.  

Imagine a world where people, corporations, organizations, and governments adhered to this!

Feeling Hot, Hot, Hot

Just when I think I'm managing my "new normal" something unexpected and significant interrupts my well-being.  My hubby asks, "when are the locusts arriving?"

This past spring, my toes, feet, fingers, and hands began to behave in a most unusual way:  they would turn red, swell up, and itch like crazy.  It starts with a tingle, then the tissue would rise before my eyes.  Remember those pieces of cardboard that turn into sponges when dipped in water?  

The first couple of months, the swelling would occur in one limb for a couple of days and then disappear, only to "re-emerge" in another extremity.  It was unpredictable and painful.

I was put back on prednisone because it's considered "the gold standard" for inflammation.  I was in so much pain that I agreed to take it despite my previous experience (a full-year of me becoming an irritable, annoying, and extremely overweight insomniac).  I was desperate!  
I tried it for 3 months;  at first it seemed to reduce the swelling, but after a couple of months it made no difference. We had to try something else.

I share these pics with the following disclaimers:  Yes, I know that I need a pedicure.  Yes, my feet could easily make Time magazine's "Ugliest feet in America" award.    

The foot tissue swells, itches & burns.

See the difference between the swollen right foot & the unaffected left foot?

Side view of both feet.

The inflammation seems to bounce around from foot to hand to foot to arm.  When my feet are inflamed, walking is extremely painful.  

Now, take a look at these ever-attractive hands:

Ring finger swells into hand.

 

Top of hand swollen, but not red.  Weird!

Hand & fingers so swollen I can't hold anything.

Right hand swollen & thumb burning red.

    

Right hand & joints swollen and sore.

When both hands are inflamed, major ouch!

In addition to the tissue inflammation, the joints became involved.  When the joints in my hands, knees, and feet are involved, my mobility is severely limited.  

Thus began a six month journey to find out what the heck is going on and what can be done to make it stop.  

I was tested for Rheumatoid Arthritis (because the inflammation had a symmetrical pattern on the extremities) and that came back negative.  Gout was also ruled out.

My rheumatologist confirmed that these symptoms are not at all related to the Behcet's Disease (auto-immune).  My Behcet's symptoms are well-managed with regular infusions of Remicade.  I also learned from others living with Behcet's that this is not one of their experiences.  

Through the great world wide web of support groups for people living with Polycythemia Vera and other MPNs, I was encouraged to pursue a line of questioning for Erythromelalgia (EM).   I brought the information (and photos) to my internist for consideration.  His research confirmed that these symptoms can occur as a result of the PV.  

The Erythromelalgia Association (www.erythromelalgia.org) provided some helpful information and links to other resources, including EM patient groups.  Once again, here's  a rare, odd chronic health condition that has no clear treatment.  What works for some doesn't work for others.  They confirmed that the trial and error path I'm on is par for the course.  

At the doc's suggestion, I apply lidocaine patches to the areas at the earliest sign of inflammation.  This helps to mitigate a full-blown inflammation for the area covered, but sometimes the swelling occurs above or below the patch.  I've also been taking antihistamines (both H1 and H2 blockers) and Colcrys (the now-expensive colchicine, an anti-inflammatory med) all to no avail.

After five weeks of continual swelling of hands, knees, and feet, I was ready to jump.

One day when my hands were swollen, I drove past a Chinese foot massage shop and decided to check it out.  Foot reflexology can be relaxing at worst, and curative at best.  Using my smart phone, I checked out the reviews of the foot massage place.  I decided to give it a try.

I must say, after the one-hour reflexology massage, I was relaxed and in less pain.  I went back the next day for more.  It didn't cure, but it does feel good!

When I showed these photos to my niece who is a chiropractor and acupuncturist in California, she said that they are signs that I have too much heat in my system.  I decided to find an acupuncturist in my area who could help me with this. 

I had my first appointments last week with Leena Sikand-Cook of Healthy Body and Soul clinic in Lawrenceville.  Leena explained that Chinese medicine is about keeping the body in balance.  She read my pulses and indicated that my blood has too much heat.  

Here are a couple of pics my friend took of me during my second appointment.

Please ignore all my chins!

These needles don't hurt a bit - really!

She also pricked the tips of my fingers and toes to get a few drops of blood to escape.  I'm going to give this some time to see if it will provide some relief.
Stay tuned...

What Happened to the Little Engine That Could?

Invisible Illness Awareness Week

September 10-16, 2012

invisibleillnessweek.com

Kind. Empathetic. Nurturing. Positive. Funny.  These are some adjectives that describe me.   I've always championed causes of the underdog and I have the resume and references to prove it.  Yet I am embarrassed to admit that until I became ill with Polycythemia Vera, I was not attuned to the suffering of millions of people who live their lives with no obvious outward sign of the pain and uncertainty they manage every day.  

My parents raised me with a strong feminist work ethic:  I had the same potential for achievement as my brothers.  I believed that if I tried hard enough, I could achieve most anything.  Persistence, stubbornness, and a bit of naiveté had served me well over the years, thus reinforcing those beliefs.  The power of my will and effort could overcome all obstacles.  That was my truth.  Until October 14, 2007.

Mid-Life's School of Hard Knocks has given me a new perspective.  I'm coming up on 5 years of a second chance at life.  Living these years has humbled me, frightened me, angered me, and depressed me.  I've been afraid to accept my 'new normal' for fear that it is akin to giving in to the diseases.  I don't want to be a victim so I try to deny what is happening in my body.  Yet the blood work doesn't lie.  The symptoms persist.  The side effects of the treatments are better than the diseases untreated.  I believe that if I keep digging into research and brainstorming the 'right' questions, cures will be found and I can get my wonderful life back.

I now assume that everyone has something that is a hidden personal challenge.  From this assumption, I try to enter interactions with a little more compassion.  I call upon patience when encountering someone may be a bit rude or disagreeable.  I don't condone rudeness, of course, but I also don't let it ruin my day.  After all, I know what prednisone did to me for one year!

I know that it is possible to be functionally 'normal' while masking chronic illness.  I know how exhilarating yet exhausting it is to be 'on' for work and family.  And I know that I still have a lot to learn about the effects of invisible illness on the patient, care givers, family, friends, employers, and community.  

The Invisible Illness Week organizers challenged us to answer the following meme.  Please share your reaction to this.

30 THINGS ABOUT MY INVISIBLE ILLNESS YOU MAY NOT KNOW

1. The invisible illness I live with is:  Polycythemia Vera, Behcet's Disease, and Migraines
2. I was diagnosed with it in the year:  PV in 2009;  Behcet's in 2010; Migraines 1983
3. But I had symptoms since:  PV since 2006; Behcet's since 2009; Migraines since 1981
4. The biggest adjustment I’ve had to make is: finding peace with limited energy and the inability to work regularly.
5. Most people assume: that I am healthy and fine because I have a happy, positive personality.
6. The hardest part about mornings are: waking up and moving through the aches and pains.
7. My favorite medical TV show is:  House
8. A gadget I couldn’t live without is: my iPhone
9. The hardest part about nights are: chronic insomnia
10. Each day I take 14 pills & vitamins. (No comments, please)
11. Regarding alternative treatments I: am open to them, but cautious of drug interactions.
12. If I had to choose between an invisible illness or visible I would choose: the invisible because I can "pass" as normal and not attract unwanted attention.
13. Regarding working and career:  I desperately miss my career and earning potential.
14. People would be surprised to know:  that I have withdrawn from many community and social functions because I don't like answering the questions, "are you well yet?" and "what are you doing these days?"
15. The hardest thing to accept about my new reality has been: feeling vulnerable and powerless about my future since there are no cures
16. Something I never thought I could do with my illness that I did was:  travel to Europe with my family
17. The commercials about my illness: do not exist because PV and Behcet's are so rare.
18. Something I really miss doing since I was diagnosed is:  being a consistent, vibrant part of my community
19. It was really hard to have to give up:  wine with dinner
20. A new hobby I have taken up since my diagnosis is: knitting (learned from YouTube videos)
21. If I could have one day of feeling normal again I would:  tour wine country and have lots of great sex with my husband
22. My illness has taught me:  that we take good health for granted.  Science and medicine have not kept pace with all the things that can go wrong in the human body.
23. Want to know a secret? One thing people say that gets under my skin is:  "You don't look sick" and "It's God's plan"
24. But I love it when people:  ask honest questions about the illnesses and listen
25. My favorite motto, scripture, quote that gets me through tough times is:  It could always be worse!
26. When someone is diagnosed I’d like to tell them:  It is scary as hell in the beginning; don't believe everything you read on the internet; there is a wonderful support community on-line  ready to welcome you to this special "club"; it gets better.
27. Something that has surprised me about living with an illness is: how many people are living with invisible illnesses
28. The nicest thing someone did for me when I wasn’t feeling well was:  two gal pals came to my house when I couldn't travel with my family.  We talked (they did most of the talking) and laughed and I momentarily forgot the pain.  They treated me as a full friend, not a fragile sick being.
29. I’m involved with Invisible Illness Week because:  I can use my voice to share my experience to dispel some myths, educate the currently healthy, and offer support and hope to others living with chronic, invisible illnesses.
30. The fact that you read this list makes me feel:  validated and grateful that you are curious to learn.

[Since September is also Blood Cancer Awareness month, I encourage you to learn about the Myeloproliferative Neoplasms family.  I have Polycythemia Vera, a MPN.  My bone marrow over-produces red blood cells (and sometimes platelets), causing thick blood and dangerous thromboses.]   MPN Research Foundation