Monday, February 1, 2016

COME AND GET ME

The thing about generics, they are not the same. Yes, the active ingredient is the same. But they are not the same. They are not studied in people. Once again, for dramatic effect: Generic medications are not studied in people.

According to an interview with C. Michael White, Professor and Head, Department of Pharmacy Practice, at the University of Connecticut, once a drug comes off patent, one manufacturer's generic version is given exclusivity for approximately six months. Right off the bat, there is an opportunity for impropriety. I have no idea what procedure is used to determine which manufacturer is chosen by the FDA for that six month period nor, at this moment, will I attempt to figure that out.

Here's the skinny. The exact same amount of the active ingredient must be in the generic version. However, just because the same amount is used, the concentration of the drug in the blood may not be the same. It's chemistry. Like I said in a prior post. So, the next time someone tells you "they use the exact same amount," you can raise the ante and explain the real issue.

The same exact amount in a generic version with different fillers, is allowed to have a 10% margin of error. Technically, it's the concentration of the active ingredient in the blood. It can swing 10% higher or lower and as long as it's within that 20% range, the FDA deems the generic will produce the same results as the brand.

Since there are never head to head tests in people, this presumption takes nothing else into account. Is the medication effective with 10% less in the blood? Is it dangerous if it's 10% higher? What about those pesky side effects? Do they matter?? Well, the answer to all of those questions is along the lines of who cares, who cares, who cares and who cares. As long as the blood concentration passes muster, it's all good.

Bearing in mind that there are about a gazillion generics ingested daily and for the most part, they work, I'm being a bit hypersensitive but here's the thing. As I shared, I already had an issue with a generic. And here's the other thing, when I learned my aromatase inhibitor would no longer be dispensed as written by my doctor, yes, I got upset.

For eight and one half years of a scheduled ten year regimen, I have been on branded medication. Taking this little gold pill is more important than the chemotherapy. That some pharmacy benefit manager (PBM) pulled the medication off the formulary entirely and, to go a step further, dictates whose generic will be dispensed based upon where the PBM can get the best deal, pisses me off. So much for patient centricity. This is top down economics and let the ingester beware. Ingester isn't a word but it sounded better, so I decided I'd presume it's a word because, well, it's a form of the word ingest so it must be okay.

That's the background. I began taking the generic version of femara well over a month ago. I sent a few tweets out about my #GenericSwitch. I bitched a bit on Facebook. I was experiencing side effects that were more than annoyances. The biggest one, I suppose, was this issue with my balance. I've had balance issues but they got noticeably worse. I was bothered by the fact that the generic pills have a noticeable odor that did not dissipate.

On January 25th, I posted all of this on Facebook. Twenty four hours later, I found myself on the ground. I was climbing the stairs. They were immaculate despite the blizzard. Not even a trace of sand or salt anywhere that could have caused a bit of slide. Down I went, landing squarely on the outside of my right pinky. I went indoors to finish my errand, trying to shake the pain away, rubbing the scraped skin. Within two hours, I realized it was continuing to swell, the pain was getting really bad, the ice wasn't doing a damn thing, ditto the advil. I dragged my battered hand to the nearest urgent care center.

Upon exiting, I looked like this:

And yes, it was beyond twisted to have The Pinky in Pink-neon pink at that..... all sorts of dark (not haha) humor. It was a reminder of the g'damn loss of balance caused by a pill I take to help keep my pink ribbon cancer in check. It was all quite bizarre.

The following day, things got very interesting. The diagnosis from urgent care was a possibly pinky fracture and a very bad sprain on the ring finger. Or in medical speak, digits four and five were basically f*ked. Recommendation? Follow up with an orthopedic.

Now I am in full blown panic mode. I CAN'T get to an orthopedic without a referral from my primary care doctor. And, I haven't yet seen, or even met my new PCP. In other words, I needed to actually visit the PCP in order to get the referral. I called the nurse hotline hoping to be told I didn't need to waste the doctor's time and have them pay for an unnecessary visit. I slept like shit. The throbbing and an angst was a lousy combination.

The following day, the fun begins. I'm in pain, I'm frustrated and although I understand the concept of this gatekeeper nonsense for plenty of other ailments, a fractured bone? Not so much. A little common sense might have been good but Oxford wasn't having it. Too bad there is an x-ray from an in network urgent care facility from the prior evening at 7PM. Too bad, the urgent care doctor said, "Orthopedic, stat." Add the blizzard into the mix and the fact that many side roads were still not plowed, anxiety through the roof and the whole PCP thing was now pissing me off as much as the g'damn generic medication upon which I lay the blame for that hot (pink) mess.

By some stroke of luck, lots of phone calls and emails and a ton of help from my rockstar insurance broker, I was in the offices of both an accomplished hand surgeon and my PCP before the day was over. The surgeon confirmed the break. Upon seeing the broken bone on the screen, I started crying. For no apparent reason. I never broke a bone in my life. Never. Ever. As for the PCP, let's just say, I'm in love.

He asked what happened. Got very concerned when I said "balance." He had that, "You need a brain MRI" look on his face and he just met me. I explained the medication debacle and the forced #GenericSwitch and now he started to get all amp'd up. Suddenly, he was writing furiously. Listening, writing, asking for clarification and low and behold, my new PCP is well versed in medication issues. He began speaking to me, teaching me, telling me to understand pharmacodynamics and pharmacokinetics. "Look it up, learn and I am going to document everything. You fell. It's your pinky, but suppose you fell and hit your head." I told him I understood how anecdotal findings have no place in evidence based care and he cut me off. I think this is when I fell in love. "No, they don't. But if there are enough of the same anecdotal findings, we have the basis for a research study." Thus, I stand fully corrected on the issue of how I feel about being forced to see a PCP. Apparently, I lucked into a doctor who truly understands patient-centered care and is my partner in care.

The orthopedic rewrapped my fingers in splints where they will remain for six weeks. Digit four can be freed as soon as the swelling goes down. It's almost a week and it still hurts as much as it did when I fell. It's still swollen and my yoga instructor who happens to be a PT explained why I better not mess with that sprain. Something about the tendons. At least the wrap suits me. I prefer to be The Lady in Red in case you haven't figure that out from the appearance of this blog......

And finally, on Saturday, my branded pills arrived. I invite, no I dare, someone to come and arrest me for my act of civil disobedience. I asked my doctor for a written prescription. I had every intention of hunting down the authorized generic identical medication, the one that is being manufactured using the Novartis formula. I had every intention of calling every pharmacy I could until I realized, the generic identical is being manufactured by a company that is not on the list of FDA approved generics. Seriously??

Plan B engaged. I found the Campaign for Personal Prescription Importation, located a legitimate Canadian pharmacy where I had the option of branded medication that was manufactured in Canada or I could have them locate the Novartis facility where they could obtain the best possible price. I went for price. I'm trusting that Novartis does quality control at every manufacturing site they use. And thus, a site for sore eyes and yesterday morning, the letrozole bottle with its odor was tossed in the back of the drawer and I tore through a blister pack to fill my pill case. No smell, the color is right, the pill is identical. The language on the packaging and the insert? Couldn't even hazard a guess who speaks that language. I managed to locate where the box originated and I can tell you, I'd love to vacation there.

For now, happiness looks like this. A big mess. And my pills. Just slightly higher than my co-pay for the highest tier drug. I believe my tier three drugs are $80.00. This illegal import of meds cost $103.00 including the shipping. I have a 90 day supply. Of branded femara. I could have paid about $725.00 for a 30 day supply at my local pharmacy. Or, I could have paid the same amount, about $725.00, for a 90 day supply from a Canadian manufacturer.

They will refill it with plenty of time to get the meds from wherever in the world Canadian King can locate the best deal on a Novartis product. And there will be no more #GenericSwitch.



There's the proof for all to see. Laws were broken. Come and handcuff me. All I'd ask? The arresting officers kindly use care when slapping the cuffs on- there is, after all, a fractured finger, a severe sprain and a bruised wrist.



And if you happen to be my one phone call, please bail me out as quickly as possible so I can raise holy hell. I'm pretty sure I can get the folks at CPPI to help.



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Monday, December 28, 2015

"I AM THEM" : A FALLEN ADVOCATE

I am choosing to bear witness. I am choosing to support a friend in need. I am choosing to share the needs of someone who has touched my life in such a profound way, I can't find the words to describe the depth of what I feel. I'm choosing to share Erin's story here and in doing so, I hope, if you have the means to help in any small way, you will consider doing so. A page has been set up on generosity.com. Perhaps you can assist navigating the programs available in Denver where she is presently living by simply providing information.

Technically, Erin is homeless. But for the grace of friends, she would be living in her car. In Denver. In the winter. She has attempted to end her life twice since November. In this season of good will and love and light, there are those among us whose very basic needs are not being met.

I met Erin at a meeting of a group of about 30 advocates and activists brought together from all different disease backgrounds.  We were discussing patient centered care. She brings a wealth of knowledge and perspective from so many angles. Her view is truly from every angle and until now, a big piece of what she lives with has not been discussed.

Erin is dealing with so much as you will see if you click over to the links in the text of this post. It is only most recently, that she made a decision to share the darkest side of her story. It was after her attempt to end her life on November 5 that she made a choice to share what she lives with on a daily basis. Borderline personality disorder is a particularly insidious mental illness and it's one many medical professionals state they are told when entering their chosen field, "Stay away from the borderlines.... they are impossible to treat."

I'm not okay with that. I'm not okay with writing off an entire population and I refuse to accept the words "impossible to treat." I have watched Brandon Marshall share his struggles with the very same illness. I understand someone of Brandon's stature within the NFL make things a bit more accessible to him than to those living with far less, but the basic needs of shelter, food and needles to administer her insulin which are essential for a Type 1 diabetic? No, I can't accept any of this. I hurt for Erin.

When I first met Erin at that meeting, she introduced herself to the group as the microphone made its way around each table. After listing the myriad of things she endures on a daily basis, she concluded her introduction by saying, to a room filled with complete strangers, "I almost didn't make it here because of a suicide attempt." I am sure my gasp was audible and I am thankful that there was one person who would have to do their introduction before the microphone would be handed to me. We were shoulder to shoulder at adjacent tables. I think I may have started my introduction by acknowledging my own gratitude that I had a moment to collect myself before having to speak.

Erin is a MedX scholar and months ago, she was very upset about not being able to get to Stanford for this year's conference. At the 2014 MedX conference, this video was presented. It was a letter she wrote to MedX organizers about disparities that prompted the invitation for her to do the presentation. It was a surgery that stopped her from being there in person. The video is powerful just like everything that Erin writes.

In her own voice, Erin speaks about disparities in her "nice white girl clothes."

 

When interviewed about her participation as a MedX scholar in 2013, Erin speaks about how she wishes to help others.



What none of us could know from her words at that time? While she was sharing her gifts with the world, she was hiding something and that something is an enormous burden. Erin lives with a mental illness.

Erin blogs at Health As a Human Right. If you want to see what has been happening with Erin since 2013 when she spoke so beautifully about giving back to others, I'd suggest you start with her November 3 post, Bearing Witness. Continue reading each subsequent post.

From Suffering to Suffering, Erin shares that she had just attempted to end her life.  She also "outs" herself publicly for the first time, in stark black and white. She had alluded to, but for the most part, chose to hide her mental health history. Fearful, I suppose, it would derail any career goals because we all know how those who admit to mental illness are stigmatized.

Erin raises points in Coping Skills that only one who has tasted those feelings could possible put on paper, including the need for coping skills to deal with her lack of coping skills. When people state, But You Have Your Law Degree, she is quick to share that there is no degree for getting through the system, only grit and determination. Erin has an abundance of both but she is being tested sorely right now. Today. In this very moment.

What Erin shares in Laundry will be triggering to anyone with thoughts of suicide. It's incumbent upon me as an advocate for all to include that trigger warning. There was one suicide attempt that was nearly fatal. It is briefly described. When she writes about doing All The Right Things, we glimpse into Erin's deepest thoughts and her feeling that maybe she didn't do enough of the right things, or maybe, just maybe, there aren't any answers.

Erin then attempted suicide for the second time just days before Christmas. She knew what was next and she wrote all about The Truth About Psych Wards. Readers of this blog may recall an episode where I was with a friend in a psych ward and Erin is spot on accurate. There is no treatment in a psych ward. Stabilize and release.

As of this writing Erin's most recent post, You Should Write A Book, captures the essence and beauty of the person I see when I speak to Erin or exchange an email or text message. She is not ready to write a book and she likely won't ever do so. She will simply offer her words as a record of what she has lived in the hopes it might resonate with another. In an hour of true personal need, she is still more concerned about advocating for all.

I'm concerned about Erin. I've watched this in real time, helpless from my warm home in New York while Erin was sleeping in a car, terrified when she was radio silent for a 12 hour stretch and today, I ask, especially for those in the advocacy community to help pick up a fellow advocate.

On any given day, this could be any one of us. "Life turns on a dime, Annie." One of my dad's quips. Today, I ask for your help in flipping the dime that is Erin's life in this moment so she can find her way back to the important things she does so selflessly for so many others. I have high hopes for Erin. Her intelligence, her ability to communicate and the fact that she has chosen to expose her deepest vulnerabilities.... putting the potential to better others above her own comfort, this is advocacy at its very very best.

And this advocate has fallen. We can not leave her lying there.



Note: If you clicked away in the middle of reading, I'd like to suggest you go back at your leisure and read this post from start to finish without clicking away. Read it in order. Listen to the videos as they pop up. Then go read everything else.

On a personal note, this will likely be the last post for 2015. I wish each and every one of you a wonderful start to 2016. I have lofty goals (no resolutions!) and I hope you will be by my side as I do my best to help when I can, to change what I can, to yell when I must.

With love,

AnneMarie


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Monday, December 21, 2015

CLINICAL TRIALS, THE LONG VERSION

In March, I wrote a post about the importance of clinical trials. It was my hope to get the word out to as many people as possible. Before starting any course of treatment, before one single thing takes place, ask the question. Whether diagnosed for the first time or because there has been a recurrence, despite that oxygen sucking news, put on your mask and breathe deeply. Remember to ask these words:

How can I find out about ongoing clinical trials that may still need patients?

If the response is nonchalant or if you have a sense that you are being dismissed, do your own homework before determining how you will proceed. Check the online forums. Use social media. Ask in Facebook groups. Send a tweet. Ask a friend. Ask me.

Why? That's a great question and if I am to be truly honest with myself, if I am to put myself back in time and parse out my feelings and the commotion that was my life between April of 2006 and September of 2006, I likely would have bitten off the head of anyone who even hinted that I might want to look at clinical trials.

This is where the experience of those who have walked the path comes into the picture. This is where it's up to us as friends and/or advocates to see if we can find the right moment, when someone is newly diagnosed, to suggest they take a look at what might be available.

Some instances are easier than others although, sadly, it seems the worst case scenarios are those where the suggestion can and does fly right off my tongue. "My (insert relative) was just diagnosed with lung cancer and it sounds really bad. I told her I'd ask if you could give her the names of people...." Yes, that really did happen and yes, my response was immediate. "If I were in this circumstance, I would be looking for a clinical trial before anyone touched me." I went on to explain how trials must adhere to the strictest standards and starting another treatment may exclude your (insert relative) from eligibility.

To take a step back a second and jump on a soapbox, this is one area I do believe advocates at the table during trial design might make a difference. I made a difference but it was well post treatment and when I shared my experience here, I didn't fully understand the manner in which trials are designed. We may have suggestions that could be incorporated into the inclusion criteria and the endpoints that may make for a more meaningful trial. Or not..... but if we aren't included, much more widely than we are now, how will we ever know?

Now, to take a step forward and back into this discussion, what about the early stage patients? They are the ones often faced with many decisions and too much time in between tests and appointments. The perfect recipe for the internet pine box. I know most everyone diagnosed with early stage disease did what I did. Pretty much every day, there came a point where I thought, "I'll take a stroll down the What If Path for the millionth time," asking the same questions with little new information to help formulate my decisions.

It is during this time that clinical trial options can be explored. I can share right off the top of my head two things I would have done. I would have sought out trials to have a cognitive evaluation done before anything else was done to my body after my diagnosis. Again, taking the truth serum, I'm absolutely certain it would have taken some pretty persuasive language to get me to slide into a functional MRI but I do know there were trials going on back then. I know that today. No one even hinted at this in 2006. And I didn't know better, so I didn't ask.

Today, I would love definitive proof that my brain looked differently before eight sessions in an operating room under anesthesia, eight rounds of mild chemotherapy wherein I never lost my hair but I did seem to lose my brain, and eight years and counting on a drug to suppress estrogen. It would have saved countless fights with people and certainly put to rest those who persist in saying, "I didn't have chemo/cancer, what's my excuse?" They mean well. I generally laugh but then, I finally found a way of explaining the difference because yes, there is a difference between chemo brain and getting old brain or too much on your mind brain.

And by the way, what's up with those eights??? I suppose I could find one of those Magic Eight Ball things and see if it has the answer but the answers to everything medical, to everything that will advance the science of understanding and the ways to better and more effective treatments aren't in that Eight Ball, they are in the hands of the researchers. And the researchers can't conduct research without a target patient population. And so, we should be asking the question because the response might be, "Yes, there's an app for that." A research trial app(lication), followed by consent forms and a possibility to help yourself, to help others, to advance the science and develop more effective evidence based practices. Take a bow. That's damn impressive in my book.

At the San Antonio Breast Cancer symposium in 2013, findings were presented for a trial I would absolutely have joined. Truthfully, I would have jumped all over it, quite possibly without even fighting. Or blinking an eye. One of my very first questions was about tamoxifen or an aromatase inhibitor. I knew the benefits and risks of each drug but frankly, although I was pre-menopausal at diagnosis, the chemotherapy pretty much put that over the edge and then, the removal of my ovaries solidified my place in menopause. I knew I preferred the risks of the aromatase inhibitor over the tamoxifen. I did have somewhat of a choice.

At that time, in May of 2007, there were open trials where women taking an AI were given the opportunity to have treatment for bone loss using bisphosphonates, specifically, zoledronic acid infusions. During the appointment for my routine mammography that began my journey into cancer land, I had my very first bone density exam. I was already diagnosed with osteopenia. It would make perfect sense for me to do something to keep my bone strong.

Again, who even knew to ask about any sort of treatment and yet, I could have been lucky enough to be part of a clinical trial to study the use of bisphosphonates administered to early stage patients on an aromatase inhibitor. And yes, a quick search of clinicaltrials.gov confirms that there was indeed an open trial, recruiting at several locations including one that was close enough for me to participate.

My doctor didn't suggest this this and I was still on that steep learning curve. I so clearly recall telling my oncologist, "I'll deal with a broken bone over a recurrence," as he was writing the prescription for my femara. The thought of looking for a clinical trial wasn't even in my vocabulary. And yet, there it was. And I was eligible. And because I wasn't a savvy patient, and I had no one to suggest looking at trials, I missed an opportunity.

Two years ago, findings were presented at San Antonio regarding an unexpected benefit of bisphosphonate treatment. It seemed to help prevent bone metastasis in a particular sub-set of patients. I decided it was time to address my osteopenia. I asked a few oncologists their feelings and given the fact that the osteopenia was worsening with every bone density test, there was a medical reason for me to seek treatment. In the scheme of things, it wasn't a broken bone that concerned me, but any edge to prevent a bone metastasis? I'm there. I wish I knew about that trial.

Instead of getting the treatment, I had a brawl with my oncologist's office, first. Then, I got the zoledronic acid infusion, and then I learned there were other studies that should have been shared with me to avoid a three week fever. In April, at my annual follow up, it was determined that I would be given denosumab for my second treatment. That fever made me a failure. I failed on the first medication so I was eligible for denosumab.

(Yes, I would like you to re-read that last thought because it's highly insulting to patients to say we failed on a drug. Did we fail, or is it more appropriate to say the drug failed the patient? A different post for another day. Along with this step therapy nonsense and the inability for a doctor to choose the right treatment for the right patient. Somehow, pharmacy benefit managers get to make those decisions and THAT is a rant that is recent and ongoing.)

Fast forward to San Antonio 2015. A few weeks ago, findings were presented for a trial I would absolutely have joined. Truthfully, I would have jumped all over it. I've always wanted to go to Vienna and this would have given me reason to travel to Austria. I suppose I'd have a bit of an issue here since I would have actually had to choose between the two trials. I couldn't absolutely have joined each of them. Although, I wonder if there was better communication if one or the other trial might have considered adding a third arm to compare bisphosphonates, denosumab or nothing.

Jokes aside,  Dr. Michael Gnant explains the trial in these three videos. I've provided the quick version, the mid version and the hard core science version. It's been written up in the AACR SABCS news release, MedPage Today (complete with video) and Medscape and I'm sure in many other places, too.

The trial was to determine the effectiveness in using denosumab to prevent fractures in patients on aromatase inhibitors. The results are so impressive they will be "unblinding" the trial.

This is important for those who resist clinical trial participation because they are hung up on the idea of "not getting the real drug." Here's why. The results were so remarkable, the effects were so beneficial, it was felt to be unethical NOT to unblind the trial. So there you have it. If you are on the placebo of the next big thing, chances are it will become obvious something is happening and you won't be on a placebo for long after the realization is made. In this case, patients will choose if they wish to be unblinded, they will learn if they were on the placebo and if so, they will be treated with the real drug. Me? I will be fighting with my health insurance company in April for my next treatment.  Clinical Trial: WINNER! AnneMarie/Health Insurer: Fight.

And then, there's the secondary benefit in post-menopausal women. Again, it would seem there is a benefit in disease free survival. Overall survival will take longer to determine and I'm sure the women will be followed. In the video, Dr. Gnant notes that bone treatment is more effective than aromatase inhibitors, tamoxifen or chemotherapy at preventing recurrence.

Looking at everything and drilling it down to get back to what's most important: Clinical trial participation, here's the thing. There are desperation, out of options, Hail Mary pass trials and there are trials to address quality of life or prevention of new cancers. However, in between the two, exist thousands and thousands of trials. We shouldn't be looking at clinical trials as the place to go when all else has failed. Nor should we be looking at trials after the damage from primary treatment has already become something that may be adversely impacting our daily lives. We should be looking into that vast space in between. That's where the advances are happening, that's where the exciting findings are being made, that's where the future of precision medicine lies.

Step up, check them out and if you are eligible, get serious about joining.

And now, let's go to the tale of the (video) tapes....








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