Is Methotrexate Underutilized?

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Methotrexate (MTX) is an accepted first-line drug for patients diagnosed with RA. Oral MTX was what my rheumatologist started me on after my diagnosis. For various reasons, the main one being I hated the side effects and I refused to take it, I was soon switched to my first biologic. However, researchers are now asking if this well-known and affordable drug is being used to its full potential.

Read the rest of this article here: https://rheumatoidarthritis.net/living/methotrexate-under-utilized/

 

Blueberries (??!!)

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There are people that I know and respect that tell me that diet affects their RA symptoms. Most frequently they avoid eating certain things that seem to worsen their RA symptoms or can even cause a flare.

I’m not one of those people. I’ve never been able to come to a cause-and-effect of what I eat and how my RA reacts. That doesn’t mean that I haven’t tried. With the close link between our digestive and our immune systems, this seems to be a logical approach. I’ve removed things like gluten and sugar and alcohol. I’ve added things like turmeric and tart cherry juice and have even tried gin-soaked raisins (mainly because I like gin and I like raisins). But I haven’t been able to see a discernible difference.

Turns out, I’m not alone. A recent survey published by Arthritis Care & Research (published by the American College of Rheumatology) and reported in MedPage Today, indicates that about 76 percent of us also report no connection – either improvement or worsening of symptoms.

But that means that 24 percent of us do!

Read the rest of the article here: https://rheumatoidarthritis.net/living/blueberries/

Pneumonia Vaccine May Not Protect RA Patients

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Like many RA patients, I take certain drugs that suppress my immune system and therefore make me more vulnerable to infections. To help counteract that risk, I’m careful about washing my hands, staying away from sick people, and getting my flu shot every year. My first pneumonia vaccination was given at my rheumatologist’s office as a condition to starting a biologic.

It was, therefore, somewhat alarming to read a recent study wherein the pneumonia vaccine wasn’t any more effective than the placebo in protecting RA patients from contracting pneumonia. In fact, there were actually two more vaccinated patients that got pneumonia than those who got the placebo. This is even more serious when you consider that pneumonia ranks fairly high in the cause of death of those of us who have RA. Considering that the researchers started out with the hypothesis that the vaccine was effective in preventing pneumonia in RA patients, I’m sure the outcome of the study was quite startling to them as well.

Read the rest of the post at RheumatoidArthritis.net: https://rheumatoidarthritis.net/living/pneumonia-vaccine/

Money and Medicine — Is Transparency the Answer?

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One of the greatest shocks that a patient has after being diagnosed with RA (which is the first shock) is how expensive treatment is. Besides doctors’ visits and labs and physical therapy and tests like X-rays, there is the cost of medication. Many patients are started on methotrexate and perhaps another DMARD which can be inexpensive to moderately priced. However at the point that the patient “graduates” to biologic medications, and many of us do, the costs really escalate. A recent study I read reported that approximately 87% of all patients were switched to a biologic as the next treatment step after oral methotrexate (as opposed to injected methotrexate or other DMARDs).

There are two ways of looking at prescription sales. The first is the physical number of prescriptions that are filled. Depending on the list you find, generic Lipitor (a cholesterol drug) is at or near the top. Interestingly in this day of opioid crisis, the hydrocodone/acetaminophen pain killer also makes the top 10 list. There are no RA-related drugs on the list. The closest I’ve found is prednisone, which is used for all kinds of things, not just RA. It comes in at number 19.

The second way to look at prescription sales is by the dollar amount. That is, even though the actual number of prescriptions is not as great as the first list, the cost of the drug propels it on to this list. Again, it depends on the list and when it was produced, but you’ll likely find not one, but four, biologics used for treating RA: Humira, Enbrel, Remicade and Rituxan. That’s 40% of the top-10 drugs by sales.

It’s hard to miss headlines that raise concerns about price-gouging by pharmaceutical companies. Turing Pharmaceuticals CEO who raised an HIV/AIDs drug from $13.50 to $750 overnight and the increase of Epipen prices to $500 are two that come immediately to mind.

But why is that? I’ve been around a lot of different industries and I’m here to testify that inflated pricing occurs all over the place. We don’t see headlines or Congressional investigations when fancy new smart phones or even basics like housing are overpriced.

It’s because, right or wrong, we hold pharmaceutical companies to a higher standard. We tend to think that it’s wrong to make a profit from people who are ill.

I agree completely that any product that affects people’s health or safety should be held to a higher standard than those that don’t. That’s why we have agencies like the FDA – to help ensure that medications do what they are intended to do and do so at minimal risk to the patient.

But should pharmaceutical companies be held to a different standard than any other company that produces commercial products? Like other companies, pharmaceutical companies have a wide range of stakeholders. Many are public companies and therefore have shareholders that have a right to expect a return on their investment. They need financial resources to attract scientific talent. They must fund new drug development. The last figure I saw, which is a few years old now, estimated that it takes $5 billion (with a “b”) to bring a new drug to market. And the drugs that do pass all the reviews and regulatory hurdles must bear the burden of paying for the research and development of drugs that didn’t make it.

So why do we think it’s such a bad idea to let pharmaceutical companies – who hold the keys to our future health – make a profit? I personally feel that all companies (not products) should be treated under the same standards. In case you missed it, the point is any company that engages in unethical behavior should face sanctions regardless of what kind of company they are. But I also believe that all companies must make a reasonable profit to thrive.

I would have loved to have been at the American Medical Association’s National Advocacy Conference this week. There was a debate about prescription drug costs between Kirsten Axelsen, VP of Global Policy for Pfizer, Inc. and Aaron Kesselheim, MD, JD, MPH who is an associate professor of medicine at Harvard Medical School and a noted policy scholar. I won’t recount the debate here, but there were some incredibly interesting and introspective points made on both sides of the argument. A report of the debate by MedPage Today can be accessed here and is well worth exploring: http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/63550?xid=nl_mpt_DHE_2017-03-03&eun=g999342d0r&pos=2

The other interesting thing that happened along these lines this week was that Janssen released its U.S. Transparency Report. (The website, the full report, and an executive summary can be accessed here: http://www.janssen.com/us/us-pharmaceutical-transparency-report)  Janssen’s parent company is Johnson & Johnson and I’ve been a fan ever since the 1982 Tylenol recall which still stands as the gold standard of public concern, crisis management, and transparency. For those of you are unfamiliar with this event, before tamper-resistant packaging, a few bottles of Tylenol were poisoned. Even though it appeared to be an isolated incident in Chicago, J&J recalled all the Tylenol capsules across the US and took steps to ensure a safe supply of the drug. It cost them millions.

Janssen’s is actually the first such transparency report I’ve seen. (That doesn’t mean that there aren’t any – just that I haven’t seen them.) Public pharmaceutical companies already face a huge amount of disclosure requirements from the Securities and Exchange Commission (SEC) and other regulatory agencies. This additional transparency reporting adds yet another layer of information to what is already available. While the full report should (IMHO) be packaged and sold as a cure for insomnia, the website as well as the executive summary is actually pretty approachable by most humans, and I applaud Janssen for that.

But is more transparency the answer?

I have done a lot of work with public companies over the course of my career. These companies (as noted above) must file all kinds of disclosure documents with the SEC to help ensure transparency for the investing public. In 2000, the SEC implemented the Regulation Fair Disclosure (Reg FD) and in 2002 Congress passed the Sarbanes-Oxley Act (SOX).  The amount of effort and associated cost for companies to comply with these regulations was enormous.

What was the effect? While it’s definitely a mixed bag of results, on the downside, it definitely dampened the market. The burden of complying with RegFD and SOX caused some companies to stop being a publicly traded company while other companies cancelled their public offerings. While the regulations were put in place, in part, to help the individual investor, they probably helped them the least. I heard one securities lawyer quip that the RegFD and SOX filings were the only documents that got read more often before they were published than after. What he meant was that they were read more by the lawyers and accountants who were paid to produce them than read by the investors they were intended to help.

I think Pfizer’s Kirsten Axelsen makes this point very well in the debate stating that additional pharmaceutical company transparency laws, like the one recently passed by New Hampshire, won’t lower medical costs. Based on previous experience with similar SEC regulations, I would suggest that it would, in fact raise those prices. Sure you want transparency, but do you want enough to pay another $5 or $50 or $500 per prescription?

As a patient, even a nerd who actually reads the full version of transparency reports, I don’t necessarily care about more transparency. What I care about is affordable medication for those people who need it. And yes, I also want pharmaceutical companies to make a reasonable profit so they can continue to hire smart people and make new drugs.

Unfortunately, there is more to the patient’s cost of medication than just drug pricing. There are a lot of factors involved, but let’s be honest that much of a patient’s actual cost is determined by insurance coverage. I take a biologic that has a list price of more than $15,000 per infusion. Right now, because I have good insurance, I pay a $50 copay. If I hit my deductible and out-of-pocket limits, it won’t cost me anything. There are many, many people in this country that are not as fortunate as I am. They cannot afford their medications. They cannot afford to treat the diseases that may be killing them.

I’m not going to debate the Affordable Care Act (also known as Obama Care). It will no doubt be repealed in the near future anyway. The bad news is that no one seems to know what will replace it, so no one really knows whether they will be able to afford medical care (including medications) going forward. This type of uncertainty is far more damaging for patients than any lack of transparency.

A patient’s cost of care is many things. But as I heard from a friend just today, “… it’s policy, not politics.” It’s not in adding transparency requirements, it’s not in throttling the marketplace, it’s not  applying a separate set of ethical standards to one type of company and not others. It’s making responsible policy decisions that create the environment in which all of us have access to reasonably priced health care.

Knees and Needles

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I am a well-scarred veteran of the knee wars. Even before my total knee replacement on the left side, I’d had multiple arthroscopic procedures and numerous office visits to address knee pain. It’s really not surprising. Knees can be damaged both by osteoarthritis as well as rheumatoid arthritis, so even if you don’t develop inflammatory arthritis, simple wear and tear over the years will take its toll on your knees. Even everyday activities can cause strain and sprains on these weight-bearing joints.

Well before surgery is even contemplated, doctors have a number of therapies available to them including physical therapy, bracing, RICE (rest, ice, compression, elevation) and similar manual techniques. There are also three frontline weapons in the physician’s arsenal involving needles. I am living proof that all three of these can provide welcome relief.

Read the rest of the post on RheumatoidArthritis.net here: https://rheumatoidarthritis.net/living/knees-and-needles/

Feels so Good, Hurts so Bad

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After more than eight years of being diagnosed with RA I truly understand that it can be weird and unpredictable. That being said, I’m in this strange place of feeling really, really good but I have joints that hurt really, really bad.

Last December I changed treatment plans yet again. I started Simponi Aria and have continued with my methotrexate injections. Simponi Aria is the infused form of the Simponi injections which I had been on before. Simponi Aria starts with a loading dose, has a second loading dose four weeks later, then continues on with regular infusions every eight weeks. I had my first loading dose in December with the second one in January, then had my regular rheumy follow-up in mid-January, shortly after the second dose.

I had felt lousy for some time. My previous treatment plan had failed then I was without any medication except MTX and a low-dose prednisone for a month waiting for insurance approvals before I started treatment. And we all know that it can take months before a treatment starts to work.

At my rheumy appointment, it was too early for the Simponi Aria to have “kicked in”, and I was so discouraged at feeling bad for such a long time, my rheumatologist suggested a steroid shot, which we did. I had been having issues with my on-again/off-again hip bursitis anyway, so we did the injection at that site.

A week or so later I realized that I was feeling better. Not great, but better. I initially put it down to the steroid shot. By then I had started trying to walk most days which I have not only been doing, but gradually adding distance to my walks. Now I walk a very respectable distance at least five days a week. Although my ankles, knees and hips get sore from the exercise, I haven’t flared from all this additional stress on my body. And as time has gone on, I’ve continued to feel better — either from the exercise or the treatment plan or both.

Beyond that (hallelujah!) the fatigue is gone. That bone-deep, unrelenting, energy-draining, spirit-killing fatigue has lifted. I now feel good when I wake up in the morning. I have energy. I want to do things.

I honestly don’t remember feeling this good all over since before my diagnosis.

On the other hand (literally), I have been having specific joint pain that would have previously sent me running to my rheumatologist’s office. Since I am feeling so good otherwise, I haven’t scheduled an appointment. However, the joints in my hands have been increasingly swollen and tender, often with sudden shooting pains that take me by surprise. I use Voltaren gel like hand lotion and I’ve quit doing things that require a lot of hand work — like extended cooking sessions.

So how can I feel so good all over but have such pain and obvious RA symptoms in my hands?

Honestly, I don’t know.

I do know that RA is a complex disease and that there are different kinds of inflammatory elements that can come into play. Simponi Aria is a TNF-blocker that interferes with that specific inflammatory response in my body. Other types of drugs work by interfering with other elements such as interleukins or Janus kinease (JAK) responses. Just because Simponi Aria is apparently calming my TNF response doesn’t mean that the other inflammatory agents also play dead. It’s possible that I feel good all over because my primary issue is TNF response and it’s coming under control, whereas interleukins or JAKs continue to be evident in my hands and (occasionally) other joints. It’s just a theory I have and, as far as I know, there is no scientific data to support it, but it seems to support what’s going on.

What I do know is to count my blessings. Right now I’m feeling good, optimistic, energetic, inspired. I haven’t had that in a very long time.

I hope you have many blessings to count in your life as well. Thanks for checking in.

We have to do better

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One of the blogs I follow is healthskills.wordpress.com. It’s written by a woman in New Zealand who originally trained as an occupational therapist but who has since achieved her masters in psychology followed by her Ph.D. The blog’s audience is health care providers but I find the posts approachable as well as being quite thoughtful and insightful, especially when they enter into areas of why things are done or why they happen and the effects not only on the patient but the therapist.

A recent article discusses the question, “What is Pain For?”. It turns out the answer isn’t quite as straightforward as you might think and has a lot to do with both being aware of and defining one’s self. I was especially struck by a quote in the post, as follows:

Our sense of self also disappears when we experience pain we can’t escape and we can’t make sense of. Throughout the time while people are trying to label their pain, establish the meaning of their symptoms, and while people are searching for a solution to their pain, people’s experience of both time and “who I am” is threatened (Hellstrom, 2001).

My husband always knows when I’m not feeling well — not because I tell him — but because I get quiet. I stop interacting. I lose interest in doing things I usually enjoy. I stop being the person he knows me usually to be.

I know this is true of a lot of people. When they hurt, they get quiet or grouchy. They don’t want people around. All they can really focus on is trying to be as comfortable as they can and perhaps find a way around or through what’s causing the pain.

Which now brings me to my rant. (You’ve been warned …)

When we deny deserving people appropriate pain relief, we are denying them their right to be themselves. We have denied them their ability to express themselves as their true individual selves. All we have left them with is their ability to respond to their pain.

I don’t use opioid pain relievers on any kind of regular basis (primarily for post-surgical pain), but I am touched by the lives of many people who do. They use them responsibly, and often as a last resort, to manage the chronic and debilitating pain that comes with long-term illness. These drugs are essential to their ability to function as humans and, as it turns out, the ability to define who they are as people.

I understand, but at times can’t fathom, the current opioid crisis that we’re in. However, the current climate of overreaction to the point of denying people the ability to control their pain is not the answer.

We have to do better.

**Note that these views are my own and do not reflect any views expressed by the author of HealthSkills.wordpress.com.

Lilly/Incite’s New JAK Inhibitor, Barincitinib, Shows Promise

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This week I got two exciting bits of news about barincitinib — a new JAK inhibitor developed by ELI Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY). This is a new medication for the treatment of moderate-to-severe rheumatoid arthritis.

The first was that the drug, with the brand name Olumiant, has been approved to treat RA in the European Union — either by itself or in conjunction with methotrexate. This is a major accomplishment in that it’s the first JAK inhibitor approved in the EU. (Full news release here.)

The second is that the drug, which is in late-stage regulatory review in the US and Japan, has shown significant patient improvement of both ACR50 and ACR70 scores starting at week 12 through week 52 as compared to the baseline treatment of adalimumab (Humira). The latest data was published in the New England Journal of Medicine and the news release can be found here.

There are several reasons why I’m excited about this news, probably the most important is that it demonstrates an impressive investment into the research and development of new treatments for RA. As I, personally, am about to run out of treatment options, this gives me hope for the future. And the drug is a once-daily oral medication — not an injection or an infusion, which will make it more approachable for many RA patients.

The first JAK inhibitor marketed in the US, Pfizer’s Xeljanz, was approved in 2012 and subsequently expanded to include Xeljanz XR. The emergence of the second drug in this class broadens the field of treatment options for RA patients and is good news for all of us with inflammatory diseases.

I hope whatever treatment plan you’re on is working well. Thanks for checking in.

Fall down, go boom (don’t repeat)

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I guess the really good news is that although it’s close to four schools ranging from elementary to high school, the area where I was walking has light traffic so I don’t have to worry about hysterically funny videos of me proliferating the Internet. In fact it was several minutes before anyone noticed me lying face down on the sidewalk. Eventually a landscape worker a few houses away saw me. By that time, I had righted myself enough to where I could sit on the curb and waved to let him know I was okay.

It happened at the 1.5 mile marker of my two-mile walk. I had posted earlier that I have been walking on a regular basis and gradually increasing how many steps I have been getting during the day. This week I hit the two-mile mark for the first time and was going for a repeat performance.

It was one of those stupid things that just happen. My foot caught an uneven piece of sidewalk and before I could catch myself, I pitched headlong onto the concrete. I took the brunt of the fall on my right side, landing hard on my hand, shoulder, hip and knee, twisting my ankle in the process and knocking off my sunglasses.

Probably what saved me from further damage was the cooler weather. After several days of spring temperatures, the weather had turned cool enough that I put on a jacket and gloves. When I hit the sidewalk, it scraped off a two-inch round patch of leather off the palm of my glove. This would have been skin without the glove. My jacket avoided much damage but I believe added some padding that helped cushion my fall.

My husband’s office is only a couple of miles away and, since I knew I couldn’t make it the rest of the way home under my own power, I called him and he was gracious enough to come rescue me. (I’m still proud I got 1.5 miles in!)

Today the red welts on my hand, elbow, hip and knee have bloomed into a bouquet of multi-colored bruises. Interestingly the worst is a deep purple bruise on the outside edge of my thumb. Beyond that, the other parts that I hurt — the wrenched shoulder, the tweaked back, the twisted ankle — are all screaming. No walks for me today.

Any kind of impact injury scares me. With three replaced joints and two levels of my spine held together by titanium rods and screws, I’m afraid that a fall, car wreck or something similar will pop something loose or even off.

Beyond that, like many RA patients, I’m probably at a higher risk for bone fracture than most. Steroids, such as prednisone or steroid shots, affect bone density and increase chances for osteoporosis. This is also true for proton-pump inhibitors (such as Prilosec, Prevacid, and Protonix) that are often taken along with prednisone and/or NSAIDs to help curtail stomach issues. While I get regular bone density screens (as should you), it’s a risk factor that we should all consider.

I’m fortunate that not much was damaged but my pride and I have now have an authentic reason to buy a good pair of end-of-season gloves on sale. That is once I can move well enough to make it to the mall.

I hope nothing bad goes boom in your life today (including you!). Thanks for checking in.