As blockbuster drugs go off patent, the pharmaceutical industry is scrambling for fresh revenue sources. Follow-on versions of biologics, or “biosimilars,” are being pitched as BigPharma’s saving grace. One question remains unaddressed in the discussion: is anyone actually planning on selling biosimilars in the United States? [...]
According to [Parexel consultant Dr. Saurabh] Aggarwal, the FDA is already planning to require too much data for biosimilars to succeed in the US. “For biosimilars to be successful, the amount of data required from a regulatory standpoint cannot be as onerous as that required to get a pioneer biologic approved.” [...]
Given that the US biosimilar approval pathway as now imagined does not anticipate full interchangeability, is US biosimilar development doomed before it begins? According to Aggarwal, quite possibly. [...]
One reason that we are not doing the same might be that the large, influential companies here in the US still have major branded biologics in the pipeline. Hence, these bigger players are waiting and watching while they lobby to protect their branded interests, which are far more profitable at present than any risky foray into biosimilars. Current budgets for lobbying Capitol Hill on behalf of these companies’ branded biologics are equal or greater to their entire budgets for US biosimilar development.
Page 5 from “My Book About Me” by Me, Myself, and Dr. Seuss
proudly filled out when I was seven years old!
The night before last, my right hand flared like it has never done before. I woke up in the middle of the night, trying to figure out where the excruciating pain was coming from. As soon as I saw my hand, I had my answer. Three of the four knuckles (minus the pinky) were covered by a bright red oval that looked like it had been painted with a red Sharpie marker. I turned my hand over to look at the palm, and saw the same thing.
A few seconds later, I realized that I was completely unable to move my fingers…not even just a little bit. The idea of individual knuckles was a distant memory, having since been replaced by one large puffy swath.
Instead of fretting about the almost complete loss of use in my right hand (luckily I’m left-handed…but still!) I fell back asleep. Not a true sleep, mind you, but some weird place that I often go to when I’m in a major flare. I both feel my pain and don’t feel my pain, all at the same time. I’m fully aware of my thoughts, but I’m not completely present. I’m so exhausted that even resting seems to take more energy than what I can muster. I’m awake, but I’m also asleep.
I’m supposed to sleep with an ulnar deviation split, this contraption with a padded metal rod along the edge and Velcro elastic straps for each individual finger, including the thumb. The idea is to keep the hand, from the wrist on down, in it’s “correct” position. My hands are not as damaged as some others that I have seen, but they’re definitely past the point of trying to pop them back into the “right” place.
After the few minutes it takes to get all of the straps in the correct position, it’s nice to see my hands looking more “normal” than usual…but within an hour, the pain is just too unbearable. My hands have a new “normal” position, one that takes into consideration the constant swelling and tugging of all the different parts inside. They are only able to experience a little bit of comfort by giving into the constant inflammation, by slowly changing their shape. I’m supposed to sleep through the night with these gloves, but I rarely ever put them on any more.
My hands have changed, and they continue to change. Some might say they’ve changed for the better, while others might say that they’ve changed for the worse. I like to say that they’ve changed for the necessary. The thought of strapping them into a position that they were once “supposed” to hold no longer seems like a smart idea to me. Yeah, I know…there’s always the notion of trying to prevent future damage, but there is also the reality of what already taken place and what continues to take place.
And as as I lay there in my “flare space”, a new thought entered my mind. I not only needed to accept my hands for what they are now, but I also needed to be ready to accept them for whatever they might become in the future. They will, after all, still be my hands. Over time they’ll probably continue to look less like other people’s hands, but that’s okay…for me, they will still be “normal”. They will be my normal.
Not every person I encounter is going to be able to understand why my hands look this way, but those of us who do know the reasons will also know the truth: rheumatoid arthritis hands are a visible sign of the enormous strength of an individual who has experienced so much pain, that their hands have literally been pulled out of shape. I, for one, am proud of my hands. They have endured a lot, and will continue to endure even more. I will never be ashamed of them, no matter what they look like.
Stay tuned…for the next adventure of Rheumatoid Arthritis Guy!
Organizations Who Can Help
Arthritis Care exists to support people with all forms of arthritis. They are the UK’s largest charity working with and for all people who have arthritis. Arthritis Care campaigns for change and offers practical support and information so that people can learn to take control of their arthritis and make positive changes to their lives.
Helpline: 0808 800 4050 General enquiries: 020 7380 6500
Arthritis Research UK
Arthritis Research UK is the charity leading the fight against arthritis by funding high class research, providing information and campaigning.
Phone: 01246 558033
National Rheumatoid Arthritis Society (NRAS)
National Rheumatoid Arthritis Society is the only charity which focuses specifically on providing support, help and information for people with rheumatoid arthritis and juvenile Idiopathic arthritis, their families, friends and carers, and health professionals with an interest in rheumatoid arthritis.
Helpline: 0800 298 7650 General enquiries: 0845 458 3969 / 01628 823524
What can you add to the list?
For a chef, the inspiration to move into new creative territory can arrive with a euphoric flash.
Sometimes, though, inspiration chooses a darker, more distressing route. Consider the story of Seamus Mullen.
“I woke up one day with pain in my hip, and I couldn’t even move,” he recalled the other day, as he took a break from overseeing the construction work on his latest restaurant, Tertulia, which is set to open in the West Village later this month.
He had experienced mysterious blasts of agony before. Now and then his shoulder would flare with searing, paralyzing pain that he compared to “having a hot knife stuck inside your joint.” But he had never endured anything like this.
- Harvard Gazette: A Journey Into IllnessJanuary 12, 2015 - 4:19 pm
- Health.com: 11 Famous People With RAOctober 1, 2014 - 9:50 am
- Arthritis Broadcast Network: Spotlight On Arthritis SuperheroesSeptember 10, 2014 - 7:34 pm
- The New York Times: Actress, Artist, Sometimes Both At OnceMay 20, 2014 - 10:29 am
- The Columbian: Arthritis Not stopping 20-Year-Old Nursing StudentApril 15, 2014 - 3:25 pm