more on the methotrexate shortage (and a short rant)

Methotrexate Teva 100mg_ml 1x50ml -pakning

Methotrexate Teva 100mg_ml 1x50ml -pakning (Photo credit: Haukeland universitetssjukehus)

I stumbled across this article from the Grey Lady via Rheumatoid Arthritis Guy on the critical need for more methotrexate. The article says, in part:

“This is dire,” said Valerie Jensen, associate director of the Food and Drug Administration’s drug shortages program. “Supplies are just not meeting demand.”

The drug is methotrexate, and the cancer it treats is known as acute lymphoblastic leukemia, or A.L.L., which most often strikes children ages 2 to 5. It is an unusually virulent cancer of white blood cells that are overproduced in bone marrow and invade other parts of the body.

The cancer commonly spreads to the lining of the spine and brain, and oncologists prevent this by injecting large quantities of preservative-free methotrexate directly into the spinal fluid. The preservative can cause paralysis when injected into the spinal column, so cannot be used for this disease. Methotrexate is also used to treat rheumatoid arthritis.

Ben Venue Laboratories was one of the nation’s largest suppliers of injectable preservative-free methotrexate, but the company voluntarily suspended operations at its plant in Bedford, Ohio, in November because of “significant manufacturing and quality concerns,” the company announced.

Since then, supplies of methotrexate have gradually dwindled to the point where oncologists now say they are fearful that shortfalls may occur at many hospitals within two weeks.

I’m not really sure what’s going on with the manufacturing of MTX. According to the FDA, several companies that make the injection form of the drug simply decided to stop making vials of certain sizes. I don’t know why and haven’t been to be able to find much information about it. I’m generally not a conspiracy theorist and tend to (want to) believe people will do the right thing, but there doesn’t seem to be much reason for creating a shortage of a drug that treats childhood cancer—and several autoimmune diseases.

Which brings me to my short rant. Just a post script for the N.Y. Times: Many of us are on methotrexate, and we don’t all have rheumatoid arthritis. We have lupus and psoriatic arthritis and ankylosing spondylitis and so many other diseases. Maybe a better way to note that MTX doesn’t only treat cancer is to say that people with certain kinds of autoimmune conditions—like R.A.—also take the drug. Just saying.

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new guidelines for diagnosing plaque psoriasis

The Heartbreak of Psoriasis

Image by tomswift46 (No Groups with Comments, no graphics,f via Flickr

This press release just came across my email (and props to the NPF for sending out press releases that are actually awesome; it makes my little journalist’s heart so happy.)

National Psoriasis Foundation releases consensus guidelines for treatment of plaque psoriasis 

PORTLAND, Ore. (January 25, 2012)—To assist the millions of Americans living with psoriasis, the most common autoimmune disease in the country, the National Psoriasis Foundation published the most recent guidelines in the United States for the management of plaque psoriasis—the most prevalent form of the disease, affecting roughly 80 percent of people with psoriasis.

The consensus guidelines from the National Psoriasis Foundation Medical Board, adapted from the Canadian Guidelines for the Management of Plaque Psoriasis to reflect U.S. practice patterns, aim to clarify when to use oral and biologic medications for people whose psoriasis is beyond topical treatment. A table summarizing the latest research and thinking on eight drugs provides data on when and how to best use them in a way that has not been done before.

“It’s a bold table in that it says directly which treatment will work or which has little evidence to support it,” said Dr. Sylvia Hsu, a member of the Psoriasis Foundation Medical Board. “It spells out clearly in one or two sentences which method is safer than we previously thought.”

One example is the recommendation that cyclosporine, an immunosuppressant drug taken orally, may be used as a short-term solution for up to 12 weeks, although FDA guidelines allow its use for up to 12 months.

The new guidelines also state that ustekinumab, commonly known as Stelara, is safe and effective as a first-line therapy. Previously, its use has been limited to second- and third-line treatment.

To view the guidelines and table, visit www.psoriasis.org/new-treatment-guidelines.

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About Psoriasis

Psoriasis is the most prevalent autoimmune disease in the country, affecting as many as 7.5 million Americans. Appearing on the skin most often as red scaly patches that itch and bleed, psoriasis is chronic, painful, disfiguring and disabling. Up to 30 percent of people with psoriasis develop psoriatic arthritis, a related joint disease. There is no cure for psoriasis.

About the National Psoriasis Foundation
The National Psoriasis Foundation is the world’s largest nonprofit organization serving people with psoriasis and psoriatic arthritis. Our mission is to find a cure for psoriasis and psoriatic arthritis and to eliminate their devastating effects through research, advocacy and education. For more information, call the Psoriasis Foundation, headquartered in Portland, Ore., at 800.723.9166, or visitwww.psoriasis.org. Follow the Psoriasis Foundation on Facebook and Twitter.

the case of the missing monocyte

This came across my inbox at work, and I thought it might interest some of you, as it did me:

The case of the missing monocyte

 

CHAPEL HILL, N.C. – An estimated 1.3 million people in the United States suffer from rheumatoid arthritis. The causes behind this chronic disease — which can exhibit itself as pain, swelling, stiffness, deformation, and loss of function in the joints — have eluded scientists for centuries. A new study by UNC researchers offers tantalizing glimmers about the roles of a gene called CCR2, an immune system cell called Th17 cell, and a missing monocyte. The study contributes to a better understanding of the disease mechanism and has implications to guide the clinical trial strategy, said lead researcher Peng Liu, MD, PhD, research assistant professor at the UNC Thurston Arthritis Research Center. Her team’s findings were reported online in PLoS One on Oct. 4. The mystery began several years ago when arthritis researchers zeroed in on a gene called CCR2. CCR2 is highly expressed in the joints of patients with rheumatoid arthritis, which led researchers to believe it might contribute to the disease. “Scientists thought that if you inhibited CCR2 you would have a beneficial effect,” said Liu. “But actually, the result was the opposite.” Studies revealed that suppressing CCR2 in fact cannot ameliorate joint inflammation, in some cases, it leads to disease exacerbation.Intrigued, Liu and her team used mice to investigate how CCR2 affects immune system cells. The immune system is critical because rheumatoid arthritis is an autoimmune disease, in which the immune system attacks the body’s own tissues, causing inflammation. They found the smoking gun when they looked at a type of immune cell known as Th17 cell. Arthritic mice without the CCR2 gene produced three times the amount of Th17 cells, increasing the inflammation in their joints. “We found that an enhanced Th17 cell response is responsible, at least in part, for the increased disease severity,” said Liu. Inhibiting the activities of Th17 cell, therefore, may be a promising new direction for drug treatments for rheumatoid arthritis. The team also found that a particular type of monocyte (a type of white blood cell) disappeared from certain tissues in the mice without CCR2. They hypothesize that the CCR2-expressing monocyte plays an important regulatory role, so without the monocyte, Th17 cells proliferate. “The potential link between CCR2 and the Th17 cells is the monocyte subset,” said Liu.“This subset of monocytes may have a suppressive function in autoimmune disease,” said Liu. The finding opens the door to new treatment possibilities, such as injecting this monocyte subset into patients with rheumatoid arthritis: “Finding this monocyte may be important for later development of cell-based therapy,” said Liu. Other collaborators from the UNC Thurston Arthritis Research Center include Teresa Tarrant, MD, Alan Fong, PhD, Rishi Rampersad, Christopher Vallanat, Tatiana Quintero-Matthews and Michael Weeks. Additional collaborators include Denise Esserman, PhD, from the UNC Department of Medicine and UNC Department of Biostatistics, Jennifer Clark of the UNC Department of Biostatistics and Franco Di Padova, MD and Dhavalkumar Patel, MD, PhD of the Novartis Institutes for Biomedical Research, Switzerland. For a report of the research, see: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0025833. Support for the research comes from the North Carolina Translational and Clinical Science (NC TraCS) Institute, home of the UNC-Chapel Hill Clinical and Translational Science Award (CTSA); the Arthritis Foundation; and the National Heart Lung and Blood Institute.

new biologic side effects warning

Fda

Image via Wikipedia

I got this new warning about anti-TNF drugs in my inbox not too long ago and thought I’d pass it along:

“The U.S. Food and Drug Administration, or FDA, is warning that people who take tumor necrosis factor-alpha blockers, also known as anti-TNFs or TNF-blockers, may be at risk of infection from the bacteria Legionella and Listeria.”

For the rest, click here.

For the record, I take a biologic: Enbrel, currently. I’ve been on several others (Humira, Orencia, Remicade). Will this stop me from taking it or any other sin the future? No, probably not. But I’ll certainly be careful—as I already am, as much as I can be—in exposing myself to sick people.

n.y. times take on psoriasis

Yvetta Fedorova / N.Y. Times

The N.Y. Times had an interesting article about psoriasis today.

The author, Jane Brody, hits the high (or low, depending on your perspective) points about having the disease: the shame and embarrassment that so often is an unwelcome side effect; the underlying immunological factors; that genetic and other factors contribute to psoriasis; the various comorbitities that can wreak even more havoc on a person’s life.

And she should know; her husband has psoriasis (well, she writes he had psoriasis—but we all know that even if it’s in remission, it’s never really gone).

Brody shares some good tips for psoriasis sufferers: don’t scratch the legions—no matter how intense the itch; be patient; moisturize, moisturize, moisturize; and, of course, seek treatment.

Overall, I thought it was a good piece, though I would have been interested in hearing from her husband, to hear more of how it has been for him in his own words. Maybe it’s just me, but I like hearing the stories of others with the disease; I like swapping war stories and treatment solutions, like finding out the crazy things doctors say to us that weren’t funny then but have to be funny now.

Most of all, I like it when people with the disease are allowed to speak for themselves, to be their own voices, instead of having healthy people speak for us. I wouldn’t go so far as to accuse the Grey Lady of ablism—I’m not so sure that’s what’s at work here—but it would be nice if one of the 7 million people with psoriasis would have been tapped to write something. (N.Y. Times, in case you’re wondering, I am always available to write a piece. Just saying.)

Regardless, it’s nice to have some pub—especially good pub like this—in a newspaper as widely read as the N.Y. Times. It can only help when good information is put out there; maybe next time readers will see someone with psoriasis and not edge away. I’d call that a victory.

we, the patients

I think just about everyone who deals with chronic illness has had at least one terrible doctor. I know I have: I’ve had a dermatologist who told me psoriasis is only a skin condition and was the result of a reaction to using a new shampoo (both wrong, by the by), and I had a rheumatologist who only wanted to treat me with pain pills (which is horrible for so many reasons).

Everyone has the right to adequate medical care, and part of that is seeing a doctor who is willing to work with you; of course, the patient must be willing to shoulder some of the burden for his or her own health, too. So, the National Psoriasis Foundation Medical Board and Board of Trustees worked with Dr. Jerry Bagel, director of the Psoriatic Treatment Center of Central New Jersey and a clinical associate professor at Columbia University, to create a patient’s bill of rights to make sure both doctors and patients know their responsibilities in making sure psoriasis and psoriatic arthritis are properly treated.

Some of the highlights are:

  • People with psoriasis and/or psoriatic arthritis have the right to receive medical care from a healthcare provider who understands that psoriasis and psoriatic arthritis are serious autoimmune diseases that require lifelong treatment.
  • People with psoriasis and/or psoriatic arthritis have the responsibility to be actively involved in managing their disease by participating in healthcare decisions, closely following treatment plans recommended by their healthcare providers, and making healthy lifestyle choices to ease their symptoms.
  • People with psoriasis and/or psoriatic arthritis have the responsibility to be honest with their healthcare provider about their health and lifestyle decisions that may affect the success of his or her treatment plan.

The rest of the document is filled with other good expectations for doctors and patients. I hope this helps doctors and patients communicate with one another and realise that we’re all on the same side—or, at least, we should be.

rikki, don’t lose that number

Wednesday is an important day for arthritis and other patient advocates; it’s “I Need My Rheumatologist” capitol call-in day.

I’m sure by now almost everyone has heard that, unless Congress acts fast to fix the sustainable growth rate (SGR), the formula used to determine payment to doctors, rheumatologists (and all other doctors!) will see a 23-percent cut to Medicare reimbursement payments. (Here’s an interesting commentary on SGR and Medicare.)

This is unacceptable. Everyone has the right to affordable health care. (The Universal Declaration of Human Rights, adopted by the United Nations in 1948, states that “everyone has the right to a standard of living adequate for the health and well-being of oneself and one’s family, including food, clothing, housing, and medical care.”) How many people will no longer be able to see their rheumatologist—or any rheumatologist—if Congress doesn’t act? How many rheumatology practices will have to close or cut back if they can no longer afford to accept Medicare patients?

Seriously, it seems like a no-brainer, Congress.

Organised by the American College of Rheumatology, numerous patient organisations have jumped on board, including the National Psoriasis Foundation, Arthritis Foundation, Lupus Foundation of America and the Spondylitis Association of America.

So, pick up the phone tomorrow and take 30 seconds to call your representatives. To quickly and easily reach lawmakers, dial the AMA Grassroots Hotline at (800) 833-6354. ACR is recommending we start the conversation with, “I need my rheumatologist (or, “My loved one needs his/her rheumatologist”). Please fix the SGR before Nov. 30 to ensure access to my doctor.”

 

(P.S.-Feel free to use the button I whipped up.)

Novartis Exec: Golden Age Of Generic Biotech Drugs Is Coming « The Science Business – Forbes.com

This, biologics — which are terribly expensive, even with insurance — becoming available as generics, could be a huge deal.

Novartis Exec: Golden Age Of Generic Biotech Drugs Is Coming « The Science Business – Forbes.com.

I’ve been on three different insurance plans (one: Dad’s stellar insurance; two: my own decent insurance with one company; three: mediocre at best insurance) and the cost of the biologics has varied dramatically, from a doctor’s office co-pay to $60 for a month’s supply to $200 for a month’s supply. I guess we’ll just have to wait and see whether the FDA will allow for the creation of generics for Enbrel or Humira or any of the others.