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Sinemet Has Left the Building

Sinemet

A recent Merck product status report shows that Sinemet 25-100 is on backorder, with no current availability date. I have been on Sinemet 25-100 for almost a year now. When my pharmacy called me to say there was no more Sinemet for my refill, I was devastated.

Generic carbidopa/levodopa (C/L) had made me nauseated when I’d tried it in the past, so my neurologist prescribed the brand name Sinemet. It took months of trial and error to find the right dosage and timing for my current “cocktail” of Parkinson’s disease (PD) medications. (I also am on the Neupro patch (rotigotine). Now, it seems I may be back to square one.

What do I do now?

Currently, under my doctor’s guidance, I am rationing my remaining Sinemet (two in the morning) and taking C/L (two in the afternoon) to ease myself into all generic. Thus far, I have had no nausea; however, I do believe my energy, balance, and fine motor skills are deteriorating. This could be because of disease progression, or perhaps, it could be due to the generic not being as effective in terms of absorption as the brand. I am back to trial and error to figure out what works for me.

In the United States, the FDA indicates that it is acceptable for a generic drug to have up to a 20 percent difference in absorption rate than the brand-name medication.

Note that symptom relief can also vary among generics, and there are several companies that manufacture C/L.

Crisis is opportunity

“When written in Chinese, the word ‘crisis’ is composed of two characters.  One represents danger and the other represents opportunity.”  — John F. Kennedy

Kennedy’s words, while not strictly accurate, make a good point. In light of this Sinemet shortage, I am trying to reframe how I view its impact on me. I am choosing to believe this may be a good thing, as I will now explore three other treatment options.

1.  Getting another opinion on my situation through a no-fee telemedicine consult.

If you have PD, live in New York, and have internet access on a computer or tablet, you may be eligible for a no-charge telemedicine consult with a movement disorder specialist.

2.  Registering for PD summer school in August 2019

This is a five-day conference at Bastyr University’s Seattle-area clinic, and it is focused on improving PD outcomes. From what I have seen on the website, most of the instructors are naturopathic; however, some are also traditional MDs.

3.  Trying infrared light therapy (photobiomodulation)

A few months ago, an Australian friend shared a video link with me about Max Burr, a man with PD who has experienced positive results from infrared light therapy. Burr is also mentioned in a news article about what is happening with infrared light therapy in Australia. John Mitrofanis, a researcher at the University of Sydney, used red lights on mice with induced PD. The animal trial found the light stopped the nerve cells in the mice’s brains from dying.

After I contacted Mitrofanis, he referred me to an Australian medical professional who was doing extensive work in creating infrared light therapy devices for humans. Her website and blog have a lot of useful information related to infrared light therapy.

I found two other promising articles about infrared light therapy, especially for treating some PD symptoms. They are:

I started this therapy at the end of May. I plan to write an article in a few months describing my experience with this treatment.

Although full clinical trials have not been completed on this therapy, I am encouraged by what I have seen. In 2018, the article “Exploring the use of transcranial photobiomodulation in Parkinson’s disease patients” was published in the peer-reviewed, open-access journal Neural Regeneration Research. It established a positive tone regarding the treatment.

Apparently, there are no side effects, and the treatment is noninvasive. My neurologist gave me his blessing to try it. I said to myself, “What have I got to lose?”

Perhaps the backordered Sinemet situation may be the best thing to have happened to me.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

The post Sinemet Has Left the Building appeared first on Parkinson’s News Today.

FDA Approves Generic Version of Sinemet for Parkinson’s Treatment, Company Says

Sinemet generic

The U.S. Food and Drug Administration (FDA) has approved a generic equivalent to Sinemet (carbidopa/levodopa) for the treatment of Parkinson’s disease, according to a press release.

The oral therapy, produced by India-based Alembic Pharmaceuticals, will be available as extended-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa.

Sinemet, marketed by Merck, was approved by the FDA in 2014 and is sold as controlled-release tablets in three different strengths: 25 mg of carbidopa and 100 mg of levodopa; 10 mg of carbidopa and 100 mg of levodopa; or 25 mg of carbidopa and 250 mg of levodopa.

People with Parkinson’s have low levels of the neurotransmitter dopamine in the brain. Neurotransmitters are substances produced in response to nerve signals that act as chemical messengers. Direct administration of dopamine cannot be used to increase its levels because it is unable to reach the brain due to the blood-brain barrier, a thin membrane that protects the central nervous system (brain and spinal cord) from the circulatory blood system.

Levodopa and carbidopa act to increase dopamine levels in the brain. Levodopa, a molecule involved in the chemical reaction that produces dopamine, has the ability to cross the blood-brain barrier.

Meanwhile, Carbidopa inhibits enzymes known as decarboxylases that would degrade levodopa, ensuring it reaches the brain. However, carbidopa cannot cross the blood-brain barrier, which allows decarboxylases in the brain to then convert the levodopa to dopamine. Using carbidopa together with levodopa enables the use of lower doses of levodopa, which decreases its side effects, including nausea and vomiting.

The carbidopa and levodopa extended-release tablets also are approved for treatment of postencephalitic parkinsonism, a progressive neurodegenerative disease with clinical features of Parkinson’s, likely caused by an infection, and for people with Parkinson’s symptoms following intoxication by carbon monoxide or manganese.

Brief exposure to air pollution, including to carbon monoxide, has been suggested to increase the risk of Parkinson’s disease and other neurological diseases.

Exposure to the metal manganese may trigger the development of Parkinson’s by promoting the release from nerve cells of the alpha-synuclein protein. The clustering of this protein causes inflammation and neurodegeneration.

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NYC Attorney with Parkinson’s Describes Positive Effects of Deep Brain Stimulation

The first time the batteries for his deep brain stimulation (DBS) device were activated, Jim McNasby had the feeling a load burdening his body had been removed.

“It felt like a very gentle posture improvement; I just sat up straighter,” McNasby said in a phone interview, as he described how the technology has helped him.  “It was like a weight was lifted and the shakiness in my limbs disappeared.”

McNasby3
Jim McNasby, an attorney with Marsh & McLennan Companies, with his DBS device at his office in New York. (Photos courtesy of Jim McNasby)

McNasby, 50, a New York lawyer first diagnosed with Parkinson’s disease in 1999 at the age of 30, now wonders why he waited so long to have the DBS mechanism implanted.

“I wanted to be careful with brain surgery,” he said. “At the time it seemed so radical. But now I think: ‘Why didn’t I get it earlier?’”

DBS uses low-voltage electricity to stimulate specific parts of the brain via surgically implanted wires attached to a pacemaker-like neurostimulator placed under the skin on the upper chest. Doctors recommend the device mainly when Parkinson’s patients stop responding to medications designed to reduce motor symptoms, such as tremors, rigidity, involuntary movements, and walking problems.

The technology is not a cure. Research on its long-term effects is still limited, and scientists don’t know exactly how it works. However, a number of studies have shown that electrical stimulation of the subthalamic nucleus can improve symptoms, lower the need for medication, and improve the quality of life for people with Parkinson’s.

Stronger symptoms prompt decision

DBS also can ease symptoms of other diseases, including epilepsy and obsessive-compulsive disorder, and is being studied as a potential treatment for issues as wide-ranging as addiction, chronic pain, headaches, dementia, major depression, Huntington’s disease, multiple sclerosis, stroke, Tourette syndrome, and traumatic brain injury. Some 150,000 Parkinson’s patients had received DBS implants worldwide as of 2018.

In the past, McNasby relied on four medications to keep his symptoms under control. These included Sinemet (carbidopa/levodopa), which he was on for 16 years. In the spring of 2018, however, he started experiencing more tremors, shuffling, and asymmetrical walking. His “off-times,” when the medication wasn’t working optimally and motor symptoms returned, felt stronger and more frequent. Friends commented that he appeared to be struggling.

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Jim McNasby, at right, with his husband, Donald Moss, during a July 2018 vacation in Norway.

“I’d feel great, and then I’d fall off a cliff and hardly be able to walk,” he said. “I felt shaky and heavy and like I couldn’t balance. … I’d have to sit on my hands and that kind of stuff to try to stabilize.”

He and his doctor tried tweaking his medications, without much success. Then a friend suggested DBS.

The procedure has reversed his Parkinson’s symptoms by about 15 years, McNasby said, to around where they were when he was initially diagnosed. With round-the-clock electrical stimulation, he wakes up feeling good and no longer has drastic ups and downs during the course of the day.

“All the symptoms have been drastically reduced” and are “well within something that’s manageable,” he said.

“I feel so much better,” he added. “It’s something I unequivocally recommend.”

Voltage is easy to adjust

Several DBS devices are on the market, and different doctors follow different protocols to implant them. While McNasby said some patients have the whole system implanted over a 12-hour period, he and his team at Manhattan’s Mount Sinai Hospital chose a series of three surgeries over the course of about a month. His doctors selected Abbott’s Infinity™ DBS system with batteries that last 5-8 years before needing replacement rather than batteries that need daily recharging.

McNasby said he was initially nervous about the prospect of the surgery. His doctor explained the potential risks, which include an electrode placed in the wrong spot, stroke, speech complications, and unpredictable effects from the electricity. His first procedure was a magnetic resonance image (MRI) to pinpoint the exact locations in his brain for the implants.

McNasby1
Jim McNasby, 50, says his DBS device has alleviated the worst symptoms of Parkinson’s.

The MRI was followed this past January by robotic surgery to insert a wire in his brain on the left frontal part of his head. The wire comes out through his skull and travels under his skin to a spot behind his left ear, then down his neck to a tiny battery placed on his chest below his collarbone. The stimulation from inserting the wire itself into his brain improved his symptoms for several days, making him more optimistic about the subsequent surgeries, he said.

The second surgery placed a wire and battery on the right side of his head and chest, and the third, on Feb. 11, connected the two sides to each other. After a three-week period of healing, and scaling down his Sinemet, doctors fully activated the device on March 5.

Today McNasby can barely see or feel the implanted wires and batteries. He likes the worry-free ease with which he and his doctor can adjust the voltage: he uses an Apple device the size of an iPhone that synchronizes with his batteries when he sets it on his chest, and his physician uses an iPad to determine the range of changes he can make. The day McNasby spoke to Parkinson’s News Today, one side of his brain was set at 2.5 volts and the other at 2.2 volts.

“You actually can’t hurt yourself with the device,” he said. “You can’t cause any damage that’s irreversible.”

Further improvement possible

And while he can’t feel the electricity while it’s stimulating his brain, he certainly can tell if it has been turned off: his symptoms come back immediately, “my tremors, especially,” he said.

Although McNasby said his case is not typical, he is now completely off the Sinemet. The only medication he uses is Amantadine, which he takes three times a day for tremors. Before his DBS implant, he had to take medication 15 times each day.

Despite developing Parkinson’s at an early age, McNasby says he feels very fortunate: his symptoms haven’t been worse, his disease progressed relatively slowly, and his response to DBS was strong. He never experienced the depression that often accompanies Parkinson’s.

He attributes his “luck” in large part to his one hour of exercise every day. He plays tennis, bikes, lifts weights, and does yoga.

McNasby said he and his doctor are still adjusting his electricity dosage, and it’s possible that he may feel even better in the future. After all, his DBS device has been operating for only two months and it has 44,000 settings.

He doesn’t want to get his hopes up too much. Still, he said, “44,000 [variations] – that’s a lot of options.”

The post NYC Attorney with Parkinson’s Describes Positive Effects of Deep Brain Stimulation appeared first on Parkinson’s News Today.

Parkinson’s Isn’t Always Invisible

invisible

I had breakfast with some friends today. One I hadn’t seen for six months and another for 10 years. Both of them are forever kind of friends, the sort who overlook your flaws. Flaws like Parkinson’s disease (PD).

It is rare for me to have tremors with all of the Sinemet (carbidopa-levodopa) that is in my body. But lately, I have noticed some breakthrough tremors. They don’t happen often or consistently. However, they occur frequently enough to remind me that despite medications to slow it down and a couple of deep brain stimulation surgeries to quieten the disease, it is continuing to progress. I notice it when I wave goodbye, put on my shoes, or try to pull a sweatshirt over my head. I’m aware of it when I stop abruptly during a conversation, having lost my train of thought.

I recognized the progression the other day when I walked 500 feet to a neighbor’s house. We went together to the mailboxes in our mobile home park. Before we left her house, she offered me one of her canes to use. I thought her offer was odd until I got home and realized I had been shuffling as I walked and she had noticed it. Ugh. 

Parkinson’s disease is often referred to as an invisible disease. I wish it would stay hidden.

So today, I had breakfast with friends. The tremors broke through. I was sharing something when I forgot what I was saying. My eyes became blurry and felt gritty. My hands cramped up and my fingers became painfully stiff. I had difficulty getting out of the booth we were sitting in, and when we got back to the house, I had trouble getting out of the car. My friends saw me struggling and came to my side to help.

It is hard to see the progression in yourself sometimes, especially when it happens quietly, gradually, and unassumingly.

But when you have good friends — forever friends — by your side, it makes living with the disease a little more bearable.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

The post Parkinson’s Isn’t Always Invisible appeared first on Parkinson’s News Today.

My DaTscan Results Made My PD Diagnosis ‘Real’

DaTscan

When I was first diagnosed with Parkinson’s disease (PD) in 2015, I asked the neurologist if there was a definitive test to confirm a PD diagnosis. I mentioned a DaTscan, but he said the test is not entirely conclusive. He also indicated that DaTscan results likely would not change his prescribed course of treatment for me.

His view was that the best way to confirm a PD diagnosis is to give a patient the medication levodopa to see if PD symptoms disappeared. Other neurologists I consulted for second opinions concurred with his assessment.

What is a DaTscan?

DaTscan is a medication that is injected into the bloodstream to assess dopamine-containing neurons that are involved in controlling movement. The contrast agent ioflupane (123I) is distributed around the body in the bloodstream and accumulates in the area of the brain called the striatum, where it attaches to the structures that transport dopamine. The patient then has a single-photon emission computed tomography (SPECT) scan.

The DaTscan test was designed to differentiate parkinsonian syndromes from essential tremor. PD is the most common form of parkinsonian syndromes, but there are other forms, including multiple system atrophy and progressive supranuclear palsy.

My DaTscan

A comparison between a normal and an abnormal DaTscan can be viewed here. A normal DaTscan will show two distinct comma-like or crescent shapes. An abnormal DaTscan will have two period-like or oval shapes, or a combination of period and comma shapes, indicating a reduced uptake of DaTscan in certain areas of the brain. Parts of the image that are “lit up,” indicate more surviving brain cells. Dark areas could mean either PD or parkinsonism.

My DaTscan image showed that the right side of my brain is less “lit up” than the left side. The right hemisphere of the brain coordinates the left side of the body. The left side of my body is the one most affected by PD, so it makes sense that my right side brain is less “lit up.”

Am I convinced that I have PD?

Three years after my diagnosis, I am still struggling to find relief from my symptoms and slow the progression of this disease. I exercise, eating a mostly vegan and gluten-free diet, take Sinemet (carbidopa-levodopa), and use the Neupro transdermal patch. I am working with my current neurologist to fine-tune my medication “cocktail.”

I had wondered whether I did have PD since I’ve never had an “aha” moment in which I feel somewhat normal after taking medications. People tell me I look fine and they don’t observe any external signs of the disease. However, my tremors are internal and I feel horrible and constantly fatigued.

Why now?

I am subjecting my body to what I believe are toxic medications to treat a disease that I feel has been subjectively diagnosed. My symptoms have not been completely alleviated with my current exercise, diet, and prescription medication regimen. I wanted more concrete evidence that I have PD, so my neurologist prescribed a DaTscan. Much to my dismay, the results were abnormal and compatible with Parkinson’s syndrome.

Seeing my brain image with areas not “lit up” where they should be, when contrasted with a normal DaTScan, made my diagnosis very real for me. I have a form of parkinsonian syndrome — most likely PD.

Would I still have gotten a DaTscan?

It was important for me to have confirmation other than my symptoms of abnormalities in my brain. I think this scan can be used as a baseline to follow my disease progression.

So, yes, I would have still gotten this test, although the $2,000 out-of-pocket cost upfront may have given me pause.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

The post My DaTscan Results Made My PD Diagnosis ‘Real’ appeared first on Parkinson’s News Today.

Finding Balance with Medications

balance

What is my strategy?

I plan to take Parkinson’s disease (PD) medications as prescribed to get me to a point where I can function well and really push hard in my exercise. Then, I hope that a combination of exercise, diet, meditation, yoga, and massage will help me to deal with my PD progression and symptoms.

Currently, I take Sinemet (carbidopa-levodopa) 25/100, two tablets, three times per day. With my doctor’s guidance, I am weaning off a daily 4 mg Neupro patch. Sinemet has alleviated my internal tremors. However, I am still extremely fatigued all of the time.

Do I really believe the medications are helping?

I have never had any “aha!” moments as a result of taking medications. It was never like “wow, I feel so much better now.” I don’t experience the “off time” that some have when the meds are wearing off shortly before the next dosage is due. So, I question how much the medications are really helping me.

Why do I want to reduce or halt my PD medications?

Opioids target the brain’s reward system by flooding the circuit with dopamine. In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid-based pain relievers. They were wrong — there is currently an opioid overdose crisis in the U.S.

Although opioids get more media attention, abuse of benzodiazepines (benzos) is equally rampant. Benzos create surges of dopamine in the body. Since their introduction in the 1960s, this class of medications, which includes Valium (diazepam), Ativan (lorazepam), and Xanax (alprazolam), have been widely prescribed to treat anxiety and insomnia, alcohol withdrawal, and other conditions. These medications must be prescribed with caution because they can be addictive.

Levodopa, a component of Sinemet, may improve PD symptoms because it causes the body to make more dopamine. Neupro (rotigotine) patches work by delivering the dopamine agonist rotigotine through the skin directly into the bloodstream. Rotigotine stimulates dopamine receptors in the brain. This, in turn, mimics the action of dopamine, which is found in lower-than-normal levels in the brains of Parkinson’s disease patients.

My conclusion

From my simplistic, high-level view, I see a common denominator (dopamine) in the three categories of the medications mentioned above. Even though my brain may not be functioning properly due to PD, taking drugs that impact the brain does not sit well with me.

What will be said about PD medications in the future? I am not sure I want to find out. This is why I am choosing to wean off as many of the PD drugs that I can. I want to continue to seek balance and to pursue my more holistic approach to diet and exercise to tame the PD dragon.

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Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

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