Grand Challenges - Unmet Needs of People with Parkinson's

Study: CBD Administration Associated With Improved Quality Of Life In Patients With Parkinson’s Disease

·       by Paul Armentano, NORML Deputy DirectorSeptember 25, 2014

    

The administration of cannabidiol (CBD), a nonpsychotropic cannabinoid, is associated with improved quality of life in patients with Parkinson’s disease, according clinical trial data published online ahead of print in the Journal of Psychopharmacology.

Investigators at the University of São Paulo in Brazil assessed the efficacy of CBD versus placebo in 21 subjects with Parkinson’s. Authors reported that the administration of 300 mg doses of CBD per day was associated with “significantly different mean total scores” in subjects’ well-being and quality of life compared to placebo.

Separate assessments of CBD versus placebo reported that the cannabinoid did not appear to mitigate general symptoms of the disease, nor was it shown to be neuroprotective.

“This study points to a possible effect of CBD in improving measures related to the quality of life of PD patients without psychiatric comorbidities,” investigators concluded. They added, “We found no statistically significant differences concerning the motor symptoms of PD; however, studies involving larger samples and with systematic assessment of specific symptoms of PD are necessary in order to provide stronger conclusions regarding the action of CBD in PD.”

Clinical reports have previously indicated that both CBD and/or whole-plant cannabis may address various symptom’s of Parkinson’s disease, including improvement in motor symptoms, pain reduction, improved sleep, and a reduction in the severity of psychotic episodes.

Survey data of patients with PD indicates that almost half of all subjects who try cannabis reportexperiencing subjective relief from the plant.

The abstract of the study, “Effects of cannabidiol in the treatment of patients with Parkinson’s disease: An exploratory double-blind trial,” appears online here.

    

Tags : cannabidiol, CBD, parkinson's 
Posted in : SCIENCE 

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7 Responses to “Study: CBD Administration Associated With Improved Quality Of Life In Patients With Parkinson’s Disease”

1.   TheAntiProhibitionist says:

September 25, 2014 at 5:16 pm

At this point I can’t feel surprised when I see an article about the many benefits of Cannabinoids and THC in healthcare applications. I feel like we don’t have to resort to the dirty tactics the prohibitionists use, because we use the facts. I think we can directly credit organizations like NORML and the MPP with our recent gains in cannabis law reform.

2.    Galileo Galilei says:

September 26, 2014 at 10:13 am

The range of maladies the noble weed proves effective against continues to amaze me. It’s great to have marijuana returned to humanity’s pharmacopoeia.

3.    Fireweed says:

September 26, 2014 at 10:17 am

because this substance acts on the body in a bidirectional homeostatic manner. which is why there is no lethal dosage. It also has an anti-inflammatory effect, which is the underlying problem with maladies of aging. Which is why individuals like Willie Nelson can look so good and function so well at age 81. (Had to do a double take when I saw his age.)

4.    Fireweed says:

September 26, 2014 at 10:18 am

the obvious hypothesis then is that cannabis is good not only for these chronic inflammatory related diseases, but good for all of us. Now put that in your pipe and smoke it.

5.    Joel Anglin says:

September 26, 2014 at 2:22 pm

Maybe the federal government in the U.S. could do some tests with medical marijuana and Parkinson’s disease.

6.    Julian says:

September 26, 2014 at 9:55 pm

Thank you NORML for bringing up the subject of quality of life. It astounds me every time I tell my own sisters that non psychoactive CBDs can help with their son’s epilepsy or chrone’s disease that I hear scared answers like, “yeah, but it won’t cure it.” Well who said anything about cure?
I watched my Godmother puke her life away on Chemo, both of us knowing I could give her some weed and even with the psychoactive THC, make the nausea go away… But I didn’t give her any and she wouldn’t accept any because we both knew her daughter would be too angry about giving her an illegal substance and not following the doctor’s orders. But cancer patients just want to die with dignity and control their own pain and share their last moments on earth with the people they love. That’s pretty hard to do when you’re puking every bit of nutrient out of your body.
My grandfather died of Parkinson’s disease. He went from a tall, strong doctor to be confined to a wheel chair. I think about how much he suffered unable to control his hands and head and the way my grandmother suffered when grandpa would go crawl up out of his wheel chair and fall out of a deer blind because he was determined to die the way he had lived.
My grandfather had begun his medical career, graduating from Harvard medical school when discussion of cannabinoids was prohibited. He was a field medic in Normandy and became president of the lower Missouri medical society. Throughout his career, doctors would be threatened with losing their license if caught prescribing or even studying marijuana without a permit the DEA would scarcely issue. When he was diagnosed with Parkinson’s, I wonder if marijuana even crossed his mind? He died in 1995; the year before the truth about the human endocannabinoid system was finally allowed to be published by doctors inside the United States.
Since the C.S.Act of 1970, the Office of Drug Control Policy uses our tax dollars to deny the medical benefits of marijuana so it cannot be descheduled for medical research. To put this into perspective in the cost of human life, imagine if your auto mechanic was prohibited from studying the wiring diagram or sensors to your brand new 2014 Chevy Cruze. A sudden recall determines your Chevy Cruze has Parkinson’s disease and will no longer deploy its airbags and occasionally, the ignition might shut you down right in the middle of traffic. So your mechanic prescribes an expensive array of dealership check ups, designed to check everything but the problem your car has, because he’s not aloud to use the wiring diagram without risking prosecution or sell you any sensors for risk of patent fraud loss of license and incarceration. That would be pretty stupid wouldn’t it? That is, unless you’re selling sensors on the dangerous black market… Where you could get mugged and hey, while you’re there they try to sell you some heroin and a stolen DVD player. Oh yeah, there are about 20 different “strains” of sensors and you need to find out which one cures your car. No textbooks. No mechanics. No diagrams. Good luck.
That’s what our government has been prohibiting from human beings for three quarters of a century now; the human endocannabinoid system; the diagram of life and a vast network of vital human hormonal traffic has been prohibited from practice or study. And since my grandfathers death cannabinoids have even been patented by our own Department of Health and Human Services patent 6630507.
It is nearly impossible to calculate the harm and suffering that prohibition continues to cause within American society and abroad. We can only be encouraged by the advance in quality and reduction in cost our medical care will achieve from the now inevitable descheduling of cannabis from the unconstitutional Controlled Substance Act, thanks to institutions like NORML and the increased access to the internet to working class American consumers and voters with less income or education.
This is why it is more important than ever to donate to NORML PAC, write your Congressman , get educated about your candidate and vote this November, or in Octobers early elections. This is the opportunity we have to stop the suffering, and begin a new era of medical enlightenment; a Green Age of sustainability where real affordable education, energy and health care is tangible and possible, and decided by doctors, patients and representatives elected by commercially taxed marijuana.

http://blog.norml.org/2014/09/25/study-cbd-administration-associated-with-improved-quality-of-life-in-patients-with-parkinsons-disease/
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Day of Event - Unity Walk - Annual Fundraising Walk In Central Park NYC To Raise Money For Research Into Parkinson's Disease

Day of Event - Unity Walk - Annual Fundraising Walk In Central Park NYC To Raise Money For Research Into Parkinson's Disease


http://unitywalk.kintera.org/2015/mswope99

Flurry of Investor Activity Accelerates Parkinson’s Therapies through Development

Posted by  Maggie McGuire, September 24, 2014

Over the last few weeks many biotechnology and pharmaceutical companies working on therapies for Parkinson’s disease have announced partnerships and investments from larger companies and funders with deeper pockets. What does this mean for patients? There’s a greater likelihood that these potential treatments will progress through development and testing — and on to pharmacy shelves — faster.

All of these projects have been supported by The Michael J. Fox Foundation, as well. Our de-risking model funds projects in the early development and testing phases so they can build the data to attract partners with the resources to bring them to the finish line. These partnerships and follow-on funding are important milestones on the path to getting these therapies into patients’ hands.

Company: Civitas Therapeutics
Project: CVT-301 is an inhaled formulation of levodopa for fast-acting relief of “off” episodes.
Recently Announced: After $55 million in venture capital investment and filing for an initial public offering (IPO) earlier this year, Civitas announced earlier today that they have been acquired for $525 million by Acorda Therapeutics.
MJFF Investment: $1.3 million

Company: MedGenesis
Project: An optimized delivery technique for neurotrophic factors could help this therapy reach its brain target to restore damaged nerve cells.
Recently Announced: Pfizer signed on to continue development of this therapy. Terms were undisclosed.
MJFF Investment: $2.1 million

Company: Neuroderm
Project: ND-0612 is a pump-patch system of delivering levodopa and carbidopa continuously, under the skin, to reduce motor complications.
Recently Announced: After a $16 million venture capital investment earlier this year, Neuroderm filed for an IPO late this summer.
MJFF Investment: $2.5 million

Company: Sapiens
Project: Their system optimizes localization of deep brain stimulation to improve outcomes and avoid side effects.
Recently Announced: Medtronic acquired Sapiens for $200 million.
MJFF Investment: $366,000

Participate in clinical trials testing new Parkinson’s therapies. Register for Fox Trial Finder to be matched with studies looking for volunteers like you.

https://www.michaeljfox.org/foundation/news-detail.php?flurry-of-investor-activity-accelerates-parkinson-therapies-through-development

New findings on how brain handles tactile sensations

Neurology / Neuroscience

Stroke

Parkinson's Disease

 Sept.26, 2014

The traditional understanding in neuroscience is that tactile sensations from the skin are only assembled to form a complete experience in the cerebral cortex, the most advanced part of the brain. However, this is challenged by new research findings from Lund University in Sweden that suggest both that other levels in the brain play a greater role than previously thought, and that a larger proportion of the brain's different structures are involved in the perception of touch.

"It was believed that a tactile sensation, such as touching a simple object, only activated a very small part of the cerebral cortex. However, our findings show that a much larger part is probably activated. The assembly of sensations actually starts in the brainstem", said neuroscience researcher Henrik Jörntell at Lund University.

According to his colleague Fredrik Bengtsson, who also participated in the research, this is the first study to show how complex tactile sensations from the skin are coded at the cellular level in the brain.

"Our findings have given us a new key to understanding how the perception of touch in the skin is processed and communicated to the brain", he said.

The Lund researchers have worked in collaboration with researchers in Paris to study how individual nerve cells receive information from the skin. They used a 'haptic interface'*, which created controlled sensations of rolling and slipping movements and of contact initiating and ceasing. Movements proved decisive for the perception of touch - something that was not previously technically possible to study.

The findings of the Swedish-French research group have been published in the distinguished journal Neuron. The work is based on animal experiments and is first and foremost basic research, which aims to increase knowledge of the function of the brain. However, there are also possible areas of application.

"Normal hand and arm prostheses do not give any feedback and therefore no sensation of being a 'real' hand or arm. However, there are new, advanced prostheses with sensors that can supply information to the amputated arm. Our research could contribute to the further development of such sensors", said Henrik Jörntell.

The new findings could also have a bearing on psychiatric illness and brain diseases such as stroke and Parkinson's disease. Detailed knowledge of how the brain and its various parts process information and create a picture of a tactile experience is important to understanding these conditions.

"If we know how a healthy brain operates, we can compare it with the situation in different diseases. Then perhaps we can help patients' brains to function more normally", said Henrik Jörntell.

http://www.medicalnewstoday.com/releases/283056.php

http://www.cell.com/neuron/abstract/S0896-6273(14)00649-7

Questions Raised Over Differences Between Brand Name Rx Drugs vs. Generic

Sep 24, 2014, 6:28 PM ET By JIM AVILASERENA MARSHALL, NICK CAPOTE and SARAH KOLINOVSKY JIM AVILA More From Jim » Senior National Correspondent   SERENA MARSHALL More From Serena »   via NIGHTLINE

When Robin Lynn, who suffers from depression, was prescribed a generic version of a popular anti-depressant medication, she didn't think it was going to be a big deal.

"I thought that generic drugs are the exact same thing as the name brand drug," Lynn said.

But after taking Budeprion XL 300, a generic form of brand-name Wellbutrin XL, Lynn, who is from New York, said she noticed over time that the drug wasn't helping.

"I would have a lot of energy, but by middle of the day I would have no energy, I would crash, and it wasn't really controlling my depression symptoms either," she said. "My outlook on life was different in a matter of hours. I knew that was just not normal, that’s not how things are supposed to be."

Prescription Drugs: Generics, Brand Names Not the Same?

In 2007, Lynn went looking for answers and reached out to pharmacologist Joe Graedon, who wrote the best-selling book, "The People's Pharmacy," with his wife Terry Graedon, and hosts a popular radio show. Around that same time that he heard from Lynn, Graedon said he began to receive complaints about Budeprion XL 300, with users reporting some intense side-effects not seen with using the brand name drug.

"They were getting very jittery. They were experiencing headaches. They were having stomach problems, insomnia, just a whole range of side effects, and it just wasn't clearing up their depression the way the brand name drug was," Graedon said. "And some of them even expressed suicidal thoughts."

"It was like getting a shot of adrenaline first thing in the morning," Lynn said. "It would make my hands shake, my heart would pound."

Eight out of 10 prescriptions written in the United States are filled with the no-brand name, generic version of the drug prescribed by a doctor, and every year generic drugs save American consumers more than $200 billion in prescription costs.

For years, Joe and Terry Graedon were strong advocates for the use of generic drugs.

"We were huge supporters of generic drugs, because you can save an amazing amount of money," Joe Graedon said. "I mean a brand name drug for heartburn or for depression can cost a couple of hundred dollars a month. The generic might cost only $5 or $10 a month... So if they were identical, I mean, What's not to like?"

But when hundreds of people started writing in with their negative experiences with Budeprion XL 300, the Graedons became concerned and contacted the U.S. Food and Drug Administration, asking them to investigate.

"Pretty much we heard nothing back," Joe Graedon said. “The FDA didn't seem very responsive to our concerns."

So Graedon decided to take the investigation into his own hands. He took the drug Budeprion XL 300 to ConsumerLab.com, which independently tests generic drugs for universities, businesses, hospitals and government agencies, and asked them to test how Budeprion XL 300 dissolves, and whether it dissolves the same way as the brand-name drug, Wellbutrin XL.

The FDA mandates that generic forms of prescription medication contain the same active ingredient as the brand name, but the agency allows the generic version to use different inactive ingredients, including binders to hold the pill together and time release agents to disperse it.

pagebreak That dissolution process was important with Wellbutrin XL and its generic forms because they are "extended release" drugs. Every time-release drug has a mechanism to distribute the active ingredient into a patient's system. The generic forms aren't required to have the same mechanism as their brand name.

"What we found was shocking," said Dr. Tod Cooperman, the president of ConsumerLab.com. "The generic released its ingredient very quickly. In fact after just two hours, 34 percent of the ingredient had come out into solution. The original product had only released 8 percent at that time. ... so you're getting a burst of medication coming out very early on with the generic that you shouldn't be getting."

Such a huge early release of the generic drug Budeprion XL 300 would mean the active ingredient would spike and be used up quickly, leaving little of the active ingredients in a patient’s body for the rest of the day, while also potentially causing unexpected side-effects.

After publishing their results, Cooperman said, "it seemed like the FDA kind of wanted to quash this issue. The manufacturer also questions, you know, did we do the right test? The FDA said everything was fine."

The drug information insert that comes with Budeprion XL 300 stated that the drug had been "tested in a study" and "equivalence was demonstrated" with the name brand Wellbutrin XL, but then, the FDA announced a shocking admission.

"The FDA finally admitted that there actually had never been a study of this generic, and it had never been tested in humans, and that the information in that package insert was therefore, just made up," Cooperman said.

As it turns out, the FDA did require testing in a lower dose of Budeprion XL and used those results to approve the 300mg-strength version.

Janet Woodcock, the director of the Center for Drug Evaluation and Research at the FDA, told ABC News that the 300mg version wasn't tested separately because "there was concern about testing the generics in normal volunteers."

"We had had seizures reported, and we were worried that we would be unethically exposing volunteers," she said.

But Cooperman believes the FDA made an error in not doing further testing.

"If you're going say 'OK it's good enough for 300 million people to take it potentially, but we're not going to test it in 24 healthy people,' I can't follow that rationale," he said. "I think they made a big mistake there."

Five years after the Graedons' first complained to the FDA, the agency took Budeprion XL 300, the 300mg version, off the market in 2012.

"It was not equivalent enough to the brand drug," Woodcock said.

Manufacturers for the drug declined ABC News' requests for comment. Other forms of generic Wellbutrin are still on the market, and they are all considered safe. In fact, experts agree that generic drugs are in general extremely safe.

But there have been other cases of generic drugs causing different effects in patients. Dr. Harry Lever, a cardiologist and the medical director of the Hypertrophic Cardiomyopathy Center at the Cleveland Clinic said he starting seeing patients having problems with a generic form of Toprol XL, a blood pressure medication.

"They began getting chest pain or shortness of breath or dizziness. And some of them I would just change the manufacturer back to the name brand... some would seem to feel better," he said.

Lever wrote to the FDA about his concerns in December 2012. He received an assurance, 18 months later, that all forms of generic Toprol were up to the FDA's standards. But then, just two weeks later, the FDA announced two forms of that drug manufactured in India were voluntarily recalled.

According to the FDA, the recall was "a coincidence." Woodcock said these recalls were routine and due to some specific lots that may have degraded over time. Dr. Reddy's Laboratories Ltd., one of the companies that manufactured the drug, also told ABC News that the voluntary recall was "related to specific manufacturing issues with the two batches in question and not related to manufacturing of any other batches."

But Lever isn't buying it.

"All I can speak to is what I'm seeing," he said. "And I've seen problems and when you have batches that are removed you begin to wonder that there are problems and you can't just ignore it."

Though watchdogs like Graedon and Cooperman believe most generics are safe, they still have concerns about others.

“We suspect there are at least dozens if not scores of generic drugs that may not live up to the standards that the American public expects,” Graedon said.

The FDA disagrees. Woodcock told ABC News that the FDA stands "behind the fact that generic drugs that are on the US market have delivered the same performance as the brand drugs."

The bottom line is generic forms of prescription medication, while generally safe, are not identical to their brand-name drugs, though critics suggest using caution and speaking with your doctor.

http://abcnews.go.com/Health/questions-raised-differences-brand-rx-drugs-generics/story?id=25729595&singlePage=true