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Category: Pharma/Medicine

Pharmacies Don’t Know How to Dispose of Leftover Opioids and Antibiotics

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Today (Dec. 30), a team of researchers from the University of California, San Francisco and the Children’s National Hospital in Washington, D.C., published the results of an investigation into whether or not pharmacy workers could provide accurate information on the disposal of two classes of drugs: opioids and antibiotics. The results are frightening:

The researchers enlisted volunteers to place calls to nearly 900 pharmacies in California, posing as parents with leftover antibiotics and opioids from a “child’s” recent surgery. They asked the pharmacy employees on the line—either pharmacists or pharmacy technicians—how to deal with these unused drugs, and then the researchers compared those answers to the guidelines for correct disposal published by the U.S. Food and Drug Administration (FDA).

The found that approximately 43% of pharmacy workers responded accurately on how to deal with antibiotics; just 23% knew what to do with opioids.

Drug disposal is one of those vexing problems where people generally want to do the right thing, but often simply don’t know how. As Hillary Copp, associate professor of urology at UCSF and the senior author of the study noted in a press release, “The FDA has specific instructions on how to dispose of these medications, and the American Pharmacists Association has adopted this as their standard. Yet it’s not being given to the consumer correctly the majority of the time.”

According to the FDA, unused medications should be put (without crushing any pills or capsules) in an “unappealing substance such as dirt, cat litter, or used coffee grounds;” that mixture should then be put into a sealed container like a secure plastic bag before it is thrown out. In addition, all personal information should be scratched out or otherwise destroyed.

Indeed, in 2017, a team of scientists from the U.S. Geological Survey and Environmental Protection Agency published a paper reporting the results of a study of 38 streams across the country. It found 230 human-created drugs and poisons. And there are significant knock-on effects of improper disposable: many of the drugs identified in the 2017 study are known to kill, harm the health of, or change the behavior of fish, insects and other wildlife. This, in turn, can impact the food chain, and eventually harm humans as well.

Antibiotics and opioids, the two drug classes that the Annals of Internal Medicine study looked at, are particularly malevolent when not disposed correctly.

When antibiotics are disseminated widely throughout the environment, it raises the chances of bacteria developing resistance to the drugs. Any bacteria that encounters an antibiotic, whether in the human body, or in a stream or pond, will attempt to survive. Those that do will pass their genes onto future generations of bacteria, fueling a growing global health concern: the World Health Organization has made it clear that antimicrobial resistance in microbes (which includes antibiotic-resistant bacteria), is one of the globes biggest impending public health challenges, given that it could eliminate some of medical science’s most effective tools against disease-causing organisms.

Meanwhile, research into the impacts of opioids on lab animals suggests that they respond to the drugs much like humans: by self-administering over and over, to their detriment. Scientists are still working on understanding how opioids in the waste stream impact animals living in the wild. One thing is for sure: opioids ARE in the global water supply. A 2018 review of the scientific literature found 22 opioids in wastewater and surface water samples from all over the world.

Perhaps the bigger issue with opioids, however, is that those prescribed them tend to keep them around. The results of a survey published in JAMA Internal Medicine in 2016 found that about 60% of Americans prescribed opioids kept their leftover meds for “future use,” and a number of recent studies and investigations have found that these drugs, when either shared with or surreptitiously taken by relatives and acquaintances, can lead to addiction and overdose.

On the flip side, other recent studies have noted that clearer guidance and take-back events can get people to not only get rid of unused opioids, but to do so in a way that’s environmentally sound. Given the ongoing American opioid crisis, any steps to get this class of deadly drugs off the street—and out of medicine cabinets—could be significant. This most recent study suggests that one place to start might be at the point-of-sale: the pharmacy.

By Elijah Wolfson December 30, 2019

Source: Pharmacies Don’t Know How to Dispose of Leftover Opioids and Antibiotics

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According to the Substance Abuse and Mental Health Services Administration, addiction to prescription opioid painkillers is real. Of the 21.5 million Americans 12 or older who had a substance use disorder in 2014, 1.9 million had a substance use disorder involving prescription pain pills. Addicts aren’t just the stereotypical shady figures hiding in dark alleys to get a fix. They are average people turning to health care providers for medication that is highly addictive. Mayo Clinic experts agree that an opioid epidemic exists in the U.S. In this Mayo Clinic Minute, reporter Vivien Williams talks to pain medicine specialist Dr. Mike Hooten about the changing face of addiction. More health and medical news on the Mayo Clinic News Network http://newsnetwork.mayoclinic.org/

 

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CBD Oil for Parkinson’s Disease

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Every year in the United States, approximately 60,000 individuals are newly diagnosed with Parkinson’s disease according to the Parkinson’s Foundation (PF).[1]

The PF adds that, by the year 2020, the number of people living with this medical condition is expected to near one million in total, making it more prevalent than multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease combined.

What is Parkinson’s disease?

The American Parkinson Disease Association (APDA) defines Parkinson’s as “a type of movement disorder that can affect the ability to perform common, daily activities.”[2]

Unlike other movement disorders, Parkinson’s disease is characterized by a loss of brain cells, specifically those in the substantia nigra region. This lowers dopamine levels which causes issues related to movement regulation, thus impacting the patients’ quality of life.

Parkinson’s disease is both chronic and progressive, making this movement disorder one that is long-lasting, while also worsening as time progresses.

Also, though it typically appears after the age of 50, roughly one in ten Parkinson’s disease patients are diagnosed at a younger age. This is called Early Onset Parkinson’s.

Symptoms of Parkinson’s tend to vary from person to person and fall into one of two categories: motor symptoms and non-motor symptoms.

The APDA shares that it is the motor symptoms of Parkinson’s that typically make these typical daily movements more difficult, some of which include experiencing tremors, having stiff or rigid muscles, walking difficulties, slowness of movement (also known as bradykinesia), and postural instability.

Another motor symptom Parkinson’s disease patients tend to notice is a change in their voice. Changes in volume are common in the early stages, whereas speaking fast, crowding words, and stuttering are more prevalent in advanced stages of this disease.

Parkinson’s symptoms that don’t involve movement and are therefore sometimes missed, include:

  • Reduced sensitivity to smells
  • Trouble staying asleep
  • Increased depression and anxiety
  • Psychotic symptoms such as hallucinations and delusions
  • Fatigue
  • Weight loss
  • Excessive sweating
  • Difficulty multi-tasking
  • Harder time with organization
  • Constipation
  • Increase in urinary frequency and urgency
  • Lightheadedness
  • Reduced libido
  • Slower blinking and dry eyes

Currently, there is no cure for Parkinson’s. However, patients do have a few treatment options that can help manage this particular medical condition.

One is taking a medication to help better manage motor function. Two well-known options include Levodopa and Carbidopa, both of which can be prescribed in varying strengths and formulations.

Another common Parkinson’s treatment is therapy. For instance, physical therapy may be pursued to aid in walking and occupational therapy can help enhance fine motor skills. Speech therapy may also be required to assist with vocal issues.

Deep brain stimulation is an option as well. Approved by the U.S. Food and Drug Administration (FDA) several years ago, this treatment method is a form of surgical therapy in which an electrode is implanted in the brain, then stimulated via a device that is placed in the chest area under the skin.

The APDA further indicates that complementary medicine such as yoga and massage can also provide relief from symptoms of PD as well. Research is also finding that CBD oil can potentially help too.

CBD is short for cannabidiol, a chemical compound found within the cannabis plant that binds to cannabinoid receptors located in the body’s endocannabinoid system.[3]

CBD is different than other cannabinoids found in the marijuana plant that are known for producing the high commonly associated with medical marijuana use. This includes tetrahydrocannabinol (THC) and a similar cannabinoid, tetrahydrocannabivarin (THCV). Both THC and THCV can produce this high effect, whereas CBD does not.[4]

Additionally, our bodies do produce some cannabinoids on its own. These are called endogenous cannabinoids because they are so similar to cannabis plant compounds. CBD works by mimicking and augmenting these natural cannabinoids, providing a more therapeutic effect.

Admittedly, information in this field is still emerging, primarily because the endocannabinoid system is a relatively new finding due to the first endocannabinoid not being discovered until 1992.[5]

After the second one was identified three years later, researchers began to realize that the human body has an entire endocannabinoid system that offers positive effects related to bone density and diabetes prevention.

Since that time, research has also connected CBD with providing benefits for Parkinson’s disease.

For instance, one 2018 study published by Frontiers in Pharmacology shares that CBD helps by increasing levels of the endocannabinoid anandamide, an agonist of cannabinoid receptors.[6] It is also thought to aid in other processes found helpful for Parkinson’s patients, such as those related to serotonin receptors like 5-HT1A, peroxisome proliferator-activated receptors, and more.

Other studies shared by the National Institute of Health (NIH) have found similar results. Specifically, they indicate that the study of CBD in relation to Parkinson’s disease is especially interesting because of the direct relationship between endocannabinoids, cannabinoid receptors, and the neurons associated with this neurodegenerative disease that impacts the central nervous system.[7]

Another piece of research, this one published in the journal Cannabis and Cannabinoid Research, indicates that many clinical trials have been conducted in this area. [8] Though some have been inconclusive or controversial, others have found that CBD has positive effects on some of Parkinson’s motor symptoms.

One such study looked at 22 patients who engaged in the medical use of cannabis, which contains CBD.[9] In this case, improvements were noted in regard to tremor, rigidity, and bradykinesia 30 minutes after using medical marijuana.

Other pieces of Parkinson’s research have found that CBD can also help relieve non-motor symptoms. For instance, an open-label study—meaning that there is no placebo group, so the subjects know that they’re receiving active treatment—found that, after being taken for four weeks, CBD helped reduce psychotic symptoms.[10]

Another double-blind trial involved 119 Parkinson’s patients who were treated with either 75 mg of CBD per day, 300 mg CBD daily, or a placebo. Although researchers could not establish a statistically significant difference in motor and general symptoms scores, there were significantly different means in relation to their well-being and quality of life.[11]

The Michael J. Fox Foundation for Parkinson’s Research adds that research in this area is somewhat limited due to governmental regulations, with interpretation of results also impacted due to no standardization of CBD doses or use of products containing CBD and THC combined.[12] Therefore, it can be difficult to determine the specific effect CBD can provide to Parkinson’s patients.

Healthline reports that CBD oil has a number of scientifically-proven benefits that extend beyond those related to Parkinson’s.[13] Among them are:

One of the major concerns patients have with the use of CBD oil is whether or not it is legal. Psychology Today stresses that, while many people think that the passing of the 2018 Farm Bill legalized CBD federally, this isn’t exactly the case.[14]

Instead, the Farm Bill only legalized hemp, which is the fibrous stalk of the marijuana plant. Technically, all other parts of the plant are still illegal under the Controlled Substances Act.

What confuses the issue even more is that each state has set its own statutes regarding hemp, medical marijuana, and CBD. For instance, in New York, patients can smoke cannabis, but they aren’t banned from accessing it as a dried flower. However, if you live in Colorado, not only can individuals use medical cannabis, but children can even legally possess it on school campuses if they have status as a medical cannabis patient.[15]

Because of these variations, it is always recommended that Parkinson’s patients check the legality of cannabis use or CBD oil in their individual states before utilizing this option for treatment purposes.

[1] “Statistics.” Parkinson’s Foundation. https://parkinson.org/Understanding-Parkinsons/Statistics

[2] “What is Parkinson’s Disease?” American Parkinson Disease Association. https://www.apdaparkinson.org/what-is-parkinsons/

[3] “What is CBD?” Project CBD. https://www.projectcbd.org/about/what-is-cbd

[4] Rahn, B. “What is THCV and What Are the Benefits of This Cannabinoid?” Leafly. Feb 03, 2015. https://www.leafly.com/news/cannabis-101/what-is-thcv-and-what-are-the-benefits-of-this-cannabinoid

[5] “A History of Endocannabinoids and Cannabis.” UTT BioPharma. https://www.uttbio.com/a-history-of-endocannabinoids-and-cannabis/

[6] Peres, F.F. et al. “Cannabidiol as a Promising Strategy to Treat and Prevent Movement Disorders?” Frontiers in Pharmacology. May 2018; 9:482. Doi:10.3389/fphar.2018.00482. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5958190/

[7] Fernandez-Ruiz, J et al. “Endocannabinoids and Basal Ganglia Functionality.” Prostaglandins, Leukotrienes and Essential Fatty Acids. Feb-Mar 2002; 66(2-3):257-67. https://www.ncbi.nlm.nih.gov/pubmed/12052041

[8] Stampanoni Bassi, M et al. “Cannabinoids in Parkinson’s Disease.” Cannabis and Cannabinoid Research. Feb 2017; 2(1):21-29. Doi: 10.1089/can.2017.0002. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5436333/

[9] Lotan, I et al. “Cannabis (medical marijuana) treatment for motor and non-motor symptoms of Parkinson disease: an open-label observational study.” Clinical Neuropharmacology. Mar-Apr 2014; 37(2):41-4. Doi: 10.1097.WNF.0000000000000016. https://www.ncbi.nlm.nih.gov/pubmed/24614667

[10] Zuardi A.W. et al. “Cannabidiol for the Treatment of Psychosis in Parkinson’s Disease.” Journal of Psychopharmacology. Nov 2009; 23(8):979-83. Doi: 10.1177/0269881108096519. https://www.ncbi.nlm.nih.gov/pubmed/18801821

[11] Chagas M.H. et al. “Effects of Cannabidiol in the Treatment of Patients with Parkinson’s Disease: An Exploratory Double-Blind Trial.” Journal of Psychopharmacology. Nov 2014; 28(11):1088-98. Doi: 10.1177/0269881114550355. https://www.ncbi.nlm.nih.gov/pubmed/25237116

[12] Dolhun, R. “Ask the MD: Medical Marijuana and Parkinson’s Disease.” The Michael J. Fox Foundation for Parkinson’s Research. May 02, 2018. https://www.michaeljfox.org/foundation/news-detail.php?ask-the-md-medical-marijuana-and-parkinson-disease-a

[13] Kubala, J. “7 Benefits and Uses of CBD Oil (Plus Side Effects).” Healthline. Feb 26, 2018. https://www.healthline.com/nutrition/cbd-oil-benefits

[14] Pierre, J. “Now that Hemp is Legal, Is Cannabidiol (CBD) Legal Too?” Psychology Today. Jan 02, 2019. https://www.psychologytoday.com/us/blog/psych-unseen/201901/now-hemp-is-legal-is-cannabidiol-cbd-legal-too

[15] “Legal Information By State & Federal Law.” Americans for Safe Access. https://www.safeaccessnow.org/state_and_federal_law

Dr. Andrew Colucci

By: Dr. Andrew Colucci

Doctor of Medicine (M.D. cum laude) from Boston University School of Medicine in 2012 – Dr. Colucci is currently a radiologist in MA

Source: CBD Oil for Parkinson’s Disease

19.5K subscribers
Does medical marijuana help Parkinson’s symptoms? Rachel Dolhun, MD, movement disorder specialist and vice president of medical communications at The Michael J. Fox Foundation, answers this and other common questions about medical marijuana and Parkinson’s disease. The “Ask the MD” series is intended as an educational resource for people with Parkinson’s and their loved ones. Please consult with your personal healthcare provider to address individual medical questions. The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson’s today. https://www.michaeljfox.org We gratefully acknowledge the Steering Committee members of our Patient Disease Education Consortium in conjunction with The Albert B. Glickman Parkinson’s Disease Education Program and Charles B. Moss Jr. and family, whose sponsorship allows us to create and distribute materials, while preserving our track record of efficiency in stewarding donor-raised contributions for maximum impact on Parkinson’s drug development. Sponsorship support does not influence MJFF’s content perspective or panelist selection. Note: Tap cc in the lower right corner of the player to enable auto-generated captions for the video.

Why Cardiac Arrest Is More Likely To Kill Women Than Men, And What We’re Going To Do About It

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If you were walking down the street and a man fell to the pavement clutching his chest, would you know what to do? According to a recent study, of 19,331 out-of-hospital cardiac arrests, there’s a 45 percent chance that someone would rush forward to give the man the CPR he needs.

Important follow-up question: if you were walking down the street and a woman fell to the pavement clutching her chest, would you know what to do? The same study showed that a woman is 27 percent less likely than a man to get CPR from a bystander in public. While there isn’t enough research on the intersecting factors of gender and race, studies looking at race and gender separately suggest that women of color are even less likely to receive bystander CPR.

As half a million Americans will die from cardiac arrest annually, timely CPR is an incredibly important matter. Even as major health organizations train tens of millions of people in resuscitation techniques each year, women still lack equal access to the lifesaving compressions of CPR.

It’s important to look at why bystanders are so much less likely to intervene to save a woman in cardiac arrest. The first barrier is a wildly inaccurate myth that women don’t even experience cardiac arrest. Though many people think heart issues are a “men’s problem,” heart disease actually affects more women than men, killing roughly one woman every minute. Even when bystanders accurately identify that a woman needs CPR, they may be afraid to touch her breasts, confused about where to put their hands, or apprehensive about pushing down hard and fast on a woman’s body.

So, how do we address this laundry list of misconceptions that are literally killing women? The same way we popularized the resuscitation techniques that remarkably double or triple cardiac arrest victims’ chances of survival: through education.

Imagine a CPR manikin (the medical term for the dummies used in training courses), that expressionless, universal human form meant to represent everybody and anybody who could suffer cardiac arrest. See something missing from the manikin’s body? Or rather, two things?

Noticing this shocking oversight, an equal parts pissed-off and inspired team at JOAN Creative had an idea—the WoManikin. The WoManikin is a universal attachment that can easily be slipped over the common flat-chested manikin to add breasts. The WoManikin teaches people how to perform CPR on a torso with breasts during training, so they’ll know what to do when they see a woman or person with breasts in cardiac arrest.

By putting the sleeve design on WoManikin.org as an open source pattern and starting a fund to create more attachments, JOAN hopes to get a WoManikin in every CPR training program in the country by 2020. JOAN developed the WoManikin in collaboration with CPR experts, cardiologists, and organizations that care about closing the gender gap in CPR. So, in that way, the WoManikin doesn’t just provide a way to challenge biased CPR training—it shows what happens when women collaborate and apply creativity to tackle the inequities around them.

To learn more and join the fight to end gender disparities in CPR, visit WoManikin.org.

Hannah Lewman Hannah Lewman Brand Contributor

Hannah Lewman is a Strategist for JOAN Creative.

Source: Why Cardiac Arrest Is More Likely To Kill Women Than Men, And What We’re Going To Do About It

Walmart Joins Pharmaceutical-Tracking Blockchain Consortium MediLedger

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Big-box retail giant Walmart has joined MediLedger, a consortium building a blockchain for tracking the provenance of pharmaceuticals.

A spokeswoman for the Bentonville, Arkansas-based company confirmed Walmart’s participation to CoinDesk but had no further comment.

The move represents a deepening of Walmart’s involvement with blockchain technology. Separately, the retailer is a key participant in IBM’s Food Trust, a system for tracking fresh produce through the supply chain that’s built on the Hyperledger Fabric platform.

Walmart has insisted that its suppliers of leafy greens integrate the IBM blockchain, and it should bring similar supply-chain clout to MediLedger, whose members already include pharmaceutical manufacturers such as Pfizer and the three largest pharmaceutical wholesalers, McKesson, AmerisourceBergen, and Cardinal Health. 

“Health and wellness,” a category that includes pharmacy and over-the-counter drugs, accounted for $35 billion of Walmart’s U.S. sales in the fiscal year ended Jan. 31, or 10% of the total, according to the company’s annual report.

Unlike Food Trust, MediLedger uses an enterprise version of the ethereum blockchain, built with a modified version of the Parity client and a consensus mechanism called proof of authority. The consortium is spearheaded by San Francisco-based blockchain firm Chronicled, which closed a $16 million funding round earlier this year.

Walmart joins as MediLedger prepares to kick off a pilot project with the U.S. Food and Drug Administration (FDA) in early June. The agency is testing various approaches to creating an interoperable, digitized system for tracking and verifying prescription drugs, something Congress has mandated it deliver by 2023. 

Eric Garvin, co-lead of MediLedger, told CoinDesk:

“The pilots only really make sense if you are working with a group of collaborators.”

MediLedger initially focused on the verification of drugs that are returned to be resold – a sliver of the pharma market, but one that’s still worth over $6 billion. Legislation to help prevent fraudulent products being resold comes into effect in November of this year.

Now the expanded group will start work on the more broad-ranging tracking of all pharma products which involves interoperable data and packaging serialization.

Why blockchain?

It could be argued that in places like the U.K. where the healthcare system is largely run by the government, a digitized system like the one FDA has been mandated to create might be implemented more easily using a centralized system.  

But the U.S. is the largest privatized healthcare system in the world (with the highest prices), which makes for a sprawling fragmentation of siloed databases, supporting the case for a decentralized solution.

The Congressionally mandated 10-year roadmap to a standardized form of serialization on all drug packaging began with the very largest firms complying with electronic tracking of lot shipments, i.e. 100 boxes of some medicine at a time. The next goal was more granular serialization at the level of pillbox or bottle

The third plank of the legislation was that the data being gathered had to be technically interoperable.

That last requirement made some people in the industry think “blockchain is the perfect solution,” said Maria Palombini, director of communities and initiatives development for emerging technology at the IEEE Standards Association.

Palombini stressed that the FDA does not advocate one technology over another and its only prescription is the use of recognized standards within each pilot’s tech stacks.

However, making data (and metadata) interoperable presents the industry with a challenge, she said:

“I think some companies will try and embrace this, and some others will try and stay away from blockchain. Because there is one word that scares them – transparency.”

Garvin said nodes are distributed and operated by industry participants and technology providers, but that data privacy is being addressed with zero-knowledge proofs, a cryptographic method that allows someone to prove something is true about a set of data without exposing the data itself.

This data transparency question is especially pointed at the ends of the supply chain with large pharma dispensers like Walmart, who are unaccustomed to potentially sharing their sales data with competitors.

“They have to try and figure out a way to share this data give far more visibility into the inventory, but also now the retailers are going to have to give data back which they have never really been required to do so,” said Palombini. “That’s going to be a really hard part here.”

Walmart Pharmacy image via Shuttersto

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Source: Pivot – Blockchain Community

How Will The Failure Of Biogen’s Alzheimer’s Drug, Aducanumab, Impact R&D?

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Photographer: Scott Eisen/Bloomberg

© 2016 Bloomberg Finance LP

The landscape of experimental Alzheimer’s disease (AD) drugs is strewn with failures, so much so that it has been referred to as “an unrelenting disaster zone”. Recognizing the greatly increasing number of patients with this disease, many biopharma companies have invested a lot of resources in attacking this problem, only to be turned away in late stage studies as happened to Merck with its BACE inhibitor, verubecestat, and Lilly with its beta-amyloid antibody, solanezumab.

Now add Biogen to the list of companies that have failed in this arena. Its drug, aducanumab, partnered with Eisai, was believed to be better in removing beta-amyloid from the brain than any agent previously tested. Many have hypothesized that beta-amyloid causes the formation of damaging clumps of debris in the brain leading to AD. Unfortunately, Biogen halted a major clinical trial with aducanumab due to a futility analysis showing that the drug doesn’t work.

This is a terrible result for Alzheimer’s patients who had hoped that this was the drug that would finally succeed in treating AD. But the demise of aducanumab is also disastrous for Biogen which had expended an enormous amount of resources into this program, likely at the expense of other opportunities. It was a risky bet and one for which Wall Street has delivered a punishing blow. Biogen’s stock dropped by nearly 30% shortly after announcing the disappointing aducanumab results.

How is Biogen going to respond? As John Carroll has reported, many industry analysts believe that there aren’t many gems in the Biogen pipeline that can make up for the loss of this potential blockbuster. In predicting Biogen’s next steps, perhaps there are some learnings from another such pipeline failure – that of Pfizer’s torcetrapib.

Torcetrapib was the first of a class of compounds known as CETP inhibitors, drugs that both raised HDL-cholesterol and lowered LDL-cholesterol. A CETP inhibitor had the potential to remodel a heart patient’s lipid profile thereby greatly reducing his risk of a heart attack or stroke. There was tremendous excitement generated in this potential breakthrough treatment, not just in Pfizer but also among cardiologists and heart patients. In fact, internal commercial analyses predicted annual sales in excess of $15 billion. However, as happened with aducanumab, on December 4th, 2006, Pfizer announced that torcetrapib failed its long-term clinical study. The drug was dead. The Wall Street reaction was swift, albeit not as dramatic as Biogen’s experience. Pfizer stock dropped 10% as a result of this news.

Internally, the Pfizer reaction was intense. Torcetrapib was supposed to be the blockbuster that would drive growth into the next decade. Its loss created an enormous hole. Pfizer CEO Jeff Kindler responded in a couple of ways. First, he decided to “right size” R&D in relation to lower expected future revenues. In effect, hundreds of millions of dollars needed to be cut from R&D. Pfizer’s R&D budget had already undergone major portfolio adjustments and reorganizations over the previous five years due to the acquisition of Warner-Lambert Parke-Davis in 2000 followed by the acquisition of Pharmacia in 2004. Meeting the new R&D budget targets weren’t going to be achieved by simple cuts; rather, major research sites had to be closed and jobs had to be eliminated. Gone were R&D sites around the world including those in France, Japan and, most significantly, the iconic laboratory in Ann Arbor, Michigan.

But budget cuts weren’t going to be enough for Pfizer to meet its desired goals. The company began assessing major M&A opportunities and in 2009 it acquired Wyeth for $68 billion leading to yet another round of reorganizations and portfolio reshuffling. The ripple effect of the torcetrapib demise was felt by the entire company and lasted for a number of years.

So, how will Biogen respond? Undoubtedly, there will be budget cuts. In addition, perhaps Biogen will look at its R&D portfolio and give a higher priority to those programs that have the potential to deliver revenues in the short term. There might also be a push to drop programs deemed to be very risky or where the proof-of-concept requires long, expensive clinical trials. Finally, it wouldn’t be surprising to see Biogen become aggressive in their M&A activities. But make no mistake. The death of an important drug like aducanumab will have both a short and a long term effect on Biogen as a company and especially on R&D.

John LaMattina

Contributor

I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and Asi…

Source: How Will The Failure Of Biogen’s Alzheimer’s Drug, Aducanumab, Impact R&D?

Blood Type: Microbiome and Diet — CFS Remission

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One of my favorite sources for information on the microbiome is run by Dr. Peter J. D’Adamo. For many years he has advocated eating for your blood type. In this week’s issue of New Scientist. an article “Your gut bacteria may match your blood group – but we don’t know why“ The difference between many […]

via Blood Type: Microbiome and Diet — CFS Remission

HLA system in solid organ transplantation part 25 — MEDICINE FOR ALL

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HLA mismatches and the production of alloantibodies HLA mismatches are not only the trigger for alloreactive T cells to destroy the transplant parenchyma, they also lead to the formation of alloreactive anti-HLA antibodies; and together they contribute to acute and chronic rejection, and the eventual immunologically-mediated transplant loss. But it is not the number […]

via HLA system in solid organ transplantation part 25 — MEDICINE FOR ALL

Human Leukocyte Antigen (HLA) part 102 — MEDICINE FOR ALL

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The discovery that foetal cells are devoid of the highly polymorphic HLA class Ia molecules, except for a low expression of HLA-C, is believed to play a dominant role for the induction of tolerance to the semi-allogenic foetus. Interestingly, the foetal-derived tissue in placenta does express the loss polymorphic HLA class Ib molecules, HLA-E, […]

via Human Leukocyte Antigen (HLA) part 102 — MEDICINE FOR ALL

Why Doctors Hate Their Computers – Atul Gawande

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On a sunny afternoon in May, 2015, I joined a dozen other surgeons at a downtown Boston office building to begin sixteen hours of mandatory computer training. We sat in three rows, each of us parked behind a desktop computer. In one month, our daily routines would come to depend upon mastery of Epic, the new medical software system on the screens in front of us. The upgrade from our home-built software would cost the hospital system where we worked, Partners HealthCare, a staggering $1.6 billion, but it aimed to keep us technologically up to date……..

Read more: https://www.newyorker.com/magazine/2018/11/12/why-doctors-hate-their-computers

 

 

 

 

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The Global Drug Industry Putting Your Life At Risk – Srinath Perur

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In late 2012, 60 people died in two cities in Pakistan after drinking cough syrup to get high. Syrups from two separate manufacturers were involved. It was found that both were using an active ingredient — dextromethorphan, a synthetic morphine-like compound — imported from the same manufacturer in India. Indian drug authorities put a halt to production while they investigated. Tests in Pakistan revealed that the medicines seemed to contain the correct amount of active ingredient. But further tests revealed something that was not supposed to be there……..

Read more: http://digg.com/2018/fake-drugs-global-industry

 

 

 

 

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