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Thursday, August 11, 2022

'Inflation Reduction Act' Will Push Cancer Patients Off a Cliff

 The doctors have sent warnings, the Congressional Budget Office has sent warnings, and economists have sent warnings. The question now – is Congress going to listen and reject the Inflation Reduction Act or blame everyone else when the consequences of this horrible bill are exposed?

Last week a new provision was added to the reconciliation process that would reduce payments to physicians that give infusions, a medication that needs to be received through an IV line; like chemo, medications for immunodeficiencies, and chronic diseases; in their offices and hospitals.

Simple right? Well, not so fast. Independent physicians will receive a substantially bigger cut—a larger cut than the physicians employed by large hospital systems that have corporate lobbyists strategically positioned around Washington DC. This new cut for independent physicians will add to the already substantial financial pressure on independent physicians to sell their practices to large hospital systems, further accelerating a trend that has already resulted in 74% of physicians being employed by such entities. Ultimately, it will hit cancer and rheumatology patients hard, as these two kinds of specialists take on substantial financial risk by using a "Buy and Bill" method to give their patients lifesaving and disease-relieving infusions. 

The consequences don't stop there – Patient Protection and Affordable Care Act (PPACA) created huge financial incentives for large hospitals to acquire physician practices. But data show that this change has resulted in higher costs for patients without providing any improvement in the quality of care.  In fact, one study goes further to recommend that "policymakers should carefully consider policies that limit consolidation of hospitals and physicians." Clearly, the Senate Democrats did not heed this warning. With the payment cuts proposed in the latest bill, hospitals will have greater ability to snap up independent practices. 

Some independent groups, like the National Cancer Care Alliance comprised of 200 oncologists, have banded together to share best practices and savings. They state they: 

"Have developed systems that are designed to greatly reduce hospitalization rates, avoid hospital facility fees and hospital associated complications, and provide care that is more efficient with better results, and is less disruptive to your life, at a significantly lower cost." 

Currently, one in five oncologists are over age of 64. They may simply decide to hang up their practice for good, not wanting to be told how to practice by hospital administrators.

This would be in addition to a 4.4% Medicare pay cut that oncologists face as of January 2023, which is on top of the 4.4% cut they already took this year. Clearly this is terrible timing, as the American Society of Clinical Oncologists estimates a 45% increase in cancer diagnosis by 2030, mostly among seniors and minority populations. Thanks to this policy, Medicare costs will go up and its beneficiaries' access to quality care will decline. As a WSJ editorial notes, "patients will pay a steep price." Both patients and physicians continue to be a casualty of political deal-making in Congress. 

Keep in mind the other deleterious effects of this bill. A year ago, the CBO warned that innovation for chronic and currently incurable diseases will decline with the passage of provisions in the Inflation Reduction Act. It is easy to brush this aside until it is you or your loved one that is suffering. It is easy to brush this aside if it isn’t your patient, who may pay with their life. It seems easy for a bunch of elected officials to take these possibilities away from our patients.

It doesn’t necessarily take a game changer to bring relief to our patients. Some new medication innovations can bring comfort. Some might recall that cancer patients treated with anti-nausea medications that barely worked. Ondansetron, now the standard, has been a Godsend.

This bill will be a problem especially for oncology and rheumatology patients. But all of America will pay the inflated prices of further consolidation, reduced access, and less innovation down the road. Congress asked Americans to listen to their doctors during COVID, Doctors are now asking Congress to listen.

Arvind Cavale is a Clinical Endocrinologist in independent practice in Bucks County, PA and a patient advocate.

https://www.realclearhealth.com/articles/2022/08/11/inflation_reduction_act_will_push_cancer_patients_off_a_cliff_111388.html

GSK: FDA, EMA Concluded No Evidence Of Causal Link Between Ranitidine Therapy, Cancer

 SAYS FDA AND EMA HAVE CONCLUDED THERE IS NO EVIDENCE OF A CAUSAL ASSOCIATION BETWEEN RANITIDINE THERAPY AND THE DEVELOPMENT OF CANCER

* PLAINTIFF LITIGATION INCONSISTENT WITH SCIENTIFIC CONSENSUS, GSK WILL VIGOROUSLY DEFEND ALL CLAIMS

https://www.marketscreener.com/quote/stock/GSK-PLC-9590199/news/GSK-Says-U-S-FDA-And-EMA-Have-Concluded-There-Is-No-Evidence-Of-A-Causal-Association-Between-Raniti-41285694/

Novartis to Update Zolgensma Labeling

 NOVARTIS - FOLLOWING 2 RECENT PATIENT FATALITIES IN ZOLGENSMA GENE THERAPY CO WILL BE UPDATING LABELING TO SPECIFY FATAL ACUTE LIVER FAILURE REPORTED

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-Says-Following-two-Recent-Patient-Fatalities-In-Zolgensma-Gene-Therapy-Co-Will-Update-Labe-41287370/

Illumina Shares Plunge 22% After Hours On 2Q Loss, Slashed Fiscal Year Outlook

 Shares of Illumina Inc. dropped 22% to $178.32 in after-hours trading on Thursday after the company posted worse-than-expected results for its second quarter and lowered its fiscal-year outlook.

The company swung to a loss of $535 million, or $3.40 a share, compared to a profit of $185 million, or $1.26 a share, a year ago. Analysts polled by FactSet were looking for a profit of 36 cents per share.

Chief Executive Francis deSouza said the company faced macroeconomic challenges that more than offset its growth in sequencing runs on its platforms. It also saw $609 million in legal contingencies, including an accrual of $453 million, for the potential fine that the European Commission may impose on revenues related to a recent settlement.

Illumina on Thursday guided for fiscal-year consolidated revenue growth in the range of 4% to 5%. It also forecast a loss per share in the range of $2.93 to $2.78 and adjusted earnings per share between $2.75 and $2.90 for the year.

In May, it said it was looking for annual consolidated revenue growth between 14% and 16%, as well as earnings per share of $2.33 to $2.53. It also forecast adjusted earnings per share between $4 and $4.20.

https://www.marketscreener.com/quote/stock/ILLUMINA-INC-9659/news/Illumina-Shares-Plunge-22-After-Hours-On-2Q-Loss-Slashed-Fiscal-Year-Outlook-41287362/

Larimar Therapeutics Shares Soar 54% After Hours On CTI-1601 Update

 


 Larimar Therapeutics Inc. shares surged 54% to $3.05 in after-hours trading on Thursday after it said provided updates following a meeting with the Food and Drug Administration on the CTI-1601 clinical program.

The company said it received feedback from the FDA on information needed to resolve CTI-1601's current clinical hold, as well as a proposed change for a second phase. CTI-1601 is a treatment for Friedreich's ataxia.

Larimer plans to submit a complete response to CTI-1601's clinical hold in the third quarter.

Larimar is also proposing a phase two, four-week dose exploration study in Friedreich's ataxia patients. Friedreich's ataxia is a rare disease that causes progressive nervous system damage and movement problems, usually beginning during childhood.

https://www.marketscreener.com/quote/stock/LARIMAR-THERAPEUTICS-INC-16725745/news/Larimar-Therapeutics-Shares-Soar-54-After-Hours-On-CTI-1601-Update-41287820/

Repurposed drug could help patients with motor neuron disease

 A drug typically used to treat enlarged prostates and high blood pressure has shown promise as a potential new therapy for motor neuron disease (MND)—also known as amyotrophic lateral sclerosis (ALS)—according to a new study.

MND is a group of rare diseases that destroy  known as motor neurons, causing patients to slowly lose function of their muscles.

In studies using zebrafish, mice and stem cell models, experts have demonstrated that the drug terazosin protects against the death of motor neurons by increasing their energy production.

Researchers say the drug could help to slow the progression of a disease that affects around 5,000 adults in the UK. The average life expectancy is three years from the onset of symptoms.

The team are starting a feasibility study into the drug's effect in MND patients. If this proves successful, they will look to launch a full clinical trial.

It is still unclear why motor neurons die, but experts know that a decrease in their energy production takes place at an early stage of the disease.

Motor neurons need to produce energy to carry the brain's instructions to the muscles. If there is not enough energy, the messages cannot be transferred effectively and movement is affected.

Researchers from the University of Edinburgh, working with partners at the University of Oxford, targeted the energy production of motor neurons as a potential therapeutic strategy for treating MND.

Using terazosin, which has previously been shown to be effective at increasing energy production in models of  and Parkinson's disease, the team wanted to determine if this drug could also protect motor neurons from MND.

They focused on an enzyme—an active molecule in the cells—involved in energy production called PGK1.

Zebrafish models of MND showed that either genetically increasing the amount of PGK1 in the zebrafish or treating them with terazosin to increase PGK1's activity improved the growth of motor neurons.

Terazosin also protected motor neurons in a mouse model of MND, improving survival and delaying the progression of paralysis.

The team also grew motor neurons in a dish and demonstrated that terazosin protects these cells by increasing .

To investigate this further the teams at the Universities of Edinburgh and Oxford are inviting 50 patients from the Oxford MND Care and Research Centre to participate in a feasibility study, which will examine the impact of terazosin on key indicators of disease progression.

The study is published in eBioMedicine.

Research at the University of Edinburgh was carried out by a team at the Euan MacDonald Centre for Motor Neurone Disease, which was established by Euan MacDonald and his father Donald to improve the lives of people with MND.

Dr. Helena Chaytow, senior postdoctoral researcher at University of Edinburgh's Euan MacDonald Centre and first author of the study, said, "Our work shows that terazosin is protective of motor neuron cell death in multiple models of MND, making it an exciting new potential therapy. The benefit of working with terazosin is that it is already prescribed for a different health condition, so we know that it is safe for humans and could quickly move to the clinic."

Professor Tom Gillingwater, Professor of Anatomy at University of Edinburgh's Euan MacDonald Centre and study co-lead, said, "We are excited about the potential for terazosin to impact on the breakdown of motor neurons in MND. The current work illustrates the importance of bringing together scientists and clinicians in order to identify new targets for therapy suitable for taking forward into studies in human MND patients"

Professor Kevin Talbot, Professor of Motor Neuron Biology at the University of Oxford and study co-lead, said, "We urgently need to accelerate the way drugs are developed from laboratory models into trials in patients. Our work uses a combination of approaches to increase the confidence that drugs will actually work in people with MND and significantly slow disease progression. It represents an important new step in the search for therapies."

Dr. Jane Haley MBE, Director of Research for MND Scotland, said, "As key funders of this research study, we are delighted to see a potential new therapy for MND on the horizon. After testing in a range of models, the results of this study show us that terazosin, a drug currently used to treat enlarged prostates and high blood pressure, may be able to protect motor neurons. We are delighted that as a result, the drug will move to a feasibility study in Oxford, involving people living with MND. This is a wonderful example of researchers, clinicians and MND charities working together to try and speed up the search for new treatments for MND—because it's about time we found a cure."

Jill Douglas, CEO of My Name'5 Doddie Foundation, said, "The Foundation is encouraged that the collaborative nature of this work will aid translation from the lab to the clinic—it means that basic scientific research will be more meaningful in clinical practice. We are proud to have supported this collaboration and are continuing to support the first clinical trial of terazosin in people living with MND."


Explore further

Big data, bench science suggests drug may slow Parkinson's progression in people

More information: eBioMedicine (2022). DOI: 10.1016/j.ebiom.2022.104202
https://medicalxpress.com/news/2022-08-repurposed-drug-patients-motor-neuron.html

Non-invasive stimulation of the eye for depression and dementia

 A joint research team from the LKS Faculty of Medicine, The University of Hong Kong (HKUMed) and City University of Hong Kong (CityU) has discovered that the electrical stimulation of the eye surface can alleviate depression-like symptoms and improve cognitive function in animal models. These findings were recently published in Brain Stimulation and the Annals of the New York Academy of Sciences.

Major depression is the most common and severe psychiatric disorder across the world. Recently, the World Health Organization reported that the COVID-19 pandemic had triggered a massive increase in the number of people with anxiety and depression. About a quarter of patients do not respond adequately to the treatments available.

Dr. Lim Lee Wei, Assistant Professor in the School of Biomedical Sciences, HKUMed and a former Lee Kuan Yew Research Fellow in Singapore, reported in 2015 that deep  of the prefrontal cortex in the brains of animals could improve memory function and relieve depressive symptoms. These  were attributed to the growth of  cells in the hippocampus, a region of the brain known to be involved in learning and memory function. However, this technique, also known as , is invasive and requires surgery to implant electrodes in the brain, which may cause side effects such as infections and other post-operative complications.

Research findings and significance

A team of Hong Kong researchers headed by Dr. Lim Lee Wei; Dr. Leanne Chan Lai-hang, Associate Professor in the Department of Electrical Engineering, CityU; Professor Chan Ying-shing, Dexter H C Man Family Professor in Medical Science, Professor of the School of Biomedical Sciences, Associate Dean (Development and Infrastructure), HKUMed, and Director of the Neuroscience Research Centre, HKU, have been looking for alternative ways to treat neuropsychiatric diseases. They discovered that the non-invasive stimulation of the corneal surface of the eye (known as transcorneal electrical stimulation, or TES) that activates brain pathways, resulted in remarkable antidepressant-like effects and reduced stress hormones in an animal model for depression. Furthermore, this technique induced the expression of genes involved in the development and growth of brain cells in the hippocampus.

In related experiments, Yu Wing-shan, Ph.D. student, and other research members from the School of Biomedical Sciences, HKUMed, investigated whether this approach could be used to treat Alzheimer's disease, a common type of dementia with no definitive cure. They found that this non-invasive stimulation in mice drastically improved memory performance and reduced beta-amyloid deposits in the hippocampus, which is one of the hallmarks of Alzheimer's disease.

Dr. Leanne Chan Lai-hang, an expert on the electrical stimulation of visual and non-visual brain targets, described this research, "Transcorneal electrical stimulation is a non-invasive method initially developed to treat eye diseases, and it would be a major scientific breakthrough if it could be applied to treat neuropsychiatric diseases."

"These research findings pave the way for new therapeutic opportunities to develop novel treatment for patients suffering from treatment-resistant depression and dementia. Nevertheless,  must be conducted to validate the efficacy and safety," remarked Professor Chan Ying-shing.


Explore further

Researchers discover non-invasive stimulation of eye as potential treatment of depression and dementia

More information: Wing Shan Yu et al, Antidepressant-like effects of transcorneal electrical stimulation in rat models, Brain Stimulation (2022). DOI: 10.1016/j.brs.2022.05.018

Wing Shan Yu et al, Transcorneal electrical stimulation enhances cognitive functions in aged and 5XFAD mouse models, Annals of the New York Academy of Sciences (2022). DOI: 10.1111/nyas.14850


https://medicalxpress.com/news/2022-08-explore-non-invasive-eye-depression-dementia.html