Day: September 20, 2022

Categories : Ethics and Law Medical IndustryTags :

Is the US Failing to Hold Crooked Medical Industry Execs Accountable?

On By ModernMedia
Photo by Tingey Injury Law Firm on Unsplash

When it comes to violations of US federal law by pharmaceutical and medical device manufacturers, the US Department of Justice (DOJ) is not exercising its full authority, according to the findings of a review published in JAMA Internal Medicine.

The conviction of Elizabeth Holmes, CEO of the failed blood-testing company Theranos, has focused attention on the personal liability of corporate officers of medical companies engaging in illegal activity. Holmes was charged with defrauding and conspiring to defraud investors, patients, and physicians, each count carrying a maximum 20-year sentence. Among prosecutors’ allegations was that Theranos’ main blood-testing device failed to work as the company and Holmes had promised. While Holmes was convicted of defrauding investors, she faced no personal liability as a CEO responsible for a company knowingly selling faulty diagnostic tests.

When a drug or medical device company violates US federal law, the government can use the Park doctrine. It holds that a CEO for a health-related company has a “position of authority” in a profitable business selling “services and products [that] affect the health and well-being of the public.” The doctrine’s aim is to protect patients from harm caused by unsafe or fraudulent medical products and services. It does this by targeting the executives who run the companies that make revenues on these products while violating federal law.

This provides an alternative to having that risk borne by patients or impersonal corporate entities; however, it is rare for there to be public reports of drug and device company executives being prosecuted with Park doctrine.

The researchers sought to identify prosecutions using the Park doctrine and characterise their role in DOJ enforcement efforts related to medical product industry misconduct. To this end, they conducted a literature search.

They found 13 cases where executives from six drug and medical device companies prosecuted under the Park doctrine since 2000. These prosecutions resulted in 11 guilty pleas and two jury trials, leading to two convictions. Of the six companies, three were drug manufacturers, two were medical device manufacturers, and one was a compounding pharmacy. All three of the drug manufacturers were opioid manufacturers, of which two executives were charged for unlawful promotion, and one was charged for manufacturing errors. Both device manufacturer executives were charged with unlawful promotion. All but three prosecutions alleged the defendants’ complicity or personal involvement in the misconduct, which Park does not require. By contrast, most large settlements with the DOJ over alleged misconduct in the past two decades did not result in individual liability for executives.

“This review suggests that federal prosecutors have exercised far less than their full capacity under the Park doctrine to sanction problematic corporate behaviour that threatens patients and the public health,” the authors concluded. They suggest that enforcement under a reinvigorated Park doctrine would help to better protect patients.

Categories : Cardiovascular DiseaseTags :

With Warfarin, Dropping Aspirin Reduces Bleeding Complications for Some

On By ModernMedia
Red blood cells
Source: Pixabay

Research from Michigan Medicine suggests that, for venous thromboembolism (VTE) or atrial fibrillation (AF) patients without a history of heart disease who are taking warfarin, stopping aspirin use causes their risk of bleeding complications to drop significantly.

For the study, which is published in JAMA Network Open, researchers analysed over 6700 people treated at anticoagulation clinics across Michigan for VTE as well as AF. Patients were treated with warfarin but also took aspirin despite not having history of heart disease.

“We know that aspirin is not a panacea drug as it was once thought to be and can in fact lead to more bleeding events in some of these patients, so we worked with the clinics to reduce aspirin use among patients for whom it might not be necessary,” said senior study author and cardiologist Geoffrey Barnes, MD.

Over the course of the study, aspirin use among patients fell by 46.6%. With aspirin used less commonly, the risk of a bleeding complication dropped by 32.3% – equivalent to preventing one major bleeding event per every 1000 patients who stop taking aspirin.

“When we started this study, there was already an effort by doctors to reduce aspirin use, and our findings show that accelerating that reduction prevents serious bleeding complications which, in turn, can be lifesaving for patients,” said Dr Barnes. “It’s really important for physicians and health systems to be more cognisant about when patients on a blood thinner should and should not be using aspirin.”

Several studies had found concerning links between concurrent use of aspirin and different blood thinners, which prompted this aspirin de-escalation.

One study reported that patients taking warfarin and aspirin for AF and VTE experienced more major bleeding events and had more ER visits for bleeding than those taking warfarin alone. Similar results were seen for patients taking aspirin and direct oral anticoagulants – who were found more likely to have a bleeding event but not less likely to have a blood clot.

“While aspirin is an incredibly important medicine, it has a less widely used role than it did a decade ago,” Dr Barnes said. “But with each study, we are seeing that there are far fewer cases in which patients who are already on an anticoagulant are seeing benefit by adding aspirin on top of that treatment. The blood thinner they are taking is already providing some protection from clots forming.”

For some people, aspirin can be lifesaving. Many patients who have a history of ischaemic stroke, heart attack or a stent placed in the heart to improve blood flow — as well as those with a history of cardiovascular disease — benefit from the medication.

The challenge comes when some people take aspirin without a history of cardiovascular disease and are also prescribed an anticoagulant, said first author Jordan Schaefer, MD.

“Many of these people were likely taking aspirin for primary prevention of heart attack or stroke, which we now know is less effective than once believed, and no one took them off of it when they started warfarin,” Dr Schaefer said. “These findings show how important it is to only take aspirin under the direction of your doctor and not to start taking over-the-counter medicines like aspirin until you review with your care team if the expected benefit outweighs the risk.”

Source: Michigan Medicine – University of Michigan

Categories : Diet and Nutrition TransplantsTags :

Is Protein Restriction the Best Option after Kidney Transplant?

On By ModernMedia
Anatomic model of a kidney
Photo by Robina Weermeijer on Unsplash

Scientists at Osaka Metropolitan University have challenged the conventional wisdom that low protein intake is essential for kidney disease patients with their recent study on the relationship between protein intake and skeletal muscle mass in kidney transplant recipients. Their findings were published in Clinical Nutrition.

Chronic kidney disease patients are known to have induced sarcopenia due to chronic inflammation, hypercatabolism, decreased nutrient intake, and decreased physical activity associated with impaired kidney function. A successful kidney transplantation is able to correct or improve many of those physiological and metabolic abnormalities, with the transplant recipients increasing skeletal muscle mass after receiving their new kidney. Since excessive protein intake worsens kidney function, it is commonly believed that patients with chronic kidney disease, including kidney transplant recipients, should limit protein intake to protect their kidneys. On the other hand, it has been suggested that severe protein restriction may worsen sarcopenia and adversely affect prognosis.

Since nutrition and exercise therapy are recommended to improve sarcopenia, protein intake is suspected to relate to recovery of skeletal muscle mass after kidney transplantation. However, few studies have examined the relationship between skeletal muscle mass and protein intake in kidney transplant recipients.

In order to fill this knowledge gap, a research group led by Drs Akihiro Kosoku and Tomoaki Iwai, and Professor Junji Uchida at Osaka Metropolitan University followed 64 kidney transplant recipients for 12 months after their procedure. They investigated the relationship between changes in skeletal muscle mass, as measured by bioelectrical impedance analysis, and protein intake from urine sample. The results showed that changes in skeletal muscle mass during this period were positively correlated with protein intake, and that insufficient protein intake resulted in decreased muscle mass.

Drs Iwai and Kosoku commented, “To improve the life expectancy of kidney transplant recipients, further research is needed to clarify the optimal protein intake to prevent either deterioration in kidney function or sarcopenia. We hope that nutritional guidance, including protein intake, will lead to improved life expectancy and prognosis.”

Source: Osaka Metropolitan University

Categories : Neurodegenerative DiseasesTags :

7 Lifestyle Habits may Reduce Dementia Risk in Diabetes

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Old man jogging
Photo by Barbra Olsen on Pexels

A combination of seven healthy lifestyle habits including sleeping seven to nine hours daily, regular exercise and frequent social contact was associated with a lower risk of dementia in people with type 2 diabetes, according to a study published online in the journal Neurology.

“Type 2 diabetes is a worldwide epidemic that affects one in 10 adults, and having diabetes is known to increase a person’s risk of developing dementia,” said study author Yingli Lu, MD, PhD, of Shanghai Jiao Tong University School of Medicine in China. “We investigated whether a broad combination of healthy lifestyle habits could offset that dementia risk and found that people with diabetes who incorporated seven healthy lifestyle habits into their lives had a lower risk of dementia than people with diabetes who did not lead healthy lives.”

For the study, researchers looked at a health care database in the United Kingdom and identified 167 946 people 60 or older with and without diabetes who did not have dementia at the start of the study. Participants completed health questionnaires, provided physical measurements and gave blood samples. For each participant, researchers calculated a healthy lifestyle score of 0 to 7, with one point for each of 7 healthy habits. Habits included no current smoking, moderate alcohol consumption of up to one drink a day for women and up to two a day for men, regular weekly physical activity of at least 2.5 hours of moderate exercise or 75 minutes of vigorous exercise, and 7 to nine hours of sleep daily.

Another factor was a healthy diet including more fruits, vegetables, whole grains and fish and fewer refined grains, processed and unprocessed meats. The final habits were being less sedentary, which was defined as watching television less than four hours a day, and frequent social contact, which was defined as living with others, gathering with friends or family at least once a month and participating in social activities at least once a week or more often. Researchers followed participants for an average of 12 years. During that time, 4,351 people developed dementia. A total of 4% of the people followed only zero to two of the healthy habits, 11% followed three, 22% followed four, 30% followed five, 24% followed six and 9% followed all seven. People with diabetes who followed two or fewer of the seven healthy habits were four times more likely to develop dementia than people without diabetes who followed all seven healthy habits. People with diabetes who followed all of the habits were 74% more likely to develop dementia than those without diabetes who followed all the habits. For people with diabetes who followed all the habits, there were 21 cases of dementia for 7474 person-years, or 0.28%.

For people with diabetes who followed only two or fewer habits, there were 72 cases of dementia for 10 380 person years or 0.69%. After adjusting for factors like age, education and ethnicity, people who followed all the habits had a 54% lower risk of dementia than those who followed two or fewer. Each additional healthy habit people followed was associated with an 11% decreased risk of dementia. The association between healthy lifestyle score and dementia risk was not affected by medications people took or how well they controlled their blood sugar.

“Our research shows that for people with type 2 diabetes, the risk of dementia may be greatly reduced by living a healthier lifestyle,” Dr Lu said. “Doctors and other medical professionals who treat people with diabetes should consider recommending lifestyle changes to their patients. Such changes may not only improve overall health, but also contribute to prevention or delayed onset of dementia in people with diabetes.” A limitation of the study was that people reported on their lifestyle habits and may not have remembered all details accurately. Lifestyle changes over time were also not captured.

Source: American Academy of Neurology

Categories : CancerTags :

Schwann Cells Turn Nerve Tumours Benign

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Microscopy image of mouse sciatic nerves showing axons (red) wrapped by Schwann cells (green) with their nuclei depicted in blue. Credit: A. Alvarez-Prats and T. Balla, Eunice Kennedy Shriver National Institute of Child Health and Human Development/NIH

In addition to forming the myelin sheath along peripheral nerves and supporting neighbouring neurons, Schwann cells have also been found to play an important immune modulating function, starting and shutting off inflammation. This function not only helps nerve repair, but may also turn nerve tumours benign. These new findings were reported in the journal Glia.

The research has revealed that Schwann cells produce signalling molecules that can activate other immune cells. In particular, however, they are able to stop inflammatory reactions in order to prevent excessive tissue damage and allow the nerve to regenerate.

“This is essential, because inflammation releases free radicals against which nerve fibers cannot protect themselves. Therefore, the inflammation must be cleared quickly, which is precisely what Schwann cells do,” explained study designer Dr. Sabine Taschner-Mandl, who designed the study and heads a research group at St. Anna CCRI.

Do Schwann cells protect against malignancy?

These findings also have implications for protection against malignancy After nerve injury, Schwann cells engage a ‘repair’ mode that is also found in benign infantile nerve tumours. There, it causes the tumour cells to mature and thus reach a stage where they lose their aggressive properties and no longer divide unchecked

“Based on the current results, we now suspect that the immune cell functions of Schwann cells also become effective in childhood nerve tumours. This is because in cancer, there is always a kind of inflammation bubbling away that never comes to a halt. In benign nerve tumours, ganglioneuromas, the accompanying chronic inflammation could be stopped by Schwann cells similar to nerve healing, because unlike malignancies, ganglioneuromas have many Schwann cells in their microenvironment. We also see that a lot of immune cells migrate into these tumours, for which the Schwann cells could also be responsible,” said Dr Taschner-Mandl.

Healthy Inflammation: First Activate, Then Shut Down

In particular, the current study shows that Schwann cells can influence T cells, which are key in cancer defence. Schwann cells – both those in nerve regeneration and those in benign tumours – carry MHC-I and MHC-II molecules on their surface that are important for T-cell regulation. Via these molecules, Schwann cells present recognition features of material they have previously taken up from their environment.

“We mimicked an inflammatory response in the laboratory and detected a whole range of additional stimulatory and inhibitory surface molecules that are also necessary for T cell activation,” explained Jakob Berner, MSc, co-first author of the study and interim PhD student at St. Anna CCRI. “Our experiments show that Schwann cells are able to take up large amounts of material via phagocytosis.”

As the first immune response to a nerve cut, Schwann cells secrete substances that attract T cells, macrophages and other immune cells. Now it turned out that not only a reaction between the classical immune cells takes place, but also between Schwann cells and T cells.

While Schwann cells initially fuel the inflammatory response by releasing interferon-gamma, they can later shut it down by up-regulating the T-cell inhibitory PD-L1 molecule.

“First activate, then shut down – that’s the normal process of an inflammatory response. If this were also the case in cancer, then it could curb cancer growth,” Dr Taschner-Mandl theorised. Researchers are now investigating whether and how these findings could be applied to cancer treatment.

Source: St. Anna Children’s Cancer Research Institute