Uncontrollable Drug Prices

The same medication to prevent preterm birth can cost $200 – or nearly $11,000, a new study finds.

Harvard Medical School researchers found that use of a brand name and prepackaging was associated with a 5,000% increase in the cost of the synthetic hormone progestin.

They said the average per-pregnancy cost of a compounded, made-to-order form of the medication known as 17P was $206. That compared with $10,917 for a brand-name prepackaged version of the same medication.

“Everyone is talking about how to pay for health care, but few talk about why health care in the United States is so expensive. Uncontrollable drug prices are a major cause of this trend,” study co-author Andrew Beam said in a Harvard news release. He’s an instructor of biomedical informatics.

The two medications have the same active ingredients and are clinically interchangeable, according to the research team.

The investigators’ analysis of costs and pregnancy outcomes among more than 3,800 women treated with the drugs also found no statistically significant difference in the rate of preterm births – nearly 24% in the brand-name group and about 25% among women who received the compounded drug.

The researchers estimated that the annual cost of treating all medically eligible women with the brand-name version would be more than $1.4 billion, compared with $27.5 million for the compounded version.

“This case is emblematic of a systemic disorder that is not unique to one particular drug, class of drugs or manufacturer. There is no transparent and systematic link between the price, or cost, of a drug and its actual value or impact in terms of health and disease,” said study co-author Isaac Kohane, chair of the biomedical informatics department at Harvard.

Breast Cancer Linked to Bacterial Imbalances

In a newly published study, Cleveland Clinic researchers have uncovered differences in the bacterial composition of breast tissue of healthy women vs. women with breast cancer. The research team has discovered for the first time that healthy breast tissue contains more of the bacterial species Methylobacterium, a finding which could offer a new perspective in the battle against breast cancer.

Bacteria that live in the body, knows as the microbiome, influence many diseases. Most research has been done on the “gut” microbiome, or bacteria in the digestive tract. Researchers have long suspected that a “microbiome” exists within breast tissue and plays a role in breast cancer but it has not yet been characterized. The research team has taken the first step toward understanding the composition of the bacteria in breast cancer by uncovering distinct microbial differences in healthy and cancerous breast tissue.

“To my knowledge, this is the first study to examine both breast tissue and distant sites of the body for bacterial differences in breast cancer,” said co-senior author Craris Eng, M.D., Ph.D. chair of Cleveland Clinic’s Genomic Medicine Institute and director of the Center for Personalized Genetic Healthcare. “Our hope is to find a biomarker that would help us diagnose breast cancer quickly and easily. In our wildest dreams, we hope we can use microbiomics right before breast cancer forms and then prevent cancer with probiotics or antibiotics.”

Published online in Oncotarget on Oct. 5, 2017, the study examined the tissues of 78 patients who underwent mastectomy for invasive carcinoma or elective cosmetic breast surgery. In addition, they examined oral rinse and urine to determine the bacterial composition of these distant sites in the body.

In addition to the Methylobacterium finding, the team discovered that cancer patients’ urine samples had increased levels of gram-positive bacteria, including Staphylococcus and Actinomyces. Further studies are needed to determine the role these organisms may play in breast cancer.

Wisdom Wednesday: Stealth Bioburden

Traditionally, the bioburden is defined as the number of bacteria living on a surface that hasn’t been sterilized. This is a real concern in the hospital setting and attempts with antibacterial soaps have led to super bugs that are antibiotic resistant.

The stealth bioburden is an emerging term used to describe commensal bacteria in the digestive tract that may have adverse effects on our health.

Under healthy conditions, commensal bacteria are kept in check by the healthy bacteria (probiotics) that vastly outnumber the commensals. The GALT (gut associated lymphoid tissue) also plays a vital role in analyzing the microbiome and transmitting data to the thymus.

Dysbiosis, the term used to describe an imbalance of the microbiome, is most commonly caused by the use of antibiotics. However, chemotherapy and radiation therapy have similar effects. Food poisoning and drinking contaminated water are other common sources.

Virtually all cases of “intestinal flu” are mild cases of food poisoning but are seldom diagnosed. The body responds by purging (diarrhea and/or vomiting) for a day or longer, then we gradually return to normal.
But do we really return to normal?

The stealth bioburden is that ongoing stress from commensal bacteria overgrowth that disrupts normal digestion and elimination. For some, it results in intermittent constipation and/or diarrhea. If it continues unabated, you might be diagnosed with IBS (irritable bowel syndrome).

For most, however, we are told that whatever bowel function we have is “normal for you”.
Laboratory evaluation of the stealth bioburden is in its’ infancy. We can only identify about 20% of the bowel flora using DNA analysis. Although this technology holds great promise for the future, the applications are currently limited.

Digestive stool analysis can readily identify many commensal bacteria. However, it is difficult to determine, which, if any of them are truly a bioburden. Measuring the immune response of the GALT is valuable in determining whether the immune system is unable to cope or is overtly responding to the presence of commensal bacteria. Zonulin, diamine oxidase (DAO), histamine, IgA, IgG, and IgM can all be measured in the gut to assess the immune response.

Obesity Linked to 13 Types of Cancer

A new study suggests that being obese or overweight was associated with cancer cases involving more than 630,000 Americans in 2014, and this includes 13 types of cancer.

“That obesity and overweight are affecting cancers may be surprising to many Americans. The awareness of some cancers being associated with obesity and overweight is not yet widespread,” Dr. Anne Schuchat, CDC deputy director, said during a midday media briefing.

The 13 cancers include brain cancer; multiple myeloma; cancer of the esophagus; postmenopausal breast cancer; cancers of the thyroid, gallbladder, stomach, liver, pancreas, kidney, ovaries, uterus and colon, the researchers said.

Speaking at the news conference, Dr. Lisa Richardson, director of CDC’s Division of Cancer Prevention and Control, said early evidence indicates that losing weight can lower the risk for some cancers.

According to the new report for the CDC and the U.S. Cancer Institute, these 13 obesity-related cancers made up about 40% of all cancers diagnosed in the United States in 2014. Although the rate of new cancer cases has decreased since the 1990s, increases in overweight and obesity-related cancers are likely slowing this progress, the researchers said.

Excluding colon cancer, the rate of obesity-related cancer increased by 7% between 2005 and 2014. During the same time, rates of non-obesity-related cancers dropped, the findings showed.

Prenatal Multivitamins Linked to Lower Autism Risk

Analyzing more than a quarter-million mother-child pairs in Sweden, researchers found a link – but not cause and effect proof – between multivitamin use and risk of developing autism.

“Multivitamin use with or without added iron or folic acid was associated with a lower likelihood of child autism with intellectual disability, compared with mothers who did not use supplements,” said lead researcher Elizabeth DeVilbiss. The odds of autism in the multivitamin group were 30% lower, added DeVilbiss, a Ph.D. graduate in epidemiology and biostatistics at Drexel University’s Dornsife School of Public Health in Philadelphia.

Autism spectrum disorder includes a range of conditions that affect social interaction, communication, interests and behavior. It’s estimated that about 1 in every 68 people in the United States has some form of autism, boys more often than girls.

Experts believe autism is caused by genetic and environmental factors. It most likely starts in the womb, and the mother’s diet during pregnancy might have an influence, DeVilbiss said. However, DeVilbiss said it’s too early to recommend multivitamins specifically for lowering autism risk.

Because the study was observational, it’s possible that women who take a multivitamin during pregnancy might engage in other healthy behaviors that account for the reduced autism risk, DeVilbiss said.

For the study, DeVilbiss and her colleagues collected data on 273, 107 mother and child pairs form Stockholm. The children were born between 1996 and 2007 and were followed at least to age 4 and to 15 in some cases. Mothers reported their use of folic acid, iron and multivitamin supplements at their first prenatal visit. Cases of child autism spectrum disorder were identified using national registers.

Wisdom Wednesday: Could Skipping Breakfast Feed Heart Disease?

Middle-aged adults who routinely skip breakfast are more likely to have clogged heart arteries than those who enjoy a big morning meal, a new study finds.

The findings are the latest to link breakfast to better heart health. They suggest that people who eat breakfast – especially a hearty one – are less likely to harbor plaques in their arteries.

Plaques are deposits of fat, calcium and other substances that can build up in arteries, causing them to harden and narrow – a condition called atherosclerosis. Atherosclerosis can lead to heart attacks, strokes and other complications.

“It’s not that you skip breakfast, you get plaques,” said senior researcher Jose Penalvo, of Tufts University’s Friedman School of Nutrition Science and Policy in Boston. But, he said, there are several reasons that forgoing the morning meal could contribute to the risk of atherosclerosis.

For many people, skipping breakfast is part of a “cluster” of bad habits, said Penalvo. These people tend to eat out a lot, and opt for nutritionally dubious convenience foods, for instance. On top of that, Penalvo said, skipping breakfast may have negative effects on appetite-regulating hormones, blood sugar and insulin (a hormone that regulates blood sugar).

Prior studies have shown that breakfast fans are less likely to be obese or have diabetes or heart disease. But the current study actually used ultrasound to screen middle-aged adults for “subclinical” atherosclerosis – early plaque buildup that is not causing any symptoms.

The study included more than 4,000 adults ages 40 to 54 from Spain. Three percent were chronic breakfast-skippers, while 27% regularly had a big breakfast. That meant they ate more than 20% of the daily calories at their morning meal. Most people – 70% - ate a relatively low-calorie diet.

Nearly 75% of breakfast-skippers showed plaque buildup. That compared with 57% of people who ate a big breakfast, and 64% of those who favored a light one.

Genetic Testing May Help Make Blood Thinner Safer

Warfarin (Coumadin, Jantoven) is often prescribed to prevent life-threatening blood clots in high-risk patients. However, a patient’s genes can influence how warfarin is processed in the body. Too little warfarin will not prevent blood clots while too much can trigger internal bleeding, the researchers explained.

Warfarin is “a widely used anticoagulant, but it causes more major adverse events than any other oral drug. Thousands of patients end up in the emergency department or hospital because of warfarin-induced bleeding. But we continue to prescribe it because it is highly effective, reversible and inexpensive,” said study first author Dr. Brian Gage. He is a professor of medicine at Washington University School of Medicine in St. Louis.

The researchers said they found that by looking for variants in three genes, it’s possible to make warfarin therapy safer.

Variants in one gene affect vitamin K recycling (vitamin K is needed for blood clotting). Variants in another gene affect warfarin sensitivity. And variants in the third gene affect warfarin metabolism in the liver and can cause an overdose if the dose is not adjusted quickly enough, the researchers said.

The study included about 1,600 people 65 and older at high risk for blood clots after undergoing hip or knee replacement surgery. They were randomly assigned to receive either warfarin dosing based on standard clinical factors such as age, height and weight. Or dosing based on those clinical factors plus variants in the three genes.