Food & Drug Administration Warns of Gastric Balloon Deaths

by Kristina Fiore

7 reports of death tied to gastric balloon obesity treatment since 2016

The FDA sent a letter to healthcare providers warning of reports of seven deaths with liquid-filled intragastric balloon systems used to treat obesity.

In five cases, the cause of death was unclear, but all occurred within a month or less of balloon placement, the agency said. In three of those cases, the patient died within one to three days of having the balloon inserted.

Four of these reports involved the Orbera Intragastric Balloon System from Apollo Endo Surgery, and one involved the ReShape Integrated Dual Balloon System by ReShape Medical.

The FDA noted that for these five cases it doesn’t know “the root cause” of the problem. It also can’t determine the incidence rate of patient death, nor could it “definitively attribute the deaths to the devices or the insertion procedures for these devices” — meaning they couldn’t tell if death was due to gastric or esophageal perforation, or to intestinal obstruction, or to some other cause.

Two additional reports of deaths in the same time period — since 2016 — were also noted in the FDA letter. One was related to gastric perforation with the Orbera Intragastric Balloon System and one to esophageal perforation with the ReShape device.

The FDA said it’s working with both companies to better understand what’s causing these issues, and to monitor potential complications of acute pancreatitis and spontaneous overinflation. It also emphasized that it had mandated ongoing post-approval studies for the devices.

Article originally appeared in MedPage Today

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Do you Really Need These Vitamin Supplements?

By  Dr. Manny

According to 2016 consumer survey data, 71% of U.S. adults take some type of dietary supplement. And the appeal of supplements is obvious. We know vitamins are necessary for health, so why not make sure we’re covering our bases?

The darker side of dietary supplements is that many of the alleged health benefits are coming straight from people who stand to make big money from vitamin sales, and the research doesn’t always agree with the claims of vitamin manufacturers and retailers.

Here’s a look at four vitamins you may want to think twice about taking.

1. Vitamin E

According to the National Institutes of Health, the recommended daily allowance (RDA) of vitamin E for adults is 15 mg (or 22.4 IU). RDAs are based on what will meet the nutritional needs of 97-98% of healthy people, but supplements are widely available from 200 to 1000 IU per pill. When it comes to vitamin E, the research is clear that you can have too much of a good thing. A large review of the research by John Hopkins University found that people who took more than 400 IU daily faced a 4-6% increased risk of death. Another large study found that, despite health claims to the contrary, vitamin E did not decrease prostate cancer risk in study participants. In fact, men who supplemented with vitamin E were slightly more likely to develop prostate cancer than men who didn’t use the supplement.

2. Vitamin C

Pricey vitamin C supplements marketed for the prevention and treatment of the common cold and the flu have popped up in every grocery store and drug store. They come as pills, lozenges, and powdered drinks and typically contain 500-1000mg of vitamin C, at least 5-10 times the RDA of vitamin C for adults. Some people use supplements daily to prevent colds, and others use high doses at the beginning of a cold to shorten its duration. But a review of the evidence shows that vitamin C only impacts the common cold in one way – if you’re already taking daily vitamin C, your colds may be a little bit shorter. Despite the claims of manufacturers, people who supplement daily don’t get fewer colds, and starting supplementation at the beginning of a cold doesn’t affect cold symptoms. If you choose to take a daily vitamin C supplement to shorten your colds, keep in mind that mega doses can contribute to kidney stones.

3. Vitamin A

Vitamin A can be toxic in large doses, causing symptoms like nausea, vomiting, and abdominal pain. Most cases of vitamin A toxicity occur in adults using mega doses of vitamins to treat illness or in children who accidentally ingest supplements, but researchers are now wondering if smaller supplemental doses of vitamin A can cause health problems too. The RDA for vitamin A for adults is 700-900 mcg, and an article published in The American Journal for Clinical Nutrition notes that just twice this amount has been connected to osteoporosis and hip fracture in people without other symptoms of toxicity.

4. Multivitamins

Seventy-five percent of Americans who take supplements take a multivitamin, making it the most popular dietary supplement in the US. Multivitamins are all different, but most contain a long list of vitamins and minerals, sometimes in amounts well over their recommended daily intakes. Over the last few years, study after study has challenged the alleged health benefits of multivitamins, but there have also been a few that show some health benefit. In a large study of older women, multivitamin use was associated with increased mortality. An eight-year study showed no protective effect against cardiovascular disease or mental decline but a slight protective effect against cataracts and cancer. And most recently, a 2016 study has contradicted previous research by showing a slight benefit for heart health. The research surrounding multivitamin supplements isn’t clear-cut, and it’s possible that not all adults benefit from them.

It’s important to consult with your doctor before taking a new supplement and to know that adding more fruits and vegetables to your diet is the most evidence-supported intervention you can make for your own health. Fruits and veggies can lower your risk of cardiovascular disease, cancer, diabetes, and high blood pressure without any dangerous side effects. And a cart full of produce is much more affordable than a cabinet full of supplements.

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Study Boosts Case for Over-the-Counter Hearing Aids

OTC hearing aids performed nearly as well as prescription devices, but not yet legal for sale

In a highly controlled comparison study, several over-the-counter hearing assistance devices performed almost as well as a conventional hearing aid that cost thousands of dollars more.

Three of five selected personal sound amplification products (PSAP) were found to improve speech understanding among participants with mild-to-moderate hearing loss to a degree that was comparable to results obtained with a hearing aid, Nicholas Reed, AuD, of Johns Hopkins School of Medicine, and colleagues wrote in the July 4 issue of JAMA

Hearing aids for both ears typically cost around $4,500, while PSAPs cost several hundred dollars or less.

The Over-the-Counter Hearing Aid Act of 2017 is being sponsored in the Senate by Elizabeth Warren (D-Mass.) and Charles Grassley (R-Iowa) and in the House by Joseph Kennedy (D-Mass.) and Marsha Blackburn (R-Tenn.).

Reed told MedPage Today that the study findings lend support to the creation of the new regulatory classification for hearing aids.

“Some of these devices did about as well as the hearing aid in our controlled environment, suggesting that some PSAPs are pretty good,” he said. “Perhaps we should support the movement to get these in the hands of more people and to regulate them to improve the quality of the products.”

Click here to read entire article published in MedPage Today

Common antibiotics help patients recover from MRSA skin abscesses

National Institute of Allergy and Infectious Diseases-funded trial counters current thinking about treatment effectiveness.

MRSA – Methicillin-resistant Staphylococcus aureus bacteria are resistant to multiple antibiotics and commonly cause skin infections that can lead to more serious or life-threatening infection in other parts of the body. In new findings published in The New England Journal of Medicine, researchers found that two common, inexpensive antimicrobials can help patients heal from MRSA skin abscesses. The findings suggest that current treatment options for MRSA still have a role, even as scientists continue to search for new antimicrobial products. The research was funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health.

The study was conducted at hospitals across the United States and involved 796 children and adults with small, uncomplicated skin abscesses.  All patients had their abscesses opened and drained as part of standard MRSA treatment. The patients were then sorted into three groups, each of which received a different, ten-day oral treatment regimen. One group received clindamycin, a second group received trimethoprim-sulfamethoxazole (TMP-SMX), and the third group received placebo.

The group treated with clindamycin had an 81.7 percent cure rate, and the group that received TMP-SMX had an 84.6 percent cure rate. The placebo group had a 62.9 percent cure rate. According to the researchers, the findings contradict a commonly held belief that antimicrobial treatment is little better than doing nothing for MRSA skin infections. It corroborates the findings of another NIAID-funded study(link is external) demonstrating that TMP-SMX treatment resulted in better clinical outcomes than placebo for MRSA skin abscesses, and also upholds other findings(link is external) that both clindamycin and TMP-SMX are equally beneficial in treating MRSA skin infections.

The researchers note, however, that the side effects of clindamycin and TMP-SMX (including nausea, diarrhea, and possible new Clostridium difficile infections) can be severe. In addition, some strains of Staphylococcus are resistant to clindamycin. The authors recommend that healthcare providers weigh the risks, but not dismiss these antimicrobials out of hand as viable treatment options for MRSA skin abscesses.

Additional funding for the study was provided in part by NIH’s National Center for Advancing Translational Sciences.

Click here for a link to the National Institutes of Health article 

Enzyme could help fight against mid-life obesity and fitness loss

National Institutes of Health discovery of enzyme in mice could lead to new class of medications to fight mid-life obesity

A team of scientists led by researchers from the National Institutes of Health has identified an enzyme that could help in the continuous battle against mid-life obesity and fitness loss. The discovery in mice could upend current notions about why people gain weight as they age, and could one day lead to more effective weight-loss medications.

“Our society attributes the weight gain and lack of exercise at mid-life (approximately 30-60 years) primarily to poor lifestyle choices and lack of will power, but this study shows that there is a genetic program driven by an overactive enzyme that promotes weight gain and loss of exercise capacity at mid-life,” said lead study author Jay H. Chung, Ph.D., M.D., head of the Laboratory of Obesity and Aging Research at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH.

Chung and his team used mice to test the potentially key role this enzyme plays in obesity and exercise capacity. They administered an inhibitor that blocked the enzyme in one group being fed high-fat foods, but withheld it in another. The result was a 40 percent decrease in weight gain in the group that received the inhibitor.

The study, the first to link the increased activity of this enzyme to aging and obesity, appears in the current issue of Cell Metabolism. Its findings could have ramifications for several chronic illnesses. With lower rates of obesity, the researchers say, rates of heart disease, diabetes, and other diseases that tend to increase with age, including cancer and Alzheimer’s disease, could fall as well.

Researchers have known for years that losing weight and maintaining the capacity to exercise tend to get harder beginning between ages 30 to 40 — the start of midlife. Scientists have developed new therapies for obesity, including fat-fighting pills. However, many of those therapies have failed because of a lack of understanding about the biological changes that cause middle-aged people to gain weight, particularly around their abdomen.

Click here to read the rest of this article originally published by National Institutes of Health

Young Women With Melanoma: Is Indoor Tanning to Blame?

Skin cancer ‘epidemic’ in under 30 expected to rise unless indoor tanning is restricted

by Charles Bankhead

Women with a melanoma diagnosis before age 30 had almost a 100% positive history for use of indoor suntanning facilities, a large retrospective case-control study showed.

Among the 63 youngest women with melanoma diagnoses, 61 had a history of indoor tanning. Younger women reported earlier and more frequent use of indoor tanning facilities as compared with patients whose melanoma diagnoses occurred later in life. A history of indoor tanning increased the likelihood of a melanoma diagnosis by two to six times among women 30 to 49. Men were about 50% less likely than women to engage indoor tanning, and data on the association with melanoma risk were inconclusive. Here are some hyperpigmentation treatments that can really help your skin.

The findings added to evidence linking indoor tanning to recent increases in melanoma incidence among young women. The study also provided support for legislative and regulatory efforts to restrict access to and use of indoor tanning facilities, wrote DeAnn Lazovich, PhD, of the University of Minnesota in Minneapolis, and colleagues in JAMA Dermatology.

“Our results indicate that these efforts need to be accelerated and expanded beyond bans on minor access to indoor tanning to curb the melanoma epidemic, which seems likely to continue unabated, especially among young women, unless exposure to indoor tanning is further restricted and reduced,” the authors stated, alluding to the FDA’s proposed ban on use of indoor tanning equipment by people younger than 18.

Click here to read the rest of this MedPage Today article

The joy is being sucked out of the practice of medicine. Here’s why.

Many providers — primary care physicians, physician assistants, and even many beleaguered specialists — are increasingly dissatisfied with their jobs.

What is happening to medical practice and what can we do to bring the joy back to being a health care provider?

She came to the urgent care center with a sprained ankle. The primary care provider gave her excellent care, expertly applying evidence-based evaluation guidelines to her situation, and, thereby, avoiding unnecessary x-rays. By all measures, the provider’s care was excellent, but the interaction still ended up reducing his salary. You see, that patient’s only medical interaction that year was for this ankle sprain, and the provider was therefore held accountable for all of her primary care needs. Since she had not received a mammogram that year, or received a diabetes screening, he incurred an end-of-the-year penalty for failing to meet these quality standards.

I am early into a one-year quest to connect with leading thinkers from inside and outside medical care, so I can better understand why many clinicians are miserable in their careers, and much more importantly, what can be done to help them thrive at work even though an increasing number of outside parties are looking over their shoulder, assessing the quality of the care they provide.

These increasingly burdensome rules and regulations are making it hard to enjoy medical practice these days. Several decades ago, physicians largely practiced as autonomous professionals, governed by standards developed by their professional peers. Physicians underwent intense and prolonged training to develop the knowledge and skills to know how best to help patients with their problems. And the world generally stood back and accepted, on faith, that most physicians would provide excellent care to most of their patients.

In recent years, however, outsiders have increasingly tried to assess just how well physicians are performing their jobs. Insurance companies and Medicare administrators are measuring the quality of care physicians provide, and even holding them financially accountable when that care is not up to standards. In part, these external accountability measures have been put into place because people paying for medical care — insurance companies, Medicare administrators, and even patients — realized that the quality of medical care wasn’t always as high as it ought to be. And since the profession wasn’t doing everything it could to promote high quality, they recognized that somebody from the outside needed to hold physicians accountable for their practice. As a result, medical practice has shifted from being autonomous to supervised; physicians have gone from being independent decision-makers to being bureaucrats forced to check boxes.

Click here to read all of this article originally posted on KevinMD.com

Many Who Think They Are ‪Allergic‬ To ‪Penicillin‬ May Safely Take It

By Julienne Roman,

Researchers found that most people who are told that they are allergic to penicillin were mistakenly diagnosed as such based on initial reactions instead of a confirmatory test.

This mistaken perception led many to opt for more dangerous antibiotics and other treatments for their infections. Researchers pointed out that the patients who were thought to be penicillin-allergic had to take other antibiotics that put them at greater risk for acquiring complications such as colitis and the development of more antibiotic-resistant strains.

Study authors therefore stress the need to specifically test for penicillin allergy on suspected patients.

“Anyone who has been told they are penicillin allergic, but who hasn’t been tested by an allergist, should be tested,”said Dr. David Khan from the University of Texas Southwestern Medical Center.

He added that if patients are determined to be allergic, doctors will be able to determine which treatment options are most suited with the full confidence that it is the best course of action for the patient. But if the tests turned negative, then the patient will be able to take a drug that is just as effective as most antibiotics while being safer and more cost-effective.

Researchers studied data from patients who were reportedly allergic to penicillin but when tested were actually found to be negative. The team later found that the patients could be treated safely with the mentioned antibiotic even through intravenous injection.

“There is often thought to be a higher risk in patients who get intravenous penicillin, but we did not find this to be the case,” Khan added.

The misconception often stems from wrongly interpreting symptoms that manifest after taking the drug as signs of an allergic reaction. This mistake happens about 90 percent of the time among patients.

Penicillin side effects that include nausea and vomiting, mild diarrhea or headache commonly occur while taking the drug but do not herald an allergic reaction or are considered dangerous enough to halt continued taking of the drug.

Ever since its discovery, penicillin still remains a popular antibiotic because of its effectiveness and relatively low level of toxicity on healthy human cells. It comes in several different, non-interchangeable forms, and each one is often used to treat different infections.

However, there are people who are allergic to the drug, and people who report developing a rash, itching or difficulty of breathing while using the drug are advised to report these findings to a physician for a confirmatory test.

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Dosage Forms: Introduction to Pharmaceuticals

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This article is a sufficient beginning to know everything about pharmaceuticals. If you are just starting to know about this amazing field, this is a good guide for you.

Drug is the substance used to cure, treat, restore the health state, or optimize a malfunction. Fundamentally, this substance is brought from plants or animals. Rarely, the drug is administered in its primary or crude form. In other words, the drug can be natural, synthetic, or semi-synthetic. The drug’s crude form passes by different processes to give rise to what is called dosage forms.

During manufacturing, the crude drug is called a pharmaceutical preparation. Dosage form is the crude drug in its final form after adding particular characteristics to it. The drug manufacture includes addition of additives; pharmaceutical ingredients.

The additives are mainly non-medicinal substances used for many purposes. They are added to enhance the drug form, quality, and efficacy.

They are used:

As solubilizing agents

For dissolving the drug in a solvent as in the formation of solutions

For dilution

To decrease or optimize concentration

As suspending agents

To suspend solid particles in a solution and form a suspension

As emulsifying agents

To dissolve water in oil or oil in water and produce an emulsion

As thickeners

To harden/thicken creams and ointments

As stabilizers

To maintain the stability of a pharmaceutical preparation

As preservatives

To protect the pharmaceutical preparations from contamination by microorganisms such as bacteria and fungi

As coloring agents

To give the drug a perfect appearance and attractiveness.

As flavoring agents

To hide a bad taste like the bitter taste. Moreover, flavoring agents are used to add a reasonably good taste to the drug and increase its palatability.

Click here to download a PDF with more information

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Drug manufacturers’ coupons can cause higher prescription prices

by Chris Lillis, MD

The tragic irony of pharmaceutical coupons .

As a primary care physician in private practice, I have my own little taste of celebrity.

Every day attractive people come to my office seeking time to speak with me and collect my autograph.  They fawn over my partners and I, and bring us food for lunch, and will invite us to the nicest restaurants in town for dinner.   These people also used to bring gifts, until they were barred from doing so a couple of years ago.  I must admit, they are not doctor-groupies.  They are pharmaceutical marketing representatives. Rather than stalking me, they are just performing the job they are paid to do.

Each year, the pharmaceutical industry and its army of salespeople spend billions of dollars marketing brand name patented drugs.  Annual estimates range from $20-60 Billion every year.    Sadly, this represents almost 30% of their sales revenue, while they invest about 11% on research and development of new pharmaceuticals.

Marketing practices of pharmaceutical companies should not be news, but you may not be noticing the building battle between insurers and pharmaceutical companies unless you are being “detailed” every day like me.

The formularies kept by private insurance companies are a great source of pain for pharmaceutical marketing professionals.  These are lists of available drugs, categorized into tiers. Tier 1 drugs are often generics: very inexpensive, and therefore offered to patients at very low copayments.  Tier 2 drugs are brand name drugs without generic alternatives, and at the other end of the spectrum are Tier 3 drugs – typically brand name drugs that may be new to market, and have several alternatives both generic and brand name. As you advance up the tiers, the copayments rise.  In order to force more generic medication usage, insurance companies are rapidly increasing these copayments to reduce their expenditures.

So begins the battle.  Pharmaceutical companies know that high copayments are effective ways to encourage patients to ask their doctors to prescribe generic drugs.  So pharma lobbies the insurance companies to reduce the tier status of their drugs.  In some cases, this leads to drugs being switched tiers, sometimes quite often.  A tier 3 drug that gets bumped down to tier 2 becomes a marketing highlight.  And it always leaves those of us with prescription pads guessing and rather frustrated.

The latest trend I have observed: coupons.  Pharmaceutical representatives will provide physicians coupons to give to patients for their new product.  The most generous of these coupons will actually cover the entire copayment of the drug, thereby eliminating the incentive designed by the insurance industry to encourage generic drug use.

Coupons may be great for individuals with higher copayments set by their insurers, but they do nothing to lower our national health care expenditures.  In fact, coupons encourage higher costs for pharmaceuticals. Go to gbk vouchers to get a bunch of different coupons.

The tragic irony of the coupon scheme devised by pharmaceutical marketing is that Medicare Part D patients cannot use them. The government by regulation prohibits any inducement that would directly or indirectly cause the government to spend money. Hence these coupons are not permitted to be split billed with Medicare or Medicaid.  Those who need help to defray their prescription costs the most cannot use them, but in some way I am glad.  This forces me to choose generic prescriptions more often.

The pharmaceutical industry lobbyists have been successful thus far in avoiding regulations that would hurt their profits.  But this is leading to skyrocketing costs.  In both the inception of Medicare Part D and in the passage of the Affordable Care Act, Congress neglected to provide the authority to Medicare to negotiate the prices of prescription medicines, leaving it to the private insurers who administer Medicare Part D.  This has led to greater profits for pharma at the direct expense of the consumer and taxpayer.

A study conducted by a prominent health care economist, funded by the Robert Wood Johnson Foundation, found that if Medicare adopted the Veterans Affairs (VA) drug formulary, America would save $14 billion a year on drug costs.  The VA directly negotiates drug costs with manufacturers, and its evidence-based formulary is able to keep drug costs down.

If any politician were bold enough to advance the proposal of allowing Medicare to negotiate drug prices, I can imagine the demagogue’s argument: “Don’t allow government to restrict your choices of drugs!”  Except that the facts point to health care consumers much preferring to have lower drug costs than infinite choices of expensive brand name drugs.  Polls show 80% of Americans would choose generic medicines in order to save money.

Between pharmaceutical marketing costs and the inflated prices of brand name medicines, there are tens of billions of dollars to be saved in health care expenditures each year.  I am confident the pharmaceutical industry will fight for those billions with vigor, but will we?

Chris Lillis is an internal medicine physician who blogs at Progress Notes.