Category Archives: Healthcare

Meningitis Outbreaks Call for FDA Leadership. Don’t Hold Your Breath

Henry Miller:

 

Vaccination is one of the most important advances in public health in recent centuries, and hundreds of vaccines have all but eradicated many of the infectious disease scourges of the past. But two recent college campus outbreaks of Meningitis B (MenB), which is caused by serotype B of a bacterium called Neisseria meningitidis, or meningococcus, show that more needs to be done. What we need right now is not scientific or technological ingenuity, but more enlightened and responsive government oversight.

Since the first MenB cases were reported at Princeton University nine months ago, the federal government has taken insufficient and piecemeal steps to stem the further spread of the highly contagious and potentially deadly disease. The second outbreak has occurred at the University of California, Santa Barbara over the past month. Twelve students in all have been infected. Worldwide, there are 20,000-80,000 cases of MenB annually, with a mortality rate of about 10 percent. Of those who survive, about one-fifth suffer from devastating permanent disabilities such as brain damage, deafness, or limb loss. One UCSB case is a freshman lacrosse player whose feet had to be amputated.

As students and administrators at UCSB have learned to their dismay, there is no approved MenB vaccine in the United States although one called Bexsero, manufactured by Novartis, has been approved by regulators in the European Union, Australia, and Canada, and is available in those countries. The same vaccine is in clinical trials in the United States, but characteristically, the FDA has slowed the testing and approval process, so officials at the affected campuses have been forced to appeal to the federal government for special permission to import and administer it.

 

FDA: stop buying antibacterial soap products

Every day, consumers use antibacterial soaps and body washes at home, work, school and in other public settings. Especially because so many consumers use them, FDA believes that there should be clearly demonstrated benefits to balance any potential risks.

In fact, there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water, says Colleen Rogers, Ph.D., a lead microbiologist at FDA.

Moreover, antibacterial soap products contain chemical ingredients, such as triclosan and triclocarban, which may carry unnecessary risks given that their benefits are unproven.

“New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Rogers says. There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects that are of concern to FDA.

(…)

In addition, laboratory studies have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics. Such resistance can have a significant impact on the effectiveness of medical treatments.

Source

 

The Best Protection Against the Spread of Disease

Excerpt from today's ProMED bulletin from the International Society of Infectious Diseases.

Vaccine hesitancy is a global problem: coverage for many of the vaccines recommended for adolescents and adults in the US is low. While vaccine adherence rates for children in developed countries are typically above 90%, data suggest that nearly 12% of parents in the US are refusing and 30% delaying one or more of the recommended childhood vaccines. There appears to be decreasing confidence in immunization worldwide.

In 1988, the WHO launched the Global Polio Eradication Initiative with the goal of ending the disease by the year 2000. In 1996, Nelson Mandela launched “Kick Polio Out of Africa” that aimed to vaccinate 50 million children that year alone. Mass immunization drives included national immunization days, acute flaccid paralysis surveillance, training of local community health workers, and door-to-door campaigns. By 2003, however, a plan to immunize more than 15 million children in west and central Africa against polio was hobbled by a boycott in northern Nigeria that ultimately led to a resurgence of polio, not just in Nigeria, but globally. (You can find contemporaneous reports and links at ProMED Archive Number: 20040630.1742.)

FDA restricts antibiotic use in livestock

This is the best news in a long time.

WASHINGTON — The Food and Drug Administration on Wednesday put in place a major new policy to phase out the indiscriminate use of antibiotics in cows, pigs and chickens raised for meat, a practice that experts say has endangered human health by fueling the growing epidemic of antibiotic resistance.

This is the agency’s first serious attempt in decades to curb what experts have long regarded as the systematic overuse of antibiotics in healthy farm animals, with the drugs typically added directly into their feed and water. The waning effectiveness of antibiotics — wonder drugs of the 20th century — has become a looming threat to public health. At least two million Americans fall sick every year and about 23,000 die from antibiotic-resistant infections.

“This is the first significant step in dealing with this important public health concern in 20 years,” said David Kessler, a former F.D.A. commissioner who has been critical of the agency’s track record on antibiotics. “No one should underestimate how big a lift this has been in changing widespread and long entrenched industry practices.”

The change, which is to take effect over the next three years, will effectively make it illegal for farmers and ranchers to use antibiotics to make animals grow bigger. The producers had found that feeding low doses of antibiotics to animals throughout their lives led them to grow plumper and larger. Scientists still debate why. Food producers will also have to get a prescription from a veterinarian to use the drugs to prevent disease in their animals.

Federal officials said the new policy would improve health in the United States by tightening the use of classes of antibiotics that save human lives, including penicillin, azithromycin and tetracycline. Food producers said they would abide by the new rules, but some public health advocates voiced concerns that loopholes could render the new policy toothless.

Health officials have warned since the 1970s that overuse of antibiotics in animals was leading to the development of infections resistant to treatment in humans. For years, modest efforts by federal officials to reduce the use of antibiotics in animals were thwarted by the powerful food industry and its substantial lobbying power in Congress. Pressure for federal action has mounted as the effectiveness of drugs important for human health has declined, and deaths from bugs resistant to antibiotics have soared.

Under the new policy, the agency is asking drug makers to change the labels that detail how a drug can be used so they would bar farmers from using the medicines to promote growth.

The changes, originally proposed in 2012, are voluntary for drug companies. But F.D.A. officials said they believed that the companies would comply, based on discussions during the public comment period. The two drug makers that represent a majority of such antibiotic products — Zoetis and Elanco — have already stated their intent to participate, F.D.A. officials said. Companies will have three months to tell the agency whether they will change the labels, and three years to carry out the new rules.

Additionally, the agency is requiring that licensed veterinarians supervise the use of antibiotics, effectively requiring farmers and ranchers to obtain prescriptions to use the drugs for their animals.

“It’s a big shift from the current situation, in which animal producers can go to a local feed store and buy these medicines over the counter and there is no oversight at all,” said Michael Taylor, the F.D.A.’s deputy commissioner for foods and veterinary medicine.

 

The EHR Debate: Fighting the Last War?

Fighting the Last War?

…Yes, we’re having the wrong fight by focusing on old problems. The EMRs that are producing the studies we’re fighting about are the current equivalent of 1990s EPR implementations. In general they’re hard to use and require lots of money and training to produce halfway decent results. The real improvements from IT came when user-centered tools came to consumers and then to business with Web 2.0 and new devices like the iPhone.

It may take months of training on Epic or Cerner to get a doctor or nurse to be three-quarters as productive as they used to be, but my two-year-old daughter can fire up an iPad and play games and watch videos with no training.What we’re seeing every day at Health 2.0 is a whole new generation of data-driven applications and devices that are going to make the health care user experience much more like the one my daughter has.

When we get there, the real improvements in both productivity and safety, as well as in quality and even cost, will emerge and we’ll wonder why we ever were having this fight.

Ignorance Of Critical Medical Information Isn’t Bliss

Read this short Forbes essay by Vasilios Tsimiklis and Henry I. Miller. These statistics are shocking:

(…) Here are just a few shockingly common self-destructive behaviors that can lead to negative – and resource-wasting — health outcomes:

• One-third of mothers answering a survey released in 2010 said they did not plan to have their children vaccinated against the flu. Worse, more than a quarter of healthcare workers polled also said they intended to forgo immunization. Flu not only causes misery and economic losses, but it is a killer — of tens of thousands in an average year in the United States.

• An astonishing 40% of women who regularly take medicine that is considered by the FDA to be “contraindicated in women who are or may become pregnant” fail to practice birth control as prescribed. That puts them at high risk of having babies with birth defects.

• Women who have a high risk of breast cancer can reduce their risk substantially by taking either of two types of drugs — selective estrogen receptor modulators (such as tamoxifen) or aromatase inhibitors (such as anastrozole and exemestane) — yet only one-fifth or fewer of eligible women take one of the effective drugs.

• Hypertension, or high blood pressure, is a common but largely symptom-free illness that is a major cause of heart attacks, strokes and kidney disease, yet only 10% of patients take their blood pressure-lowering medications as prescribed for more than one year.

• Compliance with doctor-prescribed medicines overall is dismal. For every 100 prescriptions written, patients take only 50–70 to a pharmacy; 25–30 are taken properly; and 15–20 are refilled as prescribed. Asthmatics, diabetics and even AIDS patients sometimes arbitrarily reduce the dose or frequency of their therapy or skip it altogether.

We are continually surprised by the willingness of people to put their health and lives at risk by refusing to do the tried and true but at the same time trying unproven “natural” remedies and other quack cures advertised in magazines and on TV. Not unlike the 19th-century snake-oil preparations that were dangerous but had little (if any) efficacy, many herbal supplements, for example, are toxic, carcinogenic or otherwise unsafe; and a high proportion contain undeclared substances. Known side effects include blood-clotting abnormalities, hypertension, deadly allergic reactions, irregular heart rhythms, kidney and liver failure, exacerbation of autoimmune diseases and interference with critical prescription drugs.

At the same time that they indulge in such harmful behaviors that encompass errors of omission or commission, many of these same people evince concern over various negligible threats to their health. For example, a large number of people who neglect to take critical drugs or choose to expose their children to the very real dangers of preventable childhood infectious diseases at the same time are frightened of imaginary hobgoblins such as plasticizers in toys and shower curtains and pesticide residues in foods. (Not only are the permissible levels of chemical pesticides in food extremely low — and seldom exceeded — but 99.99% of pesticidal substances in food occur naturally.)

Recommendations for the control of Multi-drug resistant Gram-negatives> carbapenem resistant Enterobacteriacea

Australian Commission on Safety and Quality in Health Care. Recommendations for the control of Multi-drug resistant Gram-negatives: carbapenem resistant Enterobacteriaceae (October 2013). Sydney. ACSQHC, 2013.

(…snip…) Gram-negative bacteria have now emerged that are resistant to most types of antibiotics, including a key “last resort” class of antibiotic, the carbapenems. These organisms are referred to as carbapenem resistant Enterobacteriaceae (CRE). Multi-resistant Gram-Negative bacteria, such as CRE, place Australian patients at greater risk of potentially untreatable infection and increased mortality. CRE is of particular concern because Enterobacteriaceae cause infections at a high frequency and resistant infections are associated with high mortality.

Patients in residential aged care facilities are also potentially at increased risk. Multi-drug resistant Gram- negative organisms have been isolated more frequently in overseas long term care facilities than some other Gram-positive multi-resistant organisms.

Over the past 2 years there have been an increasing number of cases of CRE in Australian patients. Some patients contracted the infection overseas and unfortunately some within Australia. In November 2011, the National Healthcare Associated Infection Advisory Committee of the Australian Commission on Safety and Quality in Health Care discussed the potential implications of CRE in Australian hospitals. A taskforce was established in partnership with the Australasian Society Infectious Diseases, Australasian College of Infection Prevention and Control, Public Health Laboratory Network and Australasian Society of Antimicrobials to develop recommendations for the management and testing of patients with CRE.

This paper incorporates recommendations for patient management that are contained in the Australian Guidelines for the Prevention and Control of Infection in Healthcare and the National Safety and Quality Health Service Standards. These include the use of standard and transmission based precautions, especially for patient placement, patient movement, cleaning and disinfection and antimicrobial stewardship. There are also additional recommendations for laboratory screening methods. 

The bottom line is there is no place to hide. Not even Australasia.

Maryn McKenna: When We Lose Antibiotics, Here’s Everything Else We’ll Lose Too

Maryn McKenna has a terrifying “report from the field” of the fast-approaching post-antibiotic world. That we are living in New Zealand amplifies the report only slightly, because this reality is happening everywhere — and the origin of the particular KPC-Oxa 48 bacterium was Vietnam, not NZ.

This week, [health authorities in New Zealand announced][1] that the tightly quarantined island nation — the only place I’ve ever been where you get x-rayed on the way into the country as well as leaving it — has experienced its first case, and first death, from  a strain of totally drug-resistant bacteria. From the New Zealand Herald:

[1]: http://m.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11159413

In January, while he was teaching English in Vietnam, (Brian) Pool suffered a brain hemorrhage and was operated on in a Vietnamese hospital.

He was flown to Wellington Hospital where tests found he was carrying the strain of bacterium known as KPC-Oxa 48 – an organism that rejects every kind of antibiotic.

Wellington Hospital clinical microbiologist Mark Jones (said): “Nothing would touch it. Absolutely nothing. It’s the first one that we’ve ever seen that is resistant to every single antibiotic known.”

Pool’s death is an appalling tragedy. But it is also a lesson, twice over: It illustrates that antibiotic resistance can spread anywhere, no matter the defenses we put up — and it demonstrates that we are on the verge of entering a new era in history. Jones, the doctor who treated Pool, says in the story linked above: “This man was in the post-antibiotic era.”

(…snip…)

If we really lost antibiotics to advancing drug resistance — and trust me, we’re not far off — here’s what we would lose. Not just the ability to treat infectious disease; that’s obvious.

But also: The ability to treat cancer, and to transplant organs, because doing those successfully relies on suppressing the immune system and willingly making ourselves vulnerable to infection. Any treatment that relies on a permanent port into the bloodstream — for instance, kidney dialysis. Any major open-cavity surgery, on the heart, the lungs, the abdomen. Any surgery on a part of the body that already harbors a population of bacteria: the guts, the bladder, the genitals. Implantable devices: new hips, new knees, new heart valves. Cosmetic plastic surgery. Liposuction. Tattoos.

We’d lose the ability to treat people after traumatic accidents, as major as crashing your car and as minor as your kid falling out of a tree. We’d lose the safety of modern childbirth: Before the antibiotic era, 5 women died out of every 1,000 who gave birth. One out of every nine skin infections killed. Three out of every 10 people who got pneumonia died from it.

And we’d lose, as well, a good portion of our cheap modern food supply. Most of the meat we eat in the industrialized world is raised with the routine use of antibiotics, to fatten livestock and protect them from the conditions in which the animals are raised. Without the drugs that keep livestock healthy in concentrated agriculture, we’d lose the ability to raise them that way. Either animals would sicken, or farmers would have to change their raising practices, spending more money when their margins are thin. Either way, meat — and fish and seafood, also raised with abundant antibiotics in the fish farms of Asia — would become much more expensive.

Read more..

The last paragraph I quoted bumps the priority on my todo list – to understand better the realities of agricultural antibiotics. I’m carrying around the idea that the Danes have demonstrated on the farm that pigs could be raised without antibiotics at lower cost, higher productivity and healthier pigs. Yes, the farmers did have to innovate and adopt new husbandry methods. But there must be more to the story than my simple memory.

More important, do not miss Maryn’s new in-depth report “Imagining a Post-Antibiotics Future“.

Maryn McKenna on the post-antibiotic planet

…our post-antibiotic grandchildren will be less healthy than we are: more likely to die young or spend their lives crippled by disease. In the face of such a large problem, it’s an amazement that our public-health experts have any time to spare on any other problem.

Megan McArdle:

I imagine how our descendants will look back on our world. Unless something is done about antibiotic resistance, I’m very much afraid that they’ll look upon us the way 19th-century science fiction writers viewed Atlantis: as a lost paradise of magical technology — in this case, one in which you could go to a child coughing her life out with pneumonia, stick a needle in her arm, and watch the disease melt away almost before your eyes. The first doctors who treated patients with antibiotics felt like they were witnessing miracles. Our grandchildren may feel much the same way about the ease with which we cured disease. At Wired, Maryn McKenna outlines all the medical miracles that antibiotics have made possible:

If we really lost antibiotics to advancing drug resistance — and trust me, we’re not far off — here’s what we would lose. Not just the ability to treat infectious disease; that’s obvious.But also: The ability to treat cancer, and to transplant organs, because doing those successfully relies on suppressing the immune system and willingly making ourselves vulnerable to infection. Any treatment that relies on a permanent port into the bloodstream — for instance, kidney dialysis. Any major open-cavity surgery, on the heart, the lungs, the abdomen. Any surgery on a part of the body that already harbors a population of bacteria: the guts, the bladder, the genitals.

Implantable devices: new hips, new knees, new heart valves.

Cosmetic plastic surgery. Liposuction. Tattoos.We’d lose the ability to treat people after traumatic accidents, as major as crashing your car and as minor as your kid falling out of a tree. We’d lose the safety of modern childbirth: Before the antibiotic era, 5 women died out of every 1,000 who gave birth. One out of every nine skin infections killed. Three out of every 10 people who got pneumonia died from it.And we’d lose, as well, a good portion of our cheap modern food supply. Most of the meat we eat in the industrialized world is raised with the routine use of antibiotics, to fatten livestock and protect them from the conditions in which the animals are raised. Without the drugs that keep livestock healthy in concentrated agriculture, we’d lose the ability to raise them that way. Either animals would sicken, or farmers would have to change their raising practices, spending more money when their margins are thin. Either way, meat — and fish and seafood, also raised with abundant antibiotics in the fish farms of Asia — would become much more expensive.

We are, she writes, on the brink of the “post-antibiotic era.” Already, some bacteria are resistant to everything we can throw at them. They’re mostly confined to hospitals at the moment, but they’re increasingly seen “in the community” – i.e., in all the homes and stores and workplaces where we like to spend our time.

Read more…

Nearly all hospitals will give you the price of parking. Barely any will give you the price of health care.

Wonkblog: Nearly all hospitals will give you the price of parking. Barely any will give you the price of health care.

Excerpt:

“The provision of parking prices would suggest that hospitals can indeed answer telephone queries about costs—when they want to,” authors Jillian Bernstein and Joseph Bernstein write.

This study is a follow up to another one that the latter Bernstein worked on, where he and his co-authors called hospitals to ask how much a hip replacement would cost. Like in this study, they found that about 10 percent were able to provide a price. The idea here was to test out whether that had to do with the complexity of the procedure. A hip replacement’s price could vary if, for example, there was an unexpected complication.

This new ECG study suggests that its really not about the complexity–that, overall, hospitals just aren’t good at providing prices.

“Hospitals seem able to provide prices when they want to; yet for even basic medical services, prices remain opaque,” Bernstein and Bernstein write. “Accordingly, medical insurance payment schemes that promote concern about prices without a commensurate increase in price transparency are apt to be ineffective.”