The “big, big, big mistakes” we make in drug therapy with sick infants


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The big news in medicine today is the announcement of a promising new gene-based therapy for certain leukemia patients – children and young adults aged 3 to 25 – who were facing death because every other treatment had failed: 52 of 63 patients who received the therapy last year went into remission – “a high rate for such a severe disease.”

The reports come on the heels of yesterday’s Food & Drug Administration hearing aimed at carefully assessing how safe and effective the therapy is. The FDA advisory committee wasn’t concerned about effectiveness; instead, they zeroed-in on reports of the side-effects – raging fever, crashing blood pressure, lung congestion, infertility, and the possibility of causing secondary cancers. After hearing the evidence the committee unanimously recommended that the FDA approve the drug. The agency will announce their decision in October.

And that’s how drug approval is done – except for, of all people, neonates: premature and full-term infants less than 28 days old – babies so tiny, their little hands can’t wrap around their parents’ index fingers.

Infants admitted to a neonatal intensive care unit may receive up to 60 medications – antibiotics, anesthetics, narcotics, diuretics – in their first month of life. Yet according to a report in the online medical journal STAT, 90% percent of these drugs have not been approved by the FDA for use in newborns.

Instead, doctors make treatment decisions by scaling down from how medications are used in adults: “We take it right out of the vial of an adult drug, dilute it down, and give it to the babies,” says Dr. Jonathan Davis, chief of newborn medicine at Tufts Medical Center. Doctors make decisions based on little more than anecdotes and intuition – essentially treating each sick newborn as an uncontrolled, unapproved study of one.

Result: “There have been some big, big, big mistakes in neonatology through the years when it comes to drugs,” said neonatologist Dr. Matthew Laughon of the University of North Carolina at Chapel Hill. Examples of what’s been admitted to publicly are the sudden deaths of preemies due to too-large doses of the antibiotic chloramphenicol in the 1950s; the fatal poisoning of infants from large amounts of benzyl alcohol, a preservative used to flush catheters, in the 1980s; and deaths from a preservative, propylene glycol, in a multivitamin given orally to premature infants in a dose intended for adults.

This happens because how drugs affect people is strongly age-dependent: infants absorb, metabolize, and excrete drugs differently than adults. “Yet we haven’t done the studies to know exactly what those differences are,” said Catherine Sherwin, chief of pediatric clinical pharmacology at the University of Utah School of Medicine. “We just know they’re different.”

Why is there no medical evidence and no FDA approval process for 90% of the drugs used on newborns? Fear and fear of lawyers: Pharmaceutical companies shy away from studying infants because they are fragile, cannot spare many blood samples, and are vulnerable to permanent injuries – injuries that, in the past, have been awarded large malpractice verdicts. And second, money: Newborns are a small market, so pharmaceutical companies aren’t likely to make money by getting drugs approved for neonate use.

So where does that leave us? “We’ve got to do something,” says Dr. Davis. Without drug data for newborns, he said, “we can’t be certain which drugs, in which doses, to use when.”



“Very few” people who think they have a penicillin allergy actually do


Penicillin 1


Most patients who have a history of penicillin allergy are not really allergic to penicillin.

According to a report this week in JAMAless than 10% [of people] with penicillin allergy histories who are tested in specialized allergy clinics are found to be at risk for acute allergy to penicillin’s.”

Moreover: “Careful assessment of a patient’s history of antibiotic allergy, combined with testing strategies, will result in very few of the estimated 25 million to 30 million US residents labeled as allergic to penicillin to not receive penicillin’s or other [penicillin-like] antibiotics when those drugs are indicated.

So if for any reason you think you’re allergic to penicillin the authors recommend that you arrange for an allergy specialist to do skin testing (above photo).

The reason? Not using penicillin or a penicillin-derivative when you should, means you’re (unnecessarily) using something that is less effective, more toxic, and more expensive. And thus, in hospital settings, you’re facing a “greater risk for prolonged length of stay, readmissions, and acquisition of multidrug-resistant organisms.”

So for example, when you don’t use the antibiotic of choice for Staph aureus:


The inability to use an antistaphylococcal penicillin (e.g. nafcillin) for patients with methicillin-susceptible Staphylococcus aureus sepsis, or other serious infections, for which penicillin’s are the first-line therapy … places patients at risk of treatment failure, resistance generation, and increased mortality.” [My emphasis.]


Childhood penicillin allergies will disappear “in most patients … after a decade.” But there’s another reason why you may think you have a penicillin allergy when you don’t: “… viral rashes in children may be mistaken for penicillin allergy when these children are unnecessarily given antibiotics for a viral syndrome.”





Mean Streets

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NPR reports that Trump’s proposed budget will cut over $2 billion dollars from global healthcare spending. It will, for example, eliminate U.S. aid for international family planning. And programs to combat HIV/AIDS in the world’s poorest countries will be slashed by 17 percent. One notable program on the chopping block is the Presidential Emergency Plan for AIDS Relief (PEPFAR) which funds life-saving drugs for infected people as well as prevention efforts.

There will be harm. Reduction in family planning services alone will result in about 3.3 million more abortions, 15,000 more maternal deaths, 8 million more unintended pregnancies, and 26 million fewer women and couples receiving services per year.

Condemnation was swift. This excerpt from a Washington Post op-ed explains why it’s even in America’s best interest to continue these programs and to fully fund them:


It is clear that the generosity of the American people has had a huge impact — one that reflects the view that all lives are precious, and to whom much is given, much is required. This lifesaving work also has a practical purpose for Americans. Societies mired in disease breed hopelessness and despair, leaving people ripe for recruitment by extremists. When we confront suffering — when we save lives — we breathe hope into devastated populations, strengthen and stabilize society, and make our country and the world safer …

Saving nearly 12 million lives is proof that PEPFAR works, and I urge our government to fully fund it. We are on the verge of an AIDS-free generation, but the people of Africa still need our help. The American people deserve credit for this tremendous success and should keep going until the job is done.


An example of how the cuts will hurt is seen with the effort to prevent mother-to-child transmission (MTCT) of HIV: an HIV-positive woman transmits the virus to her child during pregnancy, childbirth or breastfeeding. MTCT accounts for the vast majority of new infections in children. In 2015, 150,000 children – 400 children a day – became infected this way.

If HIV is caught in time and with appropriate lifelong treatment the child and the mother can manage the virus and prevent it from developing into AIDS. But there’s an often-overlooked catch: the people closest to the mother will punish her for having transmitted the virus to her child, and this can have lifelong consequences.

AVERT, an HIV and AIDS charity based in the UK, has documented this. For instance, because HIV is so stigmatized, a mother will not want her friends and neighbors to know for fear of being shunned. To the point where she’ll even avoid going for necessary treatment if she thinks she’ll be found out.

For women who disclose their HIV, they’ll find most husbands won’t accompany them to the prenatal clinic. As men who do are perceived as “weaklings” by their peers. Or worse, men will physically abuse or abandon their wives.

There’s even cases where women are abused by healthcare workers. This is what one woman was told by her doctor:


How can you even think about getting pregnant knowing that you will kill your child because you’re positive?!!!’ He threatened not to see me again if I got pregnant. He told me that I was ‘irresponsible’, a bad mother, and that I was certainly running around infecting other people.


We all internalize messages from those closest to us. As these mothers have. And therefore, AVERT says, they’ll sentence themselves to a lifetime of self-blame and punishment for “not fulfilling traditional gender roles of wife and mother,” and for having been abandoned by friends, family, or their husband.

One more thing: these mothers live with the dread of having to one day answer their child’s question that they know will surely come: Mother, how did I get HIV? And the fear of being pushed away – again – when they tell the truth.

It doesn’t take much to figure this stuff out – if you care to. But these days, the men – and they are mostly men; elderly, white and wealthy – patrolling the mean streets of Washington have turned a blind eye to the lives of others, not just abroad but at home too. It wasn’t always like this: the humane Washington Post op-ed above, and PEPFAR, are both authored by the same person – former president George W Bush.

On Sinusitis: Antibiotics are not necessary in the “vast majority” of cases



There’s a terrific article on sinusitis by Consumer Reports that underscores the Golden Rule of antibiotic usage: Never use them for viral-driven infections – which sinusitis almost always is – because (1) they aren’t doing a thing for what’s wrong with you, thus your condition could worsen, and (2) antibiotics are powerful drugs that produce adverse side-effects – they make you feel worse – in a quarter of the people that use them.

The bottom line: “For acute sinusitis, there are very well-done studies (JAMA) indicating that antibiotics are not necessary in the vast majority of patients, and most people will be able to clear an infection on their own,” says ZaraPatel, MD, assistant professor of Otolaryngology at the Stanford University Medical Center.

The chief concern with them is they can make you sickerFor instance, antibiotic use increases the chances of developing an infection caused by clostridium difficile bacteria that can result in life-threatening diarrhea. Almost half a million Americans contracted the infection in 2011, resulting in 15,000 deaths. Other side effects include stomach problems, dizziness/nausea, rashes, vaginal infections, swelling of the face and throat, and breathing problems. Some antibiotics can even cause permanent nerve damage and torn tendons.

Even if bacteria are the cause, the infections usually clear up on their own in about a week. In the meantime, to loosen mucus and help it drain, drink warm liquids – a salt water gargle helps some people; use a hot shower, bath, or a kettle, to breathe warm, moist air; keep your head propped up when you lie down; and because you’re fighting a virus, it’s important to rest.

But never say never. You would consider an antibiotic if: you get better and then worse again; don’t get better after 10 days; you have a fever of 102 or more; you have severe face pain and tenderness; or you have thick, colored mucus for three or more days in a row.

In any event, the purpose of this and the Consumer Reports article is to help you have a better conversation with your physician. The following video will also help and it provides a nice summary of the issues surrounding sinusitis:


Antibiotic resistance: a Global Issue

Not only does antibiotic resistance (ABR) affect you, but it also affects global populations. Due to the ease of the sharing of genetic material between bacteria and the environmental resilience of many bacterial populations, ABR can spread quickly and efficiently. ABR is found in bacteria spanning dozens of countries around the globe and continues to be a concerning issue.

In the United States alone, a multitude of antibiotic resistant bacteria have been reported by the Center for Disease Control and Prevention. An especially worrying species of bacteria is Streptococcus pneumonia, known to cause bacterial meningitis (a serious condition involving the inflammation of membranes surrounding the brain and spinal chord). The CDC reported 1.2 million cases of antibiotic resistant Streptococcus pneumonia causing an estimated 7000 deaths in the year of 20131. This is just one example from an extensive list of antibiotic resistant strains of bacteria.

Of course, ABR is not an issue isolated to the US, or even North America. Data supplied by countries around the world to the WHO illustrate an ABR epidemic spanning the globe. This table from the BC medical journal adapted from a 2014 WHO report demonstrates the widespread presence of ABR:2

This research further demonstrates ABR as a global issue. The BC Medical Journal also describes examples like MRSA bacteria in hospitals and communities necessitating “requiring second-line treatment” causing increased treatment costs and requiring additional monitoring for side effects.2 ABR not only is detrimental to the health of its patients but also to the healthcare infrastructure surrounding those patients.

ABR is a global issue with many adverse implications making it difficult for physicians and present healthcare infrastructure to provide adequate treatment for those affected by resistant bacteria.


1“Antibiotic Resistance Threats in the United States, 2013.” Center for Disease Control and Prevention. Accessed June 8, 2016.

2Wang, Sophie Y., Diana George, Dale Purych, and David M. Patrick. “Antibiotic Resistance: A Global Threat to Public Health.” BC Medical Journal, 6th ser., 56, no. BCMJ (July 2014).


Ventilator Associated Pneumonia

Ventilator Associated Pneumonia, or VAP, is a troubling condition affecting 250,000 to 300,000 patients in the ICU per year in the U.S. This is caused by infection of the airways through a ventilator—a mechanical device inserted into a patient’s airways to help with breathing. Often patients are put on a ventilator during and/or after surgery. It is important to understand prevention and treatment of VAP due to its frequent incidence and potential severity.

Pneumonia is an infection of the air sacs of one or both lungs. This causes them to become inflamed making it very difficult for the patient to breathe. Any case of pneumonia is deemed concerning and can even be life threatening. Elderly people, children and persons with weakened immune systems are prone to more serious cases of pneumonia.

Photo 1: Illustration of pneumonia infection. Credit: Mayo Clinic

Photo 1: Illustration of pneumonia infection. Credit: Mayo Clinic

Different organisms can cause these pnemonia including a variety of species of fungi, bacteria and types of viruses. In the case of VAP, bacteria species Pseudomonas aeruginosa, Acinetobacter spp., and Stenotrophomonas maltophilia are attributed to higher mortality rates in patients. Many of these species of bacteria are also multi-drug resistant which complicates treatment. The first line of defense in order to reduce VAP rates is prevention.

Photo 2: Credit: CDC

Photo 2: Credit: CDC

There are several steps healthcare professionals and patients should take in order to prevent VAP. The CDC advises to keep the head of the patient raised when put on a ventilator. Furthermore, proper sanitary precautions should take place like hand washing and mouth cleaning before the ventilator is placed in the patient. Smoking is also known to increase the risk of VAP, so patients are advised to quit well before being put on a ventilator.

VAP is often a very serious condition but can be treated. The CDC cites antibiotics as the primary means for treating VAP; however, it is important to highlight the problem multi-drug resistant bacteria pose in relation to VAP. A study conducted by Clinical Microbiology Reviews found VAP is often over treated due to poor methods of diagnosis. This causes even more antibiotic resistance in healthcare settings, making sure cases of VAP even more difficult to treat. Better diagnosis and more effective treatment must be found to ensure the health of patients.

Photo 3: Credit: VAP education

In addition detriments to a VAP patient’s health, VAP is also known to be very expensive for ICUs. Duration of ICU stays are known to increase because of VAP and have an estimated cost of $5000-$20000 per case. Assuming there are 250,000 cases of VAP each year, VAP could be costing hospitals up to $5 billion/year.

What are some things you can do to aid the problem of VAP? Help raise antibiotic management awareness and the threat antibiotic resistance poses. Advise family members to quit smoking as they never know if/when they may be placed on a ventilator for whatever reason. If you or a loved one ever requires ventilator use, inquire about ways you or your healthcare provider can avoid the risk of VAP.

VAP is both a serious risk to ICU patients in hospitals around the world and a major cost to the healthcare system. Proper steps have to be taken in order to prevent VAP and its associated complications. Moreover, treatment methods steering away from antibiotics must be developed and implemented especially with the abundance of multi-drug resistant bacteria.


Central Line-Associated Bloodstream Infections

Have you or a loved one ever needed to use a catheter for a treatment procedure in a hospital? Catheter-associated bloodstream infections also known as central line-associated bloodstream infections (CLABSI) cause illness and even death for thousands yearly. Often these infections are serious—healthcare professionals and patients must take the appropriate steps in monitoring and treating infections before severe complications arise.

Central venous catheters, also known as central lines are medical devices inserted into a patient’s large vein, typically in the neck, chest or groin in order to administer medication and/or collect blood for testing purposes. CLABSI occurs when bacteria or other harmful pathogens enter the bloodstream through a central line. Because these central lines connect to major veins, often close to the heart, in a patient’s body, these infections are deemed very serious. So who is prone to these infections?

Photo 1: Illustration of a central-line catheter placed in a patient's chest. Credit: Mosaic Life Care

Photo 1: Illustration of a central-line catheter placed in a patient’s chest. Credit: Mosaic Life Care

Patients in the ICU are known to be at risk for CLABSI. According to the Agency for Healthcare Research and Quality, 48% of patients in the ICU have central line catheters. The CLABSI rate is known to be 5.3 per 1000 catheter days, with mortality rate at 18%. This means up to 28,000 patients in the ICU die from CLABSI in the U.S. yearly. Each CLABSI infection approximately costs $26,000.

Due to the severity of these infections, prevention is of the utmost importance. Like other health-care associated infections, an essential component of prevention is proper sanitary precautions like proper hand hygiene and maintaining sterile conditions when inserting the catheter. The CDC, urges patients to minimize the frequency of visitors when being placed on a catheter to reduce the risk of infection. Furthermore, the patient should refrain from touching the catheter at any point during treatment.

While prevention is the first line of defense against CLABSI, understanding treatment mitigates severity and risk CLABSI poses. Patients should monitor their own health are watch for CLABSI symptoms like fever and/or soreness around the catheter site and alert a healthcare professional once these symptoms arise. Antibiotics can often treat these infections; however, with the rise of multi-drug resistant bacteria, treatment can be prolonged and complicated. Often, new treatments and therapies have to be considered for adequate treatment.

CLABSI is both an abundant and serious issues affecting ICU patients in hospitals around the world. Extra steps should be taken to reduce its occurrence and efforts to find adequate treatment should be taken seriously.


What is a Surgical Site Infection?

Surgery is a process that comes with tedious care from everyone involved. Even with careful precautions, tissue after surgery is often prone to exposure to pathogens and infection. Some of these infections can be superficial, but can also be more severe and affect internal organs. These infections are termed Surgical Site Infections or (SSI).

According to the Center for Disease Control and Prevention there are many symptoms that could indicate an SSI. Redness, pain and inflammation near or around the surgical site wound are common symptoms for an SSI. Furthermore, if a patient feels feverish or has excessive drainage of cloudy fluid from the surgical site wound, they should seek a healthcare professional immediately.

The use of antibiotics is ubiquitous in treating SSIs. The CDC cites antibiotics and additional surgery as the primary methods for treating SSIs. However, it is important to note that, like any other bacteria, bacteria in SSIs have the ability to become resistant to antibiotics. This makes the infection harder to treat and more dangerous. Alternatives to antibiotics should be sought out when dealing with SSIs.

There are many ways to prevent SSIs. Healthcare workers should pay careful attention to sanitation and prevent the spread of germs. Patients should also refrain from shaving near the surgical site as razors can irritate the skin and promote infection on the surgical site. Both patients and healthcare workers should observe the surgical site before, during and after the surgery in order to prevent infection, or diagnose and treat an infection as soon as possible. These precautions in tandem with treatments alternative to antibiotics will serve to minimize the risk of SSIs.


Antibiotic Resistance: More prevalent in certain countries

While antibiotic resistance (ABR) is recognized as a global issue, it is important to note that ABR is more prevalent in some countries over others. In developed countries, over prescription and use of antibiotics on livestock are overwhelming contributors to ABR; however, ABR in developing countries appears to be virulent. Why are these countries more prone to ABR?

Often, developing countries possess antibiotics readily available to the public. According to an article from the Institute of Medicine Forum on Emerging Infections, antibiotics in many developing countries are available for purchase without a prescription.1 This leads to self-medication where the patient acquires and uses antibiotics without consulting a healthcare professional—something that is often difficult to do in impoverished areas. Epidemiologist Keith Klugman from the Bill & Melinda Gates Foundation states that the problem of ABR is especially prevalent in Brazil, Russia, China, and India. Self-medication promotes the spread of ABR both in patients and the community; the use of antibiotics in this context is often superfluous and unnecessary.2

Another source of ABR in developing countries are in hospitals. The Institute of Medicine Forum on Emerging Infections states that large hospitals must employ antibiotics regularly due to the close proximity of patients increasing their susceptibility of infection1. These antibiotics are often administered without proper diagnosis and foster environments conducive to ABR. Inadequate protocol for or improper practices from healthcare workers increase the likelihood of patients being infected, which ultimately leads to administering more antibiotics. ABR in hospitals is a pronounced problem in developing countries.

So what practices will minimize the spread of ABR? Healthcare infrastructure in developing countries should limit the availability of antibiotics and require prescription and/or consultation with a healthcare professional; antibiotics should only be used when deemed necessary and when proper diagnosis is acquired. Hospitals should develop improved protocol and train healthcare workers in order to minimize the spread of infection and therefore reduce the necessity of antibiotics. Obviously these practices would require extensive logistical planning and associated cost, but initiating a conversation about them is important nonetheless.


1“Factors Contributing to the Emergence of Resistance.” NCBI. 2003. Accessed June 10, 2016.

2Reardon, Sara. “Antibiotic Resistance Sweeping Developing World.” May 06, 2014. Accessed June 10, 2016.

Antibiotic Resistance

Have you ever had to pay multiple visits to a doctor because the prescribed medication for illness just wasn’t working? This might occurred because of a natural phenomenon termed ABR or antibiotic resistance. So what is ABR? According to the Alliance for the Prudent Use of Antibiotics of the Tufts University Medical School, antibiotic resistance “occurs when an antibiotic has lost its ability to effectively control or kill bacterial growth”1. The bacteria become resistant to certain antibiotics and such therapy is rendered ineffective.

Bacteria achieve antibiotic resistance through natural phenomenon related to genetics and evolutionary mechanisms. Some bacteria in a population appear to be resistant to a specific type of antibiotic (or multiple antibiotics) due to random genetic mutation. Once antibiotics are deployed on the site of infection, the non-resistant bacteria are eliminated and the resistant bacteria are left alive. The antibiotics create a “selective pressure” that promote the survival of the resistant bacteria1. Furthermore, these bacteria will reproduce and their offspring inherit the resistant traits thus creating a new fully resistant population.

Bacteria also have multiple robust mechanisms that enable the proliferation of ABR. Their offspring can inherit resistant traits “vertically”, or they can share genetic information with other bacteria “horizontally” through a process termed conjugation1. Adding to the fact that bacteria can survive on many surfaces and travel easily on unsuspecting flights and water travel, ABR is able to spread amongst bacteria quickly.

Studies conducted by the World Health Organization show that ABR is not only a concern for the future, but also a very current worldwide issue. In 2013, there were approximately 480,000 cases of multi-drug resistant Tuberculosis evident in around 100 countries2. Like other cases of antibiotic resistant bacteria, multi-drug resistant Tuberculosis requires extended and arduous methods of treatment as the bacteria is stubborn to common antibiotic treatment.

Evidently, ABR is a current real-world issue with the potential to further escalate. This issue should be studied and better understood in order to develop alternatives to remedy the problems ABR creates.


1 “General Background: About Antibiotic Resistance.” APUA. 2014. Accessed June 08, 2016.

2 “Antimicrobial Resistance.” World Health Organization. Accessed June 08, 2016.

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