Posts Tagged ‘CDC’

Even the best of us...smallpox, anthrax, influenza and the CDC

Wednesday, July 16th, 2014
This is our premier laboratory

This is our premier laboratory

The Center for Disease Control and Prevention, AKA the CDC, America's central medical laboratory has recently had multiple problematic episodes. I was trying to follow up on the vials of smallpox virus that were found in an old refrigerator that the FDA apparently had forgotten, The question, of course, was whether the virus samples were long dead or still viable. They had been sent to the CDC to have that highly significant issue resolved.

Since then there has been a followup announcement, but also several articles on significant issues with procedures and safety at the CDC itself. The first was published in The New York Times, AKA NYT, (as well as in other papers, but I get the NYT daily on my iPad , so saw it there first). The startling title was "C.D.C. Closes Anthrax and Flu Labs after Accidents." The current director of the CDC, Dr. Thomas Frieden, called the lab/agency "the reference laboratory to the world," but admitted there had been a series of accidents (actually lapses in set safety procedures), in the recent past, that were quite frightening.

A month ago potentially infectious samples of anthrax, a bacteria found naturally in soil and commonly affecting wild and domesticated animals worldwide, causing an extremely serious, but rare illness in people, were sent to labs that were not equipped to deal with them (anthrax would normally be handled only with the highest level of protective biosafety gear and procedures (BSL-4). The CDC also has a rather simplistic YouTube video discussing anthrax's use as a potential bioterrorism weapon, but in this case 62 or more CDC employees were potentially exposed to the bacteria in the course of their work.

The good news is it appeared nobody was in danger; all those employees were given the anthrax vaccine and also begun on antibiotics. The background information available online says there has never been person to person spread of the disease.

It appears that it's exceedingly tough to get rid of anthrax in the environment; I'll go over the classic historical example of how careful government researchers have been with its spores..

In the 1940s, British scientists used a small Scottish island (Gruinard) for germ warfare research. That island, thoroughly contaminated with anthrax spores, remained off-limits for forty+ years before extraordinary efforts, begun in 1986, rendered it safe for ordinary use. The surface of the island was only 484 acres; it was sprayed with a herbicide, then all dead vegetation was burned off. Next 200 tons of formaldehyde solution was diluted in 2,000 tons of seawater and sprayed over the entire island. Perforated tubing was used to ensure that 50 liters of solution were applied to every square meter being treated.

Later the effectiveness of the decontamination process was assessed by taking two duplicate sets of soil samples. Each was tested at two major government labs. Anthrax spores were detected only in "small quantities in a few places." These specific areas were treated in July 1987, followed by further soil sampling in October 1987. No further traces of anthrax spores were found.

Blood samples from local rabbits were also tested for anthrax antibodies. No such antibodies were found.

Following these measures, a farmer grazed part of his flock of sheep on the island for six months. The sheep were inspected monthly by the District Veterinary Officer, and returned to the mainland in October 1987 in excellent condition.

On April 24, 1990, 4 years after the decontamination works had been completed, a Defense Minister visited the island and removed the safety signs, indicating that the island had finally been rendered safe. Then, per agreement  the island was sold back to the heirs of the original owner for the WWII sale price of £500.

But a senior British archeologist said he still wouldn't set foot on the island; he was concerned because of potentially infectious particles found in some of his digs.

Yet another NYT piece, "Ticking Viral Bombs, Left in Boxes," this one written by a distinguished physician, Lawrence K. Altman, M.D. recalls the irony of the outcry for mass smallpox vaccination of our entire U.S. population after 9-11 (when no Iraqi supply of the deadly bacterium was ever located), contrasted with the recent finding of six vials, two with live smallpox bugs, being found in in Bethesda, almost within "spitting distance" of our center of government.

In 2011 the Birmingham Mail reviewed a tragic lab accident which led to the last known smallpox death . The city, now England's second largest, was a site of a medical research laboratory associated with the local medical school. Viral particles got into an air duct and a photographer whose studio was one story up from the lab became the last known case of active smallpox and died from the disease in spite of having been vaccinated twelve years before

Dr. Altman discusses the pros and cons of eradicating the last two known stocks of the virus, one at the CDC, the other in a Russian lab in Siberia. Even if the natural virus is finally and totally eliminated , a rogue group may well be able to re-establish their own supply from the known genetic sequence of smallpox.

Lastly I saw a NYT article with an even more disturbing title, "After Lapses, C.D.C. Admits a Lax Culture at Labs." CDC workers had somehow shipped a dangerous strain of avian influenza to a poultry research lab run by the Department of Agriculture. Known as H5N1, the virus had killed more than half of the 650 people who had been infected with it since 2003. Again there were no deaths from this mistake.

After all of this recent furor plus the historical examples, I'm heartily in favor of the idea that's been broached saying such dangerous organisms should be confined to a minimal number of labs and even those clearly need to tighten up their standards.







Smallpox: vials found in NIH lab

Wednesday, July 9th, 2014

I was glancing through The Wall Street Journal. this morning (that period is intentional as I found out recently in their 150th anniversary issue) and saw an article about smallpox,  that old enemy of mankind. The CDC issued a media statement saying six vials labeled with the technical name of the disease, variola, had been found in an old storage room belonging to an FDA lab that is on the NIH Bethesda, Maryland facility. Forty-two years ago the FDA took over that lab, among others, and only now were those labs being moved to the main FDA location in the DC area. The vials themselves date back ~60 years and now will be tested to see if the material in them is viable (i.e., live smallpox viruses).

I reviewed the CDC's Bio-hazard Safety Levels; they range from 1 to 4 with more serious infectious agents occupying the higher levels. A BSL-3 agent can cause serious or deadly disease, but either doesn't spread from person to person (at least not easily) and/or has a preventive or treatment known. Plague, rabies virus and West Nile fit into this category. Smallpox is obviously a BSL-4 bug, the most dangerous kind and in the company of Ebola virus. A February 15, 2012 Reuters article, "How secure are labs handling the world's deadliest pathogens?" talked about the precautions used in such a lab in Galveston, Texas. The boss there got entry by swiping a key card, was scanned by 100+ closed-circuit cameras as he opened seven additional locked doors before he reached the lab where another card swipe and a fingerprint scan were necessary for entry. The Washington Post article on the recently found vials has a six-minute video on BSL-4 procedures with a comment that there are three over-lapping types of safety precautions: those for containment of the hazardous material; those for personal protection and overall administrative factors.

And this may get you into BSL-3/

And this may get you into BSL-3

The air flow and exhaust systems used in Galveston, the full-body suits with their own air supply and the intruder drills that are conducted all made me somewhat more comfortable. But that's in a government-funded laboratory. Even in the United States, a private-funded lab may not be subject to the same rules and regulations, Elsewhere the procedures that must be followed vary. In 2011 there were 24 known BSL-4 labs in the world with six in the U.S. (The GAO said we had considerably more.) In 2013 there was considerable protest in Boston over the proposed BSL-3 and BSL-4 lab there.

We don't see these anymore.

We don't see these anymore.

I've written about smallpox before, but a brief history, available online on a dermatology website was worth reviewing. The disease likely originated in Africa about 12,000 years ago. caused a major epidemic during an Egyptian-Hittite war in 1,350 B.C.E and left typical scars on the mummy of Pharaoh Ramses V who died in 1157 B.C.E. It got to Europe somewhere between the 5th and 7th centuries C.E.; millions died in Europe and the Western Hemisphere before Edward Jenner developed vaccination in 1796. The term came from the Latin word for cow (vaca), as Jenner used fluid from a cowpox-infected dairymaid's hand to inoculate an eight-year-old boy. In 1967 WHO estimated there were 15 million cases of smallpox and 2 million deaths from the disease. Total smallpox deaths over the past 12,000 years have been estimated at 300-500 million, more than all the world wars combined.

By 1980 the World Health Organization declared the globe smallpox-free. In this country, we quit vaccinating the general population in 1972 and stopped giving the inoculation to new military personnel in 1990.

My wife's old shot record shows she got her first vaccination against small pox in 1956 and the last booster in 1980. We were both assigned to bases in the Far East in the early and mid 80s. I can't find my military vaccination record from that time frame, but logically wouldn't have had a booster after 1986 when I got back to a base in Texas. Since immunity is unlikely to last more than ten years, at this stage we'd both be vulnerable to smallpox, like most everyone else.

The only known supplies of the virus remained in government laboratories in the United States and Russia. There has been considerable international protest against keeping those specimens alive starting in the early 1990s, but thus far neither country wants to give in to that pressure. One rationale was the genetic structure of the virus was known, so it could conceivably be recreated by terrorists.

In 2004 the CDC said they had stockpiled enough smallpox vaccine on hand to vaccinate everyone in the United States. I haven't found any updates on that statement. But the U.S. military was still giving those shots to personnel going to USCENTCOM areas (the Middle East and the "stans") until the middle of May, 2014, to Korea for another two weeks and to some special mission troops after that with an end date unspecified.

So now it's the middle of 2014 and, in one manner or another, smallpox is still lingering, fortunately not as an active disease. The CDC is testing those re-found vials of the virus  and we'll hear in a couple of weeks is they were still viable.






There's Silver in Them There Pills

Wednesday, December 25th, 2013

Like most medically-trained people (and hopefully many of the rest of us), I've been highly concerned about the rise of drug-resistant microorganisms, bacteria that can't be treated with our standard antibiotics. A recent article in The Wall Street Journal with the intriguing title "Antibiotics of the Future" offered considerable hope, but let look at some background on the subject first.

The WSJ article said that two million patients each year in the United States develop infections that doctors can't combat with our normal antibiotics; earlier in the year, the CDC in a report titled "Antibiotic Resistance Threats in the United States 2013" estimated that at least 23,000 of them die. They divide the microorganisms, all bacteria except for Candida (a fungus), into three groups: those whose threat levels are considered urgent, serious or concerning. The three in the urgent category include Clostridium difficile, which causes severe, life-threatening diarrhea, often in patients who have been hospitalized and are already on antibiotics, and leads to a quarter-million infections, 14,000 deaths and a billion dollars in medical expenses yearly. Then there are the carbapenem-resistant Enterobacteriaceae,  abbreviated as CRE (the carbapenems are powerful antibiotics considered the "drugs of last resort," used when all other old and modern antimicrobials fail or are thought to be likely to fail; Eneterobacteriaceae are bacteria that are part of the normal gut flora.)

CRE infections most often happen in patients getting treatment for other serious conditions. They may be on a respirator, have a long-term catheter in their bladder or have been on other antibiotics. One estimate says there are 9,000 CRE infections a year and they cause at least 600 deaths. Patients in intensive care units not infrequently have IV catheters placed in large veins in the neck, chest or groin to allow hospital personnel to give medications and draw blood sample for a prolonged period of time. If these get infected they can cause a bloodstream infection (sepsis is the medical term). About half of all hospital patients who get CRE that goes on to cause a bloodstream infection die.

The third infectious urgent threat level is the bacteria, Neisseria gonorrhoeae, that causes the STD gonorrhea. The CDC estimates more than 800,000 cases occur yearly in the United States and 30% of these are resistant to some antibiotic, but almost all can be treated, at this time, with a two-drug cocktail. Gonorrhea causes severe reproductive system complications and the CDC says it "disproportionally affects sexual, racial and ethnic minorities."

Then there is MRSA, methicillin-resistant Staphylococcus aureus. This bug is classified as serious, not urgent, yet there are roughly 80,000 severe MRSA cases a year and over 11,000 of these patients die. Most major MRSA cases are seen in healthcare setting among patients with weakened immune systems (e.g., those on hemodialysis or receiving cancer therapy) but less serious MRSA  can case problems in otherwise healthy people, including athletes who share towels or razors, children in day-care and members of the military in cramped quarters. Some of these infections, usually of the skin, can become severe and life-threatening.

The CDC piece, except for Candida, excludes non-bacterial diseases, but I received a reader comment a while back from a person whose website ( has a post on Deadly Viruses.  Like parasitic diseases, e.g., malaria, viruses through the ages have killed simply enormous numbers of people. Now we're facing a future when bacterial illnesses could overtake their status as the prime infectious threats to mankind.

An article in the December 23, 2013 online version of the New York Times described an increased death rate among dolphins, with many dying of viral disease. A number of them also showed evidence of antibiotic resistant bacteria, presumably from environmental contamination. Dolphins have been termed the modern equivalent of the canary in the coal mine, a biological early warning system analogous to the times when miners used to carry caged canaries while at work; if there was any methane or carbon monoxide in the mine, the canary would die before the levels of the gas reached those hazardous to humans.

The New England Journal of Medicine in January, 2013published an article titled "The Future of Antibiotics and Resistance." The lead author, Dr. Brad Spelberg, works where I did my research fellowship. He and two colleagues mention that antibiotic-resistant bacteria are considered, in a major yearly publication by the World Economic Forum  (WEF), to be a leading risk to human health.

The World Economic Forum's (WEF) 2013 publication on Global Risks analyzed fifty possibilities (e.g., economic disparity, religious fanaticism, rising greenhouse gas emissions, terrorism, water supply crises), examining their likelihood over the next decade, the impact if they actually happen and how interconnected they were to each other.  It used those to generate analyses of three major risk cases: one was on the threats to economic/environmental systems, a second on so-called 'digital wildfires" from misinformation, and  The Dangers of Hubris on Human Health, devoted to antibiotic-resistant bacteria.

In a study done in Europe, 50% of French patients experiencing a flu-like syndrome (FLS) expected their physician to prescribe an antibiotic; FLS may be caused by influenza virus or other viruses and antibiotics are not of any use against these viral diseases. The WEF piece mentioned an article reporting 98% of Chinese children seen in a Beijing pediatric hospital for common colds were given antibiotics.

Huge quantities of antibiotics are being used for animals as well.  Animals being raised for their meat are often given antibiotics as growth promoters. A 1950 article in Science News announced results from Lederle Laboratories that lacing the hog feed with trace amounts of an antibiotic could increase the yield of meat by a half. Then in 1977 the FDA sent out a notice that it would withdraw approval of non-medical use of penicillin and tetracyclines, but no hearings on the subject followed that non-binding pronouncement.

A Federal District judge finally ordered those FDA hearings in 2012, but an article online less than two weeks ago said only suggestions to the animal-growing industry have resulted. In 2009, more than 3,000,000 kilograms of antibiotics were given to US patients; in 2010, 13,000,000 kilograms were used for animals.

Back to the Wall Street Journal article: it mentions four new approaches to treatment of these deadly bugs. The two I found most intriguing were research to befuddle the bacteria by working against the signaling chemicals they use to become infectious and using silver to increase the ease with which antibiotics enter the microbes.

There's a way to go before these concepts are translated into bedside medicine, but there is more than a glimmer of hope on the horizon.


Lyme Disease Redux

Monday, September 23rd, 2013

Yesterday's edition of The New York Times had an article by an experienced academic physician that called for a new Lyme disease vaccine, Dr. Stanley A. Plotkin, a professor of pediatrics at the University of Pennsylvania said new CDC data had been released showing a ten-fold greater incidence of the disease than was previously thought. He explored the history of the vaccine put on the market in 1998 by a major US pharmaceutical company, then called SmithKlineBeecham (now it's become GlaxoSmithKline).

I looked for that news release from the CDC and found their old numbers in an August, 2013 online site (30,000 cases a year reported by state and DC health departments) had been superseded by new preliminary figures coming from three different databases. So instead of the numbers we've thought represented human cases, 96% of which occur in thirteen states in the Northeast and upper Midwest, we have 300,000 cases a year, still heavily concentrated in those regions.

The white-footed mouse is the main reservoir for Lyme disease.

The white-footed mouse is the main reservoir for Lyme disease.

In 2011 Richard Ostfeld, a senior disease ecologist working at the Cary Institute in New York published an excellent book, Lyme Disease: The Ecology of a Complex System, aimed at a mixed readership of scientists and nonscientists. I've mentioned this before but should reiterate his finding that white-footed mice were a highly significant reservoir (host animal) for the bacteria that is then transmitted to humans by, in this country, one particular insect-like species, the black-legged tick.It's actually an arachnid, cousin to spiders and scorpions. There are other host species and a variety of predators, weather/climate conditions and habitat factors also play a role.

His work predicted a surge in cases of Lyme disease in the spring of 2012, based on an acorn crop boom-and-bust cycle. The town of Whitman, MA, published an online summary of this prediction quoting the Cary Institute's press release. In brief that mouse species' population soars in a year with an abundant acorn crop and falls markedly when acorns are scarce. The organism that causes Lyme disease is a bacterial species called Borrelia burgdoferi, The white-footed mouse is a superb host for that bug; the mouse doesn't get sick; the bacteria multiplies and there is an abundant supply of B. burgdorferi waiting to spread to other animals. Those mice are also frequently bitten by the tick in question, especially around their ears.

In the seasons of acorn abundance the mouse population soars and the ticks, which need a blood meal three times in their life span (once in the larval storage, once as a nymph and once as an adult), have plenty of mice to feed on.

But then comes a lean crop year for the acorns and the B. burgdorferi infected ticks have to find other blood sources for their next meal. Any mammal will do, but humans are certainly among those available. If we are camping or hiking through an area where the tiny tick nymphs or abound, we may never notice the bite. We may not even be wearing any  bug spray or perhaps have more skin exposed than is safest. The nymphs are cold-blooded, so the countryside has to warm up from Winter's blasts before they are ready to feed. If it's a milder cold season (and with global warming that may be the case), the nymphs may be out looking for a meal as early as April.

Forest ecologists from the Cary Institute noted 2010's crop of acorns was very heavy;  mouse population numbers rose appropriately. Then, in the fall of 2011, their research site had a marked acorn scarcity. Mouse numbers plummeted leading to a prediction from the group of at least 20% more human cases of Lyme disease.

Let's return to Dr. Plotkin's article in the New York Times. Eight years ago he almost lost an adult son to a cardiac complication of a Lyme infection. Alec D. Plotkin was walking his dog on an August day in Pennsylvania when he abruptly lost consciousness and collapsed. In 2011 his father (Dr. Plotkin) published an article, "Correcting a Public health Fiasco: The Need for a New Vaccine against Lyme Disease," in the Journal Clinical Infectious Diseases. At that time the yearly US case estimate was (reported cases only) roughly 20,000, but as Dr. Plotkin noted, "the extent of underreporting is unknown." He mentioned that the state of Connecticut's statistics would imply that 1% of its entire population could develop the ailment over a ten-year stretch and that nine of sixteen countries in Europe, where Lyme disease is caused by a different variant of B. burgdorferi, had data showing an increased case incidence over time.

But you may or may not have the pathognomonic rash.

But you may or may not have the pathognomonic rash.

On Septmeber 19, The New York Times published the obit of Dr. Stephen E. Malawista, who, as chief of rheumatology at Yale School of Medicine had, with his postdoctoral student, Allen C. Steere, defined Lyme disease. In the fall of 1975 two women from Lyme, CT and Old Lyme had developed joint swelling, peculiar rashes and neurological complaints undiagnosable by their local physicians. Each went to Yale seeking answers.

Researchers there noted that the clinical picture, which was originally felt to be juvenile rheumatoid arthritis, had occurred in clusters and at a rate 100 times that expected for JRA. It also was clustered in warm-weather months. Dr. Malawista suggested the name Lyme arthritis and he and his team made the eventual linkage with tick bites. In 1982 Dr. Willy Burgdorfer found the bacterium responsible and Yale scientists wnet to work to develop a vaccine.

It was finally licensed in 1998, but a series of events, detailed by Dr. Plotkin in his medical article, led to it being removed from the market four years later. In brief: the CDC's Advisorty Committee on Immunization Practices (ACIP) gave greater emphasis to protective clothing, tick repellants and, in the event of an infection, consistent early diagnosis and antibiotic treatment, than to the vaccine, even for those at high risk. Then it was only tested in adults and more in the group who got the vaccine than in the control group experienced some transient joint soreness...but not actual arthritis (typically red,hot, swollen, painful joints. The marketing of the drug was inappropriately directed at a lay, not a medical audience. A class action suit was brought against Glaxo, the drug company which produced the vaccine and, in spite of later studies showing no increase in Lyme-related joint disease, was settled by Glaxo for $1 million in 2003. Only the lawyers involved got any money.

By then the vaccine was off the market.

It's clearly time for it to come back, perhaps in a new version, perhaps developed by a different company, but, in any case a human Lyme disease vaccine is needed.


team-based home blood pressure control

Wednesday, July 10th, 2013

I was reading the July 3, 2013 edition of JAMA and came across an article and an editorial on better ways to manage elevated blood pressure (BP). The basic concept stems from data reviewed by the CDC in a 2012 online publication: high BP, AKA hypertension, is a major risk factor for both stroke and cardiovascular disease which jointly are the number one causes of preventable death in the United States.

Check your blood pressure and let your healthcare team know the reading

Check your blood pressure and let your healthcare team know the reading

Do you know what your BP is? Let's start from scratch with the kind of numbers you might hear about when you see your doctor or have your BP checked in other settings (e.g., the grocery store we usually shop at has a free automated system for BP measurement).

My BP usually runs about 116/ 68, but, similar to yours and everyone else's, my BP varies from those numbers from minute to minute. The top number, called my systolic pressure is always higher than the lower (diastolic pressure) It measures pressure in my arteries when my heart contracts (beats) while the bottom number measures it between heart beats when that muscular organ is resting and refilling with blood about to be pumped out to the rest of my body. The American Heart Association has a nice webpage explaining BP.

I'd like to see BPs under 120/80 and that seems to be a reasonable consensus figure in articles I read. Hypertension (HTN) is conventionally defined as a BP higher than 140/90 and the National Heart, Lung and Blood Institute's website calls any BP between 120/80 and 140/90 prehypertension. That's new to me, as the designation used to be applied to those with BPs between 130 and 139 for the upper number and 85 to 90 for the lower one. But I retired in 1998 and the BP goals changed in 2003.

My 2006 copy of Kaplan's Clinical Hypertension, the ninth edition of this amazing, mostly one-person work by a senior professor in Dallas (I just ordered a used copy of the 2010 tenth edition), mentions that 120-129/80-84 used to be considered normal  and 130-139/85-89 was thought to be borderline. But the 2003 report of the Seventh Joint National Committee  put BPs anywhere over 120/80 into the new category saying it wasn't a disease, but a designation to identify those at high risk of developing hypertension.

So what if one of your numbers is in this range, but not the other? The Harvard Medical School's Family Health Guide article on prehypertension notes that BPs vary from time to time and from arm to arm. If you have BP numbers over 120/80, the classification will depend on your average/usual readings, not the extremes. They suggest you always use the systolic or diastolic number that puts you in a higher category (normal, prehypertension, hypertension).  So, for example, if your average is 124/76 or 118/83, you're in the prehypertensive group

The CDC paper and others say the overall prevalence (i.e., the proportion of a population having a disease) of HTN in America is ~30%, but that increases with age with many estimates stating it's 70% in those of us 65 and older. That group is more prone to systolic HTN with only the upper number being elevated. That's still high BP and dangerous.

Treatment of HTN with diet, weight control and meds is associated with considerable decreases in the dire consequences of uncontrolled HTN: strokes, heart attacks and congestive heart failure (a condition where your heart can't pump out enough blood to keep up with the needs of your body).

All of us should be screened for HTN, even if our BP is less than 120/80. Screening intervals should be at least every two years for those with normal BP and every year for people with prehypertension. Your physician will also consider your other risk factors (weight, age, gender, your blood lipid levels {e.g., total cholesterol, HDL and LDL levels} presence or absence of diabetes, heart disease or chronic kidney disease, exercise patterns) and may, in some case recommend drug therapy even if your BP is <140/80. That's especially likely for those with any of the three chronic diseases I just mentioned.

So do we all need to be on medications if our BP is >140/80 (no, your physician may start with non-pharmacologic modalities such as cutting our salt intake) and if we do start on BP meds how often do we need to see our doc? After all, they're really busy these days and we may not be able to get an appointment for several months.

Let me start with my own experience (in the "Dark Ages") and then come up to the present.

When I was in my first Air Force assignment at Langley AFB, VA from 1970 to 1972, I set up a HTN clinic run by a public health nurse, an RN with extras training who didn't want to be a ward nurse. My immediate boss was a cardiologist and, after I set up protocols (e.g., which meds to start with, appropriate followup intervals for various levels of BP, when to call for help), our nurse felt quite comfortable running the BP clinic.

She didn't see other kinds of patients, got very savvy about HTN, read a lot of the current medical literature on the subject, was entirely at ease with calling either of her two consultants whenever she had a question and our HTN patient population could easily get appointments in her clinic.

Fast forward ~forty years.

In 2011 a Veterans Administration group from Durham (coincidentally a place I worked when I was a resident and nephrology fellow at Duke) published an article in the Archives of Internal Medicine (now called JAMA Internal Medicine). Its title was "Home Blood Pressure Management and Improved Blood Pressure Control: Results From A Randomized Controlled Trial."

In brief they followed nearly 600 HTN patients who were randomized into one of four groups. The first had usual care, i.e., being seen in a primary care clinic at intervals. The other three groups involved nurses who administered behavioral management concepts, worked with docs on medication management or did both. The patients had their BPs monitored at home with data transmitted to the researchers. Incidentally 48% of the patients involved were African American.

Overall the research group felt the intervention effects were moderate, but those patients who started with the worst BP control had much better resultant effects.

there are a number of options for HTN meds

there are a number of options for HTN meds

Now there's the new JAMA article, "Effect of Home Blood pressure Telemonitoring and Pharmacist Management on Blood pressure Control: A Cluster Randomized Clinical Trial." Researchers associated with an integrated health system in Minnesota using electronic medical records, noting that typically only half of HTN patients have adequately controlled BPs, followed 450 patients, roughly half of whom got usual care. The other half got home BP telemonitoring and had PhD pharmacologists following their data and making changes in their BP meds by a protocol worked out with physicians.

BP control was better in the latter group at 6 and 12 months and was even better 6 months after the year-long study ended.

Lesson one: other healthcare professionals can manage HTN. Lesson: doing this via home BP measurements may be the path of the future.

Cholera: Part two, the nearby 21st century epidemic

Tuesday, February 26th, 2013

Until 2010 I hadn't thought much about cholera in the modern era. I had considered it a disease from the past  and associated it with Dr. John Snow, the father of modern

Algae can carry cholera bugs a long ways

epidemiology , the study of the patterns, causes and effects of health and disease in defined populations (Hippocrates, the famous Greek physician is considered the ancient father of the field).

I was clearly wrong in doing so.

I had previously read parts of the science writer Laurie Garrett's first two books, The Coming Plague: Newly Emerging Diseases in a World Out of Balance published in 1994 and Betrayal of Trust: the Collapse of Global Public Health which followed in 2000. Her first book touches on cholera in Africa and then has a section on the seventh Global Pandemic starting in 1961 in Indonesia's Celebes Islands.

Now I read Chapter 16 of The Coming Plague in detail. It mentioned that Rita Colwell, PhD, an  environmental microbiologist, was convinced in the 1970s and 1980s that bacteria and viruses could be carried in algae, the world's  oldest living life form. Algae are responsible for "red tides"  (AKA Harmful Algal Blooms or HABs), episodes when those ocean plants massively increase in number then produce toxins making shellfish dangerous to eat and killing off fish.

Colwell found that the bacterium responsible for cholera could survive encysted in algae and float long distances in their "plant capsules." The El Tor strain of the bug was responsible for the 1991 epidemic in Peru. The CDC's publication Morbidity and Mortality Weekly Report, AKA MMWR, mentioned that outbreak in its February 15, 1991 editionMMWR noted this was the first appearance of cholera in South America in the 20th century and recommended exclusive use of boiled water for drinking, careful cleaning of fruits and vegetables, and avoidance of raw or inadequately cooked fish or other seafood. It stated the risk to U.S. travelers was low.

In the next eleven months cholera claimed over 330,000 victims in the Western Hemisphere, killing just over 1%. Lima, the Peruvian capital, had stopped chlorinating its water and Peruvians often ate ceviche, uncooked fish and shellfish mixed with lime juice. By the Fall of 1993, 8,000 deaths and over 900,000 cases of cholera were reported in Latin America. The El Tor strain of the cholera bacterium had become endemic in the region.

A 1994 article in the Journal of Clinical Microbiology documented the next chapter in the modern history of cholera. A new strain struck in December of 1992, first in the Indian city of Madras and then spreading to Calcutta, Bangladesh and Thailand. Even those who had previously been through a siege of cholera were not immune to the O139 strain as the Bengal cholera Vibrio was termed.

An earthquake can be both a disaster in itself and the seed for an epidemic.

The Western Hemisphere would have another cholera epidemic eight years later. In the January 10, 2010 a major earthquake in Haiti occurred. Although its magnitude on the logarithmic Richter scale was "just" 7.0, while the offshore earthquake in Japan in 2011 was an 8.9 (an 8.0 quake is 10 times as intense as a 7.0 and a 9.0 is 100 times as powerful), the depth of the Haiti quake was ~half that of the 2011 tremor in Japan and it struck a major Haitian city. The damage was immense and the local infrastructure was severely disrupted with healthcare, water and sanitation being affected.

A recent New England Journal of Medicine article (Feb 14, 2013) reviewed the surveillance efforts during the subsequent two years. Prior to the earthquake, less than two thirds of Haiti's population of 9.8 million had access to even the lowest category of an improved water source; less than an eighth drank treated water from a pipe system and only a sixth lived with adequate sanitation. The 1991 Peruvian cholera didn't reach Haiti so there was little or no prior immunity to the El Tor Vibrio strain.

The results were predictable, a major outbreak of cholera, but the government and international medical assistance markedly ameliorated the epidemic. Through October 20, 2012 over 600,000 cases of cholera were reported and 7,436 deaths resulted. The case fatality rate was initially high in some locales (4.6%), but within three months of the start of the epidemic it fall to the World Health Organizations target of <1.0%.

In comparison there were 2.8 million cases of cholera globally in 2011 with 91,000 deaths (3.25%). The CDC notes that twenty-three cases occurred in the U.S.; 22 were associated with travel to Haiti, one with consumption of food products from that country.

The treatment of cholera is relatively simple: the WHO says rehydration with oral rehydration salts is enough in almost all cases. Intravenous administration of fluids can be life-saving in especially serious cases.

But how about preventing the disease?  A Perspective column in the same journal edition (NEJM Feb 13, 2013) is titled "The Cure for Cholera--Improving Access to Safe Water and Sanitation." The three authors, all with dual MD, MPH degrees, note that the malady is still a major source of illness and mortality in the developing world with WHO estimating 3 to 5 million cases and 100,000 to 200,000 deaths a year.

In the treatment arena, they note that antibiotics should be given to those with even moderate dehydration, that all patients should receive zinc, which can decrease the duration of diarrhea, and a newer variant of the two-dose vaccine should get wider usage.

Safe drinking water and modern sewage disposal is still a major issue for many in 2013: two and a half billion live without adequate toilet facilities and nearly 40% in the least developed regions of the world don't have bacteria-free water to drink.

More than a billion of the poor and marginalized need help. But estimates of $50 billion needed per year are daunting in these tough economic times.



Vaccination/Immunization: Part 3 Adults and the disease risks some of us take

Saturday, February 16th, 2013

You need protection against viruses and bacteria that lurk out there

After reading a number of articles, I decided that Lynnette and I  are up to date on all our vaccinations, but many adult are not; the CDC on Feb 1, 2013, published an online review titled "Noninfluenza Vaccination Coverage Among Adults--United States 2011" that reveals a sad picture. The first two sentence sums it up, "Vaccinations are recommended throughout life to prevent vaccine-preventable diseases and their sequelae. Adult vaccination coverage, however, remains low for most routinely recommended vaccines and well below Healthy People 2020 targets."

I had only a vague idea what does Healthy People 2020 referred to, so I found the definition on a CDC website. 

In December of 2010 the Department of Health and Human Services (HHS) launched a multi-faceted ten-year program with four major goals for our American population: 1). Attain high-quality, longer lives free of preventable disease, disability, injury, and premature death. 2). Achieve health equality, eliminate disparities, and improve the health of all groups. 3). Create social and physical environments that promote good health for all. 4). Promote quality of life, healthy development, and healthy behaviors across all life stages.

It's obviously a huge undertaking and HHS came up with 1,200 objectives (sic) organized into "topic areas" (42 of those) each covering something felt to be very important in our public health. That's too big of a chunk for me to even think of writing about today.

So in this post I'll focus on vaccinations for adults.

Every year an Advisory Committee on Immunization Practices is given the charge of reviewing and updating the recommendations for childhood vaccinations and also those for adults. The Annals of Internal Medicine published the adult schedule and comments on its changes January 29, 2013.

Let's go back to the non-influenza vaccination article; the discussion was on immunizations to protect us against tetanus, diphtheria and pertussis/whooping cough combined as Tdap; pneumococcal pneumonia, hepatitis A, hepatitis B, herpes zoster (AKA shingles), and the human papillomavirus (HPV).

The Tdap numbers were startling to me. Only 55.4 of adults over 65% are protected and <65% of adults from ages 19 to 64, but  fatality rates for tetanus are over 13%. Far too many people are taking chances with a terrible, but preventable disease. The American Geriatrics Society is urging all of us over age 65 to have the Tdap shot, to protect ourselves and our grandkids (from pertussis in the latter case).

I've written on pertussis, but to recap we're seeing more cases in the U.S. (22,550 were  reported in 2010 and many more, especially among the elderly, are never reported). There have been epidemics of pertussis in 2012-2013. If you think you're still immune to whooping cough  because you had the childhood vaccination five-shot series, you should know that an person's immunity wanes from 98% protection to 70% after five years have elapsed.

There hasn't been a case of diphtheria in this country since 2003, but lots of us travel to countries where that disease is endemic (regularly found) and the case-fatality rate for respiratory diphtheria is 5-10%.

The pneumoccocal vaccination rate for those in this country who are 19 to 64 and considered at high risk for this kind of infection (e.g., anyone whose immune system isn't at its best) is only a tad over 20%, while the 2011 figures for those of us over 65 are much higher, at 62.3% in 2011. Even in the older age group the data showed Caucasians have gotten this immunization much more commonly then Asians, Hispanics or blacks, all of whom had vaccination rates <50%.

I've had the herpes zoster shot, but I'm in the 15.8% (20111 figures) who've done so. I never wanted to have shingles after knowing two people who had prolonged excruciating pain from this disease.

HPV is the most common sexually-transmitted viral disease in the United States. The CDC says, "Almost every sexually active person will acquire HPV at some point in their lives." In doing so they increase their risk of certain cancers; in a major CDC study that covered everyone in the U.S. from 2004-2008 there were over 33,000 HPV-associated cancer cases per year.

There are a host of reasons people don't get vaccinated. The CDC has an article online that covers the topic of common misconceptions about the need to continue vaccination. Some people think that infectious diseases were being prevented by improvements in sanitation/hygiene even before immunizations were developed. Or they may believe that a majority of us have already been vaccinated so they don't need to (the herd immunity concept) or that certain "lots" of a particular vaccine are dangerous. Some think we've gotten rid of all the diseases that vaccines can prevent, so they reject having themselves get the shots.

Especially if "out there." in your case, means most of the world

Unfortunately, none of these concepts are valid and many of us travel to parts of the world that have much worse immunization statistics than America does. So, if we're not vaccinated before our trips, we run the risk of bringing home a disease and spreading it to others.

 There are some significant changes coming in the vaccination arena, but I'll save those for another time, including a few words on Hepatitis A and B. For now I'd suggest asking your physician is she/he thinks you're current in all the immunizations you need; that's especially true if you are planning a major trip somewhere outside the country.




Vaccination/immunization: part 1 Kids first

Sunday, February 10th, 2013

I was reading an Annals of Internal Medicine update on adult immunizations and then found it was available for the general public on a CDC website. I thought we were pretty much caught up on our own vaccinations, but decided to read the article anyways. There are, as always, some changes and I'll eventually walk through those for you.

He's up to date with his vaccinations; some others aren't

But that's not the real issue in America today. A piece in The Wall Street Journal on Feb 6, 2013 with the title "Rolling Back the War on Vaccines is dead center on. The authors are Jay Winsten, an associate dean at the Harvard School of Public Health and Emily Serazin, a principal of the Boston Consulting group, (a global management consulting firm with 77 offices in 42 countries) and they sound a very loud alarm, primarily for those with small children.

We still have too many kids who aren't vaccinated and as a country we stand in danger of losing "herd immunity," and in doing so, endangering our youth. There have already been several resultant epidemics here and elsewhere; measles in Europe in 2011 affected >30,000 and the U.S. had 222 cases, primarily linked to those who had traveled to Europe. If you look worldwide, away from places where vaccination is routine, measles killed 139,300 people in 2010.

And then there's pertussis, AKA whooping cough. A July 19, 2012 CBC News report noted that the number of U.S. pertussis cases had doubled, 18,000 at that point, with nine children dying as a result. Kids who haven't been vaccinated are eight times as likely to get pertussis, according to a CDC physician.

The Institute of Medicine (IOM) issued a January 2013 report on childhood immunizations in the United States. I knew there was such an organization, but wasn't clear as to what is was and how much credence all of us should pay to its pronouncements, so decided to read further.

The IOM is an American non-profit, non-governmental organization, founded in 1970 under the congressional charter of the National Academy of Sciences. Its purpose is to provide national advice on issues relating to biomedical science, medicine, and health, and to serve as adviser to the nation to improve health. It works outside the framework of the U.S. federal government to provide independent guidance and analysis and relies on a volunteer workforce of scientists and other experts, operating under a rigorous, formal peer-review system.

IOM committees are carefully composed to assure the requisite expertise and to avoid bias or conflict of interest. Every report produced by IOM committees undergoes extensive review and evaluation by a group of external experts who are anonymous to the committee, and whose names are revealed only once the study is published.

The summary of the IOM's report on The Childhood Immunization Schedule and Safety, with its subtitle being Stakeholder Concerns, Scientific Evidence, and Future Studies mentions that vaccines are one of the safest and most effective public health interventions available.

As a result of their effectiveness, with smallpox totally unknown as the killer it once was, measles rare in America and other diseases reduced or virtually extinct, parents of kids under five, now worry more about vaccines than the diseases they so successfully prevent. Some would deny their children the proven benefits of immunizations because of the schedule of 24 injections by age two (as many as five at one time), others for religious reasons, potential harm from side effects or mistrust of our government. Their fears are inflamed by those who, for varying reasons, inveigh against any vaccinations.

The IOM panel concluded that a prospective randomized, controlled study would not be ethical, and since fewer than one percent of all Americans refuse all immunizations, a new observational study (comparing outcomes between those kids who are vaccinated and those who aren't) would be prohibitively difficult and time-consuming. In order for such a research study to be valid, the kids would need to be matched pairs of the same age, sex, ethnicity and location in the U.S..

So the best approach appears to be one that uses the Vaccine Safety Datalink (VSD), a twenty-three-year-old project linking the CDC with nine managed care organizations. It's a well-proven tool for evaluating the safety of immunizations. The VSD could be adapted for further studies to address stakeholder (parents and others) concerns.

The scales of justice are available when needed

The U.S. has a National Vaccine Injury Compensation Program (NVICP), in part started as a result of the anti-vaccination movement. The VCIP's goals are to ensure an adequate supply of vaccines, stabilize their costs and act as an accessible/efficient modality for people actually found to be injured by vaccines. A designated section of the U.S. Court of Federal Claims reviews claims of vaccine-caused injuries. During the first eight years of NVICP a total of 786 contested cases were resolved; this is a tiny fraction of pre-vaccination adverse outcomes, but offers a mechanism to evaluate and compensate any actual immunization injuries.

No medicine is 100% safe; vaccines are among those that have the best balance between immense positive and rare negative effects.