Food Safety Issues: America in 2014

March 19th, 2014

Having written recently about China’s food problems, I knew there were some remaining in the Untied States, but their scope amazed me. Each year forty-eight million of us suffer from food poisoning. Over 125,000 of that group are ill enough to be hospitalized and 3,000 die.

Having seen those numbers on a government website, I decided to review the modern timeline of food-related illness in America and how our laws help prevent it.

One step in meat processing

One step in meat processing

My initial thought was of Upton Sinclair’s 1906 novel, The Junglea powerful expose’ of the American meat-packing industry. After its publication, public outcry led President Theodore Roosevelt to appoint a special commission to verify Sinclair’s tale of the horrors of meat production in Chicago and elsewhere, and eventually led to the meat Inspection Act of 1906 and the Pure Food and Drug Act.

For many years a so-called “Poke and Sniff” system prevailed. The 1907 law said federal employees could inspect and approve (or disapprove) any animal carcasses which were to be sold across state lines. The inspectors could physically monitor the slaughter line, touching and smelling the animals and cuts of meat. They could remove any meat that was rotten, damaged or had abrasions or growths. Some felt that provided only minimal protection for the public, but that’s what we had for over eighty years.

I grew up in Wisconsin in the 40s and 50s. My father, in addition to his medical practice, was the local Public Health Officer and I remember going to inspect local area dairy herds with his sanitarian when I was a teenager. I don’t recall major food safety issues surfacing in those decades., although there may have been some isolated cases that I didn’t pay attention to.

I was in medical school from 1962 to 1966. During that time, two women died in Michigan from botulism, a rare but extremely serious paralytic disease caused by a toxin produced by a bacteria. In their case the toxin was in canned tuna fish. There were other botulism outbreaks in 1971, 1977, 1978 and 1983 with 59 people being affected in the largest such episode. All were related to food being improperly canned or prepared.

In 1985 a huge outbreak of another form of food poisoning happened. This one involved at least 16,284 people (and perhaps up to 200,000) in six different states and was caused by bacterial contamination of milk.

Some new laws only applied to a few food items.

Some new laws only applied to a few food items.

The Department of Agriculture’s food safety and inspection timeline appears to skip over a considerable period of time, although a number of laws were passed to strengthen federal regulation of the food chain. The 1957 Poultry Products Inspection Act and the 1970 Egg Products Inspection Act added to the government’s ability to prevent food-related illness in specific areas, but wouldn’t have prevented the major food-related episodes I just mentioned.

Then in late 1992 and early 1993 an E. coli outbreak sickened 623 and killed 4 children in four western states (Washington, Idaho, Nevada and California). It was eventually traced to contamination of under-cooked Jack in the Box hamburgers with that common bowel bacterium. Those affected developed bloody diarrhea and, in a few cases, severe kidney disease from an entity termed hemolytic-uremic syndrome (HUS). This is a disease which is the most common cause of acute kidney failure in children and usually occurs when an infection in the digestive system produces toxic substances that destroy red blood cells, causing severe kidney injury. The CDC traced the meat back to five slaughter plants in the United States and one in Canada.

In 1998 the USDA introduced a brand-new method for inspecting meat. The “Hazard Analysis and Critical Control Point (HACCP) system had been pioneered by NASA. That agency had protected our astronauts by adopting a system of critical control points, anywhere a germ, invisible to the naked eye, could find its way into a food meant for a space mission.

Pinging off the NASA approach, the USDA also mandated inspectors could order meat plants to do microbial testing. The meat industry became responsible for establishing and submitting their own HACCP plans. Then USDA would review the plan, approve it if it seemed appropriate and inspectors could monitor the plans’ compliance with their own safety plans. The problem is the age-old one of the fox guarding the hen-house; inspectors no longer had the power to physically examine the meat on the line. The acronym HACCP was often derided as “Have a cup of coffee and pray.”

On January 10th, 2014 two articles were published that changed my mind: the first, in UPI.com’s website simply said, “U.S. food Safety a big issue in 2014.“ It mentioned that already in 2014 the U.S. Department of Agriculture had shut down a meat-processing facility in the state of Minnesota.

The other online article was written by Dr. Margaret A. Hamburg, the Commissioner of Food and Drugs, i.e., the head of the FDA. It discusses the Food Safety Modernization Act (FSMA), signed by President Obama in early January, 2011. It was a reaction to the figures I mentioned at the start of this article.

This law gave the FDA “a legislative mandate to require comprehensive, science-based preventive controls across the food supply.”

But let’s look at its provisions, some of which make eminent sense and others, in my opinion, ask for the impossible.

On the one hand the FSMA required food facilities to have a written preventive control plan. I agree with that idea, but note it’s a complex process with multiple steps involved. Such a plan includes evaluation of possible hazards, figuring out what one has to do to marked alleviate or totally eliminate them, noting how you will monitor these control measures (and keep appropriate records) and specifying what you will do when issues arise. Oh, and by the way, you had a year and a half to do all that.

Other parts of the FSMA involved standards for safely producing and harvesting vegetables and fruits plus another set involving the prevention of “intentional contamination” of food. The latter may be quite difficult. As the law is written, 600 such foreign food facilities must be inspected in its first year with the number doubling for each of five additional years. let’s see, that’s 600, 1,200, 2,400, 4,800, 9,600 and 19,200. Where in the world would the FDA get enough trained inspectors? And that’s assuming that the foreign countries would allow such detailed examinations of their food-producing and exporting businesses.

One of every six Americans becomes ill from food-bourne disease each year. Only a small fraction of  them (approximately 1/4th of 1%) need to be hospitalized and even of those who do only 2.3% die. But another way of looking at those mortality statistics is to say it’s equivalent to almost 10% of the number who die from motor vehicle accidents each year in this country.

 

 

They’re transplanting what?

February 24th, 2014

I read an article in The New York Times that gave me pause for a moment. It was on fecal transplants. Initially that didn’t seem to make sense. Then I remembered there had been something on this topic last year in the New England Journal of Medicine, a Dutch study done at an academic center with the title “Duodenal Infusion of Donor Feces for Recurrent Clostridium Difficile.”  So I did a Google search and found the Mayo Clinic’s website for medical professionals where the subject was titled “Quick, inexpensive and a 90 percent cure rate.”

Why in the world would you need this kind of a transplant? Well let’s start with the possibility of eliminating  a majority of 14,000 deaths a year in this country alone. The CDC website on the bacterial overgrowth that can cause the issue is a good resource, but let’s start with a few basics. Your intestines normally have lots of different kinds of bacteria, up to 1,000 varieties according to some experts. The term “gut flora” is often used to mean our normal sea of bowel bacteria.  But when you take antibiotics, especially for a prolonged time, you run a risk of getting rid of the balance between bacterial species and having some (that are normally harmless) cause major problems.

I may need another roll after this one!

I may need another roll after this one!

One of these kinds of potentially nasty “bugs” is called Clostridium difficile technically, or C. diff as a shortcut name. The WebMD site has an easy-to-understand short tutorial on C. diff When it becomes the predominant gut flora it releases toxins that attack the bowel lining and causes severe diarrhea with up to 15 watery stools a day, fever, weight loss, abdominal pain and blood or pus in the stools. The disease often hits older patients (those over 65, so I’m in that higher risk category) and, in the past, was usually treated with one of three antibiotics given orally. Up to a quarter of those so treated need a second round of antibiotics.

The Dutch study randomly assigned patients to standard treatment with a drug called vancomycin, or the same drug plus four liters of a bowel-cleansing solution, or the drug plus that bowel washout plus infusion of a solution of donor feces through a tube inserted through the patient’s nose and into their stomach (typically called an NG tube, shorthand for nasogastric). Less than a third of those in the first two groups had their diarrhea resolve while 81% of those given the fecal infusion (13 of 16) improved after one treatment and only one of the three remaining patients didn’t improve after a second infusion.

One Mayo Clinic branch had tried a fecal transplant in 2011 in a patient with severe C. diff colitis (inflammation of the large bowel). In that case the medical staff infused the patient with their brother’s stool given via a colonoscope, instead of an NG tube, therefore going up the intestinal tract, not down and getting right to the colon. The patient had been bedridden for weeks prior to the procedure, but was able to go home within one day after it.

Since then the same Mayo branch has done 24 fecal transplants. Every one of the patients had their infection go away within a short period of time; only two had a recurrence of the disease. (both had other illnesses). The senior nurse who played the major role in starting the Mayo program interviewed every patient and said their quality of life improved tremendously. Mayo now uses the procedure only for those who have severe relapsing C. diff infections, but is researching its use in other medical diseases.

Then in 2012, Mark Smith who was a doctoral candidate launched OpenBiome with three colleagues. It’s a nonprofit 501 (c)(3) organization they organized after a family member/friend had gone through seven rounds of vancomycin for a C. diff infection that lasted a year and a half. They call the procedure Fecal Microbiota Transplantation (FMT) and, according to the New York Times article, they’ve supplied more than 135 frozen, ready-to-use Fecal Microbiota Preparations to over a dozen hospitals in the last five months. Much of the work is done in M.I.T.’s laboratories. All the medical facility needs is a doctor with an endoscope.

So have we solved the C. diff overgrowth problem or nearly so? I went back to a July 12, 2010 article in The New York Times titled “How Microbes Defend and Define Us.” It described the work of a University of Minnesota gastroenterologist, Dr. Alexander Khoruts, who not only performed a fecal transplant on a woman with an intractable C. diff gut infection, but also looked closely at what bacteria were in her intestines before and after the procedure.

In this case the donor was the patient’s husband and the analysis of the gut flora revealed his bacteria had taken over, supplanting the abnormal bacteria that were there before the transplant.

Khoruts continued to use the new procedure, fifteen by 2010 with 13 cures, but according to the NYT article, is now concerned that OpenBiome’s model is just an early step. The Food and Drug Administration, in early 2013, classified fecal transplants as biological drugs. As such, any clinician who wished to use them would need to obtain an Investigational New Drug (IND) application, much as a pharmaceutical company would need in developing a new antibiotic.

Since then the FDA has relaxed their ruling, slightly, saying doctors performing FMTs for C. diff wouldn’t be prosecuted. Smith and colleagues want FMT to be classified as a tissue, not a drug, allowing more research to be done on the procedure in other diseases and conditions and, at the same time, letting clinicians use FMT, at least for C. diff, without an IND permit or fear of FDA reversing its stance on such therapy.

There are a host of other diseases where FMT has been suggested as possibly effective in treatment. Some seem farfetched to me at first glance, but investigators appear interested in pursuing research on many of those conditions. I bet they would need an IND in such cases, even if FMT is reclassified as a tissue.

We all have bacteria in our colons, but in other places too.

We all have bacteria in our colons, but in other places too.

Khoruts and others think FMT for C. diff is just the tip of the iceberg. The NIH has been carrying out a huge Human Microbiome Project since 2007 with the first five years  of the investigational study being devoted to cataloging the microbiome of our noses, skin, mouths, GI tracts and urogenital systems. That term refers to the aggregate of all the microorganisms, including bacteria and fungi that live on and in our bodies. From 2013 on they have shifted gears, aiming at an integrated dataset of biological properites in microbiome-associated diseases.

Having read a number of papers and looked at a variety of source materials on the concept I’m no longer astounded by the idea. It still sounds strange, but obviously reputable academic centers have pioneered this research with great results.

One question that seems unresolved was highlighted on a patient-website. Is my bowel flora the same as someone’s who lives in another part of the world and eats a totally different diet?

But it seems like FMT, in one form or another, is here to stay.

Electronic Health Records & Medical Scribes

February 5th, 2014
Turn over the data entry to someone else, doctor.

Turn over the data entry to someone else, doctor.

Recently, in the online version of The New York Times, I saw an article by Katie Hafner titled “A Busy Doctor’s Right hand, Ever Ready to Type.” The article described a new movement among medical personnel, one to hire scribes to make entries into an Electronic Health Record (EHR).

The concept made great sense to me, but it’s clearly not a new one. Our ophthalmologists have, over the last fourteen years, routinely had an assistant who entered data into some form of a medical record, allowing the physician to concentrate on examining us.

Only five years back the use of an EHR was clearly the exception for other medical personnel with perhaps a tenth of physician office practices and hospitals utilizing them. now that percentage is well over two-thirds.

So what are the problems with universal acceptance of EHRs?

One that I touched on in my previous post on EHRs is interoperability between different health-record systems. My translation of that term is that Dr. A using, for instance, Epic at a UCH site like our local hospital, should be able to access and read my medical record from the Department of Defense or the Veteran’s Affairs’ systems. At the moment I doubt that’s even remotely possible and there will obviously be issues with patient confidentiality. Those should be eventually solvable, although the mechanism for doing so is well beyond my computer skill level.

But, for an individual practitioner, on a day by day patient-care basis , there’s an entire other set of issues.

I had mentioned in a recent post our pleasure at watching a Family Practice intern who kept eye contact with her patient (in this case my wife) while she examined her and informed her about test results.

The intern wasn’t entering data and there’s the rub with an EHR. She presumably had the choice of doing her examination and keeping as much eye contact as possible with her patient while remembering all the accumulated data points versus typing while she asked questions and, if she were a typical doc typist, looking at the keyboard and the screen much of the time.

The opposite end of the spectrum was a nurse who, in order to give Lynnette an ibuprofen tablet, spent twelve minutes (I timed the interaction) between my request for her pain med and it being put in her mouth, mostly on the computer, occasionally glancing up to ask a question (e.g., “On a scale of one to ten, what is your pain level? What is your full name and date of birth?{the fourth time she’d asked that during her shift}).

As the EHR has grown more complex, with more mandated information being necessitated by organizational, certifying and governmental entities, the potential for increased human-machine time has grown hugely, while the doctor-patient segment of a physician’s day is squeezed.

The potential for burnout of physicians, especially in emergency medicine, family practice and primary care internal medicine has increased. The link is to a free article that appeared in the Archives of Internal Medicine in 2012 comparing both burnout and satisfaction (with physicians’ balancing work and outside life) to others in the United States. Bottom line was of the 7,000+ docs who filed in a survey, over 45% had some symptoms of burnout and were much less satisfied with their ability to find a counterpoise between their work time and the rest of their life than those with comparable professional degrees.

Burnout meant less enthusiasm for work, development of cynicism and less of a sense of accomplishment than those of us who practiced medicine years ago had. There are lots of components as to why this has become more common among “front-line” physicians, but as I’ve talked to some recently the EHR has been a very significant contributor.

This was a somewhat unexpected development for me, although based on what I had seen with my radiologists attempting to dictate into an earlier version of an EHR in 1988-1991, not one that I  should have been surprised by.

Adding one more to the medical team should be easy.

Adding one more to the medical team should be easy.

There is a growing industry providing medical scribes to physicians and others and, since 2010, certification available through a non-profit, the American College of Medical Scribe Specialists. I was somewhat surprised that patients not only haven’t objected to a scribe being present, but often have warmly welcomed them. They may be introduced as “my data entry specialist.” Obviously, in teaching hospitals, patients see a team of physicians already. Only the most intimate parts of a physical examination would need to be conducted in a one-on-one basis. Then the scribe could be on the other side of a curtain and the doctor would verbally describe her or his findings.

If I had the choice of my physician looking at me almost all of the time and, in essence, dictating her findings (my own doctor is female) or having to type much of the time, my choice would be simple.

Then there’s the possibility of a remote scribe. I had envisioned a future EHR which had set areas to be filled in and a practitioner being able to wear a headset and dictate into the EHR directly. I hadn’t realized that some practices already have scribes who may be thousands of miles away from the patient-physician encounter, sometimes in India.

I went back to the New York Times article I mentioned initially and saw a quote from a family medicine physician who said, “Having the scribe has been life-changing.” An article in the journal Health Affairs said two-thirds of a primary care doctors time at work was spent on clerical duties that could be done by others. Another doctor  said, “Making physicians into secretaries is not a winning proposition.” She had surveyed over 50 primary care practice in the past five years, finding those who used scribes were more satisfied with their work and their choice of careers.

Doctors have been dictating patient records for fifty years, but those transcriptions often made their way to the chart many hours later. Having a scribe could cut that lag time immensely.

With our growing need for primary care physicians and the tendency for medical students to avoid those specialities, aiming toward more financially rewarding and less laborious fields in medicine, the advent of medical scribes may be not only a significant improvement for the lives of those already in front-line medical areas, but an inducement for new prospective physicians to join their ranks.

I’m heartily in favor of the idea.

 

 

 

 

 

Electronic Health Records: Conquering a major “con”

January 18th, 2014
The question is how to connect the two.

The question is how to connect the two.

My first electronic medical record encounter was in 1975 at a not-for-profit hospital in California. I could enter orders for my dialysis patients and retrieve lab test results. I thought it was” better than sliced bread.” I don’t remember any negatives about the system other than not being able to connect to it from the private medical office I shared with another nephrologist. So there were lots of “pros” and no major “cons” as far as I was concerned.

Of course, it wasn’t a complete Electronic Health Record (EHR) and I couldn’t dictate the results of a physical exam or anything else into the system.

In mid-1988 I became the commander of a small Air Force hospital in Texas that was a test site for the Composite Health Care System (CHCS), a  Department of Defense effort to have a system-wide EHR. During the preceding six months, when I had been the deputy commander, I was aware there was a rudimentary system in our x-ray department, one that let our radiologists dictate a report. But they had to speak slowly, in an absolute monotone, for it to work.

I attended my first CHCS meeting, with the Assistant Secretary of Defense for Health Affairs (ASD/HA) and all three military Surgeons General seated at the front of a large room. CHCS had morphed into an endless series of blah-colored screens that my docs, nurses and other medical personnel could use to retrieve and enter patient data. At that point I thought it was an elephant designed by committee, a prototype that had a long, long way to go before it was a viable EHR.

I was the junior commander in the room, having been a bird colonel for only three years. Many of the others were long-time colonels or one-stars and even, in a few cases, two-star generals/admirals. After a few introductory remarks, the ASD/HA said, “Colonel Springberg, you’re the new kid on the block; what do you think of CHCS?

All eyes turned to me and I blurted out, “Frankly, sir, I think it sucks.”

Shocked silence for a moment, then he asked, “What do you mean?”

“My docs hate it, sir. It needs to have a touch-screen or a mouse-able interface or be on a Mac with some colorful screens. As it is, there’s row after row of green lines of questions that can easily put you to sleep.”

I survived that meeting (perhaps just barely) and my own Surgeon General showed up in my office back in Texas a few weeks later. That wasn’t unusual, as he fairly frequently came to the base for events at the Medical Service Training Wing and stopped to talk to me on the way. This time I was concerned he’d want to chastise me for my remarks.

“Peter, do you remember that CHCS meeting?” he asked somewhat rhetorically. “Do you remember what you said?”

My heart skipped a beat or two.

“Well I agree with you. I just can’t say those kinds of things. Keep it up!”

Twenty-plus years later, DOD was still using a version of CHCS for healthcare administrative purposes and had something called AHLTA (the Armed Forces Health Longitudinal Technology Application; DOD does love acronyms) as its EHR.

Then in May, 2013, the Secretary of Defense announced a plan to replace AHLTA with a commercial EHR with a short-term goal of coordinating with Veterans Affairs to “develop data federation, presentation and enhanced interoperability.”

After I looked up the term “data federation,” it made sense. We’re talking about software allowing an organization to use data from a variety of sources in a number of places with the data itself remaining “in the cloud.”

If you’re speaking about medical records for people who move around the globe and often later stay in an allied system (the VA) after they retire, it would be great to be able to access all or part of an EHR without the need to move physical patient charts.

Then how do they find my old medical records?

Then how do they find my old medical records?

I’ve got part of my old military health record sitting on a file cabinet in this room, but what I really would like is for all my records to be accessible to any doc I see. whether it’s my own ex-Air Force Family Practice physician here in Fort Collins, someone at a VA clinic I might happen to stop at on a trip, or a civilian doctor in Canada or Europe I see in an emergency room

My left shoulder has been painful for six weeks. I saw my physician, got a referral for physical therapy and drove nearly twenty miles to see the PT who works for the local hospital chain (now a part of the University of Colorado) and was moved sometime back to an outlying location. She’s really good, so I became one of her groupies, patients who, when they need physical therapy, decided they’d follow the PT they liked best.

If I were still on active duty (it’s been nearly sixteen years since I retired), she might have been sent to Italy or Guam. But twenty miles was doable.

After her usual thorough exam she started entering data into a computer. Epic, the EHR used by University of Colorado Health (UCH) meets the 2010 Patient Protection and Affordable Care Act standards, was adopted at the main UCH hospital in Denver in 2012, reached the affiliated northern Colorado hospitals and clinics in July 2013, and will extend to other UCH locations by mid-2014. So if I’m seeing a practitioner at any UCH location, they can pull up my EHR onscreen. 

There’s now a non-profit Healthcare Information Management Systems Society (HIMSS) an organization that was formed with goals to improve healthcare through information technology. As I thought about the issue on the way to the gym yesterday, I realized one problem is defining who can see my medical data.

Medical data privacy is crucial to many and my first thoughts along this line were rapidly discarded. I don’t want Joe Ripoff in Otherplace, Elsewhere, to easily access my records and couldn’t initially think of a way  that all medical personnel anywhere could have easy entry to my EHR without some hacker also being able to duplicate the necessary passcode. And if I carried a card in my wallet, it could be pick-pocketed. Even if I had my own personal code, I might forget it or be unconscious.

Then I had an idea that could safeguard my medical record while allowing any practitioner I see while traveling to gain entry to all my stored records. It turned out not to be a new idea at all; others have suggested it for the last fifteen or so years.

My dog has an implanted microchip so if he’s lost someone can scan him and find who he belongs to. I would be willing to have such a chip in, for instance the flesh of my arm, modified to contain my entire EHR.

If that technology would allow a medical team anywhere to scan my arm and then retrieve my medical data, it might be worth considering.

This sounded like science fiction, but apparently it’s possible and it also caused a furor. I Googled the idea and found that Snopes.com had debunked the rumor that the Affordable Care Act mandated such microchips be implanted in everyone. Supposedly, according to the canard, the chip, about the size of a grain of rice, would also link to your bank account (It’s not true.) However, an-EHR-microchip, while conceivable, has been resisted by some religious groups and by many who are concerned that they would lead to Big Brother government being able to track all of our movements. Some have even said the data would be accessible to anyone with a scanner.

I think those objections, except for religious ones, are a stretch. And the data could be encrypted.

So my level of paranoia on the issue being quite low, I’m ready for a microchip.

It should absolutely be your choice, of course, whether you get one or not.

 

 

 

 

 

 

 

 

 

 

 

 

 

Food Safety Issues–Part one: China

January 9th, 2014

Two recent articles in The New York Times caught my attention and highlighted a marked disparity between China, the most populous country in the world, and the United States, third in the global population list, but with a markedly differing approach to many problems.

To begin with, I knew who was in first, second and third place for the greatest number of residents (citizens and others), but was curious to see who followed so I Googled “countries with the largest population” and found the numbers on an unexpected website (I suppose I shouldn’t have been surprised). As of July, 2013, the CIA’s listing on their webpage, The World Factbook, says China has a hair under 1.35 billion people, India has 1.22 billion, the entire twenty-eight-country European Union (that number of members is also as of July, 2013)  has just over half a billion and America has 316 million. They are followed by Indonesia at 251 million, Brazil slightly over 200 million and Pakistan at 193 million. The other countries with over 100 million inhabitants are Nigeria (175 million), Bangladesh (163 million), Russia at 143 million, Japan with 127 million, Mexico with 116 million and the Philippines with nearly 106 million.

When it comes to land area, Russia clearly leads the pack with over 6.6 million square miles; Canada is second with 3.8 million square miles and somewhat surprisingly to me the United States is third with 3.7 million, slightly over  China’s size (Alaska with 586 thousand square miles of land is the reason). But China’s population density (365 per square mile) is more than four times that of America’s (84 per square mile).

A significant question is what information is available to people in various countries and what influence do they people on decisions that may affect their health and that of their children. I’m going to stick to China and the United States, but I think I could probably extrapolate to a number of others in the over 100 million population group.

China needs a "Save Our Soil" stamp

China needs a “Save Our Soil” stamp

The NYT article about China, written by Edward Wong, was titled “Pollution Rising, Chinese Fear for Soil and Food” It’s datelined from a village in Hunan Province, the breadbasket of China. Crops raised in the eastern and southern parts of the country include rice, yams, carrots, turnips, cabbage and lotus, while millet, corn and soybeans predominate in northern and northeast areas. Other major crops include sorghum, barley, tea, cotton and peanuts.

The Hunan village mentioned in the story grows rice, sweet potatoes, turnips, carrots and cabbage. The problem is the fields on which these crops are produced are far too close to industrial plants; many factories, smelters and mines surround them and the wastewater from those plants is toxic. In May, 2013, officials in Guangdong Province, in the far south, said they had discovered excessive levels of cadmium in 155 batches of rice collected from markets, restaurants and storehouses. Of those well over half were from Hunan Province.

On December 30, 2013, the Chinese Vice Minister of Land and resources, Wang Shiyuan, said an area about the size of Belgium, (or Maryland, about 12,000 square miles) but comprising only 2% of China’s 135 million hectares (roughly 520,000 square miles) of arable land, was too polluted for growing crops safely. And early in 2013 Wang’s ministry had commented that a five-year, $1 billion soil-pollution survey’s resulted were being held as a “state secret.” This came out in Bloomberg News online along with a comment from Minister Wang, “Farming on the land with medium-to-heavy pollution should be discontinued.”

One-sixth of China’s rice is produced in Hunan Province, but so is much of its cadmium, chromium, lead and non-metal arsenic.

A Chinese official admitted the pollution was due to intense industrial development, but also mentioned three other factors I thought were much less likely to be involved (chemical fertilizers, mechanized farming and household garbage).

Cadmium’s effects have been studied in detail in those exposed to inhalation of the metal: they include lung, kidney, bone and reproductive changes. Ingested cadmium is exceedingly toxic to those same systems of the body.

Although the total arable land in China has increased in the last survey, the per capita figure has shrunk secondary to both population growth and a quickening pace of urbanization. Nearly eleven thousand square miles of previous farmland has been converted into portion of cities since a 1996 survey. China’s per capita arable land, 135.4 million hectares at the end of 2012 , translates into 0.101 hectares per person, far under the world’s average of 0.225. The redline figure for China at its present population is 120 million hectares reserved for agriculture; below that, even at their present population, they would be unable to produce enough food crops for all.

But toxic chemicals aren’t the only Chinese food issue. A January 2, 2014 BBC article, “Donkey Meat Recalled in China,” It’s apparently a common snack food there, but the Wall-Mart corporation said that government testing revealed that two of its stores in an eastern area of the country (Shandong province) had sold product contaminated with fox meat.

Wall-Mart plans to reimburse customers who purchased the donkey meat and upgrade its own DNA testing.

Chinese consumer confidence has plummeted since the melamine scandal of 2007-2008. Initially pet food contaminated with an industrial compound and exported to the United caused kidney failure in dogs and cats. Then infant formula, frozen yogurt and one brand of a canned coffee drink in China itself caused six infant deaths and sickened at least 300,000 people. A February 2013 Huffington Post article gave a followup on a theory of why so few died. About 1% of humans have a gut bacteria that metabolizes melamine into a more toxic chemical. So, if that concept is correct, China was very lucky.

Think of the numbers sickened and killed if that microbial species had been present in most of their population.

There is some very good news coming from China as well, however.  The world’s largest genomics corporation, started as the Beijing Genomics Institute in 1999 and now called B.G.I., is carrying on major projects to unravel the genetic structure of thousands of economically and scientifically important animals and plants with one goal being applying the knowledge gained to better treat or even prevent diseases.. A January 6, 2014 article in The New Yorker titled “The Gene Factory” featured B.G.I. and our former Chinese graduate student (now with a Pharmacology PhD from the University of Colorado) spoke highly of the work of one of its leading figures.

Maybe China can move this way.

Maybe China can move this way.

B.G.I. is collaborating with the Bill and Melinda Gates Foundation and major American universities to increase global food production by ten percent. It’s is also sequencing the genes of rice, cucumbers and chickpeas.

So there’s both bad and some good food safety news coming from the world’s most populous country. But the majority of its people are kept in the dark as to the extent of the problems.

There’s hope in sight: in early 2013 the Chinese State Council set a 2015 goal for measuring soil pollution comprehensively and establishing initial programs for treating those injured by unsafe agricultural products.

Hopefully they will let their citizens know the results of the survey.

 

There’s Silver in Them There Pills

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 (Mphonline.org) 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.

 

Noise-Induced Hearing Loss and Acoustic Trauma

December 14th, 2013

I was in the gym recently and, after riding a recumbent bike for a little over an hour, went to the mats to do some stretches. There’s usually a class in the room on the other side of a wall and I could see young women exercising in a karate-like manner. But what immediately caught my attention was their background “music,” vaguely familiar and incredibly loud. That wasn’t the first time I’d heard an ear-threatening sound level coming from that room, but it clearly was the worst. It reminded me off a rock concert I went to many years ago.

I wondered how many of the class members had been exposed to that intensity of sound repeatedly and if it had caused them problems. Then I thought about the instructor who must hear the noise many times a week. I couldn’t tell if she was wearing any ear protection, but doubted it.

Later in the day I mentioned the episode to my wife Lynnette who wears hearing aids and is at the gym for Pilates at least three times a week. Sometimes her class has music, playing at a much lower decibel level, but when it does she has mentioned difficulty in hearing the leader’s voice calling out what move comes next. She said the women’s locker room, again a wall away from the class exercise area, almost shakes when that  other group is in session.

When I thought about the noise levels I sometimes hear (noise is defined as “unwanted sound”); one of the loudest forms is often coming from a car next to me at a stop light with a youngster listening to music while leaving the windows of their vehicle open. I guess that’s so we can all listen to their choice of music.

I went back to the basics, trying to understand just how loud that studio must be compared to other environments where noise levels can be dangerous to our hearing and our brains.

Noise is measured in decibels (dB), named after Alexander Graham Bell who invented the “electrical speech machine’ we now know as the telephone. The subject took me back to the physics of sound and its perception.When you hear a sound, anything from a whisper to a gunshot, your ears and brain are involved in a complex process that begins with an object, let’s say a gong, vibrating in something. That something could be solid, liquid or gaseous, but to simplify even a bit, we’ll assume it’s ordinary air (I’ve never heard of anyone hitting a gong underwater, so that’s a reasonable assumption.)

The anatomy of the middle and inner ear.

The anatomy of the middle and inner ear.

The frequency of the vibrations (in this case how rapidly the metal moves back and forth) is the determining factor in the pitch of the sound, but the energy of the vibration determines its loudness. So if you strike a gong hard, it emits a louder sound than if you barely touch it. The vibrations move tiny particles toward your ear which acts as a funnel to bring the sound energy to your eardrum, through a series of tiny bony connections to your inner ear.

The minuscule bones, technically the malleus, incus and stapes, but usually called the hammer, anvil and stirrup, amplify the pressure the sound exerts on your ear drum, enabling the next step in the hearing process, motion of fluid in a structure called the cochlea. This is a snail-like spiral with three tubes separated by membranes and tiny hair cells that transmit the sound as electrical impulses to your brain.Which hair cells are moved lets your brain know the pitch of the sound; how many hair cells are moved allows the brain to know how loud the sound was.

Here’s a link to a loudness comparison chart. The softest sounds we can hear (e.g., rubbing one finger over another next to an ear) are said to be zero dB, but if you whisper to someone a few feet away, the sound is somewhere between 15 and 30 dB. The scale in logarithmic, so 10 dB is 10 times as loud a zero, 20 dB is 100 times as loud and 30 dB is 1,000 times as loud. Talking  at a normal volume to a friend who is three feet away generates a 60 dB sound, a million times as loud as zero dB. Yes, that amazes me too.

Don't sit in the front row.

Don’t sit in the front row.

So the next time you (or your kids or grandkids) want to buy front row tickets to a rock concert, remember the sound level will be 115-120 dB. I had recently  seen an article on the subject of noise-induced harm in The New York Times. Its title was “Fighting Hearing Loss from the Crowd’s Roar.” Fans at several professional football games had broken a Guinness World record for the loudest crowd noise level. The first game’s crowd screamed at a measured 136.6 dB; a short time later, another team’s fans registered a 137.5 dB roar.

I found a 2001 ENT grand rounds presentation on “Noise-Induced Hearing Loss” from UTMB, the University of Texas Medical Branch. Nearly one-third of Americans with hearing loss, roughly 10 million total, had impaired hearing due to noise. It is the most common preventable cause of permanent hearing loss. Other, more recent comments, mention associated tinnitus (ringing in the ear) and hyperacusis, sensitivity or intolerance to sound, as associated effects from excessive noise.

If your ears are exposed to even less intense sounds over a period of time, the hair cells and their blood vessels, supporting structures and even nerves can be damaged. The loudest recommended exposure with hearing protection is 140 dB and OSHA, The Occupational Safety & Health Administration sets legal limits for sound intensity in workplaces at 90 dB average over an eight-hour day. If the sound is even louder, the permissible time exposure is shorter; it’s cut in half for every 5 dB increase in noise level. So if you work in an environment where the sound intensity averages 100 dB, OSHA would say you should have a two-hour shift.

Another federal group, the National Institute for Occupational Safety and Health (NIOSH) sets its eight-hour cutoff at 85 dB and halves that time for every 3 dB increase. So at 100 dB, NIOSH recommends your shift should only last 15 minutes!

This old cannon might explode if it were fired. Don't be nearby!

This old cannon might explode if it were fired. Don’t be nearby!

A sudden, exceeding loud noise can also cause a long-term hearing deficit; this form of noise-induced hearing loss is often called acoustic trauma. An explosion or a cannon going off  near to you might be examples, but other noises in the 130-140 dB range can be responsible for this form of damage to your hair cells.

For the past thirty-two years OSHA has mandated a Hearing Conservation Program to protect every worker in general industry who is exposed to 85 dB or more over an eight-hour shift. It includes baseline and yearly free hearing exams, free hearing protectors, training in their use and evaluation of their adequacy.

But a discotheque may have a 110 dB sound level and even using the OSHA limits, much less the NIOSH levels, you shouldn’t be exposed to that level of noise for more than a half hour.

So it’s wise to stay away from very intense noise levels, especially outside of your work environment, in places where those OSHA rules don’t protect you.

I’m afraid that many of our younger generations will lose their hearing as they are exposed to noise levels we once would have thought to be rare.

 

 

Medical Marijuana 2: immingrants to Colorado

December 8th, 2013
Smokeable pot or marijuana  brownies is what most officials feared.

Smokeable pot or marijuana brownies is what most officials feared.

This morning’s edition of The New York Times had an interesting article on marijuana migrants to Colorado. These aren’t people looking for recreational pot, they’re parents of kids with intractable seizures. In August, Dr. Sanjay Gupta, a neurosurgeon who was President Obama’s initial choice as U.S. Surgeon General in 2009 (he’s now CNN’s chief medical correspondent), published a bombshell article in CNN Health with the title, “Why I changed my mind on weed.” Gupta had previously published a 2009 Time magazine article, “Why I would vote No on Pot”, but then undertook an extensive review of past efforts pro and con marijuana. He discovered that the 1970 decision to make the drug a Schedule 1 substance was not based on solid evidence of addictive properties and lack of medical efficacy, but rather on the absence of studies and, presumably therefore, was a political choice, not a scientific one.

The problem, of course, is by making pot Schedule 1, those studies could not be easily done, if at all.

Gupta refers back to a 1943 study in New York City under Mayor LaGuardia. The medical arm of that research concluded smoking pot neither led to addiction nor was it a “gateway drug,”

Gupta also reviewed a huge number of relatively recent U.S. studies of the drug; interestingly, 94% of them were designed to show the dangers of marijuana and only 6% looked at its benefits.

I did find a 2009 article in The Journal of Clinical Investigation, a premier research journal, with the arcane title “Cannabinoid action induces autophagy-mediated cell death through stimulation of ER stress in human glioma cells,” Like most JCI articles it was quite complex, but the bottom line was the scientists involved (from Spain and from Harvard) concluded THC, one of the major chemicals in marijuana, may be useful in fighting cancer. They did not suggest cancer patients should smoke pot!!!! Rather, a chemical pathway uncovered in the study could lead eventually to anti-tumor therapies.

A recent review of research studies on the use of cannabinoids (marijuana contains over 500 of these chemicals with THC and CBD being the most significant) for seizure disorders was titled “Slim Evidence for Cannabinoids for Epilepsy.” It noted that marijuana appears to have an anti-epileptic effect in animal studies, but we don’t know yet if that’s true in people. The extensive literature review only found four human studies, none of high quality, and concluded no reliable conclusions could be drawn at the present time. But CBD appeared to be safe for the relatively short time it was given in these projects.

High quality studies clearly need to be done in this arena.

So why did Dr. Gupta change his mind?

In the first place he felt Americans had been misled by the 1970 decision to classify marijuana as a Schedule 1 drug. And then there is Charlotte’s Web, an oil said to be low in THC (the chemical which leads to a pot “high’) and chock-filled with CBD which has no psychotropic effects, but appears to have a variety of positive medical effects.

In 2006 a Colorado woman gave birth to twins, one of each gender. When they were only 3 months old, the girl started having seizures, first one, then many. The doctors said her scans and blood tests were normal, but eventually, when she was two and a half, a neurologist at Denver Children’s Hospital she had found a rare genetic mutation associated with an intractable type of epilepsy. Another specialist put the child, Charlotte, on a special diet sometimes useful in drug-resistant epilepsy.

A plethora of side effects and, two years later, the return of multiple seizures, drove her parents to a relentless hunt for something that could stop her convulsions. Eventually they heard of a California boy being treated with a cannabis product for the same rare syndrome as their child.

Colorado law demanded two doctors approve her application for a medical marijuana card. Charlotte’s mom found a Stanford-trained MD, PhD and a Harvard-trained internist who had significant reservations because of Charlotte’s age, but felt all other treatment options had been tried. Both signed the card.

An initial dose of a low-THC, high-CBD product in oil form from a Denver dispensary gave incredible results…no seizures for the first week of treatment. But the oil was in short supply and expensive.

And it's not the optimal form for medical use.

This is not the optimal form for medical use; the high CBD oil may be.

Enter the Stanley brothers, six men who owned a large marijuana dispensary and grew their own plants. They had developed another marijuana-derived oil that was low in THC, while containing lots of CBD. They had also started a nonprofit, the Realm of Caring Foundation, to provide cannabis and its derivatives to those who had major diseases (cancer, MS, seizures, Parkinson’s), but were unable to pay market prices for the substances.

Fast forward to Charlotte at age six, having seizures in her sleep only two to three times a month (versus up to 300 a week). Her neurologic status has markedly improved and the oil she takes has been named after her. Dr. Gupta visited her and other patients who have had similar results.

Not all find their panacea in Colorado medical marijuana derivatives, but one of the two physicians who signed Charlotte’s card, working with Dr. Edward Maa, an assistant professor of neurology at the University of Colorado School of Medicine, has accumulated a series of eleven such children with drug-resistant major seizure disorders and eight had a decline in seizure frequency of 98-100%. The data is about to be presented at an American Epilepsy Society meeting.

There’s another side to the Colorado story, a familiar and sordid one. An August, 2013 article in The Denver Post was titled “Oversight of Colorado medical marijuana doctors remains spotty.” It detailed a sting operation which led to a conviction of a Loveland physician who prescribed marijuana for an ankle sprain ten years past and for back pain even the patient said wasn’t present. The two state governmental agencies who should be providing oversight of those doctors who provide medical marijuana prescriptions have largely been inactive.

The Colorado State Health Department has referred the names to the board of medicine of a very small number of physicians who account for an inordinate percentage of medical marijuana recommendations . They say these are the outliers, implying the vast majority who prescribe the drug are doing in an ethical and appropriate manner. I’m not so sure that is true and a law enforcement officer has been quoted as saying, “Very little has occurred to any of these physicians until now.”

To complicate matters, Colorado voters (and those in the state of Washington) in November, 2012, approved the use of recreational marijuana for anyone over 21 years old. The Justice Department response is captured in an online article “Tolerating Pot With a Frown.”

I think medical marijuana is here to stay; we’ll see how many careful studies get done to determine who should get actually it.

 

 

 

 

 

 

 

Medical Marijuana: Politics versus Science

November 27th, 2013
Marijuana in its raw form.

Marijuana in its raw form.

I recently read a New York Times article by Jane Brody titled “Tapping Medical Marijuana’s Potential” in which she notes the long history of medical, spiritual and recreational use of the drug and mentions it contains  a multitude of chemicals (400 plus) in its raw form.  She confirmed my thought that if people are to use the drug for medical reasons, a joint or a pipe certainly isn’t the optimal modality for administering it, When smoked, the number of compounds released multiplies by a factor of five (over 2,000 chemicals) and some are felt to lead to risks similar to those of tobacco.

As of November, 2013, twenty states and the District of Columbia have medical marijuana clinics; two states have even legalized its recreational use and a Gallup poll in October reported fifty-eight percent of Americans support legalizing marijuana for non-medical purposes. That’s way up from the 12% in 1969 and roughly a third at the start of the 2000s who favored changing the laws concerning marijuana. Subgroups in this survey that still opposed legalization were those sixty-five and older and those who identified themselves as Republicans ( 62% of Democrats and 65% of Independents {up 12% since 2011} favored the change). Even the over sixty-five group had a considerable (+14%) increase in the last two years of those who are in favor of loosening the laws on the drug.

I’m going to stick to comments on medical marijuana, and not get into a discussion of recreational use.

Cornell University Law School’s Legal Information Institute website details 21 USC § 812 Schedules of Controlled Substances. There are five levels of these drugs (or substances) and the most tightly controlled is Schedule I, drugs/substances (D/S) with a high potential for abuse and no currently accepted medical use in treatment in the United States. Additionally there is a lack of accepted safety for those D/S even if they are given under medical supervision. There’s a long list of  Schedule I drugs including heroin, LSD, mescaline and GHB (the date rape drug). But marijuana is right alongside those, mostly for political, as opposed to scientific reasons.

Schedule II D/S  have a high potential for abuse, but do have a currently accepted  medical use in this country, some with and others without severe restrictions. Abuse can lead to severe psychological or physical dependence. Opium and cocaine are in Schedule II. Schedule III D/Ss have less potential for abuse, a currently accepted medical use and abuse can lead to moderate or low dependence. Amphetamine and its derivatives are in Schedule III. As you would expect, Schedule IV and V D/S have lower potential for abuse and habituation.

In 2005, the U.S. Supreme Court, discussing California’s medical marijuana regulation (voted in under the 1996 Proposition 215) in  a case titled Gonzales v. Raich, issued a majority opinion that Congress had the power to prohibit local cultivation and use of marijuana in that state. They did so by case precedent under the Commerce Clause referring back to a 1942 decision about wheat farming. Justice O’Connor, Chief Justice Rehnquist and Justice Thomas dissented with Justice O’Connor writing that the Court’s decision was sweeping overreach. She noted the two women who had sued the US Attorney General and the DEA were, in one case, raising a very small number of marijuana plants and, in the other case, relying on locally grown plants. Neither one was engaged in interstate commerce nor even conceivably had enough of the drug to substantially affect such. Both were acting in accordance with California law.

In 2008, an article in CMAJ, the Canadian equivalent of JAMA, reviewed safety studies on marijuana used medically and noted that short-term usage of the then existing forms of medical cannabinoids “appeared to increase the risk of non-serious adverse effects (the most common being dizziness), but not serious ones. The problem was the risks in longer-term use weren’t well defined, even in that country which had been the pioneer in 2001 by legalizing medical usage of the drug.

2009 Department of Justice memorandum, directed at “Selected United States Attorneys,” discussed “Investigations and Prosecutions in States Authorizing the Medical Use Of Marijuana.” It firmly held to the DOJ being committed to enforcing the Controlled Substances Act (CSA) in all states, saying Congress still felt marijuana was a dangerous drug; its illegal distribution and sale was a serious crime and its sale provided gangs and cartels with oodles of money. While adhering to the CSA was still a clear priority, DOJ felt federal resources should not be expended in the pursuit of individuals who use marijuana medically in compliance of state laws.

An April, 2010 article in NEJM, written by two attorneys from the University of Maryland School of Law, mentions that the American Medical Association had recently voted for reviewing marijuana’s status as a Schedule I drug. At that time, fourteen states had passed laws to allow the medical uses of the drug and over a dozen more were considering the idea. But there was very little if anything being done to “advance the development of standards” concerning dosing, packaging, potency, quality or purity issues. Experts in this country had urged reclassification to Schedule II as a means to allow rigorous testing of possible benefits, dosing and delivery means.

In early 2012, Mayo Clinic Proceedings published two articles and an editorial on Cannabis. The first article reported a case series of 98 patients with “Cannabinoid Hyperemesis.” The first term meant chemicals found in marijuana and the second implies severe, persistent vomiting. The more common use of the medical term refers to the one to two percent of women who have continued, severe, nausea and vomiting during pregnancy…a condition termed hyperemesis gravidarum (gravid means pregnant).

How much THC is in this joint? Who knows?

How much THC is in this joint? Who knows?

A superb, long and detailed review by J. Michael Bostwick, MD of Mayo’s Department of Psychiatry and Psychology has the intriguing title, “Blurred Boundaries: The Therapeutics and Politics of Medical Marijuana.” and is available on an NIH website. It is well balanced and covers many facets of the history and pharmacology of the drug with caveats on its use in young individuals, an association with psychosis (marijuana may or may not be causative, but its use appears to have a distinctly negative effect on those already psychotic), the pros and cons of using it medically, and the currently available pharmaceutical cannabinoids.

The New York Daily News, on January 22, 2012, had an article titled “Marijuana-based drug Sativex may get FDA approval.” A followup published August 14, 2013 in an industry online news source, Fierce Pharma, said the European pharmaceutical firm GW now had an American partner company working with the FDA on a Phase III trial for the drug in treating cancer pain and spasticity in multiple sclerosis patients. The oral spray has already been approved for patient use in the U.K., Canada, Denmark, Poland, Austria and Sweden. It has a mixture of THC, the psychoactive component, and cannabidiol, a non-psychoactive cannabinoid that can lessen the negative effects of THC while, potentially, offering reduced anxiety and anti-seizure effects of its own.

An October 3, 2013 article in Time Magazine’s World section was titled “Canada Rolls Out a ‘$1 Billion” Privatized Medical Marijuana Industry.” Medical marijuana has been legal in Canada for more than a decade but was strictly regulated. In a country whose population as of July, 2013, was estimated to be just over thirty-five million (versus the United States’s November, 2013 estimate of 317 million), there are almost 40,000 registered medical marijuana users. The Canadian government thinks that there will be over eleven times that number by 2024 and has recently voted to shift to private companies, as opposed to Health Canada, controlling the drug’s distribution by mail-order, but still under tight restrictions.

What next in the sweeping changes concerning marijuana? I’d like to see well-controlled prospective medical studies, but those can’t happen until (and unless) it becomes a Schedule II drug.

 

 

 

 

STARI or a Lyme Disease variant?

October 31st, 2013
Here's the spirochete you definitely don't want to have..it causes syphilis.

Here’s the spirochete you definitely don’t want to have..it causes syphilis.

There continues to be considerable controversy over the extent of Lyme Disease  in the United States. Its cause is a spirochete, a skinny, long bacteria that is coiled and looks like a microscopic spring. Historically this family of “bugs” was known to have a member that caused syphilis, a scourge of mankind for thousands of years. Then in 1975 a new disease made its first appearance with a cluster of cases in both children and adults in Lyme, Connecticut. Over fifty cases were reported in the first two years of the epidemic, the black-legged tick Ixodes scapularis was found to be the vector that transmits the disease to humans and  in 1982 the spirochete Borrelia burgdorferi was identified as the bacteria responsible for the rash, arthritis, cardiac and neurological manifestations of what was eventually termed Lyme disease. The World Health Organization calls the illness Lyme borreliosis and it is widely found in Europe from Turkey to Sweden with nearly 65,000 cases a year, some differences in signs and symptoms and another tick species as the transmitting agent.

Lyme disease has clearly spread from its origin in the northeast US and is now an illness that affects hundreds of thousands yearly. The Center for Disease Control and Prevention (CDC) has  a website with extensive information on Lyme Disease,  and links to frequently asked questions about the illness. Among those bits of information is the blunt statement that Lyme disease, to a great extent, only occurs in three endemic regions of this country. Those cases occur in the area from northeast Virginia to Maine and some north-central states, including Wisconsin and Minnesota.

But it also can be spread by another tick much further west, especially in California where a different black-legged tick, Ixodes pacificus is the vector. And the CDC’s own interactive map of Lyme disease cases from 2001 through 2012 shows it has struck in Florida, Texas and a number of other states, albeit without the number of cases seen in the east and northeast portions of this country.

Humans aren’t the only species affected; dogs can get Lyme disease also and the incidence of the illness has markedly increases. A canine vaccine is available. Horses, cattle and cats can also get Lyme, but much less commonly.

A major issue is whether Lyme disease or something quite similar occurs in the South. The debate on that started twenty-five years ago and continues to today.

In 1988, Dr. Edwin Masters, a family practice physician in Missouri and amateur forester, gave a talk on Lyme disease to a forestry association. He had extensively prepared for his lecture and subsequently began to see cases of what he thought was Lyme disease in his own practice. Many had a rash similar to Lyme victims elsewhere (erythema migrans, abbreviated as EM). Some had swollen joints, neurological signs and symptoms and positive blood tests for Lyme disease using the test most commonly available then. Masters reported his cases to the Missouri Department of Health, but found that his reports were ignored.

He didn’t give up at that point, but carefully photographed the EM rashes his patients presented with and stored blood samples. In the North the CDC said just having the reach was diagnostic, but denied that was true in the South.

A 1999 paper published by scientists from Amsterdam and New York said that there are ten different species of the spirochete bacteria that is called Borrelia. At that time three were known to cause disease in humans.

A multi-part 2009 blog post in Psychology Today‘s Emerging Diseases series (written by Pamela Weintraub, the Executive Editor at Discover Magazine) was titled “Rebel with a Cause: The Incredible Dr. Masters.” It details the last thirty years of the live of the physician who championed the cause of Southern Lyme disease.

The Lone Star tick appears to be the vector for Lyme-like diseases in the South.

The Lone Star tick appears to be the vector for Lyme-like diseases in the South.

A 2013 Discover Magazine In-Depth report Ticked: The battle over Lyme Disease in the South, tells the story well (I downloaded it for $1.99). In brief, many people who live in the South have had a Lyme-like illness that the Lyme and Tick-Borne Diseases Research Center at Columbia University calls STARI, Southern Tick-Associated Rash Illness. From the CDC’s conservative viewpoint this is not Lyme Disease since it has never been clearly proven to be caused by the spirochete Borrelia burgdorferi sense stricto (that translates to “In the strict sense”)  and, according to the CDC doesn’t cause the major complications associated with that illness. Their 2011 webpage on STARI says patents bitten by the Lone Star tick can sometimes develop an EM rash like those of Lyme disease victims, but the skin manifestations of STARI are slightly different and arthritis, cardiac or neurological complications don’t occur.

Kerry Clark, a PhD associate professor in the Department of Public Health at the University of South Florida, took up the cudgel for Southern Lyme disease after Masters’ death. He is a medical entomologist at USF who had collected and studied ticks for years. After giving a Lyme disease talk in Georgia three years ago, he was approached by a woman from an Atlanta suburb who told him there were many similar cases in her town. Clark collected many ticks from the patchy woodland areas infiltrating the area; most were juvenile (nymph phase) or adult Lone Star ticks.

Several days later he found one engorged tick on his own scalp. Since he has had fatigue, intermittent mental “fuzziness,” twitches and a strange recurrent pounding headache.

Clark recently published a major study in the International Journal of Medical Sciences (easily available on the National Library of Medicine website) with the title “Lyme Borreliosis in Human Patients in Florida and Georgia, USA.” It gives demographic, clinical and lab data on ten such patients with suspected Lyme disease. Clark and his associates used a newly developed test developed specifically for the genospecies Borrelia burgdorferi. Worldwide this includes more than 20 different “bugs” with seven in North America, but in the past only one had been generally accepted as responsible for Lyme disease. With DNA confirmation, they reported finding other closely-related spirochetes in patients’ blood and skin as well as in Lone Star ticks.

My first take was this was an impressive article, but I am aware of those who would treat many patients with a variety of symptoms for “chronic Lyme disease” over extended periods of time using repeated doses of expensive intravenous antibiotics. And there is another subset of physicians, including, unfortunately, one of Clark’s co-authors, who use treatment modalities which I view with great skepticism.

If other academic laboratories confirm Clark’s work, perhaps we can get to definitive answers and make available tests that help determine when and how to treat patients with atypical Lyme disease.

Having seen diagnoses come and go (e.g., the virus that supposedly caused chronic fatigue syndrome was eventually found to be a lab contaminant), I’m waiting for those confirmatory studies.

 

 

 

 

 

 

 

babesiosis, caused by the parasite Babesia microti —

a pathogen similar in type and impact to the one that causes

malaria. Ticks in the South also carry other diseases, including

Rocky Mountain Spotted Fever and ehrlichiosis, caused by two

kinds of related bacteria.

 

 

The Columbia University Lyme and Tick-borne Disease Research Center’s website has a nicely balanced discussion of STARI, Southern Tick-Associated Rash Illness, sometimes called Masters Disease in honor of the now-deceased Missouri family physician who initially reported cases of what was felt to be a Lyme Disease-like illness.

Discover magazine, which I subscribe to, has an In-Depth publication available for $1.99 on the controversy concerning a Lyme disease-like illness in the south. It’s well written by Wendy Orent, a PhD anthropologist/science writer who teaches at Emory University; she has also published a controversial book on plague.

Orent was also involved in a debate about the possibility of an H5N1 (bird flu) epidemic.  According to Orent, there was no legitimate basis to assume that any large-scale epidemic would ensue as a result of the H5N1 virus.