MD-Writer Blog

on medicine, science, current events, and movies

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An Important Clarification of the “Hygiene Hypothesis”: A Science Writer Explains the Balance of Cleanliness and Dirt

Too much cleanliness in modern life leads to too many modern diseases — allergy, asthma, and autoimmune diseases, like multiple sclerosis and inflammatory bowel disease, the persistent inflammations of the nervous system and the intestines that flare up in the absence of pathogenic microorganisms. One proposed explanation of this effect is called the “Hygiene Hypothesis,” which is traced to David P. Strachan, a British doctor, who formulated it in 1989 because epidemiologic studies had found that allergic diseases are less common in larger families. Though unproved, it has gained a general, but tentative and provisional, acceptance by the medical community.

In the modern era, in developed nations, infectious diseases have become less frequent and deadly, as sanitation measures, vaccination, and antibiotics have been developed and utilized. But at the same, other illnesses have taken their place, including cancer and autoimmune diseases, which result from the immune system going awry, either by failing to detect and eliminate abnormal cells or attacking and destroying normal ones. It is through the latter mechanism — the attack of immune cells against the body’s own tissues — that many modern diseases arise.

Commenting in ScienceDaily, one pediatric allergist stated the Hygiene Hypothesis as it has come to be understood by many doctors: “We’ve developed a cleanlier lifestyle, and our bodies no longer need to fight germs as much as they did in the past. As a result, the immune system has shifted away from fighting infection to developing more allergic tendencies.”

In an article today in ScientificAmerican, titled “Eating off the Floor: How Clean Living Is Bad for You,” Robert Dunn, a science writer at NC State and author of a new book, “Wild Life of Our Bodies,” provides an important clarification of the theory that modern hygiene causes diseases. It’s not so much that the cleanliness of our environment causes the absence of microbes, but rather it reduces their diversity. Our home and work environments, he says, with their

warm rooms with the windows closed and the central air turned on, lead to the lowest diversity of microorganisms in our surroundings. And what the hygiene hypothesis argues is that while we may tend to think of this as a hygiene success story, it represents failure. This lower diversity may lead our immune systems to develop in such a way as to be unable to make full sense of the world. [Emphasis mine.]

Perhaps, then, what the immune system fails to obtain in our clean world is sufficient information about what type of microbes and cells need to be attacked and destroyed and which ones can and should be tolerated.

Dunn also explains that one type of organism, in particular, is lacking in our clean environments — the worms that live in the water and the earth and can infect people. “We lost our worms because we started using indoor plumbing and walking around in shoes,” he says. People in regions of the world where infectious worms are common have fewer autoimmune diseases.

But Dunn points out that going to the other extreme and wallowing in dirt is not the answer to modern diseases either:

When people talk about getting back to nature and being less hyperclean they seldom mean pooping near other people’s feet and hands. The same public health systems that got rid of our worms also save lives, by preventing the transmission of other pathogens, such as Cholera, via that same route.

The hygiene hypothesis may well be correct. And like many Americans, I probably use too many antimicrobial cleaners and sprays. Sometimes it becomes a bit of a fetish with me. I’ve taken steps to change, no longer always washing my hands and face and showering with antimicrobial soaps. It will require an effort for Americans and the citizens of other advanced nations to find the right balance, in terms of personal cleanliness and that of our homes and workplaces.

Researchers Develop Technique for “Listening” to the Brain’s Auditory Patterns, Similar to One for “Watching” its Visual Activity

The neuroscientists at the Helen Wills Neuroscience Institute at UC Berkeley will yet succeed in reading our minds. Though they assure us that it will be many years before they achieve this capability, it looks like that’s where they’re headed. This is how the Los Angeles Times reported the story today:

In a move that brings us one step closer to a world in which Big Brother could listen in on what you’re hearing from inside your head, scientists have found that they can re-create a single word that a person has just heard by tracking the brain’s electrical response to the sound.

The Berkeley researchers were joined by others at the University of Maryland, Johns Hopkins, and other UC centers. The scientists described the experiment in a paper titled “Reconstructing Speech from Human Auditory Cortex.” They had their human subjects listen to the sounds of 47 short English words or short nonsense syllables, while they monitored electrical field signals detected by electrodes placed on the surface of the volunteers’ left temporal lobes, which is the region of the cerebral cortex that receives and processes sound. (The participants were epileptics and who were already undergoing treatments that involved placing electrodes on the surfaces of their brains.)

The researchers analyzed the electrode recordings by using a computer algorithm to map the brain activity recorded by the electrodes to the frequency patterns of vowels and consonants in the words and syllables. In that way, the researchers were able to identify the words and syllables the subjects heard.

Last September, other researchers at the same institute reported using a similar technique to reconstruct the visual images of short movies that the subjects had watched. An article in Scientific American titled “Breakthrough Could Enable Others to Watch Your Dreams and Memories,” said that “scientists at the University of California, Berkeley, have reconstructed the internal ‘movie’ that plays in a person’s head.”

In that experiment, the researchers utilized an fMRI scanner to measure the real-time neuronal activity of the occipito-temporal visual cortices of their subjects’ brains. Then a computer applied a mathematical model to transform the data into computationally reconstructed images of a movie that the volunteers watched.

The Berkeley neuroscientists have thus succeeded in detecting and reconstructing patterns of both sound and image, the two principal modalities of thought, as they were processed in their subjects’ brains. Have they, therefore, succeeded in a form of mind reading?

The researchers have made impressive findings, but they are still far from being able decipher true human thoughts by analyzing brain activity. While they have achieved the reconstruction of the raw patterns of sounds and images that their subjects listened to and watched, they apparently have not yet reconstructed what the subjects understood or thought about them. In other worlds, the scientists have not actually read minds.

Still, the higher cognitive processes that constitute such mental activity also take place as patterns neuronal activity in other regions of the brain, and those patterns could be detected by instruments similar to the ones the Berkeley researchers have already used. The difficult part would be devising the computer algorithm to translate those patterns into thoughts that involve comprehension and judgment. That accomplishment — which could justifiably be called “mind-reading,” in my view — is off in the future, as the scientists said, but they are probably working on it. Perhaps it will take them many years, or perhaps not so many.

Are Working Memories Briefly Stored in Synchronized Oscillations in the Brain?

I’ve been thinking a lot about short-term memory lately. As I’ve gotten older, I’ve noticed myself more often forgetting things I try to remember only briefly. For example, I put down a set of keys to free up a hand for some task, reminding myself not to forget them there. Then, of course, I forget them. Though I’ve always done this kind of thing, it seems to me I do it more often now-a-days. Short-term memory, which is also called “working memory,” is the brain function involved in my remembering to pick my keys. It is also the function doctors test when presenting a patient with a string of 5 or 7 numerical digits and asking they be recalled a minute or so later.

So I was interested by an article that appeared today in ScienceDaily, “Short-Term Memory Is Based On Synchronized Brain Oscillations.” A scientific paper on which the news article is based appeared in Nature Neuroscience on Sunday.

Before considering the details of this interesting research, however, it’s worth taking a moment to point out how long lasting memories are made. For many years, as the result of research done in the laboratories of Nobel Prize winner Eric Kandel and other neuroscientists, it has been thought that lasting memories involve persistent changes in the strength of the synaptic connections between neurons, which occur through a mechanism called “long-term potentiation.” Short-term memories, however, are too fleeting to get made in this way.

As described in the Nature article, neuroscientists at the Max Planck Institute for Biological Cybernetics studied the brain activity of monkeys during a visual recognition task. Monkeys were briefly shown one image and then another about a second later. The animals pressed a lever if the images matched. The experiment recorded electrical field strength in the animals’ visual and prefrontal cortexes during a series of matching trials. The visual cortex is, of course, the brain area involved in processing the images, while the prefrontal cortex is believed to be involved in working memory.

The results showed that oscillations of the field strength in the two brain regions synchronized (exhibited “phase locking”), while the monkeys were performing the visual memory task but not at other times. The oscillations of field strength were like the amplitude oscillations of radio waves. When the phases of the oscillations in the two regions were locked, the amplitudes of the field strength moved in sync.

The scientists also found that individual neurons in both brain regions emitted electrical spikes (action potentials) in coordination with the field strength oscillations. Moreover, phase locking between the two regions was more intense during trials when the monkeys performed correctly than during trials when the monkeys made mistakes.

In describing the results, one of the scientists, Stefanie Liebe, the first author of the paper, told ScienceDaily:

It is as if you have two revolving doors in each of the two areas. During working memory, they get in sync, thereby allowing information to pass through them much more efficiently than if they were out of sync

Liebe’s explanation suggests that phase-locking between the visual and prefrontal cortexes facilitates the transfer of information between them. But after reading the paper, I’m not sure I understand the point of the revolving door analogy. Why isn’t it more simple to suppose that the synchronized neuronal spiking produced the synchronized oscillations of the two brain regions? In other works, it was the exchange of signals through axons connecting the two brain regions that produced the phase synchrony of field strength oscillations, rather than it was the phase synchrony that enabled the exchange of signals.

In either case, however, the neuroscientists’ work does suggest that short-term working memories are briefly stored in electrical field oscillations synchronized between the prefrontal cortex and the sensory cortex that receives and processes incoming data.

Scientists Predict Future Oil Shocks Unless Action on Energy Sources Begins Now

An oceanographer at the University of Washington and a climate science advisor to the government of the UK write that the world already passed the tipping point of global oil production in 2005, and production is now in decline. Unless governments act immediately in forceful fashion to promote energy conservation, “the future economy is unlikely to be able to bear what oil prices have in store.”

Production of crude oil rose with demand until 2005, the authors, James Murray and David King, say in last week’s issue of the science journal Nature. But as their graph, which is shown below, indicates, oil production hit a ceiling that year and then leveled off, despite the world oil price having risen from about $60 per barrel that year to over $100 today.

Oil price vs. oil production scatterplot
Oil price vs oil production 1998-2011
James Murray, David King, Nature 481, 433–435 (26 January 2012)

Moreover, world oil production has started to decline and is likely to continue to do so. Globally, production at existing oil fields has been going down 4.5% to 6.7% per year. Moreover, the volume of oil reserves in the ground is difficult to determine, since much information is kept secret, and forecasts by state oil companies appear to have been exaggerated, the writers say.

Coal and natural gas are the likely alternatives to fill in the gap in world energy demand that will result from declining oil production. But Murray and King say those energy sources, particularly gas, have significant problems, too. In the U.S. coal production peaked in 2002, and global coal is likely to peak in one to two decades. Furthermore, estimates of coal reserves have fallen.

Production of natural gas in North America peaked around the same time as coal. Although energy companies are working hard to promote gas extraction through hydraulic fracking of shale, such wells decline rapidly in volume of gas produced after the first year, the authors say.

All these factors point to a future with unstable energy prices and spikes in energy costs that will put the economies of the oil consuming nations at risk and lead to recessions. Such a spike preceded the current economic contraction, which began in 2008, when the price per barrel topped $130. “It seems clear that it wasn’t just the ‘credit crunch’ that triggered the 2008 recession, but the rarely-talked-about ‘oil-price crunch’ as well,” Murray and King contend.

Difficult times for the economies of the world are ahead, and they can only be mitigated if governments act now to promote energy conservation, increased efficiency and use of non-fossil fuels. The writers urge measures be taken before it is too late:

We need to specify conservation goals for improving the efficiency of use of fossil-fuel energy. These include taxing oil to keep prices high and to encourage a reduction in energy use; encouraging nuclear energy; questioning if and how economic growth can continue without an increase in fossil fuels; lowering speed limits on roads and encouraging public transport; or redirecting tax credits towards renewable-energy development. The transformation will take decades, so we must begin as soon as possible.

Effectivness of Stimulant Medications in the Treatment of ADHD Remains Uncertain, Despite Many Years of Use

In an opinion article titled “Ritalin Gone Wrong” in the NYT this weekend, L. Alan Stroufe, a professor of psychology at the University of Minnesota, challenged the widespread use of stimulant drugs to treat children with attention deficit disorder. The medications, such as Ritalin (methylphenidate) and Adderal (amphetamines), “enhance the ability to concentrate,” he argued, but “they don’t improve broader learning abilities.” Three million children in the U.S. take these drugs for “problems in focusing,” he asserted, but “to date, no study has found any long-term benefit of attention-deficit medication on academic performance, peer relationships or behavior problems, the very things we would most want to improve.”

While the medications initially may improve the children’s capacity for learning, the effects “fade after prolonged use,” Sroufe explained. Similarly, decades ago, the same drugs were commonly prescribed for appetite control and weight loss, but loss of efficacy also occurred during long-term treatment, usually resulting in dieters taking off a few pounds temporarily but eventually gaining all the weight back.

Sroufe, I believe, has pointed to a major deficiency in determining scientifically whether medications of any kind are effective — not just stimulant medications used for ADD. The problem is the general absence of long-term well-designed studies of the effects of medications on patients. In the current system of drug approval and regulation, as administered by the FDA, clinical trials of new drugs are conducted by pharmaceutical companies that seek to market them as medicines. Because the trials are extremely expensive and the companies want to begin selling the drugs as soon as possible, most studies last just several days to several weeks. Fewer studies test the drugs for several months, and very few well-controlled trials extend to a year or longer.

Sometimes, however, urgent questions arise about the long-term effects of certain drugs, and the need to investigate becomes great. This apparently has happened in the case of stimulants and ADHD. Sroufe cited the publication in 2009 of a study of about 600 children that showed that the efficacy of the medicines wanes after three years of treatment, and there were no net “academic or behavioral benefits” of stimulant treatment eight years out.

The study that Sroufe referenced appears to be the Multimodal Treatment Study of Children With ADHD (MTA), which has been funded by the National Institute of Mental Health. It began in the late 1990s and is still ongoing. The investigation joins clinical scientists at the NIMH and Columbia University, University of California system, Duke University and many other American universities and academically-affiliated medical centers.

Almost 600 children with ADHD in the original cohort were divided into three groups. One group received stimulant medication only, a second cognitive-behavior therapy only, and a third received the combination of both. Academic and behavioral outcomes were assessed periodically in 485 children. A summary of the results was published in 2007 on the NIMH website. It describes the outcomes in children treated for up to three years.

The summary supports Sroufe’s analysis, in part, stating:

Initial advantages of medication management alone or in combination with behavioral treatment over purely behavioral or routine community care waned in the years after 14 months of controlled treatment ended. … After three years, 45-71 percent of the youth in the original treatment groups were taking medication. However, continuing medication treatment was no longer associated with better outcomes by the third year.

Moreover the report of the results, published in a scientific journal, stated, “In nearly every analysis, the originally randomized treatment groups did not differ significantly on … grades earned in school, arrests, psychiatric hospitalizations, other clinically relevant outcomes.”

However, the NIMH also provided the broad context in which the outcomes occurred.

After the 14 months of assigned treatments ended, families were free to choose from treatments available in their communities.

To understand why the initial advantage of medication wore off, the researchers examined medication use patterns that emerged after formal treatment in the study ended. They found that children who had been assigned to intensive behavioral treatment were more likely to begin taking medication, while those who had been taking medication were more likely to stop. For example, among children originally in the behavioral treatment group, the incidence of high medication use increased from 14 to 45 percent. …

One group, about a third of the children, showed a gradual, moderate improvement; a second group, about half of the children, showed larger initial improvement, which was sustained through the third year; a third group, about 14 percent of the children, responded well initially, but then deteriorated as symptoms returned during the second and third years.

In a 2009 sequel to the 2007 summary, the NIMH, looked at the outcomes after 8 years.

The researchers suggested that maintaining a good treatment response probably requires a sustained effort that takes into account long-term academic and behavioral problems commonly associated with ADHD and adapts to the demands of adolescence. Medication may continue to be helpful for some teenagers, but their needs should be re-evaluated periodically.

The sequel also suggested that a child’s initial presentation, in terms of “ADHD symptom severity, behavior problems, social skills and family resources,” may be the best predictor of long-term outcome.

The NIMH appears to be somewhat less pessimistic than Sroufe about the long-term effects of all three treatments, including the two with medication. One of the principle investigators wrote, “We were struck by the remarkable improvement in symptoms and functioning across all treatment groups.”

I think one of the lessons to be learned from the MTA study is how difficult it is to do long-term followup studies. Even with the resources of the NIMH and the talents of the foremost academic clinical scientists, the study turned out to be poorly designed to shed light on the long-term efficacy of stimulant medication. Too many of the parents whose children started by taking the drugs discontinued them, and too parents whose children started with non-drug treatment put them on medication while the study was still underway.

The proper conclusion, to my mind, is not the one that Sroufe drew, that stimulant drugs don’t work for ADHD in the long-run. Rather, it is that the long-term effectiveness of the medications has not been tested. Doctors should consider the example of the MTA whenever they and their patients assume that medications, continued more or less indefinitely, remain as effective as the day they were started.

Second Virologist Investigating H5N1 Influenza Strains Opposes U.S. Biosecurity Board’s Restrictions on the Research

The second of two virologists who created potentially deadly forms of H5N1 (bird flu) viruses spoke out yesterday, a month after the first scientist to disclose his work sparked a heated controversy over the safety of the research. Yoshihiro Kawaoka of the University of Wisconsin-Madison and the University of Tokyo argued in a commentary in Nature magazine that research on H5N1 pathogens should move forward, since the viruses “circulating in nature already pose a threat, because influenza viruses mutate constantly and can cause pandemics with great losses of life.”

The investigations conducted at Kawaoka’s laboratory and that of Ron Fouchier, who did similar work at Erasmus Medical Center in the Netherlands, demonstrated that the viruses could evolve into strains that are highly lethal and easily transmissible from person to person. In their laboratories, scientists manipulated the genes of the viruses, creating strains that have the potential to spread through the air in droplets emitted in coughs and sneezes. The research is important for “pandemic preparedness,” Kawaoka went on to say, and “there is an urgent need to expand development, production and distribution of vaccines against H5 viruses.”

The H5N1 form made by Fouchier may be especially lethal, since it is derived from one that had circulated among humans and caused severe disease that killed half of about 600 people who caught it. Last month, while Fouchier’s research paper was under review at Science magazine, the U.S. National Science Advisory Board for Biosecurity asked that journal and Nature to refrain from publishing the articles by Fourchier and Kawaoka as they were originally written, and instead omit crucial methodological details describing the creation of the strains.

A highly public debate ensued. Some scientists and experts believed that the research or its publication should be curtailed. Richard Ebright, a bioweapons expert at Rutgers said, “This research should not have been done.” But proponents of the research, including Fouchier and Kawaoka, said that continuing to investigate the nature of the viral threat would pose less danger than stopping it, since it is probable that the deadly strain of virus would evolve naturally or be created in some laboratory as a weapon.

For the time being, Fouchier and Kawaoka have agreed to temporarily interrupt their work. Science and Nature intend to publish only abridged versions of the papers. Next month, a WHO-sponsored international conference in Geneva will provide a forum to discuss the thorny issue of how to allow vital research on disease-causing germs to proceed, while at the same time protecting the public against the potential for pathogens to escape and spread widely.

One of the attendees, Anthony Fauci, who directs NIAID, the infectious disease institute of NIH, said the meeting would “address some of these difficult issues on an international scale instead of something restricted to the United States government.” Although he supports continuing the research, Fauci urged the scientists involved in it to agree voluntarily to the moratorium. “I think we need to get greater input on the conditions in which it goes forward,” he said.

Last month, in a blog posting on the H5N1 research, I referred to the findings on methods of creating the deadly strains. I wrote that it “will require careful supervision of the information and its release only to competent and trustworthy scientists.” That still seems the best course of action. The scientists who think this information should be as widely published and freely available as biological research usually is apparently believe it is pointless and counterproductive to take any precautions. As a member of the scientifically literate public, I am not prepared to assume that they are right.

Dealing with Insomnia — Changing Habits, Taking Pills, or Just Accepting It?

Having spent the first part of last night trying unsuccessfully to fall asleep, I’m writing about insomnia. It’s a problem I have often, particularly in the last few days.

Difficulty falling asleep is a common type of insomnia. The usual causes — noises, stresses, worries, discomforts, changes in schedule, use of stimulants or withdrawal from sedative medications — don’t apply to me. My nights this week have been quiet as usual, I’ve not been stressed or uncomfortable, and I don’t drink coffee or tea in the late afternoon or evening. I only use sedatives when, as last night, I can’t sleep.

Getting older, apparently, may also be a factor in insomnia. Too bad, nothing I can do about that. I suspect, however, that in recent days my brain has gotten too stimulated late in the day. Yesterday, I watched the State of the Union address. Obama always makes an impressive speech and gets me thinking.

Also, in the last week I’ve been reading “Crashing Through,” a remarkable book about a man who lost his eyesight in an accident at the age of three and then had it restored with a corneal transplant when he was about 30 years old. The author, Robert Kurson, presents a clear, perceptive account of the difficulties the man encountered in adjusting to vision after so many years. It’s a thought-provoking story — and perhaps too mentally activating for evening reading. The book may be the main reason for my DFA in the last few nights.

After tossing and turning for a couple of hours, I took half a tab of alprazolam (1.25 mg), a medicine I resort to a few times a month on average. When I finally got to sleep (the med took another hour or so to work), I slept soundly. I had set the alarm for 7 am, so as not to sleep late and set myself up for another restless night. I got about 5 hours sleep.

Insomnia should be taken seriously, says WebMD. According to an article on that website, it has been linked to high blood pressure, heart failure and diabetes. I suppose I should avoid reading or doing anything stimulating in the evening.

But intellectual stimulation is the most important thing in my life these days. I’m retired and lead a quiet life. Without thought-provoking activity, life would be boring. I listen to the news each evening, having little interest in other kinds of shows, because I find reports of the actual happenings around the nation and the world so much more fascinating than most other types of television programs.

On the other hand, ScienceDaily informs us this week that brain-stimulating habits have been linked to lower brain levels of Alzheimer’s protein, the substance called “beta amyloid” that accumulates in the brains of Alzheimer’s patients and to some degree in all older persons, as well. it is believed to play a role in causing the dementia.

The finding by researchers at UC Berkeley suggests that intellectually stimulating activities might actually slow down the pathological process of beta amyloid build up. The scientists studied 65 older volunteers and 10 Alzheimer’s disease patients in their 70s and 11 younger control subjects in their 20s. The older people who had been most active intellectually during their lives (by regularly reading, writing and playing games) had levels of beta amyloid (assessed with PET scans) comparable to the low levels of the young controls. The older subjects who were least active intellectually had levels of the substance comparable to the patients with AD.

If it isn’t one thing, it’s another. Perhaps I ought not to worry so much about insomnia that I resort to pills, even now and then. Since I don’t have to get up and go to work, it’s not terribly troublesome to be sleepy during the day. Rather than just toss and turn in bed at night, perhaps I should get out of bed and read or watch TV until I’m ready to drop. Maybe I’ll try that and see how it works.

Drug Shortages, One After Another, Implicate the American Free-Market Health Care System

From the beginning of the year, actually the day before, repeated reports of problems in the supply of medicines have appeared. On New Year’s Eve, the NYT ran a story on drugs for ADHD, which described parents who were unable to find pharmacies to fill prescriptions for medicine for their restless kids. Reporter Gardiner Harris wrote that the parents had gotten caught in a squeeze between the drug manufacturers, which were trying to maximize profits, and the Drug Enforcement Agency, which was setting strict quotas for the production of the Schedule II drugs (methyphenidate and amphetamine) used to treat the disorder.

The article noted, however, that there was no shortage of the more expensive brand-name drugs for ADHD, just of the inexpensive generic versions of the medications. Seeking to “maximize their profits,” Harris wrote, “each manufacturer divides its quota among its own ADHD medicines — preparing some as high-priced brands and others as cheaper generics.

During January, reports of supply problems with other kinds of drugs followed, including injectable anti-cancer medications; anti-infective drugs; injectable acetaminophen for pain; propofol for anesthesia; and succinylcholine and epinephrine, which are used in surgery. Many of the shortages involved injectable medications, and all are older, off-patent, less expensive drugs, used in common medical conditions and procedures.

The American Society of Heath-System Pharmacists, which maintains a website on the problem, currently lists 218 medications in short supply, everything from Vitamin A to zinc injection. The organization attributes the shortfalls to the interplay of production problems, raw material shortages, and business decisions about manufacturing, distribution, and mergers. In an “Action Alert!” ASHP asks consumers to “help ensure that the FDA has the tools it needs to help minimize the impact of drug shortages on patient care by urging your senators to cosponsor the Preserving Access to Life Saving Medications Act (S. 296).”

The legislation, which is in the early stages of Senate action, gives the FDA the ability to monitor drug supply problems by requiring manufacturers to report production difficulties sooner, and it empowers the agency to work with the companies to establish contingency plans to deal with supply disruptions.

S.296 was introduced in the Senate by Amy Klobuchar (D-Minn). The senator has accused brand-name drugmakers of limiting production of low-profit medications and paying generic drug manufacturers to delay introduction of new generic versions of medicines. Other Democrats in Congress have taken action on the drug shortage issue since October, when Rep. Elijah Cummings (D-Md), the Ranking Member of the House Oversight and Government Committee, began investigating so-called “gray market” companies, which engage in the trading of drugs and may be hoarding drugs and price gouging with those in short supply.

In a Viewpoint article in JAMA this month, a Washington state physician, Barbara Gehrett, noted that the number of drugs in short supply has increased from 62 in 2005 to between 200 and 300 last year. Most of the drugs, she said, are “older, generic sterile injectables,” that are manufactured through complex processes subject to a variety of defects. Common production problems may easily disrupt drug supplies in cases where only one company produces a product, or a drug has a limited shelf life and is available via inventories that use just-in-time control methods.

Gehrett said, “Industry must take the risk of redundant capacity to provide a more reliable supply stream,” but she also blamed the FDA for the slow approval of new manufacturing sites, which usually takes an “unreasonable” 2 to 3 years. Moreover, she wrote, the profit margins on the medicines in short supply “are typically small,” and drug manufacturers may abandon production of a medication that does not yield a sufficient return. She concluded, “In the current situation, high quality and low cost have led to scarcity. The brief years of cheap generic intravenous drugs may be coming to an end.”

My conclusion differs from Gehrett’s. Whatever the cause of the supply disruptions — and there are many — it boils down to price and profit. The fact that the shortages affect cheap medications, while expensive brand-name drugs remain plentiful, tells the story. In this era of rapidly rising health care costs, however, it is not a feasible solution to the problem to raise the costs of low-priced generic drugs to match to the levels, many times higher, of brand-name drugs.

Health care is a sector of the American economy where the free market has failed. It has failed to provide Americans with adequate health care of all types at affordable prices, including access to drugs. There is good evidence that government can do a better job. The government should be supplying some prescription medicines in short supply.

The evidence of government’s superior capabilities in health care comes from other countries, where most health care systems are government-run, but they are more affordable and sometimes even free. Yet, these government health care systems consume a smaller percentage of the national GDP than does the more privately run health care system of the U.S. The evidence also comes from the lower costs of large managed care organizations, which operate more like a government-run system would. Finally, there is the evidence of Medicare, itself, the government-run health care program for the elderly, which is more efficient, in terms of cost, than purely private insurance.

Pervasiveness of Surveillance Discussed at Conference on Privacy and Technology

Technological advances, particularly those involving the internet, are putting long-established privacy protections under stress. That was the take-home message from a panel four experts in privacy and the law, who spoke at a conference yesterday organized by the Electronic Privacy Information Center.

The meeting, titled “Constitution 3.0: Consitutional Rights in the Digital Age,” brought together Adam Liptak, Supreme Court reporter at the NYT; Jeffrey Rosen, professor of law at G.W. University and author of the book “Constitution 3.0“; Paul Smith, a Supreme Court litigator, and Ginger McCall, director of the Open Government Program at EPIC.

Technology has not only enabled and enhanced surveillance by government, the speakers said, but it has also made it possible for private companies, like Google and Facebook, to keep track of and compile private data on millions of people. Also, most people carry cell phones, making it possible for telecom companies to follow the whereabouts of users in real time. And soon GPS devices may be found in just about every car on the road, which could facilitate the tracking of automobiles by police, as well as by private companies that have the capability to receive GPS signals.

Governments now have aerial surveillance drones, of course, but as the devices become less expensive, private organizations and even terrorists may seek to acquire and use them. As webcams become ubiquitous, entire populations of a nation could be tracked by governments and organizations using large computers to store the data and running ingenious algorithms to sift and search it.

Anonymity has also come under threat, as personal identity data has spread through the internet. Are emails private? Most people who communicate by email assume so, but currently nothing guarantees emails won’t be searched by organizations and agencies of government. And, many people are now storing financial and other vital personal data “in the cloud,” on massive servers operated by large web hosting companies. Currently nothing guarantees this data won’t be subject to inspection by some third party.

The ordinary expectation that one’s past will be forgotten as time moves forward may no longer apply. For instance, there is a Facebook module called Timeline, which displays an index of all of someone’s entries posted to that social network. Thus a person’s past might be checked out quickly and easily, and it might never fade away.

To enable the removal of such indelible impressions, one of the speakers suggested, legislatures might enact laws guaranteeing users of websites and social networks the option of deleting their information. In Europe, another speaker noted, there is the concept of the “droit à oublier,” the right to forget, which has been codified in laws that give citizens the right to control their own image and reputation. Should we have similar laws in this country?

We Americans expect that our freedoms to congregate, communicate and conduct business in private are protected by our Constitution and our laws. But the speakers at the EPIC colloquium questioned whether the founding document and current laws are adequate shields from hi-tech surveillance.

The Fourth Amendment, with its prohibition against warrantless searchers and seizures, is the basis of privacy protection. But it was conceived and written in terms of physical intrusions and retrieval of hard documents, not in terms of electronic tracking and scrutiny. Does the Fourth Amendment clearly apply to electronic forms of surveillance that don’t involve the physical entry of private spaces and seizure of material items?

One speaker gave an example of a surveillance activity that might raise the issue of when and where Fourth Amendment protections apply. It may come as a surprise to most Americans, but the Department of Homeland Security has been combing the internet looking for comments unfavorable to its work and mission, the speaker said.

The assumption of privacy during everyday activities is a necessary component of the sense of autonomy and dignity, which people need in order to behave and converse spontaneously, free of the feeling of being watched. But sometimes that feeling may be an illusion. In London, where I vacationed a last summer, surveillance cameras are everywhere. I assumed I was not personally being tracked, but I wonder whether that assumption always correct?

In this country, the NSA, our electronic monitoring agency, has put up a system called “Einstein 3,” for the collection, processing and analysis of all person-to-person communications contents — ALL of it. It is likely, I suspect, that a similarly comprehensive program for tracking the movements of Americans, using webcams, GPS devices, and face/body recognition software, is in the works or already in operation in selected regions around the nation.

In All the Talk of Protecting America’s Energy Security by Building the Keystone Pipeline, Republican’s Say Not a Word About Global Warming

The direst threat to America’s security is not Iran or any foreign power. It is the heating of the planet. In an article this month in Scientific American titled “Devastating Drought Seems Inevitable in American West,” authors from the environmental organization Pacific Institute describe the “worst and most consistent dry period” in the history of Australia during the last ten years. Fires and dust storms are sweeping across the island nation. The writers point to evidence that climate change is playing a role in Australia’s water woes, and they warn, “What happened in Australia could happen in the U.S., with devastating consequences.”

This morning on C-SPAN, I listened to the comments yesterday of a dozen or so Republican members of Congress, who howled in anger at President Obama’s rejection of TransCanada’s application to build the Keystone XL pipeline to transport bitumenous tar through the Midwest from Alberta to the Gulf of Mexico. They bemoaned the construction jobs that will be lost, and the continuing damage to America’s energy security from having to depend on foreign oil. But not a one of them mentioned global warming.

Which is worse for America — the loss of jobs that would last only a few years or the severe weather that could last a century? Which is better for America — continuing and reinforcing our dependence on petroleum or moving now to find other supplies of energy and develop renewable energy resources?

The Washington Post — more a centrist than a liberal news organization — made the case for building the oil conduit, arguing, “Without the pipeline, Canada would still export its bitumen. … And U.S. refineries would still import low-quality crude — just from the Middle East.” Perhaps so, but oil from outside the U.S. could not leak into aquifers in the Midwest. Besides, the Post comment misses the most important point.

The NY Times, the Post’s competitor, pointed out the most relevant factor: “The extraction and production of tar sands oil in the fields of northern Alberta would also cause far more greenhouse gas emissions than drilling for conventional crude.” The reasons for this have to do with the extremely dirty nature of the Canadian tarry crude.

The Canadian petroleum reserves, moreover, are the world’s second largest supply after Saudi Arabia. Does it make sense to bring a second Saudi online, when climate change is already underway?

I feel the growing warmth this winter, when a cold day in Maryland is one when the temperature drops below freezing. Just two decades ago, I remember, the thermometer would sometimes fall near zero in January, and one year the Potomac River froze over across to the Virginia shoreline. But these days, it feels as though the fall doesn’t end before spring begins. It’s nice for now, but how much longer will the good weather last?