NATURE | NEWS

Stem-cell ruling riles researchers

Italian health minister’s support for a controversial treatment appals the country’s scientists.

A naked woman joined protesters in Rome calling for stem-cell therapy for all incurably ill patients.

BENVEGNÙ/GUAITOLI/CIMAGLIA/JPEG FOTOSERVIZI

Article too

Clinics that offer unproven stem-cell treatments often end up playing cat and mouse with health regulators, no matter which country they operate in. In Italy, however, one such treatment now has official sanction. The country’s health minister, Renato Balduzzi, has decreed that a controversial stem-cell treatment can continue in 32 terminally ill patients, mostly children — even though the stem cells involved are not manufactured according to Italy’s legal safety standards.

The unexpected decision on 21 March has horrified scientists, who consider the treatment to be dangerous because it has never been rigorously tested. In the opinion of stem-cell researcher Elena Cattaneo of the University of Milan: “It is alchemy”.

The decision followed weeks of media pressure to authorize compassionate use of the therapy, which was developed by the Brescia-based Stamina Foundation and has been repeatedly banned in the past six years. Now, patient groups are pushing for the treatment to be available to anyone with an incurable illness. Hundreds protested in Rome on 23 March, including a naked woman with pro-Stamina slogans painted on her skin.

Related stories

• Controversial stem-cell company moves treatment out of the United States
• Stem cells: Don't believe the hype
• Seven days: 6–12 May 2011

More related stories

Stamina Foundation president Davide Vannoni, a psychologist at the University of Udine, says that the publicity around the treatment has won him 9,000 new patients. He hopes that further modifications to the law will allow him to expand the therapy.

A month ago, an investigatory television programme,The Hyena, reported that children with incurable diseases such as spinal muscular atrophy were being denied supposedly important treatment, and Italian show-business personalities joined the call to relax rules on stem-cell treatment.

In Italy, the compassionate use of as-yet-unapproved therapies is allowed on an emergency basis for dying individuals who have no other options, and the national health service must provide them for free. The law requires that health authorities approve the quality of such therapies, but some of its terms are ambiguous, says Amedeo Santosuosso, a Milanese judge and a professor at the University of Pavia who specializes in science and law. “That has been the underlying problem in the Stamina debacle,” he says. “In the case of the Stamina Foundation therapy, there is no suggestion that it might be efficacious, so in my opinion compassionate use is not legitimate.”

Vannoni says that he developed the therapy after having successful stem-cell treatment for a virus-induced facial paralysis in 2004 in Russia. He invited a Russian and a Ukrainian scientist to Turin to develop the method and says that Stamina has since treated 80 or so patients — including people with Parkinson’s disease, Alzheimer’s and muscle-wasting disorders. He has not published the outcomes or precise details of his therapy, which uses the mesenchymal stem cells from bone marrow that differentiate into bone, fat and connective tissue. In his protocol, the cells are extracted from patients, manipulated in the laboratory and then re-infused.

Vannoni acknowledges that he has not published outcomes but says that the method is far from alchemy. Each treatment uses five types of cell, he explains, with their claimed characteristics tuned to replace damaged tissue or to secrete molecules that could reduce inflammation, fight infection or promote blood-vessel growth. ”Whatever the disease, one of the types of cell is going to have the right effect,” he says.

When a 2007 European Union regulation required that stem-cell therapies follow the same safety and efficacy rules as pharmaceuticals, Vannoni moved his lab to the republic of San Marino. “There, rules were not so strict,” he says.

But his work had drawn the attention of a Turin prosecutor, Raffaele Guariniello, whose investigations concluded that Vannoni’s operation could be “dangerous to public health”. Vannoni says that Guariniello marshalled international pressure to stop him working in San Marino, so he moved to Trieste, where he says Guariniello again stopped his work.

From there, Vannoni moved to a public hospital in Brescia. Last May, a delegation including representatives of the Italian Medicines Agency (AIFA) and the ISS, the health ministry’s national institute, visited the Brescia lab and reported chaotic conditions: ethics-committee approvals had been based on inadequate information, and there were no detailed protocols or patient follow-up, for example. The AIFA closed the lab, stating that the facilities could not be trusted to produce contamination-free preparations.

Patients and families turned to the legal system to allow treatments to continue as compassionate use; many of the courts concluded that it was a patient’s right to receive treatment and that health services must offer it, and in some cases the Brescia lab once again supplied cells.

Some of the compelled treatments led to the only publication of clinical results so far. Clinicians at the Burlo Garafalo Children’s Hospital in Trieste treated five babies with type I spinal muscular atrophy and published the results last October (M. Carrozzi et al.Neuromuscul. Disord. 22, 1032–1034; 2012). They found that “the treatment did not change the course of the disease”, says co-author Marco Carrozzi. Vannoni argues that the therapy failed because the clinicians did not use his exact cocktail of cells.

Setting himself against his own regulatory agencies, Balduzzi had earlier angered scientists when, on 7 March, he authorized continued therapy for a three-year-old child with the deadly disease metachromatic leuko­dystrophy — provided that the stem cells were created in a good manufacturing practice (GMP) facility. Thirteen academics, including Cattaneo and Santosuosso, published an open letter to Balduzzi warning him of the dangers (see go.nature.com/pb1wdl; in Italian).

That authorization was bad enough, says Paolo Bianco, a stem-cell scientist at the University of Rome who co-signed the letter. “Now the minister is allowing the non-GMP version and saying that an unauthorized, unpublished, unknown practice is a ‘treatment’.”

Balduzzi’s decree is likely to be his last legislative act in Italy’s outgoing government, and scientists hope that his successor will respect the role of the AIFA and other science-based agencies. AIFA president Luca Pani declined to comment on the political decision but says that his agency is sticking to its statements on the safety and efficacy of the stem-cell preparations from Brescia. “Our ban holds,” he says.

Cocaine on Money

Cocaine on Money: Drug Found on 90% of U.S. Bills

Christine Dell'Amore in Washington, D.C.
National Geographic News

August 16, 2009

If you live in the United States or Canada, chances are you have cocaine in your wallet. Nearly nine out of ten bills circulating in the U.S. and its northern neighbor are tainted with cocaine, according to what's being called the most definitive research to date on the subject.

Enlarge Photo

Printer Friendly

Email to a Friend

What's This?

SHARE

Digg StumbleUpon Reddit

RELATED

• Drugs Found in Hair of Ancient Andean Mummies
• Cocaine Country (National Geographic Magazine)
• Valentine's Day Rx: Four Future Love Drugs

What's more, researchers were surprised to find hints that more Americans are using the illegal drug, said study leader Yuegang Zuo of the University of Massachusetts in Dartmouth. In a similar study by the same team in 2007, 67 percent of U.S. bills were found to be tainted with cocaine. The new study puts the percentage at 85 to 95—a jump of roughly 20 percent, Zuo said. The drug gets on paper money during drug transactions and when people roll bills to snort cocaine powder, Zuo said. Stress spurred by the worldwide financial crisis may be driving people to abuse cocaine, one of the most common illegal drugs in the world, Zuo said in a phone interview. The new findings could "help raise public awareness about cocaine use and lead to greater emphasis on curbing its abuse," Zuo said in a follow-up email. Cocaine Country Part of the reason the new study is so complete, Zuo said, is because the team used new equipment, a gas chromatograph-mass spectrometer, which doesn't ruin the money—allowing the scientists to test more bills without breaking the bank. The team collected banknotes from the Brazil, Canada, the U.S., China, and Japan. With 5.8 million people having used the drug at least once in 2007, the U.S. is the world's biggest cocaine market, according to the 2009 UN World Drug Report. Perhaps not surprisingly, then, the U.S.—along with Canada—had the highest percentage of cocaine-permeated bills in the study. Of the 234 U.S. bills collected in 17 large and small cities, nearly 90 percent had traces of cocaine, especially in larger cities such as Baltimore, Boston, and Detroit. Ninety-five percent of the dollars found in Regardless of where you live, though, there's little chance of getting buzzed off your bills, Zuo said. Even in the U.S. and Canada, the concentrations are simply too small. Findings today at a meeting of the American Chemical Society in Washington, D.C.

Doctors Urge F.D.A. to Restrict Caffeine in Energy Drinks

Read the Letter Here

Wary of Attack With Smallpox, U.S. Buys Up a Costly Drug

By DONALD G. McNEIL Jr.

Published: March 12, 2013 68 Comment

• 
  

The United States government is buying enough of a new smallpoxmedicine to treat two million people in the event of a bioterrorism attack, and took delivery of the first shipment of it last week. But the purchase has set off a debate about the lucrative contract, with some experts saying the government is buying too much of the drug at too high a price.

Enlarge This Image

Associated Press

Lining up for smallpox vaccinations in 1947. The government is stockpiling a new drug for use if there is a bioterrorism attack.

A small company, Siga Technologies, developed the drug in recent years. Whether the $463 million order is a boondoggle or a bargain depends on which expert is talking. The deal will transform the finances of Siga, which is controlled by Ronald O. Perelman, a billionaire financier, philanthropist and takeover specialist.

Smallpox was eradicated by 1980, and the only known remaining virus is in government laboratories in the United States and Russia. But there have long been rumors of renegade stocks that could be sprayed in airports or sports stadiums. Experts say the virus could also be re-engineered into existence in a sophisticatedgenetics lab.

As part of its efforts to prepare for a possible bioterrorism attack, the government is paying more than $200 for each course of treatment.

Siga argues that the price is a fair return on years of investment. And Robin Robinson, director of the Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services, the overseer of the contract for the drug, Arestvyr, defended the size of the order and the price paid. He said that two million doses was the amount analysts predicted would be needed to contain a smallpox outbreak in a large city and that the whole country would require 12 million, along with vaccines.

The price, he said, was arrived at through federal purchasing guidelines and was “fair and reasonable” compared with the price of other commercial antiviral drugs, which he said ranged from $108 to $7,364.

But when stockpiling a smallpox drug was first proposed in 2001 after the Sept. 11 andanthrax attacks, it was expected to cost only $5 to $10 per course, said Dr. Donald A. Henderson, who led a government advisory panel on biodefense in the wake of those attacks. Dr. Henderson was a leader in the eradication of smallpox in the 1960s and is now at the Center for Biosecurity at the University of Pittsburgh Medical Center.

Dr. Richard H. Ebright, a bioweapons expert at Rutgers University, said there was little need for so much Arestvyr since the country has raised its stockpile of smallpox vaccine to 300 million doses now, up from only 15 million in 2001.

“Is it appropriate to stockpile it? Absolutely,” he said. “Is it appropriate to stockpile two million doses? Absolutely not. Twenty thousand seems like the right number.”

Vaccines are normally given before an infection to prevent a disease, while antivirals like Arestvyr are given after virus infections, to treat them. Smallpox has such a long incubation period that the vaccine can prevent disease even if it is given as late as three days after infection. Arestvyr may also prevent infection if given early enough, but that has not been proven.

Dr. Eric A. Rose, the president of Siga and a vice president of Mr. Perelman’s holding company, MacAndrews & Forbes, acknowledged that the drug cost little to make, but said the price being charged for a patented drug was a bargain compared with AIDSantiretrovirals that cost $20,000 a year and cancer drugs that cost more than $100,000 a year.

Asked about the size of the purchase, he compared it with a flu drug. “There are 80 million courses of Tamiflu in the strategic national stockpile,” he said. “Smallpox is just as contagious and has 30 times the mortality. By measures like that, I’d say 2 million is on the low end.”

He also said that Mr. Perelman had invested $80 million in the company through years of research with no sales. Without a profit potential, no company would take up smallpox, Ebola and other lethal but very rare diseases, he said.

And Dr. Isaac B. Weisfuse, who was formerly head of pandemic planning for the New York City health department and is now Siga’s medical policy director, said that plans calling for tens of million Americans to be vaccinated within days of a major smallpox outbreak were unrealistic and that Arestvyr could save lives.

Arestvyr — which until November was known as ST-246 or tecovirimat — prevents the virus from forming the double outer envelope that lets it break out of the first cells it infects and spread throughout the body. A 14-day course can be taken in combination with smallpox vaccine, offering double protection, which Dr. Henderson called “quite amazing.”

Arestvyr is not approved by the Food and Drug Administration except for use in emergencies.

It has never been tested on smallpox in humans because the disease was eradicated. However, it has prevented death in dozens of monkeys injected with what would normally have been lethal doses of smallpox or a related virus, monkey pox.

It also appears to have helped several humans suffering from potentially lethal reactions to smallpox vaccine, which is itself a live smallpox-related virus but is normally harmless. They included a child near death after catching his father’s vaccination virus, a soldier vaccinated just before discovering he had leukemia, and a woman whose immune system was suppressed by steroids and who was infected by touching bait meant for raccoons that contained a combined rabies/smallpox vaccine.

However, those patients were also given immune globulin, other drugs and hospital care, so it is hard to know exactly what worked.

Bioterrorism experts say the need for Arestvyr has declined since the United States increased its stockpile of smallpox vaccine, which was once given to people routinely before the disease was brought under control, including a less potent but less risky backup vaccine for those who cannot tolerate the standard one.

The word “smallpox” still strikes fear. John Grabenstein, a retired colonel and a top biodefense adviser to the Defense Department after the 2001 attacks, recalled reports of refrigerated Soviet warheads loaded with the virus that could, in theory, aerosolize it over large areas. Others have envisioned a few infected terrorists mingling in crowds.

Left untreated, smallpox kills a third of victims. But prominent experts say the danger is overblown. Because it can take up to two weeks before an infected person becomes seriously ill, and up to five more days before he or she begins to infect others, there is time to respond, they said.

Also, they said, by the time smallpox victims reach the infectious stage, when their pox are erupting, they are too sick to wander around. That is why outbreaks in schools or factories were nearly unheard of.

Smallpox was eradicated by “ring vaccination” — finding each case and vaccinating just the 50 to 200 people closest to it.

If there were a lage-scale bioterrorism attack using smallpox, health officials could move quickly, some experts say.

“If we had to, we could vaccinate the entire country in three days,” said Dr. William H. Foege, another leader of the smallpox eradication effort who now advises the Bill & Melinda Gates Foundation. This vaccine does not use a syringe, but a forked pin that Dr. Foege said he could “train anyone to use in 10 minutes.” In a true emergency, he argued, schoolteachers, police officers, firefighters and others would all be vaccinators.

Other experts think that is overoptimistic, since an attack would cause panic.

Also, Dr. Rose of Siga pointed out, there are only an estimated 700 million doses of smallpox vaccine in a world of 7 billion people, so the United States might use its vaccine and Arestvyr stockpile to help other countries. (Only the United States, Japan and Israel are believed to have enough doses for their entire populations, experts said.)

Dr. Henderson and Dr. Philip Russell, who formerly headed the Walter Reed Army Institute of Research and served on the advisory panel with him, said they expected the government to pay much less for an antiviral drug since they cost little to make and the alternative, vaccines, cost the government $3 a dose. “If they’re talking $250 a course, they’re a bunch of thieves,” Dr. Russell said.

Other experts, like Dr. Grabenstein, said that since the drugs have no other use, they are like aircraft carriers: to entice companies to make them, the government has to pay all the costs plus guarantee the producer a profit — and that it might be prudent to have extras on hand.

Mr. Perelman’s company, MacAndrews & Forbes, has spent more than $1 million lobbying each year since 2008, according to the Center for Responsive Politics, a watchdog group. A spokeswoman for the company, Christine Taylor, said it had done “absolutely no lobbying” for the Siga contract
.

• 

New Optimism on Resveratrol

By NICHOLAS WADE

Tony Cenicola/The New York Timesnred wineA cloud has long hung over the intriguing thesis that resveratrol, a minor ingredient of red wine, activates cellular proteins known as sirtuins that promote longer life in laboratory worms, flies and mice.
Critics have suggested that there were errors in the original experiments and that resveratrol did not in fact activate sirtuins directly. If so, resveratrol would lose much of its scientific interest because its link to the sirtuin would be unclear. But a new study led by David Sinclair of the Harvard Medical School, who in 2003 was a discoverer of resveratrol’s role in activating sirtuins, found that resveratrol did indeed influence sirtuin directly, though in a more complicated way than previously thought. Resveratrol appears to work by changing the shape of the sirtuin proteins in a cell. Thus activated, the sirtuins do several things, one of which is to switch on a second protein that spurs production of the mitochondria, which provide the cell’s energy. This would explain why mice treated with resveratrol ran twice as far on a treadmill before collapsing from exhaustion as untreated mice.A cloud has long hung over the intriguing thesis that resveratrol, a minor ingredient of red wine, activates cellular proteins known as sirtuins that promote longer life in laboratory worms, flies and mice.The exact knowledge of resveratrol’s mode of action, if confirmed, is welcome news for Sirtris, the company Dr. Sinclair helped found to explore whether resveratrol-mimicking drugs could avert the diseases of aging. Resveratrol itself is not ideal as a drug, for technical and patent reasons.

Libya: Homemade Alcohol Kills 51 and Sickens Dozens

By THE ASSOCIATED PRESS

Published: March 11, 2013

• 
  

Health Minister Nouri Doghman said Monday that 51 people had died over the previous three days from drinking homemade alcohol containing poisonous methanol and that 330 others had been sickened. Most of the victims were in Tripoli; some were blinded, while others went into comas or suffered kidney failure. Libya bans the sale and consumption of alcohol, but homemade versions are available on the black market
.

Unreported Side Effects of Drugs Are Found Using Internet Search Data, Study Finds

Using data drawn from queries entered into Google, Microsoft and Yahoo search engines, scientists at Microsoft, Stanford and Columbia University have for the first time been able to detect evidence of unreported prescription drug side effects before they were found by the Food and Drug Administration’s warning system.

Multimedia

Software and Side Effects

Connect With Us on Social Media

@nytimesscience on Twitter.

• Science Reporters and Editors on Twitter

Like the science desk on Facebook.

Readers’ Comments

Share your thoughts.

• Post a Comment »
• Read All Comments (113) »

Using automated software tools to examine queries by six million Internet users taken from Web search logs in 2010, the researchers looked for searches relating to an antidepressant, paroxetine, and acholesterol lowering drug, pravastatin. They were able to find evidence that the combination of the two drugs caused high blood sugar.

The study, which was reported in the Journal of the American Medical Informatics Association on Wednesday, is based on data-mining techniques similar to those employed by services like Google Flu Trends, which has been used to give early warning of the prevalence of the sickness to the public.

The F.D.A. asks physicians to report side effects through a system known as the Adverse Event Reporting System. But its scope is limited by the fact that data is generated only when a physician notices something and reports it.

The new approach is a refinement of work done by the laboratory of Russ B. Altman, the chairman of the Stanford bioengineering department. The group had explored whether it was possible to automate the process of discovering “drug-drug” interactions by using software to hunt through the data found in F.D.A. reports.

The group reported in May 2011 that it was able to detect the interaction between paroxetine and pravastatin in this way. Its research determined that the patient’s risk of developing hyperglycemia was increased compared with taking either drug individually.

The new study was undertaken after Dr. Altman wondered whether there was a more immediate and more accurate way to gain access to data similar to what the F.D.A. had access to.

He turned to computer scientists at Microsoft, who created software for scanning anonymized data collected from a software toolbar installed in Web browsers by users who permitted their search histories to be collected. The scientists were able to explore 82 million individual searches for drug, symptom and condition information.

The researchers first identified individual searches for the terms paroxetine and pravastatin, as well as searches for both terms, in 2010. They then computed the likelihood that users in each group would also search for hyperglycemia as well as roughly 80 of its symptoms — words or phrases like “high blood sugar” or “blurry vision.”

They determined that people who searched for both drugs during the 12-month period were significantly more likely to search for terms related to hyperglycemia than were those who searched for just one of the drugs. (About 10 percent, compared with 5 percent and 4 percent for just one drug.)

They also found that people who did the searches for symptoms relating to both drugs were likely to do the searches in a short time period: 30 percent did the search on the same day, 40 percent during the same week and 50 percent during the same month.

“You can imagine how this kind of combination would be very, very hard to study given all the different drug pairs or combinations that are out there,” said Eric Horvitz, a managing co-director of Microsoft Research’s laboratory in Redmond, Wash.

The researchers said they were surprised by the strength of the “signal” that they detected in the searches and argued that it would be a valuable tool for the F.D.A. to add to its current system for tracking adverse effects. “There is a potential public health benefit in listening to such signals,” they wrote in the paper, “and integrating them with other sources of information.”

The researchers said that they were now thinking about how to add new sources of information, like behavioral data and information from social media sources. The challenge, they noted, was to integrate new sources of data while protecting individual privacy.

Currently the F.D.A. has financed the Sentinel Initiative, an effort begun in 2008 to assess the risks of drugs already on the market. Eventually, that project plans to monitor drug use by as many as 100 million people in the United States. The system will be based on information collected by health care providers on a massive scale.

“I think there are tons of drug-drug interactions — that’s the bad news,” Dr. Altman said. “The good news is we also have ways to evaluate the public health impact.

“This is why I’m excited about F.D.A. involvement here. They do have mechanisms and ways to pick up the things that we find and triage them based on anticipated public health impact.”

In Medical First, a Baby With H.I.V. Is Deemed Cured

By ANDREW POLLACK and DONALD G. McNEIL Jr.

Published: March 3, 2013 158 Comments

Doctors announced on Sunday that a baby had been cured of anH.I.V. infection for the first time, a startling development that could change how infected newborns are treated and sharply reduce the number of children living with the virus that causes AIDS.

The baby, born in rural Mississippi, was treated aggressively with antiretroviral drugs starting around 30 hours after birth, something that is not usually done. If further study shows this works in other babies, it will almost certainly be recommended globally. The United Nations estimates that 330,000 babies were newly infected in 2011, the most recent year for which there is data, and that more than three million children globally are living with H.I.V.

If the report is confirmed, the child born in Mississippi would be only the second well-documented case of a cure in the world. That could give a lift to research aimed at a cure, something that only a few years ago was thought to be virtually impossible, though some experts said the findings in the baby would probably not be relevant to adults.

The first person cured was Timothy Brown, known as the Berlin patient, a middle-aged man with leukemia who received a bone-marrow transplant from a donor genetically resistant to H.I.V. infection.

“For pediatrics, this is our Timothy Brown,” said Dr. Deborah Persaud, associate professor at the Johns Hopkins Children’s Center and lead author of the report on the baby. “It’s proof of principle that we can cure H.I.V. infection if we can replicate this case.”

Dr. Persaud and other researchers spoke in advance of a presentation of the findings on Monday at the Conference on Retroviruses and Opportunistic Infections in Atlanta. The results have not yet been published in a peer-reviewed medical journal.

Some outside experts, who have not yet heard all the details, said they needed convincing that the baby had truly been infected. If not, this would be a case of prevention, something already done for babies born to infected mothers.

“The one uncertainty is really definitive evidence that the child was indeed infected,” said Dr. Daniel R. Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Dr. Persaud and some other outside scientists said they were certain the baby — whose name and gender were not disclosed — had been infected. There were five positive tests in the baby’s first month of life — four for viral RNA and one for DNA. And once the treatment started, the virus levels in the baby’s blood declined in the pattern characteristic of infected patients.

Dr. Persaud said there was also little doubt that the child experienced what she called a “functional cure.” Now 2 1/2, the child has been off drugs for a year with no sign of functioning virus.

The mother arrived at a rural hospital in the fall of 2010 already in labor and gave birth prematurely. She had not seen a doctor during the pregnancy and did not know she had H.I.V. When a test showed the mother might be infected, the hospital transferred the baby to the University of Mississippi Medical Center, where it arrived at about 30 hours old.

Dr. Hannah B. Gay, an associate professor of pediatrics, ordered two blood draws an hour apart to test for the presence of the virus’ RNA and DNA.

The tests found a level of virus at about 20,000 copies per milliliter, fairly low for a baby. But since tests so early in life were positive, it suggests the infection occurred in the womb rather than during delivery, Dr. Gay said.

Typically a newborn with an infected mother would be given one or two drugs as a prophylactic measure. But Dr. Gay said that based on her experience, she almost immediately used a three-drug regimen aimed at treatment, not prophylaxis, not even waiting for the test results confirming infection.

Virus levels rapidly declined with treatment and were undetectable by the time the baby was a month old. That remained the case until the baby was 18 months old, after which the mother stopped coming to the hospital and stopped giving the drugs.

When the mother and child returned five months later, Dr. Gay expected to see high viral loads in the baby. But the tests were negative.

Suspecting a laboratory error, she ordered more tests. “To my greater surprise, all of these came back negative,” Dr. Gay said.

Dr. Gay contacted Dr. Katherine Luzuriaga, an immunologist at the University of Massachusetts, who was working with Dr. Persaud and others on a project to document possible pediatric cures. The researchers, sponsored by amfAR, the Foundation for AIDS Research, put the baby through a battery of sophisticated tests. They found tiny amounts of some viral genetic material but no virus able to replicate, even lying dormant in so-called reservoirs in the body.

There have been scattered cases reported in the past, including one in The New England Journal of Medicine in 1995, of babies clearing the virus, even without treatment.

Those reports were greeted skeptically, particularly since testing methods were not very sophisticated back then. But those reports and this new one could suggest there is something different about babies’ immune systems, said Dr. Joseph McCune of the University of California, San Francisco.

One hypothesis is that the drugs killed off the virus before it could establish a hidden reservoir in the baby. One reason people cannot be cured now is that the virus hides in a dormant state, out of reach of existing drugs. When drug therapy is stopped, the virus can emerge from hiding.

“That goes along with the concept that, if you treat before the virus has had an opportunity to establish a large reservoir and before it can destroy the immune system, there’s a chance you can withdraw therapy and have no virus,” said Dr. Anthony S. Fauci, the director of the National Institute for Allergy and Infectious Diseases. Adults, however, typically do not know they are infected right as it happens, he said.

Dr. Steven Deeks, professor of medicine at the University of California, San Francisco, said if the reservoir never established itself, then he would not call it a true cure, though this was somewhat a matter of semantics. “Was there enough time for a latent reservoir, the true barrier to cure, to establish itself?” he said.

Still, he and others said, the results could lead to a new protocol for quickly testing and treating infants.

In the United States, transmission from mother to child is rare — several experts said there are only about 200 cases a year or even fewer — because infected mothers are generally treated during their pregnancies.

If the mother has been treated during pregnancy, babies are typically given six weeks of prophylactic treatment with one drug, AZT, while being tested for infection. In cases like the Mississippi one, where the mother was not treated during pregnancy, standards have been changing, but typically two drugs are used.

But women in many developing countries are less likely to be treated during pregnancy. And in South Africa and other African countries that lack sophisticated testing, babies born to infected mothers are often not tested until after six weeks, said Dr. Yvonne Bryson, chief of global pediatric infectious disease at the University of California, Los Angeles.

Dr. Bryson, who was not involved in the Mississippi work, said she was certain the baby had been infected and called the finding “one of the most exciting things I’ve heard in a long time.”

Studies are being planned to see if early testing and aggressive treatment can work for other babies. While the bone marrow transplant that cured Mr. Brown is an arduous and life-threatening procedure, the Mississippi treatment is not and could become a new standard of care.

While it might be difficult for some poorer countries to do, treating for only a year or two would be cost effective, “sparing the kid a lifetime of antiretroviral therapy,” said Rowena Johnston, director of research at amfAR
.

Patients Face More Lethal Infections from CRE

Some germs are beating even our strongest antibiotics. Rapid action by clinicians and healthcare leaders is needed to stop the rise of lethal CRE infections.

A new Vital Signs report shows that antibiotics are being overpowered by lethal germs called carbapenem-resistant Enterobacteriaceae (CRE).These germs cause lethal infections in patients receiving inpatient medical care, such as in hospitals, long-term acute care facilities, and nursing homes.

In their usual forms, germs from the Enterobacteriaceae family (e.g. E. coli) are a normal part of the human digestive system. However, some of these germs have developed defenses to fight off all or almost all antibiotics we have today.When these germs get into the blood, bladder or other areas where germs don’t belong, patients suffer from infections that are difficult, and sometimes impossible, to treat.

While CDC has warned about CRE for more than a decade, new information shows that these germs are now becoming more common. One type of CRE has been detected in medical facilities in 42 states. Even more concerning, this report documents a seven-fold increase in the spread of the most common type of CRE during the past 10 years.

Why are CRE so alarming?

Even though these infections are not common, their rise is alarming because they kill up to half of people who get severe infections from them. In addition to causing lethal infections among patients, CRE are especially good at giving their antibiotic-fighting abilities to other kinds of germs.This means that in the near future, more bacteria will become immune to treatment, and more patients’ lives could be at risk from routine bladder or wound infections. Without serious efforts to stop CRE in medical facilities, and without rapid improvement in the way doctors everywhere prescribe antibiotics, CRE will likely become a problem in the community, among otherwise healthy people not receiving medical care.

How can CRE be stopped?

There have been major successes in stopping CRE in medical facilities in the United States, and nationally in other countries. Stopping CRE will take a rapid, coordinated, and aggressive "Detect and Protect" action that includes intense infection prevention work and antibiotic prescribing changes. CDC released a CRE prevention toolkit in 2012 reiterating practical CRE prevention and control steps. Leadership and medical staff in hospitals, long-term acute care hospitals, nursing homes, health departments, and even outpatient practices must work together to implement these recommendations to protect patients from CRE.

OP-ED COLUMNIST

The Competition Drug

By ROGER COHEN

Published: March 4, 2013 121 Comments

• FACEBOOK
• TWITTER
• GOOGLE+
• SAVE
• E-MAIL
• SHARE
• PRINT
• REPRINTS
• 

Boston

Enlarge This Image

Damon Winter/The New York Times

Roger Cohen

Go to Columnist Page »

Related in Opinion

• Opinionator | Anxiety: The Last All-Nighter (March 4, 2013)

Readers’ Comments

Share your thoughts.

• Post a Comment »
• Read All Comments (119) »

THIS is America’s college town par excellence. Kids from all over the world flock to Boston to learn. I have a son who is a freshman here. Last autumn, as he entered school, I listened to warnings about the dangers of binge drinking. I think they missed the point.

The real epidemic involves so-called smart drugs, particularly Adderall, an amphetamine prescribed for attention deficit hyperactivity disorder (A.D.H.D.) but so freely available as to be the pill to take whenever academic pressure requires pulling an all-nighter with zero procrastination to get a paper done.

“Just popped an Addie, so I’m good to go” — this sort of pretest attitude has become pervasive. Conversations with several students suggested Adderall was always available, costing from $2 to $5 a pill. Adderall has become to college what steroids are to baseball: an illicit performance enhancer for a fiercely competitive environment.

What to say to doctors to get a prescription is now so widely known among students — “It’s like my thoughts are channel-surfing and I can’t stop” — as to have become a kind of joke.

“If there are no A.D.H.D. symptoms prior to college I have a very hard time writing a prescription,” Jill Kasper, a pediatrician, told me. “But if somebody wants a prescription for Adderall, they can find someone to give it to them.”

The problem is that Adderall is dangerous, a Class 2 controlled substance like cocaine. While it has helped countless A.D.H.D. sufferers, it can also lead down a dark road of dependency, ever higher doses, fight-or-flight anxiety levels, sleeplessness and depression.

Here, in his own words, is the Adderall story of Steven Roderick, 24, a smart, soft-spoken, lost senior studying health science at the University of Massachusetts Boston:

“I started taking it my first year in college. My performance had always fluctuated a lot. It was hard to pay attention, even in classes I was interested in. I was getting D’s. I felt something had to change. Adderall flies around campus. The first time I took it I wrote a paper for an astronomy class that was out of this world. I could not believe it — I was so inspired it made me want to be a doctor!

“I thought — oh my God! — this is the whole problem. You have the ability. You are intelligent. You just don’t have the link between intelligence and the capacity to be productive. The pill is the link. I felt literally unstoppable.

“I went to the doctor, said I’d like to give Adderall a try. There were no diagnostic procedures. Doctors give in too easily. I did not think there could be a risk later on. I started on 20 milligrams. I went from D’s and F’s to straight A’s. But your brain adapts, you have to increase the dose, and by 2011 I was up to 45 milligrams.

“In the spring of that year I started to feel Adderall was my best friend and my worst enemy at the same time. Because I could not sleep I went to see my psychopharm, and she prescribed me Ativan to sleep. That worked O.K. for a while. But I really ran into trouble last year. I was up to 65 milligrams, and then during finals went to 80, even 120, milligrams, and I was just locked into this Adderall-Ativan cycle. My doctor seemed scatterbrained. She’d prescribe something but not follow up.

“It’s a complicated dependency. I mean I never took Adderall to get high, never took it in a way that was not academically oriented; and I think there’s a distinction between dependency and addiction, taking something for a purpose or for a rush. But I feel awful. My baseline anxiety level would be most people’s highest anxiety level. The drop of a pin makes me spin around.

“I am living at home. My parents are clueless, and it is hard to discuss with them, although my Mom helps me now. I alternate between ‘on’ and ‘off’ states — I come off the Adderall, take Ativan and sleep for days. I miss appointments. I know I need to go to the appointments, but I wonder if I will be functional enough.

“Adderall suddenly turned its back on me. It enabled me to focus, got me to a higher place academically. But then I could no longer rely on it. I was on my own. And although I have less than three credits to go, I may have to withdraw from school because I have not been able to make it to enough classes.

“Look, I am in a culture that constantly justifies the means to an end. So how do we persuade people not to take it? All you hear is how impossible it will be to get a job when you get out, and you are going more and more into debt, and you think without this I won’t be top of the class. With other drugs you know you are ruining your life. But Adderall manipulates you into thinking you are doing what is needed to have a great life.”