Fda Panel to Vote On Painkiller Restrictions
The Food and Drug Administration has assembled more than 35 experts for a two-day meeting to discuss and vote on ways to prevent overdose with acetaminophen - the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.
Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.
“It can happen to anybody, but its very rare,” said Dr. Lee Simon, an associate professor at Harvard Medical School, who attended Mondays meeting. “Obviously its important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing.”
The drugs that could be pulled off shelves are combination medications, such as Procter & Gambles NyQuil or Novartis Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.
The FDA is not required to follow the advice of its panels, though it usually does. The panel vote is scheduled for Tuesday afternoon.
Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products.
The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.
But the industry group that represents Johnson & Johnson, Advil-maker Wyeth and other companies defended the products Monday, saying they pose a relatively small risk to patients.
Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.
The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Percocet, which combines oxycodone and acetaminophen.
“We believe there is a clear health benefit of over-the-counter combination products containing acetaminophen,” said Linda Suydam, the groups president.
Tylenol-maker Johnson & Johnson also pushed back against a proposal to lower the maximum daily dose of acetaminophen, which is currently 4 grams daily, or eight pills of a medication like Extra Strength Tylenol.
The FDA panel also will vote on a series of other proposals, including changes to the packaging and labeling of medications. Both ideas are designed to prevent patients from taking more than the recommended dose of the drug.
Jobs Travel to Liver Transplant Mecca Shows Organ System Flaws
Memphis, where Jobs got the transplant, is one of several U.S. meccas for liver patients who can afford to travel, doctors said. Flight records show Jobss personal jet flew at least six times this year from California, with one of the longest transplant lists in the U.S., to Memphis, where the wait is shorter.
Jobs, 54, got his transplant in part because regions can keep donated organs on a local list — even when there may be sicker patients not far away. His experience spotlights organ allocation practices that have been under fire for decades and will be discussed at a national public meeting the United Network for Organ Sharing in Richmond, Virginia, plans for later this year, doctors said.
“You could call it gaming the system, that may be true,” John Fung, chairman of transplant surgery at the Cleveland Clinic in Cleveland, said in a telephone interview. “But until we tackle the problem of what makes the system unfair, we cant criticize people who are trying to help themselves.”
Shorter Waits
About 17,000 Americans were on liver transplant waiting lists in 2008, and about 6,000 received them, according to the Scientific Registry of Transplant Recipients, a national database of transplant statistics based in Ann Arbor, Michigan. Patients go to transplant centers in Memphis, as well as in Jacksonville, Florida, because the wait is shorter than other parts of the U.S., said Elizabeth Pomfret, chairman of the department of transplantation at the Lahey Clinic Medical Center in Burlington, Massachusetts.
Memphis is part of Region 11 of the United Network for Organ Sharing, which administers the U.S. organ waiting list and allocation system. As of June 30, 2008, there were 4,120 patients on the list for livers in Region 5, which includes California, compared with 1,084 patients listed in Region 11, according to the registry of transplant recipients.
On the same date, there were 594 patients on the list at Stanford University Medical Center, 14 miles from Apple headquarters, compared with 98 at Methodist University Hospital in Memphis, where Jobs had his surgery.
Jobs received a liver transplant about two months ago, according to a person familiar with the matter. The median waiting time for a liver in Tennessee in 2008 was 135 days, according to the organ-sharing network. The organization hasnt been able to make the same waiting-time calculation for California since 1996 because less than half those waiting got tranpslants.
MELD Scores
Patients in the networks Region 11 receive livers before their health has deteriorated as much as in other districts, such as Californias Region 5, according to the registry of transplant recipients. The organ-sharing network divides the U.S. into 11 regions.
Under the organ-sharing networks rules, most livers are allocated locally using a system called model for end-stage liver disease, or MELD, that assigns scores to liver health and function. Patients with higher scores on the scale of 6 to 40 gain priority for receiving a liver.
Steve Dowling, a spokesman for Cupertino, California-based Apple, declined to comment on how Jobs qualified for a liver transplant, except to say, “Steve continues to look forward to returning to Apple at the end of June.” Jobs didnt respond to an e-mail seeking comment.
Geographic Divisions
Apple rose $2.58 to $142.44 on June 26 in Nasdaq Stock Market trading. The shares have gained 67 percent this year.
In Memphis, 8 percent of the waiting list patients progressed to a score higher than 30 before getting a transplant. In California, 25 percent of transplant recipients topped 30. The national average for transplant recipients above that score is 14.8 percent, according to the registry.
The geographic divisions mean a patient with just months to live can be denied a liver while a healthier person a few miles away gets a transplant because of lower demand in that area, said Russell Wiesner, a medical professor at the Mayo Clinic in Rochester, Minnesota, and former president of the United Network for Organ Sharing.
Some surgeons in low-demand areas back the system because it allows them to perform operations that cost about $350,000, including extensive post-surgical care, Wiesner said.
Organ System Criticism
Study Finds Surprising Number Of Teens Think Theyll Die Young, Leading to Behavior
The study, based on a survey of more than 20,000 kids, challenges conventional wisdom that says teens engage in risky behavior because they think theyre invulnerable to harm. Instead, a sizable number of teens may take chances “because they feel hopeless and figure that not much is at stake,” said study author Dr. Iris Borowsky, a researcher at the University of Minnesota.
That behavior threatens to turn their fatalism into a self-fulfilling prophecy. Over seven years, kids who thought they would die early were seven time more likely than optimistic kids to be subsequently diagnosed with AIDS. They also were more likely to attempt suicide and get in fights resulting in serious injuries.
Borowsky said the magnitude of kids with a negative outlook was eye-opening.
Adolescence is “a time of great opportunity and for such a large minority of youth to feel like they dont have a long life ahead of them was surprising,” she said.
The study suggests a new way doctors could detect kids likely to engage in unsafe behavior and potentially help prevent it, said Dr. Jonathan Klein, a University of Rochester adolescent health expert who was not involved in the research.
“Asking about this sense of fatalism is probably a pretty important component of one of the ways we can figure out who those kids at greater risk are,” he said.
The study appears in the July issue of Pediatrics, released Monday.
Scientists once widely believed that teenagers take risks because they underestimate bad consequences and figure “it cant happen to me,” the study authors say. The new research bolsters evidence refuting that thinking.
Cornell University professor Valerie Reyna said the new study presents “an even stronger case against the invulnerability idea.”
“Its extremely important to talk about how perception of risk influences risk-taking behavior,” said Reyna, who has done similar research.
Fatalistic kids werent more likely than others to die during the seven-year study; there were relatively few deaths, 94 out of more than 20,000 teens.
The researchers analyzed data from a nationally representative survey of kids in grades 7 to 12 who were interviewed three times between 1995 and 2002. Of 20,594 teens interviewed in the first round, 14.7 percent said they thought they had a good chance of dying before age 35. Subsequent interviews found these fatalistic kids engaged in more risky behavior than more optimistic kids.
Native Americans, blacks and low-income teens - kids who are disproportionately exposed to violence and hardship - were much more likely than whites to believe theyd die young.
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On the Net:
American Academy of Pediatrics: http://www.aap.org
Centers for Disease Control and Prevention: http://www.cdc.gov
Smell-loss Drug Escaped Fda Critique Below Homeopathic Label
Zicams homeopathic label allowed it to be marketed for a decade without a review for safety or effectiveness by the U.S. Food and Drug Administration, until its recall on June 16. Doctor and consumer reports to the FDA and Zicams maker, Matrixx International Inc., showed the Zicam nasal sprays and swabs may have caused more than 900 people to lose their sense of smell, U.S. regulators said June 16.
Homeopathic products — over-the-counter remedies that use plant, mineral or animal derivatives — dont need marketing clearance from the FDA under U.S. rules. David Schardt, of the Washington-based Center for Science in the Public Interest says Zicams recall and mainstream use highlight a need for more oversight of homeopathic products, a $200 million market, according to the American Association of Homeopathic Pharmacists.
“Homeopathic products used to be this small cult and this backwater type of thing,” said Schardt, a senior nutritionist at the center. “That has changed and they are now becoming more and more common and distributed in an entirely different way. It has become a can of worms.”
Matrixx didnt alert U.S. regulators to about 800 reports it received from Zicam users who said they lost their sense of smell. The FDA found the reports only after an inspection in May. Zicams main ingredient is zinc, which since the 1930s has been linked to loss of smell when applied inside the nose. A group overseeing homeopathic drugs says thats an improper use.
Sold at Wal-Mart
Zicam became a household name helped by television, radio and print advertising campaigns, with Matrixx spending $24.4 million last year, according to data from The Nielsen Company in New York. Major retailers such as Wal-Mart Stores Inc., Target Corp., Rite Aid Corp. and CVS Caremark Corp. sold Zicam.
The recalled Zicam nasal sprays and swabs, which sold for about $11 a box, had $44 million in sales last year, according to Matrixx. The entire line of 19 Zicam products, including liquid medicines and chewables, generated $111 million in revenue for the company in the year ending March 31.
McDaniel, 50, who works for a real estate developer near Columbus, Ohio, said she used Zicam last year at the maximum daily dose for about a week to treat a stuffy nose. When her sinuses cleared, she noticed her sense of smell was mostly gone. A bowl of chili now smelled like onion and she couldnt tell whether a gas stove was left on or detect burning odors.
“I used to be able to smell wood burning down the road,” said McDaniel in a telephone interview. “I miss that, it is something you dont realize youll miss until it is gone.”
Standing by Zicam
Matrixx, of Scottsdale, Arizona, stands by the safety of its products and plans to meet with the FDA to try to get the agency to reverse its decision, said William J. Hemelt, Matrixxs acting president, chief financial officer and chief operating officer, in a June 24 interview. He said he didnt believe the company had to turn over the 800 consumer complaints it had received.
“Im going to do everything I can and so will the rest of the employees to see that we can build a business around the 16 products we still have on the market,” said Hemelt. “But what we would like to do is get the FDA to reverse its decision.”
Active Ingredient
Zicams active ingredient, zinc, is believed to shorten the duration of a cold by preventing the viruses from attaching to cells in the nasal passages called ICAM-1 receptors, according to a study in the Journal of the American Pharmacists Association by researchers at Case Western Reserve University in Cleveland. Many studies have tested zinc in colds, and results are conflicting, according to a search of the National Institutes of Healths archive of published medical research.
Some research suggests zinc may be toxic to nerve receptors in the nose that are involved in smell, said Charles E. Lee, a medical officer with the FDAs office of compliance, in a June 16 conference call with reporters. More than a dozen studies from an NIH database show that zinc causes loss of smell in animals.
70-Year-Old Suspicions
Scientists have suspected the mineral could cause loss of smell in people since the 1930s when a zinc-based nasal spray was tested to prevent the spread of polio, Lee said. A 1938 study published in Journal of Pediatrics found that some patients who got the polio treatment lost their sense of smell.
More recently, a 2004 study by University of Colorado researchers in the Journal of Rhinology concluded that zinc gluconate “raises significant concern regarding its safety for intranasal application in humans.”
Sebelius Sees Room For U.s. Health Cooperative, Few Gop Votes
The former Kansas governor, 61, said in an e-mailed statement yesterday that the Obama administration “remains open to all serious ideas” that give all Americans “real health- care choice.” Those also include government-backed insurance based on Medicare, the program for the elderly and disabled.
Separately, she told Bloomberg News in an interview she expects both houses of Congress to approve overhaul legislation and send a final measure to the president by October. The Senate bill will have enough Republican votes to keep passage from being strictly along party lines, she said. President Barack Obama is seeking broad bipartisan support.
“I think there are five to 10 who may well be there for the final vote,” she said on Bloomberg Televisions “Political Capital With Al Hunt,” airing this weekend. The Senate has 40 GOP members, and legislation expanding benefits for children won by a vote of 66 to 32 in January. “Im encouraged by the number of people who say we need to do something,” Sebelius said.
An insurance cooperative owned by its customers is one option being weighed by the Senate Finance Committee. Obama stands by the need for a competitor to private insurance companies, she said. On June 2, in a letter to the Senate Health and Finance committees, Obama said he “strongly” supports giving Americans the choice of government-backed insurance to compete with private coverage.
Designing a Plan
You could theoretically design a co-op plan that had the same attributes as a public plan,” Sebelius said in a meeting with Bloomberg editors and reporters. In that meeting, she also said the co-op would have to be national in scope and rejected the idea of state-based insurance cooperatives. Her e-mail backed off from the comment on state-based cooperatives.
“The situation on health care is changing hourly,” she said in the e-mail. She said that in her earlier interview comments she was “reacting to information about state co-ops which appears to be changing since there are no final numbers yet.”
“The administration remains open to all serious ideas including national and state co-ops as well, public plans modeled on Medicare, as long as such plans achieve the presidents goals of reducing cost, improving quality and giving Americans real health-care choice,” Sebelius said.
Overall Goals
Democratic lawmakers are trying to create a plan to cover the 46 million people who lack insurance while curbing the growth in health-care costs, which this year are projected by U.S. government economists to consume 18 percent of the gross domestic product. Obama said in his June 2 letter that government competition will keep U.S. health-insurance companies “honest.” Sebelius rejected the argument voiced this month by Senate Republican Leader Mitch McConnell of Kentucky that a government plan would lead to a “monopoly” on coverage.
Senator Kent Conrad, a North Dakota Democrat and chairman of the Budget Committee, proposed nonprofit cooperatives as a potential compromise for Republicans who oppose Obamas call for a government-run health plan. The co-op envisioned by Conrad would be governed by a national board and split into regional or state affiliates, said his spokesman, Chris Thorne, in an interview. The affiliates would be able to form partnerships to increase their bargaining power, he said.
Conrad said he was “encouraged” by the comments from Sebelius.
“There are a number of Republicans who have expressed interest in co-ops,” he said yesterday by telephone.
While negotiations in Congress are continuing, Conrad said, he envisions state affiliates negotiating with local doctors and hospitals while the national board would bargain with drugmakers and other medical providers, using its wider scope to win lower prices for its members.
Sebelius, a former state insurance commissioner, said she expects the final bill will include some kind of nonprofit entity to compete with private insurers, whether a co-op or government-run program.
“I really dont think that theres a likelihood that private insurers will be driven out of business,” she said. “What will happen is competition. And they may not make as much money as theyre making currently.”
Lines in the Sand
Obama has no “lines in the sand,” Sebelius said, though the Democratic administration remains worried that a Senate proposal to penalize employers whose workers end up on Medicaid, the government-run plan for the poor, would discourage hiring of low-income Americans, she said.
Children With Leukemia Helped By Dropping Risky Brain Radiation
Their five-year survival rate was 93.5 percent in the research published online today in the New England Journal of Medicine, compared with an average 87.5 percent rate among similar U.S. children with radiation from 2000 to 2004, lead author Ching-Hon Pui said. Tailoring chemotherapy treatment enabled doctors to avoid radiation therapy to the head, a strategy that may prevent long-term side effects including second cancers and hormone imbalances, the researchers said.
Acute lymphoblastic leukemia is the most common cancer in children younger than 15 years old, according to the National Cancer Institute. About 100 children each year are diagnosed initially with this form of leukemia in the brain and spine, and hundreds of others with a high-risk form of the disease receive radiation to their brains preventatively, he said.
“We can eliminate a very toxic component of treatment and not only preserve the good outcome from prior trials, but improve upon it,” said study author William Evans, chief executive officer of St. Jude Childrens Research Hospital in Memphis, Tennessee, in a June 23 telephone interview. “We have better outcomes and less toxicity and that is very encouraging.”
Individual Care
Researchers studied 498 patients treated for acute lymphoblastic leukemia from 2000 to 2007 at St. Jude and at Cook Childrens Medical Center in Fort Worth, Texas. Doctors then modified doses of chemotherapy drugs based on each individual child to avoid over-treating or under-treating. They also identified which patients needed more drugs or intensified treatments such as bone marrow transplants.
The results showed the overall five-year survival rate was 93.5 percent for the 498 children.
“This is the first study that pushes the cure rate to 90 percent — the best ever,” said Pui, chair of the oncology department at St. Jude, in an e-mail. “This is the first study that proves that with effective chemotherapy, cranial irradiation can be totally omitted” in children with acute lymphoblastic leukemia.
Patients are considered cured of leukemia if they survive without relapse for 10 years or more, he said.
To determine if cranial radiation would have made a difference in relapse of the disease in the brain and spine, they compared the outcomes of 71 patients whose leukemia wouldve qualified them for radiation with those of 56 patients who received radiation in the past. The 71 patients fared “significantly better” with higher survival rates and better quality of life than the 56 patients, the researchers found.
Cranial Radiation
Cranial radiation was introduced by St. Jude doctors in the mid-1960s. It boosted the cure rate for acute lymphoblastic leukemia to 50 percent from 4 percent, Pui said in a statement. Eventually radiation was limited to the highest-risk patients because of its side effects. About 20 percent of the 3,400 cases of childhood acute lymphoblastic leukemia diagnosed in the U.S. each year are treated with radiation, he said.
A study by St. Jude researchers in the July 1 issue of the Journal of the National Cancer Institute found that people who survived childhood brain cancer were more likely than healthy siblings to suffer from neurological difficulties including impaired attention or problems with organization and regulating their emotions, depending on their type of tumor.
The research linked some of the neurocognitive problems to radiation treatment for their cancer.
Lingering Pandemic Virus Brings Summer Flu to England, Wales
There were 11.2 cases of influenza-like illnesses per 100,000 people in the week ended June 21, the London-based Royal College of General Practitioners said in a weekly report on its Web site yesterday. That compares with 6.5 per 100,000 the previous week.
The incidence of flu was highest in people aged 15 to 44 years and in the central region, the college said. In England and Wales, confirmed cases of the new H1N1 virus, known as swine flu, more than doubled to 2,550 yesterday from a week earlier, the Health Protection Agency said.
“A pandemic virus is a novel virus and one to which most people dont have immunity,” Angus Nicoll, head of the influenza program at the European Centre for Disease Prevention and Control in Stockholm, told reporters yesterday. “That means it is very easy for it to circulate, and it is obviously capable of doing that outside the influenza season.”
Influenza is more common in winter because virus particles persist longer in the air during colder, drier weather. The bug is also transmitted more easily in winter because people tend to huddle together indoors.
The World Health Organization said the pandemic virus is reported to have infected 55,867 people in more than 90 countries, killing 238 of them, since its discovery in Mexico and the U.S. in April.
Quicker Spread
Transmission of the bug, which causes little more than a fever and cough in most cases, is likely to accelerate as the flu season begins in the Southern Hemisphere and again when it returns in the Northern Hemisphere, the World Bank said in a report this week. As many as 1.5 million people die in a normal flu season worldwide, and even a mild new flu might add another 1.4 million deaths, the Washington-based lender said.
In England and Wales, the incidence of flu-like illness last week was above the 10-year average for summer, according to the colleges report. Flu typically peaks in these countries in January, and the rate reported by the colleges flu surveillance network, comprising 435 doctors, was the highest in six weeks.
Higher rates dont accord “with any substantial spread of influenza-like illness,” the college said, adding that rates of 30 to 100 per 100,000 people are usual when seasonal influenza viruses are circulating. Rates exceeding 100 represent above- average influenza activity and are “exceptional” when above 200, it said.
Firewalkers Faulty Gene May Shake Up Market For Painkillers
Geoffrey Woods, a geneticist at the University of Cambridge, was studying families that had intermarried in northern Pakistan when he heard about the boy, who felt no pangs as he performed stunts on the street. Research on other children in the area uncovered a faulty gene among them. They all were healthy and had a normal sense of touch.
Woodss findings, published in the journal Nature, spurred Pfizer Inc., AstraZeneca Plc and Merck & Co. to study drugs that work like the gene mutations by interrupting a channel that transmits pain signals. While that research is at an early stage, Newron Pharmaceuticals SpA of Italy has a product in human tests. Those studies may lead to treatments that have fewer side effects than many painkillers, which London-based Datamonitor Plc says generated $24.3 billion in sales in 2007.
“Its the ultimate target,” said John Wood, a professor of molecular neurobiology at University College London who co- wrote the Nature article with Woods in December 2006. “The people that dont have the channel are not ill, they have no problems, so if you find a drug that blocks it, they should be pain-free and also free of side effects.”
Pain is one of the bodys natural defenses, intended to compel a retreat from danger or force rest to allow healing.
Drawbacks
While a variety of painkillers exist, none is perfect. Non- steroidal anti-inflammatory drugs, a group that includes aspirin and ibuprofen, can irritate the stomach. Merck withdrew its Vioxx medicine from the market in 2004 because of a potential link to heart attacks and strokes. Opioids, which are derived from the opium poppy and include morphine, are among the most- abused prescription medicines.
The sodium 1.7, or Nav1.7, channel is a protein found in nerve cells. When a cell receives a stimulus, the tube-like channel opens and sodium ions flow into it, activating the nerves. They send an electrical signal to the spinal cord and the brain, which interprets it as pain.
In people with the gene mutations found in the Pakistani children, the sodium channel is incomplete, interrupting the chemical cascade that leads to pain sensation.
Early research on the channel, first identified in the mid- 1990s, had found gene mutations that heightened the sense of pain. Woodss work, funded by Pfizer, the University of Cambridge and the London-based Wellcome Trust, was the first to establish a link between loss of the channel and an absence of distress.
Peripheral Neurons
“Geoffs paper demonstrated that you can basically live without having Nav1.7, and for a drug company that is the most important finding they can have in defining a drug target,” said Sulayman Dib-Hajj, a neurology researcher at the Yale School of Medicine in New Haven, Connecticut, who was involved in early studies of the channel.
“The mere fact that the Nav1.7 sodium channel is primarily expressed in peripheral neurons means youre not going to worry about an effect on the heart or on the brain or on the spinal cord,” Dib-Hajj said. “And thats why it has become a very important target in the quest for new painkillers.”
Pfizer, based in New York, is developing compounds that block the sodium 1.7 channel, though they have yet to be tested in people. The channel is “high profile for us and we believe were making great progress,” said Gillian Burgess, head of the pain group at Pfizer.
Early Development
AstraZeneca, based in London, is also in early development of such compounds, said Neil McCrae, a company spokesman.
Merck of Whitehouse Station, New Jersey, aims to use the channel to treat different types of pain, said Stefanie Kane, senior director in Mercks pain research unit.
“We have initially identified compounds that in preclinical analysis are at least 100 times more potent than currently available drugs as inhibitors of this target,” Kane said in an e-mailed response to questions. She declined to say how advanced development is.
From 80 percent to 90 percent of experimental drugs fail to get through preclinical tests, the phase that occurs before human trials, according to the U.S. National Institutes of Health, in Bethesda, Maryland. It takes an average of eight years to get a drug through human testing and regulatory review, according to the Tufts Center for the Study of Drug Development, in Boston.
Un Reports Decline In Cultivation Of Some Drugs
Yet about 28 million people are heavy drug users likely to be physically or psychologically dependent on drugs, the report said.
Opium cultivation in Afghanistan, where 93 percent of the worlds opium is grown, dropped by 19 percent last year, the Vienna-based U.N. Office on Drugs and Crime reported Wednesday.
And there was a 28 percent decline - the report called it staggering - in production of cocaine in Colombia, which produces half the worlds cocaine, the report said.
Global production of coca hit a five-year low at 845 tons despite some increased cultivation in Peru and Bolivia.
Marijuana, or cannabis, remained the most widely used and cultivated drug in the world and it is more harmful than commonly believed, the report said.
As a result, the number of people seeking treatment is rising. Roughly 167 million people use marijuana at least occasionally.
Opiates and cocaine have about 18 million users a year each. And it is estimated that 11 million to 21 million people worldwide inject drugs.
Among synthetic drugs, 16 million to 50 million took amphetamines and related drugs and about 27 million took Ecstasy, the report said.
The estimated cost of the worlds illicit drug market is about $320 billion, said Antonio Maria Costa, executive director of the U.N. office.
“This makes drugs one of the most valuable commodities in the world,” he said in a telephone interview. “The proceeds of drug-related crime are of macro-economic proportions.”
In a statement issued with the report, he called for treating drug use as an illness. “People who take drugs need medical help, not criminal retribution,” Costa said. He appealed for universal access to drug treatment.
Among the striking findings in the report is the growth of what was once a cottage industry of industrial-sized laboratories in southeast Asia, particularly in the greater Mekong region of Vietnam, producing massive quantities of methamphetamine tablets and crystal meth.
“We are asking for increased investment in law enforcement and crime control,” Costa said. “Organized crime related to drugs has become a threat to a number of countries.”
The aim is to get governments worldwide to invest in public health and public security, he said. No specific amount was suggested.
Drug money perverts weak economies and corrupts weak officials, he said. And drugs are a source of revenue for insurgents, like the Taliban and FARC, the largest guerrilla group in Colombia, that control regions of illicit cultivation, he said.
Michele M. Leonhart, the U.S. acting drug enforcement administrator, said the report showed that “we have realized unprecedented victory in disrupting and dismantling criminal cartels worldwide and impacting the illegal drug market.”
“The dangerous link between drugs and crime is irrefutable, and we continue to face challenges,” she said in a statement.
Aura Migraines In Mid-life Women Linked to Brain Adjustments Later
The women were almost twice as likely to show small areas called lesions in the brains cerebellum, which controls motor activities and balance, than women who didnt have headaches, according to research published today in the Journal of the American Medical Association. Men in the study who had aura migraines in mid-life didnt show a statistically significant increase in cerebellum brain lesions compared with men who didnt get headaches, the research found.
Scientists said there is no evidence that the so-called “silent” lesions, which can be as small as a pinpoint and are common in many older people, affect mental or motor function as adults age. Still, the study of more than 4,600 men and women in Iceland is the largest prospective research to show that migraines occurring in midlife may affect the brain years later, said Lenore Launer, chief of the neuroepidemiology section of the Laboratory of Epidemiology, Demography and Biometry at the National Institute on Aging in Bethesda, Maryland.
“The importance of this study is it suggests that migraines are not just an episodic condition,” Launer said in a telephone interview. “It may lead to long-term changes in the brain. At this point theres no real clinical message for people with migraines. This really needs to be investigated further.”
Earlier Findings
One previous study of 435 younger people in the Netherlands found a similar association between migraines with aura and brain lesions, Launer said. Researchers do not know yet whether such brain lesions harm health, though they are also linked to cardiovascular risk factors, including hypertension, Launer said.
Migraines may cause intense head pain, and auras include such symptoms as dizziness, flashing lights, blind spots, and zigzag lines that advance the headache by a 10 minutes to 30 minutes, according to the National Womens Health Information Center.
This type of headache afflicts nearly 30 million or 11 percent of Americans and may cause sensitivity to light, nausea and vomiting. About 20 percent of migraines also include aura- related symptoms, according to the U.S. Department of Health and Human Services. Women are three to four times as likely as men to get migraines, most commonly between the ages of 20 and 45.
MRI Scans
In the new research, Launer and her colleagues looked at men and women who were originally part of a heart-disease study in Iceland that began in 1967. Between 1972 and 1986, when participants were an average age of 50.9, they were asked about the frequency and type of headaches they experienced. Doctors performed magnetic resonance imaging scans on two areas of the brain between 2002 and 2006 when the subjects average age was 76.2 years.
The men and women in the study were divided into four groups: Those who had a migraine with aura, migraine headaches without aura, non-migraine headaches once or more each month and no headaches.
In the study, 17 percent of women had migraine headaches, including 10.3 percent who experienced auras, while only 5.7 percent of the men had migraines and 4.2 percent had auras as well.
Previous Studies
Migraines have been associated with stroke and heart disease in previous studies. A 2006 study in the Journal of the American Medical Association found that middle-aged women who have migraines with aura are at a higher risk for heart attack, stroke, chest pain and death from heart disease than women who dont have migraines.
A September 2008 study in the journal Neurology by researchers in Austria and Italy also found that migraine sufferers may have a higher risk of developing deadly blood clots.
Todays study was funded by the National Institutes of Health, the Icelandic Heart Association and the Icelandic Parliament.
Caution
The findings “should be interpreted with caution,” wrote doctors Tobias Kurth, with the University Pierre et Marie Curie in Paris and Harvard University in Boston, and Christophe Tzourio with the University Pierre et Marie Curie, in an accompanying editorial in the journal.
“It is premature to conclude that migraine has hazardous effects on the brain,” they wrote. “Brain scans among patients with migraine should not be initiated to detect silent brain lesions but to rule out rare secondary forms or migraine among those patients with atypical migraine forms or migraine courses.”