HealthLawProf Blog

FDA Expands Use of Cervical Cancer Vaccine

The Washington Post reports that federal health officials have approved expanding the use of Gardasil to protect against other cancers.  The Washington Post writes,

The cervical cancer vaccine Gardasil also works to prevent cancers of the vagina and vulva, federal health officials said Friday, as they approved expanding its use to protect against those diseases as well.

The Food and Drug Administration first approved Gardasil in 2006 for the prevention of cervical cancer in girls and women ages 9 to 26. The vaccine works by protecting against strains of the human papillomavirus, or HPV, that cause about 70 percent of cervical cancers. The HPV virus, transmitted by sexual contact, causes genital warts that sometimes develop into cancer.

"There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same virus for which it also helps protect against cervical cancer," said Dr. Jesse Goodman, director of the FDA center that oversees vaccines.

Some 15,000 women were followed for about two years as part of a clinical study. One group had been vaccinated with Gardasil, while the other had not. In the group that did not get the vaccine, 10 women developed precancerous vulvar lesions, and nine developed similar vaginal lesions because of HPV infection. No women in the Gardasil group developed such lesions.

The government estimates that there are 3,460 new cases of vulvar cancer and 2,210 new cases of vaginal cancer each year. Cervical cancer is more common, with an estimated 11,070 new cases each year and nearly 3,900 deaths.

Gardasil is manufactured by Merck & Co., Inc. The vaccine, given in three doses over a six-month period, costs about $375.

Youths' Drug of Choice: Prescription

The Los Angeles Times reports on the federal government's National Survey, which finds that among teens and young adults 12 to 25, one-third of those who use illicit drugs say they recently have abused prescription drugs.  After years of declining American use of street drugs, prescription medications have begun moving front and center as the nation's drug of choice.  Melissa Healy writes,

It's been four decades since the dawning of the Age of Aquarius, but aging baby boomers haven't stopped turning on. The federal government's National Survey on Drug Use and Health, released earlier this month, finds that as boomers move into their 50s in large numbers, drug use among older adults in the United States has hit its highest point ever.

In the government's latest report -- reflecting drug use in 2007 -- 1 in 20 Americans ages 50 to 59 told researchers they had taken illicit drugs in the last month.

More than half of these older users still like their street drugs, including marijuana and cocaine. But as they contend with the aches and pains of aging, boomer drug users are adding prescription drug use to their mix of vices, according to the report from the Substance Abuse and Mental Health Services Administration.

A new generation of drug users, by contrast, isn't waiting to reach middle age to add prescription drugs to its portfolio of abuse, the report says. Among teens and young adults 12 to 25, one-third of those who use illicit drugs say they recently have abused prescription drugs -- including painkillers, tranquilizers and stimulants. Among kids 12 to 17, 3.3% had abused prescription psychotherapeutic drugs in the last month. Among 17- to 25-year-olds, 6% had abused prescription drugs in the last month.

Those generational trends are driving a significant change on the landscape of American drug abuse. After years of declining American use of street drugs -- cocaine, hallucinogens and even marijuana -- prescription medications have begun moving front and center as the nation's drug of choice.

The result, according to the latest federal drug-use survey: Last year, Americans who began abusing prescription drugs outnumbered those who took up smoking marijuana -- traditionally the nation's "gateway drug."

Dr. Nora Volkow, director of the National Institutes of Health's National Institute on Drug Abuse, says the report underscores a "paradigm shift" in drug abuse -- and hence, in its likely treatment. Though addiction to prescription drugs is not new, the current generation of teens and young adults has grown up around unprecedented widespread medical use of prescription drugs, Volkow says, and is inclined to view them as safe because they are prescribed by doctors.

"That comfort level," Volkow says, "facilitates the abuse" of these medications. Add to that the high from such drugs as narcotic pain relievers, she adds, and young users are at high risk of becoming addicted.

Reaching for Mom and Dad's pills

Peter S., a 26-year-old recovering addict from New Jersey, says the ubiquity of prescription drugs in American homes is reassuring to kids eager to take a controlled risk or dull the emotional challenges of being a teenager.

"You don't have to go to the drug dealer, or even leave the house," says Peter, who spoke on condition that his last name not be used. "You can just go upstairs to Mom's medicine chest and boom! You're locked and loaded. . . . People feel like, 'Wow, how bad could it be? It came from our doctor. And I'm not doing street drugs -- cocaine or mushrooms. I'm doing what Mom has in her medicine cabinet.' "

Many adults, whose images of drug abuse may be dominated by street drugs, "just don't realize," Peter says, that the leftover pain pills from Mom's back spasm or the unused anti-anxiety pills prescribed for Dad during a rough patch at work may furnish a kid's first chance to experiment with drugs. Parents "take one and feel better and put the rest up there in the medicine chest," Peter says. "They just don't know."

Volkow adds that a shift toward prescription drug abuse also may make it harder for the new generation's drug users to "age out" of their habit, as many baby boomers -- though clearly not all -- have done. Users of street drugs, Volkow says, frequently quit as they find that unpleasant side effects become more pronounced with age and prolonged use.

Users of prescription medications, by contrast, tend to build tolerance to the effects over time, prompting them in some cases to use more, not less, and more often, Volkow says.

Researchers with the federal substance abuse agency said they remain uncertain if baby-boomer drug users had continued to take illicit substances through mid-adulthood or, rather, returned to a youthful habit as they aged. John P. Walters, the nation's drug czar, expressed surprise that although young Americans are turning away from cocaine and methamphetamine, use of such street drugs continues among their elders.

Jim Steinhagen, executive director of the Hazelden Center for Youth and Families in suburban St. Paul, Minn., says that for young people, experimentation with prescription drugs only seems safer than their parents' drug forays.

"We're seeing kids coming to the treatment center more acutely addicted than we ever have before, so the degree of detox we need is more extensive and takes a longer period of time," says Steinhagen, a 32-year practitioner of addiction treatment. "The kind of substance use that goes on today is like extreme sports for this generation -- quicker, faster, a more dangerous thrill-seeking experience."

Easy access

Studies suggest that for the current generation, as for past drug users, efforts to thwart distribution of some drugs shift thrill-seekers to others that are easier to score -- a dynamic that helps explain the move toward prescription drugs.

The recent government report comes on the heels of a study by the National Center on Addiction and Substance Abuse at Columbia University, showing that 19% of 12- to 17-year-olds believed prescription drugs were easier to lay hands on than cigarettes, beer and street drugs. The new report also underscores the ease with which abusers of prescription drugs can get these controlled substances. More than half who reported they had recently taken prescription drugs for nonmedical uses said they got the drugs from a friend or relative for free, and almost 20% got them from a physician. About 1 in 10 who took prescription pain relievers said they bought or stole them from a friend or relative.

Drug enforcement officials have long noted that teens and young adults widely trade, sell and steal stimulant medications, heavily prescribed among student populations to treat symptoms of attention deficit hyperactivity disorder.

Fewer than 5% told interviewers that they had had to resort to a drug-dealing stranger to acquire prescription drugs, or even to log onto an Internet site selling prescription drugs.

Peter S. says his initiation to prescription drugs came from the medicine chests of his -- and a friend's -- parents.

"I had found Vicodin and Percocet and had heard about them and Xanax and Valium -- the benzodiazepams -- and took a couple," Peter says. "I reached up in that medicine chest and took a couple and thought, 'Oh this is fun.' It made me feel floaty . . . . It was fun in the beginning."

The government report, which also tallies Americans' mental health status, makes clear that illicit drug use is frequently a form of self-medication. It found that among 12- to 17-year-olds, roughly 2 million had experienced a major depressive episode in 2007 -- about 8.2% of that age group's population. Illicit drug use was roughly twice as high -- 35% -- among those youths who had experienced depression than among those who had not.

FDA Issues Warning on Imported Chinese Baby Formula

The Washington Post reports that FDA officials are urging US consumers to avoid all infant formula from China, after several brands sold in that country came under suspicion of being contaminated with melamine, a chemical used in plastics.  Ricardo Alonso-Zaldivar writes,

Tainted infant formula from China may be on sale at ethnic groceries in this country, even though it is not approved for importation, federal officials warned on Thursday.

However, the Food and Drug Administration stressed that the domestic supply of infant formula is safe.

FDA officials are urging U.S. consumers to avoid all infant formula from China, after several brands sold in that country came under suspicion of being contaminated with melamine, a chemical used in plastics. Officials said there have been reports from China of babies developing kidney stones as a result. There have been no reports of illnesses in the U.S.

"We're concerned that there may be some infant formula that may have gotten into the United States illegally and may be on the ethnic market," said Janice Oliver, deputy director of the FDA's food safety program. "No infant formula from China should be entering the United States, but in the past we have found it on at least one occasion."

After hearing of the latest food safety scandal in China, the FDA checked with formula manufacturers who have approval to market here. But none receive formula or ingredients from China. Formula manufacturers get close scrutiny from the government. They are required to register with the FDA and comply with specific nutritional standards.

"We want to assure the American public there is no threat of contamination to the domestic supply," said Oliver.

But officials are concerned that some Chinese formula may be on sale at Asian groceries, particularly in places like New York, San Francisco, Los Angeles and Boston that have large numbers of Chinese immigrants. The FDA is working with state officials to spread the word in immigrant communities to remove any Chinese formula from store shelves and to warn consumers not to feed it to their children.

"We want people in those communities, if they are in the habit of buying those Chinese products, not to use them," said FDA spokeswoman Judy Leon. "We are doing this to be proactive."

Melamine is the same chemical involved in a massive pet food recall last year. It is not supposed to be added to any food ingredients, but unscrupulous suppliers in China sometimes mix it in to make foodstuffs appear to be high in protein. Melamine is nitrogen rich, and standard tests for protein in bulk food ingredients measure levels of nitrogen.

Health Net to Reinstate 926 Dropped Policyholders in California

The Los Angeles Times reports that under an agreement with the state, Health Net Inc. will pay $3.6 million in penalties and as much as $14 million in medical reimbursements it had earlier denied. It does not admit wrongdoing.  Lisa Girion and Marc Lifsher writes,

In a continuing state crackdown on health insurers, Health Net Inc. of Woodland Hills has agreed to offer new coverage -- no questions asked -- to 926 people whose policies it canceled after they got sick.

One of the state's largest insurers, Health Net signed a first-of-its-kind agreement with the California Department of Insurance, agreeing to pay $3.6 million in penalties, plus as much as about $14 million in reimbursements for medical charges that the insurer had refused to pay. The company, however, did not admit to any wrongdoing.

This was the first such action by the Department of Insurance but only the most recent in a string of similar insurer fines and penalties imposed mainly by the state Department of Managed Health Care. The two agencies together regulate health insurance in California.

"These practices damage the trust of consumers who pay their premiums and believe they are protected," said Insurance Commissioner Steve Poizner. "Moreover, stripping away someone's coverage can have devastating medical, emotional and financial effects."

Poizner's agency said it would continue to oversee Health Net's compliance at the same time it investigates rescission activities at other insurance companies.

The Health Net agreement came under immediate fire from critics, who called it a partial solution at best. They suggested that the deal announced Thursday might short-circuit plans to sue the insurer and eliminate the potential for more lucrative court damage awards.

Health Net has been zapped by fines, penalties and court judgments in the last year. Most prominent was a $9.4-million judgment awarded in February to Patsy Bates, a Gardena hair salon owner. Her coverage was dropped by Health Net while she was undergoing chemotherapy to treat breast cancer.

The company also was fined $1 million in November for misleading state investigators about bonuses paid to employees based in part on how many policyholders were dropped. In February, Los Angeles City Atty. Rocky Delgadillo sued the company, alleging fraudulent practices, and Health Net is fighting the complaint. And in May, Health Net agreed to reinstate 85 former enrollees and pay a $300,000 administrative fine to the state Department of Managed Health Care.

Health Net Chief Executive Jay Gellert said his company did "not necessarily agree with the California Department of Insurance" on the latest allegations. Nevertheless, he called the settlement an opportunity "to move forward and make sure these affected individuals can obtain coverage."

Gellert said his firm was committed to helping the governor and the Legislature overhaul the healthcare system to provide coverage for all Californians.

Reports by the Los Angeles Times over the last two years helped prompt state and local investigations, lawsuits and legislation dealing with the insurance industry's cancellation and rescission practices.

Critics charge that Health Net and its competitors have long gamed the system in order to dump policyholders who buy coverage for individuals and families. Federal law prohibits canceling policies of people who get coverage as members of an employee group.

The critics contend that the insurers ask detailed and often complicated questions about past conditions on confusing applications designed to elicit mistakes; they then issue coverage without verifying the accuracy of the information on the applications.

Only after a policyholder submits a claim for a serious illness do insurers dig into the medical history, using any purported omission of a symptom or condition as an excuse to drop coverage, critics say.

In its agreement with Poizner, Health Net will pay $3.6 million in fines and work with the Insurance Department to improve its practices and reduce rescissions. An additional penalty of as much as $3.6 million could be levied on Health Net if a follow-up examination finds that it did not correct all deficiencies.

The agreement allows Health Net to avoid being targeted for more enforcement action relating to potential legal violations uncovered by auditors.

The department has yet to release a formal report of its investigation. But officials said investigators found evidence that Health Net failed to follow state laws intended to guarantee that policyholders are treated fairly. The insurer halted rescissions this year after a private arbitration judge in the Bates case called its actions reprehensible.

During that trial, Health Net was forced to disclose documents that showed that the company paid bonuses to an employee based in part on how many policies she rescinded. The insurer in court documents credited rescissions with helping it avoid $35 million in medical claims over six years.

Health Net now has agreed to repay expenses for reasonable, medically necessary care that would have been covered by the policies had they not been canceled. The company values those expenses at more than $14 million.

Health Net's agreement with the Department of Insurance is similar to those that the company and other big insurers struck with the Department of Managed Health Care this year.

In August, California lawmakers passed a bill that would extend protections to individual policyholders by barring insurers from dropping people who make innocent mistakes on their policy applications.

On Thursday a group of rescinded policyholders carried a letter to Gov. Arnold Schwarzenegger's Los Angeles office urging him to sign the bill into law.

New legislation is needed to allow cancellations only in cases in which people intentionally lied on their insurance applications, said Jerry Flanagan, healthcare policy director for Consumer Watchdog, a Santa Monica advocacy group.

Health Net's agreement to reinstate policyholders who had been unfairly dropped is a positive step, said William Shernoff, a Claremont attorney who represents rescinded policyholders in a class-action suit in Los Angeles County Superior Court. But Shernoff fears that the deal could give insurers a way to quietly contact plaintiffs and persuade them to give up their rights to seek damages for economic losses and emotional distress.

"This is woefully inadequate and misleading," he said, "and I think that once it's brought to the attention of the court, it will not be allowed to stand."

Analysis Confirms AIDS Epidemic Hits Men Hard

The Washington Post reports that according to an analysis published on Thursday, AIDS remains largely a disease of gay and bisexual men in the United States, but also disproportionately infects black women.  Maggie Fox writes,

Last month, the U.S. Centers for Disease Control and Prevention reported that more than 56,000 people in the United States become newly infected with the human immunodeficiency virus each year, far more than previous estimates of about 40,000.

Now the CDC has further analyzed those numbers to find the fatal and incurable virus largely infects men who have sex with men, or MSM -- a group that includes gays, bisexuals and men who may have the occasional sexual encounter other men.

"The male-to-male sexual contact transmission category represented 72 percent of new infections among males, including 81 percent of new infections among whites, 63 percent among blacks, and 72 percent among Hispanics," the report said.

Of the new infections in 2006, more than half were among gay and bisexual men, the CDC found. Of these, 46 percent of new infections were among whites, 35 percent among blacks and 19 percent in Hispanics.

But among the overall U.S. population, more blacks are affected -- 46 percent of new infections were among blacks.

The CDC said it needed to redouble prevention efforts, especially in the black community.

"The alarming number of new infections among young black MSM underscores the need to ensure that each new generation has the knowledge and skills to prevent HIV infection beginning early in their lives," the report reads.

Girls and women made up 27 percent of new infections, with high-risk sexual contact with men causing 80 percent of new infections.

"Among females, 61 percent of infections were in blacks, 23 percent were in whites, and 16 percent were in Hispanics," the CDC report reads.

There is no cure for the AIDS virus, which is transmitted in bodily fluids such as blood, semen and breast milk. Around the world, sexual contact is by far the most common mode of transmission although people who use contaminated needles can be infected, and blood transfusions also can cause infection.

"African-Americans make up 12 percent of the total U.S. population, yet represented 45 percent of new HIV infections in the United States in 2006," the CDC wrote.

Globally, 33 million people are infected with HIV and 25 million have died of it. There is no vaccine or cure although drug cocktails can help control the infection.

Few Hospitals Meet Colon Cancer Care Standard

The Washington Post reports that according to a study advising patients to ask about quality of care before surgery, nearly two-thirds of hospitals fail to check colon cancer patients well enough for signs that their tumor is spreading.  Lauren Neergaard writes,

National guidelines say when colon cancer is removed, doctors should check at least 12 lymph nodes for signs of spread. Checking fewer than 12 isn't considered enough to be sure the cancer is contained.

But a study of nearly 1,300 hospitals found that overall, just 38 percent fully comply with the guideline, Northwestern University researchers report Tuesday in the Journal of the National Cancer Institute.

"It's a fairly simple thing we can do to try to improve care for our patients," said lead author Dr. Kyle Bilimoria, of Northwestern and the American College of Surgeons.

Colorectal cancer is the nation's second leading cancer killer, set to claim almost 50,000 lives this year.

Some 148,000 Americans are diagnosed annually. For many, the node check can be crucial. Whether cancer has entered these doorways to the rest of the body is an important factor in long-term survival _ and thus helps doctors decide who gets chemotherapy after surgery and who can skip it.

"Patients who could benefit from additional chemotherapy may not be getting complete treatment and have a higher chance of relapse," said Dr. Durado Brooks of the American Cancer Society, who wasn't involved with the study. "It is something that consumers need to begin asking. ... Frankly, that is most likely to change medical practice."

To check enough nodes, surgeons must remove enough of the fat tissue by the colon where they hide, and pathologists must painstakingly dissect that tissue to find the tiny nodes.

Surgeons frequently tell of getting a pathology report of four clean nodes and asking the pathologist to find more, "and lo and behold, one of those additional nodes turns out to be positive," Bilimoria said.

Previous studies have estimated that up to half of colon cancer patients have at least 12 nodes checked. Bilimoria's study is the first look at which hospitals are most likely to follow the guideline _ and will report the rates directly to each institution. His team examined a national cancer database for records showing which hospitals checked 12 or more lymph nodes in at least 75 percent of eligible patients in 2004 and 2005, the latest data available.

National Cancer Institute-designated "Comprehensive Cancer Centers" did the best job, with 78 percent complying. Just under 34 percent of community hospitals, which are far more common and care for many more patients, complied. Just over half of other academic medical centers and Veterans Administration hospitals met the standard.

Improvement takes work from both surgeons and pathologists, Bilimoria said, noting that Northwestern went from about 50 percent compliance a decade ago to full compliance today.

But he expects more 12-node checks soon, saying the National Quality Forum recently listed the standard as a sign of quality care and that at least one insurance giant has begun requiring proof of 12-node checks before listing surgeons as preferred providers.

Meanwhile, he advises patients to ask about the 12-node check in choosing a surgeon and to check their pathology report to be sure it was done.

McCain and Obama on Same Side in War on Cancer

The Washington Post reports that both Obama and McCain agree to fight harder in the battle against cancer by increasing research funding to better detect and treat cancer as well as support cancer survivors.  Deborah Charles writes,

If there is one war John McCain and Barack Obama agree on, it's the one against cancer.

Thirty-seven years after President Richard Nixon launched the "war on cancer," the two U.S. presidential candidates agree on a need to fight the disease that kills more than 560,000 Americans each year.

The close personal ties each candidate has to the disease ensures that cancer advocates will find support in the White House regardless who wins the November 4 election.

McCain, the 72-year-old Republican presidential nominee, survived multiple skin cancers. Democratic nominee Barack Obama, 47, lost his grandfather to prostate cancer and watched his young mother die from ovarian cancer.

With 1.5 million Americans expected to be diagnosed with cancer this year, McCain and Obama both say it is time to add some fire to the battle against cancer.

Though their plans differ in the details, both White House hopefuls want to increase research funding, streamline government organizations dealing with cancer and improve access to screening and clinical trials.

"We are pleased to see that both candidates acknowledge the importance of stepping up the fight against cancer, a disease that claims more than a half million lives and costs us more than $219 billion in medical costs and lost productivity each year," said Hala Moddelmog, president of Susan G. Komen for the Cure, the global leader of the breast cancer movement.

"Funding for cancer research has been flat or declining for six years, which means fewer research grants are awarded, programs are scaled back, and fewer patients are being enrolled in clinical trials," she said.

Both candidates have pledged to increase U.S. investment in research to better detect and treat cancer and to help the 10.5 million cancer survivors in the country.

PERSONAL STORIES

"Despite achieving many life-saving advances, the war against cancer is an ongoing struggle that continues every day," said McCain, who has had four malignant melanomas -- a potentially lethal type of skin cancer -- removed since 1993.

"This is a fight we must and will win as a nation," he said in a video statement aired during a telethon to fight cancer.

Obama, who in campaign speeches often talks about how frustrated he was that his mother was forced to argue with her insurance company from her hospital bed, vowed to improve insurance coverage and treatment for those with cancer.

"That was the most painful time of my life. She had ovarian cancer -- was diagnosed in February and was gone by November," Obama told Reuters in an interview on his airplane.

He said the personal links to cancer have sparked him to give priority to implementing a plan to fight the disease.

"I know what it does to families, I know what it does to people," he said.

"It is not going to be easy to completely eliminate cancer but when I think about all the steps that we can take that we're not taking, it makes me frustrated. It's something that I will prioritize as president," he said.

Cancer survivor and seven-time Tour de France champion Lance Armstrong challenged both men to lay out their priorities in fighting cancer during the weekend televised celebrity fund-raiser. It raised more than $100 million.

Obama vowed to double funding for the National Institutes of Health and National Cancer Institutes to $10 billion, a promise that drew applause from the audience.

Asked in the Reuters interview about the increased funding, Obama said: "Ten billion dollars is real money, but that's what we spend in Iraq in a month."

Back and Forth on Stem-Cell Research Energizes Race

The New York Times reports on the clashing views over stem-cell research in the presidential campaign.  Larry Rohter writes,

First abortion, now embryonic stem-cell research. An issue that energizes social conservatives has once again been thrust into the presidential campaign, after Senator Joseph R. Biden Jr., the Democratic nominee for vice president, attacked Republicans on Tuesday for rejecting President Bush’s limited support for using human embryonic cell lines to develop medical therapies.

“I hear all this talk about how the Republicans are going to work in dealing with parents” who face “the joy and the difficulty of raising a child who has a developmental disability, who were born with a birth defect,” Mr. Biden said at a campaign stop in Columbia, Mo. “Well, guess what folks? If you care about it, why don’t you support stem-cell research?”

The Republican Party platform, just adopted in St. Paul, opposes any form of human embryonic stem-cell research. The McCain campaign, however, immediately cried foul, accusing Mr. Biden of “offensive” behavior and implying that the attack was directed at Gov. Sarah Palin of Alaska, the Republican vice-presidential nominee, who in April gave birth to a son with Down syndrome and has promised parents of children with disabilities that she will be “a friend and advocate in the White House” if elected.

“Barack Obama’s running mate sunk to a new low today launching an offensive debate over who cares more about special-needs children,” said Ben Porritt, a spokesman for Senator John McCain’s campaign. “Playing politics with this issue is disturbing and indicative of a desperate campaign.”

The Obama campaign lost no time in responding. “John McCain has adopted and promises to implement a Republican platform that takes an even more extreme position in opposing stem-cell research than that of George Bush four years ago," said Hari Sevugan, a spokesman for the Obama campaign. “While the McCain campaign may not believe the American people deserve a debate on the issues, it’s simply insulting for them to suggest that raising a substantive difference on this critical issue is playing politics.”

Until last week’s convention, Mr. McCain’s personal position on stem-cell research had in fact sharply diverged from that of his party’s platform, which advocates “a ban on the creation of or experimentation on human embryos for research purposes” and a “ban on all embryonic stem-cell research, public or private.” In a debate last year, Mr. McCain said he supported federal financing for stem-cell research. He also voted last year with the majority of his Senate colleagues for the Stem Cell Research Enhancement Act, which Mr. Bush later vetoed, and in 2004 he joined 57 senators who signed a letter to the president, urging him to “modify the current embryonic stem cell policy.”

Consumer Group Sues Miller Over New Drink

The Wall Street Journal reports that a consumer-advocacy group sued MillerCoors over their new Sparks drink, claiming that Sparks contains unapproved ingredients and might pose health and safety risks for consumers.  David Kesmodel writes,

A consumer-advocacy group sued MillerCoors LLC in an effort to have the company's Sparks beverage removed from the Washington, D.C., market in the latest campaign against the caffeinated alcoholic beverage.

The nonprofit Center for Science in the Public Interest sued the second-largest U.S. beer maker in District of Columbia Superior Court, contending that Sparks contains unapproved ingredients and poses health and safety risks for consumers.

MillerCoors, a joint venture of SABMiller PLC and Molson Coors Brewing Co., declined to comment on the suit. But spokesman Julian Green said "it is important to note" that the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau had approved all formulas and labels for Sparks, Sparks Light and other versions of the drink. "We have and we will continue to ensure that the labeling, marketing and product formulations of all our brands meet all applicable federal regulations and that our brands are marketed responsibly to legal drinking age adults," he said in a prepared statement.

The suit came amid probes of Sparks's marketing by various state attorneys general, who are concerned about the drink's appeal to minors. In June, MillerCoors's main rival, No. 1 beer maker Anheuser-Busch Cos., agreed to stop selling similar products in a settlement with 11 state attorneys general.

But MillerCoors seems to be taking a firm stance against moves by regulators and consumer groups to curtail Sparks. The brewer has more at stake with Sparks than Anheuser-Busch did with its Tilt and Bud Extra drinks, which Anheuser pledged to reformulate. Sparks is the No. 1 selling drink in the caffeinated alcoholic-beverage category, with 60% market share, and SABMiller paid $215 million to acquire the brand and other products from McKenzie River Corp. in 2006.

In its suit, the center says U.S. alcohol regulators are only supposed to permit the use of ingredients that the Federal Drug Administration has "affirmatively" determined to be "generally recognized as safe."

The center contends four of the food additives in Sparks -- caffeine, guarana, taurine and ginseng -- haven't met that threshold for use in alcoholic drinks. A spokesman for the Tax and Trade Bureau declined to comment, but referred to a letter it sent to state attorneys general in April that said "any manufacturer can self-certify that an ingredient is 'generally recognized as safe'" under federal guidelines.

The center's lawsuit accuses MillerCoors of irresponsibly marketing Sparks to young consumers. "Mix alcohol and stimulants with a young person's sense of invincibility and you have a recipe for disaster," said George A. Hacker, director of the center's alcohol-policies project.

DNA Testing Expands to Lesser Crimes

The Washington Post reports on the expansion of DNA testing used in less violent crimes such as robberies, burglaries, and drug deals to lead to faster convictions.  Defense lawyers worry that this will boost the odds of false matches.  Dan Morse writes,

While unusual, here is a crime as alleged by Montgomery County police that joins the list of things harder to get away with in the era of DNA evidence:

Man walks into a Starbucks, says he wants to apply for a job. He's given an application and a complimentary cup of coffee. Minutes later, he walks around the counter and threatens a barista with a ballpoint pen. He flees with $204 from the cash register and keys to another barista's 1993 Nissan Maxima, leaving behind the partially consumed cup of coffee.

Dominic J. Wilson is scheduled to stand trial today in the Starbucks case.

"Saliva," said Ray Wickenheiser, director of Montgomery's crime lab, "is a good source of DNA."

DNA testing in the county is expanding from killings and rapes to less violent robberies, burglaries and drug deals. Prosecutors say this will lead to quicker convictions because defendants will cave and plead guilty. Defense lawyers worry that as more DNA samples are pushed through the county's crime lab, it will boost the odds of false matches.

"It runs the risk of turning the gold standard of evidence into fool's gold," said Stephen Mercer, a Montgomery lawyer who has taken on so many of these cases lately that one of this clients calls him "the DNA Dude."

To read how detectives describe the Starbucks case in their arrest documents, the case appears to reside in the gold-standard realm. The incident took place in 2002, so long ago that the Starbucks in question, along Washington Street in downtown Rockville, doesn't exist anymore, although there is a new one around the corner.

For years, detectives didn't make an arrest. They did have a seized coffee cup, though, from which they lifted a DNA sample, according to charging documents filed in Montgomery Circuit Court. In 2007, the details of that sample were entered into a statewide database of convicted felons.

Up popped a connection to Wilson, who shortly after the alleged Starbucks job was arrested on assault and battery charges, according to court records. In March, a Montgomery grand jury indicted Wilson on one count of theft, two counts of robbery and one count of "robbery with a dangerous weapon," according to a copy of the indictment.

Montgomery's crime lab has been dogged by backlogs of several hundred DNA cases. It is generally hard to keep labs fully staffed, in part because analysts are in such demand. Wickenheiser, the lab director who took over in March, said additional employees have cut the backlog to about 100 cases. His staff is running validation tests on new countertop robots that can do such things as automatically extract DNA from other cellular components. Wickenheiser hopes the robots will start producing evidence for cases by the spring. Coupled with a new gene-sequencing machine, the robots could increase DNA analysis output by at least 30 percent, he said

Wickenheiser said he wants to make DNA testing routine for all robberies and residential burglaries in Montgomery within five years. Already, courthouse attorneys are dealing with more DNA cases.

"In the early days, you would see them in rapes and murders," said Paul DeWolfe, the chief public defender in Montgomery, who says DNA evidence now shows up in virtually every type of crime.

As that happens, evidence technicians are swabbing for DNA on such things as gun handles, car interiors, cocaine bags and articles of clothing used in strangulation attempts. The problem, said Mercer, is that although the evidence can show that a suspect was near the evidence, it doesn't necessarily show that the suspect committed a crime.

An article of clothing used in a strangulation could have been touched by the suspect weeks earlier in innocent fashion, he said. Also, surface samples often require DNA lab analysts to sort out the suspect's DNA from other people's, introducing a greater chance of error.

Wickenheiser said he has established a "prioritization policy" with detectives and prosecutors that is expediting the most urgent cases. He said detectives and prosecutors know to seek other evidence tying suspects to crimes. And he said that as DNA testing gets more exacting, it simply makes sense to use it more. His analysts now can pull evidence out of DNA samples weighing 100 picograms, a picogram being one-trillionth of a gram. Such precision, he said, can also exonerate innocent suspects.

One of Montgomery's top prosecutors, Laura Chase, a deputy state's attorney, said defense lawyers have feared challenging DNA evidence before a jury. As DNA evidence moves to less-violent crimes, she said, "I think it will encourage pleas. It always has encouraged pleas, and that will make the system more efficient."

Facing Veto, Democrats Drop Plan for Vote on Child Bill

The New York Times reports that Congressional Democrats have scrapped plans for another vote on expansion of the Children’s Health Insurance Program, thus sparing Republicans from a politically difficult vote just weeks before elections this fall.  Robert Pear writes,

Before the summer recess, Democrats had vowed repeatedly to force another vote on the popular program. But Democrats say they have shifted course, after concluding that President Bush would not sign their legislation and that they could not override his likely veto.

Mr. Bush vetoed two earlier versions of the legislation, which he denounced as a dangerous step toward “government-run health care for every American,” and the House sustained those vetoes.

Congress returns on Monday for a session expected to last three or four weeks. Lawmakers say they will focus on energy legislation, essential spending bills and efforts to revive the economy and to create jobs.

The fight over the children’s insurance program prefigures a larger legislative debate, expected to start next year, over the future of health care and the role of government in providing it.

Representative Rahm Emanuel of Illinois, chairman of the House Democratic Caucus, said: “We are not going to change any votes on the children’s health insurance bill. We still don’t have enough to override a veto. Those who opposed this bill can face the voters and explain why they believe 10 million kids should not get health coverage.”

The child health program has become an issue in some Congressional races. In almost every speech, Kay Barnes, a Democrat running for Congress in northwest Missouri, criticizes Representative Sam Graves, a Republican, for voting against the bill last year. Mr. Graves said the bill would have allowed illegal immigrants and some high-income people to get “free taxpayer-funded health care.”

House Democrats fell 13 votes short of the two-thirds majority needed to override Mr. Bush’s first veto last October, and they were 15 votes short when they tried again in January.

Democrats cited several reasons for their second thoughts about the wisdom of another vote on the child health bill. The cost of the bill has increased, according to the Congressional Budget Office, though the revenues expected from higher tobacco taxes are about the same. Under current rules, Congress would need to find a way to defray the extra cost.

In addition, time is short, and the Congressional calendar is packed with other issues.

Bruce Lesley, president of First Focus, a bipartisan advocacy group for children, said: “We definitely would prefer for Congress to vote on the legislation next year rather than this year. Why would you pass a bill now when, in six months, you could get a better bill covering more uninsured children?”

Since it was created with bipartisan support in 1997, the program has reduced significantly the number of low-income children who are uninsured.

The Census Bureau reported last month that the number of people under 18 without health insurance had decreased, to 8.1 million in 2007, from 8.7 million in the prior year. Economists say the number could climb this year because of the weak economy and rising unemployment.

The Congressional Budget Office estimates that the bill, financed by an increase in tobacco taxes, would reduce the number of uninsured children by 4.4 million by 2013. But at the same time, the budget office says, the bill could encourage some families to substitute public for private coverage, reducing by 2.3 million the number of children who would otherwise have private coverage.

A few House Republicans in tight races might switch sides and vote for the bill, in an effort to win the approbation of voters, Democrats say. But supporters of the bill believe that they would still not have enough votes to override a veto by Mr. Bush.

Hispanic, black and Asian-American members of Congress have complained that the bill does not provide coverage for legal immigrants who are now generally barred from benefits under Medicaid and the children’s health program during their first five years in the United States.

Many Democrats would like to lift those restrictions. But if they tried to do so, they could draw Congress into a bitter debate over immigration policy.

Poverty-Reduction Aid Lags, Study Finds

The Los Angeles Times reports that the United Nations says an ambitious goal embraced by wealthy countries to cut extreme global poverty by 2015 is in jeopardy.  Richard Boudreaux writes,

Development aid from the United States and other wealthy countries has declined since the middle of this decade, jeopardizing the ambitious U.N. goal they had embraced for reducing poverty by 2015, according to a report issued Thursday.

The report card on the Millennium Development Goals, the United Nations' 15-year global anti-poverty plan, cites improvement in easing the debt burdens of the world's neediest countries, but says pledges to help them with stepped-up aid and lower trade barriers were faltering.

It says development aid from the United States, the largest benefactor, fell 10% last year to $21.7 billion. Japan's dropped 30% and the European Union's nearly 6%. The report says the 22 donor countries committed to the plan must increase their development aid by $18 billion a year between now and 2010 to meet targets they accepted three years ago.

"This report sounds a strong alarm," Secretary-General Ban Ki-moon said in releasing the study by a U.N. task force. "We are running out of time."

Ban has called a one-day summit of world leaders here Sept. 25 to prod wealthy countries to do more.

American officials said President Bush has remained committed to the U.N. plan.

U.S. development aid has doubled since 2002 and was boosted by a five-year, $48-billion package for Africa that Bush signed this summer, said Carolyn Vadino, a deputy spokeswoman for the U.S. mission here.

Even so, the United States gives a smaller share of its national income, 16 cents for every $100, than any other member of the donor group, the report says. The average for the group, which includes Japan, Canada, Australia, New Zealand and 17 European countries, is 28 cents. The U.N. target is to raise development aid to 70 cents per $100 of rich country income by 2015.

Although China and India have become significant benefactors in recent years, the report does not quantify their assistance.

The United Nations called in 2000 for cutting in half the number of people in the developing world who live on less than $1 a day. It set seven other targets for impoverished nations: enrolling every child in primary school, promoting gender equality, reducing child mortality, improving maternal health, stemming epidemics, protecting the environment, and reducing debt and tariffs.

The World Bank last week adjusted the recognized dollar-a-day yardstick for measuring extreme global poverty to $1.25 and said 1.4 billion people, one-fourth of the developing world, are living on less.

The U.N. report finds some encouraging signs:

Of the 41 most heavily indebted countries, 33 have received debt relief. Access to medicines to fight AIDS and malaria has improved, thanks in part to a Bush administration initiative. More than three-fourths of the developing world's population have access to cellphones. And aid comes with fewer obligations to buy goods from donor nations.

However, 52 nations still spend more on debt service than on public health, the report says.

After growing steadily in the first half of this decade, it says, development aid dropped by about 13%, to $104 billion last year.

Rob Vos, the report's lead author, said aid started to lag after a major debt relief effort in 2005. "There's no reason to be pessimistic about meeting the development goals, but you have to regain focus and attention and priority," he said.

FDA to List Drugs Being Investigated

The Washington Post reports that the FDA will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients.  David Brown writes,

The FDA will name the drug and the nature of the "adverse events" but will not describe their seriousness or the number of complaints received, officials said yesterday. Being on the list does not mean the drug is unsafe, only that the FDA is looking into that possibility.

FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients.

The agency's Adverse Event Reporting System (AERS) last year received 482,154 unsolicited reports of potential reactions to drugs. The vast majority were false alarms, with the reported problem having nothing to do with the medication a patient was taking.

Presumably, many of the investigations that the FDA will now announce will not find any new problem with the drug in question.

"The risk is that people will read more into this than what it is, which is a statement that an evaluation is underway," said Paul Seligman of the agency's Center for Drug Evaluation and Research. He added that he hopes patients will not stop taking a medication simply because they saw it on the list.

Another official, Gerald Dal Pan, said that the FDA's "post-market surveillance" system is not changing, only the timing and extent to which the public is informed.

"I think the public has told us in recent years that 'we want to know what you are working on.' We are telling the public at pretty much the earliest stage what we are working on," he said.

A drug is evaluated for safety in many ways in the long process leading to the FDA's decision to approve or reject it for sale. Nevertheless, rare side effects and interactions sometimes are not recognized until after a drug is on the market and taken by many more people -- and people with more health problems -- than those in pre-market studies.

In the last decade, the painkiller drug Vioxx was found to increase the risk of heart attack and stroke; the diabetes drug Avandia to increase the risk of congestive heart failure; and numerous anti-epilepsy drugs to increase the risk of suicide. In each case, the hazard was not fully recognized until years after the drug was approved.

The quarterly list, which can be found on the FDA Web site, will name only drugs being reviewed because of reports to the AERS program. The agency also starts investigations because of data from clinical trials and other studies. Those will not be on the list.

When the FDA finds that a drug has newly recognized hazards, it can add warnings to the official directions for the drug's use ("the label"), send warning letters to physicians, require patients taking the drug to be monitored closely, or take the medication off the market.

FDA officials said yesterday that they had not yet decided how to inform the public when an investigation exonerates a drug.

The first quarterly report, covering Jan. 1 to March 31, listed 20 drugs. Four were being investigated for problems that already announced to the public: heparin and severe allergic reactions; the diagnostic "contrast agent" Definity and cardiopulmonary reactions; Cymbalta and urinary retention; and tumor necrosis factor inhibitors and cancer in children and young adults.

Some of the newly revealed investigations involve confusing names or packaging, not novel side effects. For example, FDA regulators are looking into problems caused when a cream with the trade name Carac used to treat precancerous skin conditions is confused with a cream called Kuric prescribed for fungal infections.

Vaccinations of Toddlers Set a Record

The New York Times reports that federal health officials are urging parents to trust vaccine safety as last year's numbers of vaccinations set record levels.  The New York Times writes,

Toddlers received the recommended vaccinations against childhood diseases at record levels in 2007, federal health officials said on Thursday, as they urged parents to continue to trust vaccine safety.

The Centers for Disease Control and Prevention issued its report on vaccination rates for children ages 1 1/2 through 3 a day after another study came out showing no link between autism and the vaccine given to guard against measles, mumps and rubella.

A record 77.4 percent of children in this age group received the full recommended series of vaccinations, the centers said.

Ninety percent of children got all but one of the six individual vaccines in the series, it said.

The one exception was the four doses of diphtheria, tetanus and pertussis or whooping cough vaccine, received by 84.5 percent of toddlers, the centers said.

The report, based on data on 17,017 children, found that less than 1 percent were given no vaccines.

The immunization program’s success hinges on parents’ trust in vaccine safety, the centers’ director, Dr. Julie Gerberding, said.

Public health officials have expressed concern in recent years that some parents fearful about vaccine safety were declining to get their children vaccinated, making them more likely to catch and spread preventable diseases.

“We really recognize that ultimately our program is dependent on trust — trust of moms and dads, trust of caretakers and trust of the clinicians, pediatricians, family practice professionals who take care of our children,” Dr. Gerberding told reporters in a conference call.

Officials at the centers have attributed this year’s largest American outbreak of measles since 1997, with 135 people sickened, to lack of vaccination often due to “personal or parental beliefs.”

Childhood vaccinations save an estimated 33,000 lives a year in the United States, said Dr. Anne Schuchat, of the C.D.C.

Coverage with the full vaccine series ranged from 91 percent in Maryland to 63 percent in Nevada.

The recommended series tracked in the report was four doses of diphtheria, tetanus and pertussis vaccine; three doses of polio vaccine; one or more doses of measles, mumps and rubella (German measles) vaccine; three doses of haemophilus influenzae type B vaccine (Hib); three doses of hepatitis B vaccine; and one or more doses of chickenpox vaccine.