HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, September 13, 2008

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,

Gardasil_vaccineThe 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.

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September 13, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

Pills10It'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.

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September 13, 2008 | Permalink | Comments (2) | TrackBack (0)

Friday, September 12, 2008

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,

Baby_bottleTainted 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.

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September 12, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

Medicare_3In 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.

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September 12, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, September 11, 2008

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,

Red_ribbonLast 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.

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September 11, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

Emergency_sign2National 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."

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September 11, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, September 10, 2008

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,

Obama_and_mccain 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.

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September 10, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

BidenFirst 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.”

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September 10, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, September 9, 2008

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,

SparksA 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.

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September 9, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

Genetic_testing4While 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."

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September 9, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, September 8, 2008

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,

Child_billBefore 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.

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September 8, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

Millenium_campaignDevelopment 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.

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September 8, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, September 7, 2008

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,

Doctor6The 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.

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September 7, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

Measles_vaccineToddlers 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.

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September 7, 2008 | Permalink | Comments (0) | TrackBack (0)