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May 17, 2012

Data suggests drug treatment can lower U.S. crime

WASHINGTON (Reuters) – U.S. crime statistics show illegal drugs play a central role in criminal acts, providing new evidence that tackling drugs as a public health issue could offer a powerful tool for lowering national crime rates, officials said on Thursday.

An annual drug monitoring report, released by the White House Office of National Drug Control Policy, also showed a decline in the use of cocaine since 2003, a sign that drug-interdiction efforts and public education campaigns may be curtailing the use of the drug’s powder and crack forms.

The rate of overall illegal drug use in the United States has declined by roughly 30 percent since 1979.

But Thursday’s report, based on thousands of arrestee interviews and drug tests, showed that on average 71 percent of men arrested in 10 U.S. metropolitan areas last year tested positive for an illegal substance at the time they were taken into custody.

The figures ranged from 64 percent of arrests in Atlanta to 81 percent in Sacramento, California, and were higher for nearly half of the collection sites since 2007.

U.S. officials held up the data as evidence to support President Barack Obama’s strategy aimed at breaking the cycle of drugs and crime by attacking substance abuse with treatment rather than jail for nonviolent offenders.

“Tackling the drug issue could go a long way in reducing our crime issues,” Gil Kerlikowske, head of the office that issued the report, told Reuters in an interview.

May 15, 2012

FDA panel backs OraSure’s In-Home HIV test

WASHINGTON (Reuters) – A U.S. Food and Drug Administration panel of outside experts concluded that OraSure Technologies Inc’s over-the-counter, in-home HIV test is reasonably safe and effective for determining whether someone has the AIDS virus.

The 17-member FDA advisory committee voted unanimously that the drug’s ability to prevent new HIV infections and provide HIV-positive people with access to medical care and social services outweighed the risks of false results.

Tuesday’s recommendations will now be considered by agency regulators as they determine whether the product, known as the OraQuick In-Home HIV Test, should be approved as the first-ever over-the-counter, completely in-home HIV test.

Advocates say the in-home test would provide a new and potentially powerful strategy for attacking an U.S. HIV epidemic that has infected nearly 1.2 million people and increases by 50,000 new cases each year.

Trading in OraSure’s shares was halted for the FDA meeting after closing on Monday at $9.10.

The company said it would expect the product to retail for less than $60, if approved and marketed over the next the several months.

Panel members urged OraSure to undertake post-marketing studies to ensure that the test is available to under-served populations in a manner that would link those who use the kit to the healthcare services including confirmatory tests at professional settings.

May 14, 2012

FDA says unsure if Novartis MS pill caused deaths

WASHINGTON (Reuters) – Health regulators said on Monday they could not definitively link Novartis AG’s multiple sclerosis pill Gilenya with the deaths of people who took the drug.

The Food and Drug Administration said the deaths included a patient with extensive brainstem lesions from multiple sclerosis who died of unknown causes within 24 hours of taking the drug. Other deaths were linked to cardiovascular issues.

“For each of these deaths, Gilenya’s contribution to the death was unclear,” the agency said on its website. “The number of deaths of apparent cardiovascular origin or of unknown origin does not appear to be higher than in MS patients not treated with Gilenya.”

The agency did not specify the number or nature of the deaths included in recent clinical and postmarket studies.

“On the basis of the available data, a link between the first dose of Gilenya and the patient’s death could not be ruled out, however, there is not clear evidence that the drug played any role in the death,” Novartis spokeswoman Julie Masow said in an e-mailed comment.

The company said it believes the benefit/risk profile of Gilenya “remains favorable for appropriate patients when used according to the updated label.”

The FDA report came weeks after U.S. and European regulators decided to back continued use of the drug, while expressing concern that it could pose cardiovascular risks for some patients by lowering their heart rate after the first dose.

May 11, 2012

FDA panel recommends Gilead’s Quad for HIV

WASHINGTON (Reuters) – A U.S. Food and Drug Administration panel of outside experts on Friday recommended the use of Gilead Sciences Inc’s Quad pill for untreated HIV patients.

The FDA advisory committee voted 13-1 to endorse the four-drugs-in-one treatment, but members said there should be effective monitoring for potential kidney problems among patients and urged further research to determine the drug’s safety profile for women, who have been under-represented in clinical research.

The panel’s recommendation will now be taken into account by agency regulators, who are expected to decide on final approval for Quad by August 27.

An overwhelming number of the experts said they were satisfied with Gilead’s demonstration of safety and efficacy.

But Dr. Michelle Estrella of Johns Hopkins University School of Medicine, the panel’s lone ‘no’ vote, said data on potential renal problems and women’s health was too limited to justify her approval.

“There are plenty of alternatives to Quad,” she said. “There’s no huge hurry in approving this drug before the outstanding studies are completed.”

Shares in Gilead traded at $51.81, up 1 percent, after the committee voted.

May 10, 2012

FDA panel backs Gilead’s Truvada to prevent HIV

WASHINGTON (Reuters) – A U.S. Food and Drug Administration panel of outside experts recommended Gilead Sciences Inc’s Truvada as a treatment for preventing HIV infection among people at risk for contracting AIDS, including homosexual and bisexual men.

In a move that could lead to a new milestone for treatment in the evolution of the worldwide AIDS epidemic, the FDA advisory committee voted 19-3 to endorse the drug’s use for controlling HIV infection among the highest risk group – men who have sex with men.

The panel also approved Truvada’s use for the domestic partners of HIV-infected people and others at risk for sexual transmission, but several members said there should be more data on the drug’s efficacy to justify its use in the wider population.

Dr. Lauren Wood of the National Cancer Institute said she voted against all preventive applications because clinical studies did not measure the dangers of drug-related renal problems among black people, who are among the hardest impacted by HIV infection and the most susceptible to kidney problems linked to AIDS drugs.

“I don’t think that is adequate when you’re talking about the population that is most at risk,” she said.

The recommendation will be forwarded to FDA regulators, who must decide whether to give Truvada final approval as the first drug for use as a preventive treatment for HIV in the United States.

Shares in Gilead Sciences closed 1.2 percent higher at $51.25 before the panel voted. The drug combines Gilead’s HIV drugs Emtriva, also known as emtricitabine, with Viread, or tenofovir. It already has FDA approval to treat people infected with the human immunodeficiency virus that causes AIDS.

May 9, 2012

U.S. Senate probes painkiller makers, allied groups

WASHINGTON (Reuters) – A U.S. Senate panel has launched a probe of possible links between three drugmakers and nonprofit medical groups that advocated for increasing the use of prescription painkillers, now the target of a nationwide law enforcement crackdown.

Senate Finance Committee Chairman Max Baucus, a Democrat, and the panel’s leading Republican, Senator Chuck Grassley, said the drugmakers and allied groups could be behind dubious marketing practices that have coincided with a huge jump in deadly overdoses from painkillers known as opioids.

“These painkillers have an important role in health care when prescribed and used properly, but pushing misinformation on consumers to boost profits is not only wrong, it’s dangerous,” Baucus said in a statement.

Baucus and Grassley said they sent letters to drugmakers Johnson & Johnson, Endo Pharmaceuticals and Purdue Pharma and seven medical groups seeking documents about their financial connections.

Officials at the three companies were not immediately available for comment.

Lawmakers hope to find out if medical groups have promoted misleading information about the risks and benefits of opioid use while receiving financial support from manufacturers.

The Senate investigation comes at a time when federal, state and local law enforcement officials are coming to grips with a national epidemic involving the illicit use of prescription drugs. Their abuse has surpassed heroin and cocaine as a source of fatal overdoses.

May 9, 2012

FDA report on Gilead’s Quad focuses on kidney safety

WASHINGTON (Reuters) – Gilead Sciences Inc’s Quad pill appears to be effective at controlling HIV infection but could lead to kidney problems, a U.S. Food and Drug Administration staff report said on Wednesday.

The regulators said the four-drugs-in-one treatment has a generally acceptable safety profile. But they found evidence of disproportionate numbers of adverse renal events among test subjects that may need to be monitored.

They also cautioned that safety measures for women could be limited because only a small number of women were tested.

The staff document will be scrutinized on Friday by an FDA panel of outside experts whose recommendations will be considered when the agency decides whether to approve Quad. A final decision is expected by August 27.

Quad is seen as key to Gilead’s continued dominance of the market for HIV drugs. Most of the company’s current drug sales, which totaled $8.1 billion last year, come from Atripla, a once-daily pill that combines Truvada with Bristol-Myers Squibb’s Sustiva. Truvada consists of Gilead’s older HIV drugs Emtriva and Viread.

Gilead shares were up 1.8 percent to $50.34 in morning trading after the FDA released the staff review.

J.P. Morgan analysts called the review “fairly benign,” saying potential kidney issues were already well known. “Given what we view as minor issues, we believe the panel will likely support approval,” the analysts said in a note to clients.

May 8, 2012

FDA staff: Gilead’s Truvada may help reduce HIV risk

WASHINGTON (Reuters) – Gilead Sciences Inc’s Truvada tablets appear safe and effective for reducing the risk of HIV infection, U.S. regulators said on Tuesday. But they recommended a cautious approach for using the drug in efforts to prevent the virus that causes AIDS.

Food and Drug Administration staff said Truvada, which is already being used by patients with the human immunodeficiency virus, is well tolerated overall by uninfected people and may prevent infection in high-risk individuals when used in combination with other strategies.

FDA staff also acknowledged a strong correlation between the drug’s efficacy at reducing HIV infection and the willingness of those taking it to adhere to the treatment.

Their 47-page review document said preventive use of the drug — a combination of Gilead’s HIV drugs Emtriva, also known as emtricitabine, and Viread, or tenofovir — should be weighed carefully against an individual’s risk for infection, readiness to adhere to the treatment and potential for kidney problems.

“The individual at risk may be spared infection with a serious and life-threatening illness that requires lifelong treatment,” the report said.

Truvada represents a potential milestone in the evolution of the worldwide AIDS epidemic by offering a tablet capable of preventing infection. An estimated 1.2 million Americans have HIV, according to the Centers for Disease Control and Prevention.

An outside panel of experts is scheduled to examine the FDA review documents on Thursday and make recommendations that U.S. health regulators will consider in deciding whether the drug should be used as a preventive treatment.

May 7, 2012

Healthcare access to erode if law struck down: study

WASHINGTON (Reuters) – Most Americans have seen a decade-long erosion in access to medical services that is likely to continue if President Barack Obama’s healthcare law is struck down by the Supreme Court or repealed in Congress, a study released on Monday shows.

The study, one of a series on the fractured state of the $2.6 trillion U.S. healthcare system published in the May issue of the journal Health Affairs, says access to health care deteriorated for U.S. adults aged 19 to 64 between 2000 and 2010, even among those with private health insurance.

The age group represents about 195 million people, according to U.S. Census data, and has been targeted for expanded health coverage under the 2010 Patient Protection and Affordable Care Act, Obama’s signature domestic policy achievement.

The Supreme Court is considering whether to strike down all or part of the law, with a ruling due next month.

The law would extend affordable health coverage to more than 32 million uninsured Americans beginning in 2014, by creating subsidized, state-regulated health insurance markets and by expanding the joint federal-state Medicaid program for the poor.

The U.S. Department of Health and Human Services says access to care and use of healthcare services has declined in recent years, partly as a result of a recession that swelled the ranks of the unemployed and uninsured.

Researchers at the nonpartisan Urban Institute found the deterioration in access to care was evident even earlier, from 2000 to 2010, as spiraling healthcare costs led to reductions in employer-sponsored insurance benefits and strained the existing Medicaid system for the poor.

May 1, 2012

U.S. health centers for poor, uninsured see ranks swell

WASHINGTON (Reuters) – U.S. community health centers that cater to the poor and uninsured saw their patients’ ranks swell by nearly 18 percent from 2008 to 2011 as job loss left more Americans without health insurance, the Obama administration said on Tuesday.

A report released by the White House said 20 million Americans now receive healthcare services through 8,500 community health centers, up from 17 million four years ago.

“Those numbers really took a big jump,” Mary Wakefield, who heads the U.S. Health Resources and Services Administration, told reporters. “A lot of those folks were people who, when they lost their jobs early on, lost their coverage.”

The administration said health centers were able to accommodate larger numbers of patients because of funding provided by President Barack Obama’s embattled healthcare reform law and the administration’s earlier economic stimulus package.

The report, the latest in a series of government releases aimed at underscoring the value of healthcare reform, surfaced as the U.S. Supreme Court deliberates about the future of the law known as the Patient Protection and Affordable Care Act.

Community health centers, which often serve low-income areas where there are few doctors or hospitals, provide a cornerstone for the law’s goal of expanding healthcare access to more than 30 million uninsured Americans.

The ranks of the uninsured, which equaled 1-in-4 Americans last year, pose major social and financial challenges for the $2.6 trillion U.S. healthcare system.

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      "David Morgan has covered news from Wall Street and Fleet Street to the White House, the Pentagon and Congress, including politics, macroeconomics, military affairs, corporate finance, U.S. intelligence, national security and the international markets. He has also reported from Atlanta on the rise of American conservatism, civil rights, homegrown terrorism and the Olympics, and helped chronicle the Sept. 11 attacks and their aftermath from Philadelphia, New York and Washington."
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