Illicit Drugs Bought Off Internet May Be Poisons, Experts Warn

Mediator, a drug licensed for use by diabetics that became widely prescribed in France as a slimming aid, "probably" caused at least 1,300 deaths before it was withdrawn, a study published on Thursday said.

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Merck says hepatitis pill hampers HIV Drugs

(Reuters) - Merck & Co's recently approved Victrelis treatment for hepatitis C considerably lessens the effectiveness of some widely used medicines against the virus that causes AIDS, Merck and U.S. regulators said in separate reports.

"These drug interactions may be clinically significant for patients infected with both chronic hepatitis C virus and HIV by potentially reducing the effectiveness of these medicines when co-administered," Merck said in a February 6 letter to healthcare professionals.

Victrelis, approved last May, attacks the hepatitis C virus that over decades can lead to cirrhosis and liver failure. A significant percentage of hepatitis patients are also infected with the human immunodeficiency virus, or HIV, which weakens the immune system and is fatal without treatment.

The drug interactions were seen in a study among healthy volunteers who took Victrelis and the widely used HIV treatment Norvir in combination with one of three other anti-HIV pills: Reyataz (atazanavir), Prezista (darunavir) and Kaletra (lopinavir/ritonavir). All of the HIV drugs work by blocking protease, an enzyme the virus requires to replicate.

Victrelis reduced concentrations in the blood of Reyataz, Prezista and Kaletra by an average 49 percent, 59 percent and 43 percent, respectively.

Further, levels of Victrelis itself were reduced by 45 percent among volunteers who took it with Kaletra, and 32 percent among those who took it with a combination of Norvir and Prezista.

ISI Group analyst Mark Schoenebaum said 10 percent to 15 percent of patients with hepatitis C are co-infected with HIV, and the findings could crimp Victrelis sales by as much as 25 percent. But he said the setback would have little impact on Merck's earnings this year or in 2013.

The reduced prospects for Victrelis come even as its sales are being dwarfed by Vertex Pharmaceuticals Inc's Incivek, a rival protease inhibitor that was also approved last May.

The U.S. Food and Drug Administration, in an announcement of the findings that appeared on the agency's website on Wednesday, said patients should not stop taking any of their medicines without talking to healthcare professionals.

Drug interactions had previously been found between Victrelis and another HIV treatment called Sustiva (efavirenz). Sustiva belongs to a family of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Merck said it was conducting drug-interaction studies of Victrelis with other HIV drugs. They include Intelence (etravirine), which is also a NNRTI, and Isentress (raltegravir), which belongs to a class of drugs called HIV integrase inhibitors,

Merck shares slid 14 cents to $38.28 in afternoon trading on the New York Stock Exchange.

(Reporting By Ransdell Pierson; editing by John Wallace and Maureen Bavdek)

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Generic Drugs Easing Out-of-Pocket Medical Costs in U.S.

WEDNESDAY, Feb. 8 (HealthDay News) -- More Americans are buying the generic forms of medications, and this practice has made their prescriptions more affordable, according to a new report.

But even though some out-of-pocket drug costs may have declined, paying for prescription drugs remains an obstacle for people with low incomes, public insurance and those with chronic conditions such as diabetes, high blood pressure and mental disorders, noted the researchers at RAND Corp., a nonprofit research organization.

"Our findings are evidence of the success of strategies already in place to help lower the cost of medications for consumers, even during a period when medication use was increasing," study leader Dr. Walid Gellad said in a RAND new release. "But the burden of drug costs remains high for many Americans, which is an important issue for policymakers to consider as health reform extends insurance coverage to more people."

The study, published in the February edition of Health Affairs, revealed that more than 8 million nonelderly Americans faced a significant cost for their prescription drugs in 2008, with one in four allocating more than half of their total out-of-pocket medical expenses to prescription drugs, the investigators found.

"Because medications are a large part of the household health budget, they are obvious targets for households when they need to decrease their health expenses, which can have adverse consequences down the road," noted Gellad, who also is an assistant professor of medicine and health policy at the University of Pittsburgh, a staff physician at the Pittsburgh VA Medical Center, and a researcher with the VA Center for Health Equity Research and Promotion.

In conducting the study, RAND researchers examined the individual drug spending of those tracked by the federal Medical Expenditure Panel Survey from 1999 to 2008. They found the percentage of people with a high financial burden for prescription drugs has been volatile, increasing from 1999 to 2003, decreasing from 2003 to 2007, and slightly increasing again in 2008.

From 1999 to 2003, the percentage of nonelderly Americans who spent more than 10 percent of their income on prescription drugs rose from 3 percent to 4 percent. During that timeframe, the percentage of Americans with family out-of-pocket drug costs that accounted for more than half of their total out-of-pocket medical expenses also increased from 27 percent to nearly 34 percent.

The researchers also revealed that by 2008, however, these numbers dropped back down to 3 percent for families with a high drug-cost burden and 25 percent for families with drug costs that accounted for more than half of all out-of-pocket health care costs.

Family income and types of insurance played a significant role in Americans' drug-cost burden, the study showed. In 2008, the percentage of people living in families with considerable drug costs was 7.5 percent among those with public insurance and 4.5 percent among those with privately purchased individual health plans.

Those who fared the best were those with group or employer-related insurance. Only 1.2 percent of those Americans faced a high drug-cost burden.

"These differences are important as the Affordable Care Act will expand coverage to 24 million people through new health insurance exchanges that build on the nongroup insurance market," Gellad said. "There is the expectation that future nongroup policies will provide better, more-generous drug coverage than existing policies, but the level of generosity remains to be seen."

More information

The U.S. Food and Drug Administration has more about prescription drug costs.

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FDA says ulcer drugs may raise diarrhea risk

US researchers have begun a groundbreaking trial to test the potential of umbilical cord blood transplants, a kind of stem cell therapy, to treat and possibly reverse hearing loss in infants.

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FDA says ulcer drugs may raise diarrhea risk

US researchers have begun a groundbreaking trial to test the potential of umbilical cord blood transplants, a kind of stem cell therapy, to treat and possibly reverse hearing loss in infants.

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HIV drugs not linked with child psychiatric problems

CHICAGO (Reuters) - Drugs used to treat children infected with the virus that causes AIDS do not appear to increase the risk of psychiatric problems in children, U.S. researchers said on Monday.

Scientists have been worried about the high rates of psychiatric and academic problems in children infected with the human immunodeficiency virus, or HIV -- the virus that causes

AIDS.

"The question that is coming up is why do they have so many issues? Is it their HIV, is it their antiretrovirals or is it other factors?" said Dr. Sharon Nachman of Stony Brook University in New York, who worked on the study published in Archives of Pediatrics & Adolescent Medicine.

In an earlier study, the team found similarly high rates of psychiatric problems in children with HIV and in those who have a family member with HIV, suggesting that stresses in the environment likely play some role.

For the latest study, Nachman and colleagues looked specifically at children with HIV in an attempt to tease out some of those answers.

They analyzed data on 319 HIV-infected children and adolescents aged between 6 and 17 years who were enrolled in the International Maternal Pediatrics Adolescent AIDS Clinical Trials Group study.

A third of the children had at least one psychiatric disorder, such as depression or attention deficit hyperactivity disorder (ADHD).

The team also reviewed the children's disease history and markers of disease severity, such as their viral load -- the levels of the virus in their blood -- and measures of infection-fighting cells known as CD4 cells.

The team found no link between the HIV drugs known as antiretrovirals that the children were taking to control their disease and any psychiatric problem.

"It wasn't the antiretrovirals. It didn't matter which antiretrovirals the kids used. Those didn't predict or prevent a kid from getting a psychiatric illness" or having social or academic problems, Nachman said in a telephone interview.

When they looked at severity of the disease, as measured by how much virus was in the blood or how well the immune system was working, the results were mixed.

For example, they said children who entered the study with a lower CD4 percentage -- a reflection of the number of infection-fighting cells in the blood -- had less severe depression.

But children who had high levels of the HIV virus in their blood when they entered the study had more severe depression.

However, severity of disease did appear to play a role when it came to critical cognitive skills known as executive functioning.

The team found children who had the most severe disease when they entered the study did worse on tests of executive functioning, such as remembering a sequence of numbers, Nachman said.

"It appears if you had a high viral load at a young age or a low CD4 percentage, you did get a hit on your brain" in terms of executive functioning, Nachman said.

The study does not prove cause and effect, but Nachman said it does suggest that HIV infection could affect the brain.

Some doctors are debating about whether to treat a child who has less severe disease, Nachman said, but added that tests of the immune system or levels of the virus may not reveal the whole picture.

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