Alimta regimen didn't meet goal in study

Eli Lilly and Co. said Thursday a drug regimen including its Alimta therapy did not improve the survival of lung cancer patients in a late-stage clinical trial.

Lilly said patients who were treated with a combination of Alimta, Avastin, and the chemotherapy drug carboplatin lived for 12.6 months after the start of treatment. Patients who were treated with chemotherapy and Avastin, a drug that is made by Roche, had median survival of 13.4 months. There was not a statistically significant difference between the results of the two regimens.


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HIV Drug Reduces Transmission Among Men By Over 40%, Study Finds


A daily dose of antiretroviral medication lowered the risk of contracting HIV by more than 40% among men who have sex with men, according to a study published Tuesday in the New England Journal of Medicine, the New York Times reports.

The results of the study -- nicknamed iPrEx -- "are the best news in the AIDS field in years" and "could change the battle" against HIV/AIDS, according to the Times . Experts suspect the medication will be successful in other groups but caution that it must be tested first.

Details of Study

An international team of researchers enrolled 2,499 MSM at 11 sites in six countries to test a prevention strategy known as pre-exposure prophylaxis, which has been successful in preventing other diseases. The team was led by Robert Grant of the University of California-San Francisco Gladstone Institute of Virology and Immunology and Javier Lama of the Investigaciones Medicas en Salud in Lima, Peru . NIH and the Bill and Melinda Gates Foundation funded the study .

Half of the participants received a daily dose of Truvada, an antiretroviral drug containing emtricitabine and tenofovir, while the other half received a placebo. Both groups received counseling about condom use and safer sex practices. The researchers found that 36 participants taking Truvada contracted HIV, compared with 64 in the placebo group, representing a 43.8% reduction. They noted that the decrease was dependent on how frequently the subjects took the medication. Those who adhered to their medication at least half of the time experienced a 50.2% decline in risk, while those who took their medication at least 90% of the time saw a 72.8% risk reduction .

Caveats to Strategy

The researchers noted several limitations to the study, including that it only involved MSM and one combination of antiretroviral drugs. They said additional studies are under way to test Truvada in other high-risk groups, such as commercial sex workers and intravenous drug users, and heterosexual men and women.

Some HIV/AIDS advocates and scientists expressed concern about the cost of the strategy. Truvada costs between $12,000 and $14,000 annually in the U.S. Generic versions in developing countries cost as little as 40 cents per pill. They said they are also concerned that placing people on the drugs will speed the evolution of drug resistant strains of the virus or that people will stop using condoms .

Kevin Fenton, AIDS prevention chief at the Centers for Disease Control and Prevention, said that prophylaxis "should never be seen as a first line of defense against HIV," adding, "It's not time for gay and bisexual men to throw out their condoms" .

Grant said that the findings are "a major advance," but the strategy "will only work if people use it consistently, and the real challenge is how do you use it consistently" .

Advances in Preventive Approach

The findings follow this year's success with a vaginal microbicide gel and a proof-of-concept trial on an HIV vaccine . The microbicide study indicated that the gel protected 39% of all women testing it and 54% of those who used it consistently .

Alan Bernstein, health of the Global HIV Vaccine Enterprise, said, "This is a very exciting, dynamic time in HIV prevention research," adding, "There's clearly a growing realization that we're not going to be able to treat our way out of this epidemic" .


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Breastfeeding While Taking Seizure Drugs May Not Harm Childs IQ, Study Suggests


"While more research is needed with larger numbers of women and their babies, these results are reassuring to women who want to give their babies all the benefits of breastfeeding but also need to remain on their epilepsy medications to avoid devastating seizures," said study author Kimford Meador, MD, of Emory University in Atlanta and a Fellow of the American Academy of Neurology (AAN).

The study followed 194 pregnant women who were taking one epilepsy drug. Of their 199 babies, 42 percent were breastfed. When they were three years old, the children were given IQ tests.

The study found that there was no difference in IQ scores between the children who were breastfed and those who were not. Those who were breastfed scored 99 on the test, while those who were not scored 98, which is not a significant difference.

The women were taking the drugs carbamazepine, lamotrigine, phenytoin, or valproate. Meador noted that more research is needed on the effects of other, newer drugs for epilepsy. The children whose mothers were taking valproate had lower IQ scores, whether or not they were breastfed. American Academy of Neurology guidelines recommend that valproate be avoided during pregnancy due to risks of birth defects and effects on cognitive skills. AAN guidelines also recommend that women avoid taking more than one epilepsy drug at a time during pregnancy since taking more than one drug has been found to increase the risk of birth defects compared to taking only one medication.

Editorial author Autumn Klein, MD, PhD, of Brigham and Women's Hospital and the Harvard Medical School in Boston said that this is one of the first large studies on breastfeeding while taking an epilepsy drug.

"Many women are counseled not to breastfeed due to the lack of information on the effects of these drugs, but breastfeeding has many positive emotional effects for the mother and the baby along with the decreased risks for heart disease, diabetes, and obesity in the child and breast and ovarian cancer in the mother," Klein said. "This study highlights the pressing need for more data on epilepsy drugs in breast milk and the long-term effects."

The study was supported by the National Institutes of Health and the UK Epilepsy Research Foundation.



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No Link Between Heartburn Drugs and Birth Defects: Study


Babies born to women who took a popular class of heartburn drugs while they were pregnant did not appear to have any heightened risk of birth defects, a large Danish study finds.

This class of drugs, known as proton-pump inhibitors (PPIs), include blockbusters such as Prilosec (omeprazole), Prevacid (lansoprazole) and Nexium (esomeprazole). All were available by prescription-only during most of the study period (1996-2008), but Prilosec and Prevacid are now sold over-the-counter.

While the authors and an editorialist, publishing in the Nov. 25 issue of the New England Journal of Medicine, called the results "reassuring," experts still recommend using drugs as little as possible during pregnancy.

"In general, these are probably safe but it takes a lot of time and a lot of exposures before you see some of the abnormalities that might exist," explained Dr. Eva Pressman, professor of obstetrics and gynecology and director of maternal-fetal medicine at the University of Rochester Medical Center. "My recommendations are always to avoid medication exposure if at all possible. There are very few life-threatening disorders that require these PPIs," she noted.

"There are other ways to get the same effect," added Pressman, who was not involved in the study. "Most pregnant women have heartburn but most of it is relatively easy to treat with simple antacids such as Tums and Maalox and Mylanta, all of which are locally acting and absorbed, and don't pose any risk to the fetus."

Even propping yourself up so you're in a semi-vertical position, as opposed to lying flat, can help, said Dr. Michael Katz, senior vice president for research and global programs at the March of Dimes.

The research was funded by the Danish Medical Research Council and the Lundbeck Foundation.

The authors of the new study used linked databases to glean information on almost 841,000 babies born in Denmark from 1996 through 2008, as well as on the babies' mothers' use of PPIs during pregnancy.

PPI use by expectant women was the highest between 2005 and 2008, when about 2 percent of fetuses were exposed, but exposure during the critical first trimester was less than 1 percent.

Babies were followed until they were one year old.

The proportion of babies with birth defects hovered at about 3 percent in both groups -- 3.4 percent of those who had been exposed to a PPI in utero, and 2.6 percent for unexposed babies.

In an unexpected finding, there was a 39 percent increased risk of major birth defects among children whose mothers had taken PPIs in the month before conception, a finding the authors are attributing to either chance or to another factor, perhaps the reason the mother was taking the medication in the first place. This could have been infection with Helicobacter pylori, the bacteria that causes most ulcers.

In addition to Prilosec, Prevacid and Nexium, the authors also looked at Aciphex (rabeprazole) and Protonix (pantoprazole).

Prilosec was the only drug not associated with an increase in birth defects when taken during the month before conception, leading the editorial author to suggest this drug as a first line of treatment.

A related journal editorial, written by Dr. Allen A. Mitchell, director of the Slone Epidemiology Center at Boston University School of Medicine, also noted some caveats. These included the fact that even this big of a sample may not have been large enough to detect specific birth defects (such as heart defects) or to ascertain the effect of specific drugs within the class. Nor can the influence of other factors be ruled out, Mitchell wrote. Perhaps folic-acid supplementation during pregnancy is hiding the true effects of the PPIs, Mitchell said.

The bottom line, according to the experts, is that it's still not clear whether these drugs are safe or not for pregnant women.

"Having negative observations is never absolutely reassuring," Katz said. "All you can say is that within that range [in this case, 800,000 infants], the probability is that it is safe," he explained.

"The balance in pragmatic terms is how important is it to treat the symptoms that any drug is designed to treat versus the safety of pregnancy," he added. "That's a very difficult decision to make."



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In Early Trial, Targeted Therapy Fights Advanced Melanoma


By probing deeper into the biological mechanisms that go awry in melanoma, scientists have come up with an experimental drug that has had an effect in a surprising number of patients with advanced melanoma.

The drug, PLX4032, just completed a phase 1 clinical trial in which 81 percent of participants with a particular gene mutation had a partial response, meaning at least some shrinkage of the tumor.

The current standard treatments for metastatic melanoma -- chemotherapy and interleukin-2 (IL2) -- only have response rates in about 15 percent of these patients, said Dr. Paul Chapman, senior author of a study in which the findings are described.

The average survival time for someone diagnosed with melanoma is nine to 11 months, added Chapman, who is an attending physician in the Melanoma Sarcoma Service at Memorial Sloan-Kettering Cancer Center in New York City.

One expert cautioned that it's too early to say whether the drug will actually prolong patient's lives, or if it might be helpful to patients in earlier stages of the disease.

"I don't want to say this is going to change survival rates but they're working with the most ill people, so you can't really generalize [to other patient populations]," said Dr. Alice Pentland, chair of dermatology at the University of Rochester Medical Center. "I think the most important part of this breakthrough is the bigger percentage of people who responded."

The study, which is published in the Aug. 26 issue of the New England Journal of Medicine, was funded by drug makers Plexxikon and Roche Pharmaceuticals.

About nine years ago, scientists discovered that the tumors of about half of patients with melanoma have a mutation in a gene called BRAF.

The gene appears to help drive the runaway cell division that is a hallmark of cancer. "It's always on. It's always signaling to the nucleus [of the tumor cells] that it's time to divide," Chapman explained.

That finding opened the door to potential targeted, molecular therapies for melanoma, which has been sorely lacking in effective treatments.

PLX4032 is the first potent inhibitor of BRAF that has made it to the clinical trial stage, Chapman said.

In the trial, 55 patients received escalating doses of the drug. Ten of 16 patients who had the BRAF gene mutation had a partial response to the drug, meaning the tumor shrank by at least 30 percent, while one had a complete response, with the tumor disappearing altogether.

Among 32 patients with BRAF-mutated melanoma in the second phase of the study, 24 had a partial response and two had a complete response.

"It worked: 81 percent had a partial response -- which has never been seen. I don't know of any solid tumors that have a response rate that high," said Chapman. "What's different here is that we've discovered a molecule that is responsible for driving the melanoma cell. It turns out that the melanoma really cares if we block the gene BRAF. It matters. It's addicted to this pathway."

There are some important caveats, however. It's not known at this time if the drug can improve overall survival, and a sizable proportion of participants developed resistance to the drug, the researchers say.

The findings join other recent reports of potential treatments for melanoma in what appears to be an exciting time for the field. Progress in this field has essentially been stalled for decades, experts say.

Recently, scientists reported that another experimental drug, ipilimumab, prolonged median survival in patients with metastatic melanoma from 6.4 months to 10 months.

"[Existing therapy] is not good for melanoma, so this is really a new opportunity that I think may have some importance to people," Pentland said.

However, she stressed that the best defense against melanoma is to get your skin examined regularly by a professional who knows what to look for.

"Our most successful treatment is to get [the lesion] early, get it before it's thick, get it before it spreads," she said.



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