Physicians more likely to accept gifts if reminded of hardships, study finds

Physicians more likely to accept gifts if reminded of hardships, study findsby Lianne Dane
A study published Wednesday in JAMA suggests that reminding physicians of their medical training, including the lack of sleep and the financial burden, more than doubled their willingness to accept gifts from pharmaceutical companies. Commenting on the findings, study author Sunita Sah said "the pharmaceutical industry and the medical profession do need to interact," but noted that "that interaction, particularly in light of the temptations involved and the potential threat to the public trust, does need to be more carefully managed than it traditionally has been."

Reference Articles
Notions of personal 'sacrifice' help docs take gifts from industry - (BusinessWeek)
Effect of reminders of personal sacrifice and suggested rationalizations on residents' self-reported willingness to accept gifts - (JAMA)
Doctors feel entitled to drug company gifts, study suggests - (Pittsburgh Business Times)
Study: Physicians see gifts as payback - (Pittsburgh Post-Gazette)
Drug company perks may sway doctors - (Pittsburgh Tribune-Review)

**Published in "First Word"

PSA Tests for Prostate Cancer May Not Save Lives

Routine PSA screening tests for prostate cancer don't save lives.
That's the bottom line from a painstaking analysis of major clinical trials by University of Florida researcher Philipp Dahm, MD, and colleagues. They reviewed data on 387,286 men enrolled in six large clinical trials.
"We found no evidence to support the notion that prostate cancer screening improves overall survival or prostate cancer survival," Dahm tells WebMD. "It clearly increases the number of men diagnosed with prostate cancer. But based on high-quality evidence, there does not appear to be an impact on these two important outcomes."
Most U.S. men start getting PSA tests at about age 40. That's a good idea for men at high risk of prostate cancer: African-American men and men with a father, brother, or son who had prostate cancer before age 65.
Routine screening does, indeed, increase a man's chances of a prostate cancer diagnosis. For every 1,000 men screened, Dahm and colleagues find, 20 more cancers are diagnosed than in similar men who are not screened.
Nearly all of these cancers are early-stage cancers. But detecting these slow-growing cancers -- most of which will not be life threatening -- does not save lives.
Overdiagnosis of prostate cancer can lead to unnecessary treatments, including surgeries and radiation therapies that can leave men incontinent and/or impotent. Does this mean that routine PSA testing does more harm than good? Oddly enough, Dahm says, there's not enough study data to answer this question.
"Men diagnosed with prostate cancer typically get treated -- and we know there is a significant impact on quality of life: urinary function, erectile function, and so on. But none of these screening studies are comprehensive enough to look at what happens downstream to these patients," he says.
If saving lives is the point of routine PSA testing, the benefit is "not so great," says Gerald L. Andriole, MD, chief of urologic surgery at Washington University in St. Louis. Andriole's editorial accompanies the Dahm team's report in the Sept. 14 online issue of BMJ.
"When we do routine mass screening for prostate cancer there are winners and losers," Andriole tells WebMD. "Some men clearly benefit from early detection and early treatment. But other men are losers. They are diagnosed with a cancer, undergo unnecessary treatment and have side effects, and they go through all pain and anxiety associated with having cancer."
1 PSA Test at Age 60?
The key question for men is not whether they have prostate cancer, suggests Hans Lilja, MD, PhD, of New York's Memorial Sloan Kettering Cancer Center. What they need to know is whether the cancer will cause symptoms or shorten their lives.
Lilja and colleagues wondered whether the PSA test could help men answer this question. To that end, they looked at a unique set of data collected from some 1,200 60-year-old Swedish men who donated blood plasma in a 1982 study of heart disease.

**Published in "Web MD"

A new treatment for patients with irritable bowel syndrome with constipation has produced promising results in a phase III trial.

The drug, linaclotide, is being co-developed by Ironwood Pharmaceuticals with Forest (in the US) and Almirall (in Europe) and was shown to help relieve the symptoms of irritable bowel syndrome (IBS) and constipation.
“The results of this phase III trial, combined with previously reported positive linaclotide trial results, further support our belief that linaclotide has the potential to improve abdominal pain and bowel symptoms, offering a promising treatment for individuals suffering from this chronic gastrointestinal disorder,” said Peter Hecht, chief executive of Ironwood.
The two co-primary endpoints required by the European Medicines Agency (EMA) were met in this study, showing statistical significance and clinically relevant improvement for
linaclotide-treated patients both for abdominal pain/abdominal discomfort responder and IBS degree of relief responder over the three-month period.
Significant improvement was also seen for all pre-specified main secondary endpoints (stool frequency, stool consistency, straining, and bloating). The safety results were in-line with those observed in earlier linaclotide trials, with diarrhoea being the most common adverse event.
“IBS is a disease that severely impacts the quality of life of patients and linaclotide is a specific treatment developed for the relief of symptoms in this condition,” said Per Olof Andersson, Almirall’s executive director of R&D.
“These results are very promising and we believe linaclotide will be a valuable treatment in an area with such high unmet need. We look forward to the results of the second pivotal trial in Q4 2010 led by our partner Ironwood.”
Analysts at Jeffries International say the data is ‘consistent and compelling’ but they have issued a ‘conservative’ forecast of peak sales of $200 million in Europe.

**Published by "InPharm"

Amgen's osteoporosis drug Prolia recommended by NICE

In final draft guidance published Wednesday, the National Institute for Health and Clinical Excellence recommended that postmenopausal women at increased risk of osteoporotic fractures should be treated with Amgen's Prolia (denosumab) if other treatments are unsuitable. Carole Longson, Health Technology Evaluation Centre Director at NICE, noted that the agency "felt that there was good quality evidence to show that denosumab is a useful addition to the treatment options available for women who can't have oral bisphosphonates."

Reference Articles
Final draft guidance recommends osteoporosis treatment as a new option for women at increased risk of fractures - (NICE)
UK's NICE approves Amgen's Prolia for osteoporosis - (The Wall Street Journal)

**Published by "First Word"

Neurocrine: depression drug ineffective in study

Neurocrine Biosciences Inc. said Tuesday a potential treatment for major depressive disorder conferred no benefit on patients in a midstage study.
The study on GSK561679 involved 150 patients and was conducted by partner GlaxoSmithKline. It compared the drug candidate with placebo.
Neurocrine said it plans to meet with GlaxoSmithKline in the coming months after full clinical data are available to discuss next steps for the program.
Other ongoing clinical trials on the drug are testing it against post-traumatic stress disorder, anxiety and alcoholism.
Shares of Neurocrine Biosciences fell 79 cents, or 12.6 percent, to $5.46 in after-hours trading after rising 18 cents to close at $6.26 during the regular trading session.

GlaxoSmithKline gets $21.3M defense contract

GlaxoSmithKline PLC has won a $21.3 million contract to provide medical supplies to the U.S. Army, Navy and Air Force, the Defense Department said Tuesday.
The British company is expected to complete the contract work by Dec. 30, 2011.

The contract was awarded by the Defense Logistics Agency Troop Support in Philadelphia.
Shares of GlaxoSmithKline added 10 cents to $39.87 in aftermarket trading after rising 29 cents to $39.77 during the regular session.

**Published by "AP"

FDA staff question effectiveness of Arena, Eisai's obesity drug lorcaserin

FDA staff said Tuesday that Arena Pharmaceuticals and Eisai's experimental weight loss drug, lorcaserin, met one of the agency's effectiveness standards "by a slim margin," but concerns remain about the drug's safety. Arena shares fell as much as 37 percent on the news.
In documents released ahead of an advisory panel meeting Thursday, Eric Colman, deputy director of the FDA’s Division of Metabolism and Endocrinology Products, noted that lorcaserin did "satisfy the categorical efficacy criterion" of helping at least 35 percent of patients lose at least 5 percent of their weight.
However, the study results "did not satisfy the guidance’s mean efficacy criterion," where the difference in weight loss between patients treated with the drug compared to patients in the placebo group be different by at least 5 percent. In the BLOOM trial, patients treated with the drug lost an average of 5.8 percent of their body weight compared with 2.2 percent body weight loss in the placebo group. The agency noted that a product is considered effective if it meets at least one of the criteria after one year of treatment.
FDA staff also noted that studies of the lorcaserin in rodents demonstrated there was an excess of breast tumours among those dosed at 7 times higher than the proposed clinical dose for humans, but said that no such imbalance in reports of cancer was observed among the more than 7000 patients treated with lorcaserin in late-stage clinical trials. The panel will be asked to vote on whether it thinks the benefits of lorcaserin outweigh the potential risks "when used long-term in a population of overweight and obese individuals."
Commenting on the documents, Hapoalim Securities analyst, Jon Lecroy, said that "knowing the drug doesn’t work that well, I knew the safety concerns would be looked at extremely closely," but said that "the big surprise to us here is the cancer" risk.

Reference Articles
Arena’s diet pill works by a ‘slim margin,’ FDA says - (Bloomberg)
FDA questions safety, effectiveness with diet pill - (MSN Money)
FDA: Arena's weight-loss drug lorcaserin meets one standard (free preview) - (The Wall Street Journal)
Arena tanks on drug safety concerns - (TheStreet.com)
Arena obesity drug was effective by ‘slim margin,’ FDA staff raises rat concern; shares tumble - (Xconomy)

**Published by "First Word"