Drug Companies Keep Quiet On Drugs That Don’t Work

Unfavorable results of drug trials are often swept under the rug, according to a new review of FDA drug applications. Nearly a quarter of drug trial outcomes submitted to the FDA by pharmaceutical companies—most of them unfavorable—remained unpublished or only partially published after five years. Published results were often positively skewed from those originally reported to the FDA. “These new findings confirm our previous suspicions that this is happening on a much broader systemic level. It shows that information is unavailable to those who really need it the most — the clinicians and the researchers,” [Science News] says An-Wen Chan of the Mayo Clinic.

Drug companies are required to submit the results of all drug trials to the FDA as part of new drug applications. After approval, these results are supposed to be made public, usually in the form of scientific publications. However, the new review published in PLoS Medicine found disturbing omissions and bias on the road to publication. The new analysis examined 164 trials for 33 new drugs that were approved by the FDA from January of 2001 to December 2002. By June 2007, one quarter of the trials were either published only in a partial form — as an abstract, or part of a pooled publication — or were not published at all [Science News]. Of 43 negative outcomes reported to the FDA, only 20 were later published. Nine percent of all published outcomes were more positive than those originally reported to the FDA.

The mechanisms behind the apparent publication bias is unclear, though it is understood that manufacturers of new drugs rely on publications to market their products, often with billions of dollars on the line. In discussions with investigators on unpublished trials, [the study authors] found no cases where companies prohibited the researchers from publishing. But they did describe two cases in which the investigators said they wanted to publish the results but had not had full cooperation from the sponsors [MedPage News].

“It confirms that this is not an open, transparent process. There is still the opportunity for sponsors of new products to try and tip the scales in their favor,” [Wired Science] said Arthur Levin, director of the Center for Medical Consumers. Since September, federal law requires all clinical trials to be registered in a publicly accessible database, ClinicalTrials.gov, run by the National Institutes of Health. But the law still does not require full disclosure of all outcomes.

Source

In a Few Years, Men Could Pee in a Cup to Diagnose Prostate Cancer

A simple urine test is being developed that would revolutionize the treatment of prostate cancer by differentiating between the benign and aggressive forms of the disease.

While prostate cancer is one of the most commonly diagnosed cancers in men, the real challenge for treatment tends to lie in measuring the progress of the disease. A person can live a long time with benign prostate cancer, but the aggressive kind of tumor grows much more quickly and requires urgent treatment. The current method for distinguishing between the two can involve several rounds of testing, including an invasive and painful biopsy.

The urine test, which will not be ready for at least another three to five years, would be an easy and inexpensive way to determine which type of cancer is present, researchers report in Nature [subscription required]. Research for the test began when doctors found that men with an aggressive form of prostate cancer carry elevated levels of a particular molecule in their urine [The Guardian].

The researchers pinpointed about 10 molecules–or metabolites–that were more often present in samples taken from patients with advanced cancer. One metabolite in particular, sarcosine, was often found at elevated levels in samples taken from patients with advanced cancer, or cancer that had spread, but not at all in samples taken from healthy tissue. In fact, sarcosine was a better indicator of advancing disease than the traditional marker, a protein called prostate specific antigen [BBC].

The new research has potential implications for treatment of other cancers as well. Scientists believe that cancer cells need the molecule [sarcosine] to spread around the body, so drugs that stop it working could effectively contain cancers and stop them spreading to other organs…. “This is the molecule that the cancer cells use when they want to spread. If it turns out to be involved in metastasis in other cancers, then this discovery will be huge,” said Christopher Beecher, a co-author on the study [The Guardian].

Source

Eating Meat Destroys You — Eating Meat Destroys the World

Eating meat is destructive to your body, to the earth, and to the entire universe. It’s just that simple, yet so difficult for most of the world to understand. When will we wake up? Hopefully sooner than later. Hopefully…

Watch This Video

More info

Mystery Roar from Faraway Space Detected

Space is typically thought of as a very quiet place. But one team of astronomers has found a strange cosmic noise that booms six times louder than expected.

The roar is from the distant cosmos. Nobody knows what causes it.

Of course, sound waves can't travel in a vacuum (which is what most of space is), or at least they can't very efficiently. But radio waves can.

Radio waves are not sound waves, but they are still electromagnetic waves, situated on the low-frequency end of the light spectrum.

Many objects in the universe, including stars and quasars, emit radio waves. Even our home galaxy, the Milky Way, emits a static hiss (first detected in 1931 by physicist Karl Jansky). Other galaxies also send out a background radio hiss.

But the newly detected signal, described here today at the 213th meeting of the American Astronomical Society, is far louder than astronomers expected.

There is "something new and interesting going on in the universe," said Alan Kogut of NASA's Goddard Space Flight Center in Greenbelt, Md.

A team led by Kogut detected the signal with a balloon-borne instrument named ARCADE (Absolute Radiometer for Cosmology, Astrophysics, and Diffuse Emission).

In July 2006, the instrument was launched from NASA's Columbia Scientific Balloon Facility in Palestine, Texas, and reached an altitude of about 120,000 feet (36,500 meters), where the atmosphere thins into the vacuum of space.

ARCADE's mission was to search the sky for faint signs of heat from the first generation of stars, but instead they heard a roar from the distant reaches of the universe.

"The universe really threw us a curve," Kogut said. "Instead of the faint signal we hoped to find, here was this booming noise six times louder than anyone had predicted."

Detailed analysis of the signal ruled out primordial stars or any known radio sources, including gas in the outermost halo of our own galaxy.

Other radio galaxies also can't account for the noise – there just aren't enough of them.

"You'd have to pack them into the universe like sardines," said study team member Dale Fixsen of the University of Maryland. "There wouldn't be any space left between one galaxy and the next."

The signal is measured to be six times brighter than the combined emission of all known radio sources in the universe.

For now, the origin of the signal remains a mystery.

"We really don't know what it is,"said team member Michael Seiffert of NASA's Jet Propulsion Laboratory in Pasadena, Calif.

And not only has it presented astronomers with a new puzzle, it is obscuring the sought-for signal from the earliest stars. But the cosmic static may itself provide important clues to the development of galaxies when the universe was much younger, less than half its present age. Because the radio waves come from far away, traveling at the speed of light, they therefore represent an earlier time in the universe.

"This is what makes science so exciting," Seiffert said. "You start out on a path to measure something – in this case, the heat from the very first stars – but run into something else entirely, some unexplained."

Source

Love spray being developed by scientists

Love really could be a drug, say scientists, who believe that one day the feelings may be induced by popping a pill or smelling perfume.

It may not be the most romantic gesture but scientists are developing drugs that can boost that most human of emotions.

They are studying the brain chemistry responsible for the complex feelings that draw us to a particular member of the opposite sex and help keep us monogamous.

Animal testing is beginning to shed light on the complex neural and genetic components of love in the same way they have led to pharmaceutical therapies for anxiety, phobias and post-traumatic stress disorders.

The behavioural scientist Professor Larry Young, of Emory University, Georgia, writing in the journal Nature, said: "For one thing, drugs that manipulate brain systems at whim to enhance or diminish our love for another may not be far away."

Experiments have already shown a nasal squirt of the hormone oxytocin enhances trust and tunes people into others' emotions.

Websites are marketing products such as Enhanced Liquid Trust, a cologne-like mixture of oxytocin and chemical scents called pheromones "designed to boost the dating and relationship area of your life".

Prof Young said: "Although such products are unlikely to do anything other than boost users' confidence, studies are under way in Australia to determine whether an oxytocin spray might aid traditional marital therapy."

Prof Young said: "The hormone interacts with the reward and reinforcement system driven by the neuro-transmitter dopamine – the same circuitry that drugs such as nicotine, cocaine and heroine act on in humans to produce euphoria and addiction.

"Dopamine-related reward regions of the human brain are active in mothers viewing images of their child. Similar activation patterns are seen in people looking at photographs of their lovers."

Source