In the wake of shocking reports on how the FDA, terrified of being outed for its questionable practices, spied on its own employees in the hopes of rooting them out before they could become whistleblowers, a new story has emerged on how deep the deceit goes. From marginalizing safety reports to not reading them at all―and then going ahead and approving the drugs in question―the FDA once more stands accused of being little more than a rubber-stamping agency for Big Pharma.

Explosive revelations of an intensive spy operation by the FDA on its own scientists emerged last month. Using sophisticated spy software, the agency tracked and logged every move made by the targeted individuals. The program even intercepted personal emails and copied documents on their personal thumb drives.

The targeted scientists had expressed concern over the agency's approval of dangerous medical imaging devices for mammograms and colonoscopies, which they believe expose patients to dangerous levels of radiation. Now, another whistleblower has stepped forward, and what he has to say about the agency's drug safety reviews is shocking even to the jaded...

Former FDA Reviewer Speaks Out About Systemic Suppression of Safety

Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview for the online news magazine Truth-Out, he tells Martha Rosenberg¹:

"In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee.

There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees.

In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug's approval - which of course was our job as drug reviewers - management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor."

According to Kavanagh, people would be shocked if they knew just how malleable safety data is. As examples, he points out that human studies are typically too short and contain too few subjects to get a clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be taken very seriously, and data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the medical safety reviewer completely failed to make such evaluations prior to the drug's approval.

A pair of widely used chemicals in the form of tiny "nanoparticles" have been shown to spread throughout a crop plant or affect growth and soil fertility.

The use of nanoparticles is increasing, yet their environmental impact is poorly understood.

A report published in PNAS shows that nanoparticles present in exhaust gases and some fertilisers adversely affect soybean growth and surrounding soil.

The nanoparticles harmed bacteria that the plant relies on for growth.

A nanoparticle is defined as a particle that has at least one diameter that is less than 100 nanometres (nm). A nanometre is a length measurement that exists at the microscopic end of the size spectrum - you can fit one million nanometres into one millimetre.

Exposure to a common parasite hosted by cats could make people more likely to attempt suicide, according to new research.

Toxoplasma gondii - which can cause toxoplasmosis - is easily transmitted to humans and has already been linked to a series of personality and behavioural changes.

A recent study found that people who tested positive for exposure to toxoplasmosis were seven times more likely to have a history of suicide attempts.

State medical regulators have warned a Dubuque "alternative health care consultant" that she has been illegally practicing medicine without a license.

The Iowa Board of Medicine, which licenses physicians, sent a letter this month warning Erin Gotz that she is breaking state law. "The information reviewed by the board indicates that you use tuning forks and specialized crystals to diagnose health conditions and prescribe a high-dose vitamin regimen to your clients," regulators wrote to Gotz.

"The board has serious concerns that the use of such high-dose vitamins may be toxic and could cause serious harm to your clients."

The letter says that if Gotz fails to heed the cease-and-desist order, the state could seek a court injunction against her or refer the case to the Dubuque county attorney for possible prosecution.

Gotz, who did not respond to a request for comment, has said alternative medical techniques, including sound therapy and Chinese medicine, helped her overcome anxiety and panic attacks as a teenager.

Regardless of how much a high school student generally studies each day, if that student sacrifices sleep in order to study more than usual, he or she is more likely to have academic problems the following day. Because students tend to increasingly sacrifice sleep time for studying in the latter years of high school, this negative dynamic becomes more and more prevalent over time.

Those are the findings of a new longitudinal study that focused on daily and yearly variations of students who sacrifice sleep to study. The research was conducted at the University of California, Los Angeles (UCLA) and appears in the journal Child Development.

"Sacrificing sleep for extra study time is counterproductive," says Andrew J. Fuligni, professor of psychiatry and biobehavioral sciences and a senior scientist at the Jane and Terry Semel Institute of Neuroscience and Human Behavior at UCLA, who worked on the study. "Academic success may depend on finding strategies to avoid having to give up sleep to study, such as maintaining a consistent study schedule across days, using school time as efficiently as possible, and sacrificing time spent on other, less essential activities."

For 14 days in each of the 9th, 10th, and 12th grades, 535 students from several Los Angeles-area high schools reported in diaries how long they studied, how long they slept, and whether or not they experienced two academic problems - they didn't understand something taught in class or they did poorly on a test, quiz, or homework. The students represented a mix of socioeconomic and ethnic backgrounds.

Earlier this month, a federal magistrate judge in New York told the Food and Drug Administration to quit dillydallying on its three-decade effort to curb indiscriminate use of antibiotics in farm animals to spur their growth. He set a timetable for the agency to follow in withdrawing two important drugs - penicillin and two forms of tetracycline - from widespread use in animals. The trouble is, that timetable will give the F.D.A. five more years to complete the process.

The feeding of antibiotics in small doses to entire herds or flocks to promote rapid weight gain poses a serious threat to human health. The constant dosing promotes the emergence of germs that are resistant to veterinary drugs and to the very similar drugs used in humans. That raises the risk that when humans are infected by the germs, the medicines they rely on will be less effective.

The F.D.A. had proposed long ago to start proceedings to remove antibiotics from use on farms (except to treat sick animals) unless manufacturers could prove that such usage would not promote drug-resistant microbes. But no hearings were ever scheduled. Then the agency decided that it could make faster progress against a broader range of drugs by gaining the voluntary cooperation of drug makers and animal producers to limit usage.

The Paleo - prehistoric, or early human - diet seems to create more questions than answers. This is because its premise is based on a theory that eating like primitive humans is the closest diet to perfect. But the biggest problem comes in an attempt to identify what early bipeds really ate without considering a host of other important factors ranging from stomping grounds to food availability and everything in between.

A study conducted in Mongolian schoolchildren supports the possibility that daily vitamin D supplementation can reduce the risk of respiratory infections in winter. In a report that will appear in the journal Pediatrics and has received early online release, an international research team found that vitamin D supplementation decreased the risk of respiratory infections among children who had low blood levels of vitamin D at the start of the study.

"Our randomized controlled trial shows that vitamin D has important effects on infection risk," says Carlos Camargo, MD, of Massachusetts General Hospital (MGH), the study's corresponding author. "In almost 250 children with low blood levels of vitamin D during winter, we found that taking a daily vitamin D supplement cut in half the risk of a respiratory infection."

Several recent investigations have suggested that vitamin D -- best known for its role in the development and maintenance of strong bones -- has additional important roles, including in immune function. Studies led by Camargo and other researchers have associated higher vitamin D levels with reduced risk of respiratory infections such as colds or flu, but such observational studies cannot prove that the vitamin actually protects against infection. That kind of evidence must come from randomized controlled trials comparing two similar populations that either do or do not receive an intervention such as vitamin D supplementation. The first such trial, in Japanese schoolchildren, had equivocal results, showing a reduction in the risk of one type of influenza but no effect on another type, so many organizations have called for further randomized trials to settle the issue.

The underlying causes of Alzheimer's disease are not fully understood, but a good deal of evidence points to the accumulation of β-amyloid, a protein that's toxic to nerve cells. β-amyloid is formed by the activity of several enzymes, including one called BACE1.

Most Alzheimer's disease patients have elevated levels of BACE1, which in turn leads to more brain-damaging β-amyloid protein. In a paper published August 15 in The Journal of Neuroscience, researchers at Sanford-Burnham Medical Research Institute (Sanford-Burnham) found that BACE1 does more than just help produce β-amyloid -- it also regulates another cellular process that contributes to memory loss. This means that just inhibiting BACE1's enzymatic activity as a means to prevent or treat Alzheimer's disease isn't enough -- researchers will have to prevent cells from making it at all.

"Memory loss is a big problem -- not just in Alzheimer's disease, but also in the normal aging population," said Huaxi Xu, Ph.D., professor in Sanford-Burnham's Del E. Webb Neuroscience, Aging, and Stem Cell Research Center and senior author of the study. "In this study, we wanted to better understand how BACE1 plays a role in memory loss, apart from β-amyloid production."

To do this, Xu and his team used a mouse model that produces human BACE1. Mice produce a different type of β-amyloid, one that's far less toxic than the human version. So, in this system, they could look solely at how BACE1 functions independent from β-amyloid formation. If BACE1 only acted to produce β-amyloid, the researchers would expect to see no effect when mice produce human BACE1 -- since mouse β-amyloid isn't very toxic, extra BACE1 would be no big deal. Instead, they saw that the enzyme still impaired learning and memory, indicating a secondary function at work.

Scientists have cracked a molecular code that may open the way to destroying or correcting defective gene products, such as those that cause genetic disorders in humans.

The code determines the recognition of RNA molecules by a super-family of RNA-binding proteins called pentatricopeptide repeat (PPR) proteins.

When a gene is switched on, it is copied into RNA. This RNA is then used to make proteins that are required by the organism for all of its vital functions. If a gene is defective, its RNA copy and the proteins made from this will also be defective. This forms the basis of many terrible genetic disorders in humans.

RNA-binding PPR proteins could revolutionize the way we treat disease. Their secret is their versatility -- they can find and bind a specific RNA molecule, and have the capacity to correct it if it is defective, or destroy it if it is detrimental. They can also help ramp up production of proteins required for growth and development.