Day: 02/03/2012

Omega-3 foods essential to treat nerve damage after traumatic injury.

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People that have suffered a traumatic injury face an uphill battle as they attempt to regain their health and fight the risk of depression as a long term consequence of the event. British researchers from Queen Mary at the University of London have published the result of a study in theJournal of Neurosciencethat explains how omega-3 fatty acids play a significant role in preventing and protecting nerves from injury. The research focused on peripheral nerve cells which transmit signals between the brain and the spinal cord to the rest of the body. Omega-3 fats from food sources including sardines, salmon, walnuts and flax seeds provide for decreased cell death from injury and may offer significant protection against future damage.

Current research indicates that our nerves do have a limited capacity to regenerate, but recovery is severely limited depending on the extent of the injury. Omega-3 fatty acids are essential for the body’s normal growth and development and have been well researched for their health benefits, largely focused on brain and heart health. The body is unable to manufacture its own Omega-3 fat supply, so it is necessary to obtain sufficient intake from foods such as oily fish, nuts and seeds or through supplementation.
Researchers studied the effect of omega-3 fats on isolated mice nerve cells, known to parallel human nerve responses. They simulated nerve damage caused from an accident or injury by either stretching the cells or starving them of oxygen. Both types of damage can kill a significant portion of nerve cells, but enrichment with omega-3 fatty acids in cells gave them significant protection and decreased cell death.

The study also examined sciatic nerve damage in the mice. They found that a high level of omega-3 fatty acids helped mice to recover from sciatic nerve injury more quickly and more fully, and that their muscles were less likely to waste following nerve damage. The team leader, Dr. Adina Michael-Titus, Professor of Neuroscience concluded“Our previous research has shown that these fatty acids could have beneficial effects in a number of neurological conditions. This new study suggests that they could also have a role in treating peripheral nerve injuries.”

The findings from this research should come as no surprise to integrative health followers. The omega-3 fats EPA and DHA are essential building blocks to all cellular structures in the body and are particularly dominant in the brain and nervous system. A healthy supply of omega-3 fatty acids allows for natural cell repair and the effective chemical and electrical communications that are important to optimal nerve function. Consuming fatty fish three to four times a week or supplementing with molecularly distilled fish oil (1 to 2.4 grams total EPA/DHA) supports the nervous system and regeneration process after injury.

Source: Natural News

Frequent bone scans for osteoporosis revealed as yet another medical scam.

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seems to be a scan for almost every medical condition these days. But not all of these scans have been proven safe or effective, or even necessary for that matter. A new study published in theNew England Journal of Medicine(NEJM) has revealed that bone mineral density scans, which check for early signs of the bone disease osteoporosis, are often conducted too frequently on many people, and in many cases may not even be necessary.

According toABC News, Dr. Margaret Gourlay from the University of North Carolina and her colleagues evaluated data from nearly 5,000 women aged 67 years and older, none of whom had osteoporosis at the outset of a national health study they participated in beginning in the 1980s. Using public funds for their research, Gourlay and her team determined that women who have a healthy initial screening do not need another screening for up to 15 years.

This finding contrasts with current recommendations on bone mineral density tests which, admittedly, are not scientific, but have simply been made up over time. So-called medical experts say they really do not know how often people should get these screenings, which makes one wonder if they know whether or not the screenings are even effective to begin with. And yet most women are urged to get a bone mineral density test every one or two years

“It’s an expenditure of time, it’s exposure to radiation, and it’s a cost,” said Dr. Virginia Moyer, head of the US Preventive Services Task Force, a government panel responsible for establishing testing guidelines, concerning bone mineral density tests. “And there’s no reason to expose yourself to any risks if there’s going to be no benefit.”

The health risks Dr. Moyer speaks of involve the use of radiation as part of the testing procedure. While the amount of radiation emitted from a dual-energy x-ray absorptiometry (DXA) scan is said to be only a fraction of what is emitted during a chest x-ray, routine exposure to ionizing radiation is known to cause cancer and other health problems .

Mammograms, medical x-rays, CT scans, and bone mineral density scans all emit ionizing radiation, and some of these procedures have questionable or unproven efficacy at providing any benefit. With medical authorities practically making up the rules as they go along, it seems, it is really anyone’s guess whether or not such tests are worth the time, the expense, or the health risk.

Source: Natural News

Walnuts Are Drugs, Says FDA

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Seen any walnuts in your medicine cabinet lately? According to the Food and Drug Administration, that is precisely where you should find them. Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply.

Diamond’s transgression was to make “financial investments to educate the public and supply them with walnuts,” as William Faloon of Life Extension magazine put it. On its website and packaging, the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer. These claims, Faloon notes, are well supported by scientific research: “Life Extension has published 57 articles that describe the health benefits of walnuts”; and “The US National Library of Medicine database contains no fewer than 35 peer-reviewed published papers supporting a claim that ingesting walnuts improves vascular health and may reduce heart attack risk.”

This evidence was apparently not good enough for the FDA, which told Diamond that its walnuts were “misbranded” because the “product bears health claims that are not authorized by the FDA.”

The FDA’s letter continues: “We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?

“The FDA’s language,” Faloon writes, “resembles that of an out-of-control police state where tyranny [reigns] over rationality.” He adds:

This kind of bureaucratic tyranny sends a strong signal to the food industry not to innovate in a way that informs the public about foods that protect against disease. While consumers increasingly reach for healthier dietary choices, the federal government wants to deny food companies the ability to convey findings from scientific studies about their products.

Walnuts aren’t the only food whose health benefits the FDA has tried to suppress. Producers of pomegranate juice and green tea, among others, have felt the bureaucrats’ wrath whenever they have suggested that their products are good for people.

Meanwhile, Faloon points out, foods that have little to no redeeming value are advertised endlessly, often with dubious health claims attached. For example, Frito-Lay is permitted to make all kinds of claims about its fat-laden, fried products, including that Lay’s potato chips are “heart healthy.” Faloon concludes that “the FDA obviously does not want the public to discover that they can reduce their risk of age-related disease by consuming healthy foods. They prefer consumers only learn about mass-marketed garbage foods that shorten life span by increasing degenerative disease risk.”

Faloon thinks he knows why this is the case. First, by stifling competition from makers of more healthful alternatives, junk food manufacturers, who he says “heavily lobb[y]” the federal government for favorable treatment, will rake in ever greater profits. Second, by making it less likely that Americans will consume healthful foods, big pharmaceutical companies and medical device manufacturers stand to gain by selling more “expensive cardiac drugs, stents, and coronary bypass procedures” to those made ill by their diets.

But people are starting to fight back against the FDA’s tactics. “The makers of pomegranate juice, for example, have sued the FTC for censoring their First Amendment right to communicate scientific information to the public,” Faloon reports. Congress is also getting into the act with a bill, the Free Speech About Science Act (H.R. 1364), that, Faloon writes, “protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.”

Of course, if the Constitution were being followed as intended, none of this would be necessary. The FDA would not exist; but if it did, as a creation of Congress it would have no power to censor any speech whatsoever. If companies are making false claims about their products, the market will quickly punish them for it, and genuine fraud can be handled through the courts. In the absence of a government agency supposedly guaranteeing the safety of their food and drugs and the truthfulness of producers’ claims, consumers would become more discerning, as indeed they already are becoming despite the FDA’s attempts to prevent the dissemination of scientific research. Besides, as Faloon observed, “If anyone still thinks that federal agencies like the FDA protect the public, this proclamation that healthy foods are illegal drugs exposes the government’s sordid charade.”

Source:The New American

Renowned physicist invents microscope that can peer at living brain cells.

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Hell (which in German means “bright”) and others at the Institute have been working for years on ultra high resolution microscopes that go by the name “stimulated emission depletion” or STED microscopes. Now, they’ve taken their work to a whole new level by cutting away a small portion of a mouse’s skull and replacing it with a glass window and then placing their latest STED microscope against the glass to peer inside. To make it easier to see what is what, the team first genetically altered the mouse to make certain brain cells fluorescent. Then, to allow for focusing exclusively on just those cells that are lit up, they added software to the microscope to blot out anything that was not lit up. The result is super high resolution real time imagery of the neurons that exist on the exterior part of a living mouse brain.

The new microscope provides clear resolution down to 70 nanometers, which is four times that ever achieved before and is enough to allow scientists to see the actual movement of dendritic spines, which may help researches understand why they do so.

It is likely that researchers will find many varied uses for the new microscope. One prominent area will almost certainly involve looking into what psychiatric drugs are really doing within synapses, perhaps leading to breakthroughs in pharmaceutical drugs that are better able to target specific illnesses.

One downside to any new scientific breakthrough however, is the natural tendency of many to move from excitation, to wondering about what will come next. In this case, Hell and his team have already started contemplating ideas on ways to allow researchers to study any cell in the living brain at suchhigh resolution, not just those that lie on the surface.

Source:Science

Two thousand schoolgirls suffer suspected ill-effects from cervical cancer vaccine.

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Thousands of schoolgirls have suffered suspected adverse reactions to a controversial cervical cancer vaccine introduced by the Government.

Doctors’ reports show that girls of 12 and 13 have experienced convulsions, fever and paralysis after being given the vaccine, which is now administered in schools as part of efforts to prevent women developing cancer.

Others suffered nausea, muscle weakness, dizziness and blurred vision, according to a special report drawn up by drug safety watchdogs.

A support group says it has received dozens of calls from parents who believe their daughters have been damaged by the vaccine.

The parents of one teenage girl given the jab last autumn believe it was to blame for repeated seizures which have left her with brain damage and psychosis.

The immunisation programme for teenage girls is controversial because it protects them from the sexually transmitted human papillomavirus which causes 70 per cent of cervical tumours

When the Government introduced the Cervarix vaccination programme last year, some campaigners dubbed it a “promiscuity jab”.

Campaigners and families said the new figures showed the vaccination should not have been introduced via a mass programme.

More than one million girls have already been given the jab, which is offered to all as they enter their teens.

Until 2011 it will also be administered to older girls, so that all female teens below the age of 18 will be covered by the programme.

Ministers say that ultimately the scheme will save 700 lives a year, while drug safety experts insist the number of suspected reactions are outweighed by the benefits from the jab.

Most of the more than 2,000 suspected reactions recorded by drug safety watchdog Medicines and Health care products Regulatory Agency (MHRA) were mild, with dozens of girls recording rashes, pain in the arm, and allergies.

But the report prepared by the MHRA earlier this month also discloses cases in which teens have suffered convulsions, eye rolling, muscle spasms, seizures and hyperventilation soon after being given the jab.

The analysis by the MHRA, drawn up this month, found 2,107 patients had reported some kind of suspected adverse reaction to Cervarix. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total.

Jackie Fletcher, founder of Jabs, a support group for families whose children have fallen ill after immunisation, said she had taken dozens of calls from parents who believed their daughters had been damaged by the cervical cancer vaccine.

She said: “We have spoken to parents whose daughters have had seizures, paralysis, blurred vision, severe headaches and the loss of feeling in parts of their body.

“Doctors will try to convince parents that these problems are in their child’s mind, or have nothing to do with the vaccines, but we don’t think there is sufficient evidence to show Cervarix is safe.”

Medical safety experts insist the benefits of the vaccine outweigh the risks.

They say many of the patients who experienced an “adverse” reaction to the jab since April 2008, including some who took part in drug trials or bought the drug privately, only suffered short-term side effects from the injection process, not as a result of the drug.

There was no evidence to suggest “isolated cases of other medical conditions” were actually caused by the vaccine, and not just a coincidence, the regulator’s report said.

Cancer charities urged parents to continue allowing their daughters to have the jabs, saying the numbers were well within what would have been expected for a large-scale programme, and that most of the side effects were minor.

Robert Music, director of cervical cancer charity Jo’s Trust said: “I can understand why parents would feel cautious, but this programme could reduce 70 per cent of cervical cancers.

We need to keep reviewing the evidence, but we would really urge parents to make sure their daughters have the vaccination.”

Stacey Jones is one of those who believes she has suffered side effects from the vaccine. She was 17 when she had her first Cervarix injection.

Her parents Julie and Kerry, from Bilston, West Midlands, noticed her becoming increasingly emotional in the weeks following the first two jabs, but feared their “happy-go-lucky” girl had finally succumbed to adolescent moodswings.

Within four days of the third injection in March of this year, Stacey suffered an epileptic seizure, followed by 17 more in the following week.

She has now been diagnosed with a brain injury, caused by inflammation of the brain, and is being treated in an NHS rehabilitation unit in Birmingham, which helps her with basic tasks like making a sandwich.

Seizures are minimised by five types of medication, but her memory is badly damaged.

The family has been given no explanation for how the damage occurred. Mrs Jones, 44, said: “She was such a lovely, happy go-lucky girl, now she is just a shell.

“When we go to see her, she can’t remember what she has just eaten for tea. The impact on her and all of us has been absolutely devastating. I feel she has been used as a guinea pig.”

A spokesman for GlaxoSmithKline, which makes Cervarix, said the drug had to undergo rigorous testing, with over 70,000 doses used in trials before a licence was granted.

He said: “The UK medicines safety agency has reviewed all reported adverse events relevant to Cervarix and there is no evidence to suggest that the vaccine carries any long-term side effects.

“The symptoms this girl has experienced are clearly upsetting and it is understandable that the girl and her parents want to uncover the cause.”

Source:The Telegraph

 

Illusion Contest Offers Mind-Warping Visions.

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10 brain twisters compete to be the best illusion of 2011.

Jordan Suchow came to three rapid-fire conclusions as he watched his Macintosh laptop plummet toward the floor. First, in approximately 300 milliseconds he was going to be in a heap of trouble—the machine had been given to him by his thesis adviser, George Alvarez of Harvard University. Second, hoping against all hope, he decided that Harvard could probably afford to buy him a new computer. Third, he realized that the most important observation of his life was unfolding right in front of him as his laptop accelerated toward the parquet: the onscreen doughnut that he had programmed to scintillate appeared to have stopped doing so.

Suchow’s Ph.D. research project on cognition and attention had required him to program a visual display in which every element changed continuously, hence the scintillating doughnut. While working on the project at home, Suchow pulled his Mac from a coffee table to his lap. During the transfer, he noticed that the cycling of the doughnut’s colors seemed to slow down. Startled, he dropped the machine altogether and was fascinated to see the color cycling cease completely as the doughnut fell.

His accidental discovery won the top prize at the 2011 Best Illusion of the Year Contest. A professional wrestling match of the minds, the contest barraged the audience’s brains with perceptual pile drivers, mental Mongolian chops and cognitive clotheslines—moves designed to conjure up a reality that does not actually exist.

Inside your brain, you create a simulation of the world that may or may not match the real thing. Your “reality” is the result of your exclusive interaction with that simulation. When you experience an illusion, your perception differs from physical reality in substantial ways. You may see something that is not there, or fail to see something that is there, or see something differently from the wayit actually is. Suchow’s visual neurons failed to see the doughnut’s scintillating colors, even though they were most definitely there.

Yet illusions are not the failures of perception that they are often portrayed to be. Rather they can result from evolutionary adaptations. Sometimes illusions occur because of shortcuts that your brain takes to help you survive and thrive. They allow you to make lightning-fast assumptions that are technically wrong but helpful in practice. For example, you may underestimate or overestimate distances, depending on various contextual cues. In 2007 psychologists Russell E. Jackson of California State University, San Marcos, and Lawrence K. Cormack of the University of Texas at Austin reported that observers estimated the height of a cliff when looking down from the top to be 32 percent greater than when looking up from its base. Given that accidents are more likely to happen while climbing down rather than up, this miscalculation may make you descend cliffs with greater care, reducing your chances of falling.

Illusions also offer a window into how our neural circuits create our first-person experience of the world. Suchow’s doughnut is just one of this year’s top illusions that rely on a phenomenon called silencing, in which changes go unseen because the motion of something else captures all the viewer’s attention. Silencing illusions are reminiscent of the magician’s adage that “a big motion covers a smaller motion.”

As with most of the top illusions of the past few years, most of the 2011 winners are “dynamic”—that is, they rely on moving images to work their magic. Such images are difficult to reproduce on the printed page; instead this article reveals the secrets behind the illusions.

Source: Scientific American

The Righteous Mind: Why Good People Are Divided by Politics and Religion.

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In a world where people draw lines in the sand between religions and the vitriolic waters of politics make islands of ideologies, Jonathan Haidt’s new book, The Righteous Mind, offers a glimpse of hope.

According to Haidt, a professor of social psychology at the University of Virginia, logic is not a suitable guide for interpreting moral issues. To better explain the relation between our moral inclinations and conscious thought, he uses the metaphor of an elephant and its rider. The bulky elephant, which signifies our emotions, makes the first decisive moves along a moral trajectory. The rider, who embodies reason, attempts to steer the giant beast by concocting justifications for the new course. Understanding that our emotions are in control, Haidt believes, will help bridge the gap between groups with conflicting ideas.

Throughout the book, Haidt broadens the definition of morality to clarify why polarized groups, such as religious conservatives and atheists or Democrats and Republicans, often fail to see eye to eye. Morality, Haidt says, is not solely about fairness and preventing harm; it also incorporates notions such as liberty, loyalty and authority, and it serves to create bonds between people.

In the political realm, Haidt presents research to explain why Republicans and Democrats diverge as much as they do. Democrats care more about harm and fairness when making moral decisions than loyalty, authority or sanctity. Republicans, on the other hand, are better able to interweave these moral threads. Understanding that our feelings guide our behavior and that political adversaries have different emotional triggers, he writes, will help both groups come to terms with each other.

As for spirituality, Haidt argues that religions are ultimately less about believing in a higher power than about forming bonds with others and being part of something larger than oneself. To illustrate, Haidt draws parallels between religious groups and fans who pack college football games every week adorned in team colors, locked arm in arm and singing fight songs with their brethren. People are built to seek membership in a like-minded community, he attests, be it a Sunday church service or a stadium.

Though at times highly philosophical, Haidt’s book is a must-read if you want to understand how conflicts arise—and how we might prevent them.

Source: Scientific American

 

 

 

Molecules to Medicine: Plan B: The Tradition of Politics at the FDA.

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In my last post, I focused on flaws in the medical device approval process. The Union of Concerned Scientists’ “FDA at a Crossroads” meeting also covered problems with drug approval. This is perhaps no better illustrated than by the disappointing decision by Secretary of Health Kathleen Sebelius’ to deny the emergency contraceptive, Plan B, over-the-counter status for women under the age of 17. This was a particular disappointment to many because President Obama had promised that decisions at the FDA would be made based on science, rather than politics. Some of us, naively, hoped that “change we can believe in” was real, having forgotten that the Tooth Fairy wasn’t.

Two of the speakers at the recent FDA at a Crossroads meeting were formerly at the FDA; both left because of political pressures. Dr. David Ross, was an FDA reviewer for Ketek (an antibiotic). In a Congressional hearing, Dr. Ross testified that he had been pressured to soften his findings about liver toxicity due to the drug and threatened by FDA Commissioner von Eschenbach, who said, “If you don’t follow the team, if you don’t do what you’re supposed to do, the first time you’ll be spoken to, the second time you’ll be benched, and the third time, you’ll be traded,” according to Ross.

The other was Dr. Susan Wood, former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, who resigned from the FDA after Plan B’s approval was initially denied.

The Tradition of Politics at the FDA

Before we delve into the specific discussion of Plan B, let’s look at the context of the politicization of the FDA, under the recent Bush administration in particular, which led to the characterization of the “broken FDA.” During that period access to healthcare information, health services, and medical research became limited by two growing trends: the infusion of increasingly restrictive religious doctrines and the implementation of ideology-driven—rather than scientific, evidence-based—public policies. Initially, access to science-based information was limited through censorship and even distortion in government sources (e.g., data regarding the efficacy of condoms in preventing HIV infections and STDs were removed from the CDC’s Web site). This neither helped reduce the teen birthrate nor STDs. They used the same misinformation tactic with the now discredited breast cancer-abortion link.

Ideologic shifts were also demonstrated by resource allocations. For example, HIV prevention programs at the CDC were reduced by $4 million while funding for abstinence-only programs rose from $20 million to $167 million, despite the lack of evidence of effectiveness, in contrast to the previous peer-review, scientific-merit-based process of NIH grant funding. No federal money is spent on comprehensive sex education. Even worse, since 1982, “Over $1 billion in government funding has been granted to abstinence-only programs…[which] are expressly forbidden from discussing contraception…and often contain factually inaccurate and distorted information. Those who design and operate these programs are often inexperienced, religiously-motivated and frequently have close ties to the anti-abortion movement.”

The trend away from evidence-based medicine affects healthcare practitioners in numerous areas, ranging from patient education and disturbingly eroding standards of medical care to selection of research topics, grant writing, and the research funding process. Upon her dismissal from the President’s Council on Bioethics in 2004 for disagreeing with the administration’s stance on stem cell research, Dr. Elizabeth Blackburn, a prominent cancer researcher and one of only three full-time biomedical researchers on the council, wrote, “When prominent scientists must fear that descriptions of their research will be misrepresented and misused by their government to advance political ends, something is deeply wrong.” Among her many honors, incidentally, is the 2009 Nobel Prize in Medicine.

David Kessler (commissioner,1990–1997) took a great deal of heat for trying to have the FDA regulate tobacco products and for trying to gain approval for RU-486 (mifepristone).(He lost on both counts.) He was also notable for being appointed by President George H. W. Bush and retained by President Clinton.

Jane Henney (commissioner, 1998–2001), also appointed by Clinton, authorized FDA approval of RU-486. She was, not surprisingly, ousted when George W. Bush took office. She also tried to change business as usual by filling positions with career appointees rather than political ones, actively demonstrating her goal of “leading policy and making enforcement decisions based on science, not on political whims.”

An infamous nominee for chairing Bush’s FDA advisory panel on women’s health policy was Dr. W. David Hager, an obstetrician-gynecologist. He had helped prepare a “citizens’ petition” calling for the FDA to reverse its approval of RU-486. He was perhaps more widely known for his reported refusal to prescribe contraceptives to married women and as author of a book that “recommends specific Scripture readings and prayers for such ailments as headaches and premenstrual syndrome.” After the outcry of critics, he was not appointed chair of the advisory panel but did serve on it in 2002–2005, despite bipartisan opposition.

Mark McClellan (commissioner, 2002–2004) was an economist appointed by George W. Bush. McClellan reportedly had decided against approving Plan B for emergency contraception even before his staff completed its analysis.

Lester Crawford (commissioner, July–September 2005) was a veterinarian also appointed by George W. Bush. His term is perhaps best remembered for three features: the audacity of a veterinarian making decisions about women’s health and reproduction, his vehement opposition to Plan B’s approval, and the criminal charges against him for false reporting about holdings relevant to his appointment (that he and his wife owned stocks in food, beverage, and medical device companies that he was in charge of regulating). He got off with probation and a fine.

Susan F. Wood was another casualty of Crawford’s brief and divisive tenure at the FDA. As noted, she resigned because of the politicization of the agency—specifically, having the approval of Plan B emergency contraception denied, despite scientific evidence of the pill’s safety and recommendations from the FDA’s own advisory committee.

Andrew C. von Eschenbach (commissioner, 2005–2009) had been the head of the National Cancer Institute before being appointed as FDA commissioner. He was also tied to the decision of the FDA to deny emergency contraceptives over-the-counter status, despite the recommendation of the FDA’s advisory group and its own staff members, as well as that of many medical organizations.17 The FDA had followed advisory committee recommendations in every other case in the past decade. He is also known for reportedly threatening FDA reviewers who disagreed with him. Von Eschenbach’s ideologic, rather than evidence- based, decisions were so egregious that on March 23, 2009, the U.S. District Court (Tummino v. Torti) ordered the FDA to reconsider its decision blocking access to Plan B. It also ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. The court’s conclusions about the FDA’s behavior were damning.

The FDA’s ability to function and its reputation have been seriously hurt in the past decade. In a 2006 survey of FDA scientists, about 18 percent responded that they had been asked to exclude or alter information or their report’s conclusions for nonscientific reasons. A further 60 percent were aware of cases where industry “inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” One-fifth (20 percent) said they had been “asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.” Lest you think this survey was markedly biased, even Senator Chuck Grassley, a staunch Republican, commented on the survey report, “The responses of these scientists reinforce the findings of the independent Government Accountability Office, which said the process for reviewing drugs on the market is deeply flawed.”

As a result of the politicization, the FDA staff has reportedly become greatly demoralized, interfering with its ability to function and protect the public. FDA whistle-blowers have testified that the agency considers the drug companies its clients, and its decision-making furthers the interests of those clients.

Many experienced and valuable clinicians have left the agency, leaving a void. Equally importantly, the FDA has lost considerable respect and authority in the eyes of both the public and important members of Congress.

From 2001 to 2009, the most obvious politicization at the FDA was related to women’s health issues, and especially access to contraception.

In March 2009, President Obama issued a memorandum on scientific integrity. A further encouraging sign of change was the May 2009 appointment of two well-respected physicians to lead the FDA, Drs. Margaret Hamburg and Joshua Sharfstein. Dr. Sharfstein has since left. Dr. Hamburg, the opening speaker at the UCS conference, noted that it was imperative to build trust in FDA’s integrity, and that it is science-based. Dr. Hamburg concluded that “I agree with the Center [for Drug Evaluation and Research (CDER)] that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

Unfortunately, Dr. Hamburg—and all women—just had the rug pulled out from them by Sebelius’ overtly political, evidence-be-damned stance.

Plan B Perspective

The irrational decision to overrule the recommendation of numerous experts appears based on the idea that young girls would be buying the pill without parental consent, and that such girls could not do so safely. They ignore that kids can readily buy Tylenol, which has significant liver toxicity and is often a component of deadly drug overdoses. Plan B is far safer—and also unlikely to be used routinely because, at ~$50, it is relatively expensive.

Even the conservative American Academy of Pediatrics urged approval of the morning-after pill for young teens, recognizing Plan B as being a safer alternative to abortions or unwanted pregnancies.

Plan B has the same hormone found in birth control pills, progestin, but in a larger dose. It works primarily by preventing ovulation. In contrast, mifepristone, or RU-486, is used to induce a medical abortion in a process similar to a miscarriage.

What were the arguments against Plan B this time? President Obama expressed his concern as a parent, that his daughters must not have access to such a medicine without adult guidance. His personal preferences are not “evidence-based science”. And he is deluding himself. We can guide our children, but we cannot control their behavior. My hope has been to educate my kids and offer them counsel knowing that, for better or worse, they will make many mistakes along the way. Prevention of pregnancy through ready access to contraceptives is far safer than an abortion or unwanted pregnancy. . .which may doom a teen to a lifetime of poverty and misery. There is a superb cartoon capturing the debate, Matt Davies,’ “Which of these responsibilities is a 15 year old too young to be handed?”—a screaming baby or Plan B pill.

Even the digital world seems to be biased, as now even Siri is getting into the act. Siri conveniently can direct you where to buy Viagra, but feigns ignorance when asked to direct to a reproductive health center offering abortion counseling or services.

The Plan B Decision has been characterized as “Sacrificing ‘Change We Can Believe In’ for Expediency?” “Only half of the nation’s teen moms ever earn a diploma; more than half go on welfare; and more than half of the families started by teens live in poverty.” The Ft. Wayne paper has it right stating, “Plan B politics ignore human toll.” I have never understood how many conservatives can demand censorship, restriction of contraceptives, and control of women’s bodies, all in the name of being “pro-life.” Fetal rights trump a woman’s…but then these people take no responsibility for the care, feeding, and education of these unwanted children. The sanctity of life ends at the womb. A life sentence is a huge price for a moment’s mistake.

 

Even Thailand, which many US citizens likely would (erroneously) consider to be a third-world country, is more enlightened in some health-related ways. For example, Mechai Viravaidya, a former Thai senator and founder of the Population and Community Development Association (PDA), and enormously successful family planning NGO, made a brilliant educational campaign focused on reducing both the birthrate and the AIDS epidemic, by making sex education fun and promoting condoms to be as readily available as cabbages. He even has a restaurant and resort known as “Cabbages and Condoms.” It was a wonderful place to visit. (insert pic)

So why did Obama and Sebelius kill OTC Plan B—the first time that the Health and Human Services Commission has ever overruled the FDA? Only two reasons come to mind. The first is that Obama is overtly campaigning for the conservative vote. The second is similar, but a bit less overt—that OTC Plan B was sacrificed to take a firmer stance on having contraceptive coverage as part of all insurance plans.

And Plan B’s got it right, too, in their ad: “I chose a condom but it broke. Now I Have A Second Chance.”

Why don’t the politicians get it?

Source: From the blog of Judy stone/Scientific American

Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden.

Path Is Found for the Spread of Alzheimer’s.

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Alzheimer’s disease seems to spread like an infection from brain cell to brain cell, two new studies in mice have found. But instead of viruses or bacteria, what is being spread is a distorted protein known as tau.

The surprising finding answers a longstanding question and has immediate implications for developing treatments, researchers said. And they suspect that other degenerative brain diseases like Parkinson’s may spread in a similar way.

Alzheimer’s researchers have long known that dying, tau-filled cells first emerge in a small area of the brain where memories are made and stored. The disease then slowly moves outward to larger areas that involve remembering and reasoning.

But for more than a quarter-century, researchers have been unable to decide between two explanations. One is that the spread may mean that the disease is transmitted from neuron to neuron, perhaps along the paths that nerve cells use to communicate with one another. Or it could simply mean that some brain areas are more resilient than others and resist the disease longer.

The new studies provide an answer. And they indicate it may be possible to bring Alzheimer’s disease to an abrupt halt early on by preventing cell-to-cell transmission, perhaps with an antibody that blocks tau.

The studies, done independently by researchers at Columbia and Harvard, involved genetically engineered mice that could make abnormal human tau proteins, predominantly in the entorhinal (pronounced en-toh-RYE-nal) cortex, a sliver of tissue behind the ears, toward the middle of the brain, where cells first start dying in Alzheimer’s disease. As expected, tau showed up there. And, as also expected, entorhinal cortex cells in the mice started dying, filled with tangled, spaghettilike strands of tau.

Over the next two years, the cell death and destruction spread outward to other cells along the same network. Since those other cells could not make human tau, the only way they could get the protein was by transmission from nerve cell to nerve cell.

And that, said Dr. Samuel E. Gandy, associate director of the Alzheimer’s Disease Research Center at Mount Sinai School of Medicine in New York, was “very unexpected, very intriguing.”

Although the studies were in mice, researchers say they expect that the same phenomenon occurs in humans because the mice had a human tau gene and the progressive wave of cell death matched what they see in people with Alzheimer’s disease.

One study, by Karen Duff and Dr. Scott A. Small and their colleagues at the Taub Institute for Research on Alzheimer’s Disease and the Aging Brain at Columbia University Medical Center, was published on Wednesday in the journal PLoS One. The other, by Dr. Bradley T. Hyman, director of the Alzheimer’s Disease Research Center at Massachusetts General Hospital, and his colleagues, is to be published in the journal Neuron.

Both groups of researchers were inspired by the many observations over the years that Alzheimer’s starts in the entorhinal cortex and spreads.

But, said Dr. Small, “what do we mean by ‘spreads?’ ”

Researchers knew that something set off Alzheimer’s disease. The most likely candidate is a protein known as beta amyloid, which accumulates in the brain of Alzheimer’s patients, forming hard, barnaclelike plaques. But beta amyloid is very different from tau. It is secreted and clumps outside cells. Although researchers have looked, they have never seen evidence that amyloid spreads from cell to cell in a network.

Still, amyloid creates what amounts to a bad neighborhood in memory regions of the brain. Then tau comes in — some researchers call it “the executioner” — piling up inside cells and killing them. If some cells take longer than others to succumb to the bad neighborhood, that would explain the spread of the disease in the brain, and there would be no need to blame something odd, like the spread of tau from cell to cell.

Studies in humans, though, could not determine whether that hypothesis was correct. They involved autopsy and brain imaging studies and were “indirect and inconclusive,” Dr. Small said.

Looking at the brains of people who have died of the disease, Dr. Duff said, is like looking at a wrecked car and trying to figure out the accident’s cause. Faulty brakes? Broken struts?

The question of which hypothesis was correct — tau spreading cell to cell, or a bad neighborhood in the brain and cells with different vulnerabilities to it — remained unanswerable. Dr. Hyman said he tried for 25 years to find a good way to address it. One of his ideas was to find a patient or two who had had a stroke or other injury that severed the entorhinal cortex from the rest of the brain. If the patient developed Alzheimer’s in the entorhinal cortex — and it remained contained there — he would have evidence that the disease spread like an infection. But he never found such patients.

The solution came when researchers were able to develop genetically engineered mice that expressed abnormal human tau, but only in their entorhinal cortexes. Those mice offered the cleanest way to get an answer, said John Hardy, an Alzheimer’s researcher at University College London who was not involved in either of the new studies.

There is another advantage, too, Dr. Hyman said. The mice give him a tool to test ways to block tau’s spread — and that, he added, “is one of the things we’re excited about.”

But if tau spreads from neuron to neuron, Dr. Hardy said, it may be necessary to block both beta amyloid production, which seems to get the disease going, and the spread of tau, which continues it, to bring Alzheimer’s to a halt.

He and others are also asking if other degenerative diseases spread through the brain because proteins pass from nerve cell to nerve cell.

Dr. Hardy thought he saw provocative human evidence that it might be happening in Parkinson’s disease. Two Parkinson’s patients being treated by a colleague had fetal brain cells implanted to replace dead and dying neurons. When the patients died, years later, autopsies showed they still had the fetal cells, but they had balls of a Parkinson’s disease protein, synuclein, inside. The most obvious way that could happen, the researchers reasoned, was if the toxic protein had spread from the patient’s diseased cells to the healthy fetal cells. But they could not rule out the bad-neighborhood hypothesis.

Now, Dr. Hardy said, with the mouse studies, the issue of a bad neighborhood is settled. The answer in Alzheimer’s disease, he said, “is that isn’t possible.”

“That is what is different between these papers and all the others,” Dr. Hardy said. “It isn’t a bad neighborhood. It is contagion from one neuron to another.”

Source:Nature

Surface of Mars an unlikely place for life after 600 million year drought, say scientists.

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Mars may have been arid for more than 600 million years, making it too hostile for any life to survive on the planet’s surface, according to researchers who have been carrying out the painstaking task of analysing individual particles of Martian soil. Dr Tom Pike, from Imperial College London, will discuss the team’s analysis at a European Space Agency (ESA) meeting on February 7, 2012. The researchers have spent three years analysing data on Martian soil that was collected during the 2008 NASA Phoenix mission to Mars. Phoenix touched down in the northern arctic region of the planet to search for signs that it was habitable and to analyse ice and soil on the surface.

The results of the soil analysis at the Phoenix site suggest the surface of has been arid for hundreds of millions of years, despite the presence of ice and the fact that previous research has shown that Mars may have had a warmer and wetter period in its earlier history more than three billion years ago. The team also estimated that the soil on Mars had been exposed to liquid water for at most 5,000 years since its formation billions of years ago. They also found that Martian and Moon soil is being formed under the same extremely dry conditions.

 and previous studies have proven that the soil on Mars is uniform across the planet, which suggests that the results from the team’s analysis could be applied to all of Mars. This implies that liquid water has been on the surface of Mars for far too short a time for life to maintain a foothold on the surface.

Dr Pike, from the Department of Electrical and Electronic Engineering at Imperial, who is lead author on the study published in the journal , explains:

“We found that even though there is an abundance of ice, Mars has been experiencing a super-drought that may well have lasted hundreds of millions of years. We think the Mars we know today contrasts sharply with its earlier history, which had warmer and wetter periods and which may have been more suited to life. Future  and ESA missions that are planned for Mars will have to dig deeper to search for evidence of life, which may still be taking refuge underground.”

During the Phoenix mission, Dr Pike and his research group formed one of 24 teams based at mission control in the University of Arizona in the USA, operating part of the spacecraft’s onboard laboratories. They analysed soil samples dug up by a robot arm, using an optical microscope to produce images of larger sand-sized particles, and an atomic-force microscope to produce 3D images of the surface of particles as small as 100 microns across. Since the end of the mission, the team has been cataloguing individual particle sizes to understand more about the history of the Martian soil.

In the study, the researchers looked for the microscopic clay particles that are formed when rock is broken down by water. Such particles are an important marker of contact between liquid water and the soil, forming a distinct population in the soil. The team found no such marker. They calculated that even if the few particles they saw in this size range were in fact clay, they made up less than 0.1 percent of the total proportion of the soil in the samples. On Earth, clays can make up to 50 percent or more of the soil content, so such a small proportion in the Martian samples suggests that the soil has had a very arid history.

They estimated that the soil they were analysing had only been exposed to liquid water for a maximum of 5,000 years by comparing their data with the slowest rate that clays could form on Earth.

The team found further evidence to support the idea that  has been largely dry throughout its history by comparing soil data from Mars, Earth and the Moon. The researchers deduced that the soil was being formed in a similar way on Mars and the Moon because they were able to match the distribution of soil particle sizes. On Mars, the team inferred that physical weathering by the wind as well as meteorites breaks down the soil into smaller particles. On the Moon, meteorite impacts break down rocks into , as there is no  or atmosphere to wear down the particles.

Source: Imperial College London