Big Pharma Researcher Admits to Faking Research!

February 23, 2010 by JP  
Filed under Health

February 23, 2010

Natural News

By Mike Adams

It’s being called the largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer’s speakers’ bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals.

Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as “proof” that Celebrex helped reduce pain during post-surgical recovery. There’s only one problem with all this: No patients were ever enrolled in the study!

Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway.

It wasn’t the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal.

As a result of Dr. Reuben’s faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 “scientific” papers authored by Reuben. The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.

After being caught fabricating research for Big Pharma, Dr. Reuben has reportedly signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.

He was also fired from his job at the Baystate Medical Center in Springfield, Mass. after an internal audit there found that Dr. Reuben had been faking research data for 13 years. (http://www.theday.com/article/20100…)

Business as usual in Big Pharma
What’s notable about this story is not the fact that a medical researcher faked clinical trials for the pharmaceutical industry. It’s not the fact that so-called “scientific” medical journals published his fabricated studies. It’s not even the fact that the drug companies paid this quack close to half a million dollars while he kept on pumping out fabricated research.

The real story here is that this is business as usual in the pharmaceutical industry.

Dr. Reuben’s actions really aren’t that extraordinary. Drug companies bribe researchers and doctors as a routine matter. Medical journals routinely publish false, fraudulent studies. FDA panel members regularly rely on falsified research in making their drug approval decisions, and the mainstream media regularly quotes falsified research in reporting the news.

Fraudulent research, in other words, is widespread in modern medicine. The pharmaceutical industry couldn’t operate without it, actually. It is falsified research that gives the industry its best marketing claims and strongest FDA approvals. Quacks like Dr Scott Reuben are an important part of the pharmaceutical profit machine because without falsified research, bribery and corruption, the industry would have very little research at all.

Pay special attention to the fact that the Anesthesia & Analgesia medical journal gladly published Dr. Reuben’s faked studies even though this journal claims to be a “scientific” medical journal based on peer review. Funny, isn’t it, how such a scientific medical journal gladly publishes fraudulent research with data that was simply invented by the study author. Perhaps these medical journals should be moved out of the non-fiction section of university libraries and placed under science fiction.

Remember, too, that all the proponents of pharmaceuticals, vaccines and mammograms ignorantly claim that their conventional medicine is all based on “good science.” It’s all scientific and trustworthy, they claim, while accusing alternative medicine of being “woo woo” wishful thinking and non-scientific hype. Perhaps they should have a quick look in the mirror and realize it is their own system of quack medicine that’s based largely on fraudulent research, bribery and corruption.

You just have to laugh, actually, when you hear pushers of vaccines and pharmaceuticals claim their medicine is “scientific” while natural medicine is “unproven.” Sure it’s scientific — about as scientific as the storyline in a Scooby Doo cartoon, or as credible as the medical license of a six-year-old kid who just received a “let’s play doctor” gift set for Christmas. Many pharmaceutical researchers would have better careers as writers of fiction novels rather than scientific papers.

For all those people who ignorantly claim that modern pharmaceutical science is based on “scientific evidence,” just give them these three words: Doctor Scott Reuben.

Drug companies support fraudulent research
Don’t forget that the drug companies openly supported Dr. Scott Reuben’s research. They paid him, in fact, to keep on fabricating studies.

The drug companies claim to be innocent in all this, but behind the scenes they had to have known what was going on. Dr. Reuben’s research was just too consistently favorable to drug company interests to be scientifically legitimate. If a drug company wanted to “prove” that their drug was good for some new application, all they had to do was ask Dr. Reuben to come up with the research (wink wink). “Here’s another fifty thousand dollars to study whether our drug is good for post-surgical pain (wink).”

And before long, Dr. Reuben would magically materialize a brand new study that just happened to “prove” exactly what the sponsoring drug company wanted to prove. Advocates of western medicine claim they don’t believe in magic, but when it comes to clinical trials, they actually do: All the results they wish to see just magically appear as long as the right researcher gets paid to materialize the results out of thin air, much like waving a magician’s wand and chanting, “Abra cadabra… let there be RESEARCH DATA!”

Shazam! The research data materializes just like that. It all gets written up into a “scientific” paper that also magically gets published in medical journals that fail to ask a single question that might exposed the research fraud.

I guess these people believe in magic after all, huh? Where science is lacking, a little “research magic” conveniently fills the void.

The whole system makes a mockery of real science. It is a system operated by criminals who fabricate whatever “scientific evidence” they need in order to get published in medical journals and win FDA approval for drugs that they fully realize are killing people.

What is “Evidence-Based Medicine?”
The fact that a researcher like Dr. Reuben could so successfully fabricate fraudulent study data, then get it published in peer-reviewed science journals, and get away with it for 13 years sheds all kinds of new light on what’s really behind “evidence-based medicine.”

The recipe for evidence-based medicine is quite simple: Fabricate the evidence! Get it published in any mainstream medical journal. Then you can quote the fabricated evidence as “fact!”

When pushers of pharmaceuticals and vaccines resort to quoting “evidence-based medicine” as their defense, keep in mind that much of their so-called evidence has been entirely fabricated. When they claim their branch of toxic chemical medicine is based on “real science,” what they really mean is that it’s based on fraudulent science but they’ve all secretly agreed to call it “real science.” When they claim to have “scientific facts” supporting their position, what they really mean is that those “facts” were fabricated by criminal researchers being paid bribes by the drug companies.

“Evidence-based medicine,” it turns out, hardly exists anymore. And even if it does, how do you know which studies are real vs. which ones were fabricated? If a trusted, well-paid researcher can get his falsified papers published for 13 years in top-notch science journals — without getting caught by his peers — then what does that say about the credibility of the entire peer-review science paper publishing process?

Here’s what is says: “Scientific medicine” is a total fraud.

And this fraud isn’t limited to Dr Scott Reuben, either. Remember: he engaged in routine research fraud for 13 years before being caught. There are probably thousands of other scientists engaged in similar research fraud right now who haven’t yet been caught in the act. Their fraudulent research papers have no doubt already been published in “scientific” medical journals. They’ve been quoted in the popular press. They’ve been relied on by FDA decision makers to approve drugs as “safe and effective” for widespread use.

And yet underneath all this, there’s nothing more than fraud and quackery. Sure, there may be some legitimate studies mixed in with all the fraud, but how can we tell the difference?

How are we to trust this system that claims to have a monopoly on scientific truth but in reality is a front for outright scientific fraud?

Keep up the great work, Dr Reuben
Thank you, Dr Scott Reuben, for showing us the truth about the pharmaceutical industry, the research quackery, the laughable “scientific” journals and the bribery and corruption that characterizes the pharmaceutical industry today. You have done more to shed light on the true nature of the drug industry than a thousand articles on NaturalNews.com ever could.

Keep up the good work. After paying your fine and serving a little jail time, I’m sure your services will be in high demand at all the top drug companies that need yet more “scientific” studies to be fabricated and submitted to the medical journals.

You may be a dishonest, disgusting human being to most of the world, but you’re a huge asset to the pharmaceutical industry and they need you back! There are more studies that need to be fabricated soon; more false papers that need to be published and more dangerous drugs that need to receive FDA approval. Hurry!

Because if there’s one place that extreme dishonesty is richly rewarded, it’s in the pharmaceutical industry, where poisons are approved as medicines and fiction is published as the truth.

Click here for the full report.

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Illegally Obtained Blood Samples of Babies in Texas Ordered Destroyed

February 22, 2010 by joel  
Filed under NWO

February 22, 2010

Natural News

By Ethan A. Huff

The subject of a recent federal lawsuit, routine blood samples legally taken from Texas newborns to screen for disorders and diseases were illegally being kept by the Texas Department of State Health Services without parental consent. Found to have begun holding and retaining such blood samples since 2002, the agency is being sued on behalf of the children’s parents by the Texas Civil Rights Project.

Legislation passed in May 2009 allows for blood samples to be retained indefinitely but allows parents to opt out if they wish to do so. However the lawsuit maintains that all blood samples obtained prior to the legislation be destroyed in cooperation with the law at that time. While the Health Department has agreed to destroy the samples, which have been preserved as blood spot cards, it is requesting permission to keep the blood samples of 400 children whose blood tested positive for certain atypical disorders.

The lawsuit is demanding no financial restitution for the state’s crimes, citing only privacy concerns and the principle of holding the government accountable when it violates the rights of its people. According to Andrea Beleno, an Austin mother and plaintiff in the suit, people must stand up and oppose governmental lawlessness otherwise nobody will.

An agreement was reached on December 14 whereby the Center must destroy all samples within 120 days unless the state receives written permission to retain specific samples. The Health Department must also inform the parents who were plaintiffs in the suit how their children’s blood samples were used and if any financial transactions took place during the research process. All projects must also be published on the agency’s newborn screening website.

Spokesmen from Texas A&M’s Health Science Center, the facility where the blood cards were being stored, expressed relief that a settlement has been agreed upon and the lawsuit dismissed, but it mourned the loss of what it described as a “superb database” that would have helped to prevent future birth defects in children.

The Health Department has agreed to comply fully with the new law concerning blood sample retention and is assuring parents that all information will be kept confidential and privacy maintained. The agency hopes that new parents will be willing to voluntarily allow their children’s blood samples to be retained for research purposes that could lead to novel new treatments for serious medical problems.

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Tantrums in Children May be Labeled ‘Psychiatric Disorder’

February 15, 2010 by Brandy  
Filed under Health

February 15, 2010

Guardian

By Daniel Nasaw

Childhood temper tantrums, teenage irritability and binge eating may soon rate as psychiatric disorders in the US, according to proposed changes to the Diagnostic and Statistical Manual, the bible of the psychiatric profession.

The proposals are the product of a 10-year effort to update the handbook, which influences the vast network of American healthcare providers, insurance companies, courts, prisons and universities. At stake are billions of dollars in insurance payments, pharmaceutical sales and medical fees. The proposed revisions, published online today , will be subject to public comment until late April.

“It not only determines how mental disorders are diagnosed, it can impact how people see themselves and how we see each other,” Alan Schatzberg, president of the American Psychiatric Association, which publishes the guide, told reporters. “It influences how research is conducted as well as what is researched. It affects legal matters, industry and government programmes.”

The DSM is in its fourth edition. It has been criticised for formalising character traits and emotions into mental conditions and for encouraging their medical treatment, often with drugs that have powerful side effects.

Christopher Lane, a professor at Northwestern University and author of 2007 DSM critique Shyness: How Normal Behavior Became a Sickness, said: “The organisation is clearly opening another Pandora’s box here, as well as paving the way for the medication of even-greater numbers of children and teenagers cycling through emotional stages as part of normal development.”

In an email, Lane said that categorising binge eating as a psychiatric disorder risks classifying millions of Americans as mentally ill at a time when the country is trying to rein in health care costs.

Among the proposals is a new condition, “temper dysregulation with dysphoria”, characterised by “severe, recurrent outbursts of temper” several times a week, that are “grossly out of proportion to the situation or provocation and that interfere significantly with functioning”. To be considered, the “symptoms” must have been “diagnosed” before age 10.

The proposed revisions would also recognise binge eating as a disorder. The condition is “characterised by recurring episodes of the consumption of unusually large amounts of food, accompanied by a sense of loss of control and strong feelings of embarrassment and guilt”. These episodes would need to occur at least once a week over the last three months, and the writers were keen to distinguish it from mere overeating.

“While overeating is a challenge for many Americans, recurrent binge eating is much less common and far more severe and is associated with significant physical and psychological problems,” wrote Dr B Timothy Walsh.

The panels proposed a new category of condition called “risk syndromes”, in which a patient is at risk for a mental disorder that is not yet present.

For example, a moody teenager who displays “excessive suspicion, delusions and disorganised speech or behaviour” may be labelled as having psychosis risk syndrome. The panel estimated that a quarter to a third of people who suffer from those “symptoms” go on to develop a psychotic disorder, and the writers acknowledged the new category could lead to inaccurate diagnosis of some who are not at risk.

“Given the severity of psychotic disorders, and evidence that early treatment may mitigate its long-term consequences, we believed that it was important to begin to recognise these conditions as early as possible,” wrote Dr William Carpenter of the American Psychiatric Association’s psychotic disorders work group.

The panels who proposed the revisions also took into account how race, ethnicity and gender affect the incidence of psychiatric disorders, and studied how those categories affect the expression of symptoms. For example, researchers noted differing ways of experiencing and describing symptoms of panic among some Asian and Hispanic patients.

The panel also recommended discarding the term “mental retardation” in diagnoses, replacing it with “intellectual disability”.

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Illinois Supreme Court Strikes Down Medical Malpractice

February 8, 2010 by Brandy  
Filed under Health

February 8, 2010

Chicago Tribune

By Bruce Japsen and Ameet Sachdev

The Illinois Supreme Court on Thursday struck down the state’s medical malpractice law, saying limits on damages awarded to victims of medical negligence are unconstitutional.

The much-anticipated ruling deals a blow to doctors and hospital officials who say caps on damages are a way to tame rising health care costs.

State lawmakers in 2005 passed legislation, which was signed into law by then-Gov. Rod Blagojevich, that established limits on pain and suffering and other non-economic damages of $500,000 in cases against doctors and $1 million against hospitals. Illinois followed other states, such as California, that capped damages years ago.

The court said the law violates the state’s separation-of-powers clause between the branches of government by allowing lawmakers to interfere with a jury’s right to determine damages. “The crux of our analysis is whether the statute unduly infringes upon the inherent power of the judiciary,” the majority opinion said.

Justices also said they were not persuaded by arguments used in other states. “That ‘everybody is doing it,’ is hardly a litmus test for the constitutionality of the statute,” wrote Chief Justice Thomas Fitzgerald in delivering the opinion for four siding in the majority of the seven-member court.

Justices Lloyd Karmeier and Rita Garman dissented on certain key points of the decision and expressed sympathy to providers of medical care, citing President Barack Obama’s recent address to a joint session of Congress that they said admonished the nation’s collective failure to enact health care reform.

But limiting medical liability is no silver bullet for controlling health costs. The Congressional Budget Office reported in September that reforms, such as capping non-economic damages, would lower the nation’s health care bill by only 0.5 percent.

The majority said the court’s decision was not made with Washington’s health care reform efforts in mind.

Still, the ruling could figure in the national debate of stalled health care legislation. Though Obama and Democrats have said they are unlikely to cap damages in federal health care legislation, they have been open to a compromise on liability reform.

The Obama administration, Republicans and doctor groups have made attempts to scale back the practice of “defensive medicine,” in which doctors perform medical procedures that are not necessary because of legal concerns. The CBO said recent studies have shown that liability reforms can slightly reduce the use of health care.

Thursday’s decision will not end the heated debate over whether lawsuits affect the quality and costs of medical care.

One area where there is agreement is on establishing evidence-based medicine, which offers guidelines for doctors to follow when treating patients.

“The high cost of potential damages impacts how insurers rate different types of practices,” said Larry Boress, chief executive of Midwest Business Group on Health, a coalition that represents some of the region’s largest employers. “While we encourage physicians to practice evidence-based medicine to ensure high quality medical care is provided, we know that not all of medicine has evidence-based guidelines. Our state and nation need alternative methods of addressing malpractice allegations.”

To continue reading this report, click here.

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81% of America Favor Legalizing Medical Marijuana

January 19, 2010 by joel  
Filed under Government

January 19, 2010

The Raw Story

By Stephen C. Webster

The medical marijuana debate among American voters is over.

Eight in 10 Americans — 81% overall — support allowing doctors to prescribe cannabis, according to an ABC News/Washington Post poll.

That’s up from just 69% in 1997, the last time the two firms asked that question, and from 75% in 2003, according to Gallup.

The main divide among American voters today is how the medical community should be enabled to doll out the drug. The most recent state to allow medical marijuana — New Jersey — has the most strenuous controls found anywhere in the nation.

Legislators prohibited doctors from prescribing the drug to anyone they think would benefit from it, instead limiting access to patients suffering from a specific list of illnesses. They also limited marijuana production to a series of non-profit facilities, as opposed to the dispensaries popular in California and other states.

A slim majority, 56 percent, support differing to a doctor’s discretion on who should be prescribed marijuana, according to the poll.

In spite of the apparent national mandate for medical marijuana, just 14 states allow it.

When it comes to outright legalization, the news agencies found that just 46 percent are in favor. Gallup said in October that it had found 44 percent of Americans support legalization, while an Angus-Reid poll in December resulted in 53 percent in favor.

“Medical marijuana, for its part, receives majority support across the political and ideological spectrum, from 68 percent of conservatives and 72 percent of Republicans as well as 85 percent of Democrats and independents and about nine in 10 liberals and moderates,” ABC noted. “Support slips to 69 percent among seniors, vs. 83 percent among all adults under age 65.”

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Nasty Side-Effects from Pfizer’s Quit-Smoking Drug

January 15, 2010 by joel  
Filed under Health

january 15, 2010

Reuters

By Ransdell Pierson

Three personal injury lawsuits were filed against Pfizer Inc (PFE.N) on Thursday, claiming its smoking cessation drug Chantix caused attempted suicides and death.

The lawsuits, filed in New York State Supreme Court in Manhattan, claim that at the time the plaintiffs took Chantix, Pfizer did not tell doctors and patients about dangers it allegedly knew were related to the drug, including depression and thoughts of suicide.

Although Pfizer subsequently added warnings to its package insert, the law firm that filed all three lawsuits alleged the drug’s label is still inadequate.

Pfizer introduced Chantix in the United States in 2006, hoping it would become a multibillion-dollar product and revive flagging profits. The drug’s sales have fallen off as concerns about side effects increased.

Chantix sales fell 15 percent to $155 million in the third quarter of 2009.

Attorney Marc Grossman alleged in the lawsuits that the company “intentionally, recklessly, and/or negligently concealed, suppressed, omitted, and/or misrepresented the risks, dangers, defects and disadvantages of Chantix.”

Grossman is with Sanders Viener Grossman LLP in Mineola, New York.

Two lawsuits claim the plaintiffs tried to kill themselves as a result of using Chantix. The third is a wrongful death lawsuit filed on behalf of Indiana resident Annette Pine, claiming she committed suicide after using Chantix.

The lawsuits seek trials by jury, punitive and compensatory damages, medical and legal expenses, and, in Pine’s case, funeral expenses.

Pfizer issued a statement defending the drug, approved in some 86 countries as a smoking cessation aid.

“At all times, Pfizer has clearly communicated important information about the safe use of Chantix, which is available only with a prescription,” Pfizer spokeswoman Sally Beatty said in the statement.

“We intend to vigorously defend this medicine,” she said, adding that Chantix has helped many smokers to quit.

The lawsuits claim that each of the plaintiffs used the drug properly. They also claim that in each case the plaintiffs and their doctors were “not aware and through diligent efforts were not able to discover the risk of serious injury, and/or depressed mood and/or suicide associated with and/or caused by Chantix.”

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Statin Drugs Diminish Body’s Vitamin D

January 8, 2010 by joel  
Filed under Health

January 8, 2010

Natural News

By E. Huff

Many in the medical profession are beginning to recognize that people who take cholesterol-lowering statin drugs are becoming vitamin D-deficient. Cholesterol is required by the body to synthesize vitamin D and statin drugs are are responsible for eliminating it, leading many to speculate that statin drug users do not have enough cholesterol to process vitamin D.

Contrary to popular belief, cholesterol actually plays an important role in maintaining health. It regulates proper hormonal levels and is the precursor substance for the production of vitamin D. Cholesterol also works to digest and absorb fats, nutrients, and vitamins.

When converting sunlight into vitamin D, cholesterol in the skin acts as the catalyst for this important process. Vitamin D is crucial for mineral metabolization and is said to target over 2000 human genes. Deficiency is linked to over 17 varieties of cancer as well as heart disease, autoimmune diseases, muscle and bone problems, and other serious diseases.

In the study, researchers found a clear connection between vitamin D deficiency and muscle pain. Over 64 percent of patients with muscle pain who were taking statin drugs were also deficient in vitamin D. Those with muscle pain in general were found to be deficient in vitamin D.

When study participants who reported muscle pain were given 50,000 IU of vitamin D a week for 12 weeks, more than 92 percent of them were completely relieved of all muscle pain. The prescribed supplementation also raised blood levels of vitamin D to normal levels.

It is also known that statin drugs are responsible for depleting CoQ10 levels, a vital substance that metabolizes energy in the body. Both CoQ10 and vitamin D supplementation are recommended for anyone who takes statin drugs. A minimum of 2,000 IU of vitamin D and between 100 and 200 mg of CoQ10 daily are appropriate doses.

Studies have shown that taking CoQ10 by itself helps to maintain proper cholesterol levels without the need for statin drugs. While keeping bad cholesterol (LDL) levels low is beneficial, it is important to keep good cholesterol (HDL) levels high. CoQ10 works well at maintaining healthy levels of both.

Some other alternatives to keeping cholesterol levels in check include supplementation with niacin and policosanol. In conjunction with a healthy diet low in refined sugars and bad fats, these natural alternatives are both safe and effective. Exercise and a diet rich in omega-3 fatty acids are also good suggestions.

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17,000 Harmful Chemicals Kept Secret Under Obscure Law

January 5, 2010 by Andrew  
Filed under Health

January 5, 2010

The Raw Story

By Raw Story

Of some 84,000 chemicals being used commercially in the United States, some 20 percent — or 17,000 — are kept secret not only from the public, but from medical professionals, state regulators and even emergency responders, according to a report at the Washington Post.

And the reason for this potentially harmful lack of openness? Profit.

A 1976 law, the Toxic Substances Control Act, mandates that manufacturers report to the Environmental Protection Agency any new chemicals they intend to market, but manufacturers can request that a chemical be kept secret if disclosure “could harm their bottom line,” the Washington Post reports.

Because they are secret, it’s impossible to tell how many of the 17,000 chemicals are potentially harmful to people. But the Post notes that, in March of last year, more than half of the “substantial risk” reports filed with the EPA involved secret chemicals.

And chemical makers may be abusing their privilege under the law. According to the EPA, in recent years 95 percent of manufacturers’ reports of new chemicals have made some request for secrecy. Ten of the secret chemicals are used in children’s products.

EPA head Lisa Jackson has begun an effort to increase transparency in commercial chemicals. The EPA recently announced it is creating a “Chemicals of Concern” list, which will detail substances that “may present an unreasonable risk of injury to health and the environment.” The power to do that was granted to the EPA under the 1976 law, but has never been used before.

Environment News Service reports:

Jackson says the 1976 law is both outdated and in need of reform. The decision to list the chemicals further signals “this administration’s commitment to aggressively use the tools at its disposal under TSCA,” she said.

“At the same time,” Jackson said, “I will continue to fight for comprehensive reform of the nation’s outdated chemical management laws that ensures a full assessment of the safety of chemicals on the market today and effective actions to reduce risks where chemicals do not meet the safety standard.”

“Chemical safety is an issue of utmost importance, especially for children, and this will remain a top priority for me and our agency going forward,” said Jackson, who is a mother.

In a press release, the EPA noted that, since the 1976 law was put on the books, the number of listed chemicals used in the US has increased from 60,000 to more than 80,000, but the EPA “has only successfully restricted or banned five existing chemicals and has only required testing on another two hundred existing chemicals.”

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Two Leading Medical Journals Criticizing FDA

December 30, 2009 by joel  
Filed under Health

December 30, 2009

The Wall Street Journal

By Jared A. Favole and Alicia Mundy

Two leading medical journals found weaknesses in how the Food and Drug Administration approves cardiovascular medical devices, saying some products reached the market based on tests that were inadequate and open to bias.

The studies come as the FDA is facing intense pressure to overhaul the medical-device approval process following several incidents in which the agency acknowledged missteps, including the case of a knee device that was approved a year ago under political pressure.

Jeffrey Shuren, acting director of the FDA’s device division, acknowledged weaknesses in clinical trials used to approve some cardiovascular devices. One of the studies was co-authored by an FDA scientist. Dr. Shuren said the FDA has begun toughening standards for device approvals and intends to do more.

Dr. Shuren said he wanted companies to work closely with the FDA in setting specific goals for their studies, which hasn’t always been the case. “We want to be clear to manufacturers about what is expected of them,” he said.

One of the articles, published Tuesday in the Journal of the American Medical Association, or JAMA, says many cardiovascular devices are approved based on a single study; most drugs go through several layers of testing.

Many heart devices are implanted in patients and are essential to keeping them alive. They are subject to the FDA’s most stringent review process, but the JAMA study said the standards are still weaker than those used for drugs.

“The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can,” the researchers said in the JAMA paper.

The other study, published in the American Journal of Therapeutics, included as an author a medical reviewer in the FDA’s cardiovascular device division. The authors concluded that studies submitted to get a cardiovascular device approved “frequently lack important details” such as information about the people used in research.

The researchers for both articles looked at about 80 cardiovascular devices that were approved from 2000 through 2007. The JAMA article, by researchers at the University of California, San Francisco, was based on publicly available FDA summaries of the safety and effectiveness of the devices.

William Maisel of Beth Israel Deaconess Medical Center in Boston, who participated in the American Journal of Therapeutics study, said the unreliability of the data “is why we have been pushing the FDA to raise its clinical trial standards for medical devices.”

Janet Trunzo, an executive vice president at AdvaMed, the device industry’s main advocacy group, said the FDA spends 1,200 hours reviewing each device application, and companies submit myriad data to the FDA to get a device approved.

Ms. Trunzo also noted that the authors of the JAMA study didn’t have access to all of the data companies submitted to get devices approved.

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Meditation Helps Reduce Heart Disease Deaths

December 28, 2009 by Andrew  
Filed under Health

December 28, 2009

Natural News

By E. Huff

The Medical College of Wisconsin in conjunction with Maharishi University in Iowa funded a study about the effects of transcendental meditation on health. Researchers discovered that over the course of nine years, the group assigned to meditate saw a 47 percent reduction in strokes, heart attacks and deaths.

Two groups of African-Americans were assigned either to meditate or to make certain lifestyle changes. The group told to meditate was instructed to do so twice a day for 20 minutes. The other group was given instruction on traditional methods to reduce the risk of heart disease. After nine years, 20 incidences of stroke, heart attack, or death occurred in the meditation group while 31 incidences occurred in the health education group.

Dr. Robert Schneider, lead author of the study and the director of the Centre for Natural Medicine and Prevention at Maharishi University, stated that the meditation group experienced an overall reduction in blood pressure as well as a significant reduction in psychological stress. Supporters of transcendental meditation claim that the study proves the long-term positive effects of the practice on those who participate in it.

Researchers noted, however, that among those in the health education group, very few followed the instructions and made any sort of significant changes in their lifestyles. Such lifestyle changes may have proven more effective if group participants would have followed the instructions in the same way as those in the meditation group did. For this reason, the study does not accurately capture the positive benefits of lifestyle changes apart from meditation.

Because transcendental meditation involves spiritual practices that conflict with the beliefs of various other faiths, some may wish to pursue other avenues of achieving better health and preventing the onset of heart disease without violating their convictions.

CoQ10, omega-3 essential fatty acids (EFAs), vitamin C, B vitamins, and vitamin D are a few of the many vitamins and nutrients that work to maintain heart health. Blueberries are an excellent source of pterostilebene, a compound identified by the U.S Department of Agriculture (USDA) to help prevent heart disease and type-2 diabetes.

Resveratrol, another powerful antioxidant found in the skins of both grapes and blueberries has received a lot of attention recently for its powerful effects in bolstering cardiovascular health. A Harvard Medical School study showed that high doses of resveratrol given to obese mice allowed them to live long, healthy lives despite eating diets high in fat.

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