Category: Featured Articles

The “study” was led by Serbian scientist and “visiting researcher” at Copenhagen University Hospital, Goran Bjelakovic, whose name is now synonymous with vitamin meta-analyses (studies of other studies) which appear to show that vitamin supplements either don’t work or end up increasing your risk of death.  Two similar Bjelakovic “studies” on vitamin supplements, in October 2004 and February 2007, resulted in similar outbursts of negative international headlines.

Upon closer examination, the flaws in the so-called study are apparent.  First of all, in evaluating studies for inclusion, the authors omitted a massive 405 potentially eligible studies because there were no deaths in the studies and another 69 studies were excluded because they weren’t randomized controlled trials.

In other words, instead of conducting an honest review of all the studies, the authors arbitrarily eliminated all studies in which vitamins prevented mortality and kept people alive – leaving only the studies in which people died from various causes.  Most of the trials used pertain to already sick people being given very high dose, synthetic, isolated nutrients for relatively short periods – they therefore have no relevance to the vast majority of vitamin consumers.

When you select or reject studies on criteria that only mean something to statisticians, and ignore important things like duration, how long the study ran for — which ranged from 28 days to 14 years — your findings are immediately meaningless. Even the huge difference in dose of supplements between different studies was not deemed important – for example, Vitamin E ranging from 10 to 5000 units daily.

The studies in the latest meta-analysis not only relied on synthetic forms of vitamins, in most instances they relied on very high dosages of pharmaceutical-grade, synthetic forms of supplements manufactured by the pharmaceutical industry. The dosages used are typically much greater than those recommended on the labels of food or dietary supplement products. In most countries, the dosages used in the trials would be considered ‘medicinal’ by regulatory authorities and therefore would not legally be allowed for food or dietary supplements.

As a result, these studies actually apply only to synthetic forms of vitamins produced by the pharmaceutical industry in amounts much larger than most consumers would ever take. The authors of this latest Cochrane review state: “The present review does not assess antioxidant supplements for treatment of specific diseases (tertiary prevention), antioxidant supplements for patients with demonstrated specific needs of antioxidants, or the effects of antioxidants contained in fruits or vegetables.” This shows that the study has no relevance to natural sources of vitamins and minerals or antioxidants sourced from plants (e.g. flavonoids, anthocyanins, sulforaphanes, salvestrols/resveratrol, etc.), which are included in many of the leading-edge natural health supplements claiming potent antioxidant activity.

Make no mistake, this isn’t research. This is a re-analysis of studies that have been conducted and reported on previously, by a group of men with a known axe to grind, who have never produced a study favorable to supplements, which is itself statistically unlikely unless you have a bias.

There is extensive scientific evidence that higher intakes of vitamins in the forms and combinations consumed in the diet substantially reduce risk of killer diseases such as cancer and heart disease. In fact, it is this research (some of which is referenced in the introduction to both the JAMA and Cochrane papers) that has stimulated pharmaceutical companies to undertake research on pharmaceutical-grade, synthetic forms of supplements, which they manufacture.  As is often the case when pharmaceutical companies try to synthesize or unnaturally isolate compounds found in nature so they can patent and profit from them, their synthetic version have been largely disappointing.

A good source to see why their results have largely failed can be seen in this paper by the Alliance for Natural Health:

http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_231.pdf

As a final note on the study:  although presented as a “new”, the study is really no more than a rehash of a paper by the very same authors, published last year (February 2007) in the Journal of the American Medical Association (JAMA). Extensive international media followed the 2007 JAMA paper, including a front page articles in major newspapers telling consumers that vitamin pills could cause early death. The “new” study review relies on 67 of the 68 studies used in the JAMA paper.

The world pharmaceutical empire is a trillion dollar juggernaut whose continued profits depends on continued illness as well as a continued monopoly on approved medications and suppression of any alternatives which might provide prevention and treatment more effectively, more safely and less expensively – such as those found in nature.  And so there are a trillion reasons why we see the repeated headlines about misleading and flawed studies like this one on vitamins, minerals and other natural supplements that represent billions of dollars in potential lost profits due to improved health and competition with patented drugs.

The best possible model for profits would be a monopoly on side-effect laden drugs which lead to complications requiring yet more side effect laden drugs in a never ending cycle so that by the time a person reaches the age of 65 they take an average of 15 prescribed and over the counter medications daily when it all started with one or two conditions that could have been treated naturally.  A great model for profits and a horrible one for health and humanity.

The bottom line for all those who reject such a model:  don’t stop taking your vitamins, minerals and other supplements – especially those derived from natural sources which insure adequate amounts of daily nutrition vital to your optimum health.

Sources:

Alliance for Natural Health
Natural News
JAMA
Lancet

About the Author:

Tony Isaacs, is a natural health advocate and researcher and the author of books and articles about natural health including "Cancer's Natural Enemy" and "Collected Remedies"as well as song lyrics and humorous anecdotal stories. Mr. Isaacs also has The Best Years in Life website for baby boomers and others wishing to avoid prescription drugs and mainstream managed illness and live longer, healthier and happier lives naturally. He is currently residing in the scenic Texas hill country near Utopia, Texas where he serves as a consultant to the Utopia Silver colloidal silver and supplement company and where he is working on a major book project due for publication later this year. Mr. Isaacs also hosts the CureZone "Ask Tony Isaacs" forum as well as the Yahoo Health Group "Oleander Soup"

by Tara Parker-Pope 

 

How much a mother eats at the time of conception may influence whether she gives birth to a boy or a girl, a new report shows.

The report, from researchers at Oxford and the University of Exeter in England, is said to be the first evidence that a child’s sex is associated with a mother’s diet. Although sex is genetically determined by whether sperm from the father supplies an X or Y chromosome, it appears that a mother’s body can favor the successful development of a male or female embryo.

The study, published in the journal Proceedings of the Royal Society B: Biological Sciences, shows a link between higher energy intake around the time of conception and the birth of sons. The difference is not huge, but it may be enough to help explain the falling birthrate of boys in industrialized countries, including the United States and Britain.

The reason food intake may influence the development of one sex of infant rather than another isn’t fully understood. However, in vitro fertilization studies show that high levels of glucose encourage the growth of male embryos while inhibiting female embryos.

It may be that male embryos are less viable in women who regularly limit food intake, such as skipping breakfast, which is known to depress glucose levels. A low glucose level may be interpreted by the body as indicating poor environmental conditions and low food availability, the researchers said.

The findings are based on a study of 740 first-time pregnant mothers in Britain who didn’t know the sex of their fetus. They provided records of their eating habits before and during the early stages of pregnancy, and researchers analyzed the data based on estimated calorie intake at the time of conception. Among women who ate the most, 56 percent had sons, compared with 45 percent among women who ate the least. As well as consuming more calories, women who had sons were more likely to have eaten a higher quantity and wider range of nutrients, including potassium, calcium and vitamins C, E and B12. There was also a strong correlation between women eating breakfast cereals and producing sons.

The data are limited by the fact that they are based on self-reported food intake, which can be unreliable. However, the consistency of the trend offers an explanation for the small but consistent decline in the proportion of boys born in industrialized countries over the last 40 years, where even though women in general appear to be consuming more, eating habits have changed.

In the United States, for instance, the proportion of adults eating breakfast fell from 86 percent to 75 percent between 1965 and 1991. And although women may be eating more overall, a nutrient-poor diet could be less favorable to a male embryo. Glucose levels may also fluctuate in women who are dieting and trying to lose weight prior to pregnancy. In animals, more sons are produced when a mother ranks high in the group or has plentiful food resources.

From The Economist print edition

ANCIENT Phoenicians stored their drinking water in silver vessels, but not for aesthetic reasons. They discovered that by doing so they remained healthier. The reason for that is now understood: silver has antimicrobial properties.

by Ron Paul 

 

Taxes were on the forefront of many Americans’ minds this week as they scrambled to meet the April 15th deadline to file their returns.  Tax policy in this country hurts taxpayers twice – once when they pay taxes, and then when the government spends the money.  Americans are sick and tired of the financial burden and the endless forms to fill out.  To add insult to injury, after collecting this money the government does some very detrimental things to the economy.

The burden of complying with the income tax is tremendous.  Since its inception in 1913, the tax code has gone from 400 pages to over 67,000.  The Tax Foundation estimates that around $265 billion dollars and 6 billion hours are spent just on compliance.  That expense amounts to about 22 cents of every dollar the IRS collects.  Imagine the boon to the economy if we spent that time and money expanding our businesses and creating jobs!

Aside from the direct loss of money and productivity, the funds from the income tax enable the government to do some very destructive things, such as vastly over-regulating economic activity, making it difficult to earn money in the first place.  The federal government funds over 50 agencies, departments and commissions that formulate rules and regulations.  These bureaucracies operate with little to no oversight from the people or Congress and generate around 4,000 new rules every year and operate at a cost of about 40 billion dollars. There are some 75,000 pages of regulations in the Federal Register that Americans are expected to know and abide by.  Complying with these governmental regulations costs American businesses more than one trillion dollars per year, according to a study by Mark Crain for the Small Business Administration.  This complicated system drives production to other countries and shrinks our job market here at home.

Big government is destructive when it takes your money and when it spends it.   There is no economic benefit to supporting a government sector as massive as ours.  In fact, this country thrived for well over 100 years without an income tax.  Today, if you took away the income tax, the government would still have revenue from other sources equal to total government spending in 1990, when government was still too big.  $1.2 trillion should be more than enough to fund a government operating within its constitutional confines, and that is exactly what we need to get back to.

I have introduced legislation many times to abolish the IRS and the income tax.  It is fundamentally un-American to require taxpayers to testify against themselves and be considered guilty until proven innocent.  Abolishing the IRS altogether would trigger an avalanche of real growth in the economy.

With these financial hard times only just beginning, this would be the most efficient and logical way to get our economy growing again, and Americans would need not dread the 15th of April every year.

Our Disappearing Minerals and The Vital Role They Play in our Health
First in a series by Tony Isaacs author of Cancer's Natural Enemy

"You can trace every sickness, every disease, and every ailment to a mineral deficiency." – Dr. Linus Pauling, two-time Nobel Prize winner

by Michael Kabel

It´s a devastating disorder that strikes as many as six out of every thousand children in the United States alone.

Autism, sometimes called "classical autism," is one of the five developmental disorders collectively known as Autism Spectrum Disorders, or ASDs. The signs are often marked and startling, and can lead to intense difficulties for children growing up and later functioning in the everyday world as adults. The disorder is also often heartbreaking for parents who feel powerless against its effects.

As public awareness of the disorder´s widespread presence grows, new research is diving headlong into the search for a cure, including ways to regulate diet and lifestyle in order to manage and minimize symptoms. While there´s still no known solution, patients and their families are quick to point out that autism is a disease, not a disability.

Understanding Autism and the Autism cluster

Autism is one of the five known Pervasive Developmental Disorders (PDD´s), which are characterized by the presence of several telling and compelling symptoms. Of the other four, Asperger´s syndrome is very similar in neurological basis to classical autism, while Rett Syndrome, Childhood Disintegrative Disorder, and a miscellaneous grouping of symptoms known as PDD-Not Otherwise Specified (or PDD-NOS) have similar signs but different causes.

In particular, Asperger´s Syndrome is sometimes understood as a milder form of autism. Children with very mild symptoms of too little severity to make a formal diagnosis are sometimes also considered as having PDD-NOS.

Autism is understood as a spectrum disorder because its symptoms and traits routinely present themselves in a variety of conditions and levels of severity. Even children with approximate diagnoses can still exhibit vastly different behavior. There is a strong hereditary factor to autism´s presence, and male children are four times more likely to have it than females.

Autism and other disorders

Children with autism are often at higher risk for neurological and learning disabilities, including Tourette syndrome, Attention Deficit Disorder, and Martin-Bell syndrome (a leading cause of mental retardation.) As many as thirty percent of autistic children develop epilepsy before reaching adulthood.

Autism is a complex and life-long condition.

Autism symptoms usually begin during infancy or early childhood and continue without remission – the symptoms are constant and pervasive throughout the patient´s life. Medical researchers believe it comes from a neurological disorder deep within the brain´s chemistry.

Autism´s basic symptoms are easy to identify.

Autism´s symptoms are easily recognized in children – sometimes alarmingly so. Typical symptoms include a variety of behavioral disorders, including impaired social interaction, repetition of hand and body movements and other compulsive behavior, impaired speech and communication skills, and limited interests or activities.

At their most severe, symptoms can totally prevent speech and make impossible even the most basic social and environmental interactions.

Spotting the early warning signs.

Autism´s most telltale sign is lack of social interaction during infancy. The child may be unresponsive to stimuli or appear unwilling to engage in interaction with one or both parents. Autistic children may also develop normally at first but then retreat from social interaction when prompted. As symptoms manifest, children will fail to answer when their name is called or refuse to return conversation. They may also avoid eye contact and shun new faces and personalities introduced into their surroundings.

Some of the more visibly obvious symptoms of autism and its related disorders come from repetitive behavior. Parents of children up to three years old should be aware that such behavior may indicate autistic tendencies.

Understanding repetitive behavior

Many younger children with autism often rock their bodies or move their limbs in a highly repetitive fashion, a condition known as stereotypy. They may also harm themselves with biting, clawing, or scratching at their limbs and bodies. Witnessing such behavior is often frightening, not least of which for parents and siblings. Nevertheless, it´s important to remember that the autism patient is unable to control their actions – the behavior is involuntary.

Autistic children sometimes engage in compulsive behavior such as organization or classification of normal everyday objects. Such activities can include stacking or linking together toys and accessories found in the nursery or throughout the house. Other behavior may include a marked and emotional resistance to change in daily routine, and an insistence that daily activities be performed the same way each time.

Restricted behavior includes fascination or preoccupation with the same stimulus over and over again, without a loss of interest. Autistic children sometimes insist on watching the same television show or hearing the same story; again, they can become quite emotional if this perceived routine is changed.

The autism diagnosis

Because the severity of autism varies almost from child to child, doctors are often extremely cautious in making a formal diagnosis. They will instead use a series of questionnaires and interviews with children and their parents to gauge its necessity. Patients and their families can understand autism as a "diagnosis of last resort" – applied only when other potential explanations for symptoms have been exhausted.

The formal diagnosis is obtained through a thorough and complex procedure, involving the consultation of the doctor, a neurologist, psychiatrist, a speech therapist, and possibly other professionals knowledgeable in autistic symptoms. In particular, doctors will often request that a child have their hearing tested before concluding a diagnosis. Behavior stemming from hearing and speech development problems often mirror autistic behavior.

Understanding the causes of autism

While an exact cause is yet to become identified, scientists strongly believe a combination of genetics and environment play a role. Research has already discovered several genes they believe play a contributing factor.

Another theory believes that increased or abnormal amounts of neurotransmitters such as serotonin contribute to autism by hampering early brain development. While genetics play a key part (as evidenced by the strong hereditary component), autism has yet to become traced to a single gene or chromosome abnormality or mutation.

In recent years a growing and vocal group of parents of autistic children have advocated a theory linking early and heavy vaccinations with autism disorders. In particular, some believe that heavy metals such as ethyl mercury used in vaccine preservatives results in a form of heavy metal poisoning, the effects of which are very similar to autism.

Though conclusive evidence one or way or another is still forthcoming, many doctors and researchers have called for the removal of heavy metals from vaccines or a slower vaccination schedule as a safety precaution until a link is proven or debunked. The state of California began a phase-out of ethyl mercury from vaccines beginning in 2000; autism diagnosis rates there have since fallen six percent. Because vaccinations are regulated at the state level, legislation regarding the issue elsewhere has been slow in coming.

Proponents of the "vaccination theory" urge parents to parse out their children´s vaccinations over the first two years. They point to a study by the Center for Disease Control indicating that slower vaccination schedules are just as effective as faster-paced regimens in preventing their respective diseases.

Treating the symptoms of autism

The Autism Society of America (ASA) is quick to point out that the word "treatment" is used in a very limited sense, owing to the diversity and severity of symptoms. Nevertheless, symptoms often improve with age and concentrated therapy, and some autistic children can grow up to lead normal, fully functional lives.

Because there is no cure for autism, doctors instead focus their treatment on helping patients manage the symptoms. Early diagnosis is important, and intensive special education programs focus on helping children overcome symptoms and to control behavior.

Medications for autism

The use of medications is hampered somewhat by the very neurology of autistic patients. Because autism sufferers possess extremely sensitive nervous systems, coming to a widespread prescription protocol is all but impossible. The ASA does not formally endorse any medications or treatment approach; instead, they recommend that each patient seek out the best treatments options for their own symptoms.

Some medications have proven successful in treating different symptoms. For example, serotonin reuptake inhibitors treat much of the obsessive-compulsive behavior and anxiety common in many patients. Common brand names of such medications include Prozac, Anafranil and Luvox.

Other anti-anxiety drugs and antidepressants such as Wellbtrin, Ativan and Xanax lack formal study via-a-vis autism but may offer powerful aids to controlling behavior. However, each one carries the risk of serious side effects.

The stimulants Ritalin, Adderall, and Dexedrine have been given as a means of controlling hyperactivity in mild autistic cases. However, their dosages require constant scrutiny and frequent modulation.

Anti-psychotic medications have received extensive study over the past several decades. So far, only Risperidone has received FDA approval for treatment of adults with autism.

Nutritional and vitamin approaches to management and treatment

Many parents are now seeking alternative approaches to symptom management that include dietary supervision and the steady use of vitamins and minerals. In particular, parents are regulating their autistic child´s intake of gluten and the dairy protein casein in order to encourage strong autoimmune responses that may help curb symptoms.

Vitamins and minerals used regulate symptoms include Vitamin B-12, Omega-3 Fatty Acids, Magnesium, and Colloidal Silver. Daily-recommended dosage guidelines should be strictly followed, so as to prevent overdosing of these materials.

Michael Kabel is senior staff writer for Corner Stork Baby Gifts.com. Stop by for parenting and baby resources, unique baby gifts, baby gift baskets and baby shower favors.

By Anna Boyd

A new TV ad, featuring a woman suffering from extreme back pain, is the first in a new series meant to urge Governor Tim Pawlently not to veto a bill in order to protect suffering Minnesotans from arrest for using medical marijuana under a doctor’s recommendation.

The upshot of the report is that tens of millions of Americans are unwittingly being subjected to a bizarre medical experiment with unpredictable results. No scientist can say for certain whether long-term exposure to micro doses of multiple pharmaceuticals is safe because such an experiment has never before been conducted on any population.

One of the most startling realizations of the study is that Americans are now using so many medications that their own biological waste products are becoming large-scale environmental pollutants. Yet neither the EPA nor drug companies have yet said anything useful about attempts to protect the environment from the chemical toxicities of pharmaceutical waste. Drug companies have so far pretended the problem doesn't exist. Their goal is to simply sell more drugs, and they seem to be entirely unconcerned about what happens after a typical medication consumer flushes the toilet and sends the toxic chemicals downstream.

If trace amounts of multiple pharmaceuticals are now in the tap water supplies, it also means that any use of tap water involves the further spread of those pharmaceutical chemicals. Watering your lawn, for example, means spraying small amounts of pharmaceuticals on your lawn. For ranchers, watering their cows, pigs or chickens also means dosing those animals with small amounts of pharmaceuticals, and for public schools in the affected cities, all the water fountains used by the children are now functioning as mass medication dispensing machines.

The most dangerous medical experiment in the history of our nation

The mass medication of America has now turned into a grand medical experiment that exposes infants, children, expectant mothers, senior citizens, voters, law enforcement officers, doctors and everybody else to a combination of drugs known to have extremely dangerous, mind-altering side effects when taken in full doses. And yet this mass medication of the population is being conducted with no doctor visits, no prescriptions, no consent and no medical assessment whatsoever. It is essentially a mandatory medication carpet-bombing of the entire population.

We can only guess what the results will be a generation from now. But clues can be gathered by watching the impact of such drugs on aquatic organisms. Amphibians exposed to very low doses of these types of chemicals, for example, begin to grow dual sex organs and suffer widespread infertility problems. Deformities in fish are being increasingly reported in rivers, and the world's oceans now have over a hundred "dead zones" where agricultural runoff and medication runoff have combined to form a toxic aquatic poison that kills all fish. This is the same water being used to create tap water in U.S. cities.

What's in recycled urine, anyway?

I remember hearing people snicker when they learned that NASA was recycling urine on the space shuttle and that astronauts would be drinking each other's recycled urine. Well guess what, folks? In major U.S. cities, almost everybody is drinking somebody else's recycled urine!

And guess what's in that urine? Toxic medications, caffeine, painkillers, and a cocktail of other chemicals like personal care product fragrances, pesticides and more. It's enough to make you sick. Literally.

Guess what else? This is the water used to make sodas and other beverages at local bottling plants. So every time you pick up a can of soda and drink it, not only are you getting the dangerous chemicals intentionally added to those sodas — like aspartame and phosphoric acid — you're also getting trace amounts of medication chemicals recycled from other peoples' urine, too! Yum!

Water treatment plants don't remove medication chemicals from the water!

Many consumers mistakenly believe that water treatment plants actually remove these contaminants, but that's not true. Municipal water treatment facilities do remove large solids (like dirt, sand and leaves), but they only sanitize the water by adding chlorine to kill microorganisms. They don't actually remove toxic chemicals from the water. Only distillation — a highly energy-intensive process — removes everything from the water (including the minerals).

A few cities treat their water with ozone, which is a far healthier method that avoids the use of toxic chlorine (which is linked to bladder cancer). Ozonation can break down some — but not all — medications. So what about countertop filters that use carbon blocks? I'm going to find out the answer to that question later this week when I interview Aquasana, the company that makes countertop filters and shower filters. I'll be sure to ask them for technical details about the ability of their filters to remove trace amounts of pharmaceuticals. That's suddenly an increasingly important question to consumers who don't want to consume toxic chemicals in their water.

Terrorists couldn't have done a better job of poisoning America

What's really interesting in all this is that the water supply is often cited as a security vulnerability to the nation; a weakness in the defense where terrorists could easily dump chemicals and poison the American people. But why would they bother? Drug companies have already poisoned the water supply for them!

And just in case the medication chemicals in the water aren't enough to poison the nation, many water treatment facilities add even more poison in the form of artificial fluoride chemicals that cause bone loss and weaken the immune system. Terrorists could hardly do a better job of poisoning the water supply than what corporate America has done already… with the help of criminally negligent government regulatory agencies, of course.

That brings us to the Environmental Protection Agency, a corrupt organization that has now sold out to big business. Read the following article to learn how the EPA now conspires with the chemical industry to censor scientists who try to protect the public from toxic chemicals: http://www.naturalnews.com/022773.html

The EPA has taken no action whatsoever to regulate or eliminate the presence of pharmaceutical chemicals in the water supply. Apparently, the EPA doesn't mind the fact that infants, babies and pregnant women are now drinking six different medications in their tap water. The agency remains either silent on the issue or in agreement with the corrupt scientists who say the levels of contamination are too low to really matter. But in truth, nobody knows the health effects of combining multiple low-dose pharmaceuticals and feeding it to the population. Anybody who says there's no risk of harm is simply lying.

How to avoid contaminated water

The solution to all this? On a personal level, you'll need to avoid drinking tap water, period. Or filter it really well. Distillation, as I mentioned, is very energy intensive (which makes it bad for global warming), but it does get the water very, very clean. Other consumer-level water filters may remove some amount of pharmaceuticals, but I don't have all the facts on that yet, so I'm not going to make any recommendations until I learn more.

By Salynn Boyles

(WebMD) Two studies appearing in the Journal of the American Medical Association have prompted the journal's editors to call for "drastic action" to prevent drug companies from misrepresenting data from clinical trials.

The two investigations involve the pain medication Vioxx, which was taken off the market in 2004 after being linked to an increased risk of heart attacks and strokes among long-term users. The revelations are the latest to come to light from lawsuits brought by people who claimed they'd been harmed by Vioxx.

Researchers charged that the drug's manufacturer, Merck, withheld key data from Vioxx trials from federal regulators and misrepresented the Vioxx research. The JAMA editors agreed, but they added that the problems are pervasive within the industry and not confined to Merck.

"The (two studies) document how one company, Merck & Co. Inc., apparently manipulated dozens of publications to promote one of its products," the journal's editor in chief and executive deputy editor write. "But make no mistake — the manipulation of study results, authors, editors, and reviews is not the sole purview of one company."

Merck Responds to Criticism

In one of the JAMA articles, researchers charge that data from clinical trials showing a threefold increase in deaths among Vioxx users were withheld from the FDA for more than two years.

In their review of the data and internal company documents made public during civil litigation against Vioxx, the two researchers from the University of Washington, Seattle say the company appears to have misrepresented Vioxx's safety profile in studies involving Alzheimer's patients.

In a separate analysis of the court documents, another group of researchers concluded that Merck misled federal regulators and the public about its role in the Vioxx studies by naming outside investigators who had little to do with those studies as principal investigators.

A spokesman for the company tells WebMD that both charges are unfounded and that the company plans to formally respond to the JAMA editorial.

"All of Merck's disclosures to the FDA and the medical community were proper and appropriate," Merck legal spokesman Kent Jarrell says.

"We heard the points presented in these articles during the litigation and we rebutted them with evidence," Jarrell says. "It was a case of trial lawyer's antic masquerading as scientific substance."

JAMA Calls for Reforms

The JAMA editorial notes that the "manipulation of studies and misrepresentation of study results could not have occurred without the cooperation (active and tacit) of clinical researchers, other authors, journal editors, peer reviewer, and the FDA."

It further noted that the public's trust in clinical research is in great jeopardy because the extent of the problem is not known.

"Although we truly believe that the vast majority of researchers and other authors are honest and have the highest scientific integrity, manipulation of studies and publications by the pharmaceutical and medical device industries is either increasing or there has been more exposure of these practices," JAMA editors Catherine D DeAngelis, MD, and Phil B. Fontanarosa, MD, write.

They go on to propose reforms aimed at minimizing the influence of the pharmaceutical industry on the clinical trials process, including registering all clinical trials prior to patient enrollment and full disclosure of the relationships of study authors with the companies paying for the research.

Vioxx Study Deaths Underreported

The University of Washington review included data from two studies designed to determine if Vioxx had a role in the treatment of Alzheimer's disease.

Researchers Bruce M. Psaty, MD, PhD, and Richard A. Kronmal, PhD, compared the two published trials to inernal Merck documents about the studies made public during the court trials.

Psaty tells WebMD that internal documents show that as early as spring 2001 Merck identified a threefold increase in the risk of death among Vioxx users vs. patients taking placebo, but the information was not given to federal regulators.

"These analyses were not submitted to the FDA or the public in a timely fashion, and when Merck did submit the data to the FDA, they used accounting methods that minimized the appearance of risk," he says.

Specifically, Psaty says the company's April 2001 analysis of pooled data from two trials identified 34 deaths among 1,069 Vioxx patients and 12 deaths among 1,078 patients in the placebo arms of the studies.

"If you were to ask independent scientists whether a threefold increase in mortality represented a safety problem, I think you would be hard pressed to find many, if any, who would say no," Psaty says.

But Psaty says safety data submitted by Merck to the FDA a few months later showed a smaller difference in deaths between the Vioxx and placebo-treated patients because the company included only the patients who were actually taking the treatment they were assigned to take.

"This on-treatment approach to reporting minimized the appearance of any mortality risk," Psaty and Kronmal write.

In the other review of the court documents, Joseph Ross, MD, of New York's Mount Sinai School of Medicine, and colleagues conclude that Merck misrepresented the authorship of many Vioxx studies by recruiting outside investigators with impressive academic affiliations.

These investigators were often listed in the published studies as first, second, and third authors, even though they had little active role in the research, which was done internally by Merck, Ross tells WebMD.

"This gave the appearance of more academic rigor and more objectivity than there actually was in these studies," Ross says.

Merck Calls Reports Misleading

In a written statement, the company says it is the authors of the two JAMA studies who misrepresented the facts by failing to provide appropriate context for their claims.

"Merck is disappointed that we did not have an opportunity to respond to the misleading claims made in these articles prior to their publication," the statement reads. "We believe that a full, unbiased evaluation of the Merck papers shows that many of the conclusions put forward by the authors of the JAMA papers are incorrect."

In the statement, Merck officials say the review of deaths in the Alzheimer's trials was misleading because it failed to include information about the causes of death among the patients in the Alzheimer's studies.

"Merck carefully analyzed the data and found that there was no pattern suggesting the deaths had any connection to Vioxx; some of the deaths were caused by car accidents, poisonings, infections, and other causes that are not related to Vioxx," the statement reads.

Jarrell says the authorship review misrepresented the role of the academic authors involved with the studies.

"We certainly feel that our actions on disclosure were appropriate and in line with industry practice," Jarrell tells WebMD. "And, most importantly, the data in the articles were completely accurate."

Merck agreed to pay $4.85 billion last November to settle lawsuits brought by people who claimed to have been harmed by Vioxx.