Why Big Pharma Continues To Lie About Avandia

July 22, 2010

Natural News

By: Mike Adams

Sometimes the degree of fraud that takes place in the drug industry is so mind-boggling that it’s hard to determine whether drug regulators and the media are paying attention at all. For the past several months, drug giant GlaxoSmithKline (GSK) has been under scrutiny for tampering with clinical trial data for its diabetes drug, Avandia. Reports show that the company lied about Avandia’s safety in order to get the drug approved and keep it on the market. But despite numerous pieces of credible evidence and witness testimonies that have all come forward — all of which reveal GSK’s deception — an FDA advisory panel is still recommending that Avandia remain on the market.

Back in February, a Senate Finance Committee report revealed that not only is Avandia dangerous, but GSK knows this and has deliberately tried to hide this crucial information from the public. The report even goes so far as to openly name the FDA as a culprit in conspiring with GSK (and other drug companies) to deceive the public. (You can read the article I wrote about this report at: http://www.naturalnews.com/028233_G…)

Right after this extensive report was released, an FDA advisory panel voted 22 – 1 in favor of keeping the drug on the market. And just a few days ago, another FDA panel did the same thing following official hearings that showed even further that GSK committed fraud in getting Avandia approved. (It has since been revealed that at least one expert on the FDA panel voting for Avandia’s approval was on the take, receiving “speaking fees” from GSK. But no one seems to care about this disturbing fact…)

You can read the details of the report at the following link:
http://finance.senate.gov/newsroom/…

The lies and manipulation of GlaxoSmithKline

Pharmaceutical companies are notorious for skewing the truth in order to get their next blockbuster drug approved for sale. These companies are vicious, money-hungry, multi-national corporate monsters that will stop at nothing to make an obscene profit, even if it means exposing their customers to harm.

It’s one thing for a company that sells, say, televisions, to lie about the quality of its product. Nobody ultimately dies from false claims about a poor quality TV and, if found guilty, the company that produced the TV will likely be held liable for any crimes it committed through deceptive marketing. But when it comes to drug companies that peddle dangerous toxins as medicine, it’s a whole different story.

Sadly, Big Pharma is one of the most protected industries on the planet. Big Pharma gets away with murder (literally), and nobody really seems to care. You and I would be hauled off to jail immediately for doing even a small fraction of what Big Pharma does, but when Big Pharma does it, the blinders go up because observers falsely believe that drugs are “science-based”, and that the wonderful drug companies would never do anything to harm us.

Such thinking is pure foolishness, of course, especially when you examine the plain facts in the GSK case.

Hiding the truth

First of all, internal documents reveal that GSK knew about the dangers of Avandia since the early days of its development, but didn’t disclose any of this information to the public or to the FDA. And why would they? The FDA, according to the same reports, has been in collusion with GSK since the beginning to hide the truth, so GSK has had no reason to disclose anything.

Think about it. GSK created a diabetes drug that, at its high point, was raking in more than $3 billion a year in profits. GSK spent millions of dollars for research and development of the drug, paid for the clinical trials, and purchased approval from the FDA for the several million dollars it costs to complete the FDA drug application. And GSK did all this knowing full well that the drug causes a substantial increase in the risk of heart attacks and death.

With all of this in mind, do you really think that the company is now going to simply own up to the fact that it lied, and willingly agree to have the drug pulled from the market?

Truth be told, drug companies like GSK practically never tell the truth. They don’t have to. Even when their racket gets exposed, it all gets glossed over and covered up by the bureaucrats in our government agencies.

GSK’s flawed safety studies

It’s amazing to me just how many people put their trust in the “safety studies” the drug companies conduct on their own drugs. That such studies are considered credible by anyone just goes to show you that critical thinking skills are severely lacking among both the public and members of the medical profession.

Drug companies spend millions of dollars on studies and clinical trials that are designed to show that their drug is safe, and with enough manipulation, they usually get the results they’re looking for. These studies have little or nothing to do with actual science or unbiased inquiry; it’s all about using “pretend science” to produce a result that will allow them to achieve FDA approval.

And this scenario is no different in GSK’s trials for Avandia which, according to reports, didn’t properly reflect the inherent dangers of the drug.

When challenged about her concerns over the quality of GSK’s safety data for Avandia, Dr. Nancy Geller, a member of the FDA advisory committee and director of the Office of Biostatistics Research at the National Heart, Lung, and Blood Institute, responded by explaining that clinical trial data is “not [reliable] if you report the wrong follow-up date and not if you withdraw someone from a trial just before their death.”

In other words, drug companies change all sorts of things during a trial in order to achieve a desired result (which makes them anything but trustworthy). This includes removing people from the clinical trial right before they die in order to avoid having a death statistic show up in the final data. Oh look, is Mary about to expire? Hurry, kick her out of the testing group before she ruins the safety record of our drug!

These are the types of things GSK was doing to hide the truth about Avandia. To call these clinical trials “scientific” is an affront to the entire science community. And yet, somehow, the scientists continue to go along with all this…

According to a leaked internal GSK email, study results from a 1999 trial of Avandia that found the drug to be dangerous were intentionally kept “under the radar”. Dr. Martine Freed, a GSK company executive, explained in that same email that none of the data from that particular study should “see the light of day to anyone outside of GSK.”

Bloomberg’s BusinessWeek has the full report on the FDA Panel’s evaluation prior to its Wednesday vote: http://www.businessweek.com/lifesty…

FDA orders GSK to do another trial

The funny thing about all this is that, in light of the concerns over GSK’s trial tampering, the FDA actually ordered the company to conduct another trial to reevaluate Avandia’s safety. How this was expected to accomplish anything productive is anyone’s guess, considering that GSK lied about the previous trials. What makes the FDA think that a new trial is going to be beneficial? (But remember, insanity is doing the same thing repeatedly and expecting different results, and the FDA isn’t anything if not insane…)

But that’s the way the game is played between the FDA and Big Pharma. It’s a never-ending circus of so-called investigations and busywork designed to fabricate the results they’re looking for. Nobody asks the tough questions, and nobody ever states the obvious which, in this case, is that GSK committed fraud and must be held criminally responsible. The two entities work hand-in-hand to fulfill an agenda that’s based on greed and nothing more. Science is abandoned from the start.

FDA panel refuses to support pulling Avandia from the market, let alone prosecute GSK

So after witness testimonies (one of which you can read about here: http://www.businessweek.com/news/20… ) and a pile of credible evidence presented as part of the mounting case against GSK, an FDA advisory panel voted last Wednesday to recommend that Avandia remain on the market, according to a Wall Street Journal report. Twenty of the 33 members ultimately voted against pulling Avandia from the market, and the FDA is expected to make its final decision about the drug soon, based on this recommendation.

You can read the full Wall Street Journal article here: http://online.wsj.com/article/BT-CO…

Members of the panel who voted against pulling Avandia from the market explained to reporters that they believe there isn’t strong enough clinical data to show that Avandia is dangerous. But how much more evidence do these panel members need to conclude that there’s a problem?

If evidence of falsified study data and reports showing that Avandia is dangerous isn’t enough, it’s difficult to say whether any amount of evidence would ever be enough for these people. According to the BusinessWeek article, the FDA itself even posted official remarks on its website stating that GSK mishandled its earlier Avandia trials, but apparently even that isn’t enough for some of the FDA advisory panel members to put two and two together.

It seems that even if GSK came right out tomorrow and admitted that Avandia is dangerous (which the company’s leaked internal emails basically reveal on their own), some members of the FDA advisory panel would argue with the company itself, saying that there’s not enough evidence and that the drug should stay on the market.

And what about the potentially 100,000 heart attacks and deaths that may be linked to Avandia? Aw, just sweep that under the rug. Pretend it doesn’t exist. Dead people don’t talk, and they don’t sue corporations either, so that’s nothing to be concerned about.

All diabetes drugs are dangerous, Avandia is just more dangerous

Oddly enough, the primary issue with Avandia in this case isn’t just that it causes heart attacks or that the company lied about its research, but rather that Avandia trials show the drug appears to be more dangerous than competitor’s drugs like Actos. In fact, the main focus at the hearing was whether or not GSK had falsified study data to make it look as if Avandia isn’t any worse than Actos.

In reality, both Actos and Avandia can cause heart failure. They both come from the thiazolidinediones family of diabetes drugs, and they’re both potentially dangerous. In fact, both drugs bear the FDA’s “black box” warning label, which is the agency’s most extreme warning label.

So you’ve really got these two drug companies arguing over which of their drugs kills fewer people. And achieving that requires distorting a lot of clinical trials, burying other trials, spreading the money around to FDA panel experts and other similar criminal activities which now seem to typify Big Pharma.

What’s now obvious to us all is that GSK lied about the safety of Avandia, and it has harmed untold numbers of people as a result. According to a statistical analysis in the Senate Finance Committee report, more than 83,000 heart attacks have been caused by Avandia. Several hundred people reportedly die every month because of Avandia.

So removing Avandia from the market is only a very small part of the equation. True justice will be served when GSK is held criminally responsible for lying to the FDA and deceiving the public. GSK’s greed is harming and killing thousands of people every single year, and regulators are bickering over whether or not Avandia is a little more dangerous than Actos. Something is seriously wrong with this picture.

I’ve mentioned this before in previous articles, but there actually is a cure for diabetes, and it doesn’t involve either Avandia or Actos. You won’t hear about it from the mainstream media or the medical industrial complex, but we’ve got some great resources here on NaturalNews that talk all about it, and you can find those at: http://naturalnews.com/diabetes.html

The truth is no person needs to take Avandia or Actos. Both drugs are needless, irrelevant and entirely outmoded. Simple foods and nutrition can cure diabetes, especially when tied to small doses of regular physical exercise. Rather than pushing dangerous, deadly drugs onto patients, our nation’s doctors should be well versed in nutrition and exercise physiology. They should be recommending radical changes in the diets of diabetic patients to get them off all refined, dead foods and onto fresh, living foods and superfoods.

This is the true answer to our nation’s diabetes pandemic. But of course teaching patients how to take care of their own health never made a dime for Big Pharma. And sending a patient home with the knowledge they need to stay well and avoid hospitals and doctor visits never made any money for the doctors.

America’s health system isn’t designed to keep you well, or cure your disease, or even prevent disease. It’s designed to sucker you into a system of pharmaceutical dependency that’s fronted by drug-pushing physicians who for the most part believe that patients have virtually no role in their own health or disease — and only doctors know what they’re talking about.

That might carry some weight if the doctors themselves weren’t dying of cancer, heart attacks and strokes — all at a rate much higher than the general public. There are a lot of sick, dying conventional MDs out there. They’re all on pharmaceuticals. They all believe in the “science” of Big Pharma. And they’re all paying for that foolish gullibility with their lives.

Don’t you make the same mistake.

And just for the record, there are also some really good MDs who don’t buy into Big Pharma’s lies and who actually follow a more holistic, natural lifestyle. If you can find one of those, stick with them!

click here to read full article

Avandia Now In FDA’s Hands

July 14, 2010

USA Today

by Rita Rubin

A large clinical trial of Avandia, sponsored by its maker, “was inadequately designed and conducted to provide any reassurance” that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday.

The lengthy memo by Thomas Marciniak, a medical team leader in the Division of Cardiovascular and Renal Products, is part of a 765-page briefing document prepared by FDA scientists in advance of next week’s advisory committee meeting on Avandia’s fate.

The RECORD trial, a study ordered by the European Medications Agency, enrolled 4,447 patients. It compares Avandia, the trade name for rosiglitazone, combined with metformin or a sulfonylurea, which are two other diabetes drugs, to metformin combined with sulfonylurea.

It is an “open label” trial, which means that the patients and researchers are aware of who’s getting which drugs, knowledge that could bias the findings, Marciniak wrote.

He cited a number of other problems with the study, including a lack of complete information about which study participants had died, information that could have made Avandia look riskier.

Next Tuesday and Wednesday’s advisory committee meeting will be the second in three years to review Avandia’s risk/benefit profile.

At a July 2007 meeting, the panelists voted 20-3 that Avandia did raise heart attack risk. Yet, the panel voted 22-1 to recommend keeping the drug on the market. The FDA usually, but not always, follows its advisory committee recommendations.

Although their terms have expired, the FDA has taken the unusual step of inviting the 2007 advisory committee members to vote alongside their successors at next week’s meeting.

Concerns surfaced in ’07

Concerns about Avandia’s safety were raised in May 2007, when Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, and coauthor Kathy Wolski published a report in The New England Journal of Medicine suggesting Avandia increased users’ risk of heart attacks. That term refers to problems related to an inadequate blood supply to the heart, including angina and heart attacks.

In February of this year, an investigation by the Senate Finance Committee concluded that maker GlaxoSmithKline, or GSK, knew of possible Avandia heart risks for several years before publication of Nissen’s study.

In a statement Friday, Murray Stewart, vice president for clinical development at GSK, said the company stands by its conviction that Avandia does not have unique cardiovascular risks.

“Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia,” Stewart said, “and together they show that this medicine does not increase the overall risk of heart attack, stroke or death.”

The FDA has compiled a list of eight questions for the advisory panel members to consider. The next-to-last question asks them to recommend a specific regulatory action, ranging from keeping Avandia on the market and removing all warnings on its label about heart attack risk to pulling the drug off the market.

A split decision?

Committee members have their choice of five answers to that question, reducing the odds “of an overwhelming/unanimous vote for any one option,” according to a report released Friday by Concept Capital’s Washington Research Group, which advises institutional investors.

The Concept Capital report speculated that the FDA advisory panel might end up evenly split between allowing Avandia to stay on the market, with additional label revisions and restrictions on prescribing, or taking it off the market.

However, the Concept Capital report said, the most important question might be the one before that: “Based on the available data, please discuss the benefit-to-risk profile of rosiglitazone in the context of other available anti-diabetic therapies.”

As Concept Capital’s Cole Werble, Michael McCaughan and Ramsey Baghdadi write, “this is the critical question FDA decision-makers ask of a therapy that might have serious safety risks when other therapies exist on the market.” The agency did not ask that question of advisory committee members in 2007.

David Graham, the FDA scientist who made headlines in 2004 when he testified before a Senate committee that the agency was not equipped to prevent another Vioxx — the pain-reliever pulled from the market after a study found it increased heart attack risk — said in an interview Thursday that studies consistently have shown that Actos, the only other drug in the same class as Avandia, protects against heart attacks.

On the other hand, Graham says, Avandia, which has never been shown to be more effective than Actos in controlling blood sugar in diabetes, consistently appears to be riskier to the heart in comparisons with other drugs. Graham will be presenting an overview of the research at the advisory committee meeting.

“Really, what is most clinically relevant is the comparison of Avandia vs. Actos in the same study,” Graham said.

In a paper published online June 28 by The Journal of the American Medical Association, Graham and his coauthors analyzed data from 227,571 Medicare beneficiaries who’d been prescribed Avandia or Actos. They concluded that Avandia was associated with a higher risk of stroke, heart failure and death from any cause than Actos.

At the advisory meeting, Graham will report on eight other studies comparing patients prescribed Avandia to those prescribed Actos. All eight, he says, suggest Actos is safer.

To definitively answer whether Avandia increases cardiovascular risk, the FDA asked GSK to conduct the TIDE trial. The trial, which aims to study 16,000 patients in countries around the world, began enrolling participants in May. It is designed to compare the risk of heart attacks, stroke and cardiovascular death in diabetes patients randomly assigned to take either Avandia or Actos. It is also designed to test the impact of vitamin D supplement use on risk of death and cancer.

He called the TIDE trial unethical because “it’s treating humans as if they are laboratory rats. Why on Earth would anyone want to be randomized to Avandia in a clinical trial the purpose of which is to prove with absolute certainty that Avandia increases risk?”

In April 2010, the FDA asked the Institute of Medicine, or IOM, to answer five questions about ethical and scientific issues in studying the safety of approved drugs. The IOM is part of the National Academies, created to advise the government and the public. In light of the Avandia advisory committee meeting, the FDA asked the IOM to answer one question first: “What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?”

In a letter released today, the IOM said, “It is appropriate for FDA to require that a properly designed trial be conducted to provide additional evidence about an approved drug’s efficacy and safey” when there is too much uncertainty about risks vs. benefits to make “a responsible policy decision.”

In addition, the IOM said, the FDA should ensure that the trial includes an ongoing, “comprehensive and meaningful” informed consent process. But Graham says the TIDE informed consent process is more like “misinformation.” For example, he says, it does not mention the 2007 advisory committee’s overwhelming vote that Avandia raises heart attack risk or that the American Diabetes Association says Avandia shouldn?t be prescribed.

Graham and colleague Kate Gelperin?s critique of both the TIDE and RECORD trials is among the briefing documents for the advisory committee.

At a news conference Thursday, Deputy FDA Commissioner Joshua Sharfstein said he couldn’t predict when the agency would make a decision based on the advisory committee’s recommendations.

“Obviously, we’re going to have to look at a lot of information,” Sharfstein said. “We’re going to try to make a decision as quickly as we can under the circumstances.”

Click here to read the full report

FDA To Halt Avandia Safety Study

April 19, 2010

Wall Street Journal

By Alicia Mundy and Jennifer Corbett Dooren

The Food and Drug Administration is weighing whether to halt a safety study involving thousands of patients taking GlaxoSmithKline PLC’s Avandia diabetes drug, a decision that could also determine whether the drug stays on the U.S. market.

Studies during the past three years have tied the medicine to an increased risk of heart attacks. In 2007, the FDA approved a trial comparing Avandia with a rival drug called Actos made by Takeda Pharmaceutical Co. that hasn’t raised as many safety flags.

Some scientists inside and outside the FDA have said it is unethical to compare a drug with known cardiac …

To continue reading this report, click here.

GlaxoSmithKline Knew of Drug Dangers

February 23, 2010

Natural News

By Mike Adams

GlaxoSmithKline, maker of the diabetes drug Avandia, knew the drug was linked to tens of thousands of heart attacks but went out of its way to hide this information from the public, says a 334-page report just released by the Senate Finance Committee. (http://finance.senate.gov/press/Gpr…)

This report also accuses the FDA of betraying the public trust, explaining that FDA bureaucrats intentionally dismissed safety concerns found by the agency’s own scientists.

The report says that Big Pharma’s drugs “put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.” Sales of Avandia were $3.2 billion (yes, billion) in 2006.

According to a statistical analysis in the report, if all the diabetics currently taking Avandia were put on a “safer” drug, it would avert 500 heart attacks and 300 cases of heart failure every month in the United States alone. Presently, hundreds of thousands of Americans are still taking this drug, and hundreds will continue to die each month as a result, according to the report estimates.

This report, championed by U.S. Senators Grassley and Baucus, is the result of investigators pouring through more than 250,000 pages of documentation gathered from GlaxoSmithKline and the FDA. The document reveals some rather startling facts about the dangers of Avandia, including evidence from the FDA’s own scientists who concluded that Avandia was associated with 83,000 heart attacks.

GlaxoSmithKline intimidates scientists
This investigative report also reveals that GSK engaged in the intimidation of physicians, saying: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

“Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.” said Sen. Baucus. (Gee, really? Is anyone really surprised that GSK put its own financial interests ahead of a few thousand human lives?)

A separate letter sent to FDA Commissioner Margaret Hamburg by Senators Baucus and Grassley added, “the totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.”

The FDA’s own research also showed Avandia to be associated with a significant increase in heart attack risk, yet the FDA did nothing to protect the public. The agency’s own scientists wrote in 2008, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [a rival drug on market].” This evidence went completely ignored at the FDA.

The FDA’s famous Dr David Graham — the key whistleblower on the Vioxx scandal — concluded from his own research, “Rosiglitazone should be removed from the market.”

Even the American Medical Association — a long-time defender of Big Pharma’s drugs — admitted Avandia was dangerous. Its journal, JAMA, wrote in 2007: “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.”

The New England Journal of Medicine also warned about the safety of the drug in an article published in 2007.

Despite these multiple warnings, an FDA panel voted 22 – 1 in favor of keeping Avandia on the market. This is no surprise, of course, to those who know how the FDA really operates (and where its priorities really lie).

To continue reading this report, click here.

ADHD Drugs Abuses by Teens

January 21,2010

Natural News

By David Gutierrez

Inquiries to poison control centers about teenage abuse of drugs for attention deficit hyperactivity disorder (ADHD) increased by 76 percent over the last eight years, indicating a surge in rates of the abuse itself, according to a study conducted by researchers from the Cincinnati Children’s Hospital Memorial Center and published in the journal Pediatrics.

“It’s more bad news on an entrenched problem,” said Steve Pasierb, head of The Partnership for a Drug-Free America, who was not involved in the study.

The researchers reviewed data collected by the American Association of Poison Control Centers between 1998 and 2005. They found that the number of calls by parents, emergency room doctors and others about teenagers abusing ADHD drugs increased from 330 per year in 1998 to 581 per year in 2005, far outpacing the rate of increase in calls about other forms of teenage substance abuse. The majority of teenagers involved in the calls ended up being treated in emergency rooms, and 42 percent suffered moderate or severe side effects. Four of the teenagers died.

Far more teenagers are probably experiencing side effects, the researchers noted, since most cases of abuse don’t end in calls to poison control.

During the time period covered by the study, prescriptions for ADHD drugs rose 86 percent in children between the ages of 10 and 19, from roughly four million to almost eight million.

Pasierb said that many teenagers do not understand that abuse of prescription drugs can lead to potentially fatal side effects. In the case of ADHD drugs, these can include agitation, rapid heartbeat and dangerously high blood pressure.

“They say, ‘It’s FDA approved, how dangerous could it be?’” he said.

Click here to read full report

Controling Diabetes and Insulin Sensitivity With Chromium

November 05, 2009

NaturalNews

by: Mike Adams, the Health Ranger, NaturalNews Editor

Of all the trace minerals, chromium may be the most beneficial to diabetes patients. It’s an insulin potentiator, so it makes the body’s own insulin production go further.

If you have diabetes or blood sugar disorders, you need to know about chromium. We’ve assembled a large collection of quotes for you right here, but at the same time, we encourage you to check with your naturopathic physician before beginning chromium supplementation so that you can get a full review of your diet, supplements and blood sugar situation.

Here’s the collection of quotes from many of the top health authors writing today…

Chromium vs. diabetes

Both celiac disease and diabetes are major contributors to the epidemic of magnesium deficiency and chromium deficiency. Up to 90 percent of Americans and Canadians consume less than the minimal 50 micrograms of chromium a day. It follows that celiacs eating a normal diet would be profoundly chromium deficient. Chromium deficiency is associated with 1. hyperglycemia 2. hyperinsulinism/insulin-resistance 3. insulin-dependent diabetes (IDDM, Type 1) 4. adult-onset diabetes (NIDDM, Type 2) 5. gestational diabetes (diabetes of pregnancy) 6. corticosteroid-induced diabetes
- Dangerous Grains: Why Gluten Cereal Grains May Be Hazardous To Your Health by James Braly M.D. and Ron Hoggan M.A.

Industrial chromium, a completely different form than that found in foods, is toxic. People with diabetes who take chromium should be under medical supervision, since their insulin dosage may need to be reduced as blood sugar drops. Many studies detailing chromium’s benefits have used chromium picolinate, an easily absorbed form. Chromium nicotinate and amino acid forms of chromium are less easily absorbed than chromium picolinate but can supply adequate amounts of the mineral. The least absorbable form is chromium chloride, which is found in some multivitamin/mineral supplements.
- Prevention’s Healing With Vitamins : The Most Effective Vitamin and Mineral Treatments for Everyday Health Problems and Serious Disease by The Editors of Prevention Magazine Health Books

When sufficient levels of chromium are present much lower amounts of insulin are required. Diabetes has been shown to develop as a consequence of chromium deficiency in experimental animals and in humans sustained by prolonged total parenteral nutrition. Chromium deficiency is relatively common in patients with Type II diabetes and may impair the function of GTF, causing the uptake of glucose into cells to become less efficient. Impaired chromium metabolism may also play a role in diabetes of pregnancy. High insulin levels also seem to increase chromium excretion.
- The New Encyclopedia of Vitamins, Minerals, Supplements and Herbs by Nicola Reavley

The results of several studies suggest that chromium may play a role in controlling diabetes and heart disease. For example: Diabetes. In one study, 180 people with type 2 diabetes were randomly assigned to receive 100 mcg elemental chromium, 500 mcg elemental chromium, or a placebo. Four months later, those taking either dose of chromium scored significantly lower on their fasting and two-hour insulin level tests, indicating improvement in their disease. Those taking the higher amount of chromium were also found to have lower total cholesterol levels.
- The Side Effects Bible: The Dietary Solution to Unwanted Side Effects of Common Medications by Frederic Vagnini, M.D. and Barry Fox, Ph.D.

Very small amounts of organic Chromium are found in the blood. That small amount is extremely important in aiding insulin in glucose metabolism. Chromium is the active factor in the substance GTF-glucose tolerance factor. It makes insulin more effective. In fact without Chromium insulin can’t do its job. It can help prevent diabetes or hypoglycemia or help those with diabetes and hypoglycemia get by with less insulin. As one gets older less Chromium is retained in the body. Also, a fetus may rob the Chromium stores of pregnant women.
- The How to Herb Book: Let’s Remedy the Situation by Velma J. Keith and Monteen Gordon

A deficiency of CoQ10 has been linked to diabetes. Chromium – a trace mineral depleted by diabetic medication, excess iron, processed foods, refined carbohydrates, and sugar. Chromium is necessary for maintaining stable blood sugar levels through proper insulin utilization. Chromium assists in the treatment of diabetes and hypoglycemia. A deficiency can produce glucose intolerance (especially in diabetics). Deficiency symptoms parallel those of diabetes. Diabetes and coronary heart disease have been linked to low chromium concentrations in human tissue.
- A Drug-Free Approach To Healthcare, Revised Edition by Dr. David W. Tanton; Ph.D.

Symptoms of chromium deficiency – increased glucose, insulin, total cholesterol, and triglycerides – resemble those of prediabetes. This certainly doesn’t mean that chromium alone will reverse prediabetes; however, many studies have shown that either chromium polynicotinate or chromium picolinate supplements do in fact improve insulin function and can lead to improved glucose tolerance. Based on the research, the most effective dose of chromium appears to be 1,000 mcg, or 500 mcg twice daily with meals.
- Stop Prediabetes Now: The Ultimate Plan to Lose Weight and Prevent Diabetes by Jack Challem

While the improvements are not dramatic, it makes sense to include chromium for improved heart health. Anyone with diabetes or hypoglycemia should definitely be supplementing with chromium. The fact that chromium makes the cells more sensitive to insulin has been borne out by studies done with people who had Type 2 diabetes. Often, those who have Type 2 diabetes have a chromium deficiency, which appears to make them more susceptible to the condition.
- The Natural Physician’s Healing Therapies by Mark Stengler, N.D.

Glycation is responsible for many of the complications of diabetes, a process that chromium inhibits. To assess the effects of chromium on glycosylated hemoglobin levels, 180 Type II diabetes patients were divided into three groups and supplemented daily with 200 mcg of chromium, 1000 mcg of chromium, or a placebo (Baker 1996). After 4 months, there was improvement in both chromium-treated groups. Glycosylated hemoglobin (a measurement of average blood glucose) over a 2- to 3-month period was (on an average) 6.6% in the high dose group, 7.5% in the low-dose group, and 8.
- Disease Prevention and Treatment by The Life Extension Editorial Staff

It occurs naturally in three different forms with one particular form (chromium III) making up the majority of dietary chromium. The average adult body contains between 0.4 and 6 mg of chromium and older people usually have lower levels. There is a wide geographical variation in chromium levels and population studies suggest that the incidence of diabetes and heart disease is lower in areas where chromium intakes are relatively high. Chromium is essential for normal sugar metabolism.
- The New Encyclopedia of Vitamins, Minerals, Supplements and Herbs by Nicola Reavley

Because chromium appears to enhance the action of insulin and chromium deficiency results in impaired glucose tolerance, chromium insufficiency has been hypothesized to be a contributing factor to the development of Type-2 diabetes. Individuals with Type-2 diabetes have been found to have higher rates of urinary chromium loss than healthy individuals, especially those with diabetes of more than two years duration.
- There Is a Cure for Diabetes: The Tree of Life 21-Day+ Program by Gabriel Cousens

In double blind studies, just the addition of chromium supplementation, with no other dietary changes, altered the body fat composition to increase non fat body mass. One factor affecting chromium stores in the body is the amount of sugar that an individual consumes. Once chromium has acted as a cofactor in insulin response, it is excreted in the urine. With the high sugar diet of today, the turnover rate of chromium is quite high. Patients with the highest risk for developing frank diabetes need chromium the most. The highest tissue stores of chromium occur in newborns.
- The Miracle Enzyme Is Serrapeptase by Robert Redfern

Women with gestational diabetes whose diets were supplemented with 4 mcg of chromium per kilogram of body weight daily as chromium picolinate for eight weeks had decreased fasting blood glucose and insulin levels, compared with those who took a placebo. Dosage: Niacin-bound chromium is more bioavailable than chromium picolinate. A recent study at the University of California found that chromium polynicotinate was absorbed and retained up to 311 percent better than chromium picolinate and 672 percent better than chromium chloride.
- There Is a Cure for Diabetes: The Tree of Life 21-Day+ Program by Gabriel Cousens

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FDA Reviews Sanofi’s Lantus, Says Patients Should Stay On It

July 1, 2009

Wall Street Journal

by Jared A. Favole

WASHINGTON (Dow Jones)–Patients should continue taking Sanofi-Aventis SA’s (SNY) diabetes drug, Lantus, despite recent studies showing the drug may be linked to cancer risks, the Food and Drug Administration said on Wednesday.

The FDA said it’s reviewing the safety of Lantus, an artificial form of insulin that had sales of $3.45 billion in 2008, and is in talks with Sanofi about whether any more studies need to be done to determine the drug’s safety.

Studies published Friday in Diabetologia, the journal of the European Association for the Study of Diabetes, showed a possible link between Lantus and cancer. The FDA criticized the studies in an early communication warning posted Wednesday on its Web site.

The agency said the duration of follow-up for patients in the studies was shorter than what is generally considered necessary to evaluate cancer risk from drug exposure.

“Further, inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists,” the FDA said, using the scientific name for Lantus.

This is the FDA’s first comment on the recent concerns about Lantus, which have helped drive Sanofi’s share price down more than 10% over the last week. Shares recently traded up 3.7% at $30.59.

Sanofi representatives weren’t immediately available to comment.

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