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
FDA Reviews Sanofi’s Lantus, Says Patients Should Stay On It
July 1, 2009 by mike
Filed under Government
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.
Click here for the full story from the Wall Street Journal.
