Call for Diabetes Drug Avandia to Come off Market
February 22, 2010
Reuters
The Food and Drug Administration will again ask an advisory panel to consider the risks of the drug, Glaxo’s second biggest-selling product before questions about a possible link to heart attacks emerged in 2007.
Senators Max Baucus and Charles Grassley meanwhile released a report saying evidence suggested Glaxo knew of possible cardiac risks associated with Avandia years before the issue became public.
“I await the recommendations of the advisory committee,” FDA Commissioner Margaret Hamburg said in a statement.
“Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved,” she said.
In an October 2008 memo released by the senators, FDA reviewers David Graham and Kate Gelperin concluded “the risks of (Avandia) are serious and exceed those for” Takeda Pharmaceutical Co’s competitor Actos.
They said there was “strong evidence that (Avandia) confers an increased risk of” heart attack and heart failure when compared to Actos. They estimated that 500 more heart attacks and 300 cases of heart failure were occurring every month with use of Avandia instead of Actos, based on levels of use at the time of their memo.
Graham, an outspoken critic of the FDA’s handling of drug risks, had argued to an advisory panel in 2007 that Avandia sales should be stopped. The panel voted 22-1 to urge the FDA to keep the drug on the market.
Glaxo said in a statement “the scientific evidence simply does not establish” that Avandia increases risks of cardiovascular problems such as heart attacks.
Sales of Avandia, known generically as rosiglitazone, topped $3 billion in 2006 but fell to $1.2 billion in 2009.
The FDA decided in November 2007 Avandia should carry a warning saying a review of 42 studies associated the drug with an increased risk of a heart attack or chest pain compared with a placebo. But it said overall data were “inconclusive.”
Concerns about Avandia emerged in May 2007 when Cleveland Clinic researchers published a study saying there was a link between the drug and heart attacks.
FINDINGS MISREPRESENTED?
The senators’ report said evidence reviewed by investigators on the Senate Finance Committee, which Baucus chairs, showed Glaxo “knew for several years prior to this study that there were possible cardiac risks associated with Avandia.”
Glaxo 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,” the report said.
Committee staff reviewed more than 250,000 documents provided by Glaxo, the FDA and others, the report said. Anonymous whistleblowers provided hundreds of other pages.
The New York Times first reported on the memo from FDA reviewers and the senators’ report on Friday night on its website.
Glaxo said it rejected the report’s conclusions. The company said the report “cherry-picks information from documents, which mischaracterizes GlaxoSmithKline’s comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients.”
Glaxo said it had rigorously studied Avandia’s safety and “consistently shared this data with regulators around the world.” The company said it “does not condone any effort to silence scientific debate.”
FDA spokeswoman Karen Riley said on Saturday an advisory panel, a group of outside experts, will be asked “to provide advice about safety issues” with Avandia. The FDA usually follows panel recommendations.
Glaxo spokeswoman Mary Anne Rhyne said the company was told the panel would review results of a Glaxo-sponsored study called Record. That study showed Avandia was not associated with an increase in cardiovascular-related hospitalization or death compared to older diabetes drugs, she said.
The company has asked the FDA for permission to include those results in Avandia’s prescribing instructions, she said.
Click here for the full report
The Kevin Trudeau Show: 2-17-10
Today, Kevin explains why he is in court today and the real reason he didn’t get fair coverage from the mainstream media. Plus, more predictions! You won’t want to miss this vital information!!
Foreclosures Reach 315,000 in January
Corporations Have No Interest In Your Safety
Updates to Mental Health Disorders Manual
Speaking of New Made-Up Disorders…
Anti-Depressant Drugs No More Effective Than Placebos
Household Cleaners May Cause Breast Cancer
Take Trudeau on the Go! Click here to download this show to your iPod, mp3 player, or PC through iTunes!
Click below to hear The Kevin Trudeau Show RIGHT NOW!!!
Group Urges Recall of Fibromyalgia Drug
January 20th, 2010
abcnews.go.com
By Matthew Perrone
A consumer advocacy group is asking government regulators to recall a drug they approved last year for a little-understood pain ailment, saying the pill can lead to dangerously high blood pressure.
A letter Wednesday from Public Citizen calls on the Food and Drug Administration to pull Savella off the market, almost exactly a year after it was cleared to treat fibromyalgia.
The drug is co-marketed by Forest Laboratories Inc. and Cypress Bioscience Inc.
Fibromyalgia is characterized by a wide range of pain-related symptoms, including muscle soreness, headache, fatigue and depression. Last summer European regulators rejected the drug due to lack of effectiveness data and side effects. Public Citizen argues the FDA should have reached the same conclusion.
“FDA should never have approved Savella for fibromyalgia, and should now immediately undo its error by removing it from the market,” states the petition from Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.
Company studies of the drug showed 20 percent of patients taking Savella had hypertension, or high blood pressure, compared with 7 percent of those taking a dummy pill. Savella, known generically as milnacipran, is part of an antidepressant class of drugs that have been associated with increased blood pressure.
Public Citizen also points out that the original study of Savella failed to meet the companies’ own study goals for effectiveness. Company scientists reanalyzed the study, with a larger population and a shorter time span and recorded relatively meager benefit: 9 percent of patients on Savella significantly reduced their pain, compared with 7 percent of those taking placebo.
Public Citizen cites complaints from FDA’s own statistical reviewer, who wrote: “there is no evidence … that milnacipran is associated with improvements in pain or improvements in function at three months of therapy.”
Since the FDA approved Savella last January, doctors have written more than 250,000 prescriptions for the drug, according to data from IMS Health.
Click here for the full report
Blueberry Juice Could Stave Off Dementia & Improve Memory
January 22, 2010
Web Md
By Jennifer Warner
Swapping out the usual OJ for blueberry juice in the morning may give your brain a memory boost.
A new study shows that drinking a daily dose of wild blueberry juice improved the memory of older adults with age-related memory problems.
It’s the first study to show a potential benefit of blueberries in improving memory in older adults at risk for dementia.
“The findings of this preliminary study suggest that moderate-term blueberry supplementation can confer neurocognitive benefit,” write researcher Robert Krikorian, of the University of Cincinnati Academic Health Center, and colleagues in the Journal of Agricultural and Food Chemistry.
Researchers say blueberries contain a wealth of phytochemicals that have antioxidant and anti-inflammatory effects. In addition, animal studies have shown that the polyphenols found in blueberries, anthocyanins, have been shown to increase signaling in brain centers associated with memory as well as improve how the brain gets rid of glucose, all of which may help slow memory decline.
In the study, researchers looked at the effects of drinking wild blueberry juice on memory decline in nine adults in their 70s who were experiencing age-related memory decline problems, such as memory lapses.
The participants drank about two and a half cups each day of blueberry juice made from commercially available frozen wild blueberries for 12 weeks. A comparison group of seven older adults drank a similar amount of placebo non-juice beverage for the same time period.
Researchers conducted memory tests, such as word association and list learning and recall tasks, at the beginning and end of the study.
The results showed that those who drank blueberry juice showed significant improvement on learning and memory tests compared to the placebo group.
Researchers say there were also trends suggesting reduced symptoms of depression and lower glucose levels among the wild blueberry juice drinkers, but further research will be needed to confirm these results.
Click here for the full report
Swine Flu Deaths Occurred Even After Vaccination
January 18, 2010
Natural News
By Mike Adams
The CDC is engaged in a very clever, statistically devious spin campaign, and nearly every journalist in the mainstream media has fallen for its ploy. No one has yet reported what I’m about to reveal here.
It all started with the CDC’s recent release of new statistics about swine flu fatalities, infection rates and vaccination rates. According to the CDC:
• 61 million Americans were vaccinated against swine flu (about 20% of the U.S. population). The CDC calls this a “success” even though it means 4 out of 5 people rejected the vaccines.
• 55 million people “became ill” from swine flu infections.
• 246,000 Americans were hospitalized due to swine flu infections.
• 11,160 Americans died from the swine flu.
Base on these statistics, the CDC is now desperately urging people to get vaccinated because they claim the pandemic might come back and vaccines are the best defense.
But here’s the part you’re NOT being told.
The CDC statistics lie by omission. They do not reveal the single most important piece of information about H1N1 vaccines: How many of the people who died from the swine flu had already been vaccinated?
Many who died had already been vaccinated
The CDC is intentionally not tracking how many of the dead were previously vaccinated. They want you (and mainstream media journalists) to mistakenly believe that ZERO deaths occurred in those who were vaccinated. But this is blatantly false. Being vaccinated against H1N1 swine flu offers absolutely no reduction in mortality from swine flu infections.
And that means roughly 20% of the 11,160 Americans who died from the swine flu were probably already vaccinated against swine flu. That comes to around 2,200 deaths in people who were vaccinated!
How do I know that swine flu vaccines don’t reduce infection mortality? Because I’ve looked through all the randomized, double-blind, placebo-controlled clinical trials that have ever been conducted on H1N1 vaccines. It didn’t take me very long, because the number of such clinical trials is ZERO.
That’s right: There is not a single shred of evidence in existence today that scientifically supports the myth that H1N1 vaccines reduce mortality from H1N1 infections. The best evidence I can find on vaccines that target seasonal flu indicates a maximum mortality reduction effect of somewhere around 1% of those who are vaccinated. The other 99% have the same mortality rate as people who were not vaccinated.
So let’s give the recent H1N1 vaccines the benefit of the doubt and let’s imagine that they work just as well as other flu vaccines. That means they would reduce the mortality rate by 1%. So out of the 2,200 deaths that took place in 2009 in people who were already vaccinated, the vaccine potentially may have saved 22 people.
61 million injections add up to bad public health policy
So let’s see: 61 million people are injected with a potentially dangerous vaccine, and the actual number “saved” from the pandemic is conceivably just 22. Meanwhile, the number of people harmed by the vaccine is almost certainly much, much higher than 22. These vaccines contain nervous system disruptors and inflammatory chemicals that can cause serious health problems. Some of those problems won’t be evident for years to come… future Alzheimer’s victims, for example, will almost certainly those who received regular vaccines, I predict.
Injecting 61 million people with a chemical that threatens the nervous system in order to avoid 22 deaths — and that’s the best case! — is an idiotic public health stance. America would have been better off doing nothing rather than hyping up a pandemic in order to sell more vaccines to people who don’t need them.
Click here for the full report
Anti-Depression Drugs Found Mostly Useless in Study
January 13, 2010
LA Times
By Shari Roan
Antidepressant medications probably provide little or no benefit to people with mild or moderate depression, a new study has found. Rather, the mere act of seeing a doctor, discussing symptoms and learning about depression probably triggers the improvements many patients experience while on medication.
Only people with very severe depression receive additional benefits from drugs, said the senior author of the study, Robert J. DeRubeis, a University of Pennsylvania psychology professor. The research was released online Tuesday and will be published today in the Journal of the American Medical Assn.
Hundreds of studies have attested to the benefits of antidepressants over placebos, DeRubeis said. But many studies involve only participants with severe depression. Confusion arises, he said, “because there is a tendency to generalize the findings to mean that all depressed people benefit from medications.”
The current analysis attempted to quantify how much of antidepressants’ benefit is attributable to chemical effects on the brain and how much can be explained by other factors, such as visiting a doctor, taking action to feel better or merely the passage of time.
Researchers reviewed six randomized, placebo-controlled studies with a total of 718 patients who took either an antidepressant or placebo. The patients were adults with levels of depression ranging from mild to very severe based on the Hamilton Depression Rating Scale, a questionnaire widely used in depression research. The studies did not exclude patients who were likely to have a strong response to a placebo. Researchers then compared the patients’ depression scores at the beginning of treatment with those after at least six weeks of treatment.
The study found that the magnitude of the drugs’ benefit increased with the baseline level of depression. The effect of treatment was similar in people with mild, moderate and severe symptoms, regardless of whether they took an antidepressant or placebo. Only the people who rated very severe on the depression scale at the start of the study showed measurable improvements on antidepressants.
“There is no doubt that there are tremendous benefits from antidepressants, as our study showed,” DeRubeis said. “But this study helps us resolve, to some degree, the question of how much benefit people can expect from the medicines themselves when symptoms are not severe.”
Herb May Treat Chemotherapy Liver Damage
December 15, 2009
U.S. News
By Steven Reinberg
Chemo drugs
often cause liver inflammation, making it necessary to lower the dose or suspend treatment until the inflammation subsides. These interruptions in therapy can make treatment less effective, the researchers said.
“We found that milk thistle, compared to placebo, was more effective in reducing inflammation,” said lead researcher Dr. Kara Kelly, from New York-Presbyterian Hospital/Columbia University Medical Center’s Herbert Irving Comprehensive Cancer Center in New York City.
“If these results are confirmed, milk thistle may allow us to treat liver inflammation or prevent it from occurring, which will allow better delivery of chemotherapy drugs,” she added.
The report is published in the Dec. 14 online edition of Cancer.
Milk thistle, a longtime folk remedy, is often recommended to treat liver damage and mushroom poisoning. No other treatment for liver toxicity exists, Kelly said.
For the study, Kelly’s team randomly assigned 50 children undergoing chemotherapy for acute lymphoblastic leukemia to receive milk thistle or a placebo for 28 days. All the children had liver inflammation at the start of the study.
Twenty-eight days later, the children who had received milk thistle had improved liver enzymes, compared with the children who received a placebo, the researchers said.
The milk thistle group had significantly lower levels of one enzyme in particular, AST, and a trend towards lower levels of another enzyme called ALT, Kelly’s group found.
In addition, milk thistle appeared to help patients tolerate higher doses of chemotherapy. Sixty-one percent of the children receiving milk thistle needed dose reductions, compared with 72 percent of the children receiving placebo, but this difference is not significant, the researchers noted.
Related lab experiments showed the herb did not lessen the effectiveness of the chemotherapy drugs, and Kelly thinks milk thistle might reduce liver inflammation for patients with other cancers who are taking other types of chemotherapy as well. Further research is needed, she said, to determine the appropriate dose and duration of milk thistle therapy.
Her team also hopes to evaluate the herb’s ability to prevent chemo-induced liver inflammation.
Still, some experts remain unconvinced about the herb’s value in cancer treatment. Dr. Julio C. Barredo, director of pediatric hematology-oncology at the University of Miami Miller School of Medicine, said that the study’s small size, the low doses of milk thistle used and the short time frame of the study make the findings inconclusive.
Also, there was no difference in the delay of treatment in either group, he said.
“Improvement in one liver enzyme did not lead to patients who received the drug being delayed less than patients who received placebo in getting their chemotherapy,” Barredo said.
“I don’t think that you could recommend that people go and take this supplement when they are taking chemotherapy from the results of this study,” Barredo said. “Maybe a larger study, using a higher dose is warranted.”
Liver inflammation from chemotherapy usually abates when treatment stops or doses get reduced, Barredo added.
Click here for the full report
Drug Companies Ignore or Distort Side Effects
December 7, 2009
The Epoch Times
By Dr. John Briffa
Some of you may remember that in 2004 the drug company Merck pulled its painkiller Vioxx (rofecoxib) from the market after research revealed it more than doubled risk of heart attack.
Subsequently, there were accusations that Merck knew about the problems way before it pulled its money-spinner. This story has resurfaced now, on the publication of a study in the Nov. 23, 2009, edition of Archives of Internal Medicine titled “Pooled analysis of rofecoxib placebo-controlled clinical trial data.”
In this study, research (some published, some not) was analyzed, to see at what point there was a clear indication that Vioxx was increasing the risk of “cardiovascular thrombotic (CVT) events” such as heart attack and stroke, as well as death. It turns out that by 2001, there was clear evidence of harm.
This was more than three years before Merck “voluntarily withdrew” Vioxx from the market. In the intervening time, literally thousands of people died and had heart attacks as a result of this drug.
I saw a report of this study on Reuters Health in which one of the study authors, Dr. Harlan Krumholz, makes the point that “most of the information we are using in this study was never published, or if it was published, they never included the key safety data.” This sounds like information on critically important adverse effects might have been “neglected, restricted, distorted, and silenced” to me.
Of course Merck denies any wrongdoing and is sticking with its story that the first time it was aware of any problems was in 2004. I suppose we need to take this stance in context. It has emerged in a review published in the April 16, 2008, Journal of the American Medical Association titled “Guest Authorship and Ghostwriting in Publications Related to Rofecoxib” that some studies and review articles supportive of Vioxx were ghostwritten by employees of Merck.
In addition, an article in the British Medical Journal, April 2009, titled “Moynihan R. Court hears how drug giant Merck tried to ‘neutralize’ and ‘discredit’ doctors critical of Vioxx” reveals that doctors who were not “on side” regarding Vioxx were targeted by Merck for softening-up, and if that didn’t work, an attempt was made to discredit them.
Merck happens to manufacture ezetimibe, the cholesterol-reducing drug. Ezetimibe doesn’t appear to do anyone much good and has also been linked with a statistically significant increased risk of death due to cancer.
Never mind, though, because it appears Merck has managed to find some scientists who claim that this association is likely to be due to chance, even though the stats show it’s very unlikely to be due to chance. This analysis was published in the New England Journal of Medicine on Sept. 2, 2008, titled “Analyses of cancer data from three ezetimibe trials.”
Let’s hope history isn’t repeating itself.
Click here for the full report
Organization Calls for Ban on Meridia
December 7, 2009
Examiner
By Dave Chism
Public Citizen, a national, nonprofit consumer advocacy organization, called for a ban on the popular weight loss drug, Meridia, today. The call comes after the results of a recent study were released showing an increased risk of heart attacks, strokes, and death in obese patients taking the drug.
From the Public Citizen press release:
This is Public Citizen’s second petition to have Meridia banned; the FDA rejected the first four years ago, saying it was awaiting results of an ongoing trial. The results are in, and they show that the drug’s dangers significantly outweigh its benefits.
Public Citizen has previously attempted to have sibutramine banned on March 19, 2002. The request was based on the results of clinical trials which showed an increased risk of high blood pressure, elevated pulse rate, and heart palpitations in obese patients taking Meridia when compared to a group taking a placebo.
The FDA rejected their initial claim in 2002 because there had not been a large scale study at the time to conclusively show the increased risks. With the new study, Public Citizen feels they now have the large scale study the FDA requires.
Even though the larger study has been performed, only preliminary results are available. According to the Associated Press, the FDA stated it is “making no conclusions about the preliminary findings,” when they were released.
Meridia is manufactured by Abbott Labs which is located in North Chicago. The spokesman from Abbott, Kurt Ebenhoch, told the AP:
Sibutramine is not recommended or approved for use in more than 90 percent of the patients who participated in the SCOUT study. Abbott’s assessment is that the data do not indicate a change in the safety profile of sibutramine when used in the approved patient population.
It is estimated that Meridia is currently prescribed to approximately 250,000 people. Meridia is intended to be used as a weight loss aid along with proper diet and exercise.
Click here for the full report
FDA Investigating Weight Loss Drug for Heart Attacks and Stroke
Novemver 25, 2009
Atlanta Weight Loss Examiner
By Dave Chism
The Food and Drug Administration is investigating the possibility that the weight loss drug, Meridia, may increase the risks of cardiovascular events. The cardiovascular events include heart attack and stroke.
The official name of the study is a mouthful – Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event – or SCOUT for short. It was started in 2002 with 10,000 participants that were over 55 years-old, obese, and had a history of cardiovascular events or diabetes. Some of the participants were given Sibutramine (Meridia) and the rest were given a sugar pill placebo.
The preliminary findings revealed that those taking Meridia encountered cardiovascular events at a rate of 11.4 percent compared to 10 percent of the participants taking the placebo. The FDA did note that warnings with the drug do state that it should not be taken by people with a history of heard disease, stroke, heart rhythm problems, or congestive heart failure.
A spokesman for Abbott, the maker of Meridia, told Dow Jones that the drug wouldn’t be prescribed for almost 90% of the participants in the study. “Abbott’s assessment is that the data do not indicate a change in the safety profile of [Meridia] when used in the approved patient population,” he said.
Sibutramine first gained FDA approval in 1997 as a prescription drug to aid in weight management. Clinical trials have shown that it significantly effects total weight loss and weight loss maintenance.
