FDA Report Urges Avandia to be Pulled from the Market

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

"Rosiglitazone should be removed from the market," one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that "scientific evidence simply does not establish that Avandia increases" the risk of heart attacks.

The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug's potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.

Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug.

Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night. "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."

The bipartisan multiyear Senate investigation -- whose results are expected to be released publicly on Monday but which were also obtained by The Times -- sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

"Instead, G.S.K. 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," concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

Mr. Baucus said of the report, "Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust."

In response, GlaxoSmithKline said that it disagreed with the Senate investigation's conclusions. The company said that it could not comment on internal F.D.A. documents but that "the official ruling from F.D.A. is that Avandia remain on the market."

In the wake of the controversy, agency officials ordered GlaxoSmithKline to undertake a study comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. Studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without hurting the heart as much.

But Dr. Graham and Dr. Gelperin, working in the F.D.A.'s office of surveillance and epidemiology, argued in two separate internal reports that the new GlaxoSmithKline study, called TIDE, is "unethical and exploitative" because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. The trial may include patients who have had heart attacks or chest pains even though some foreign drug authorities have warned against Avandia's use by precisely such patients, the reports note.

"Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable," one of the reports concludes.

These concerns, in internal reports dated October 2008 but not made public until now, were later overruled by other agency officials, and GlaxoSmithKline is currently enrolling patients in the TIDE trial. The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014. The company's patent on Avandia expires in 2012, and generic versions will probably swallow most remaining profits.

In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked "what steps the F.D.A. has taken to protect patients in the TIDE trial" and said the trial's patients had never been told about the concerns raised by the agency's own safety officers.

Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.

"It doesn't make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision," Mr. Grassley said. "The Avandia case may be the most alarming example of the problem with this setup."

The question of when and how to communicate possible drug risks has long bedeviled drug makers and regulators. Hints are common that drugs may cause injuries; thousands of drug injury reports pour into the Food and Drug Administration every week. For example, Avandia ranked first among all prescribed drugs in the number of serious, disabling and fatal problems -- including 304 deaths -- reported to the agency in the third quarter of 2009, according to an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group.

But companies say that such reports do not offer proof of a problem and that highlighting them can scare patients away from needed treatment, so they often argue that more certainty is needed before alarms are raised. GlaxoSmithKline said a "vast majority" of the recent reports regarding Avandia was related to litigation.

The Senate investigation -- the result of years of digging through more than 250,000 internal company documents -- concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.

In November 2003, for instance, the company completed a study in which diabetics given Avandia had far more heart problems than those given placebos. Two months later, the World Health Organization sent the company an alert linking Avandia to heart ailments. In a June 2004 meeting, the company's Global Safety Board said a hard look should be taken at all Avandia clinical trials for more signs of heart problems, documents show.

European regulators had earlier ordered GlaxoSmithKline to conduct a study -- called the Record trial -- to examine Avandia's heart risks because hints of these problems appeared in the company's earliest trials.. But the Senate report shows that by at least 2004, company executives were aware that the Record trial was going so poorly that it would never answer the heart question with any kind of certainty.

So company executives gathered dozens of Avandia studies and sifted their combined data. Called a meta-analysis, this combined look found first in 2005 and in an updated look in 2006 that Avandia increased the risks of serious heart problems by nearly a third, the Senate investigation shows. Because two-thirds of diabetics die of heart problems, this was hugely worrying.

In 2005, executives revealed the results of their meta-analysis to the F.D.A., and in 2006 they provided the agency with the underlying data.

Two large company-sponsored trials -- called Dream and Adopt -- were published near the end of 2006, and each provided more hints that Avandia hurts the heart, the documents show. In a March 2007 meeting of the company's Diabetes Franchise Cardiology Advisory Board, advisers called the safety worries found in these many studies "disquieting." Negotiations with agency officials about how and whether to alert the public continued.

Meanwhile, the company continued to market and advertise Avandia aggressively. The Senate inquiry concludes that the company threatened doctors who suggested in public that Avandia might have serious risks.

In 1999, for instance, Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. GlaxoSmithKline executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by GlaxoSmithKline agreeing not to discuss his worries about Avandia publicly. The report cites a separate episode of intimidation of investigators at the University of Pennsylvania.

GlaxoSmithKline said that it "does not condone any effort to silence" scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation "could have been handled differently."

You can read more about Avandia and it's history here: http://www.thesandersfirm.com/avandia

New Scientific Studies Show Further Evidence of Avandia Dangers

Two independent studies document serious medical risks associated with use of popular GlaxoSmithKline diabetes drug

Mineola, NY (Lexis Nexis) February 4, 2010 -- Pharmaceutical giant GlaxoSmithKline is about to suffer more setbacks in the ongoing battle of opinions concerning the safety of its much touted diabetes drug Avandia, according to Marc Grossman, senior partner of leading national personal injury law firm of Sanders Viener Grossman, LLP, in Mineola, N.Y.

The American Diabetes Association has accepted for publication in its prestigious medical journal, Diabetes Care, a study by Harvard researchers that shows users of the diabetes drug Avandia have more than double the risk of a heart attack compared to other diabetes drugs. Further, a jointly sponsored study by both GlaxoSmithKline and i3 Drug Safety, an independent drug-safety firm, will appear in the journal Clinical Therapeutics, showing that Avandia users have a 35-41% increased risk of a heart attack over users of Actos©, Avandia's main competitor.

These findings are the latest in a series of published studies that indicate Avandia users are at an unacceptably increased risk of a heart attack. In 2007, the Food and Drug Administration required a "Black Box" warning be added to Avandia's label about the heart risks associated with drug, but allowed the product to remain on the market even though numerous Endocrinologists and other diabetes experts called for its removal from the market like the other ill-fated drugs Vioxx and Rezulin.

The Harvard group analyzed clinical care data taken from the electronic medical records of patients at several Boston area hospitals and clinics associated with Harvard Medical School. All 26,375 patients records reviewed included a diagnosis of Diabetes and the use of at least one oral diabetic medication used between years 2000 and 2006. The researchers then reviewed the records for all patients who suffered "Myocardial Infarction" or heart attack. The incidence of heart attack was more than double for Avandia compared to its competitor Actos. The researchers chose Avandia to confirm their methodology because of its known "…relative adverse cardiovascular risk profile…" The GlaxoSmithKline-i3 study analyzed health-insurance data from July of 2000 through March of 2007 for 2 groups of 47,501 subjects each; one group using Avandia and the other Actos.

Almost 13,000 former Avandia users who have suffered heart attacks and other significant injuries have filed claims against GlaxoSmithKline in both Federal and State courts.

"This study adds to the overwhelming evidence that Avandia causes heart attacks in an already vulnerable population and it further confirms the basis of these lawsuits," said Marc Grossman, a New York attorney who represents hundreds of former Avandia users in Federal Court in Philadelphia. "It's very disturbing to see what appears to be a pattern of pharmaceutical corporations placing profits ahead of people. The recent studies raise serious questions about the health risks associated with Avandia, yet GSK continues to shirk its responsibility to the thousands of victims of Avandia whose lives are ruined or lost."

The Sanders Firm is a National Law Firm and has recovered over $500 Million for its clients, including thousands of victims of defective drugs and products. For further information or press inquiries, please contact Marc Grossman at 1-800-FAIR-PLAY, via email at mgrossman(at)thesandersfirm(dot)com or go to www.thesandersfirm.com.

Nasal Spray Damage Sense of Smell?

FDA advises consumers not to use certain Zicam cold remedies.

Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration’s announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives’ Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

“Loss of the sense of smell is potentially life threatening and may be permanent,” said Dr. Charles Lee. “People without the sense of smell may not be able to detect life dangerous situations, such as gas leaks or something burning in the house.”

The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.

A warning letter issued to Matrixx on Tuesday asked the company to stop marketing its zinc-based products, but the agency did not issue a formal recall. Instead, regulators said Matrixx would have to submit safety and effectiveness data on the drug.

“The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them is for them to come in and seek FDA approval,” said Deborah Autor, director of FDA’s drug compliance division.
The agency is requiring formal approval now because of the product’s safety issues, she added.

Growing homeopathic marketThe global market for homeopathic drugs is about $200 million per year, according to the American Association of Homeopathic Pharmacists. The group’s members include companies like Nutraceutical International Corp. and Natural Health Supply.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its Web site: “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”

The company said in a statement Tuesday that the Zicam Cold Remedy’s safety is “supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists.”

But government scientists say they are unaware of any data to support Zicam’s labeling, which claims the drug reduces cold symptoms, including “sore throat, stuffy nose, sneezing, coughing, congestion.”

Matrixx said it will consider withdrawing the products, which accounted for about 40 percent of its $111.6 million in sales last year.

Facing multiple lawsuitsHealth officials said they have asked Matrixx executives to turn over more than 800 consumer complaints concerning lost smell that the company has on file. A 2007 law began requiring manufacturers to report such problems, but FDA regulators declined to say Tuesday whether the company broke the law.

The 130 reports received by the FDA came entirely from physicians and patients, not the manufacturer.

Regulators said the relatively small number of complaints accounted for the agency’s lengthy investigation.

“FDA doesn’t take action against drug products without evaluating all of the circumstances surrounding the issues with the product,” Lee said.

For more information, visit: www.thesandersfirm.com/zicam

Hydroxycut Recalled due to liver damage.

On May 1, 2009, The Food and Drug Administration (FDA) announced a warning to all Hydroxycut consumers to immediately stop the use of the dietary supplement produced by Iovate Health Science Inc., of Oakville, Ontario. According to the FDA number of Hydroxycut products are associated with several serious liver injuries. The drug manufacturer has agreed to recall the product from the market.

In the report the FDA stated that it has received over 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, which is an indicator of potential liver injury that can lead to liver damage requiring liver transplants.

While the report claims that liver damage cases were rare, they were nevertheless reported by patients taking Hydroxycut doses as prescribed on the bottle. Symptoms of liver damage include jaundice (yellowing of the skin or white of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

Chief Medical Officer Linda Katz, M.D., of the FDA's Center for Food Safety and Applied Nutrition, urged consumers to discontinue use of Hydroxycut to avoid serious health complications.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

•Hydroxycut Regular Rapid Release Caplets
•Hydroxycut Caffeine-Free Rapid Release Caplets
•Hydroxycut Hardcore Liquid Caplets
•Hydroxycut Max Liquid Caplets
•Hydroxycut Regular Drink Packets
•Hydroxycut Caffeine-Free Drink Packets
•Hydroxycut Hardcore Drink Packets (Ignition Stix)
•Hydroxycut Max Drink Packets
•Hydroxycut Liquid Shots
•Hydroxycut Hardcore RTDs (Ready-to-Drink)
•Hydroxycut Max Aqua Shed
•Hydroxycut 24
•Hydroxycut Carb Control
•Hydroxycut Natural

Although the FDA did not receive serious liver damage related reports regarding all of the Hydroxycut products, the manufacturer has agreed to withdraw all of the above products from the marketing at this time.
If you or someone you know has been injured or experienced serious side effects from Hydroxycut, contact our law offices immediately for a free online, over the phone or in person consultation.

Chantix Investigation. BBC News

To watch the rest of the video visit: http://www.thesandersfirm.com/articles/read/?SAf5551e_2

Sanders Law Firm Files Claim for Good Samaritan Beaten by NYC Cops Gone Wild

Marc Grossman, Senior Partner of the law firm of Sanders, Sanders, Block, Woycik, Viener & Grossman, P.C. in Bronx, New York, announced today that it has just filed a Notice of Claim against The City of New York and The New York City Police Department on behalf of Cyle Perry-Osby with regard to the injuries he sustained when he was violently assaulted by 2 female New York City Police Officers in the highly publicized incident of August 15, 2008. The filing of the Notice of Claim is a pre-requisite to filing a lawsuit against The City of New York.

Cyle Perry-Osby was driving on 218th Street in the Bronx when he came upon New York City Police Officers Michelle Anglin and Koleen Robinson, who were assaulting a motorist at the intersection of White Plains Road and 218th Street. When Mr. Osby questioned the 2 females as to what was happening, one of the officers replied "You don't know who you're f---ing with, we're the f---ing cops." The officers then sprayed mace on Mr. Osby and struck him in the head and face. One of the officers then held a gun to Mr. Osby's face, causing Mr. Osby to fear for his life, before the officers finally left the scene.

Mr. Osby was immediately treated at Our Lady of Mercy Medical Center for a severe head injury and will require continued medical attention.

Mr. Osby was only trying to be a good Samaritan and assist a man he saw was in trouble. Mr. Osby is with his family now trying to recover and is thankful that arrests have been made in this case. Attorney Michael Villeck, Esq. of the firm believes "It's a terrible injustice when people abuse their position of power. When those entrusted with preserving civility and protecting the public commit this type of horrendous act and cause serious injury to innocent civilians, the entire city suffers."

Sanders, Sanders, Block, Woycik, Viener & Grossman, P.C. has extensive experience handling litigation involving assaults, excessive force and violation of civil and constitutional rights. The firm has received broad media coverage over its recently filed product liability lawsuits against Pfizer, Inc., the manufacturer of the hugely popular Chantix smoking cessation drug; and for its role in the ground-breaking $4.85 Billion Vioxx settlement against Merck & Co. According to Marc Grossman, "It's been a very busy Summer for the Firm which, in a recent span of just 8 days, recovered 8 million dollars in damages for its clients, including a 5 million dollar product liability settlement."

For more information about the firm, contact Marc Grossman, Esq. at 1-800-FAIR -PLAY or via email to mgrossman@thesandersfirm.com or click here.

Chantix pulled from Military Base Pharmacy

Not letting people who are carrying rifles to take a drug that has been linked to suicide sounds like a good idea to me. Marc Grossman

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

The decision to remove Chantix from the pharmacy at the Yokata Air Base was made after the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.

The report noted that in the fourth quarter of 2007, Chantix accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.

Two days after the institute’s report, the Defense Department’s Office of the Chief Medical Officer recommended that Chantix “should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.”

According to the “Stars and Stripes” website, no Chantix patients at Yakota have reported any adverse reactions. A patient with approval from his doctor can opt to continue the medication, and special order the drug. In the meantime, Yokota has suspended all refills of Chantix until patients review with their health care provider the potential risks and benefits of continuing the drug.

Since Chantix was approved by the FDA in 2006, the number of military prescriptions for the drug has exploded. In 2006, only 262 Chantix prescription were written at U.S. military medical facilities. By 2007, that number had jumped to 67,580.


Source: newsinferno.com/archives/3606