On December 11, 2007, a study published in the Journal of the American Medical Association concluded that older patients treated with Avandia had a significantly increased risk of suffering from a heart attack or dying. The findings mirror earlier studies, which also linked Avandia and cardiac risks.

The new study found Avandia patients had a 60 percent increased risk of heart failure, a 40 percent increased risk of heart attacks, and a 30 percent increased risk of death. This research also suggests that for every 100 people taking Avandia over a four-year period, there would be five additional deaths, four additional heart attacks, and three additional episodes of heart failure.

“Our study suggests that, at least in this high-risk population, the harms of the drug may outweigh the benefits,” said Dr. Lorraine L. Lipscombe, lead author of the study.

In May 2007, Dr. Steven E. Nissen from the Cleveland Clinic published a study suggesting Avandia patients had a 42 percent increased risk of heart attack. After reviewing Nissen’s study, the Food and Drug Administration (FDA) said in November 2007 that the evidence was inconclusive, and allowed Avandia to remain on the market with a “black box” warning on the label.

“As you accumulate more and more evidence that Avandia has this problem and it involves a very serious consequence, namely heart attack and death, it puts a lot of pressure on the FDA to do more,” Nissen said.

The FDA, however, is standing by its earlier decision.

“This new study we have just seen today does not change the FDA’s recommendations,” read a statement from the agency, adding that the data is inconclusive.

Source: “Study adds to Avandia doubts,” News and Observer, December 12, 2007.

On Thursday, September 27, 2007, U.S. researchers released a report revealing that the popular diabetes drugs Avandia and Actos increase heart failure risk but do not increase the risk for cardiovascular death in patients with type 2 diabetes.

The already controversial Avandia and Actos medications, which belong to a class of sugar-lowering drugs called thiazoilidinediones (TZDs), prompted the United States Food and Drug Administration (FDA) to require makers to place a “black box” warning on the labels after the risk of heart failure was linked to the medications.

The FDA decided not to remove the drugs from the market in July 2007, reasoning that evidence linking Avandia to heart failure was inconclusive.

Dr. Robert Nesto is the chair of the department of cardiovascular medicine at the Lahey Clinic Medical Center, in Burlington, Massachusetts, and the lead researcher of the September 27th study of Avandia and Actos. This study examined the results of seven clinical trials involving 20,000 patients administered Avandia or Actos.

Nesto’s team discovered a 72 percent increase of congestive heart failure among diabetes patients with different medical backgrounds and congestive heart failure histories. The risk of cardiovascular death was not increased in the patients, however, according to the study.

GlaxoSmithKline, maker of Avandia, suggests that congestive heart failure and fluid retention are linked, and “it is well known that TZDs can cause some fluid retention, which can lead to, or worsen, congestive heart failure. If congestive heart failure signs and symptoms develop, and heart failure is confirmed, heart failure can be appropriately managed by a physician.”

Dr. Nesto however, believes that doctors should avoid prescribing Avandia and Actos to patients with heart failure.

Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, was the original researcher who linked Avandia to heart attack risk. He lightly criticizes Nesto’s study for not dealing with specific risks of using the drugs.

“The new analysis does not answer the question whether the observed increase in heart failure leads to other serious complications, including death,” according to Nissen. “The authors did not examining the risk of cardiac death in patients who developed congestive heart failure while taking a TZD drug. Instead they looked at overall cardiovascular mortality. This finding neither confirms, no refutes, the hypothesis that TZDs lead to major complications of heart failure.”

Source: “Diabetes Drugs Boost Heart Failure But Not Death,” Forbes.Com, September 28, 2007.

GlaxoSmithKline’s embattled diabetes drug Avandia suffered a major blow July 17, 2007, when German researchers said the drug may complicate the disease and questioned whether it was ethical to continue researching Avandia when safer alternatives were available.

Known generically as rosiglitazone, Avandia is in the middle of an investigation by the U.S. Food and Drug Administration, which is scheduled to review the drug July 30. One American researcher, Dr. Steven Nissen, published a report indicating Avandia increased the risk of a heart attack by 43 percent.

The ongoing controversy over Avandia has financial analysts humming about the drug’s sales. Even if the FDA allows the drug to remain on the market, analysts are forecasting Avandia’s sales to be down 35 percent in four years.

“Avandia itself is going to struggle whatever happens,” Mike Ward, an analyst at Nomura Code Securities in London, said. “Whether it ever bounces back, even if the [FDA] advisory committee is relatively kind, it’s going to take time.”

Sources: Ben Hirschler, “New study slams safety of Glaxo’s Avandia drug,” Reuters, July 18, 2007; Michelle Fay Cortez and Lisa Rapaport, “Glaxo’s Avandia Pill Faces FDA Warning, Doctor Revolt (Update 4),” Bloomberg, July 19, 2007.

A July 5, 2007 article in the Washington Post asked questions about the long-term effects of the Prescription Drug User Fee Act of 1992, a piece of legislation originally aimed at getting innovative and highly beneficial drugs to market more rapidly. Fifteen years later, the result may be drugs raced through clinical trials and into the market, where consumers are now suffering. The Post cited three drugs in particular: Vioxx, Ketek and Avandia.

In the decade after 1993, the average approval time for standard drugs went from 22 months to 14, and “priority” drugs decreased from 13 months to six. But now, in the middle of 2007, the U.S. Congress is rethinking the 1992 act. Among the options facing the legislature is increasing the fees and devoting them to “post-market surveillance.”

The Post equated post-market surveillance to someone trying to chase horses once they leave the barn.

“I am deeply disappointed in the way things are headed,” Jerry Avorn, a Harvard Medical School physician, said. “This is our last chance to get it right before five more years go by.”

Source: David Brown, “Congress Seeks to Balance Drug Safety, Quick Approval,” Washington Post, July 5, 2007.

In the wake of published research possibly linking diabetes drug Avandia to heart risks, federal regulators said reports of the drug’s side effects tripled in a single month, according to an Associated Press report released July 13, 2007. The Associated Press obtained the information from the FDA through a Freedom of Information Act request.

In the 35 days prior to the New England Journal of Medicine’s published analysis, the FDA received reports of five heart attacks and 11 heart-related hospitalizations concerning rosiglitazone, the drug in Avandia and Avandamet. However, 35 days after the report, the FDA received reports of 90 heart attacks and 126 heart-related hospitalizations involving the same drug. The FDA received reports of 11 deaths in the 35 days prior to the study, compared to 38 in the same time after.

Dr. David Graham, a drug-safety expert with the FDA, said consumers “can’t infer anything about incidence rates” from the increased reports because the increase is likely due to the study’s “publicity effect.”

Dr. David Nathan, the head of diabetes care at Massachusetts General Hospital, echoed Dr. Graham when he said it was “not conceivable” that only five in one million Americans taking Avandia had heart attacks in the month preceding the study.

Source: Marilynn Marchione, “Diabetes Drug Side Effect Reports Triple,” Associated Press, July 13, 2007.

In the midst of links to serious heart ailments, new studies are pointing to additional increased health risks associated with GlaxoSmithKline’s drug Avandia. With tests already demonstrating the drug weakened bones in women, a June 2007 article in Diabetes Care found men on the product had lower bone mineral density in the spine and hips.

“This suggests that thiazolidinedione treatment Avandia is a risk factor and can contribute to excess incidence of fractures in diabetes,” researchers from the Virginia Medical Center and Louisiana State University in Shreveport, Louisiana wrote in the study.

The new study could lead to a warning label on the drug. The FDA is scheduled to discuss Avandia at a meeting on July 30, 2007.

Source: Kari Lundgren and Andrea Gerlin, “Glaxo’s Avandia May Get Bone Warning, Analyst Says,” Bloomberg, July 4, 2007.

On June 12, 2007, USA Today reported on a scientist from the U.S. Food and Drug Administration (FDA) who said her directors reprimanded her for recommending that Avandia get a “black box” warning about congestive heart failure.

Rosemary Johann-Liang, the former deputy director of the Division of Drug Risk Evaluation, said she recommended the Avandia warning on the suggestion of her staff. The FDA is investigating the validity of Johann-Liang’s claims.

In the meantime, the Senate Finance Committee is asking the FDA to make sure no scientist is reprimanded for raising safety questions.

“Those FDA employees dedicated to post-marketing surveillance…should be able to express their opinions in writing and independently without fear of retaliation, or reprimand or reprisal,” Sen. Chuck Grassley wrote in a letter dated June 4, 2007.

Johann-Liang said she wanted to be an advocate for drug safety, but oftentimes, her bosses did not want to hear about it.

“A lot of times the agency doesn’t want to hear that there are problems,” she said. “I think, in general, there is a culture of ‘The drug is always innocent.’”

Specifically Johann-Liang is warning people about Avandia, which she feels is a dangerous drug.

“People are continuing to be hurt,” she said. “Congestive heart failure is a very, very clear adverse reaction syndrome with Avandia.”

Source: Rita Rubin, USA Today, “FDA scientist says she was reprimanded for warning.” June 12, 2007.

On June 6, 2007, University of Washington medicine and epidemiology professor Bruce Psaty testified that GlaxoSmithKline (GSK) did not address safety questions in Avandia trials. Instead, he said, the trials focused on marketing questions.

Psaty wrote editorials accompanying Dr. Steve Nissen’s recent meta-analysis of Avandia published in the New England Journal of Medicine.

“GSK did not make a serious effort to verify the presumed health benefits of Avandia in a timely fashion,” Psaty testified at a congressional hearing of Avandia. “The…trials focused largely on marketing questions and failed to address directly questions of heart-attack risk or benefits.”

He also said the U.S. Food and Drug Administration (FDA) lacks the leadership and authority to require pharmaceutical companies to conduct high-quality trials.

“If sponsors do not voluntarily initiate large long-term trials of public health importance, then the FDA needs the authority to insist that they do so in a timely fashion,” he said.

GSK has conducted a trial, called RECORD; but Psaty said it is limited and, even if the study is finished, it will not be complete.

“GSK’s RECORD study has several major limitations in design and conduct, and even if it continues to its planned conclusion, information about heart attack risk from the RECORD trial is likely to be incomplete,” Psaty said.

With Avandia, he claims, the FDA failed in warning and informing consumers of the risks associated with the drug. He added that the U.S. product label for Avandia still does not identify heart attack as a potential reaction in diabetics.

Psaty says there is a crisis in confidence about the safety of medicines in America that began with the withdrawal of rofecoxib (Vioxx), a drug developed to treat osteoarthritis. Vioxx was recalled in September 2004 because it was found to increase heart attack and strokes. Vioxx was one of the most widely used medications to ever be withdrawn from the market.

The FDA has still not announced an Avandia, recall.

Sources: “Testimony of Bruce M. Psaty, M.D., Ph.D.,” before the House Committee on Oversight and Government Reform, June 6, 2007; “Rofecoxib,” Wikipedia, June 8, 2007.

At least two cases have been filed against GlaxoSmithKline PLC (GSK) about the company’s diabetes drug Avandia. The lawsuits allege that GSK caused patients to suffer heart attacks

Shareholders in GSK. also filed a lawsuit, claiming the company misled investors about the safety of the drug. The lawsuit seeks class-action status and alleges the company failed to acknowledge a link between Avandia and higher risk of heart attacks.

On May 29, 2007, Sharon Ann Dabon filed a suit against GSK claiming Avandia caused her to suffer injuries like heart injury and liver failure. Another case, filed June 1, 2007 by Benjamin Sarconi, claims Avandia caused a heart attack and congestive heart failure.

Some attorneys said the personal injury lawyers for those filing Avandia lawsuits may have difficulty proving the drug caused heart problems because diabetes itself increases a person’s risk for heart attacks.

Source: “Jeanne Whalen,” Shareholders sue Glaxo over Avandia disclosure,” Wall Street Journal, June 13, 2007.

When Dr. John B. Buse testified at a U.S. Congressional hearing on June 6, 2007, he explained how a top executive at pharmaceutical giant GlaxoSmithKline (GSK) threatened him with a lawsuit because the doctor warned the public about Glaxo’s drug, Avandia.

Buse’s confrontation with GSK began in 1999, he said, when he told the U.S. Food and Drug Administration that Avandia raised the risk of chest pain and heart attacks by 50 percent. He said he was given 25 minutes to present two hours worth of research at that hearing.

After that hearing, Buse said “an executive,” later tabbed as Dr. Tadataka Yamada, the then-chief of research and development at SmithKline Beecham, called him a “liar” and a “scoundrel” for his research on Avandia.

According to Buse, the company went as far as suggesting to his boss that the doctor wanted to be paid off. Buse wrote in a letter to Yamada in 1999, in which he said “I was not upset when my chairman called me into his office to tell me that some in your company perceive me as being ‘for sale,’ as he knows me well enough to doubt it.”

In addition, GSK suggested Buse might be sued for lost profits. “The market capitalisation of the company had declined by $4 billion and there were people in the company who felt I might be liable for that,” he stated.

Representative John Yarmuth, Democrat from Kentucky, said in the June 6 hearing, “We cannot have a post-regulatory environment where manufacturers intimidate scientists.”

Sources: Stephanie Saul, “Doctor Says He Was Assailed for Challenging Drug’s Safety,” New York Times, June 7, 2007.

One day before a Congressional hearing to evaluate the safety of GlaxoSmithKline’s drug Avandia, the New England Journal of Medicine released early findings of a study called “RECORD,” which will not be finished until 2008.

The RECORD study is funded by Glaxo, and according to the Journal, it does not provide enough data to show whether Avandia is associated with a higher rate of heart attacks. The article comes in the midst of Cleveland Clinic cardiologist Steven Nissen’s research, also printed in the Journal, which tied the drug to a higher risk of heart attacks.

Specifically, the study followed 4,447 people with Type 2 diabetes for an average of 3.75 years. In the Avandia group 217 people died of cardiovascular causes, and in the non-Avandia group, 202 died from the same.

Despite the study being incomplete and the Journal’s analysis saying the study was inconclusive, Glaxo continued to suggest the drug is safe.

“Patients and physicians should find these data reassuring,” Moncef Slaui, the head of research and development at Glaxo, said in a statement.

Glaxo has blitzed newspapers across America with full page ads printing a letter from its chief medical officer, Dr. Ronald Krall. In the letter, Krall said “GlaxoSmithKline stands firmly behind Avandia.”

Source: Jeanne Whalen and Anna Wilde Mathews, “Analysis of Avandia Finds No Increased Risk of Death,” Wall Street Journal, June 6, 2007.

The U.S. Food and Drug Administration wants its most serious warning, a “black box,” printed on GlaxoSmithKline’s second-best selling drug, Avandia. The FDA made the request to GSK on May 23, and it informed the U.S. House of Representatives of the request at a June 6, 2007 hearing on Avandia’s potential health risks.

The black box would warn patients that Avandia increases the risks of congestive heart failure. Glaxo has not agreed to the request. The drug company makes $3 billion annually from Avandia sales.

The FDA has also asked for Avandia’s leading competitor, Actos, to carry a black box warning as well. The FDA has not issued an Avandia recall.

Concern in the House was that the FDA is not doing enough to protect consumers. The FDA is still investigating claims the drug causes heart attacks and chest pain. A similar warning or Avandia recall could follow. Nevertheless, some representatives are frustrated with the FDA’s apparent failure to take action.

“The FDA dropped the ball,” Rep. Henry Waxman, Democrat from California, said at the Congressional hearing.

Source: Sabine Vollmer, “FDA asks for stiff Avandia warning,” Raleigh News & Observer, June 7, 2007.

In 1999, University of North Carolina at Chapel Hill professor John Buse voiced his concerns about the safety of diabetes drug Avandia to its manufacturer, GlaxoSmithKline (GSK).

On June 6, 2007, Dr. Buse will testify at a congressional hearing about whether the company and the Food and Drug Administration (FDA) should have alerted the public about the potential risks associated with Avandia.

The hearing comes after a study conducted by cardiologist Steven Nissen was published in the New England Journal of Medicine that linked Avandia to a potential heart attack risk.

In addition to focusing on how GSK and the FDA handled the drug, the hearing will focus on whether Dr. Buse was intimated by GSK to silence his criticism of the drug. A letter to GSK from the Senate Finance Committee said investigators are looking into claims that GSK silenced medical professionals.

In March 2000, Dr. Buse sent a letter to the FDA saying Avandia may raise a patient’s risk of heart attack**. He also said that GSK manipulated the data from clinical trials to overstate the drug’s benefits and understate the drug’s risks.

GSK has not yet issued an Avandia recall.

Sources: Stephanie Saul, “Doctor says drug maker tried to quash his criticism of Avandia,” New York Times, June 2, 2007; Anna Wilde Mathews, “Diabetes expert to testify on Avandia,” New York Times, June 1, 2007.

On March 15, 2000, Director of the Diabetes Center at the University of North Carolina at Chapel Hill John Buse sent a letter to the U.S. Food and Drug Administration (FDA) voicing his concerns about Avandia’s safety.

In his letter, Dr. Buse outlined his concerns about the adverse cardiovascular effects of Avandia. He even said that he rarely prescribed the diabetes drug to his own patients.

Dr. Buse alleges that GlaxoSmithKline, then named SmithKline Beecham, rampantly abused clinical trial data. Dr. Buse goes so far as to say the company blatantly manipulated the data from trials to conceal information about the drug that may imply it is unsafe.

“I am sure there have been abuses by representatives of all companies that market drugs,” Buse wrote, “but there is something pervasive and systematic that I detect in my travels regarding the marketing of rosiglitazone,” the generic name for Avandia.

On May 21, 2007, a study published in the New England Journal of Medicine raised questions about the safety of Avandia Dr. Steven Nissen with the Cleveland Clinic analyzed 42 clinical trials involving the drug and concluded the drug increased the risk of heart death by 64 percent and the risk of heart attack by 43 percent.

GlaxoSmithKline released a statement saying it “strongly disagreed” with both Buse’s statements and Nissen’s study. The company is now testing a11 other drugs in the same family as Avandia, all of which could be tainted if suspicions about the cardiovascular risks associated with them rise.

Analysts have drawn parallels between Avandia and Merck & Co.’s Vioxx, a painkiller recalled in 2006 after it was linked to heart attacks and deaths. The drug was recalled, causing a ripple effect relating to other, similar painkillers.

The FDA has not issued an Avandia recall.

Source: Chris Coletta, “UNC doctor warned FDA about Glaxo drug years ago,” Triangle Business Journal, May 23, 2007; Letter from John B. Buse to Food and Drug Administration, March 15, 2000; Sabine Vollmer, “GSK’s Avandia problem may grow,” New and Observer, May 25, 2007.

On May 22, 2007, Dr. Steve Nissen spoke out about his study of Avandia, a drug used to treat Type 2 diabetes. The study revealed that patients who take Avandia are at a 43 percent higher risk of heart attack and a 64 percent greater risk of cardiovascular death.

In response, the Food and Drug Administration (FDA) issued a safety alert about the drug’s potential risks but did not issue a recall because other studies of Avandia did not necessarily confirm the risks.

Dr. Nissen said regulators assumed that if the drug lowered blood sugar then it would help to control diabetes and lead to health outcomes benefits, like reducing complications of diabetes or heart disease. But the drug is a paradox, he said.

“Lowering blood sugar is not necessarily related to these health outcomes benefits,” he said. “What we found was a fairly striking increase in the risk of heart attack or heart-related death in people who took Avandia.”

Dr. Nissen said there was an excess of cardiovascular events in the trials that led to Avandia’s approval in 1999. While it was not statistically significant, he said, it was a signal that the drug needed to see a large clinical outcomes trial.

“But here we are, eight years later and we don’t have it,” Dr. Nissen said. “They’re telling us now maybe 2009. That’s 10 years after the drug was approved.”

There were weakness in the study, he added. The study was a meta analysis, which looked at data obtained from publicly available sources instead of raw data, but it was the only data available in the absence of a single large trial.

“[W]hen you see this kind of signal in a population as vulnerable as diabetics, you’ve got to sit up and take notice,” said Dr. Nissen. “And when it’s for a drug that has no established health benefits, well, it’s now up to the individual practitioners to weigh those risks very carefully.”

Dr. Nissen said that patients should never stop taking a drug based on what they hear in a news report, but stressed the importance of discussing any drugs with their physicians.

“[W]e hope that physicians who prescribe diabetic medications will read our study, will understand the strengths and limitations of our study, and will make their own minds up about whether to prescribe the drug or not,” he said.

Source: Ron Winslow, “Avandia critic Nissen speaks,” Wall Street Journal Online Health Blog, May 22, 2007; “Did FDA know of Avandia dangers in 2002?” CBS News, May 22, 2007.

An analysis of GlaxoSmithKline’s diabetes drug Avandia published in the New England Journal of Medicine says elevated heart risks are associated with the medication, and members of Congress from both parties are voicing their concerns.

Representative Henry Waxman, D-California, chairman of the House Committee on Oversight and Government Reform, announced that a hearing has been scheduled for June 6, 2007 to discuss the role of the U.S. Food and Drug Administration (FDA).

Iowa Republican Charles Grassley has criticized the FDA for not responding more quickly or efficiently to concerns about the safety of Avandia.

“Do we have another Vioxx on our hands with Avandia? I am not sure, but I intend to find out,” Grassley said. “Tens of millions of prescriptions have been written for Avandia, and Medicare and Medicaid have paid hundreds of millions of dollars for this drug.”

Vioxx was a drug to relieve signs and symptoms of osteoarthritis, acute arthritis pain and painful menstruation. It was recalled on September 29, 2004 after a trial found that patients taking Vioxx were at a greater risk of sudden cardiac deaths. The drug was recalled from the market.

The FDA has received criticism for not studying the safety of Avandia. Agency officials said their evaluations of the drug provided conflicting data and did not prove the drug was dangerous.

GlaxoSmithKline has disputed the results of the new analysis. The company cited a similar review that found a 30 percent increased risk of heart problems associated with Avandia, but said the risk was not confirmed after additional studies.

The FDA said an advisory panel would be convened to discuss the safety of Avandia, but it did not plan to make any immediate changes to the current side effects warnings on the packaging of the drug.

Grassley also said that nearly five years ago the FDA’s safety office recommended that Avandia have the strongest possible warning, but the recommendation was overruled by other FDA offices.

“The FDA didn’t take that advice,” Grassley said. “Instead, the warning about congestive heart failure risks with this drug is currently buried.”

Grassley is the ranking Republican for the Senate Finance Committee, one of three congressional panels investigating the FDA’s management of Avandia. The FDA is also conducting a review.

Source: Marilynn Marchione, “Diabetes drug may raise risk of heart attack,” PressofAtlanticCity.com, May 22, 2007; Ricardo Alonso-Zaldivar, “Diabetes drug Avandia caused concern 5 years ago,” Star Tribune, May 23, 2007; Ricardo Alonso-Zaldivar, “Concerns about diabetes drug Avandia aren’t new,” LA Times, May 23, 2007.

On May 22, 2007, consumer advocacy group Public Citizen said the Food and Drug Administration (FDA) knew about the dangers of diabetes drug Avandia in 2002. The group sent a letter to the FDA about an internal memo from July 2002 written by FDA scientists. The memo included recommendations from scientists about changing Avandia’s label to include a warning about reports of heart failure for patients using the drug.

In 2002, the FDA Division of Drug Risk Evaluation found 25 patients taking Avandia who had cases of heart failure serious enough to require hospitalization. In most cases, the heart failure improved when the patient was taken off Avandia.

The memo also cites data that Avandia “may be associated with [congestive heart failure to an extent not clearly defined in the product labels.” The product labels have still not been changed.

“The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said. “As a result, millions of people - to the detriment of their health - are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.”

Public Citizen has called on the FDA to ban Avandia or require a black-box warning on its labels.

On May 21, 2007, a review published in the New England Journal of Medicine revealed patients who take Avandia are at a 43 percent higher risk of heart attackand a 64 percent greater risk of cardiovascular death.

In response, the FDA issued a safety alert about the drug’s potential risks but did not issue a recall because other studies of Avandia did not necessarily confirm the risks.

Sources: Sidney M. Wolfe, “Letter demonstrating that the FDA knew about Avandia dangers, urging action (HRG Publications #1820),” Public Citizen, May 22, 2007; “FDA knew of Avandia’s dangers nearly five years ago, memo shows,” Public Citizen, May 22, 2007 (http://www.citizen.org/pressroom/release.cfm?ID=2442); “Memo Re: Adverse Event - Congestive heart failure requiring hospitalization,” FDA Department of Health and Human Service, July 16, 2002 (http://www.citizen.org/documents/AvandiaMemo.pdf); “Did FDA know of Avandia dangers in 2002?” CBS News, May 22, 2007.

On May 21, 2007, a study published by Dr. Steve Nissen in the New England Journal of Medicine alleged there is an increased risk of cardiovascular disease associated with the diabetes drug Avandia. The following are some questions and answers relating to the new study:

1. Who is Dr. Steve Nissen?

Steve Nissen is a cardiologist and chairman of cardiovascular medicine for the Cleveland Clinic, one of the most pre