18 Stories

Critics Fume as Big Pharma Funds Drug Studies

'The evidence base has been perverted,' expert says

(Newser) - Think studies of new drugs in the New England Journal of Medicine are unassailable? Experts are beginning to wonder, because pharmaceutical companies pay academics to conduct many of those studies—and the approval of high-profile drugs like Vioxx, Avandia, and Celebrex has led to thousands of deaths, the Washington Post... More »

GlaxoSmithKline Settles Fraud Case for Record $3B

It's the largest penalty ever paid by a health care company in US

(Newser) - GlaxoSmithKline is about to set a new record: It's paying $3 billion in what government officials say is the largest health care fraud settlement in US history, the AP reports. The company will plead guilty to charges related to three drugs, the Justice Department says: Prosecutors say GSK promoted... More »

FDA Restricts Diabetes Drug Over Heart Risk

But regulators stop short of an outright ban on Avandia

(Newser) - The FDA today put severe restrictions on Avandia, GlaxoSmithKline’s embattled diabetes drug, but stopped short of banning it outright. The once-popular drug will now only be available only as a last resort to type 2 diabetes patients who can’t control their glucose levels with any other medication, the... More »

FDA Panel: Keep Avandia on Market

But it may get warning label on heart risks

(Newser) - A majority of federal health experts has voted to keep the controversial diabetes pill Avandia on the market despite evidence that it increases the risk of heart attack. A panel of Food and Drug Administration advisers voted 20-12 against withdrawing GlaxoSmithKline's once-blockbuster drug. The agency is not required to follow... More »

Avandia Woes Mount Ahead of FDA Hearing

Agency flags flawed study, may ban diabetes drug

(Newser) - As the FDA prepares to consider whether to ban Avandia, agency scientists have discovered another problem with the diabetes drug: flaws that disqualify a clinical study sponsored by its maker. The trial, organized by GlaxoSmithKline, sought to evaluate the relative heart risks of Avandia and two other diabetes drugs, but... More »

Diabetes Drug Linked to Heart Woes Again; FDA Weighs Ban

Avandia less safe than alternatives; FDA weighs action

(Newser) - The mountain of evidence against diabetes drug Avandia grew a bit bigger today, with two major studies linking the medication to heart disease and stroke, the LA Times reports. An FDA panel will meet next month to discuss recalling the drug, which has been on the agency's radar at least... More »

Feds Further Link Avandia to Heart Risk

FDA, Senate reports lambaste GlaxoSmithKline, want to yank drug

(Newser) - Some 800 people every month suffer heart attacks or heart failure because of the diabetes medication Avandia, according to government reports obtained by the New York Times . Under fire since 2007, the GlaxoSmithKline drug was linked to 304 deaths in the final quarter of last year and hundreds of thousands... More »

Drug Companies Hide Data From Docs

Edited info could mislead those prescribing meds

(Newser) - Pharmaceutical companies aren't as upfront with doctors as they are with the government about their new products, a study finds. Though drug companies must provide the FDA with all of the data from clinical trials, related papers published in medical journals were found to omit info from 20% of the... More »

8 Meds Docs Won't Take

If trained professionals won't use them, why would you?

(Newser) - Some drugs have such serious drawbacks that even doctors won’t take them, Men’s Health reports. The big eight:
  • Advair: Can actually increase the severity of asthma attacks
  • Avandia: Diabetes drug carries risk of heart attack
More »

Serious Side Effects Linked to Avandia, Fosamax

Heart trouble, brittle bones tied to drugs

(Newser) - Two new studies have linked the popular prescription drugs Fosamax and Avandia to serious side effects, Reuters reports. Fosamax, prescribed for osteoporosis, has been tied to a type of abnormal heartbeat that can cause dizziness and fatigue. Another study links Avandia, used to treat diabetes, to a double or even... More »

Diabetes Drug Given Strictest Warning Label

FDA's 'black box' adds risk of heart attack to concerns on Avandia

(Newser) - The FDA has applied its harshest warning to the diabetes drug Avandia, declaring the product potentially increases risk of heart attacks. Now marked with a “black box” warning, GlaxoSmithKline’s drug will stay on the market pending a continuing “safety assessment,” the Wall Street Journal reports; FDA... More »

FDA Panel Votes to Keep Avandia on Shelves

Controversial diabetes drug still faces heart-attack link

(Newser) - An FDA panel said today that GlaxoSmithKline's diabetes drug Avandia should remain in drugstores, despite earlier evidence the pill ups heart failure risks. Glaxo has defended its drug, countering that the risks associated with the popular Avandia are the same as those of other diabetes drugs. More »

Dow Sinks Further on Credit Jitters

GDP report, earnings, can't stave off 208.10 point slide

(Newser) - Stocks tumbled more than 200 points for the second day in a row, on fears that small-cap securities might be especially hard hit by a possible collapse in certain financial services. The Dow was down 208.10 to 13265.47, despite a report that the GDP grew faster this quarter... More »

Controversy Rages Over Diabetes Drug's Heart Risks

FDA official says superiors ordered her to back off serious warning

(Newser) - Troubling questions about the diabetes drug Avandia persisted yesterday as an FDA official revealed that she was barred from recommending a critical warning about the medication, the Times reports. In the run-up to congressional hearings that began today, manufacturer GlaxoSmithKline rushed to disseminate interim clinical findings in hopes of blunting... More »

Glaxo Stems Stock Slide Over Avandia

Medical chief rebuts findings on heart risks; claims comparable to other drugs

(Newser) - Glaxo shares pulled out of a tailspin after the pharma giant defended its second biggest selling drug, Avandia, against claims that it triggers heart attacks.  A sharply worded letter from the company's chief medical officer on the website of medical journal The Lancet pointed out that the increased incidence... More »

FDA Warned of Avandia Risks Years Ago

Doctor alerted agency to cardiovascular concerns in 2000

(Newser) - A diabetes doctor warned the FDA of heart risks posed by the diabetes drug Avandia seven years ago, the New York Times reports. The same concerns raised by Dr. John Buse in a 2000 letter were reiterated in a study published by cardiologist Steven Nissen this week. More »

Drug Company Nemesis Strikes Again

Crusading cardiologist took on Vioxx, now Avandia, for heart risks

(Newser) - The doctor who helped to raise concerns about the painkiller Vioxx is back—with the study released earlier this week linking the same company's popular diabetes drug, Avandia, to higher risk of heart attacks. The Wall Street Journal looks at 58-year-old cardiologist Steven Nissen's role in identifying and publicizing drug... More »

Diabetes Drug Ups Heart Risk

New study documents dangers of Avandia, but company nixes recall

(Newser) - A popular diabetes drug may increase heart attack risks, a study reported in the New England Journal of Medicine concludes. Patients who took Avandia, which treats Type 2 diabetes, were 43% more likely to have a heart attack than those who took a placebo, the Cleveland Clinic study found. More »

18 Stories