Avandia News: What You Need to Know
Avandia (AP)
(CBS) In a split decision, an FDA panel has decided to leave diabetes drug Avandia on the market despite concerns over increased heart risks.
The drug's manufacturer, GlaxoSmithKline, says it expects to take a $2.6 billion hit in the second quarter to settle lawsuits for Avandia as well Paxil, an antidepressant linked to birth defects and problems at a plant in Puerto Rico.
For the drug maker, that's actually good news. Analysts expected the company could have shouldered as much as $6 billion if the FDA took Avandia off the market, according to the Wall Street Journal.
Meanwhile, a coaltion of diabetes doctors is recomended that Avandia patients remain on the drug until they can find other treatment options. That's despite the fact that studies have suggested an increased risk of heart attacks, strokes and death in some users.
"The worst outcome would be to not treat diabetes properly, thereby risking its complications," Dr. Daniel Einhorn, president of the American Association of Clinical Endocrinologists, said in a statement joined by the Endocrine Society and the American Diabetes Association.
Twenty-four million Americans have diabetes, according to the American Diabetes Association.
Popular in Health
- Flesh-eating disease victim gets bionic hands
- Controversial update to psychiatry manual, DSM-5, arrives
- Skin cancer self-exam: What to look for (PHOTOS)
- Shocking study: Math skills improved by electric stimulus
- Handbags have more germs than toilet seats, study finds Play Video
- Handbags may contain more germs than average toilet flush
- Doctor: Gel manicures a potential skin cancer risk
- Malaria-infected mosquitoes may prefer smelly humans
It has been estimated that Vioxx killed between 26,000 and 56,000 of its users before being removed from the market in September 2004. Records produced during litigation with Merck revealed that the company knew about the drug's propensity to produce blood clots at least two years before it was approved by the FDA. Paxil was initially marketed in 1993 for the treatment of depression. But by 2004, postmarket studies were reporting that with many children and young adults the drug increased depression and was inducing suicidal thoughts, doubling the risk of suicide. But the real shocker occurred in 2008, when records produced by GlaxoSmithKline pursuant to court orders revealed that premarket studies with the drug had been manipulated - that the drug company had concealed the fact that studies going as far back as 1989 demonstrated an 8-fold increase in the risk of suicide.
The above facts are just two of many examples of why it is absolutely insane that the very studies which determine whether a drug is approved by the FDA for market ARE CONDUCTED AND CONTROLLED BY THE DRUG COMPANIES THEMSELVES. This is the way it has been since the FDA was formed 72 years ago in 1938. It is thus about time that we took the fox out of the henhouse and established an impartial and objective entity to oversee all premarket clinical studies of drugs. We also need to REMOVE THE 10-MONTH AND 6-MONTH ARBITRARY DEADLINES for standard and priority new drug reviews, which were established by Congress at the behest of the drug industry in 1997. This has created an environment at the FDA where drugs are being rushed to market without an adequate opportunity to assess their safety and effectiveness.
I would thus encourage everyone to go to my website at www.FDAReformPetition.com and sign my petition to Congress demanding the above changes. Only as potential voters speaking in a unified voice will we ever have any hope of enhancing the safety of marketed drugs and slashing a huge chunk out of our future healthcare costs.