Heart x-ray linked to risk of cancer
Filed under: Women Heart Health, Children Heart Health
When a doctor wants to see inside a heart, one option is to use a procedure called computed tomography (CT) coronary angiography, which can identify problems inside the heart and arteries without making a cut. But the use of the higher radiation procedure on certain patients is being questioned. By taking what they know about certain kinds of radiation, researchers were able to predict the risk of developing cancer for various groups of people. What they found was that women who underwent the procedure were especially at risk, because the breasts may be damaged by the x-ray. Young women, especially, had an increased chance of developing cancer, because their is a longer period of time in front of them for cancer to develop. There are other procedures that can help make a diagnosis of a heart condition if a patient falls into a high-risk group, so it's likely that doctors will start weeding out who gets this kind of heart x-ray and who doesn't.
German research study flattens Avandia
Filed under: Type 2, Adult Onset, Drugs, Research
Dr. Steven Nissen is not the lone fighter questioning Avandia's safety anymore. Dr. Bernd Richter of Duesseldorf's Heinrich-Hein University just laced up his gloves and jumped into the ring. Popular type 2 diabetes drug Avandia was challenged in late May by top cardiologist Dr. Nissen, after he published a meta-analysis of 42 previous Avandia trials revealing an alarming 43 percent increased risk for heart attack.
The German researchers studied pooled data from 18 past Avandia trials involving 8,000 patients. The researchers hit Avandia with a jab when they stated little evidence was found that Avandia improved quality or length of diabetics' lives -- then came the stiff uppercut when they concluded Avandia could actually worsen type 2 complications. Is Avandia manufacturer, GlaxoSmithKline, seeing stars, yet?
Lead researcher, Dr. Berndt Richter, questioned the ethical implications of conducting any further clinical tests with Avandia as there are many less dangerous options on the market. The analysis found Avandia had similar reductions in blood sugar levels as other oral antidiabetic drugs, but patients gained up to 11 pounds and their edema risk doubled. Heart failure and bone fractures were also linked to Avandia. Richter stated even very small risks can equate into a big effect since millions take the drug.
Glaxo's knees aren't buckling, yet, this prizefight purse is immense with $3.3 billion in Avandia sales last year. Ronald Krall, Glaxo's chief medical officer claimed the German analysis examined a tiny slice of the total available evidence for Avandia, and the dataset involving more than 52,000 patients showed Avandia's safety profile is similar to other oral antidiabetic drugs. A knockout punch could come on July 30 when Food and Drug Administration meets to discuss Avandia's safety.
Interestingly, the German study was entirely independent of Nissen's, and the timing of its release purely coincidental. Read more in Reuters.
FDA slaps diabetes drugs Avandia and Actos with black box label
Filed under: Type 2, Adult Onset, Drugs
Call the art director and the printer. It's time for a label redesign.
Glaxo just finished revving up the printing press for their aggressive PR campaign assuring us all Avandia is safe. Yesterday, the FDA ordered Glaxo to add their strictest warning to bottles of Avandia - the dreaded black box label. They also ordered the black box label be placed on Avandia's closest competitor, Actos, manufactured by Takeda Pharmaceuticals and Eli Lilly & Company.
This bomb was dropped by FDA commissioner, Dr. Andrew C. von Eschenbach, in the midst of a packed House hearing investigating the FDA's questionable handling of Avandia. In a written statement, he said the agency asked Avandia and Actos makers to add the more prominent black box warning of heart failure because the drugs were being prescribed to patients with significant heart failure, despite existing warnings on the bottle. Dr. Nissen's May 21 study, which sparked the controversy, revealed a 43 percent higher risk of a different side effect, heart attack.
Revealed to the public only yesterday, turns out the FDA had requested drug makers for the black box label on May 23, a mere two days following publication of Dr. Nissen's study in the New England Medical Journal.
Democrats on the House committee strongly criticized the FDA, while some Republicans challenged Democrats were drawing conclusions with uncertain data. Representative Virginia Foxx, Republican of North Carolina, questioned whether those researching the drug had spoken only to Democrats on the committee and not the FDA. She then called for the press to investigate if certain members of Congress conspired with a few FDA staffers to seriously embarrass the drug agency.
Democrats asked Dr. von Eschenbach if the FDA needed more authority to require drug safety studies or correct drug advertisements. He replied more money is needed, not authority. He also said separating the drug agency's safety and approval offices, suggested by some Congressional critics of the agency, was more destructive than constructive.
In a testimonial moment, Representative Diane E. Watson, Democrat of California, said her doctor ordered her off Avandia after she developed a heart murmur. She said Avandia should have heart attack on the label, and she thinks she was headed toward one at the time.
In an awkard moment for the FDA, Representative Stephen F. Lynch, Democrat of Massachusetts, asked the FDA officials to look at the current Avandia label and find the warning about heart attacks. As Representative Lynch repeatedly asked the officials if they had found the warning yet, one official eventually pointed to an embarrassingly small table in the labeling information. Dr. von Eschenbach explained the agency was working toward improving readability of all drug labels. Can you just see a spoof of this scene on NBC's Saturday Night Live? See the full story in the New York Times.
Get in the drug label printing business, there is a fortune to be made.