Posted on 02-06-2014
FDA PANEL FROWNS ON THIS PAIN RX
WASHINGTON (AP) - A painkiller proposed as a successor to Vioxx should not be approved, a panel of federal health advisers recommended Thursday.
The nonbinding 20-1 vote was on the prescription drug Arcoxia, made by Merck & Co., Inc.
A Food and Drug Administration drug safety expert had told the panel the drug may increase substantially the risk of stroke and heart attack and is no more effective for pain relief than other medicines in the same class.
''What you're talking about is a potential public health disaster,'' Dr. David Graham told the outside experts before the vote. Graham was a leading critic of Vioxx, a related drug also known as rofecoxib.
Merck is seeking the FDA's approval to sell Arcoxia, also known as etoricoxib, to treat the signs and symptoms of osteoarthritis. Merck, based in Whitehouse Station, N.J., withdrew Vioxx in 2004 after the drug was linked to a higher risk of stroke and heart attack when compared with dummy pills.
Panel member Dr. Richard Cannon said the decision came down to whether patients needed another nonsteroidal anti-inflammatory drug, or NSAID. These kind of drugs are a comment treatment for osteoarthritis, which affects an estimated 21 million people in theUnited States.
''We don't have strong data that there is a need for this drug, compared to what's already available,'' said Cannon, a cardiologist with the National Heart, Lung and Blood Institute.
Fellow panelist Dr. James Fries, a Stanford University rheumatologist, called it a ''weak argument'' that there was a ''crying need'' for more treatment options.
Arcoxia is the first drug of its class to go before the FDA for approval since Merck withdrew Vioxx.
''We at Merck believe etoricoxib represents a valuable treatment option for patients with osteoarthritis. We would like to emphasize there is more long-term safety data'' for etoricoxib than there is for any other NSAID, said Peter Kim, president of Merck's research laboratories.
Arcoxia and Vioxx are types of NSAIDs called Cox-2 inhibitors, developed to be gentler on the stomach.
The FDA said this week that new NSAIDs that increase the risk of stroke and heart attack should not win approval if safer alternatives are available.
''The idea should not be we need new drugs. The idea should be we need better drugs,'' said Martha Solonche, the advisory panel's patient representative.
In evaluating Arcoxia and all other drugs from that class, the FDA said it would focus on the risks to the cardiovascular system.
NSAIDs deserve approval only if they fill a need for a particular group of patients for whom there are no relatively safer options, the FDA said in a memorandum released this week. The FDA does not doubt Arcoxia works for osteoarthritis.
Merck said the cardiovascular risk of Arcoxia was comparable to another older NSAID, diclofenac, based on the results of a study that enrolled nearly 35,000 patients. Arcoxia causes more high blood pressure than the older drug.
Based on smaller and shorter studies, Merck said the cardiovascular risk of Arcoxia was consistent with that posed by other NSAIDs, but greater than that posed by naproxen. The company sells Arcoxia in 63 other countries.
Merck has been swamped by more than 27,000 personal injury lawsuits alleging harm from Vioxx.
Food and Drug Administration: http://www.fda.gov/
Merck and Co., Inc.: http://www.merck.com/
Folks, other then the deadly and/or other kinds of side effects, a big problem with the drug industry is that it distracts from looking into the actual cause of the problem. The disturbing side of this issue is that, as you can read in the article, the drug companies know they are deadly and know there are alternative, safe solutions.
Ask anyone, "Are drug companies concerned about your family's life or health?"
Instantly, that person will say, "Of course not. They just want to make money!" If they are a little bit more business savvy, they might say, "They just want to raise stock prices."
Then ask, "Who tells your doctor to prescribe which drug for which condition? Is itHarvard Med School?"
Instantly, most people will say, "Of course not. It is the drug company salesman/woman."
People know this. They just have not put two and two together. If you are hurting, you hope there is a quick drug fix. However, when you get the inside scoop like the article above, you realize that these drug manufacturers are like pure evil.
To pitch a drug, knowing that it will kill people, and then to say that they should be allowed because others are getting away with it is truly satanic. It ranks up there with terrorism any day and it actually injures and kills more people.
Please seek alternatives. Millions of people seek safe, gentle, sane Chiropractic and other lifestyle approaches to pain. Studies show that no medication can match the power of these kinds of lifestyle changes that get to the root cause of the problem and do not just cover up symptoms.
Even more importantly, no one gets hurt.
If you want a better way at caring for your pain call WellnessOne at 530.243.9464 or click HERE to make an appointment online!
It's your future…be there healthy with WellnessOne! Have a blessed day!
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