Dr James Schaller
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FDA Warns Aleve & Naproxen users: Federal Researchers Found Excess Heart Attacks and Strokes

If you walk into any supermarket or drugstore you can casually pick up some Aleve, commonly promoted on TV. Of course, since it is a medication that does not need a prescription, no one thinks of the mild strain it presents to the entire gut, liver and kidneys.

But now we learn that this medication is added to the other ones that are a recent FDA concern. Simply, the FDA issued warnings of an increased number of heart attacks and strokes among Aleve users.

Why now?

Naproxen or Aleve was part of an NIH study and had to be stopped since people who took naproxen were 50 percent more likely to have heart attacks or strokes. The FDA feels any use over 10 days should be under a physician's direct care. Common medications are getting a second look.

A National Cancer Institute study last week that found that Celebrex users had a higher risk of heart attack or stroke. The FDA warned doctors to consider "alternative therapy" for patients taking Celebrex since some researchers found a higher risk of cardiovascular problems.

Another painkiller, Bextra, according to the FDA, has also shown increased risks of cardiovascular events in some settings.

About two months ago, Merck recalled a similar arthritis drug, Vioxx, after similar problem findings became public.

FDA drug safety researcher and whistleblower, David Graham, who has been with the FDA for 2 decades, said the recent issues surrounding the medications point to larger problems at the FDA, such as a lack of agency accountability. The agency, he said, remains in denial about problems with the way drugs are approved.

"I think this asks the larger question, 'Why has FDA not done the job it needs to do to protect America from unsafe drugs?' " He said.

Graham said in his 20 years at the FDA, "safety has been at the back of the bus, if it's on the bus at all."

FOR CNN'S FULL STORY PLEASE FOLLOW THIS LINK: www.cnn.com/2004/HEALTH/12/20/study.halted.ap/index.html


Some Things The FDA has Attacked

  1. Essential nutrients are not made by the body, and are usually at fair levels in my research testing. They are safer than synthetic medications which are not essential for life -- like essential nutrients.
  2. Any medication that is carefully compounded and custom-made for you by a specially trained pharmacist and your doctor is likely safer than what is prescribed in 3 minutes. Both the physician and the pharmacist have to study extensively to be able to tailor an FDA approved powder to your body. Special attention commonly means less error. FDA relentlessly harasses brilliant compounders virtually every year.
  3. If a doctor finds that a new treatment helps pateints, and it has not gone through tens of millions in drug research, he is supposed to ignore the world data on its benefits and just let you suffer. If he or she uses the treatment, they can expect a raid. Good to know some of the smartest non-drug company doctors are being raided despite offering excellent informed consent to pateints and education about the treatment.
  4. If you decide you want cheaper Canadian medications at a fraction of the price, a state may not do so, since the super power's FDA has decided the States and you are stupid and naive.
  5. You see Canadians can barely make fire; so buying from them at a major discount is stupid. It is true that some scam operations exist in Canada, and certainly any package could have harmful terrorist materials. So can a mailed Bible. This is really silly.

How About You Get The Facts and You Decide!

What a Novel American Idea.

So if a medication comes from Canada, it has a sticker or permanent stamp saying the source.

How About A New FDA Goal & Rating System?

Stop pretending that drug safety is something that is entirely certain and possible, and offer graded and educational ratings of safety.

Rough ideas to allow us access to all possible data to make our own decisions as adults.

  • If a medication has been used in other countries on 50 million people, it gets an F rating for foreign data only.
  • If it has had studies done in the USA, but only on a few thousand people, it gets an A, or approval.
  • For each year it is approved it gets a number, such as A3, which means it has been available three years post USA approval.
  • For each ten million patients treated the medication gets a 10M.
  • If a medication is not FDA approved, the physician must have a patient note, or a court appointed guardian saying the patient understands that the medication is being used in an experimental manner and should be offered the option of the medication. Why should some of our useful options wait 10-20 years or never come to the USA due to the massive cost of FDA experiments for approval and the FDA barriers? A medication available in 70 countries for ten years should be able to be prescribed to those who want it in the USA. Period. Why wait for the Ivy League and Drug Company fusion to decide what you are allowed to have for treatment.

If You Have Better Ideas. Certainly Let the Lawyers Running all Three Branches of State and Federal Government Know.


Dr. J

Bank Towers, Tamiami Trail, Naples, FL
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