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The Greatest Drug Disaster Ever!

Joe and Terry's Blog October 2, 2006

Welcome to Joe's Blog. This is Number 1 and I sincerely hope that you will find my ramblings of interest and worthy of comment. I welcome your feedback.

Even before I started writing about drug-related issues 30 years ago, I was aware of the thalidomide scandal. In the 1950s thousands of babies were born with severely deformed limbs and other malformations. For years thalidomide represented the worst drug scandal in history. That the U.S. largely avoided the thalidomide tragedy was a point of pride for the FDA. The agency maintained that its rigorous testing and high standards protected the American public from this drug disaster.

Fifty years later the FDA is disgraced and in disarray. Over the intervening years we have watched as the agency was slow to recognize serious drug problems. Diet pills like Redux and phen-fen were allowed to linger on the market long after the handwriting was on the wall. The FDA dawdled over the herbal weight-loss and energy booster ephedra while gullible consumers experienced strokes or heart attacks. But all these misadventures pale in comparison to the FDA's latest screw-up.

The greatest drug disaster in history has occurred while our federal watchdog was asleep at the switch. In fact it wasn't the FDA that discovered the Vioxx disaster, but rather the manufacturer. When I asked one of the key FDA officials why the agency missed the iceberg that has nearly sunk his organization, he replied that the FDA is not very good at catching common things like heart attacks or strokes. They seem to be able to detect strange or rare complications like liver failure, but "common" problems frequently go undetected.

The FDA still to this day does not know how many people experienced heart attacks or strokes from Vioxx, Bextra or Celebrex and how many died. FDA safety officer, David Graham, MD, has estimated that it could be as many as 30,000 or 40,000 deaths, but that's just an educated guess. That would make Vioxx the greatest drug disaster in history, dwarfing thalidomide and fen-phen and all the other drug scandals combined.

What is even scarier, though, is that virtually all NSAIDs (nonsteroidal anti-inflammatory drugs) can do the same thing. For decades doctors have been prescribing drugs like ibuprofen (Motrin), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), piroxicam (Feldene) and sulindac (Clinoril) to ease patients' arthritis pain or strained muscles. No one knows how many heart attacks and strokes may have resulted from the hundreds of millions of prescriptions that have been filled over the last 40 years. The number could be in the hundreds of thousands. And even though naproxen (Aleve) has been reported to be neutral for cardiovascular complications, it is not entirely clear that it is perfectly safe either. At the very least, it and all the other NSAIDs can cause stomach ulcers that in some cases may lead to hospitalization or even death.

The bottom line is that the FDA has let us down for decades. It has allowed these pain relievers to be marketed without recognizing that millions of people would be put at risk for heart attacks and strokes. Only in the last few years have we seen strong warning labels on prescription-strength NSAIDs. But I doubt that most Americans still to this day realize how dangerous these drugs may be. Perhaps even scarier, we don't know what other drug disasters the FDA continues to miss.

If there is a lesson to be learned from this sad chapter in American medicine, it is that the FDA is no longer capable of protecting you from dangers in the drugstore. Without adequate warning information, your doctor can't protect you either.

You're on your own. Good luck!

Joe and Terry's Blog Main Page

Comments

Ugh. Disheartening. But better to be forewarned (and reminded of the need on a regular basis) than inappropriately trusting. Thanks for the post. Please keep them coming.

Thank you for your blog, I respect your opinions and advice. I will make it a point to read the blog weekly for good information. Will we learn from the past?

Is it possible for us to change either the people who are in charge of the FDA, or the way it runs its business?

Not only are the FDA and AMA not protecting citizens from drug reactions they are not honest about their knowledge concerning genetic disorders contributin to drug reactions. Have the Graedons researched the actual incidence of porphyrias in the world population and the technological problems in diagnosing these disorders in latent genetic carriers and in autopsies?

I read your column every Sunday. I lowered my tryglycerides by 47 point by just sprinkling common household "Cinnimon" on my oatmeat everyday or you can take Cinnimon capsules daily and still do the same thing safely with no side effects unless you are allergic to cinnimon.

I was wondering how do you get appointed to the FDA??I worked in hospitals for 20 year and Drs. are absolutely oblivious as to what medicines work. They will give you all the anti psychotics meds you want for anxiety but my gosh ask them for an anti anxiety medication for the patient and they don't want to give them anything. It might help.The government has these drs. afraid of their own shadow. Health care is disgusting. Our controlled meds should be ukp for review. If patients are responsible people they do not abuse their drugs. We all pay for the people who do.

I WISH YOUR COLUMN WAS IN EVERYDAY. I OFTEN TEAR IT OUT FOR MY FAMILIES BENEFIT.
I THINK I'LL JUST BUY YOUR BOOKS. I'M MUCH MORE INTERESTED IN THE NATURAL METHOD THAN THE PRESCRIBED MEDICINES.

Thank you for educating the public who seem to believe those ads. I read 2 daily newspaper and all I read about is celebrities and garbage of lack of underwear. thank you.

FDA and most doctors need to be aware of the effects of generics on people with autoimmune probems. I have Sjogren's Syndrome and can use only 2 generics out of 6 prescription meds. The side effects are drastic in some cases. There needs to be much more info on this syndrome. Also too many doctors don't know of the side effects of the medicines they prescribe. Please make this information available in your column.
Thank you.
Ruth B. Jones

The topic "restless legs" has been a topic by Dr. Gott in the Topeka Capitol Journal for at least 3 years by using and putting a bar of soap under the sheet next to one's legs. Many people have stated this has eliminated the symptom and is being used by many people who write in to Dr. Gott.

You're right and what is worse is that topical NSAIDs, which bypass the stomach and liver, are readily available through a compounding pharmacy, but your doctor probably never mentions that possibility to you. Of course, those topical NSAID prescriptions don't benefit the big drug companies, so they sure aren't going to tell you that you don't need to swallow their pills and risk bleeding ulcers.

I understand what you mean about not being able to trust what you get prescribed anymore. I'm 26yrs. old and I just now got in to Herbalogy. Its slow coming, but I will try anything at this rate! The Doc's medicine is just not working!

I am waiting for many more people to recognize the side effects of statin drugs, which doctors give out like candy. no dr. warned me about the severe muscle pain that goes with it. when i advised him that he suggest that patients take coq 10 he looked at me like i was from another planet.

Whenever I read the drug literature regarding the possible bad effects of a drug, I feel fortunate that so many drugs break me out in a rash, that I cannot take them.

I worked in the medical field for so long. What I found out, is most doctors know only what the drug salesman tell them. The salesman come in every two months and spend time telling the doctor about the drugs. And that is the extent of the doctors knowledge. It is scary.

I take a couple of asprin if my arthritis hurts too much. And one drug for HBP. Thats it. If I can stand the pain, or get by without an antibiotic, I do it. The over use of antibiotics is terrible. We have built up a tolerance, so they sometimes do not work.

I would rather save my use of antibiotics until I really need it. Doctors over prescribe most medications.

Carol H.

My husband did have problems with restless legs and we tried the bar of soap. Happily, his restless leg syndrome has ceased.

Also, thought my neighbor had an intersting solution to high blood pressure readings when she was scheduled for outpatient surgery. She remembered older people doing using this technique when she was a child and strangely enough it worked for her. She put Spanish Moss in her shoes and went about her daily activities. Her blood pressure went from high to normal and she was able to have her eye surgery.

A brief thank you for all the great information in your weekly column in my daily newspaper. There is a big group of people I know that follow your column regularly in the Long Beach (California) Press Telegram. Keep up the good work.

I am currently taking 400mg Gleevec/Day for Chronic Myeloid Leukemia.
Gleevec causes the liver to be agitated and my liver enzymes were 79 in Feb 07.
Thanks to your website, I started taking Milk Thistle and today my liver enzymes are 37 well within the range of normal 7-56.

The drs at MD Anderson Cancer Center in Houston want to know what I am doing because so many patients taking Gleevec are suffering from serious liver disorders.

Thank you Joe and Terry for looking out for us, and sharing your info.

My liver is functioning perfectly now, and I thank you, again.

Wally Dawid

I took a generic 800mg of "MOTRIN". My ears are STILL ringing.
We went on a road trip the last weekend of Oct.2006. That early fri morning I took a generic "Motrin" 800 mg in advance, as it was going to be a rather long road trip.
The next evening, with supper, I took another generic "MOTRIN" 800 mg. (as tourists, we did a lot of walking and sitting and I wanted to take these as a preventative).
I awoke the next morning, Sunday, with ringing ears. I am on an enteric coated baby-dose/adult low-dose aspirin daily. No problems with that from July 2004 until the last sunday in OCT, 2006, when I took the two generic MOTRIN-800's in a 36 hr. period.
Hey, could any body tell me if the (NON-time-release) "motrin" caused the ringing? (I thought the thing was time-released, being 800 mg and all....I should have KNOWN better....)
Here it is, July 2007 and my ears still are ringing;and it does not sound like the OUTSIDE-caused ringing, like loud music, etc. This seems internal.
Thanks for any helpful comments.
Sheila Henderson

I have the same report about Carpal Tunnel and Prednisone. I was diagnosed with carpal tunnel syndrome. Shortly thereafter, my son was killed by a drunk driver. I developed PolyMyalgia Rhumatica.

After trying one anti-inflammatory which didn't work at all, I was prescribed Prednisone. It started working immediately. Not only did it clear up my PMR, but it 'cured' my Carpal Tunnel.

I read the article about ALS, and Lipitor's possible connections to this disease. I told my family that my slurred speech and balance difficulties were the result of taking Lipitor. I firmly believe this is the case. I only took the drug for 3 1/2 months, but the speech and balance damage is done. My speech seems to be more affected when I am tired or under a great deal of stress. The statins are bad drugs.

You recently had a man talking about diabetes, and he said that if a restaurant labeled a dish as heart healthy, people would shy away from it. About 30 yrs. ago, I was working as a location motion picture caterer, and I served ratatouille. No one would eat it. I put it in the fridge and served it the next day as Willie Nelson casserole, and the gruff old Teamsters, the film guys, everyone ate it and loved it.

I learned that naming dishes made a big difference in what I could get people to eat--just as I learned putting onions on the grill while people were going through the serving line could encourage people to eat more veggies (helping us to "get rid" of the fresh foods we purchased). A little psychological nudge
really does help in getting people to eat healthy.

Greg Williams - Garland, TX

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Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio.

© 2006