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Jerrold S. Parker

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FDA, It's Time to Rein in Misleading Pharmaceutical Ads

Posted: 08/01/11 02:23 PM ET

If you've stayed tuned in for commercial breaks during your favorite primetime show in recent years, then it is safe to assume that you have probably, on more than one occasion, caught a commercial for a popular osteoporosis pill, touted by Sally Field.

What she doesn't say -- and many consumers may not realize -- is that oral bisphosphonates (osteoporosis pills) have been linked to numerous side effects, including femur fractures and osteonecrosis or "dead jaw" syndrome. Just Thursday, the Food & Drug Administration (FDA) announced it would investigate claims that these medications increased the risk of throat cancer as well.

In 2010, the FDA ordered oral bisphosphonates manufacturers to include a warning label to alert patients to the risk of femur fractures, after studies linked the drugs to two rare types of thigh fractures, known as subtrochanteric and diaphyseal femur fracture -- nevertheless, persuasive ads remained on the air.

Osteoporosis medications are not the only pharmaceutical drugs whose ads have warranted FDA mandated-warnings in recent years.

Bayer Healthcare Pharmaceuticals launched the multi-million dollar ad campaign -- at the insistence of the FDA and 27 attorneys general -- after original ads for Yaz oral contraceptives were deemed misleading. The commercials, punctuated by the tagline "beyond birth control" not only downplayed the severe health risks but, according to the FDA, suggested that Yaz was for women with PMS, who in actuality "may not be appropriate candidates for the drug."

While the FDA often requires drug manufacturers to pull deceptive ads, it's quite rare to mandate an on-air correction. As part of a lawsuit settlement, Bayer is also required to submit all Yaz ads for federal screening before they air. Perhaps the popularity of the product (according to The New York Times, Yaz grossed sales of more than $616 million in 2007) and the severity of potential health hazards compelled the FDA to take these measures.

But for the thousands of women who have suffered the side effects, it's too little, too late. Those commercials should never have been approved for air in the first place.

In an age when tiny inserts in prescription packaging have largely replaced one-on-one pharmacist consultations, pharmaceutical ads are becoming a primary source of risk information for many patients. Therefore, it is up to regulators to ensure that dangerous drugs are kept off the airwaves -- as well as off the shelves.

The use of clever marketing to mask the potential risks of popular products is a universal issue. Proctor & Gamble has recently come under fire for similar misinformation around the widely-used denture cream Fixodent.

Approximately 35 million Americans wear dentures and many of them use Fixodent, made famous by the memorable tagline "Fixodent. And Forget It." What the manufacturer failed to disclose is that this adhesive contains zinc, which when absorbed in high amounts can lead to zinc poisoning - a condition that affects the nervous system and sometimes leads to death.

For years Fixodent and other zinc-laden denture adhesives were sold without adequate warning labels. It wasn't until 2009, after studies linking denture cream to zinc poisoning were made public, that the manufacturer added warning labels to Fixodent packages vaguely cautioning that "prolonged zinc intake may be linked to adverse health effects." Failure to properly warn millions of American denture cream users has left many with permanent nerve damage, wheelchair bound and unable to work.

Drug companies have pumped billions of dollars into ad campaigns in recent years for one simple reason: they work. The majority of consumers base their product choices on what they recognize from commercials, and most patients report being prescribed the specific brand-name drugs they request from their doctor.

This is where government oversight becomes crucial.

Regulators must do more than pull spots and mandate corrections when pharmaceutical ads are determined to be inaccurate -- at that point the damage is done. Instead the FDA must tighten regulations on pharmaceutical ads, monitoring accuracy as well as tone, before they're ever approved. It could literally save lives.

 

Follow Jerrold S. Parker on Twitter: www.twitter.com/@jerryparkeresq

 
 
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11:50 PM on 08/17/2011
Actonel And Other Bisphosphonates Cause Cancer
Target: Procter and Gamble, Sanofi Aventis, Warner Chilcott, FDA, President Obama, Hillary Clinton
Sponsored by: Brenda Kidd
Tell the FDA: Actonel and all other Bisphosphonates cause different types of Cancer, such as, Esophagus Cancer and surgeries, as well as, Femur Fractures, life threatening side effects and deaths in humans and animals.

The FDA must take Bisphosphonates off the market.
Stand up to harmful dangerous toxic chemical Bisphosphonates Drugs that dates back to the 1800’s…Osteoporosis Drugs claim to cure or prevent Osteoporosis, cause cancer of the esophagus, stomach, lungs, breast, liver, and varies other cancers.

They also cause broken bones, femur fractures, thigh pain, osteonecrosis of the jaw known, as phossy jaw, ulcers, gastrointestinal problems, bleeding from the rectum, black tarry bloody stools, swelling around the neck, swelling under the eyes, spots on the lungs and tumors in the liver. These are not all the side effect from Actonel Risedronate sodium and all other Bisphosphonates.

http://www.gopetition.com/petitions/save-the-population-stand-up-to-dangerous-toxic-chemic.html

http://standuptoharmfuldangeroustoxicdrugs.blogspot.com/

http://www.thepetitionsite.com/1/save-the-population/

Fact: Actonel and all other Bisphosphonates cause life threatening side effects, including deaths in Humans and Animals.
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rodjard
I Update my brain frequently
12:46 PM on 08/09/2011
Rinse your ears out with hydrogen peroxide duri if you have the slightest earache or
ear iritation. You will likely not get a cold.
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rodjard
I Update my brain frequently
12:23 PM on 08/09/2011
I had Gout several years ago. Brewers Yeast made it go away.
Now I take B complex. No more gout.
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rodjard
I Update my brain frequently
12:17 PM on 08/09/2011
A fact: Enough (At least 6 mg. Iodine/Iodide works better than
Prescription drugs for underactive thyroid in almost all cases.
It won't hurt you to try it. You will likely be shocked with the results..
You are probably being lied to.
HUFFPOST SUPER USER
Ranveig Elvebakk
Innovator, author and lecturer on weight and nutri
01:16 PM on 08/08/2011
"Ask your doctor about this NEW medication." meaning pressure your doctor to use the latest most research-intensive/expensive drug for the same problem, only more money per unit. For instance, did you know that aspirin has never been superceded as an anti-inflammatory/ant-platelet drug? That blockbuster drugs for bestselling diseases such a allergies,blood pressure have tried-and-true older counterparts that are affordable, effective and safer? The worst is cholesterol medications, where the peddlers have managed to create guidelines to scare everyone into taking them and and spend millions on TV ads. "Ask your doctor about it" (meaning if your doctor does not agree s/he is not current No wonder the health care system is bulging at the seams.
Coming to our senses about this, is part of health care reform if we really mean it, which I seriously doubt. Reason? The people at the helm have free, full health insurance and are feeling no pain---
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rodjard
I Update my brain frequently
01:01 PM on 08/09/2011
The best way to make sure you stay sick is to beleive those who keep you hooked on
prescription drugs. To follow doctors orders who march to the tune of the Pharmaseutical
companies will provide you with constant Lab fee, tests, office visits, and presceiptions
but never a cure.
I never got healthy until I got off of that system. The wealthy are dumbly not healthy.
They have money to be made by that system and are victims of it.
Poetic Justice in most cases.
04:44 PM on 08/03/2011
Wasnt there recent litigation over osteoporosis drugs in which it was concluded that although they do cause jaw destruction , the plaintiffs didn't prevail because they could not prove their jaw damage was due to the drugs rather than some other cause ?
04:42 PM on 08/03/2011
One problem with getting the truth out about pharmaceuticals is that when a person gets a settlement from a drug company , the settlement usually is confidential so the public remains uninformed .
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maribelles
have opinion? win fans, lose fans
06:23 PM on 08/02/2011
It would be wonderful if we actually had a truly functional democratic government, but what we have is big Pharma and other related business conglomerates essentially owning the government, and the FDA, with it's connection to the two most immense concerns for humanity- food and health - in particular.
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VA Jill
I'm not perfect and neither are you
02:32 PM on 08/02/2011
Pharmaceutical companies should not be allowed to advertise prescription drugs, period. The ads create "diseases" and "conditions" where none exist. Besides, if they didn't spend so dang much money advertising they could stop squalling about how they're going broke!
03:18 AM on 08/02/2011
Now THIS is an article worth reading!

Thanks !
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Chas53
04:21 PM on 08/01/2011
Overdosed America, By John Abramson MD, The Broken Promise of American Medicine.
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HUFFPOST SUPER USER
Brandt931
03:00 PM on 08/01/2011
Pharmaceutical companies cause OVER 100,000 deaths each year from the drugs they push on the public… that’s 10 times more deaths than from street drugs. Does EVERYone need a pill for something? The real drug cartels moving their product on unassuming victims are the Big Pharma Companies, averaging over $25 Billion in revenue EACH. Their agenda and money has corrupted Washington and the FDA. Voice your concern with me at http://tinyurl.com/3ut7m4z
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maribelles
have opinion? win fans, lose fans
06:20 PM on 08/02/2011
Actually, I believe the figures are now more like 300,000. Big Pharma IS a Drug Cartel.
01:50 PM on 08/03/2011
No, you're wrong. I followed your link, read what you had to say and checked out your links. Here are a few things I noticed:

·You claim that prescription drug accidental death was the #2 cause of death in the US.
·The link you provide first says that accidental prescription drug overdoses surpassed car accidents as the leading cause of unintentional injury deaths, then goes on to say that in other words it's the second leading cause of unintentional injury deaths

The 2009 leading causes of death in the US preliminary report (the most recent data available) names the top causes of death in the US as follows:
1.Diseases of heart .............................................................598,607
2.Malignant neoplasms ........................................................568,668
3.Chronic lower respiratory diseases .................................137,082
4.Cerebrovascular diseases ................................................128,603
5.Accidents (unintentional injuries) ..................................117,176*
6.Alzheimer’s disease........................................................78,889
7.Diabetes mellitus ................................................................68,504
8.Influenza and pneumonia ..................................................53,582
9.Nephritis, nephrotic syndrome and nephrosis ..................48,714
10.Intentional self-harm (suicide) ..........................................36,547
11.Septicemia ..............................................................................35,587
12.Chronic liver disease and cirrhosis .....................................30,444
13.Essential hypertension and hypertensive renal disease ...25,651
14.Parkinson’s disease ...............................................................20,552
15.Assault (homicide)..................................................................16,591

*This would be the total number of accidental drug overdoses of all kinds AND car accidents, falling off ladders et cetera
04:46 PM on 08/03/2011
Many of those conditions are the result of drugs . Pharmaceuticals are also one the the leading causes of cancer.
01:58 PM on 08/01/2011
This is a timely article, especially given the recent SCOTUS decision in Pliva v. Mensing, that essentially immunizes generic drug manufacturers from failure-to-warn state law claims (available here: http://www.scotusblog.com/case-files/cases/pliva-inc-v-mensing/). As an attorney who is handling Fosamax investigations, this is a critical issue, as Fosamax has been available as a generic for over a decade. People with possibly Fosamax-related femur fractures should seek an attorney to help evaluate these issues.