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Vioxx & The Future of the FDA

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Mistletoe Angel
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0 posted 01-25-2005 03:23 PM       View Profile for Mistletoe Angel   Email Mistletoe Angel   Edit/Delete Message      Find Poems   Click to visit Mistletoe Angel's Home Page   View IP for Mistletoe Angel

http://www.bloomberg.com/apps/news?pid=10000103&sid=aYylPaMtm4GY&refer=us

A newly published study on the arthritis drug Vioxx has estimated the drug caused as many as 140,000 cases of heart disease and 56,000 deaths during the five years that it was on the market.

The study appears on the website of the British medical journal Lancet. The study publication had been previously blocked by the Food and Drug Administration.

The study found that low doses of Vioxx increased the risk of heart disease by about 50%, and higher doses increased it by 358%.

The author of the study, Dr. David Graham of the FDA, now considered the whistleblower among the FDA, said he was pressured not to publish the study last November. The pharmaceutical company Merck withdrew Vioxx from the market in September.

Meanwhile the watchdog group Public Citizen petitioned the Food and Drug Administration Monday to immediately remove the widely prescribed pain relievers, Celebrex and Bextra. Both drugs are in the family of drugs as Vioxx. The group has cited several studies that show the drugs increase the risk of heart attacks in patients.

With Merck and Co. already setting aside $600 million to defend against many possible further lawsuits, which has slashed its fourth quarter profit by 21 percent, this pharmaceutical company, along with the Food and Drug Administration, is destined to face a rough year, or years, ahead.

What will all of this mean for pharmaceutical companies in general, as well as the Food and Drug Administration, in the years ahead?

While thinking, also consider the following on FDA's accelerated drug approval over the past two decades, as specified in sources like this one:

https://www.aslme.org/aslmesecure/shop/show_product.php?prod_id=462/

Sincerely,
Noah Eaton


"You'll find something that's enough to keep you
But if the bright lights don't receive you
You should turn yourself around and come back home" MB20
Aenimal
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1 posted 01-25-2005 04:17 PM       View Profile for Aenimal   Email Aenimal   Edit/Delete Message      Find Poems  View IP for Aenimal

I've been prescribed Vioxx, Celebrex and Naproxen(amongst others) at various times in the last 2 years. None of them helped much, but I have enjoyed some interesting side effects, coupled with all the recent revelations, and I've sworn off all of them. sighs.

Not sure if you've ever read No LOGO by Naomi Klein Noah, but there's an interesting section on drug testing/studies and how corporations are getting away with murder. And that's not a new book, god only knows what's going on now.
serenity blaze
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2 posted 01-25-2005 05:40 PM       View Profile for serenity blaze   Email serenity blaze   Edit/Delete Message      Find Poems  View IP for serenity blaze

"getting away with murder"

nodding. They almost got me.

I'm still pissed.

When I'd complain of bad reactions from one, they blithely substituted another.

I should have just chewed some white willow bark.

serenity blaze
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3 posted 01-25-2005 05:44 PM       View Profile for serenity blaze   Email serenity blaze   Edit/Delete Message      Find Poems  View IP for serenity blaze

Came back to add, though.

One good thing that came of it?

I have learned to respect drugs, and I am much more cautious of all of them now.

Aenimal
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4 posted 01-25-2005 06:39 PM       View Profile for Aenimal   Email Aenimal   Edit/Delete Message      Find Poems  View IP for Aenimal

"When I'd complain of bad reactions from one, they blithely substituted another."

Exactly what happened with me, one of them almost tore a hole in my stomach. Just give good old fashioned percocet already..grins
serenity blaze
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5 posted 01-25-2005 07:34 PM       View Profile for serenity blaze   Email serenity blaze   Edit/Delete Message      Find Poems  View IP for serenity blaze

Apparently, they'd rather kill us.

*shaking my head*

Mistletoe Angel
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6 posted 01-25-2005 07:54 PM       View Profile for Mistletoe Angel   Email Mistletoe Angel   Edit/Delete Message      Find Poems   Click to visit Mistletoe Angel's Home Page   View IP for Mistletoe Angel

I've only been on three drugs during the whole course of my life to date. Tegretol when I was young and having seizures, and Clindamycin HCL 150mg capsules and Percocet 7.5/325 MG Tablets when I got my wisdom teeth removed.

(giggles) But seriously, when did we all step so far away from nature's pantry in recent memory? Rather than taking that Levitra with the constant concern you might keep your freak on and short-circuited for over four hours, and learn later that your blood pressure is dangerously high, when you could just bathe in a bathtub of Kava Kava root, saw palmetto berries and Damiana leaves. (giggles)

I guess I can be a pretty ecumenical individual, but I am so shy of drugs I've even been afraid to sample a trickle of red wine from my parents a few times. Pomegranate juice is an even more powerful antioxidant anyhow, so I boost my immune system like that. If I have a headache, clary sage and lavender oil does the trick to relax it. You can clean your system with one tablespoon aloe vera juice, one teaspoon of liquid chlorophyll, and one teaspoon of psyllium husk in a cold glass of water. I find the more organic, the more dependable.

In the end, I guess you can put Champissage in a box, but you just aren't touched and your blood just doesn't circulate like the real thing.

Sincerely,
Noah Eaton

"You'll find something that's enough to keep you
But if the bright lights don't receive you
You should turn yourself around and come back home" MB20

serenity blaze
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7 posted 01-25-2005 07:58 PM       View Profile for serenity blaze   Email serenity blaze   Edit/Delete Message      Find Poems  View IP for serenity blaze

*chuckle*

Damiana?

I was once well known for a liqueur I made...and you know what Damiana does for ya, don't ya?

*wicked eyebrows*

Mistletoe Angel
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8 posted 01-25-2005 08:05 PM       View Profile for Mistletoe Angel   Email Mistletoe Angel   Edit/Delete Message      Find Poems   Click to visit Mistletoe Angel's Home Page   View IP for Mistletoe Angel

(giggles) I think I'm going to need a Verdi chamomile right about now, and stare at a blue wall for at least forty minutes.

LOL!

Sincerely,
Noah Eaton

"You'll find something that's enough to keep you
But if the bright lights don't receive you
You should turn yourself around and come back home" MB20

Aenimal
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9 posted 01-25-2005 09:46 PM       View Profile for Aenimal   Email Aenimal   Edit/Delete Message      Find Poems  View IP for Aenimal

lol, laughter is the best medicine in the end..well in the absence of percocet or sex
serenity blaze
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10 posted 01-25-2005 10:02 PM       View Profile for serenity blaze   Email serenity blaze   Edit/Delete Message      Find Poems  View IP for serenity blaze

When in the absence of what would work best--
finding myself bereft percocet
don't get me started to talkin' 'bout sex--
when it comes to laughter, I just may die yet.

*sigh*

signed,

reluctantly retired
hush
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11 posted 01-25-2005 10:35 PM       View Profile for hush   Email hush   Edit/Delete Message      Find Poems  View IP for hush

Uh...

Well, for once I'm going to speak out and defend the system (??!!)- this is all pretty fresh in my mind, since I'm taking pharmacology this semester and we just covered that class of drugs...

There is the added risk of heart disease with COX-2 inhibitors (Vioxx, Celebrex, etc.) But there is a significant group of people who benefit from these drugs- people with arthritis who respond better (believe it or not) to these drugs than to narcs- besides, a one-time RX of percocet might be nice, but do you really want to be on it the rest of your life? They have some nasty side effects, too. So pulling all these drugs off the market would protect against the heart disease, but it would basically screw a certain population out of pain relief. Seems to me it would be better to warn patients that the risks aren't entirely understood, blah blah blah, and see if they still want them.

Now, will a doctor do that with the drug company pushers giving them free samples and presenting them with gifts galore? That's another story...
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12 posted 01-25-2005 10:52 PM       View Profile for Alicat   Email Alicat   Edit/Delete Message      Find Poems  View IP for Alicat

Part of the problem is the medication.  The other signicant part are the people taking it.  Like the thing I read about Naproxen (one among many names) which linked it to very serious problems, but only if massive doses were taken.  The OTC version says no more than 3 250mg tablets a day, with no more than 2 in an eight hour period.  Yet people persist in taking grams of that stuff in a single 24 hour period.

People have perpetually upped their dosages to degrees which would kill a lab rat, based on body proportion, long before it was even born.  And some times, many times, those were not dosages prescribed.  So is the drug company still responsible for human stupidity?
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13 posted 01-25-2005 11:02 PM       View Profile for serenity blaze   Email serenity blaze   Edit/Delete Message      Find Poems  View IP for serenity blaze

But it's not "only if"....

Bro? I know naproxen worked for you.

but laughing, you were there with me! (Remember the fog) So nod, and know that stuff is some bad for some.

I'm not saying it's ALL bad.

I am managing on high dosages of Motrin now. But I'm getting that ulcer Raph talked about too.

*and kudos to hush* for pointing out the pharmaceutical kick-back connection too*
LeeJ
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14 posted 01-26-2005 06:59 AM       View Profile for LeeJ   Edit/Delete Message      Find Poems  View IP for LeeJ

any medication is a risk...but sometimes people need to take them...I took Vioxx for quite sometime...no side effects, and deemed it a miracle drug...as I could hardly walk without limping...and did benefit from it a great deal...but b/c it was a drug, researched other avenues and stopped taking it, b/c any medication is a risk...even asprin, depending on each & every individual.  

We've become a quick fix nation, and if these kinds of drugs were not in demand, they would not sell, forcing the drug companies to research other areas...

Anytime a doctor perscribes any medication, it is solely up to the individual to read all the information that comes with the drug and decide for himself/herself if they want to risk those side effects, including any self perscribed over the counter meds.

It is up to the individuals of this country to assume some responsibility & research what we're putting into our bodies.

I also had Laser surgery on my eyes...and researched any meds that were perscribed at that time.

If I go into the hospital, I refuse to take anything to help me sleep or for pain, unless I absolutely have no other alternative.  And one night a nurse came into my room with a needle.  I inquired what it was she was about to give me...she said...something to ease the pain & help you sleep.  I explained nicely that I didn't want it...why, b/c years before that, I had two bouts with kidney stones, and they shot me up while in the hosptital with all kinds of pain killers...after being discharged from the hospital, it took two weeks for those drugs to leave my system...all kinds of problems staying awake...focus...etc.  

So what I'm saying is...it's ok to say no to drugs...research the internet, and educate yourself with any possible side effects.  

Years ago, penicillin also caused some pretty nasty side effects and even deaths due to allergies...etc.  But helped thousands of people otherwise.  

I've looked at other remedies...such as natural over the counter suppliments with a combination of juicing and have had some pretty significant & beneficial results.

Before you take any medication, think first about what your putting into your body.  Drugs do help people...they do...and have been and will continue to be very beneficial
keeping people alive.  

Take for instance any drug that is given to a child for hyperactivity.  There are very few children who are hyperactive.  Most of the time, it's a behavoral problem and the parents go to the doctor beside themselves, not knowing what to do, so the doctor gives them a quick fix...drug the child and the child will be more managable.  

I suppose what I'm saying is...Vioxx along with many other drugs have helped a lot of people...including myself...but unless it's a life threatening situation, dependency on any drug over a long period of time, might very well be of risk.  

Read all information which comes with your drug before digesting it...if there is a history of heart attack/strokes...etc in your family, which is genetic...then I suggest you not take any drug which offers information, warning against these side effects.

Check to see if the Drug is black boxed, which means...it has been tested and proven to cause major side effects...  

Somewhere along the line...people have to start assuming responsiblity and face the consequences for their actions and stop blaming everything & everyone else for their lack of education, so to speak.  And I don't mean that in a condescending way...what I'm saying is...if you know you have a severe allergy to shellfish...are your going to chance eating it suffering severe complications.  

If your in pain...ask your doctor about the side effects of any drug he perscibes...and if he doesn't have the time to sit down and discuss the issue with you...then, read up on the drug yourself and change doctors.  Doctors are not Gods...and it's ok to fire them.

And if you experience any side effects, it is up to you to contact your doctor immediately...stop taking the drug immediately, and evaluate perhaps other avenues.  

I realize there are many many people who need to take meds...otherwise they would gravely suffer...but when you take any medication, realize there is no perfect world, and understand that what ever drug your taking...might help one issue, but also, effect another...

I know a gal who suffers severe convulsions...she was a neighbor of mine with 4 children.  The drug she was taking gave her a better quality of life, suffering less and less convulsions...yet, she knows quit candidly, that this drug will eventually effect her liver...what other choice does she have?  With the drug she can function rather normally, and without it, the convulsions can kill her?  

What would you do?  I do not take many meds but rely on vitamins and other natural herbs and suppliments...and yet, the pain in my knee was so so bad...I resorted to Vioxx and it did a much better job then I thought it would.  And yes, I read all the literature which came with the drug and was fully aware of any side effects (of which I didn't suffer) while researching other avenues...got off the drug and have been doing much better the past few months.  The only other option I'd have and might have to face in the future is surgery...but will ward that option off as long as pratically possible.  Why?  Due to new technologies and new meds being researched all the time.

What it comes down to, is common sense, responsibility of and for self, depending on your health, amount of pain, and your quality of life.  


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15 posted 01-26-2005 10:01 AM       View Profile for jbouder   Email jbouder   Edit/Delete Message      Find Poems  View IP for jbouder

I'm going to have to agree with Amy.  In addition to the Vioxx issue, some believe a mercury-based preservative in vaccines (call thimiserol) is a cause of autism.  I, personally, haven't seen enough evidence that this is true, but I still felt some apprehension while having my younger son immunized.

On one hand, I think it is important to be reasonably certain that prescription drugs are safe.  On the other hand, we also have to weigh the potential risks against the benefits.  We should hold pharmeceutical companies to a very high standard of care, but also recognize, as Amy pointed out, that new drugs entering the market do a tremendous amount of good to many people.

Jim
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16 posted 01-26-2005 12:55 PM       View Profile for GG   Edit/Delete Message      Find Poems  View IP for GG

I was prescribed quite a bit of Naproxen for about a month. No side effects, but then, it gave me no effects at all... it didn't help so they stopped that and prescribed something new. More recently I stopped taking daily meds... I only take vitamins and supplements on a daily basis now. But you'd better believe if I found something that helped, risk or not, I'd start taking it. Percocet and hydrocodone and all the other narcs end up hurting far more people than things like vioxx (imo) because they cause such strong addictions and are so hard on the stomach. I take hydrocodone with some midrin about once every other week and I'm still puking blood with a sting in my stomach. Oh well. Until I can find something better, it's all I have. People just need to inform themselves about what it is they're doing. Not everything is the doctors fault or the FDA's fault, sometimes it is... but usually it's just plain patient ignorance.
Mistletoe Angel
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17 posted 01-26-2005 01:09 PM       View Profile for Mistletoe Angel   Email Mistletoe Angel   Edit/Delete Message      Find Poems   Click to visit Mistletoe Angel's Home Page   View IP for Mistletoe Angel

Oh, I absolutely agree that you've only got yourself to blame ever so often for not even bothering to look at the side effect information and warning labels.

Still, I think its crucial that many become more informed on the acceleration of drug approval under the FDA within the past twenty years. It almost seems that so many drugs are being put on the market without further testing or study, if this were a candy factory, far more syringes might accidentally be going by on the conveyor belts.

I certainly hope Celebrex doesn't become Vioxx II. But it seems studies show Celebrex causes similar side effects to Vioxx, and that may be a warning signal.

Sincerely,
Noah Eaton

"You'll find something that's enough to keep you
But if the bright lights don't receive you
You should turn yourself around and come back home" MB20

Alicat
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18 posted 01-26-2005 01:17 PM       View Profile for Alicat   Email Alicat   Edit/Delete Message      Find Poems  View IP for Alicat

Well, at least now, compared to years prior, they actually tell you, albiet in very fast used car speech, some of the side affects, real or possible.  Often, when I hear the litany, I can only shake my head and openly wonder why someone would take something with that many possible sideaffects, moreover those shown to exist from clinical studies.
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19 posted 01-26-2005 04:01 PM       View Profile for LeeJ   Edit/Delete Message      Find Poems  View IP for LeeJ

exactly Alicat, but some do not have a choice...if a vaccine cause one death, to me, that is way to many, but, my point being, would you want to take the risk and not vaccinate your child b/c of an alergic reaction or otherwise in one?  Its a real tough call...it is...but...in the end, when it comes down to pain, and/or life or death, most would choose life...even if quality of life would not ever be the same.

And I mean no insult to anyone...but what is safe?  Drugs were never full proof safe?  Not ever?  Since the beginning of heal treatments...what drug or pill or any health agent is absolutely safe? And I honestly say this from my heart...I cannot believe America thinks or believes this way.  Again...an asprin or cold medication, or even vitamins, can cause side effects or harm in some, not the majority of people, but there is always risk, chance and consequences which may occur.  And believe me, some calls are very very tough.  

The meds my mom was on, destroyed brain cells which will never rejuvinate, hari loss, upset stomach, and more...but she is alive, she chose that medication over death...and I'm glad she did?  

What about Diabetis taking insulin...any medication is foreign to the body, but when you weigh what might happen without them, sometimes there is no alternative?

  

Mistletoe Angel
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20 posted 02-22-2005 03:00 PM       View Profile for Mistletoe Angel   Email Mistletoe Angel   Edit/Delete Message      Find Poems   Click to visit Mistletoe Angel's Home Page   View IP for Mistletoe Angel

Is anyone else just outraged that Merck is about to get away with murder again?

From Democracy Now!:

The FDA panel proposed that the drugs be sold with an FDA "black box" warning. Vioxx is now expected to return to the market even though nearly half the FDA panel voted against it being sold. Its manufacturer Merck voluntarily withdrew the painkiller drug in the fall. Studies have show as many as 55,000 people may have died from taking the drug.

A Food and Drug Administration advisory panel has voted to allow doctors to keep prescribing the popular painkillers Vioxx, Celebrex and Bextra even though the panel overwhelmingly agreed that the drugs significantly increase the risk of cardiovascular problems in patients.
The panel proposed that the drugs be sold with an FDA "black box" warning. Vioxx is now expected to return to the market even though nearly half the FDA panel voted against it being sold. Its manufacturer Merck voluntarily withdrew the painkiller drug in the fall. The FDA panel decided whether a drug should be allowed to be sold on a straight majority vote.

The vote for Vioxx was 17 to 15. For Bextra, 17 panelists vote for the drug and 13 voted to ban it. The panel nearly unanimously recommended Celebrex remaining available.

Last year FDA whistleblower Dr. David Graham publicly estimated that 139,000 Americans who took Vioxx suffered serious side effects. Of these users he estimated that the drug killed between 26,000 and 55,000 people.

The FDA is not required to follow the recommendations of the panel, but generally does so. Minutes after the announcement, Merck stock shot up nearly 12 percent on the New York Stock Exchange. Pfizer shares rose by 5.6 percent.

*******************************************


Unbelievable!

We all are shocked to hear that Vioxx was linked to the deaths of half a hundred thousand users, and rather than learn the true lessons here and ban this drug from the market, this drug, which increases the risk of heart attacks four times above that of Aleve or Naproxen, is allowed back on the market with nothing but a mere change in the warning label.

What's important to also note out here is that Dr. Sidney Wolfe, the Director of Public Citizen's Health Research Group, asked among other others in the group for a black box warning over four years ago on both Vioxx and Celebrex.

So let's review here. Over 100,000 Americans die from adverse drug reactions. 2.1 million get bad enough reactions so they have to go to the hospital voluntarily. This is said to be the fourth to sixth greatest cause of death in the United States, there can very well be safer alternatives put out on the market, but rather the advisory committee chooses in response to what should be done about this insists to give this another lethal go-around.

The time has come to demand changes, to demand responsibility and accountability for these pharmaceutical corporations and for the FDA.

Sincerely,
Noah Eaton

"If we have no peace, it is because we have forgotten that we belong to each other"

Mother Teresa

LeeJ
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21 posted 02-22-2005 03:35 PM       View Profile for LeeJ   Edit/Delete Message      Find Poems  View IP for LeeJ

Noah, please believe that I mean no disrespect and understand your anger and concern...but...these statistics are not true...how can you absolutely prove that 56,000 people suffered a heart attack or stroke from taking these drugs...and again...Noah, until the day comes, that you are in so much horrible pain, that you cannot rise from bed without taking pone of these drugs...

Noah, I couldn't walk without limping due to so much knee pain...I took Vioxx for months...and it was a miracle drug...it worked for me...and if down the road, I do suffer a heart attack or stroke, it was my choice...

What are the ages of these people who claim to have suffered stroke or heart attacks, or who died?  I saw a woman on TV who cried and said her 60 some year old husband was killed b/c he took the drug and it murdered him.  

Noah????  He was in his 60's....maybe it did, but Noah, maybe it didn't...how do your prove it did?  Perhaps his family had a long history of heart attack and strokes?  

Perhaps he was a giant of a man and didn't watch his weight...
Perhaps he had high blood pressure and ignored the warning signs...

Noah, there are many many people out there who need these drugs...and someday, perhaps when your older, you will to...and if it means a diffence in your quality of life...believe me, you are going to take the meds or perhaps die, or suffer....this is the best we have right now on the market....and until there is better, what other choice do we have?  

Once again...please be open to all that you read, and the money that will be made off of this accusation...Consider, please the good these drugs have done for people....

And again...if your going to take any medication, even an aspirn, then I beg you to please read the side effects...b/c just last week an 11 year old child died b/c his parents gave him an advil.  Whose to blame here...the company that makes advil, the parents?  No, it was sadly and painfully the chemical make up of the child, and unfortunately the side effects for him were fatal.  It isn't a nice thing, it isn't....
and it happens, but for the thousands of others who take the drug and gain relief, it is a comfort zone and increases their quality of life....even with the risks or possible side effects...some people have no other alternative and are more then greatful for the drug...any drug...Again...my mom took a drug with worse side effects, which destroys brain cells, and it did, but by God, she's alive....and she wants to be, regardless of the risks...

Christopher
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22 posted 02-22-2005 03:55 PM       View Profile for Christopher   Email Christopher   Edit/Delete Message      Find Poems  View IP for Christopher

you sure demand a lot of concessions, noah, without providing any real, alternate solutions...

egowhores.com - really love yourself.

Mistletoe Angel
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23 posted 02-22-2005 04:02 PM       View Profile for Mistletoe Angel   Email Mistletoe Angel   Edit/Delete Message      Find Poems   Click to visit Mistletoe Angel's Home Page   View IP for Mistletoe Angel

Lee, I appreciate your concerns, and I sympathize very much with your struggles with your knee pain, I really do.

Actually, this problem goes far deeper than in Vioxx and sister drugs itself. It's all rooted in the accelerated drug approval under the FDA, which has really kicked off in the past twelve years since the 1992 Prescription Drug User Fee Act passed.

I think the problem here is that in these last twelve years especially, the FDA has been like a handmaiden to these pharmaceutical companies. And in regards to that, where is the responsibility and accountability? Who's looking out for those beyond the likes of Pfizer, Merck, GlaxoSmithKline, etc?

Five years ago a major study showing a significant increased risk in heart risk for Celebrex was finished, but was suppressed by Pfizer for months, then sent to the FDA almost four years ago, where they disclosed the results for the first time last week but only briefly.

I'll tell you one thing, if things were different in these last five years and been fully explained and evaluated, the vote would never have been 31-1 in allowing Celebrex to stay on the market.

The fact is the FDA should be representing the public here. Obviously it is clear the drug industry's first priority is simple; to sell drugs. The FDA really needs to tell people about the risks, but moreover operate under an algorithm like this: Do they benefit overall? Is it truly a life-saving benefit? Does the benefit outweigh the risks? And so on.

The problems go far beyond just Vioxx. Look at what Meridia is doing to young people. This weight-reducing drug is killing and ailing people in their 20's, 30's and 40's. The FDA reviewed this drug in the 1990's, called it too dangerous, then the drug industry pressured the FDA to force approving it. Since dozens have died from this and older people get strokes induced from it.

Could you imagine something like GHB being put back out on the market? I believe it's time to say "Enough!".

And I'll tell you that that just-passed class-action bill is one step backward in holding the industry responsible and allowing the taking advantage of the average American citizen.

Sincerely,
Noah Eaton

"If we have no peace, it is because we have forgotten that we belong to each other"

Mother Teresa

Christopher
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Member Rara Avis
since 08-02-99
Posts 9130
Purgatorial Incarceration


24 posted 02-22-2005 07:01 PM       View Profile for Christopher   Email Christopher   Edit/Delete Message      Find Poems  View IP for Christopher

your statements also seem to assign a lot of ubsubstantiated motivations... and still no alternatives?

egowhores.com - really love yourself.

 
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