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HuffPo: "Big Pharma Wont Police Itself" - 8 Years Without Oversight Puts Lives at Risk

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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Jan-29-09 07:19 PM
Original message
HuffPo: "Big Pharma Wont Police Itself" - 8 Years Without Oversight Puts Lives at Risk

Big Pharma Wont Police Itself

Les Weisbrod Huffington Post Jan 27, 2009

"FDA Criticized on Device Approvals"
"FDA Is Lax on Oversight During Trials, Inquiry Finds"
"In FDA Files, Claims of Rush to Approve Devices"
"Financial Disclosures on Drug Studies Found Lacking"
"Glaxo's Emails on Avandia Reveal Concern"
"FDA rule makes it easier for drugmakers to distribute scientific articles on off-label uses"


The headlines above paint a startling picture of the Food and Drug Administration and pharmaceutical industry.
You know what's even scarier?
Those stories are just from the last two weeks.

It has become devastatingly clear that the drug and medical device companies will do just about anything to make a buck, regardless of the effect on public health and safety. And the FDA is unable to police an industry that time and time again has engaged in dubious tactics and put lives at risk.

This begs the next question: why are we now giving drug and device companies, faced with only lax oversight, complete immunity from any liability if their products injure, or even kill, Americans?
That's exactly what's been going on the last eight years, and exactly what we need to turn back in this new administration.


...The Bush administration decided that since the FDA approved the drug or medical device, the manufacturer should be immune if something goes wrong. Vioxx, Rezulin, fen-phen and Bextra (just to name a few) all injured or killed thousands of people. Should those people be left with no legal recourse while the drug company can keep billions of dollars in profit?

...more at the link



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stray cat Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Jan-29-09 07:22 PM
Response to Original message
1. thats why there is the fda - and they need to do their job
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whistle Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Jan-29-09 07:26 PM
Response to Original message
2. Lives? Who gives a rat's ass about human lives when there are billions
...of dollars of profits to be made!
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Donnachaidh Donating Member (1000+ posts) Send PM | Profile | Ignore Thu Jan-29-09 07:46 PM
Response to Original message
3. The tobacco industry cannot advertise because the product causes cancer and death
But I've seen at least *6* drug ads that list cancer and death as possible side effects.

What's WRONG with this picture? And when do we get the ads totally YANKED from our airwaves?
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jan-30-09 08:23 AM
Response to Reply #3
4. Because with ANY treatment or even supplement...
there are risks. Researchers, doctors, and patients must understand risk and how statistics are used to state it. Say, for instance, you are in excruciating pain 24 hours a day. Traditional pain medication does nothing for you. There is a new drug that shows promise, but trials showed that people had a 50% greater chance of dying from liver cancer if they took it. It is extremely important to recognize what this is saying. It does NOT mean that 50% of the people who took it got liver cancer. It means that of the people who took it, there was a 50% greater incidence of liver cancer than in the general population.

Using an example of real numbers, this would be saying the "normal" rate of liver cancer is 2 in every 100,000 people. In a trial of 100,000, if 3 people got liver cancer then the people in the trial had a 50% higher rate of liver cancer. 2 out of 100,000 is .002%. 3 out of 100,000 is .003%. "50% greater" sounds scary. .001%, not so much. Especially when it might alleviate your pain when nothing else has. Depending on its severity and its impact on leading a normal life, some people might choose to take it even if the risk of liver cancer was substantially greater. Again, it's about understanding risk and statistics. So many alarmist posts on this forum and sites on the Internet completely fail to grasp this.

Recognize too that there are toxic doses of quite "natural" substances that are sold in health food stores. Many vitamins have harmful and even toxic side effects in large enough quantities. But since none of those are sold to "prevent, cure, or treat any disease" they are subject to much less strict regulation.
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Donnachaidh Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jan-30-09 12:11 PM
Response to Reply #4
5. sure there are *risks*, but when it is KNOWN that death HAS been caused
We should still allow the sale of this crap?

We have far too many apologists for the Pharma Cartel in the US.
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jan-30-09 12:22 PM
Response to Reply #5
6. Did you hear that wooshing sound?
That's called a point, and it just went sailing right over your head. But color me so un-surprised that your retort is a nasty insinuation that somehow I'm a "pharma apologist."
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BuddhaGirl Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jan-30-09 02:00 PM
Response to Reply #4
7. vitamin stores don't sell "toxic" doses of supplements
a "toxic" dose is if someone maybe takes the entire bottle...as with anything
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jan-30-09 02:59 PM
Response to Reply #7
8. You sure about that?
GNC sells 25,000 IU caplets of Vitamin A. Liver damage from Vitamin A can occur at dosages of a little as 15,000 IU per day.

GNC also carries Vitamin D supplements containing 2000 IU. The Mayo Clinic states that 2000 is the upper limit of Vitamin D intake, above it toxicities can occur.

Still sure about that? Would you need to take "the entire bottle" of either of these to cause damage?
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BuddhaGirl Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jan-31-09 12:55 PM
Response to Reply #8
9. yes, I am sure - I work in a vitamin store
we sell the dosages that you mentioned, every day :shrug:

Myself, I take 4000IU of D every day...I have customers who take even higher therapeutic doses that their doctors have recommended.

So yes, I am sure :-)

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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 10:46 AM
Response to Reply #9
16. Think about your logic for a moment.
Experts have said that large doses of vitamins can be deadly. They KNOW this from not only experimental testing (on animals, sadly), but from real-world examples of people who essentially "ODed" on vitamins. Just because neither you nor anyone to your knowledge has died doesn't invalidate this. Because if your logic was valid, then you must also believe Vioxx is perfectly safe because not everyone who took it died. In fact, comparatively few did. But Vioxx was still pulled, and Merck was held responsible. Which was good.

But no, you are not sure that megadoses are vitamins are safe, because they're not. They can kill.
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BuddhaGirl Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 01:19 PM
Response to Reply #16
17. think about this
we obviously have different perspectives/opinions. I don't fully buy into your "experts." I have knowledge of other experiences. I know what works for me, and I have seen what works for others.

YMMV

:-)
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 01:39 PM
Response to Reply #17
18. Sorry, but you are not entitled to your own reality.
You are completely wrong on this issue. It is possible to take too much of certain vitamins, and such doses can be harmful and even fatal.
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BuddhaGirl Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 08:40 PM
Response to Reply #18
19. "You are completely wrong on this issue."
Well, you are entitled to your opinion ;-)

According to the American Association of Poison Control Centers' National Poisoning and Exposure Database: "Over a twenty-four year period, vitamins have been connected with the deaths of a total of eleven people in the entire United States. Poison control statistics confirm that more Americans die each year from eating soap than from taking vitamins."

Annual deaths alleged from vitamins:
2006: one
2005: zero
2004: two
2003: two
2002: one
2001: zero
2000: zero
1999: zero
1998: zero
1997: zero
1996: zero
1995: zero
1994: zero
1993: one
1992: zero
1991: two
1990: one
1989: zero
1988: zero
1987: one
1986: zero
1985: zero
1984: zero
1983: zero

more:
http://www.doctoryourself.com/vitsafety.html

Now, I realize that this site will raise a red flag with you, but the official Poison Control statistics are posted on it. Pharmaceutical drugs cause far, far more deaths than vitamins.

*****

Reports of Drug Side Effects Rise, U.S. Study Finds

By Michelle Fay Cortez

"Sept. 10 (Bloomberg) -- U.S. regulators received more than twice as many reports of deadly or debilitating side effects from drug treatment in 2005 as they did seven years before, a study found.

Fifty-one drugs accounted for almost half of the 467,809 cases reported during the eight years covered, researchers wrote in today's Archives of Internal Medicine. Painkillers, such as Teva Pharmaceutical Industries Ltd.'s generic oxycodone, and drugs that alter the immune system, including Johnson & Johnson's Remicade, were linked to a disproportionate number of deaths, which almost tripled in 2005 compared with 1998.

2005 Deaths

More than 15,000 people died from drug reactions in 2005, compared with 5,519 people in 1998, the researchers said. Most of the fatalities were linked to generic pain pills, including oxycodone, fentanyl, morphine and acetaminophen, which is sold without a prescription by Johnson & Johnson as Tylenol.

A total of 89,482 serious side effects from drug treatment were reported to the FDA in 2005, more than 2 1/2 times the 34,966 reported in 1998, the study found. The number of serious reactions increased four times faster than the total number of prescriptions written for patient use outside the hospital. About 1,500 drugs had reported side effects."

more:
http://www.bloomberg.com/apps/news?pid=20601103&sid=atZc0BAmATBM&refer=us

*****

FDA Claims "Food Supplement" Deaths; Hides Details from the Public
Orthomolecular Medicine News Service, October 9, 2008

"(OMNS, October 9, 2008) "Dietary supplements cause 600 'adverse events'", reported USA Today on 22 Sept, 2008. In an article that looks much like an official US Food and Drug Administration press release, it said that "Serious side effects from the use of food supplements resulted in 604 "adverse-event" reports - a list that includes at least five deaths - through the first six months that such accounts have been required by law." (1)

Good grief! Looks like all those supplement-popping health nuts really are nuts after all. Food supplements simply must be dangerous! Or are they?

Later on in the article, far from the headline, USA Today conceded that "An adverse event can be anything from a concern that a supplement isn't working to a serious illness that follows consumption." And, FDA spokesman Michael Herndon admitted that of the five deaths and 85 hospitalizations reported, "Some of these deaths were likely due to underlying medical conditions."

By comparison, FDA acknowledges that prescription drugs resulted in 482,154 adverse-event reports in the year 2007. That is nearly 400 times as many adverse events from prescription drugs per six-month period. And this much higher number does not include over-the-counter drugs, a striking omission. Many non-prescription drugs, such as Tylenol (acetaminophen), are a long way from safe. Liver toxicity from acetaminophen poisoning is by far the most common cause of acute liver failure in the United States. Acetaminophen accounted for 51% of all acute liver failure cases in 2003. (3) Indeed, the Associated Press previously reported that common drug dangers are so bad that "Harmful reactions to some of the most widely used medicines - from insulin to a common antibiotic - sent more than 700,000 Americans to emergency rooms each year."

more:
http://www.orthomolecular.org/resources/omns/v04n13.shtml
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 08:50 PM
Response to Reply #19
20. Excellent to see you've backed off.
Now it's not that vitamins are safe at any dose, but that pharmaceuticals are MORE DANGEROUS. Well of course they are - and I'll let you argue against whatever strawman you've concocted. You have tacitly admitted your error, and that's all I wanted you to do. Go find someone who thinks drugs are perfect and never harm anyone, and argue with them. That person is not me. :hi:
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BuddhaGirl Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 09:28 PM
Response to Reply #20
23. ahhh...I have not admitted any such thing
If you wish to believe that I've backed off, well, whatever floats your boat! You have your position; I have mine. Just wanted to provide you with some perspective, to appeal to your particular orientation. That's all. :-) And, as WillYourVoteBCounted said, even doctors prescribe vitamins - and - in the dosages that my store carries. I say that from personal experience.

Cheers!
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 09:30 PM
Response to Reply #23
24. Well of course doctors prescribe vitamins.
They're part of any healthy diet. But there ARE harmful and fatal doses - and you have acknowledged that at last. Thank you.
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BuddhaGirl Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 09:57 PM
Response to Reply #24
25. *anything* can be harmful and fatal but you already know that
As I have already said, the dosages that my store carries, are dosages that doctors often recommend, and are safe. I guess you're saying then, that people shouldn't listen to their doctors LOL

I posted statistics that confirm that vitamins are very safe, which is really the bigger picture.
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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 10:03 PM
Response to Reply #25
26. You're spending a lot of effort posting that you've agreed with me.
Apparently the only point of dispute now is that you don't believe harmful doses of vitamins can happen with less than, say, a full bottle of them. On this point, you evidently think you know more than educated professionals at the Mayo Clinic. Talk about people who won't listen to doctors. :eyes:
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 08:51 PM
Response to Reply #19
21. Hell, even doctors recommend vitamins - especially to pregnant women
so its funny how some are trying to say that vitamins are dangerous.

I feel better when I take vitamins, and I also take prescription meds when needed.

Folks can find out what works best for them.


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trotsky Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Feb-01-09 08:54 PM
Response to Reply #21
22. You really can't help yourself, can you?
Vitamins can be dangerous. There are harmful and even fatal doses of some vitamins. Why do you have to distort so much?
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jan-31-09 05:27 PM
Response to Original message
10. Unbelievably, there are some who defend the FDA
and the Big Pharma
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cosmik debris Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jan-31-09 05:59 PM
Response to Reply #10
11. Why don't autism support groups do the research?
Why don't they put up or shut up?
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jan-31-09 06:31 PM
Response to Original message
12. Whoever opposes research into the cause of Autism is corrupt - congress wants to study it
and should fund the studies this year.
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cosmik debris Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jan-31-09 06:33 PM
Response to Reply #12
13. Put your money where your mouth is
Why don't the autism support groups fund your research?

You know why!
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jan-31-09 06:47 PM
Response to Original message
14. Bush Cronies worried about autism cases filed in federal vaccine court
Bush cronies fear that vaccine/autism research would hurt help those with
autism cases filed in the federal vaccine court.

http://www.ageofautism.com/2009/01/national-autism-association-on-iacc-removal-of-vaccine-safety-research.html

And there are likely other special interests who fear what research might turn up.
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WillYourVoteBCounted Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jan-31-09 06:57 PM
Response to Original message
15. Department of Health and Human Services is the defendant in Vaccine Court.
And hence some strings pulled to stop the funding of the studies.

From the Age of Autism website:

"The department of Health and Human Services is the defendant of Autism Omnibus Cases; it is a conflict of interest in having them research vaccine safety. Independent studies are something the autism community must demand.

...The response plan is still being hammered out by many of the Autism Organizations. In the next weeks, we may have call to actions for parents, friends and family to take part in as this situation evolves. Please check the TACA website http://www.talkaboutcuringautism.org/index.htm and E-news for more information"

http://www.ageofautism.com/2009/01/iacc-rescinds-vaccine-research-initiatives.html


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