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  Topic Review (Newest First)
01-28-2013 01:35 AM
prosciencemum
Quote:
Originally Posted by Turquesa View Post


Taxi's post covers it well. But I'll add that post-release recalls do just the opposite of inspiring confidence because they signal inadequate Phase 3 testing.

 

Sure - you wouldn't want to see it happening too often, and I hope every time it does happen they review the recommendation on medical testing.

 

But that it happens ever surely points out that these massive "coverups" in which pharmaceutical companies are persuading millions of health workers to keep using drugs they "know are dangerous" just can't be true.

 

Or it does to me.

01-26-2013 09:39 AM
Turquesa [quote name="prosciencemum" url="/community/t/1373054/piers-morgan-falls-ill-days-after-
a-public-flu-shot-with-dr-oz/120#post_17244543"]Aren't drugs being pulled post release because on going safety monitoring picks up unacceptable problems exactly what we want to see happening? Why isn't that reassuring that the kinds of safety checks we all want to see on vaccinations are actually happening pretty effectively? Isn't that a demonstration that if they had serious and common side effects they would in fact get pulled off the market?[/quote]

Taxi's post covers it well. But I'll add that post-release recalls do just the opposite of inspiring confidence because they signal inadequate Phase 3 testing.
01-26-2013 09:15 AM
serenbat

they claims the staffs of the places are at near 100% yet they are sick too-most people I know working there are currently doing double shifts because so many are with "flu"

01-26-2013 09:02 AM
Rrrrrachel Some of those groups are different than the general population in some really important ways, though. Nursing homes, for example, are full of immunosuppressed people. The information we get from them is worthwhile, but only so far.
01-26-2013 08:40 AM
serenbat
Quote:
You want 100 people to receive a flu vaccine, just to prevent one case of flu?  Not even one death, just one CASE?  And we don't even know how many of the other 99 might experience chronic problems as a result of that shot?

and we have many good study groups that info should be taken from - nursing home/prisons etc were we have staff and residents that have near 100% compliance, yet every year we hear about local out breaks in these places and closed facilities and no info on the long tern and true numbers - at least in my area- they just say they are closed to the public-epedemic levels

01-26-2013 08:21 AM
Taximom5
Quote:
Originally Posted by erigeron View Post

There is doubt in using any medication. It has risks. Risks of a side effect, either an established one or one that hasn't been detected yet, risks that you'll have an allergic reaction (even if you've taken the same medication before), risks that it won't have the desired effect on you and you'll still be subject to the risks from whatever it is you're trying to treat. To a certain extent we are all guinea pigs. No matter how long a medication has been around and how many people have taken it, it's not a sure thing. But there are risks to not using the treatment too, which obviously vary based on what said treatment is, and there are risks to using alternative medical therapies. (Please don't argue with me about whether vaccines are or aren't a treatment. Vaccines are like birth control pills--they're preventative.) Everything has risks and benefits, pros and cons. 

 

As a pharmacist and all, I too am chagrined by the attempts of drug companies to cover up safety data. There are definitely aspects of this system that I'd change if I could. Patients deserve accurate information about what they are putting in their bodies. 

 

I also think part of the problem is overprescribing. Drug companies encourage this because they want to get their investment back, but not everything should be a blockbuster drug. When it comes to something like Vioxx, it should never have been prescribed as much as it was given its cardiovascular side effects. But there might have been a population of people--probably those with low cardiovascular risk and terrible arthritis for which nothing but Vioxx worked--for whom the risk-benefit ratio could have been worth it. 

 

But birth control pills aren't mandated.  Neither was Vioxx.  Health care workers aren't being fired for refusing to take birth control pills or Vioxx. They're not being injected into 4-hour-old infants and pregnant women.  Parnets aren't being threatened with their child being banned from school, or CPS removing their children from their home if they don't give them birth control pills or Vioxx, but they ARE threatened with that if they don't vaccinate.

 

So it's obviously not a valid comparison.

 

We're being told that "the risks of not vaccinating are worse than than the risks of the diseases," but the only "evidence" of that comes from the manufacturer of the product!  Independent analysis of the industry's own studies confirm that, for the flu shot, there IS no discernable benefit!

 

So what do you think is a reasonable amount of risk to take for an invasive preventative treatment that has no discernable benefit?  You want the entire population to play Russian Roulette with possible Guillaine-Barre syndrome, rheumatoid arthritis, seizure disorders, thyroid disorders, other autoimmune disorders, paralysis, or even  for NO DISCERNABLE BENEFIT?  You want 100 people to receive a flu vaccine, just to prevent one case of flu?  Not even one death, just one CASE?  And we don't even know how many of the other 99 might experience chronic problems as a result of that shot?

01-26-2013 07:24 AM
erigeron

There is doubt in using any medication. It has risks. Risks of a side effect, either an established one or one that hasn't been detected yet, risks that you'll have an allergic reaction (even if you've taken the same medication before), risks that it won't have the desired effect on you and you'll still be subject to the risks from whatever it is you're trying to treat. To a certain extent we are all guinea pigs. No matter how long a medication has been around and how many people have taken it, it's not a sure thing. But there are risks to not using the treatment too, which obviously vary based on what said treatment is, and there are risks to using alternative medical therapies. (Please don't argue with me about whether vaccines are or aren't a treatment. Vaccines are like birth control pills--they're preventative.) Everything has risks and benefits, pros and cons. 

 

As a pharmacist and all, I too am chagrined by the attempts of drug companies to cover up safety data. There are definitely aspects of this system that I'd change if I could. Patients deserve accurate information about what they are putting in their bodies. 

 

I also think part of the problem is overprescribing. Drug companies encourage this because they want to get their investment back, but not everything should be a blockbuster drug. When it comes to something like Vioxx, it should never have been prescribed as much as it was given its cardiovascular side effects. But there might have been a population of people--probably those with low cardiovascular risk and terrible arthritis for which nothing but Vioxx worked--for whom the risk-benefit ratio could have been worth it. 

01-26-2013 06:11 AM
Rrrrrachel That's just not true Emmy.
01-26-2013 04:46 AM
Taximom5
Quote:
Originally Posted by Jennyanydots View Post

Score one for spin! Ladies and gentlemen, this is how you do it! A true spinmaster finds a way to make any situation work to his advantage, as demonstrated here with the revamping of pharmaceutical negligence. And a nice, slow clap for you, psm. smile.gif

And this would be a good time to remind those reading the spin (and possibly even buying it) that the pharmaceutical industry has been caught, over and over and over again, lying about the safety/efficacy of their products in order to get them approved in the first place. Just in case anybody's managed to forget Vioxx, Lipitor, Avandia, Celebrex, or the recently reported whistleblower lawsuit against Merck by its own virologists, alleging data falsification for the mumps portion of the MMR and resultant coverups, and threats to the virologists for not going along with it.

And no mention by pharmaceutical spin masters of the recent concession by both US and Italan governments that the MMR caused autism cases. In fact, the media has apparently agreed to blackout these facts.

Yep. Very reassuring indeed.
01-26-2013 04:21 AM
emmy526
Quote:
Originally Posted by MamaMunchkin View Post

 

Because children/people are not guinea pigs.

exactly....lots of pills and scripts are pulled off the market when a handful of people experience an adverse event....not so with vaccines...they continue the experiments to suit their agenda. 

01-26-2013 04:14 AM
MamaMunchkin
Quote:
Originally Posted by prosciencemum View Post


Aren't drugs being pulled post release because on going safety monitoring picks up unacceptable problems exactly what we want to see happening? Why isn't that reassuring that the kinds of safety checks we all want to see on vaccinations are actually happening pretty effectively? Isn't that a demonstration that if they had serious and common side effects they would in fact get pulled off the market?

 

Because children/people are not guinea pigs.

01-26-2013 04:00 AM
prosciencemum
Quote:
Originally Posted by Jennyanydots View Post

Score one for spin! Ladies and gentlemen, this is how you do it! A true spinmaster finds a way to make any situation work to his advantage, as demonstrated here with the revamping of pharmaceutical negligence. And a nice, slow clap for you, psm. smile.gif

Well it genuinely is a question - why isn't that reassuring to you that the process and safety check in place actually are effective?
01-26-2013 01:15 AM
Jennyanydots
Quote:
Originally Posted by prosciencemum View Post

Aren't drugs being pulled post release because on going safety monitoring picks up unacceptable problems exactly what we want to see happening? Why isn't that reassuring that the kinds of safety checks we all want to see on vaccinations are actually happening pretty effectively? Isn't that a demonstration that if they had serious and common side effects they would in fact get pulled off the market?
Score one for spin! Ladies and gentlemen, this is how you do it! A true spinmaster finds a way to make any situation work to his advantage, as demonstrated here with the revamping of pharmaceutical negligence. And a nice, slow clap for you, psm. smile.gif
01-26-2013 12:36 AM
prosciencemum Aren't drugs being pulled post release because on going safety monitoring picks up unacceptable problems exactly what we want to see happening? Why isn't that reassuring that the kinds of safety checks we all want to see on vaccinations are actually happening pretty effectively? Isn't that a demonstration that if they had serious and common side effects they would in fact get pulled off the market?
01-25-2013 07:32 PM
erigeron

What rrrrachel said. Pre-marketing clinical trials can't catch really rare side effects, or ones that take a long time to show up. 

 

However, that doesn't mean that data is not still being collected in Phase 4 (once a drug is on the market). Although there certainly have been problems with drugs not getting relabeled or pulled when they probably should have been. But this isn't related to inadequate clinical trials--it's related to problems that pre-marketing trials can't address. 

 

The hydrocodone thing serenbat linked is totally different. Hydrocodone has been around for a while. It isn't intrinsically dangerous (not any more so than anything else, anyway). But there is a rising problem in this country with prescription drug abuse and that's what is being addressed, and that's different than when a safety issue surfaces for people who are using a drug as prescribed. 

01-25-2013 05:55 PM
Rrrrrachel The complications that got rotarix pulled of were incredibly rare. So rare if the dug was given to a sick population the risk probably would've been acceptable and it never would've been pulled. Those are the kinds of complications that clinical trials miss. Because they aren't big enough.

If getting sick from the flu vaccine was COMMON, more common than one in several thousand or one in millions, clinical trials would show it.
01-25-2013 05:34 PM
emmy526

FDA Likely to Approve H1N1 Vaccine In Advance of Data

 

 

Quote:

GAITHERSBURG, Md., July 23 -- The FDA is likely to approve 2009 H1N1 (swine flu) vaccines before trial data can prove their safety and effectiveness against the virus.

 

Approving a vaccine without safety and immunogenicity data is not uncommon, FDA officials said during a daylong meeting of the Vaccines and Related Biological Products Advisory Committee.

http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/15230

01-25-2013 05:30 PM
emmy526

from what i remember, the H1N1 trials  in '09 only lasted  60?days or so before they claimed it was safe...now look at all the reports coming out about it.   

01-25-2013 05:29 PM
serenbat

and still the FDA manages to pull some drugs off each year! and restrict others as well -

 

rotarix vaccine

 

 

 http://www.nytimes.com/2013/01/26/health/fda-vote-on-restricting-hydrocodone-products-vicodin.html?_r=0

 

http://en.wikipedia.org/wiki/List_of_withdrawn_drugs

01-25-2013 05:16 PM
Rrrrrachel Mos drugs never make it to market.
01-25-2013 05:10 PM
serenbat
Quote:
If rates of sickness after the vaccine were high it would also absolutely show up in clinical studies.

 

I do find it "funny" that most drugs get pulled off the market well after the clinical studies for those little pesty things that don't seem to show up right away.

01-25-2013 02:52 PM
Rrrrrachel Here are some examples of studies using vsd to monitor flu vaccine safety.

http://www.cdc.gov/flu/professionals/acip/adversetiv.htm

If rates of sickness after the vaccine were high it would also absolutely show up in clinical studies.
01-25-2013 02:48 PM
Rrrrrachel I think it would be great if the public we more aware of vaers. However, I'm also glad we don't have to rely solely on it for data on vaccine safety.
01-25-2013 02:45 PM
beckybird

I would LOVE to see a VAERS awareness campaign accompanying the flu vaccine campaign:

"If you get sick after receiving the flu vaccine, please report to VAERS." Wouldn't it have been nice to see this during Piers' televised vaccination? Wouldn't it have been great if Dr.Oz informed everyone of VAERS?

The public needs more balanced information.

01-25-2013 02:38 PM
Rrrrrachel I take vaers seriously for what it is, which is an early warning system. I dismiss studies that use it to try and show causality.

There are other vaccine monitoring systems, like vaccine safety data link, that don't rely on reporting at all. They use medical records. So thy would look for something like an increase in regent care, pcp, or er visits in a certain time frame after a vaccine is given.
01-25-2013 02:33 PM
beckybird

VAERS? I thought most of you dismiss reports from VAERS, so what good would that do?  Plus--and I'm assuming here--most people who get the flu vax don't even know what VAERS is. So, maybe the reason there isn't enough evidence of people getting sick after vaccination is that they are just not reporting.

Lack of reports does not mean illness after the vaccine is rare.

 

So, if your average vaccine-receiving patients don't report to VAERS (I'm assuming most don't)  then where will they report? Or, where is there a place to report that the medical establishment will take seriously?

01-25-2013 02:07 PM
Rrrrrachel Vaers? All the usual vaccine surveillance systems would be actively looking for these masses of people who got sick after vaccination, too, just like any other vaccine. Plus clinical trials.
01-25-2013 02:05 PM
beckybird
Quote:
Originally Posted by Rrrrrachel View Post


Where's the evidence more people than we would expect are getting sick after the flu shot?

 

Unfortunately, I don't think most people report when they get sick after the flu shot. This is probably why we don't have enough hard evidence of masses of people getting sick after the flu shot. Currently, all we really have are anecdotes, but lots of them!

Where might someone report illness after the flu vaccine, I'm wondering?

01-25-2013 01:45 PM
Rrrrrachel
Quote:
Originally Posted by Taximom5 View Post


Where's the evidence more people than we would expect are getting sick after the flu shot?
01-25-2013 01:37 PM
erigeron
Quote:
Originally Posted by Taximom5 View Post
Seems like it would be more reasonable and prudent to say something like, "wow, there are many more people getting sick following the flu shot than anyone expected.  Maybe this phenomenon should be studied.  Maybe there are adverse effects that nobody predicted (imagine that!), or maybe the immune system doesn't work entirely the way the experts think it does.  We need to learn more about this before other people become unnecessarily ill!"

I certainly don't disagree that the flu shot (as well as other vaccines, and other medical treatments in general) should be studied on an ongoing basis. I think it is a mistake, though, to assume that the scientific community isn't already doing so. 

 

I too think hash tags can be very obnoxious, primarily when they are used in a snarky, pointed way. I'm not so bothered when someone on Facebook writes "My kid got on the table and flung all my stuff everywhere. #HousekeepingFail" or the like, because that's not aimed at anybody. 

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