What Else Does the FDA Approve without Adequate Research? - Mothering Forums
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#1 of 22 Old 07-01-2013, 02:04 PM - Thread Starter
 
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http://www.forbes.com/sites/davidmaris/2012/10/10/fda-recall-points-to-serious-problems-at-the-fda/

 

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The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured byImpax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

 

what else are they approving without REAL research?

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#2 of 22 Old 07-05-2013, 12:00 PM
 
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Vitamins and complementary medicine......

Mother of two living in UK. Daughter (2007) born in USA, son (2010) born here. I'm pro natural birth, midwife care, breastfeeding, co-sleeping, baby wearing and a keen advocate of cloth diapering. I'm a full time working research scientist (physical sciences) and I'm pro-vaccine.

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#3 of 22 Old 07-05-2013, 12:24 PM
 
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Vitamins and complementary medicine......

the FDA doesn't really "approve" vitamins. It's responsibility is merely taking action against any supplement that proves to be unsafe AFTER it comes to market. 

 

and as for it's "approval" or regulation of CAM therapies - often it regulates or approves of devices not the practice it self. For example, it regulates acupuncture needles, but not the practice of acupuncture itself. 

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#4 of 22 Old 07-05-2013, 01:40 PM
 
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Well, let's see….the FDA never approved thalidomide for morning sickness, but millions of doses were distributed as part of a clinical testing program, according to Wikipedia.  My mother was given thalidomide when she was pregnant, and never told that it had not received FDA approval.  (Luckily, she never bothered to take it, as her morning sickness was pretty mild.)

 

The FDA did approve Vioxx, and Lipitor, and a truckload of antidepressants, all of which can have very serious side effects that were not initially disclosed.  The antidepressants have been declared by the Cochrane Review as being no more effective than a placebo for mild-to-moderate depression, which is the majority of the cases where antidepressants are prescribed.

 

Lipitor has several class-action lawsuits pending. It has recently been announced ("announced" almost silently--it never made mainstream news) that it is linked with high risk of diabetes in middle-aged and older women, kidney failure, musculo-skeletal problems, liver problems, and memory problems.

 

Antidepressants can cause long-term serious problems, including increased risk of stroke, thicker arteries, miscarriage, birth defects, sudden cardiac arrest in women--and, of all things, antidepressant use may be linked with autism.  There are no long-term studies, because they haven't been in common use for that long, and there are very, very few unbiased studies.

 

The flu shot is FDA-approved, even though efficacy is very poor, and people have been permanently damaged by it.

 

The Hep B shot is approved for ALL infants, for the day of birth, even though it, too, has some serious side effects in a small subgroup, efficacy is not long-lasting, and most infants are not at risk during their first year of life.

 

Gardasil was fast-tracked to FDA approval, and has the highest rate ever of reported severe adverse reactions.  Merck never bothered to tell the public that efficacy is 4-5 years.

 

The chicken pox vaccine was FDA-approved, NOT because chicken pox is inherently a dangerous disease, but becasue it is so inconvenient for working parents.  But FDA approval of a pediatric vaccine always leads to that vaccine's becoming mandated--as it now is.  We are only now learning of complications from the varicella vaccine--including the fact that older vaccinated children have a significantly higher rate of shingles than their unvaxed counterparts.  Shingles is far more serious than chicken pox.

 

I'm sure there are more...

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#5 of 22 Old 07-05-2013, 04:44 PM
 
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The FDA did approve Vioxx, and Lipitor, and a truckload of antidepressants, all of which can have very serious side effects that were not initially disclosed.  The antidepressants have been declared by the Cochrane Review as being no more effective than a placebo for mild-to-moderate depression, which is the majority of the cases where antidepressants are prescribed.

 

 

The Vioxx case is a good example of what constitutes "adequate" research. It was initially approved based on eight studies with a total of 5400 people. Eleven months after the VIGOR study (with 8000 participants) began, the discussions ensued of what to do with these cases of heart problems in the stats. The Vioxx group had nearly double the amount of serious cardiac events or death compared with the naproxen group, but Merck says it's small enough numbers to discount. At the last safety meeting, the data indicated there was a noticeable doubling of serious or fatal cardiac events. It probably didn't help much either in the scheme of things that the chairman of the safety monitoring board at that time owned almost $80K in Merck stock and was offered a consulting contract with Merck as well at a rate of $5K a day. Merck published their VIGOR paper in NEJM, leaving out three of the heart attacks and other cardio events, but told the FDA about heart attacks 18-20. The FDA held an advisory meeting on the VIGOR trials and published all the data on its website, but it was still business as usual. When a group of cardiologists did a meta-analysis of the data, using the FDA's own stats, they found the argument that "well, we thought that maybe the numbers were skewed because naproxen was protecting the heart," to be utter nonsense and they advised caution about using COX-2 inhibitors due to increased cardiovascular risk. They urged further study to see if the medication was worth the demonstrated risk to the heart. This was back in 2001. Vioxx wasn't withdrawn from the market until September 2004, after other studies starting piling up with a red flag for cardio risk, and the APPROVe study was the final nail in the coffin for the product. 

 

I was on Vioxx for the chronic pain associated with endometriosis back in 2002. I lasted about a month on it until I complained to my OB/Gyn that the episodes of racing heartbeat (something I'd never experienced before as a young, fit person in a healthy weight category with no history of cardio issues whatsoever) were disconcerting and I quit taking it. 

 

We're supposed to trust the FDA, right? Yet when you look at how flawed the system is, with conflict of interest, selective reporting, inadequate follow up studies, it's hard then to believe that because something's been approved by the FDA, it's somehow in the clear and beyond reproach because it's supposedly gold standard and has the FDA seal of approval. I mean, they had the data in 2001 that Vioxx was causing serious cardiac events at almost double the rate of the drug they tested it against. They let consumers continue taking it for three more years. End result: an estimated 88,000-140,000 heart attacks or other serious cardiac events, with approximately 30-40% fatality rate. 

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#6 of 22 Old 07-05-2013, 10:12 PM
 
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I wish the FDA had the funding to do their own testing rather than have to rely on manufacturers to do it. 

 

As for Vioxx, that points to another problem I have with drug marketing--every drug company wants their drug to be a new blockbuster drug. Vioxx had some nasty side effects, but there were also some people for whom it worked when NOTHING else did. If it had been a niche drug, used only as a last resort, then it might still be available to people who feel its benefits outweigh its risks. But for the general population, with lots of options available, the risks outweighed the benefits and it was pulled. Yet there are drugs still on the market that are known and acknowledged to have side effects as bad as Vioxx or worse--they're just used only in those very limited cases where the benefits outweigh the risks. (Heck, thalidomide is still on the market! But it's used only in cancer patients, and very rigorous procedures are used around its distribution and to make sure patients are aware of the risks and preventing pregnancy.) 

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#7 of 22 Old 07-05-2013, 10:18 PM
 
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 Yet when you look at how flawed the system is, with conflict of interest, selective reporting, inadequate follow up studies, it's hard then to believe that because something's been approved by the FDA, it's somehow in the clear and beyond reproach because it's supposedly gold standard and has the FDA seal of approval.

Best statement Ever!

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#8 of 22 Old 07-13-2013, 06:24 AM
 
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I wish the FDA had the funding to do their own testing rather than have to rely on manufacturers to do it. 

 

 

The FDA is staffed by the pharmaceutical industry and Monsanto.  How would it be any different ?

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#9 of 22 Old 07-13-2013, 07:18 AM
 
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Pharma isn't much better, either. Dh used to work in QA and they just keep testing medicine until they get the results they want. No joke, that's top down, not departmental.

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#10 of 22 Old 07-13-2013, 09:14 AM
 
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The FDA is staffed by the pharmaceutical industry and Monsanto.  How would it be any different ?

It would be an improvement as they would not be in favor of any particular drugs. What's the alternative? I suppose farming it out to independent contractors with no stake in the process... if you could find any. There is going to be a risk of corruption no matter what we do. And I don't think that ceasing drug development and sales altogether would be a good choice either. What do you suggest?


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#11 of 22 Old 07-14-2013, 06:37 AM
 
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I would suggest considering the possibility maybe the world doesn't actually need drugs.

 

How many "outbreaks" of disease were there before there were pharmaceutical companies?  To me this seems to have all started with that flu outbreak in the early 1900s.  Was it 1918?

 

The only outbreak before that was the black plague, and everybody knows that was caused by the unsanitary conditions.  They fixed the sewers in Europe and no more black plague.

 

For every NATURAL disease, there is already a cure readily available in NATURE.

 

Since you asked, I suggest if there weren't any pharmaceutical companies, there wouldn't be any more outbreaks.

 

Take a minute to consider the possibility everything you ever thought about pharmaceuticals just might possibly be mistaken before the attacks begin.

 

If you every have the opportunity, pick up an unedited copy of The Impact of Science on Society by Lord Bertrand Russell.  Read it years ago, and highly recommend it.  Extremely enlightening.

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#12 of 22 Old 07-14-2013, 09:19 AM
 
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How many "outbreaks" of disease were there before there were pharmaceutical companies?  To me this seems to have all started with that flu outbreak in the early 1900s.  Was it 1918?

The only outbreak before that was the black plague, and everybody knows that was caused by the unsanitary conditions.  They fixed the sewers in Europe and no more black plague.

Wow

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#13 of 22 Old 07-14-2013, 09:43 AM
 
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I would suggest considering the possibility maybe the world doesn't actually need drugs.

 

How many "outbreaks" of disease were there before there were pharmaceutical companies?  To me this seems to have all started with that flu outbreak in the early 1900s.  Was it 1918?

 

The only outbreak before that was the black plague, and everybody knows that was caused by the unsanitary conditions.  They fixed the sewers in Europe and no more black plague.

 

For every NATURAL disease, there is already a cure readily available in NATURE.

 

Since you asked, I suggest if there weren't any pharmaceutical companies, there wouldn't be any more outbreaks.

 

Take a minute to consider the possibility everything you ever thought about pharmaceuticals just might possibly be mistaken before the attacks begin.

 

If you every have the opportunity, pick up an unedited copy of The Impact of Science on Society by Lord Bertrand Russell.  Read it years ago, and highly recommend it.  Extremely enlightening.

So for those of us who don't want to live like it's 1795, this isn't a particularly helpful suggestion for how to deal with any issues the FDA has. Moving right along. 


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#14 of 22 Old 07-14-2013, 10:38 AM
 
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I would suggest considering the possibility maybe the world doesn't actually need drugs.

 

How many "outbreaks" of disease were there before there were pharmaceutical companies?  To me this seems to have all started with that flu outbreak in the early 1900s.  Was it 1918?

 

The only outbreak before that was the black plague, and everybody knows that was caused by the unsanitary conditions.  They fixed the sewers in Europe and no more black plague.

 

For every NATURAL disease, there is already a cure readily available in NATURE.

 

Since you asked, I suggest if there weren't any pharmaceutical companies, there wouldn't be any more outbreaks.

 

Take a minute to consider the possibility everything you ever thought about pharmaceuticals just might possibly be mistaken before the attacks begin.

 

If you every have the opportunity, pick up an unedited copy of The Impact of Science on Society by Lord Bertrand Russell.  Read it years ago, and highly recommend it.  Extremely enlightening.

 

Historical records of epidemics go back at least as far as 1650 BC.  Plus all the Old Testament references to "great sickness". 

 

Black plague wasn't spread by sewage (it's spread by fleas and droplet contamination), and still exists - there are a few cases (usually limited to rodent populations) in the U.S. every year.  Since we don't generally live in close proximity with rodents and their fleas these days, it's not as much of a problem.

 

I'm willing to consider that everything I thought I knew about pharmaceuticals might be mistaken, but I don't think GlaxoSmithKline was involved in the Great Yellow Fever Epidemic of 1793, or the English Sweating Sickness (1485-1551), or the Antonine Plague (165-180).  Outbreaks and epidemics happened pretty frequently before pharma came along, so it's hard to argue, now, that we could eliminate outbreaks of contagious disease by getting rid of pharmaceutical companies.

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#15 of 22 Old 07-14-2013, 11:09 AM
 
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Yeah, I'm not ready to call for an end to pharmaceuticals. And I don't think all disease outbreaks are marketing and propaganda. Seems like what's wrong with Pharma is the same thing that's wrong with Big Industry in general in the US- industry has too much influence in government. It's a sick system, that's nothing new- but I wouldn't throw the baby out with the bath water.

That's the very thing that makes the vaccine issue so vexing to me- I can't say with confidence that vaccines are a bad idea and that they haven't been a great invention, and maybe my kids should get some of them. But at the same time, I know when I'm being lied to, and when info is being dumbed down, and marketing is heavily laden with emotional appeals and propaganda- and that's happening all over the place with vaccines.

Who do you believe? Absolute denialists who make sense sometimes and sometimes sound like they're best friends with puff the magic dragon, or the voice of industry through its government mouthpiece?

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#16 of 22 Old 07-14-2013, 11:18 AM
 
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Yeah, I'm definitely not calling for an end to pharmaceuticals! My dh is diabetic and my 8 yo has profound Hashimoto's. Pharma makes some life saving drugs! That doesn't mean I agree with everything they do and I'm not scared by my own inside knowledge of development and QA, though.

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#17 of 22 Old 07-14-2013, 12:02 PM
 
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The FDA is staffed by the pharmaceutical industry and Monsanto.  How would it be any different ?

 

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It would be an improvement as they would not be in favor of any particular drugs. What's the alternative? I suppose farming it out to independent contractors with no stake in the process... if you could find any. There is going to be a risk of corruption no matter what we do. And I don't think that ceasing drug development and sales altogether would be a good choice either. What do you suggest?

The problem is that they are ALWAYS in favor of medical intervention as treatment.  Their approval of a drug seems to be a tacit statement that that is the preferred treatment--even in cases where treatment with a medication might not be the best course.

 

Tingling hands and feet? Fluctuating hearing loss, tinnitus, dizziness? We don't hear from the FDA that any of these could be a symptom of B12 deficiency, and can be easily diagnosed with blood work, and treated with B12.  People who report with these symptoms are given Lyrica, prednisone, diuretics, valium, and even surgical interventions, including gentamycin shots that totally destroy hearing.

 

Mild to moderate depression?  We don't hear from the FDA that vitamin D and exercise are EACH more effective than anti-depressants, nor that anti-depressant treatment can cause many different kinds of severe side effects, including some that can be irreversible.

 

Present to a doctor with intestinal problems, and be prepared for a diagnosis of "IBS" and medications, as opposed to a simple blood test for celiac disease.

 

Children with attention problems and other symptoms of ADD/ADHD are given meds instead of tests for food allergies/celiac disease, which can cause the same symptoms.

 

I'm sure other posters can come up with many other examples...

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#18 of 22 Old 07-14-2013, 02:27 PM
 
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I would suggest considering the possibility maybe the world doesn't actually need drugs.

 

 

On an individual basis this is a pretty extreme statement.  I am quite certain one of my 3 children would not be here without pharmaceuticals (antibiotics).  I am not being melodramatic.

 

On a societal level, you are probably right.  The world went ticking along without pharmaceuticals for many, many years. 

 

I see it as a spectrum:  I have seen reasonably healthy people who view most drugs as evil demon.gif and stay far away; and I have met reasonably healthy people who are pill poppers for every.little.thing.  Neither view seems very wise to me, and I have known people to suffer because of extremist views where meds are concerned. 

 

It would be interesting to know if those who reject vaccines are more likely to be on one side of the spectrum, and if those who accept vaccines are more likely to be on another, but I do not think we will sort it out here.  I am closer to the "drugs are evil side" than pill popper, and I would say my feelings about  drugs in general  influences my vaccine decisions.


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#19 of 22 Old 07-15-2013, 07:51 AM
 
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Funny you should mention that, Kathy. I'm a pharmacist and I do vaccinate my child and myself. And I do believe there is a role for pharmaceuticals in society. But I'm not really a fan of drugs in general, do feel they're overprescribed (driven by many factors) and would really like to see more cures for diseases (rather than just having them be managed with pills) as well as more focus on ways of managing a disease using lifestyle methods. Incidentally, we did learn about non-pharmacological approaches to disease management in pharmacy school, so we are not schooled solely in the drugs themselves.

 

There is also a class issue here. If their kid gets a VPD, middle-class professionals are more likely to be able to take off work without getting fired and bear any financial penalty from the time off than is a single mom working the fryer at Burger King. Or in a family that can afford to have one SAH parent, it's not an issue. The idea of kids being vaccinated so their parents don't have to miss work sounds repugnant to some people, but depending on the consequences for the parent missing work, it may be better than the alternative. Similarly, it's a lot easier to control diabetes with diet and exercise when you have time to join a gym and can afford a membership, or live in a neighborhood where you feel you can jog safely without getting mugged, and have a car you can use to drive to a supermarket that has healthy food that you can afford to buy. These resources may be beyond the reach of some socioeconomic groups, and at least medication is a resource they can access. 

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#20 of 22 Old 07-15-2013, 07:56 AM
 
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I also tend to avoid an over-reliance on drugs. For example I would never use benadryl to drug my children as I've seen advice for long flights. We also minimize as much as possible the use of tylenol type drugs. I agree that many "diseases" in the modern life seem like they could be cured by better diet and exercise too. 

 

However I think routine vaccination is a great idea as all regular posters know. There's clear data that this has saved millions of lives and that serious reactions are extremely rare.


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#21 of 22 Old 07-15-2013, 10:02 AM
 
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Funny you should mention that, Kathy. I'm a pharmacist and I do vaccinate my child and myself. And I do believe there is a role for pharmaceuticals in society. But I'm not really a fan of drugs in general, do feel they're overprescribed (driven by many factors) and would really like to see more cures for diseases (rather than just having them be managed with pills) as well as more focus on ways of managing a disease using lifestyle methods. Incidentally, we did learn about non-pharmacological approaches to disease management in pharmacy school, so we are not schooled solely in the drugs themselves.

 

There is also a class issue here. If their kid gets a VPD, middle-class professionals are more likely to be able to take off work without getting fired and bear any financial penalty from the time off than is a single mom working the fryer at Burger King. Or in a family that can afford to have one SAH parent, it's not an issue. The idea of kids being vaccinated so their parents don't have to miss work sounds repugnant to some people, but depending on the consequences for the parent missing work, it may be better than the alternative. Similarly, it's a lot easier to control diabetes with diet and exercise when you have time to join a gym and can afford a membership, or live in a neighborhood where you feel you can jog safely without getting mugged, and have a car you can use to drive to a supermarket that has healthy food that you can afford to buy. These resources may be beyond the reach of some socioeconomic groups, and at least medication is a resource they can access. 

You bring up some very interesting and valid points.

 

But nobody should be required to vaccinate their children (or any other invasive procedure) in order to increase convenience for others.  I agree that that sucks for those who can't afford to miss work.  But the bottom line is, parents should have a choice as to what risks they are or are not willing to take with their children's health.  It's not right to ask parents to play Russian Roulette with their children's health by risking an adverse reaction to a vaccine that may or may not prevent a minor-but-inconvenient illness for someone else.

 

We don't require moms to breastfeed, even though that clearly reduces both the number and the severity of most illnesses.  We allow moms to make that choice. We also don't legally require or even recommend that ill people to wear masks in public, or that sick people (including doctors and nurses) stay home from work. In fact, most companies have very limited sick leave. We allow people to make their own choices about whether or not they leave their home when sick, and infect people.  

 

Seems to me that the answers to our societal problems in dealing with illness of self or child and work are not found in vaccines, which cause such serious problems for a small subgroup. The answers lie in changing the policies and attitudes in our society.

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#22 of 22 Old 07-15-2013, 10:02 AM
 
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Originally Posted by prosciencemum View Post

I also tend to avoid an over-reliance on drugs. For example I would never use benadryl to drug my children as I've seen advice for long flights. We also minimize as much as possible the use of tylenol type drugs. I agree that many "diseases" in the modern life seem like they could be cured by better diet and exercise too. 

 

However I think routine vaccination is a great idea as all regular posters know. There's clear data that this has saved millions of lives and that serious reactions are extremely rare.

Again?  You call it "clear data?"  When the data is based on 

1) reports from an industry that has a well-documented history of not reporting serious side effects

2) a VOLUNTARY reporting system

3) medical caregivers who are not taught to recognize the possibility of vaccine reaction (for example, that MMR is known to cause seizures 2 weeks AFTER the shot)

 

And you talk about "routine vaccination?"   "Routine vaccination" in the US entails mandatory Hep B shots within 4 hours of birth, and is increasingly understood to mean mandatory flu shots.

 

Hey, I'm all for routine vaccination for polio (shot only, not oral), diphtheria, and possibly separate measles, mumps, and rubella shots.  I'd be all for routine vaccination for pertussis if a MUCH safer and more effective vaccine were developed, IF we had independent assessment of safety and efficacy.

 

But that's not what we have.


We have routine vaccinations for flu, venereal warts, and rotavirus, that may cause a significant problem for some while not being necessary for most.

 

We have a routine vaccination for pertussis that is combined with other vaccines--and that combination may be related to adverse effects, while the pertussis component of the vaccine is simply not effective enough to prevent transmission.

applejuice, Marnica and BeckyBird like this.
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