Interview: Paul Offit, M.D.

Nurseworks, ASN, RN · Apr 19, 2014

A rough guesstimate that I saw on one website put Offit's wealth at 13-35million, and really who cares. When is the last time you or any one of us has spent a couple of decades developing and patenting a new safer medication? Do you work for free, because I sure don't.

I care as it denotes a clear bias for him when discussing the topic. It's called a conflict of interest. You're constant defense of that pearl is bordering on irrational/fanboism. That his vaccine didn't cause as many cases of intussusception isn't at all germane to the argument.

This hardly is any proof that the vaccine he helped produce is unsafe and since all vaccines used in the United States go through constant phase IV studies that are mostly funded through government grants it further highlights the safety of vaccines in general.

Not sure if at any time I stated that his vaccine was unsafe, so why bring that into the conversation?

I think your other posts on the other threads in this forum clearly suggest that you think vaccines are unsafe.

Well, you're certainly entitled to your opinion, but my statements, while critical, clearly show that I support vaccines. I'll clue you in a bit more, if for no other reason than to show just how overzealous you are on the topic; my children are not only developmentally delayed and up to date on their vaccines, they very likely were injured by them ala Hannah Poling due to a similarly diagnosed (at the Cleveland Clinic, no less!) mitochondrial disorder. Did I mention that they are up to date on all their vaccines, in spite of this? 'Cause if I didn't, they're up to date on all their vaccines.

But you go right ahead judging and doling out that heaping pile of hubris.

allnurses Guide · Apr 20, 2014

I care as it denotes a clear bias for him when discussing the topic. It's called a conflict of interest. You're constant defense of that pearl is bordering on irrational/fanboism. That his vaccine didn't cause as many cases of intussusception isn't at all germane to the argument.
Not sure if at any time I stated that his vaccine was unsafe, so why bring that into the conversation?
Well, you're certainly entitled to your opinion, but my statements, while critical, clearly show that I support vaccines. I'll clue you in a bit more, if for no other reason than to show just how overzealous you are on the topic; my children are not only developmentally delayed and up to date on their vaccines, they very likely were injured by them ala Hannah Poling due to a similarly diagnosed (at the Cleveland Clinic, no less!) mitochondrial disorder. Did I mention that they are up to date on all their vaccines, in spite of this? 'Cause if I didn't, they're up to date on all their vaccines.
But you go right ahead judging and doling out that heaping pile of hubris.

It would be a conflict of interest if Dr. Offit was only discussing the rotavirus vaccine and not all vaccines. His net worth isn't going anywhere whether he supports other vaccines or not, and like I have pointed out already Dr. Offit does not support all vaccines i.e. he does not support small pox or the oral polio vaccines d/t their inherent dangers.

Actually, the new rotavirus vaccine probably does not increase rates of intussusception. JAMA Network | JAMA | Risk of Intussusception Following Administration of a Pentavalent Rotavirus Vaccine in US Infants

You are and were trying to link Dr. Offit to being biased, because he profited off a vaccine he helped developed so I think it is prudent to point out that this vaccine along with all vaccines used in United States go through constant Phase IV testing/studies which is unlike any other medication.

It is rare, but not unknown that vaccines may trigger developmental disorders with children with mitochondrial disorders. It is also possible that fevers, flu, dehydration, and other illnesses can also trigger developmental problems with children that have mitochondrial disorders. This does not change my mind on anything about vaccines. I would like to see more research on this subject, but it does seem that there is at least some research is at least being done on the subject. I am in no way advocating that we should stop researching vaccine safety or stop looking for safer and more effective vaccines. I am hopeful that someday that vaccine use will come so prevalent that we can eliminate most vaccine preventable diseases like we did with small pox and stop utilizing many of the vaccines that we currently use. CDC | Mitochondrial Disease | Autism Spectrum Disorder (ASD) | NCBDDD

I have one daughter with pseudopsuedohypoparthyroidism, and there is almost no chance that there is going to be any research into a cure for this disease because it is so rare. The only way more research will get done on this subject is if someone like myself with a vested interest does the research which is one of many reasons I am getting my PhD. Pseudopseudohypoparathyroidism | Disease | Overview | Office of Rare Diseases Research (ORDR-NCATS)

I do understand that as parents with a special needs child that we are constantly questioning ourselves and our decisions to see if there is anything that we could have done not for this to happen to our children.

Nurseworks, ASN, RN · Apr 20, 2014

It would be a conflict of interest if Dr. Offit was only discussing the rotavirus vaccine and not all vaccines. His net worth isn't going anywhere whether he supports other vaccines or not, and like I have pointed out already Dr. Offit does not support all vaccines i.e. he does not support small pox or the oral polio vaccines d/t there inherent dangers.

No, it's a conflict of interest that should be declared and accounted for when he talks about the subject as a whole (but never is in almost every interview I've seen him give). It's a CoI that should should require his recusing himself when the subject turns to his particular vaccine as well as any of those that are manufactured from the company that paid him millions for it, Merck. As for not supporting that which is unsafe, particularly the oral polio vaccine that started this whole mess of a program, bully for him.

Actually, the new rotavirus vaccine probably does not increase rates of intussusception. JAMA Network | JAMA | Risk of Intussusception Following Administration of a Pentavalent Rotavirus Vaccine in US Infants

Hadn't read that, last literature I read just spoke of the decreased rate of incidence. I'll read the rest of the paper when I have time.

You are and were trying to link Dr. Offit to being biased, because he profited off a vaccine he helped developed so I think it is prudent to point out that this vaccine along with all vaccines used in United States go through constant Phase IV testing/studies which is unlike any other medication.

And unlike any other medication, it is exempt for being held to the same legal standards of responsibility, due mostly to the aforementioned oral polio vaccine. Funny thing is, if they're so incredibly safe and well-tested, why do the pharmaceutical companies need to be insulated from litigation? I know the reasons that were put forth for the initial drafting of the law and subsequent decisions in various courts, but it runs counter-intuitive to the pro-arguments you've put forth. Certainly something worth pondering...

It is rare, but not unknown that vaccines may trigger developmental disorders with children with mitochondrial disorders. It is also possible that fevers, flu, dehydration, and other illnesses can also trigger developmental problems with children that have mitochondrial disorders. This does not change my mind on anything about vaccines. I would like to see more research on this subject, but it does seem that there is at least some research is at least being done on the subject. I am in no way advocating that we should stop researching vaccine safety or stop looking for safer and more effective vaccines. I am hopeful that someday that vaccine use will come so prevalent that we can eliminate most vaccine preventable diseases like we did with small pox and stop utilizing many of the vaccines that we currently use. CDC | Mitochondrial Disease | Autism Spectrum Disorder (ASD) | NCBDDD

I too would like to see more research done on the subject. There are some studies that have looked at the connection between mitochondrial dysfunction and autism, but the only one I know of looking at vaccines (but instead of autism, encephalopathy) is the Zimmerman/Poling paper. Here's one that utilized a small, but statistically significant, cohort:

JAMA Network | JAMA | Mitochondrial Dysfunction in Autism

For more on the subject, especially as it relates to oxidative stress in particular, I'd recommend anything published by the Chauhans.

Interesting that you referenced that particularly FAQ. Did you happen to recognize the part where the CDC states that some children with autism have had a regression? Just last week I believe the subject of this thread stated that's not the case, claiming that when you have autism, you're born with it. So much for his expert status on the subject...

I have one daughter with pseudopsuedohypoparthyroidism, and there is almost no chance that there is going to be any research into a cure for this disease because it is so rare. The only way more research will get done on this subject is if someone like myself with a vested interest does the research which is one of many reasons I am getting my PhD. Pseudopseudohypoparathyroidism | Disease | Overview | Office of Rare Diseases Research (ORDR-NCATS)

I'm very sorry that you know the life of a parent tasked with having to care for a special needs child with a rare disorder. I can profoundly relate to that as my daughter, in addition to her autism, also suffers from Ehlers-Danlos Syndrome, catamenial seizures, apraxia, tethered cord syndrome (corrected), and now possibly endogenous Cushing's Syndrome. Having to advocate on her behalf for her medical needs is the singular driving force for my returning to school to become a nurse, and like you, this vested interest will direct my career/education in helping those similarly affected. I wish you nothing but success in finding answers for your daughter and anyone else that has her disorder.

I do understand that as parents with a special needs child that we are constantly questioning ourselves and our decisions to see if there is anything that we could have done not for this to happen to our children.

The only thing I question now is my ignorance then. I listened to the advice given to me by healthcare professionals, including the pediatrician, all of whom said many of the same things you have in the various threads. What I wish is that there had been someone to show me the outline you posted from the CDC for healthcare providers. Perhaps that may have given me the necessary pause to question why 4-5 vaccines were given whenever my kid showed up at the office with a sniffle, or that why giving a kid Tylenol after a (temporal, lol) febrile vaccine reaction isn't necessarily the best practice. I know you'll probably scoff at that, but I've done enough research on the subject to know that being prudent may have been the best course of action over blindly following the advice of others back in 2000 who said that vaccines are safe, nothing to worry about.

allnurses Guide · Apr 20, 2014

No, it's a conflict of interest that should be declared and accounted for when he talks about the subject as a whole (but never is in almost every interview I've seen him give). It's a CoI that should should require his recusing himself when the subject turns to his particular vaccine as well as any of those that are manufactured from the company that paid him millions for it, Merck. As for not supporting that which is unsafe, particularly the oral polio vaccine that started this whole mess of a program, bully for him.
Hadn't read that, last literature I read just spoke of the decreased rate of incidence. I'll read the rest of the paper when I have time.
And unlike any other medication, it is exempt for being held to the same legal standards of responsibility, due mostly to the aforementioned oral polio vaccine. Funny thing is, if they're so incredibly safe and well-tested, why do the pharmaceutical companies need to be insulated from litigation? I know the reasons that were put forth for the initial drafting of the law and subsequent decisions in various courts, but it runs counter-intuitive to the pro-arguments you've put forth. Certainly something worth pondering...
I too would like to see more research done on the subject. There are some studies that have looked at the connection between mitochondrial dysfunction and autism, but the only one I know of looking at vaccines (but instead of autism, encephalopathy) is the Zimmerman/Poling paper. Here's one that utilized a small, but statistically significant, cohort:
JAMA Network | JAMA | Mitochondrial Dysfunction in Autism
For more on the subject, especially as it relates to oxidative stress in particular, I'd recommend anything published by the Chauhans.
Interesting that you referenced that particularly FAQ. Did you happen to recognize the part where the CDC states that some children with autism have had a regression? Just last week I believe the subject of this thread stated that's not the case, claiming that when you have autism, you're born with it. So much for his expert status on the subject...
I'm very sorry that you know the life of a parent tasked with having to care for a special needs child with a rare disorder. I can profoundly relate to that as my daughter, in addition to her autism, also suffers from Ehlers-Danlos Syndrome, catamenial seizures, apraxia, tethered cord syndrome (corrected), and now possibly endogenous Cushing's Syndrome. Having to advocate on her behalf for her medical needs is the singular driving force for my returning to school to become a nurse, and like you, this vested interest will direct my career/education in helping those similarly affected. I wish you nothing but success in finding answers for your daughter and anyone else that has her disorder.
The only thing I question now is my ignorance then. I listened to the advice given to me by healthcare professionals, including the pediatrician, all of whom said many of the same things you have in the various threads. What I wish is that there had been someone to show me the outline you posted from the CDC for healthcare providers. Perhaps that may have given me the necessary pause to question why 4-5 vaccines were given whenever my kid showed up at the office with a sniffle, or that why giving a kid Tylenol after a (temporal, lol) febrile vaccine reaction isn't necessarily the best practice. I know you'll probably scoff at that, but I've done enough research on the subject to know that being prudent may have been the best course of action over blindly following the advice of others back in 2000 who said that vaccines are safe, nothing to worry about.

It is not a conflict of interest when giving a speech to not say that my research was funded by x or I invented x. Everything I have seen written by Dr. Offit clearly states his rotavirus research was funded by x or he clearly outlines he helped develop the new rotavirus vaccine. It is a well known fact. It isn't like politicians getting up and giving a speech, but refusing to declare who his or her sponsors are. It is considered unethical when authors of research articles do not declare funding sources. All the articles I can find from Dr. Offit clearly state his funding sources. Influence of Potential Protective Mechanisms on the Development of Live Rotavirus Vaccines I think you clearly have a bias against Dr. Offit. His explanations on vaccines, the development of vaccines, and the history of the anti-vaccine movement in the U.S. are clear and easily referenced. This is much more than anyone can say for the anti-vaccine movements that are out there.

The United States wanted to ensure that vaccine supply would always be available, so we went to the vaccine injury compensation program. Vaccine Injury Compensation Programs â€” History of Vaccines The older more common vaccines are not a high profit margin business, and most companies would simply stop making them over legal fees from fighting litigations that are often false (i.e. MMR vaccine and autism). The only people that truly would profit, at least short term, from changing this program would be the attorneys who would get 25-60+% of settlements/judgements. Have you ever looked at many of the class action law suits? The judgements in those big cases are often in the millions, but each person usually only gets a very small percentage while the attorneys often get 40-60% of the entire judgment, so if you want to talk about a conflict of interest I think that is a huge one no one ever talks about. The VICPs does not absolve pharmaceutical companies from criminal negligence or FDA oversight, and it also still allows people to be compensated from vaccine injuries. The decisions from the VICPs have historically been in the favor of the plaintiff.

I posted an article in nursing news about the link to children being born with autism.

It is funny I have never heard a true expert on vaccines say they are completely safe. It is risk to benefit scenario. The risk from vaccines are incredibly small, but benefit is almost immeasurable.

Research is a wonderful thing, but each article has to be put into perspective with all the other similar research articles that is why is important to consider the hierarchy of evidence and to "grade" articles based on levels of evidence. It is similar to having 1 witnessed account of a crime versus a 100 witnesses with a video too of the same crime. Hierarchy of evidence - Wikipedia, the free encyclopedia Evidence-based medicine - Wikipedia, the free encyclopedia

By the way I think I read that you are an avid bicycle rider..? I just did a 33 mile bicycle ride through Palmer Alaska yesterday in the MatSu Valley in 55 degree sunny weather while surrounded by snow covered mountains. palmer alaska I thought you would get a kick out of that.

Nurseworks, ASN, RN · Apr 21, 2014

I'm not going to bother with the rest as we're at a loggerhead on the subject as a whole. One thing I will say is that pharmaceutical companies are not subject to any litigation with regard to vaccines, including design defect.

http://www.supremecourt.gov/opinions/10pdf/09-152.pdf

Justice Sotomayor's dissenting commentary expresses my views and reservations far more eloquently than I could ever hope to.

Wow, that is some beautiful scenery to ride through! I'm stuck with the confines of NYC, can't even begin to imagine how serene it must be up there. I usually try to get in 15 mile rides at least 3-4 days a week. Weekend rides I'll get in some 30 milers, but not always.

allnurses Guide · Apr 22, 2014

I'm not going to bother with the rest as we're at a loggerhead on the subject as a whole. One thing I will say is that pharmaceutical companies are not subject to any litigation with regard to vaccines, including design defect.
http://www.supremecourt.gov/opinions/10pdf/09-152.pdf
Justice Sotomayor's dissenting commentary expresses my views and reservations far more eloquently than I could ever hope to.
Wow, that is some beautiful scenery to ride through! I'm stuck with the confines of NYC, can't even begin to imagine how serene it must be up there. I usually try to get in 15 mile rides at least 3-4 days a week. Weekend rides I'll get in some 30 milers, but not always.

http://www.hrsa.gov/vaccinecompensation/authoringleg.pdf Do a search for criminal on this document, and the samething for the link you provided. Vaccine manufactures can still be held liable if criminal negligence is found.

Europe is looking to pass a law that would force drug companies to publish all their research data from the development/research on drugs. http://www.nytimes.com/2013/06/30/business/breaking-the-seal-on-drug-research.html?pagewanted=all&_r=0 This would actually be the best thing for transparency on all pharmaceuticals.

The reason I comment that vaccines are different from other drugs is that vaccines undergo much more research that is not funded by pharmaceutical companies i.e. phase IV studies that are open to all researchers.

klone, MSN, RN · Apr 22, 2014

Again, can you provide any peer-reviewed scientific evidence to support your views that vaccines are unsafe?

Did he say that, though? That he believes vaccines are unsafe? I did not see that anywhere; in fact, I saw him say that all his children are fully vaccinated, as is he. It seems odd that someone who voluntarily fully vaccinates his own children believes that vaccines are unsafe.

It seems like anyone who doesn't buy every aspect of vaccines hook, line and sinker, or has the audacity to QUESTION some aspect of the routine vaccine schedule, is branded as an anti-vax conspiracy nut who shouldn't even be practicing healthcare. I think that's ridiculous and very narrow-minded (and like Nurseworks, I'm a little leery of those people who are so dogmatic that they don't seem willing to acknowledge the drawbacks of the current vaccine schedule as it stands).

allnurses Guide · Apr 22, 2014

Did he say that, though? That he believes vaccines are unsafe? I did not see that anywhere; in fact, I saw him say that all his children are fully vaccinated, as is he. It seems odd that someone who voluntarily fully vaccinates his own children believes that vaccines are unsafe.
It seems like anyone who doesn't buy every aspect of vaccines hook, line and sinker, or has the audacity to QUESTION some aspect of the routine vaccine schedule, is branded as an anti-vax conspiracy nut who shouldn't even be practicing healthcare. I think that's ridiculous and very narrow-minded (and like Nurseworks, I'm a little leery of those people who are so dogmatic that they don't seem willing to acknowledge the drawbacks of the current vaccine schedule as it stands).

It is hardly dogmatic to use EBP to guide your nursing practice.

I think people that question vaccines or defend vaccines use should be able state their argument using peer-reviewed scientific evidence. Can you find one of my posts on vaccines where I haven't provided some kind of scientific reference? I don't believe it is too much to ask that people who are actively denying multiple medical societies recommendations on vaccines to do the same.

IMHO I do not think healthcare professionals that are not fully vaccinated per personal choice should practice any kind of public healthcare, obviously that does not apply to nurseworks d/t his choice to be fully vaccinated.

Now, if you have some peer-reviewed scientific to support an alternate vaccine schedule I would love to see it.

Nurseworks, ASN, RN · Apr 22, 2014

http://www.hrsa.gov/vaccinecompensation/authoringleg.pdf Do a search for criminal on this document, and the samething for the link you provided. Vaccine manufactures can still be held liable if criminal negligence is found.
Europe is looking to pass a law that would force drug companies to publish all their research data from the development/research on drugs. http://www.nytimes.com/2013/06/30/business/breaking-the-seal-on-drug-research.html?pagewanted=all&_r=0 This would actually be the best thing for transparency on all pharmaceuticals.
The reason I comment that vaccines are different from other drugs is that vaccines undergo much more research that is not funded by pharmaceutical companies i.e. phase IV studies that are open to all researchers.

You're right, I missed the criminal part. So short of their willfully ignoring safety and/or poisoning someone, they are in the clear. Terrific. Nice work if you can get it, don't you agree?

Vaccines are exempt from PDUFA or a similar testing requirement? If so, that means pharmaceutical companies aren't required to assume responsibility for damages caused by their product (criminality notwithstanding), nor the funding to study the safety/efficacy of said product? And that's a good thing when it comes to vaccines, but a bad thing for other drugs? Or vice-versa? One would seem to stand in oppositional logic of the other.

Part of the reason I don't cite "peer-reviewed" sources, especially as it relates to a vaccine-autism connection, is because the veracity of some of the studies most often cited, specifically those on thimerosal and MMR, is now in doubt due to the actions of Poul Thorsen. His offenses are more egregious than those of Wakefield, but the latter is the only one I ever hear mentioned in these types of debate. Additionally, there are other aspects of the vaccine program that have not been looked at within peer-reviewed settings, yet all we ever hear is "the question has been asked and answered; vaccines don't cause autism" (that's another blanket statement from your pal Dr. Offit).

I dislike those who speak in absolutes, especially in regards to science. As someone who holds peer-review in such high regard, I would expect that you would feel the same way. While going with consensus science is typically prudent, holding such views as absolutes is dogmatic and helpful to neither the public in general nor the scientific community in particular.

allnurses Guide · Apr 23, 2014

You're right, I missed the criminal part. So short of their willfully ignoring safety and/or poisoning someone, they are in the clear. Terrific. Nice work if you can get it, don't you agree?
Vaccines are exempt from PDUFA or a similar testing requirement? If so, that means pharmaceutical companies aren't required to assume responsibility for damages caused by their product (criminality notwithstanding), nor the funding to study the safety/efficacy of said product? And that's a good thing when it comes to vaccines, but a bad thing for other drugs? Or vice-versa? One would seem to stand in oppositional logic of the other.
Part of the reason I don't cite "peer-reviewed" sources, especially as it relates to a vaccine-autism connection, is because the veracity of some of the studies most often cited, specifically those on thimerosal and MMR, is now in doubt due to the actions of Poul Thorsen. His offenses are more egregious than those of Wakefield, but the latter is the only one I ever hear mentioned in these types of debate. Additionally, there are other aspects of the vaccine program that have not been looked at within peer-reviewed settings, yet all we ever hear is "the question has been asked and answered; vaccines don't cause autism" (that's another blanket statement from your pal Dr. Offit).
I dislike those who speak in absolutes, especially in regards to science. As someone who holds peer-review in such high regard, I would expect that you would feel the same way. While going with consensus science is typically prudent, holding such views as absolutes is dogmatic and helpful to neither the public in general nor the scientific community in particular.

Pharmaceutical companies are hardly in the clear. They cannot hide behind confidential settlements with vaccines as they can with other prescription medications, and scientists or CEOs I think would worry a lot more about criminal negligence versus a civil lawsuit.

http://www.fas.org/sgp/crs/misc/R42366.pdf Vaccines are required to pay under prescription drug user fee act.

"Stages of Vaccine Development and Testing

In the United States, vaccine development and testing follow a standard set of steps. The first stages are exploratory in nature. Regulation and oversight increase as the candidate vaccine makes its way through the process.

First Steps: Laboratory and Animal Studies

Exploratory Stage

This stage involves basic laboratory research and often lasts 2-4 years. Federally funded academic and governmental scientists identify natural or synthetic antigens that might help prevent or treat a disease. These antigens could include virus-like particles, weakened viruses or bacteria, weakened bacterial toxins, or other substances derived from pathogens.

Pre-Clinical Stage

Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. Animal subjects may include mice and monkeys. These studies give researchers an idea of the cellular responses they might expect in humans. They may also suggest a safe starting dose for the next phase of research as well as a safe method of administering the vaccine.

Researchers may adapt the candidate vaccine during the pre-clinical state to try to make it more effective. They may also do challenge studies with the animals, meaning that they vaccinate the animals and then try to infect them with the target pathogen. Challenge studies are never conducted in humans.

Many candidate vaccines never progress beyond this stage because they fail to produce the desired immune response. The pre-clinical stages often lasts 1-2 years and usually involves researchers in private industry.

IND Application

A sponsor, usually a private company, submits an application for an Investigational New Drug (IND) to the U.S. Food and Drug Administration. The sponsor describes the manufacturing and testing processes, summarizes the laboratory reports, and describes the proposed study. An institutional review board, representing an institution where the clinical trial will be conducted, must approve the clinical protocol. The FDA has 30 days to approve the application.

Once the IND application has been approved, the vaccine is subject to three phases of testing.

Next Steps: Clinical Studies with Human Subjects

Phase I Vaccine Trials

This first attempt to assess the candidate vaccine in humans involves a small group of adults, usually between 20-80 subjects. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. Phase I trials may be non-blinded (also known as open-label in that the researchers and perhaps subjects know whether a vaccine or placebo is used).

The goals of Phase 1 testing are to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes. A promising Phase 1 trial will progress to the next stage.

Phase II Vaccine Trials

A larger group of several hundred individuals participates in Phase II testing. Some of the individuals may belong to groups at risk of acquiring the disease. These trials are randomized and well controlled, and include a placebo group.

The goals of Phase II testing are to study the candidate vaccine's safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.

Phase III Vaccine Trials

Successful Phase II candidate vaccines move on to larger trials, involving thousands to tens of thousands of people. These Phase III tests are randomized and double blind and involve the experimental vaccine being tested against a placebo (the placebo may be a saline solution, a vaccine for another disease, or some other substance).

One Phase III goal is to assess vaccine safety in a large group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine might occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include 60,000 subjects, half of them in the control, or no vaccine, group (Plotkin SA et al. Vaccines, 5^thed. Philadelphia: Saunders, 2008).

Vaccine efficacy is tested as well. These factors might include 1) Does the candidate vaccine prevent disease? 2) Does it prevent infection with the pathogen? 3) Does it lead to production of antibodies or other types of immune responses related to the pathogen?

Next Steps: Approval and Licensure

After a successful Phase III trial, the vaccine developer will submit a Biologics License Application to the FDA. Then the FDA will inspect the factory where the vaccine will be made and approve the labeling of the vaccine.

After licensure, the FDA will continue to monitor the production of the vaccine, including inspecting facilities and reviewing the manufacturer's tests of lots of vaccines for potency, safety and purity. The FDA has the right to conduct its own testing of manufacturers' vaccines.

Post-Licensure Monitoring of Vaccines

A variety of systems monitor vaccines after they have been approved. They include Phase IV trials, the Vaccine Adverse Event Reporting System, and the Vaccine Safety Datalink.

Phase IV Trials

Phase IV trial are optional studies that drug companies may conduct after a vaccine is released. The manufacturer may continue to test the vaccine for safety, efficacy, and other potential uses.

VAERS

The CDC and FDA established The Vaccine Adverse Event Reporting System in 1990. The goal of VAERS, according to the CDC, is "to detect possible signals of adverse events associated with vaccines." (A signal in this case is evidence of a possible adverse event that emerges in the data collected.) About 30,000 events are reported each year to VAERS. Between 10% and 15% of these reports describe serious medical events that result in hospitalization, life-threatening illness, disability, or death.

VAERS is a voluntary reporting system. Anyone, such as a parent, a health care provider, or friend of the patient, who suspects an association between a vaccination and an adverse event may report that event and information about it to VAERS. The CDC then investigates the event and tries to find out whether the adverse event was in fact caused by the vaccination.

The CDC states that they monitor VAERS data to

Detect new, unusual, or rare vaccine adverse events
Monitor increases in known adverse events
Identify potential patient risk factors for particular types of adverse events
Identify vaccine lots with increased numbers or types of reported adverse events
Assess the safety of newly licensed vaccines

Not all adverse events reported to VAERS are in fact caused by a vaccination. The two occurrences may be related in time only. And, it is probable that not all adverse events resulting from vaccination are reported to VAERS. The CDC states that many adverse events such as swelling at the injection site are underreported. Serious adverse events, according to the CDC, "are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes."

VAERS has successfully identified several rare adverse events related to vaccination. Among them are

An intestinal problem after the first vaccine for rotavirus was introduced in 1999
Neurologic and gastrointestinal diseases related to yellow fever vaccine

Additionally, according to Plotkin et al., VAERS identified a need for further investigation of MMR association with a blood clotting disorder, encephalopathy after MMR, and syncope after immunization (Plotkin SA et al. Vaccines, 5^th ed. Philadelphia: Saunders, 2008).

Vaccine Safety Datalink

The CDC established this system in 1990. The VSD is a collection of linked databases containing information from large medical groups. The linked databases allow officials to gather data about vaccination among the populations served by the medical groups. Researchers can access the data by proposing studies to the CDC and having them approved.

The VSD has some drawbacks. For example, few completely unvaccinated children are listed in the database. The medical groups providing information to VSD may have patient populations that are not representative of large populations in general. Additionally, the data come not from randomized, controlled, blinded trials but from actual medical practice. Therefore, it may be difficult to control and evaluate the data.

Rapid Cycle Analysis is a program of the VSD, launched in 2005. It monitors real-time data to compare rates of adverse events in recently vaccinated people with rates among unvaccinated people. The system is used mainly to monitor new vaccines. Among the new vaccines being monitored in Rapid Cycle Analysis are the conjugated meningococcal vaccine, rotavirus vaccine,MMRV vaccine, Tdap vaccine, and the HPV vaccine. Possible associations between adverse events and vaccination are then studied further.

In Conclusion

Vaccines are developed, tested, and regulated in a very similar manner to other drugs. In general, vaccines are even more thoroughly tested than non-vaccine drugs because the number of human subjects in vaccine clinical trials is usually greater. In addition, post-licensure monitoring of vaccines is closely examined by the Centers for Disease Control and the FDA." Vaccine Development, Testing, and Regulation â€" History of Vaccines

Someone who is dogmatic has arrogant attitudes based on unproved theories. If you dogmatically assert that the moon is made of green cheese, you'll just get laughed at.

The most basic definition of the adjective dogmatic is that it is related to dogma-doctrines relating to morals and faith-but what it has come to mean is attitudes that are not only based on unproved theories but are also arrogant in nature. The root of dogmatic is the Greek word dogmatikos. A synonym of dogmatic is "dictatorial" and because there are religious associations to the root word dogma, someone who is dogmatic tends to "pontificate." dogmatic - Dictionary Definition : Vocabulary.com

Using research to prove a point is hardly dogmatic. Good healthcare providers use their best clinical judgement and the most current research available at that time to guide their practices this is often referred to EBP.

We never stop asking questions, but we shouldn't expect researchers to keep doing the same research over and over and expect them to come up with a different answer either.