Recent Blogs and Reports Posted Elsewhere

From time to time I publish on other websites.  Below are links to some of those postings:

On September 18, 2017, the World Mercury Project published a report that I authored. The Report is entitled, Poul Thorsen-Fugitive Researcher   Links to the Report and the Exhibits entitled which can be found at:  https://worldmercuryproject.org/advocacy-policy/criminal-conduct-poul-thorsen/

On September 5, 2017, I published the blog:

Congressman Asks GAO to Investigate VA’s Drug-Centric Approach to PTSD  – Rep. Mike Coffman wants the GAO to look at the “drug-centric” approach to caring for our veterans.  To read this click here:  http://news.cchrint.org/2017/09/05/congressman-asks-gao-to-investigate-vas-drug-centric-approach-to-ptsd/

On August 18, 2017, I published the blog:

A Note to Our DoD and VA Health Systems: Psychiatrists Cannot Drug a Person Back to Feeling Safe with Polypharmacy.  To read this click here:  http://news.cchrint.org/2017/08/18/cannot-drug-person-back-feeling-safe-polypharmacy/

Results of Survey on Medical Interactions on Suspected Vaccine Adverse Reactions

4 August 2017

On 1 August 2017, I posted a survey on Facebook to gather information about the interaction between families and their medical professionals when a suspected vaccine adverse reaction occurred.  The purpose of this inquiry is two-fold:

  • To gain insights into the interactions between health professionals and families when a suspected adverse reaction has taken place; and
  • To gain more knowledge about how often suspected adverse reactions are reported to the US Food and Drug Administration’s (FDA’s) MedWatch or VAERS (Vaccine Adverse Events Reporting System); and

This survey was not intended to suggest that every individual receiving a vaccine experiences an adverse reaction. In fact, I am thrilled when someone does not experience a life altering adverse reaction after administration of a vaccine because I have come to know so many families whose lives have been irreparably harmed when a loved one experienced a serious adverse reaction to one or more vaccines and suffered seizures, brain swelling, or death. Vaccines, like all drugs, have inherent risks.  In looking at recommendations of vaccines and other drugs, there is always supposed to be the consideration of the balance of risk versus benefit.  Once a product enters the marketplace, the post marketing surveillance is key looking for unexpected adverse events as well as monitoring the number of known risks so that the risk/benefit ratio may be updated as more information becomes known.

The decision to vaccinate, like all medical decisions, is one that is best made by the individual and for children, best made by their parents.  Information is key. It is one of the reasons when I am asked, that I advise individuals to go to the FDA website and read the package inserts for the vaccines they are considering in addition to any other research they are doing.  The information in the package insert covers the use, contraindications, and warnings.  It is the information that the FDA has reviewed with the company and required to be included.  Any questions that arise from reviewing this information should be resolved before administration.

One’s own medical history and family medical history is important in making these decisions.  A family history of auto-immune disorders is a red flag.  A history of drug allergies or allergies to eggs, neomycin, and other vaccine ingredients is also important.  Religious considerations regarding porcine, bovine, and aborted human fetal tissue being utilized in some vaccines is also important for some.

Because vaccines recommended for administration to children in the United States, including the adult versions, are different than other drugs and vaccines in that the manufacturers and those who administer the vaccines are protected from being sued by those who experience life altering medical injuries, greater focus on monitoring adverse events, and improving safety is vital.

Adverse Event Reporting

Reporting adverse reactions, even those known to occur with a drug or vaccine are important in post marketing surveillance.  Government and media alike frequently report that vaccine reactions are rare and typically mild reactions. In 1999 while leading the House Oversight investigation looking at vaccine injuries, I learned that like most drugs, vaccine adverse reactions are vastly under reported.  I also heard from thousands of families that they were not truly informed what reactions to look for, or what to do in the event of a serious reaction (such as spiking a high fever, or high-pitched screaming that goes on for hours – signaling a potential encephalopathy). Parents also often reported that the pediatrician would ignore the cause and effect of vaccination and subsequent sudden change in health status.

At the time of the passage of the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34), medical professionals submitted adverse vaccine reactions to the FDA in what would become known as the MedWatch system. Few studies have been done to confirm how often reports are made, since the system is a passive voluntary system. From their own data, FDA has previously suggested that only between 1 and 5.6% of drug adverse reactions are reported.

In 1990, the Vaccine Adverse Events Reporting System (VAERS) system was created as a joint activity between the FDA and the Centers for Disease Control and Prevention (CDC).  https://vaers.hhs.gov/index.html

It is considered the national ‘early warning system’ for post marketing surveillance of US vaccines.  Like the MedWatch system, it is a ‘passive system’.  The public may make their own reports, however; the same law that created the National Vaccine Injury Compensation Program (VICP) mandated that health care professionals (physicians, etc) report vaccine adverse reactions.  Vaccine manufacturers are also required to report all adverse events that are reported to them. While the mandate to report exists, the law did not include any consequence for doctors who fail to report.  Learning through this survey the frequency of reports will provide evidence as to whether the system is working as Congress intended or not.

According to their website, the primary objectives of VAERS are:

  • 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;
  • Assess the safety of newly licensed vaccines;
  • Determine and address possible reporting clusters (e.g., suspected localized [temporally or geographically] or product-/batch-/lot-specific adverse event reporting);
  • Recognize persistent safe-use problems and administration errors;
  • Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program. ( https://vaers.hhs.gov/about.html)

About the Survey

I posed the following five questions:

  1. Have you or a member of your immediate family (child, spouse, parent) ever suffered a suspected adverse reaction to a vaccine?
  2. After the suspected vaccine reaction, did you call your doctor’s office, go to an emergency room, or seek medical input in any way?
  3. In looking back, did the health professionals you interacted with document and report to the FDA the suspected vaccine adverse event? (FDA manages the MEDWatch system and the VAERS system, both of which are avenues to report adverse reactions.)
  4. Please describe briefly the vaccine adverse event including age of individual, type of reaction, and how the medical professionals involved responded.
  5. For demographic purposes only, please list the state you lived in at the time (or country if outside of the USA).

No names, emails or other personally identifying information was collected from responders. While this increased the risk of trolling, I felt it important to keep the survey as short as possible and to allow responders to maintain their privacy.

In the first 72 hours the survey was open, 256 individuals responded. This resulted from two postings on Facebook.  In preparing this survey initially, I did not configure the first question to go to the end if the answer was no. After reviewing these initial responses, I have since corrected that.  The 72 ‘No’ responses to Question 1were excluded from further evaluation.

Responses From 184 Individuals

Question 2 was intended to gain a greater understanding of how families interacted with health professionals while dealing with your own or a loved ones suspected adverse reaction.

Question 3 was intended to gather information about whether or not the adverse event was reported.

Question 4:  The responses to Question 4:  “Please describe briefly the vaccine adverse event including age of individual, type of reaction, and how the medical professionals involved responded.” uncovered that 30 of the 184 responders were not serious responders but trolls – providing flippant answers.

After removing the 30 trolls, the following outcomes on the Questions 2 and 3 show slightly different outcomes.  The largest difference being in Q2 when initially there were more individuals who reported ‘No’.

 

I was initially surprised by how many did not call their doctor or go to the emergency room.  Some of those who did not seek medical input were dealing with mild reactions; others did not connect their child’s sudden changes to the vaccine until later.  Of greater concern 59 out of 65 calls to the doctor did not result in a suggestion to come back in or go to the emergency room.  If the doctor had liability for the reaction the same as other medications prescribed, would the response to these calls be any different? It is a question I cannot answer, but believe needs serious review.  Are doctors trained to understand vaccine adverse reactions, or have they been discouraged from connecting the dots between vaccine administration and the onset of high fevers, brain swelling, seizures, and other adverse reactions other than anaphylactic shock. This is another issue I do not have answers for, but believe needs serious consideration.

As noted on the VAERS website, even known adverse reactions are supposed to be reported. This survey confirms that too often this is not happening.  Numerous parents reported in the survey that the reactions their children were experiencing were ‘normal’ and did not need to be reported to VAERS.  Only seven percent of these responders stated the adverse reaction was included in the medical chart and reported to VAERS.  Ninety-three percent of adverse events were likely not reported to VAERS. Clearly there needs to be improved training to the health professions about the importance of reporting even the ‘expected’ side effects to VAERS so that FDA and CDC can better track reactions to include in their risk/benefit ratio analysis.

 Question 4: Please describe briefly the vaccine adverse event including age of the individual, type of reaction, and how the medical professionals involved responded.

Many individuals did not include the age of the individual. The responses that were included ranged from the day of birth to individuals over 60.  Most appeared to be parents reporting on the pediatric event.  There were responses from more than 25 states, Guam (a US Territory) and several countries including Australia, Sweden, Northern Ireland, Israel, and England.

Several themes seemed to be present in the responses:

Pediatric Reactions

  • High fever – 105 F and above
  • Rash
  • Development of gastric issues that had not been present before.
  • Loss of verbal and social skills
  • Head banging
  • High pitched prolonged inconsolable crying or arched back screaming (one responder called it the ‘encephalitic cry’)
  • Seizures
  • Skin issues including eczema developed
  • Autism behaviors developed

Several parents mentioned their child had the MTHFR genetic mutation.  Two pediatric deaths were reported.  One was attributed to a vaccine adverse reaction; the other physicians did not make the connection.

There were fewer adult responses. However, the below reactions were mentioned.

  •  Migraines
  • Fatigue
  • Abdominal pain
  • Guillain Barré syndrome
  • Shoulder pain
  • Developed shingles from shingles vaccine
  • Development of auto-immune conditions

Many parents reported that the doctor or nurse they spoke with made one of the following comments to them.

  • High fever its normal, give them Tylenol or Motrin.
  • The reaction is normal, no need to report it to VAERS.

Survey responders also reported frequently that the doctor or nurse was dismissive of their concerns about a reaction to a vaccine.  One mother reported her two-month-old infant developed a golf ball sized lump in thigh were injected that was still present at the four-month office visit. The nurse had no concern about the swelling and was prepared to inject another vaccine into the swollen area. Mom declined vaccines on that visit.

Summary

The VAERS system appears underutilized by health professionals.  Because health professionals are not fully utilizing the VAERS system, the FDA and CDC are hamstrung in their ongoing post-marketing surveillance of vaccines.  This creates a domino effect on monitoring the risk/benefit ratio and undermines the mission of both agencies in relation to vaccine safety matters.

The VAERS team should increase their social media profile and capitalize on the agency’s relationships the professional medical trade associations to remind doctors, nurses, and other health professionals of the primary objects of the VAERS program:

  • 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;
  • Assess the safety of newly licensed vaccines;
  • Determine and address possible reporting clusters (e.g., suspected localized [temporally or geographically] or product-/batch-/lot-specific adverse event reporting);
  • Recognize persistent safe-use problems and administration errors;
  • Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.

There is an urgent need to improve the education and awareness among health professionals of the signs and symptoms of vaccine adverse reactions including the link between high fever, inconsolable and arched back crying and possible development of encephalitis after vaccination.

Not everyone will suffer a serious reaction to a vaccine.  Several respondents talked about mild reactions, but appreciate that their child was protected against the infectious diseases from their vaccines.

Vaccines like every medication can and do cause serious adverse reactions including death. Too little accurate information is known about how often a serious reaction develops and who is most vulnerable. Generals in the military develop guidance on the levels of acceptable collateral damage in the development of military maneuvers.  It may seem callous, but it is one of the ways of measuring progress.  Has the public health community developed their own guidance on acceptable collateral damage?  If they have, they have not made it public.  Is a 1% serious reaction acceptable? Would a 10% serious reaction be acceptable?  If 1 in 10,000 infants die from a mandated vaccine, is that acceptable?  If 1 in 1,000 develop a seizure disorder and suffer irreparable brain injury, is that acceptable?  If anyone has research in which the actual percentages of vaccine reactions are included, I hope you will share it with me.  Too often we have the numerator without the denominator.  (vaccine reactions are the numerator, vaccines administered are the denominator).

Unless and until we have an honest dialogue free of name calling and bullying behavior and honest transparent research, we will not see the development of safer vaccines.

The survey will remain open at least through August.  I will provide an update if there are significantly more responses to it in September.  To take the survey, click herehttps://www.surveymonkey.com/r/LZFXKJZ

Working together we can improve our knowledge base.

Always,

Beth

 

Health Insurance and Care – Getting to Real Reform

28 July 2017

In the wee hours of the morning, Senator John McCain cast the deciding vote to kill the ‘Skinny Repeal’ bill that Majority Leader, McConnel had finally made public in the middle of the night.  This bookended his vote earlier in the week to support the vote to initiate the debate on the repeal and replace bill.  He will be off now to seek treatment for the Glioma brain cancer discovered recently.

I am among those nerdy types in Washington that watch the process and who read bills.  Not just the words of a bill, I  put those edits into the law to see what the words of a bill actually change. I also am one of those that appreciates protocol and process.  Like many Americans, I have been frustrated with the entire process this year because the GOP leadership seemed to be doing so many of the things the DNC leadership on the Hill did seven years ago during the development of the Patient Protection and Affordable Care Act (the actual name of the law commonly referred to as ObamaCare).  A lack of transparency, putting a bill up for a vote without members or the public having a chance to read it.  There were also no hearings in the House or Senate in this session of Congress to review the issues.

Seven years ago America was told this health insurance reform was needed to help people get insurance and access health care.  It was obvious seven years ago that the bill that became law that it was based on false promises and that it would not be sustainable.  As someone who has seen her health insurance premiums double in two years with less coverage, I know first hand that the changes to the law are driving the cost up to where most of us next year will not be able to afford insurance.

Fixing health insurance is important, but the most compassionate piece is the discussion got lost then and has not been addressed this year either.  That piece is the ability for all Americans to access care when needed.  This is not just about Medicaid, but about the working poor who may have insurance but cannot afford to seek medical care because of co-pays and high deductibles.  Places like Minute Clinics and Urgent Care walk in clinics have taken some of the burdens off Emergency Rooms, but community-based health solutions are what our nation urgently needs.

County public health clinics could serve this purpose, but they are typically focused on immunization services and other government programs.  There is a federal program managed by the Bureau of Primary Health Care at the Department of Health and Human Services that suppports this concept, but it is typically underfunded and poorly promoted in the local community.

Whether a community clinic receives federal funding or not, I believe they should offer a fully integrated approach to care, focusing on promoting wellness through lifestyle education programs, access to alternative therapies including chiropractic and acupuncture.   Too often clinics turn into prescription writing factories.  Science supports the use of non-Rx solutions, but too often, including in the latest health insurance reform debate, these options do not get introduced.  There are lower cost, safer, and effective solutions that everyone should be able to access.

As for health insurance reform, in my opinion, I would much prefer having the option to put my pre-tax health dollars into a Health Savings Account (HSA) and use that to buy catastrophic care insurance and visit the health professionals of my own choosing and to purchase the health products of my own choosing.  That way, my annual trip to the Nurse Practitioner is covered, my dental, vision and chiropractic trips can be paid for through the HSA, as can any acupuncture visits, dietary supplements, over the counter medical supplies as well as prescriptions.

I have said many times over the last decade that we as a nation are not having the real conversation that needs having.  Using the Constitution as the framing document, what are the roles of the federal, state and local government in health care and health insurance regulation?  What are the roles of the local community,  philanthropy, families, and individuals in providing solutions for accessing and paying for health care? Who should be paying?  Too often in the last decade or so, it seems many hand over all the responsibility (and power) to the federal government.  The regulation of the practice of medicine as well as health insurance regulations has always been mostly managed by the states until Obamacare.

At the end of the day, the GOP has all the power right now and are squandering it.  Eight months into this Congressional session and the promise to repeal and replace has failed.  What will they do now?  It is time for true leadership to rise to the surface.  During the Senate debate, I saw some real progress in what Sen. Bill Cassidy (a physician) and Sen. Lindsay Graham put forward on Medicaid.

We are an innovative and compassionate nation.  I have every confidence that by working together we can find solutions.  Maybe now, with this new development, legislators will be open to scrapping the failed approaches and looking for effective solutions.

Always,

Beth

RESTORING A CIVIL SOCIETY – STRONGER TOGETHER

15 June 2015

Today I am still reeling from the emotions that came to the surface yesterday after the attempted assassination of members of Congress who were on a practice field in Alexandria, Virginia early in the morning. As I write this, two of the five injured as still in critical condition.  Congressman Steve Scalise, Republican from Louisiana and Majority Whip – a member of the leadership – has been through three surgeries in 24 hours.  Matt Mika, a former Congressional staffer, who now lobbies for Tysons Foods and was helping coach was shot twice in the chest.

Zack Bart a young legislative staffer with Congressman Roger Williams of Texas suffered a through and through shot to the calf.  He was released from the hospital yesterday.  Congressman Williams injured his foot/ankle when diving into the dug out and today as he coaches the team, is hobbling on crutches.

The heroes of the day were the two Capitol Hill Police officers, David Bailey and Crystal Griner who were on protective detail with Congressman Scalise.  Their presence, training, and swift action surely saved many lives.  Senator Rand Paul said that had they not been there, it would have been a massacre.  Officer Bailey has been released from hospital on crutches, Officer Griner remains in the hospital with a gun shot wound to her ankle.

I like many Americans was glued to the television and watching members of Congress recount their experience.  I recognized that like anyone who has been through a traumatic event, it is important for them to talk about it, to tell their stories.  For me, and for many others I am sure, memories of September 11, 2001 flew up to the surface.

In many ways, Washington has been a lot like it was in 2001, fresh off an election,  the partisan divide larger than ever and rife with vitriol.  And because the entire nation has been affected by these events, there is a call for unity.

Can we as a nation, focus on becoming more civilized with one anther?  Can we remember to be respectful, to cease the name calling, accept that everyone is entitled to their own opinions, political views, and spiritual beliefs?  Can we remember that we are stronger together?

None of us knows what tomorrow will bring.  I hope we can truly focus on unity and civility.

Always,

Beth