Saturday, May 18, 2019

NIH: Informed consent "NEEDED" for "most vaccines", AND PATIENTS HAVE THE RIGHT TO REFUSE

Skip navigation

While the legislature has gone mad, fueled by fake news and Pharma largesse, forgotten are our minimum, legal standards that guarantee informed consent and prevent US patients from being forced to comply with vaccinations and other medical procedures.  

Interestingly, the NIH has not forgotten we have this right.



Informed consent - adults

You have the right to help decide what medical care is best for you. By law, your health care providers must explain your health condition and treatment choices to you.
Informed consent means:
  • You are informed. You have received information about your health condition and treatment options.
  • You understand your health condition and treatment options.
  • You are able to decide what health care treatment you want to receive and give your consent to receive it.
To obtain your informed consent, your provider may talk with you about the treatment. Then you will read a description of it and sign a form. This is written informed consent.
Or, your provider may explain a treatment to you. They will ask if you agree to have the treatment. Not all medical treatments require written informed consent.

What Treatments Need Informed Consent?

Medical procedures that may require you to give written informed consent include:
  • Most surgeries, even when they are not done in the hospital
  • Other advanced or complex medical tests and procedures, such as an endoscopy (placing a tube down your throat to look at the inside of your stomach) or a needle biopsy of the liver
  • Radiation or chemotherapy to treat cancer
  • Most vaccines
  • Some blood tests, such as HIV testing (need for written consent varies by state)

What Should Occur During the Informed Consent Process?

When asking for your informed consent, your doctor or other health care provider must explain:
  • If treatment is necessary now or if it can wait
  • Your health problem and the reason for the treatment
  • What happens during the treatment
  • The risks of the treatment and how likely they are to occur
  • How likely the treatment is to work
  • Other options for treating your health problem
  • Risks or possible side effects that may happen later on
You should have enough information to make a decision about your treatment. Your provider should also make sure you understand the information. One way a provider may do this is by asking you to repeat the information back in your own words.
If you would like more details about your treatment choices, ask your provider where to look. There are many trusted websites and other resources your provider can give you.

What is Your Role in the Informed Consent Process?

You are an important member of your health care team. You should ask questions about anything you do not understand. If you need your provider to explain something in a different way, ask them to do so.
You have the right to refuse treatment if you are able to understand your health condition, your treatment options, and the risks and benefits of each option. Your doctor or other health care provider may tell you they do not think this is the best choice for you. But, your providers should not try to force you to have a treatment you do not want to have.
It is important to be involved in the informed consent process. After all, you are the one who will receive the treatment if you give your consent.

Other Tips

Informed consent is not needed in an emergency when delayed treatment would be dangerous.
Some people are no longer able to make an informed decision, such as someone with advanced Alzheimer disease or someone in a coma. In both cases, the person would not be able to understand information to decide what medical care they want. In these types of situations, the provider would try to obtain informed consent for treatment from a surrogate, or substitute decision-maker.
Even when your provider does not ask for your written consent, you should still be told what tests or treatments are being done and why. For example:
  • Before they have the test, men should know the pros, cons, and the reasons for a PSA blood test that screens for prostate cancer.
  • Women should know the pros, cons, and the reasons for a Pap test, a mammogram, or other tests.
  • Anyone who is being tested for an infection that occurs after sexual contact should be told about the test and why they are being tested.

References

Emanuel EJ. Bioethics in the practice of medicine. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine. 25th ed. Philadelphia, PA: Elsevier Saunders; 2016:chap 2.
United States Department of Health and Human Services website. Informed consent. www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/index.html. Accessed January 2, 2018.

Review Date 11/20/2017

Updated by: Laura J. Martin, MD, MPH, ABIM Board Certified in Internal Medicine and Hospice and Palliative Medicine, Atlanta, GA. Also reviewed by David Zieve, MD, MHA, Medical Director, Brenda Conaway, Editorial Director, and the A.D.A.M. Editorial team.

Thursday, May 9, 2019

Meryl Nass, MD's medical practice


I am a board-certified internal medicine doctor.  I graduated with a degree in biology from MIT, attended NJ Medical School and the University of Mississippi Medical School. I have practiced in Maine since 1997.  

I am passionate about improving the lives of my patients.  I try to find the least toxic methods of treatment for each individual.  I use medicines, supplements, diets, and other healing modalities, as needed, for tough clinical problems like chronic fatigue syndrome, chronic lyme disease and fibromyalgia. 

I believe in First, Do No Harm.  My goals are 1) to use a minimum of medications and avoid iatrogenic (doctor-caused) harms, and 2) answer all my patients' questions as thoroughly as possible.  

I opened a medical practice because there were no local physicians treating chronic, complex disorders like Lyme--despite the large number of affected patients.  (According to the CDC, Maine has the highest rate of reported Lyme cases, per person, in the US.  Hancock County, where I practice, has the highest rate of Lyme in Maine.)

In order to make this practice work, I cannot accept any insurance plans, and patients must pay for my services when services are rendered. While some insurance plans will reimburse patients for the cost of visits, other (including Medicare) do not.

I hope to see patients with challenging disorders, those who wish to reduce their medications and/or use diet and lifestyle changes to improve health, and those with illnesses occurring after tick bites, fibromyalgia-related, or occurring as a consequence of military service or anthrax vaccine.  In my opinion, Lyme and tick-borne diseases should be considered in every patient with an undiagnosed illness.  Tick-borne diseases have taken a large and varied toll on our community. 

I also treat the range of illnesses seen in primary care internal medicine.  

The office phone number is (207) 610-5885.  The fax number is 610-5886.
The office address is 210 Main Street, Ellsworth, Maine, 04605.  My cell (for emergencies) is (207) 522-5229.  My email address is merylnass@gmail.com.  I do see patients evenings and weekends, if needed for acute illnesses, and can be reached by email as needed.

Friday, April 26, 2019

Maine's vaccine exemption bill supported by "false claims"

Four incorrect (but widely repeated) claims were made by Maine representatives to justify getting rid of religious and philosophical vaccine exemptions.  Here I list them and provide documentation to show why they are wrong.


1.  "Only 6 states have higher opt-out rates."  "We have one of the worst vaccination rates in the country."  The CDC published vaccination rates for all the states for the required number of doses for MMR, DTaP and chickenpox vaccine in kindergartners.

Table 1 shows the median vaccination rate for all states for the MMR is 94.0.  Maine's rate is 94.5.
The median rate for DTaP is 94.5.  Maine's rate is 96.6.
The median rate for chickenpox (Vaccinia) vaccine is 96.5.  Maine's rate is 96.7.

Maine’s rate for all children exempted from any required vaccine is 5.0%.  While this is exactly in the middle of all states, at first glance it appears very high.  On closer look (see the Figure at the end of the article) 23 or 24 states have lower vaccination rates, but lower exemption rates—because they have an appreciable number of students who are unvaccinated but have obtained no exemptions.  The CDC’s graph shows this for the MMR.  That is why Maine beats the median vaccination rates, but appears to have a high exemption rate.


FIGURE. Estimated percentage of kindergartners with documented up-to-date vaccination for measles, mumps, and rubella vaccine (MMR)*; exempt from one or more vaccines†,§; and not up to date with MMR and not exempt — selected states and District of Columbia,** 2017–18 school year
 The figure shows the estimated percentage of kindergartners with documented up-to-date vaccination for measles, mumps, and rubella vaccine (MMR); exempt from one or more vaccines; and not up to date with MMR and not exempt in selected states and District of Columbia during the 2017–18 school year.

2.  "We Need to Achieve Herd Immunity."  There is no established percentage of people who need to be vaccinated to achieve herd immunity,  Herd immunity numbers are estimates, which vary by disease and vaccine.  An NIH newsletter noted that mathematical models is where these percentages come from:  "Using mathematical formulas and computer programs, NIH-funded scientists like Lipsitch have developed models to determine what proportion of the population has to be vaccinated to eliminate the spread of disease." 

The textbook Vaccines 6th Edition, page 1399, shows that estimates from experts for needed vaccination rates have ranged from 50%-95%.  While Maine has small pockets with lower levels of vaccinations, there have been no significant  vaccine-preventable disease outbreaks in them.  (Given CDC-acknowledged pertussis immunity 3-4 years after vaccination of 9%, I do not consider herd immunity achievable for pertussis.) 

https://www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6702a1-H.pdf)

 3.  "Measles was eradicated, and now it is back."  Eradication of measles in the US was declared in 2000.  This designation by the WHO meant that measles  did not continuously circulate in the US.  It still doesn't —or didn't until some NY health depts failed to require isolation of cases and contacts in late 2018-2019.  But eradication did not mean that outbreaks stopped.  The US has had 10-20 measles outbreaks/year since 2000; 90% were due to travelers incubating measles when they entered the US, and 10% of cases were of unknown cause.  

https://www.cdc.gov/measles/cases-outbreaks.html

4. "Vaccines are Safe.  Vaccines are Effective.”  Well, vaccines are somewhat safe and somewhat effective.  Each vaccine is different.  Congress charged the Institute of Medicine (now called the National Academy of Medicine) with studying vaccine safety.  Its 2011 report on adverse events and vaccines concluded that the most important information (such as whether specific vaccines cause autism) has not been resolved.  The science is not settled.


"The Institute of Medicine (IOM) was charged by Congress when it enacted the National Childhood Vaccine Injury Act in 1986 with reviewing the literature regarding the adverse events associated with vaccines covered by the program, a charge which the IOM has addressed 11 times in the past 25 years. Following in this tradition, the task of this committee was to assess dispassionately the scientific evidence about whether eight different vaccines cause adverse events (AE), a total of 158 vaccine-AE pairs, the largest study undertaken to date, and the first comprehensive review since 1994.

The committee had a herculean task, requiring long and thoughtful discussions of our approach to analyzing the studies culled from more than 12,000 peer-reviewed articles in order to reach our conclusions, which are spelled out in the chapters that follow. In the process, we learned some lessons that may be of value for future efforts to evaluate vaccine safety. One is that some issues simply cannot be resolved with currently available epidemiologic data, excellent as some of the collections and studies are.

Here are all the conclusions of the Committee for adverse events possibly due to the MMR vaccine.  For most, the evidence is insufficient to judge:


Here are all the conclusions of the Committee for adverse events possibly due to the DTaP vaccine.  For most, the evidence is insufficient to judge:


Tuesday, April 2, 2019

MIssing, hidden and destroyed adverse event data. Who vaccinates?


Who are the anti-vaxxers, really?

If I asked you whether you were for or against pharmaceutical drugs, you would think my question absurd.  Obviously, each drug is different and should be judged on its own merits; furthermore, the usefulness of a drug depends on the specific needs of the person to whom it is given.  Yet we have become accustomed to thinking about the vaccine issue in terms of being pro or con the entire class of vaccines.
Most parents who do not fully vaccinate their children are not "against" vaccination. The media have incorrectly framed the debate this way, for a reason.  The for--or--against meme is very powerful propaganda, designed to suggest that this issue is black and white, which it most assuredly is not.  It is further designed to create a picture in people's minds that those "against" vaccine mandates are anti-science, uneducated 'deplorables' (and who wants to be in that camp?) while those "for" vaccinations and mandates are the educated, pro-science, savvy people.
But guess what? Families who vaccinate less turn out to be wealthier and more highly educated than families that receive all the recommended vaccinations.  So, if they aren't the 'deplorables,' are they entitled elites trying to get a 'free ride' off the backs of everyone who fully vaccinates?

What might be the true reason they decline vaccinations?

In the US, only 1.1% of children receive no vaccinations at all.  According to CDC about 25% of children receive some, but not all recommended vaccinations. Their parents are choosy. They may have recognized that the birth dose of Hepatitis B is an unnecessary vaccine for 99% of babies. They may have learned that the age 12 dose of Tdap has little value. It doesn't prevent much pertussis, and kids are already immune to tetanus and diphtheria after 5 earlier vaccine doses.  They may have cottoned on to the fact that their child doesn't need either Meningitis A,C,W,Y or Men B vaccines when there is less than a one in a million chance of getting meningococcal disease. (Rates of meningitis had dropped before current vaccines came into use.)  They may know that while the vaccines certainly generate an antibody response, real world efficacy of these 2 vaccines has yet to be determined.  

For these diseases, herd immunity does not exist. [Hep B requires bloodborne or sexual transmission. Pertussis immunity wears off so quickly that the vast majority of pertussis cases are vaccinated, but non-immune. Vaccination may increase the duration of pertussis shedding. Meningococcus is carried in the nose/throat of from 1-25% of the population, with or without vaccination.]  Therefore, for these specific conditions, the unvaccinated get no free ride from the vaccinated, nor do the unvaccinated pose more than a minuscule increased risk to others.  
Parents have a legal right to opt out of vaccines using religious or philosophical exemptions in 47 US states.  I wasn't choosy when my kids were small, but today I certainly would be, if only because the benefits and risks are different for each vaccine.

Why does this author claim authority?
I strongly support vaccinations, and everyone's right to vaccinate with any licensed vaccine they choose.  But I know a lot about how vaccines are made, and the serious adverse effects they can cause.  I am an expert on the anthrax vaccine, and have provided expert testimony on this vaccine to several congressional committees, the National Academy of Sciences, the Canadian military courts (which led to ending its use in Canada) and a British tribunal.  And I, through my patients' bitter experiences, learned it is critical to retain the right to choose your vaccines.

Choice leads to better vaccines
The fact is, every vaccine is made very differently from every other. Just like drugs, no vaccine is "100% safe," and some are not very effective. You will lower your family's risk of an adverse effect by choosing only those vaccines that provide high value:  needed benefit and relatively low risk. This is of course what doctors are expected to do when they prescribe drugs.
When vaccines are mandated, there is no incentive for their manufacturers to improve them.  Sometimes, vaccine effectiveness becomes less over time.  The whole-cell pertussis vaccine was replaced by the current acellular pertussis vaccine in 1997 both because its effectiveness had lessened, and because it caused a high rate of adverse events. Had consumers not been refusing it, there might have been no switch to an acellular vaccine.  Now, we need a more effective pertussis vaccine, but with a guaranteed market for existing vaccines, industry has been slow to respond.

Unknown substances

Vaccines are both 'biologics' and drugs, according to the Food, Drug and Cosmetic Act. And according to the FDA, "Most drugs consist of pure chemical substances and their structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized." Translation:  vaccines contain unknown substances.  Unknown even to the FDA.

Doctors are not trained about vaccines in med school

Doctors are not taught about vaccines the way they are taught about drugs' risks and benefits.  I received very thorough training on drugs, but no more than an hours' training on all vaccines. Thus, doctors usually don't learn about vaccine adverse reactions until something happens to their own patients.  In the past twenty years, vaccines that caused more problems than they solved (and were subsequently taken off the market) have included Rotashield, Lymerix and Pandemrix. Few doctors were aware of any problems until the vaccines were withdrawn.  Yet this is the proof that vaccines can be either good or bad.  
What data do FDA use to license drugs and vaccines?
We rely on the FDA to assure that vaccines are relatively safe and effective.  The FDA relies on the results of clinical trials and other tests.  Testing before licensure is entirely paid for and/or conducted by the manufacturer, and all data are owned and supplied by the manufacturer. FDA approves vaccines and then crafts a label in conjunction with the manufacturer, describing the safety and efficacy of the vaccine based only on manufacturer data. 
Do the data become public after licensing a vaccine or drug?

For vaccines, as much else in life, the devil is in the details. And public access to those details (especially regarding safety) is very limited. Twenty years ago, when Congress was examining the safety of vaccines, CDC answered my Freedom of Information Act requests for data on their own anthrax vaccine studies. But for the past ten years they have only provided excuses and stonewalling.
The book Vaccine Whistleblower tells Dr. William Thompson's story of how CDC employees, including himself, were made to put unwanted data in a garbage can and rework their analyses until a strong statistical association between black males who received an early MMR and becoming autistic just--disappeared.  Then CDC published this doctored paper.
A new Hepatitis B vaccine, Heplisav, may cause a considerable number of excess heart attacks. It may cause other significant problems, and may not be safe in pregnancy. The data needed to resolve all of this don't exist yet.  FDA licensed the vaccine anyway, asked the manufacturer to conduct the needed studies in tens of thousands of patients (who are unlikely to know they are receiving an experimental product they have paid for) and FDA will look at the studies after they are completed in 2021, 2022 and 2023 to determine if the vaccine is safe.

Heplisav is only the latest example of 'license first, get the answers later'--at FDA.

Agency malfeasance
The fact is, information on the safety of vaccines is being withheld from the American people by their own government. The only explanation is that the leaders at FDA and CDC have been captured by industry, along with a massive agency-industry revolving door 

That adverse event information for licensed vaccines, drugs and medical devices, collected or generated by federal health agencies--as in this recent FDA scandal -- gets hidden, destroyed or does not even exist should be a compelling concern of everyone.