Answers to questions from anti-vaxers

If I could say but one thing: recognize hype versus objective observation and honest inquiry when you see it, and don't hold each to the same standard.

The following comes across to me as merely pile-it-on anti-vax propoganda.

These are the views from the anti-vaxers.

1. Why doesn't the NIH replicate the clinical science studies that Dr.Vijendra Singh and Dr. Andrew Wakefield have done and take it to the next level?

2. Why isn't there scientific curiousity as to why children with autism have elevated measles antibody titers, measles in the gut and measles in the spinal fluid. Isn't there an interest to explain this especially when the CDC, NIH, and IOM say that the autism epidemic is a mystery but then deny a link between the MMR vaccine and autism.

dras reply--The NIH has responded to these first two questions: http://www.nichd.nih.gov/publications/pubs/autism2.htm

3. Why is there a conflict of interest between pharmaceutical companies and the CDC and FDA as per this article........ http://www.upi.com/view.cfm?StoryID=20030718-012134-4422r Aren't these government health agencies responsible to the American public rather than serve their masters at the pharmaceutical companies?

dras reply----This line of questioning is not objective, contains or infers invalidated statements and suppositions ("serve their masters"), and serves only to appeal to emotions, rather than as a query for facts. The referenced article is an argumentative editorial. That means it is written with the intent to raise some eyebrows. It is nevertheless, someone's opinion based on some chosen observations. There is always two sides to a story. Quite likely is the fact that these agencies overall serve the public good and any relationship or "conflicts of interest" members have in no way is related to a controversy between autism and vaccines.

4. Why hasn't the FDA conducted any independent, long-term safety studies on vaccines? If as in number 3 they can't do this then what public agency can do it?

dras reply----Again refer to the NIH site linked above, also the following are helpful: http://www.nichd.nih.gov/autism, http://medlineplus.nlm.nih.gov/medlineplus/autism.html.

5. Why hasn't the NIH conducted any immunology studies regarding autism since it is well known that autism involves an autoimmune component.

dras reply----Even though I doubt the "well known" statement in the question has always been widely accepted, it looks like they are looking into this: http://www.nlm.nih.gov/medlineplus/news/fullstory_20959.html There is other research going on (Vijendra K. Singh, Phd is a leading researcher) but conclusions are still very preliminary.

6. Why are all studies done by the IOM, CDC and NIH denying links between vaccines and autism just epidemiology studies and none of the studies involve clinical science such as immune blood panel tests, colon biopsies, etc.

dras reply----I do not know that these studies are "denying" links between vaccines and autism. This is another question phrased to raise emotions rather than facts. Resources for research are limited and devising a clinical research study becomes a very formal as well as scientific process. An oversight panel or internal review board (IRB) will review proposed clinical trials. Among many things required for qualification is that the objectives must be based on a valid theory, which in turn is based on already understood scientific concepts, or data from preliminary studies. Where this question infers a conspiracy, it is more likely due to science's natural hesitancy to jump to conclusions or to gauge the cart before seeing the horse.

7. Why is mercury in fish and broken therometers dangerous while mercury in vaccines is not according to the IOM and CDC.

dras reply---The same way that the carbon dioxide we breath is not dangerous, but inhaling it for several minutes through a tank and mask is likely fatal. Even the most natural substances in our bodies have a toxic threshold, where too much is dangerous. And the most biologically toxic substance may not be harmful in the smallest of doses.

8. Why isn't there more questions about what is put in vaccines when the product package inserts says it all as per........ http://www.whale.to/vaccines/ingredients1.html

dras reply---Why stop at vaccines, what about ingredients on the labels of anti-biotics, IV saline solutions, sterile surgical instruments, etc? Why stop there, what about the ingredients labels on Pepsi, or baby teething toys? Point being is that there is likely no conspiracy over the industry standard for labeling protocols.

9. Why the denial of a vaccine link to autism when clearly there has been no clinical science to disprove the link. There has been no clinical science to explain why children with autism have elevated measles antibodies in their blood, measles in the gut and measles in the spinal fluid.

dras reply---The answer to #6 above applies here as well. To expand further, there has likely not been enough scientific evidence to infer that there is a link to carry out more specific clinical studies on this issue up until now. Despite this question's blunt attempt to make a supposed obvious correlation, science cannot accept speculative correlations without clear clinical study observations and comparisons.

10. Why does the FDA keep a file called VAERS (Vaccine Adverse Event Reaction System) that documents adverse reactions to vaccines and nothing is done with it.

dras reply----That "nothing is done with it" is subjective reasoning. See http://www.fda.gov/cber/vaers/vaers.htm to understand what is done with the reports. This, again, is not a fact-finding question. It is leading to an invalidated implication of conspiracy.

10. Shouldn't the NIH and CDC be interested in looking into stopping the epidemic of autism and see if they can develop immunology treatment strategies to help those children and their families who are victims.

dras reply---Science can question whether there is an "epidemic of autism." The one study from California is often cited; however, there are inherent difficulties to epidemiological studies. Shortcomings of the CA study are noted here: http://www.autism-biomed.org/fombonne.htm Nevertheless, the public fervor generated seems to be mustering enough political clout to put this issue on a short list for increased tax funding. Sometimes I wonder which other needed and worthy, and maybe more valid and utilitarian (more good for more people) issues will get the short-end because of it.

12. Why do the NIH, CDC, IOM and FDA get money if they aren't concerned about the autism epidemic and they want to continue to look the other way. Why are they funded by the general public and not the pharmaceutical companies who they represent more effectively. What benefit do these agencies give the American public.

dras reply---It is implied that these last questions are rhetorical, and need no answer, so I will not attempt. They are the attempt to bring-home the implication that it is all a big conspricacy. I will conclude that few other biomedical advancements other than vaccines (even those with thimerasol) have contributed more to the health and longevity of the human race. Also, that no one person or entity is infallible, and few things are perfect. The current emotional passions rampant on the autism/vaccine issue does little to advance, and serves more to hinder the progress of scientific knowledge and understanding. No amount of clinical observation and conclusion will change the minds of true-believers; the conspiracy just gets darker and deeper for them. Unfortunately as well, there are those that create and use the emotional energy to their own benefit and profit, all the while creating and accusing antagonists as conspirators and gluttons.
signed, dras (seeker of knowledge, with no personal or vested interest in the autism/vaccine issue)

Stem cell research

I think issues of embryonic stem cell research is health fraud related because there appears to be a tendancy to let emotionally charged buzzwords and predetermined opinions of issues related to the matter cloud judgement and understanding, before really looking at the science and it's potential for impact on real life. More effort is made over arguing or placating issues of "life" and "murder" than educating about what the next steps of the research will really be.

It is nice to be reminded that embryos are not the only source for stem cells. However, it appears scientifically that the future and potential of embryonic stem cell research far exceeds that of any other source.

The political forum of embryonic stem cell research I think is best presented here: http://www.bioethics.gov/topics/stemcells_index.html

I have a separate paper that presents the science behind ES cell research, the "religious right" argument for banning it, the argument for supporting it (why the Governator supports it), and President Bush's compromise. Following the completion of that paper I wrote the observation pasted below about the ethics and morals of ES research, that I feel is tragically missed in the debates.

Alternately, the ethical/moral issue can be pushed completely aside for the issue of Federal tax dollars used in the research. Seems many loose sight that it's not a stem cell research ban, it's a tax funding for research ban. The cost is HUGE, and comes without any foreseeable real and practicle return on investment. Thus, only entities like the US government can afford to accept the risk.

We need to look at all of the science, the particulars over any proposed immediate and long-term research. We need to understand exactly what will be being done in the research, and for what purpose. Then make the qualified decisions.

Important info on Health Savings Accounts

Health Savings Accounts or HSA's are the result of last year's Medicare Reform legislation. They are a "consumer-driven" health plan option that combines a tax-exempt account for medical expenses with a high-deductible health benefits plan. Both the employer and employee can contribute to the account and unused balances rollover into the next year and earn tax-free interest. The employee maintains the account if employment is terminated. The idea is that the consumer chooses when and how the money in the account is used, making him/her more accountable for health care spending.

The HSA must be administered by a qualified financial institution such as a bank or insurance company and despite other Federal Treasury rules and applicable State laws, there has already been reports of financial misconduct/fraud associated with these accounts by a sponsoring institution or the account owner.

The biggest appeal for HSA's is in the healthy upper middle class, and healthy self-employed. They appreciate the tax break, and can afford to contribute into one. For the most part, there are few limitations on how the money can be used. Money in these accounts are supposed to be part of the US health dollar, but there's plenty of risk that the account would be used primarily for tax-sheltering expenses that are not traditionally part of the US health care dollar.

Our system of health care is essentially a rob from the rich, give to the poor system. Premiums and payments from those who seldom use the benefits or the system are used to subsidize those who use in excess of their contribution. An HSA option allows for a benefit model that weeds out the high-end users and the poor from participation. Here, HSA's become a matter for health policy philosophy and politics. It's said that it is fair that those who use less, pay less; and it's fair that the individual decides how to use several hundred, or several thousand of the money contributed specifically for his/her own healthcare. But, what about the person who hasn't the money to contribute in the first place, or whose chronic condition costs in excess of their ability to contribute? These people end up in a non-HSA benefits model that is now bereft of rich, healthy contributors who seldom used the benefits. The per person healthcare expense of this left-over group of cost sharers goes up. Who's going to subsidize now?

Speculatively, HSA systems will alter the demand in the healthcare market. They create tons of potentially extra cash for elective health care services, including your favorite sCAMs. Some percentage of these tons of cash has been directly taken away from programs that are more about providing only necessary services keen to the collective good. Where will this loss be made up?

DHEA may prevent that age related spare tire around the middle

Comment: This JAMA published study went over only 6 months, and only used a little over 100 participants. Serum Levels of DHEA in the active group was raised to that of a normal young person by the end of the study. Remember, DHEA is hormone, and we know there are consequences for taking hormones for replacement or otherwise. DHEA is known to raise testosterone in females, and insulin like growth factor (IGF 1) in everyone. Since we don't know what consequences DHEA can present over longer term, JAMA publishes this under the heading "preliminary communication."

dras

http://jama.ama-assn.org/cgi/content/abstract/292/18/2243
Results Of the 56 men and women enrolled, 52 underwent follow-up evaluations. Compliance with the intervention was 97% in the DHEA group and 95% in the placebo group. Based on intention-to-treat analyses, DHEA therapy compared with placebo induced significant decreases in visceral fat area (–13 cm2 vs +3 cm2, respectively; P = .001) and subcutaneous fat (–13 cm2 vs +2 cm2, P = .003). The insulin area under the curve (AUC) during the OGTT was significantly reduced after 6 months of DHEA therapy compared with placebo (–1119 µU/mL per 2 hours vs +818 µU/mL per 2 hours, P = .007). Despite the lower insulin levels, the glucose AUC was unchanged, resulting in a significant increase in an insulin sensitivity index in response to DHEA compared with placebo (+1.4 vs –0.7, P = .005).
Conclusion DHEA replacement could play a role in prevention and treatment of the metabolic syndrome associated with abdominal obesity.

Eureka! I know how to fix the DSHEA supplement law

FOR IMMEDIATE RELEASE Media Inquiries: 301-827-6242P04-101 Consumer Inquiries: 888-INFO-FDA
November 4, 2004
FDA ANNOUNCES MAJOR INITIATVES FOR DIETARY SUPPLEMENTS
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The FDA appears to be trying to make some sense and rationality of DSHEA. Admirable. I make some points below as to why FDA will still not be able to do all that is right by it. The FDA should do what it can to get the DSHEA law changed, perhaps they are or intend to.

FDA classifications/definitions of a "food," "food additive," and "drug" are not based on what the product is, but for what use it is intended. They are labeled for how or why they are used. This is not the case for the DSHEA derived classification of "dietary supplement," which is based a definition of what they are. Thus, DSHEA can allow a food, a food additive, or a drug (by definition) to be reclassified and sold as a nutritional supplement that is not subject to regulations of these other classifications.

An obvious fix is to further define "dietary supplement" by how and why it is intended to be used. How about something like: "intended to supplement, improve or increase the healthiness or nutritional aspects of one's diet."

Right away this excludes all the DSHEA protected "natural" male enhancement, "energy," hair growth, hormone and weight loss products, just to mention a few. It leaves alone the products for which DSHEA was advocated, namely, vitamins, minerals, amino acids, and basically those things for which the USDA has RDA's. In the least, these products can be labeled "When taken as labeled, (product) can promote good nutrition for better health throughout life."

What's to be done with all the "natural" health remedies included in DSHEA but are excluded from my proposed definition? Make a new classification like "traditional health remedy" with label and advertising requirements that clearly state that these products "may contain active ingredients with drug-like properties for which safety and efficacy have not been established for any health condition. Taking traditional health remedies may be dangerous, especially to those with chronic health conditions (blah, blah.) Tell your doctor about any health remedies you choose to use." Also, make manufactures and marketers set up an adverse event reporting system and bank for research into these products, etc, etc.



Per the press release:

"...FDA will also implement a transparent, systematic, and predictable process to evaluate safety concerns about dietary ingredients and dietary supplements. The process begins with a "signal detection" (identifying an issue of concern). Signals of a possible safety concern can come from Federal, state and local counterparts; adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts. ..."

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Why put this burden on government and consumer groups? Why aren't marketers and manufacturers obligated to solicit, record, or report adverse events possibly associated with their products.
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"...FDA has a variety of options for pursuing its public health mission, including making a determination of unreasonable risk, issuing public health advisories, educating consumers, conducting research, and requiring labeling changes...."

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Besides being coerced into making a labeling change, where is the manufacturer or marketer's obligation or responsibility in assessing risk, educating consumers, or conducting research?

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One big problem with DSHEA is that is classifies a product centered around what it is. Conversely, The Act classifies a food, food additive, or a drug by why it is used. "Used to supplement the diet" does not infer WHY a supplement would be used. If it is not used to influence a structure/function of the body like a drug, is not a food source like food, and is not added to foods like a food additive, what is it for? Now we have artificial sweeteners (an additive by obvious definition) marketed as a dietary supplement (as long as it's not packaged with food.) We have myriads of products chemically similar to classified drugs marketed as dietary supplements (as long as they don't make a real health claim.) We have a hole Health vocabulary of complete ambiguity uniquely structured to avoid health claims about structure/function.

Another DSHEA shortcoming is that it essentially allows manufacturers to package up about any item and sell it without much obligation to identify or accept liability for it's safety, or to discover any real impact to human physiology.

Lastly, a big DSHEA misstep is that it requires nowhere near the manufacturing or quality control standards that food additives or drugs are subject to. They are less than foods in most cases. Contents are not even guarenteed.

Goals of a new DSHEA. 1. Protect the public against dangerous health effects of unlabeled products that physiologically influence a body function or structure. 2. Prevent the health fraud of snake-oil marketing tactics. 3. Prevent repercussions of a mass placebo/nocebo effect that could happen should many current supplements be removed from the market.

Things a new DSHEA should do. 1. Disqualify manufactured products that concentrate or compound natural ingredients (usually to enhance a pharmacological effect) beyond what would be commonly available or usable in the natural form. 2. Labeling centered around health warnings of the fact that the natural product is a traditional health remedy for which safety and efficacy have not been established. 3. Require manufacturer's/marketers to maintain an adverse event reporting system for compounded, proprietary, or unique products similar to that used for drugs. (FDA could set up a system for "generics".)

Things a new DSHEA should not do. 1. Cause rampant disqualification of current supplements from the market. 2. Allow packaged powders, pills, elixirs, etc. to bypass quality of manufacturing or production and/or ingredient (chemical makeup) and labeling standards similarly in place for processed foods. 3. Bunch a 350mg vitamin C tablet in the same regulatory class with the latest proprietary blend "all-natural" ingredients marketed to "restore vigor, enhance the body's natural ability, etc."