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Independent Perspectives

Last update: 07/25/2013

Perspectives
Vitamin D report | H1N1 vaccination - Controversies and Myths | Slamming the Umpire

See also Advocacy Perspectives

 

The Need to Standardize Reporting of Clinical Trial Outcomes  - DRAFT

Vitamin D Deficiency Associated with Inferior Outcomes in DLBCL  http://bit.ly/vit-D-survival

Conclusions from abstract:  

1) Approximately 50% of all DLBCL patients in this northern US latitude population are vitamin D deficient at the time of diagnosis and treatment.

=> That part is not surprising since vitamin D deficiency is equally common in the general population as described here: 

"Vitamin D inadequacy has been reported in approximately 36% of otherwise healthy young adults and up to 57% of general medicine inpatients in the United States and in even higher percentages in Europe. Recent epidemiological data document the high prevalence of vitamin D inadequacy among elderly patients and especially among patients with osteoporosis. "

Source: http://www.ncbi.nlm.nih.gov/pubmed/16529140

2) Vitamin D deficient patients [in these samples] have an inferior event-free and overall survival compared to patients with vitamin D levels within the normal range.

=> This part is intriguing and begs the questions: 

A) is this in part coincidental, or 

B) does higher-risk DLBCL decrease serum levels of vitamin D - making it a useful marker to identify high-risk DLBCL? (i.e., is it influenced by a genetic factor in these patients) ... or 

C) does having a deficiency in Vitamin D contribute to resistance to treatment, which might be remedied in part with supplementation?  -- The latter possibility has to be asked cautiously in a clinical trial -- with careful monitoring to avoid the known risks of vitamin D supplementation in lymphoma survivors.

Expect the Vitamin industry to exploit this report to promote the sale of vitamin D to lymphoma patients, despite the known risks of Vitamin D supplementation in this population ... and the lack of data showing that supplementation could improve the outcome.

KarlS


H1N1 vaccination – Controversies and Myths 10/09

Click here to provide comment by e-mail.

At issue is the safety of H1N1 vaccine (injection of dead virus antigens) to prime our immune systems against a virulent live virus. 

Instead of applauding the response time in testing and developing a vaccine to protect us from a virus that can kill, we have wide-spread mistrust about the safety of the remedy, even though the process for creating the H1N1 vaccine is reported by experts to be the same as for other flu vaccines. 

What inflames the issue is that our assumed "right" to make  independent decisions can put others (our children) at greater risk ... that is, the ability to control an infectious disease  - preventing its rapid spread - requires that we work as a community and are vaccinated.   

The uncertainty or controversy seems to be really about lack of trust in our public agencies, in this case the CDC (Center for Disease Control) and the FDA ... Which I think speaks to our failure to effectively communicate how they operate;  but also a lack of commitment to address misinformation and myth, which then percolates on the airways and Internet ... becoming the "truth" in large segments of the public. 

... For example, the false belief (the toxic idea) that childhood immunizations cause autism.  Although scientists have not identified any evidence to support this  belief, the myth lives on: 

“Despite compelling scientific evidence against a causal association, many parents and parent advocacy groups continue to suspect that vaccines, particularly measles-mumps-rubella (MMR) vaccine and thimerosal-containing vaccines (TCVs), can cause autism.” 1

So it comes back to a familiar topic of discussion for cancer survivors ... that an association (an observation that an action occurred before an event) is not evidence of causation (that the action caused the event), and that knowing the difference can be a vital public health matter.

"There are about 2,400 miscarriages a day in the U.S.," said Dr. Jay C. Butler, chief of the swine flu vaccine task force at the federal Centers for Disease Control and Prevention. "You’ll see things that would have happened anyway. But the vaccine doesn’t cause miscarriages. It also doesn’t cause auto accidents, but they happen."  3

I don’t think the lay public is aware that the CDC and FDA operate with evidence-based standards.  That's not to say these government agencies are immune from error, but it’s important to recognize that the decisions made here (as directed by Congressional legislation) are science- and peer-based, not based on individual opinion, or by partisan or profit motives. 

-- However being government agencies it appears that they are associated in the public mind with how other political decisions are made -- with too many instances of policy corrupted by special interests.

 KarlS 

References and additional information: 

  1. Vaccines and autism: evidence does not support a causal association
    http://www.ncbi.nlm.nih.gov/pubmed/17928818 
  1. Misconceptions about Vaccines http://www.quackwatch.com/03HealthPromotion/immu/autism.html 
  1. CDC Ready to Battle H1N1 Vaccine Ignorance
    http://www.rbguy.dailykos.com/storyonly/2009/9/29/787579/-CDC-Ready-to-Battle-H1N1-Vaccine-Ignorance 
  1. HIN1: Doctor chides doctors "don't silently do things your own way" http://bit.ly/10jp3W 

Reply to inquiry:  What about Guillain-Barre syndrome, associated with the 1976 swine flu? 

I'm not aware of any risk that's specific to "swine" flu vaccines - compared to previous more common seasonal varieties.

Copying: 

"Guillain-Barré syndrome in the adult population was just less than one case per 100 000 vaccinations, and the period of increased risk in swine-flu vaccinated versus non-vaccinated individuals was concentrated primarily within the 5 weeks after vaccination (relative risk 7•60).48 

... With subsequent influenza vaccines, no significant increase in the development of Guillain-Barré syndrome was noted,49 

... and the risk of developing the Guillain-Barré syndrome after vaccination (one additional case per 1 million people vaccinated) is now judged substantially lower than the risk for severe influenza and influenza related complications.50" 

 http://www.hcvets.com/data/hcv_liver/vaccination&autoimmune.htm 

sources:

48 Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, et al. Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976–1977. Am J Epidemiol 1979; 110: 105–23. 

49 Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barre syndrome and the 1992-1993 and 1993-1994 influenza vaccines. 

N Engl J Med 1998; 339: 1797–802. 50 Chen RT, Pless R, Destefano F. Epidemiology of autoimmune reactions induced by vaccination. J Autoimmun 2001; 16: 309–18.

 


Slamming the Umpire - comment on advocacy that demonizes the FDA (Sept 18, 2009)

Re: NY Times article: Where Cancer Progress Is Rare, One Man Says No http://bit.ly/4Bppb2  

Click here to provide comment by e-mail.

I think that reviewers at FDA work conscientiously to make the right call ... but that its public image suffers in part because it's not permitted to disclose its reasons for rejecting or accepting a new drug application.

 -- Noting that it was the industry that lobbied for non-disclosure rules ... the rationale being the protection of intellectual property. A questionable concern as evidenced in any Advisory Committee review -- conducted transparently to address the main issues with the submitted study data -- with no apparent harm to the drug sponsors. 

This is NOT to suggest that the agency always gets it right, or that the reviewers are always experienced enough with all aspects of the medical condition (have the context right or the correct interpretation of the data) ... or that informed patient perspectives are not needed to help make these difficult decisions. 

(Typically the assessment is complex. The new drug can harm some patients while benefiting others, or the benefit is modest relative to existing care. Critical to assessment is the net effect, including the clinical significance of the responses, weighed against adverse events and what is already available as therapy.) 

However, mistrust with the review process should be expected when the raw data is not published in the public domain ... leaving the community to see only the biased interpretations of the sponsors, and, yes, sometimes the investigators as well. The agency, as noted above, by law, can say nothing to defend its decision. 

I suspect that a rationale for aggressive patient advocacy against FDA is based on an assumption that what worked for early HIV activists (creating needed regulatory change at that time) is still needed today, or that the AIDS activists formula for success will lead to similar results in any medical conditions?

But diseases (heart disease, AIDS, cancers) can have very different potentials to be effectively treated, dependent on the underlying nature of it, and technologies that can effectively and safely target disease processes. Progress against some diseases will take decades, others years, even if given the same effort - and it may be that some diseases will never be cured. 

(Fortunately experts say, and evidence shows, that the blood cancers are not among these!, but in general it has proven more difficult to safely treat cancers than most viruses.)

Meanwhile the FDA review process is widely accepted as efficient and fair within the industry and among mainstream investigators. And if the agency was not fair, was arbitrary in its decision process, why would any company invest so much to develop and test new drugs for disease? That a good number of new drugs for cancers are approved rapidly by FDA, should be evidence of the agency's intent? 

Clearly, aggressive advocacy is needed, always, to maintain or create a sense of urgency. But it's misplaced if its purpose is to demonize the FDA or individuals that lead it - who are, by the way, also impacted by cancers, sometimes directly. 

(Remembering our beloved colleague, Pattie Delaney http://www.patientadvocate.org/news.php?p=613  ) 

Instead advocates should work to raise awareness that studies testing urgently needed new cancer agents are starving for participants. Many never completing enrollment. Today's count: 1,226 studies actively recruiting patients for the treatment of lymphoma and CLL. 


KarlS

 

 

 
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