Hypothetical "What would you do?"

iVillage Member
Registered: 08-09-2009
Hypothetical "What would you do?"
163
Wed, 09-09-2009 - 5:53pm

This question is for those parents that have chosen not to vaccinate based on information they have read on the interwebz.

What would you do if your child caught and died or was permanently disabled from a disease that they were supposed to be vaccinated against early in life?

Who would you blame? Would you try to sue someone?

I'm not trying to flame anyone for their choices, but I've always wondered this "what if". Just as I'm free to choose to vax my child, everyone else is free to not to.

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iVillage Member
Registered: 07-17-2005
Sat, 10-10-2009 - 12:23pm
I think, just like with you and I, that you two got off to a bad start. You will learn a lot from her if you just let your guard down, she's incredibly knowledgeable and extremely logical in her thoughts.
iVillage Member
Registered: 07-17-2005
Sat, 10-10-2009 - 5:28pm

Randi sent me this about a year ago:

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

FYI

Amid much fanfare, on Sunday, November 9, AstraZeneca announced the results
of its drug trial, Justification for the Use of Statins in Prevention: an
Intervention Trial Evaluating Rosuvastatin (JUPITER). The results were
announced at the American Heart Association conference and simultaneously
published in The New England Journal of Medicine (Nov. 9). The study was
hailed as a watershed event in heart disease prevention: "In this trial of
apparently healthy persons without hyperlipidemia but with elevated
high-sensitivity C-reactive protein levels, rosuvastatin
significantly reduced the incidence of major cardiovascular events."

Current treatment algorithms for the prevention of myocardial infarction,
stroke, and death from cardiovascular causes recommend statin therapy for
patients with established vascular disease, diabetes, and overt
hyperlipidemia. Last year Statins command a $34 billion market share.
http://www.forbes.com/2008/10/29/cholesterol-pharmacuticals-statins-biz-cx_m
h_1030cholesterol.html

Not satisfied with selling pharmaceuticals to the sick, drug manufacturers
seek to expand the market for prescription drugs to healthy people. They
promote drugs as though they were toothpaste-disregarding the drugs'
hazardous effects. Companies do this by persuading an unsuspecting public
about the need to take drugs as a preventive measure against presumed risks
of future illness. And, more importantly, drug companies set out to convince doctors-providing cash incentives-to prescribe drugs for healthy people despite documented--even life-threatening risks.

Doctors have adopted a specious corporate rationale to justify prescribing
drugs for healthy people as "preventive therapy." All-too-often, doctors
accept findings from company-controlled, biased studies, ignoring the
indicators for potential serious hazards posed by drugs. In the case of the
JUPITER study, there was "a higher incidence of physician-reported diabetes" in the group exposed to Crestor.

To their credit, the NEJM, published an editorial by Mark A. Hlatky, M.D.
who took a more critical view of the study design, its reliance on a single
biomarker, CRP, and he raises doubts whether the findings warranted expanded use of statins. Dr. Hlatky points to other flaws in the JUPITER study design: "the study provides only limited and indirect information about the role of high-sensitivity C-reactive protein testing in clinical management, since the trial did not compare subjects with and those without high-sensitivity C-reactive protein measurements, nor did it compare the use of high-sensitivity C-reactive protein with the use of other markers of cardiovascular risk."

"The relative risk reductions achieved with the use of statin therapy in
JUPITER were clearly significant. However, absolute differences in risk are
more clinically important than relative reductions in risk in deciding
whether to recommend drug therapy, since the absolute benefits of treatment
must be large enough to justify the associated risks and costs. The
proportion of participants with hard cardiac events in JUPITER was reduced
from 1.8% (157 of 8901 subjects) in the placebo group to 0.9% (83 of the
8901 subjects) in the rosuvastatin group; thus, 120 participants were
treated for 1.9 years to prevent one event."

"On the other side of the balance, of concern are the significantly higher
glycated hemoglobin levels and incidence of diabetes in the rosuvastatin
group in JUPITER (3.0%, vs. 2.4% in the placebo group; P=0.01). There are
also no data on the long-term safety of lowering LDL cholesterol to the
level of 55 mg per deciliter (1.4 mmol per liter), as was attained with
rosuvastatin in JUPITER, which is lower than in previously reported trials.
Long-term safety is clearly important in considering committing low-risk
subjects without clinical disease to 20 years or more of drug treatment.
Finally, the cost of rosuvastatin (roughly $3.45 per day or $1,250 per year) is much higher than that of generic statins."

The cost-for the drug alone--of treating 120 people for 1.9 years to prevent one serious cardiac event would be $ 285,000.

Dr. Hlatky further notes: "Ridker et al. suggest, from their meta-regression analysis, that the risk reduction observed in JUPITER was greater than that expected on the basis of previous trials. Meta-regression is not a reliable technique, however, and the early termination of JUPITER owing to the efficacy data probably exaggerated the results to some degree."

Which brings us to the issue of conflicts of interest:

AstraZeneca funded the JUPITER study in order to justify prescribing its
cholesterol-lowering statin, Crestor for people with normal cholesterol
levels. Needless to say, a favorable result would exponentially increase
the sales of the drug. The potential profit is in the trillions of dollars.

The research objective had a built-in bias, and the sponsor and principle
investigator had a strong stake in a desired outcome. Furthermore, in light
of the increased incidence of diabetes among the group prescribed Crestor
(3.0%, vs. 2.4% in the placebo group), the trial's early suspension raises
red flags about the extent of that (and other risks) that are known to occur mostly after extended exposure.

Not disclosed in the NEJM, is the discovery by Merrill Goozner: "the first
thing you need to know about this trial is that its lead investigator, Paul
Ridker of Brigham and Women's Hospital in Boston, owns a patent on the $20
test that measures CRP." http://www.gooznews.com (posted below)

The JUPITER trial screened nearly 90,000 people to find the 17,800 with
elevated CRP measures who were eligible for the trial. If 10 million people are tested to find the estimated two million with elevated CRP levels, "it's $200 million in test sales, which, if the royalty is only 1 percent, amounts to a hefty $2 million a year in extra income for Dr. Ridker." If AstraZeneca can get two million more "apparently healthy men and women" on rosuvastatin, it's an additional $2 billion-plus in sales."

In light of AstraZeneca's record of corrupt practices, the following
authors' statement should taken with a high degree of skepticism.
"The trial was financially supported by AstraZeneca. The sponsor collected
the trial data and monitored the study sites but played no role in the
conduct of the analyses or drafting of the manuscript and had no access to
the unblinded trial data until after the manuscript was submitted for
publication."

American medicine has been derailed from its therapeutic focus and ethical
principle, "first, do no harm," into a commercially driven enterprise since
it aligned itself with the pharmaceutical industry. Industry's
unconscionable marketing strategy-promotes the use of drugs for healthy
people-is accomplished with assistance from professional medical societies
and influential physicians at prestigious academic centers.

Doctors at the American Heart Association, lent legitimacy to prescribing
statins for long-term use in healthy people, simply on the basis of a
screening test that showed they had elevated levels of CRP, a biomarker for
inflammation. They predicted that the JUPITER study might lead as many as 7 million more Americans to consider taking cholesterol-lowering statin drugs, such as: Crestor, Lipitor, Zocor,

Similarly, the prescribing practices of US psychiatrists are driven by
industry's marketing agenda with no scientific-medical evidence to support
the widespread prescribing of psychotropic drugs. Dubious screening
tests-such as DISC, TeenScreen, KiddieSADS, TRAYY-provide the basis for
"diagnosing" mental disorders in millions of otherwise healthy American
children who are then exposed to harmful toxic drugs that interfere with
normal physiological and neurological development. Even as these drugs'
labels now carry black box warnings, the most severe drug warnings mandated
by the FDA-including the increased risk of suicide-prominent psychiatrists
promote the use of these drugs in children. Financially compromised
psychiatrists regularly pen their name (for hefty fees) to
industry-generated clinical trial reports and clinical practice guidelines
whose prescription drug recommendations have propelled the most toxic
psychotropic drugs into blockbuster sellers.

*AstraZeneca in the news:

Nov. 6, 2008: Astra Zeneca Reps Told To Use Disney Characters In Seroquel
Marketing How is this for creative selling? .the idea was conveyed at a national sales meeting and on field rides with sales reps, who were told to use Tigger as a bipolar patient and Eeyore - the down-in-the-mouth donkey - as a depressed patient. The reps were allegedly encouraged to use Tigger dolls as giveaways." See:

http://www.pharmalot.com/2008/11/tiggergate-using-disney-icons-to-sell-seroquel/

June 19, 2008: Judge Price of the Montgomery County Circuit Court upheld the fraud verdict obtained by the State against AstraZeneca in the Medicaid drug pricing suit. Judge Price upheld the compensatory damage award of $40 million and, pursuant to the statutory cap on punitive damages, cut the punitive damages from $175 million to $120 million, making the total verdict $160 million. AstraZeneca has stated they will appeal, so the Alabama Supreme Court will be looking at it. For more information, follow the link
http://www.forbes.com/feeds/ap/2008/06/19/ap5134622.html

May 6, 2008: AstraZeneca released limited performance data for a trial using its antipsychotic, Seroquel for depression. The company released the data during a poster session at the American Psychiatric Association's
convention. The data has not been published yet in a peer-reviewed journal,
so no information on drop out rates or whatever statistical methodology may
have been used. The expanded use of antipsychotics for depression would
represent a "huge tectonic shift" in treating depression-and a huge influx
of profits. AZ hadn't released any efficacy data for Seroquel XR's
performance versus placebo in treating depression (or Major Depressive
Disorder, as AZ has it). See: Furious Seasons

http://www.furiousseasons.com/archives/2008/05/astrazeneca_releases_limited_seroquel_data_for_depression.html

April 6, 2007: AstraZeneca, 'Bucket of Money'
Group of 7 Whistleblowers Allege Off-Label Campaign for cancer drug,
Faslodex, "There is a big bucket of money sitting in every office. Every
time you go in, you reach your hand in the bucket and grab a handful. The
more times you are in, the more money goes in your pocket. Every time you
make a call, you are looking to make more money." See:
http://www.brandweeknrx.com/2007/04/az_bucket_of_mo_1.html and
http://tinyurl.com/5sjuq7

June 21, 2003: AstraZeneca, the large pharmaceutical company, pleaded guilty today to a felony charge of health care fraud and agreed to pay $355 million to settle criminal and civil accusations that it engaged in a nationwide scheme to illegally market a prostate cancer drug. The government said the company's employees had given illegal financial inducements to as many as 400 doctors across the country to persuade them to prescribe the drug, Zoladex. Those inducements included thousands of free samples of Zoladex, worth hundreds of dollars each, which the physicians then billed to Medicare and other federal health care programs, prosecutors said. The company also gave doctors financial grants, paid them as consultants and provided free travel and entertainment, the government said. See: AstraZeneca Pleads Guilty In Cancer Medicine Scheme By MELODY PETERSEN,
The New York Times
http://query.nytimes.com/gst/fullpage.html?res=9C07E7D8163BF932A15755C0A9659
C8B63

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

http://www.gooznews.com
November 09, 2008
CRP -- The Next Chapter in Medical Waste?

The latest study on statins and heart disease, which appeared in the New
England Journal of Medicine website yesterday and in all the major papers
this morning, is worth a second look, not because of what it says about
heart disease, which is mildly interesting at best, but because of what it
reveals about profit-driven medical research and how it contributes to
making the U.S. health care system the most bloated and wasteful in the
world.

The randomized clinical trial, code-named Jupiter, involved giving a statin
drug or placebo to 17,802 "apparently healthy men and women" (their words)
with normal cholesterol but elevated levels of a biomarker for inflammation
called C-Reactive Protein (CRP). Did it reduce CRP levels, and did that
reduce heart attacks, strokes and, most importantly, sudden death from
cardiovascular disease?

The answer to both those questions is yes. But before we go to the data, the first thing you need to know about this trial is that its lead investigator, Paul Ridker of Brigham and Women's Hospital in Boston, owns a patent on the $20 test that measures CRP, and the trial was funded by AstraZeneca, whose $3.45-per-day or $1,250-per-year statin (rosuvastatin or Crestor), was used in the trial. If they can get two million more "apparently healthy men and women" on rosuvastatin, it's an additional $2 billion-plus in sales for AstraZeneca. If they can test 10 million people to find the estimated two million with elevated CRP levels (they had to screen nearly 90,000 people to find the 17,800 eligible for the trial), it's $200 million in test sales, which, if the royalty is only 1 percent, amounts to a hefty $2 million a year in extra income for Dr. Ridker.

I don't mention these conflicts of interest to cast doubt on the validity of the data presented in the NEJM paper. Rather, it puts me, as it should all analyzers of this trial, on guard to see if there were any flaws in its
construction, biases in its analysis, or slants in its presentation. The
answer to all three of those questions is yes.

First let's take a look at these "apparently" healthy people (men over 50
and women over 60). The median body mass index for the group was 28.3, which means more than half were significantly overweight. Indeed, a third were categorized as obese, which isn't surprising since 41 percent had metabolic syndrome, a suite of conditions that suggests the person is well down the road to developing Type II diabetes.

This profile raises some disturbing questions about the ethical oversight of this trial. Were these trial participants offered counseling about lifestyle changes necessary to avoid developing diabetes, which is recommended for people with metabolic syndrome? The methods section suggests they were only offered the right to participate in the trial, which involved taking a drug that might prevent a heart attack because they had heightened levels of CRP.

The data monitoring committee overseeing the trial stepped in to halt it
once it became apparent there would be a statistically significant reduction in cardiovascular events. Where were they when the protocols were being written? Why didn't they step in at the beginning to insist that the at-risk portion of this patient population be offered the best available treatment (diet and exercise counseling) for their condition (metabolic syndrome)?

This oversight becomes even more glaring when we look at one of the more
disturbing findings of the trial, noted in an accompanying editorial but
"not adjudicated" by the study's endpoint committee. The group on
rosuvastatin developed diabetes at a higher rate than the group given a
placebo, 3.0 percent versus 2.4 percent, an increase of six-tenths of a
percentage point.

Keep the size of that percentage in mind as I now turn to the actual
benefits of giving the statin for elevated CRP. While the overall rate of
cardiovascular incidents fell from 2.8 percent to 1.6 percent by giving the
statin, the number of so-called hard events -- heart attacks and strokes,
including those that were fatal -- fell from 1.7 percent in the placebo
group to 0.9 percent in the statin group, a drop of eight-tenths of a
percentage point. In other words, for every person who didn't get a serious cardiovascular event, three-quarters of a person got diabetes.
We can look at the benefits another way -- in terms of the number of people
who need to be treated to avoid a serious event. In this trial, 120 patients had to be treated for 1.9 years to prevent one serious cardiac event. Remember what rosuvastatin costs? $1,250 a year. That's $285,000 per event prevented just for the statin pills. The physician visits, CRP tests and lab work add additional thousands more. Can you imagine how many heart attacks and strokes could be prevented if that money were targeted at people who are truly at risk of heart disease (the obese, smokers, hypertensives, diabetics) to help them modify their lifestyles and get treatment for their underlying conditions?

There's one other curious element in the trial data. In table 4, Ridker and
his fellow authors report that the number of "serious adverse events" in
both arms of the trial was almost exactly equal: 15.2 percent in the statin
arm versus 15.5 percent in the placebo arm. Presumably, all cardiovascular
events (2.8 percent and 1.6 percent, respectively) were included in this
total.

On the one hand, I'm not surprised that one in seven trial participants
suffered a serious health event during the two years of this trial. The
median age of this predominantly overweight group was 66, with some as old
as 90. But what were those other serious events? Alas, the study is silent on this point. I, for one, would like to have seen that data published since the raw number suggests that at the end of the day, both of these groups fared almost exactly the same. In other words, giving a statin to people with elevated CRP did nothing to improve this population's overall health.

So there you have it. A possibly unethical trial with marginal results gets
trumpeted in the media as showing "wide benefit" (New York Times). Based on
the laudatory quotes coming from the leaders of the American College of
Cardiology, this off-label use of statins will quickly find its way into
clinical practice guidelines and drug compendia. Within a few years, health
care payers will be forking over billions more dollars to the statin drug
makers in the name of preventing heart disease. Meanwhile, our health care outcomes -- including cardiovascular disease -- will still rank somewhere between Romania and Poland. Health care costs will still be rising at twice the rate of overall inflation. And those truly at risk of heart disease still won't be getting the counseling that might save their lives.

iVillage Member
Registered: 10-18-2007
Sat, 10-10-2009 - 6:20pm

>>>the body is meant to self regulate, but there are times when it can't.<<<

I dislike this kind of vague statement. What times are you referring to?

>>>You answered your own question so why should I answer what you already know?<<<

I didn't have any questions... these are the last ones you had, since you seem to have forgotten that you asked any at all.

>>>And you know this how? What would you consider to be a dangerous level? My cousin reached 106 and I assume you think that's fine and dandy?<<<

You seem to be skating over the point of this discussion, and that is that the brain of a normally functioning person will not allow this "level" to be met... and are still insinuating that there "are times when the body can't self regulate" without giving any specifics. I'm asking you, politely, to be specific.

>>>I attempted to be polite and you took it as passive aggressive words and in replying to me, you were the first to bring any sarcastic comments....I called you a good mom. <<<

If you say so, but you might benefit from re-reading our entire exchange. I don't consider some of your questions or some of your comments polite, and this is fine. But what's good for the goose....

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