> And that includes adults. How many children were there? Mumps is much more
> likely to cause complications in adults than in children, so my guess is
> zero. If there is other data I would like to see it.
>>>>> Hi, this has been on my mind for sometime now, and I wanted to ask you
>>>>> all a few questions. I have read an article at 'Mumps Prevention'
[quoted text clipped - 61 lines]
> appreciate your learned qualifications:
> http://www.cdc.gov/nip/acip/
http://groups.google.com/group/misc.health.alternative/msg/80c8ab13dcf62782?dmod
e=print
Tsu Dho Nimh <abac...@hotmail.com>
jdrew63...@aol.com (Jan) wrote:
>1. That members, including the Chair, of the FDA and CDC advisory
>committees who make these decisions own stock in drug companies that make
>vaccines.> (could this possible have a bearing on HOW they vote,,,,,TDN??)
FYI - people tend to invest in industries they know about. It's
not surprising that medical people invest in medical stocks
rather than Schlumberger or AOL-Time Warner.
The fastest way to send the stock of a company into the toilet is
to release a product that doesn't work, or a product that is
dangerous when used as prescribed. I'm sure any major
shareholder (and you have no evidence that anyone owns a
significant amount of stock) knows this.
It's common in the semiconductor industry for engineers to own
stock in their companies, and it's also common for those
engineers to be on standards boards making decisions about
standards that affect the entire industry, including consumers
and the competition. Is this wrong too?
>3. That three out of five of the members of the FDA's advisory committee
>who voted for the rotavirus vaccine had conflicts of interest that were
>waived.
>( Is this honest, TDN??)
Yes, it's honest. They informed the comittee of the potential
conflict of interest before voting. Dishonest would have been
concealing their interest in the product before voting on its
fate.
How about those members that own stock in the *competitors* of
the product under discussion (in this instance, the makers of IV
fluids used to treat rotavirus dehydration, or stock in the
hospitals the infants are treated in)? Should they recuse
themselves because they stand to profit from suppressing a
product? Conflict of interest works both ways.
>4. That seven individuals of the 15 member FDA advisory committee were not
>present at the meeting, two others were excluded from the vote, and the
>remaining five were joined by five temporary voting members who all voted
>to license the product. ( do you wonder why, TDN??)
Geee ... board members missing a meeting. How suspicious.
Because the evidence it worked was pretty compelling. And the
evidence it works is still compelling. Compelling enough that
India is beginning production soon because they lose thousands of
infants each year to rotavirus.
>5. That the CDC grants conflict-of-interest waivers to every member of
>their advisory committee a year at a time, and allows full participation in
>the discussions leading up to a vote by every member, whether they have a
>financial stake in the decision or not. (Same questions, TDN)
Has any member of the comittee ever CONCEALED their affiliation
or stock holdings?
How about those members that own stock in the competitors of
the product under discussion? Should they recuse themselves
because they stand to profit from suppressing a product?
Who would be left to vote?
>6. (snip) no parents have a vote in whether or not a vaccine belongs on the
>childhood immunization schedule.
Are you sure that EVERY member of the CDC advisory comittee is
childless? Last I looked, celibacy was not a prerequisite.
> The FDA's committee only has one public member. (Should parents be a part
> of this commitee, TDN??)
Parents are a part of the committee ... and part of the
research teams too. Just not "parents" as you define them.
When I worked in hospitals that did field trials for various
pharmaceutical and medical device manufacturers, one of the
questions we were asked was:
"If your ____ was in hospital, and you knew this ____ was going
to be used during their care, how would you feel about it?"
>These are just a few of the problems we found. Specific examples of this
>include:
>Dr. John Modlin-He served for four years on the CDC advisory committee and
>became the Chair in February 1998. He participated in the FDA's committee
>as well owned stock in Merck, one of the largest manufacturers of vaccines,
>valued at $26,000.
That's 500 or so shares, worth $26,000 in a company that has
$120 BILLION in outstanding shares and trades 5-7 million shares
a day. I bet he owns/ed similar amounts of the competitors of
Merck as well.
>He also serves on Merck's Immunization Advisory Board. Dr. Modlin was the
>Chairman of the Rotavirus working group. He voted yes on eight different
[quoted text clipped - 3 lines]
>divest himself of his vaccine manufacturer stock. (WHY do you suppose he
>voted YES to all eight, TDN??)
Because he thought it was a good idea. Preventing 50,000 or
more infants from hospitalizations and a 50-100 deaths each year
does sound like a good idea. I've seen the initial reports: I
would have voted the same way.
> At our April 6 autism hearing, Dr. Paul Offit disclosed that he holds a
> patent on a rotavirus vaccine
I found several ... and he is not in a position to profit
personally from the patents, despite having his name on the
paperwork. It appears that the Children's Hospital and the
Wistar Institute are the actual owners ... a children's charity
hospital and the nation's first independent medical research
facility.
www.chop.edu
www.wistar.upenn.edu/about_wistar/history.html
5,750,109 Assignee: The Wistar Institute of Anatomy & Biology
(Philadelphia, PA); The Children's Hospital of Philadelphia
(Philadelphia, PA)
5,626,851 Assignee: The Wistar Institute of Anatomy and Biology
(Philadelphia, PA); The Children's Hospital of Philadelphia
(Philadelphia, PA)
6,113,910 Assignee: The Wistar Institute of Anatomy and Biology
(Philadelphia, PA); The Children's Hospital of Philadelphia
(Philadelphia, PA)
6,290,968 Assignee: Children's Hospital of Philadelphia
(Philadelphia, PA); Wistar Institute of Anatomy and Biology
(Philadelphia, PA)
>and receives grant money from Merck to develop this vaccine.
Merck is GIVING him grant money to develop the vaccine when the
owners of the vaccine patent are a children's charity hospital
and the nation's first independent medical research facility?
What shocking news!
>He also disclosed that he is paid by the pharmaceutical industry to travel
>around the country and teach doctors that vaccines are safe. Dr. Offit is
>a member of the CDC's advisory committee and voted on three rotavirus
>issues - including making the recommendation of adding the rotavirus
>vaccine to the Vaccines for Children's program. ( piad by pharmaceurical
>industry,, does this tell you anything, TDN??)
I've worked on projects where my salary came from a
pharmaceutical company. No more shocking than Ford paying a
racecar driver to make public appearances, or Revlon paying a
supermodel.
>Dr. Patricia Ferrieri, during her tenure as Chair of the FDA's advisory
>committee, owned stock in Merck valued at $20,000 and was granted a full
>waiver. (WHY was she granted a full waiver, TDN??)
That's about 400 shares ... in a company that has $120 BILLION
in outstanding shares and trades 5-7 million shares a day. Yes,
she's a major stockholder, really major.
And how much stock in Merck's competitors did she own? How
much stock in companies that make IV fluids, for example.
Look at the math: which company makes more money off a child?
the one that sells $5 worth of vaccine or the one that sells
$500+ in IV fluids, plus $$$ in testing reagents for every case
of rotavirus that is admitted. If you want conflict of interest,
look at who holds stock in Pedialyte!
>Dr. Neal Halsey, who serves as a liaison member to the CDC committee on
>behalf of the American Association of Pediatrics, and as a consultant to
[quoted text clipped - 4 lines]
>was found in the transcripts to be offering his personal opinion as well.
>( Any question for this, TDN??)
OK ... Halsey has a personal opinion. We all do. And he's
apparently clearly identifying which hat he's wearing when he
speaks (according to the transcripts).
>Dr. Harry Greenberg, who serves as Chair of the FDA committee, owns
>$120,000 of stock in Aviron, a vaccine manufacturer. He also is a paid
>member of the board of advisors of Chiron, another vaccine manufacturer and
>owns $40,000 of stock. This stock ownership was deemed not to be a conflict
>and a waiver was granted. To the FDA's credit, he was excluded from the
>rotavirus discussion because he holds the patent on the rotashield vaccine.
I checked the USPTO database, and Greengberg does NOT appear as
the owner of a patent on any rotavirus *vaccine*. He DID patent
a couple of methods for selecting rotavirus for vaccine
production, but he is not in a position to profit from them.
Note that the OWNER of both of the patents is YOU! Yes, Jan,
YOU as a citizen of the USA are the part-owner of a patent for a
process used in vaccine production! How does that make you feel
to know you now have a vested interest in vaccines that is as
great as that of the doctors you have been griping about?
4,571,385 Genetic reassortment of rotaviruses for production of
vaccines and vaccine precursors
Assignee: The United States of America as represented by the
Department of Health (Washington, DC)
4,341,870 Cultivatable human rotavirus type 2
Assignee: The United States of America as represented by the
Secretary of the Department of Health (Washington, DC)
>( well, well, why was he excluded, TDN??)
I haven't a clue. Was he "excluded" or did he recuse himself?
>How confident can we be in the process when we learned that most of the
>work of the CDC advisory committee is done in "working groups" that meet
>behind closed doors, out of the public eye?
I personally am quite confident.
Does the public have enough "eyes"? And is the public ready
for the sight of "vigorous participation". Working groups can
get vehement as they discuss issues, and the words "hammered out
a conclusion" are close to literal sometimes.
>Members who can't vote in the full committee because of conflicts of
>interest are allowed to work on the same issues in working groups, and
>there is no public scrutiny.
Peer scrutiny is much more effective. The general public
doesn't know enough about the technology or the issues to know
when someone is blowing smoke and playing to the audience. Take
away the audience and you have to impress your fellow scientists
with hard facts.
>I was appalled to learn that at least six of the ten individuals who
>participated in the working group for the rotavirus vaccine had financial
>ties to pharmaceutical companies developing rotavirus vaccines.
>(see anything appalling there, TDN??)
No. You yourself are one of the owners of patents on rotavirus
vaccine.
>How confident can we be in the recommendations with the Food and Drug
>Administration when the chairman and other individuals on their advisory
>committee own stock in major manufacturers of vaccines?
>( can you answer this, TDN??)
How much stock? And in which companies? And are the companies
competitors?
>How confident can we be in a system when the agency seems to feel that the
>number of experts is so few that everyone has a conflict and thus waivers
>must be granted.
If you got rid of everyone who had ever worked for, recieved
grant money from, or held stock in a pharmaceutical company ...
the talent pool would be damned slim. And there are truly few
American experts in any field.
>It almost appears that there is a "old boys network" of
Note the weasel words: "almost appears"
>Some of these individuals serve for more than four years. We found one
>instance where an individual served for sixteen years continually on the
>CDC committee. With over 700,000 physicians in this country, how can one
>person be so indispensable that they stay on a committee for 11 years?
Maybe of the 700,000 physicians they were among the top dozen
or so with the background to do the job. I'd hate to have the
average family care physician sitting on a board about vaccione
technology or cardiac drugs ... they didn't get enough classes in
that area.
Maybe no one else wanted the job? Committee work takes a lot
of time and effort. How many of the 700,000 physicians can take
hours a day to read through all the reports. Committee members
tend to be high-ranking professors, or senior staff in
institutions and it's part of their job to read this stuff.
>It is important to determine if the Department of Health and Human Services
>has become complacent in their implementation of the legal requirements on
>conflicts of interest and committee management. If the law is too loose,
>we need to change it. If the agencies aren't doing their job, they need to
>be held accountable. That's the purpose of this hearing, to try to
>determine what needs to be done.
>(Is the law to loose, TEN??)
I don't think so. This author is throwing out a lot of
misleading factoids with nothing concrete to back up the
speculations. Has anyone found a smoking gun memo? Is there a
pattern of voting that indicates the various committees are
placing financial rewards above their scientific integrity?
>Can the FDA and the CDC really believe that scientists are more immune to
>self-interest than other people?
There are various kinds of "self-interest", and the reputation
for doing good research counts way more for most scientists than
money. They are driven to succeed, but their idea of success is
not the same as the typical American consumer's idea.
>(please answer this, TDN!)
Can you name scientists that REALLY sold out who were not
scorned by their peers for fudging the research?
>Maintaining the highest level of integrity over the entire spectrum of
>vaccine development and implementation is essential. The Department of
>Health and Human Services has a responsibility to the American public to
>ensure the integrity of this process by working diligently to appoint
>individuals that are totally without financial ties to the vaccine industry
>to serve on these and all vaccine-related panels.
Interesting ... if total lack of financial ties to industry is
important on these comittees, why is it not equally important
that politicians be without financial ties to ALL industries.
After all, they make laws that mandate what industries can and
can't do. What industries contribute to Burton's campaign funds?
>(is intregrity important, TDN??)
Yes, and it's sadly lacking when politicians accept money form
the very industries they write laws about.
>No individual who stands to gain financially from the decisions regarding
>vaccines that may be mandated for use should be participating in the
>discussion or policy making for vaccines.
May I remind you that THE AMERICAN PEOPLE, including you, are
the assigned owners of many patents having to do with vaccines.
They stand to profit form any income from licensing the
technology.
>polluted and the public trust has been violated. I intend to find out if
>the individuals who have made these recommendations that effect every child
>in this country and around the world, stood to gain financially and
>professionally from the decisions of the committees they served on.
Well, he says he intends to find out ... what has he managed to
discover? Where are the smoking guns and the secret bank
accounts?
Tsu Dho Nimh

Signature
If we are what we eat, I'm fast, cheap and easy
>
>>> Also, if a young man got mumps post-puberty there was a chance of
[quoted text clipped - 68 lines]
>>>> http://www.nytimes.com/2007/03/25/opinion/25CIfry-revere.html
>>>> But that is a different topic.
>>>>> Hi, this has been on my mind for sometime now, and I wanted to ask you
>>>>> all a few questions. I have read an article at 'Mumps Prevention'
[quoted text clipped - 40 lines]
> mumps cases). It is usually unilateral. The patient may not, in fact, have
> overt mumps. Deafness may improve with time but is usually permanent."
From the same page: "there were 212,000 reported case in the United
States in 1964". Divide by 20000 and get 10.6 people becoming deaf due
to mumps in a year. I would like to see an explanation how it could be a
leading cause of acquired deafness.
And I bet most of them were adults.
>> And that includes adults. How many children were there? Mumps is much more
>> likely to cause complications in adults than in children, so my guess is
[quoted text clipped - 3 lines]
> university students in the UK (and recently some colleges in the USA). Are
> college and university students adults or children?
Adults, of course. What's the point?
By the way before the vaccination there couldn't outbreaks in colleges.
Everyone was immune due to having had mumps. Now everyone is vaccinated
but not necessarily immune.
From the same page: "Before 1967, most mumps patients were under 10
years of age but since the advent of the attenuated vaccine, the
remaining cases occur in older people with almost half being 15 years of
age or older." That might mean that older people are more likely to
develop mumps then they did before. Maybe not, I did not find hard numbers.
> See http://www.acha.org/mumps_06.cfm
>
[quoted text clipped - 4 lines]
> appreciate your learned qualifications:
> http://www.cdc.gov/nip/acip/
One must be a Brownie to get such a job these days.
>>> Also, if a young man got mumps post-puberty there was a chance of
>>> becoming sterile.
[quoted text clipped - 20 lines]
>
> From the link above (which has one big glaring error later in the page!):
You forgot to point out the error.
> "Orchitis (testicular inflammation). This is especially severe in adolescent
> and adult males and occurs in about 50% of cases. Sometimes, it occurs along
> with parotitis. The painful swelling diminishes after about seven days but
> tenderness can last for weeks. In 70% of cases, orchitis is unilateral and
> results in some degree of testicular atrophy. Damage tends to be patchy and
> rarely causes infertility."
Yes, and what is the point? Again, my point is that mumps vaccination
might be desirable only if a child did not have mumps by a certain age,
say 10 years.
>> Here is a tidbit about such an outbreak
>> (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55d330a1.htm): "Of the 219
[quoted text clipped - 9 lines]
> why vaccination of those who may not seem to be at risk for complications
> protects those who may be at risk. Look up "herd immunity".
This is not a case of herd immunity but rather of destruction of herd
immunity. A combination of 3 factors is at play:
a) without vaccination, the disease is widespread, everyone has it.
b) it is mostly mild in childhood but in adulthood it may be severe and
much more likely to cause complications
c) the disease leaves 100% lifetime immunity but vaccine does not.
And what is the result? It is quite possible that while disease goes
down the complications do not. In fact, they may even go up. For
example, mumps outbreak in colleges were unheard of.
> Also, you seem to equate "small risk" with "NO risk"... there is a
> difference. The problem being that if the risk is 1 in 10000 then it may
> not matter if only 1000 get it... but if vaccination should stop, then the 1
> in 10000 gets more significant when 1000000 people get the disease.
I do not equate "small risk" with "no risk". The problem is that the
risk might have increased. If the vaccinations stop outbreaks in
colleges will stop too. And speaking about the risk without giving
numbers is fear mongering.
>>> Now, with most kids vaccinated, unvaccinated children
>>>> are not "guaranteed" to catch it early as before. For them the danger of
[quoted text clipped - 16 lines]
>>>> http://www.nytimes.com/2007/03/25/opinion/25CIfry-revere.html
>>>> But that is a different topic.
JOHN - 11 Apr 2007 14:36 GMT