Gardasil - HPV Vaccine: Betting on a Mercky Record/Testing in India

[Guest guest]

have info on my webpage

http://www.wellwithin1.com/hpv.htm

and much in my classes

" It also contains a large amount of aluminum,

the required three shots would introduce 675 mcg

of the toxic metal which adversely affects the

muscles, tissues, nerves and brain. Instances of

Alzheimers, a crippling brain disorder which may

be caused by aluminum, has already skyrocketed in the US.

"

HPV Vaccine: Betting on a Mercky Record/Testing in India

Views > February 27, 2007

HPV Vaccine: Betting on a Mercky Record

By Terry J.

Share Digg del.icio.us Reddit Newsvine

Merck launched its new cervical cancer vaccine

with a major advertising and lobbying blitz, and

pushed to make the drug mandatory for all 11- to

12- year-old girls. Cervical cancer, caused by

the sexually transmitted human papillomavirus

(HPV), affects 10,000 women in the United States

every year, and kills 3,700. The toll is far

greater in the developing world, where women lack diagnostic Pap tests.

Gardasil may well be what Merck claims: a

lifesaving vaccine that protects against key HPV

strains without any significant side effects.

Because the drug is most effective on unexposed

populations, the FDA recommends vaccinating girls

as young as nine — before they are sexually active.

Merck — along with Women in Government (WIG), a

recipient of Merck funding — went one step

further, advocating mandatory vaccination. WIG

has introduced bills in 20 states; in Florida,

Merck helped write the legislation. In Texas,

brushing aside abstinence junkies and the

legislature, Gov. Rick issued an executive

order requiring vaccination for all girls

entering the sixth grade unless parents opt out.

The stealth timing (late on Friday, just before

Super Bowl Sunday), politics ( is a

pro-abstinence Christian Conservative), and speed

of ’s order (just months after the FDA

approved the vaccine and before all the data have

been published) raised questions. It soon emerged

that the WIG state director is the mother-in-law

of ’s current chief of staff, and his former

chief of staff is now one of Merck’s three Texas

lobbyists. The governor received $6,000 from

Merck’s political action committee.

While ’s pace is suspect, Merck’s is

transparent. If Gardasil becomes routine, the

$360 course will generate annual sales of $3.2

billion by 2010. This potential windfall has led

cynics to dub the push the “Help Pay for Vioxx”

program. Before Merck withdrew the arthritis drug

in 2004, it may have caused almost 28,000 deaths,

according to FDA estimates. In one Texas

liability trial, lawyers produced documents and

e-mails from Merck scientists discussing Vioxx’s

potential heart risks as early as 1997, more than

two years before it went on the market.

In the meantime, people will have to weigh the

risks of trying a new vaccine. While there are

good reasons for women to take Gardasil —

especially if they lack access to regular Pap

tests — there are also solid reasons for waiting

before making it mandatory. (They do not include

the paranoid belief that all vaccines are evil,

or the worry that protecting against an STD

encourages girls — already undeterred by fear of

AIDS, pregnancy, fumbling teenage foreplay,

eternal damnation, or being labeled a slut — to indulge in unbridled sex.)

“The safety of new agents cannot be known with

certainty until a drug has been on the market for

years,” according to a 2002 study in the Journal

of the American Medical Association. “Serious

ADRs [adverse drug reactions] commonly emerge

after Food and Drug Administration approval.”

Reacting to outrage over Vioxx and other drug

safety debacles, the FDA announced on Jan. 30

that it will eventually require comprehensive

safety reviews of new drugs 18 months after their introduction.

For now, assurances of efficacy and safety are

only as good as the data on which they are based.

While more than 20,000 women between ages 16 and

26 took part in trials, the sample of 9- to

15-year-old girls was small — only 1,184. And

since no participants have been followed for more

than five years, long-term effects remain unknown.

“The published data looks great, but at the very

least, I would like to see efficacy data among

11- and 12-year-olds, which won’t emerge until

they are sexually active,” says

-McCune, a professor of obstetrics and

gynecology at the University of California, San Francisco.

It also takes time to assess whether data are

comprehensive and reliable, and mirror real-world

conditions. Merck outsourced some of its Gardasil

trials to Contract Research Organizations (CROs)

in the developing world, including JayaJan

Pharmaceutical Research in India. CROs are part

of a $14 billion industry that recruits subjects

and runs trials for Big Pharma. Conflicts of

interest can arise when CROs are paid royalties

only after a drug is approved rather than getting

a set fee independent of results, or when CROs

believe favorable findings will lead to future

contracts. Merck spokesperson Amy Rose refused to

specify how, or even if, the company oversees CROs.

The FDA — hobbled by underfunding, politicization

and dependence on Big Pharma money — has few

resources to assess foreign trials and relies on

drug companies. Even U.S. studies are subject to

manipulation, as when researchers simply exclude

unfavorable trials from those submitted to the FDA.

Of course, none of this means that Gardasil is

unsafe. Few things in medicine are guaranteed,

and odds are good that the HPV vaccine is a

life-saving breakthrough. But consumers,

activists, health professionals, and parents

wanted the option of waiting for more data. The

mighty PR stink they raised smothered Merck’s

lust for an instant blockbuster. On Feb. 20, the

company announced it would immediately stop

lobbying state legislatures to make vaccination mandatory.

Contact Terry J. at tallen@....

************

>From: Jagannath Chatterjee <jagchat01@...>

Dear Sirs,

This report says that the HPV vaccine " Gardasil "

was tested in India by JayaJan Pharmaceutical

Research at Bangalore. It also says that payment

for such trials is made only if the drug or

vaccine is approved. Thus the research

organisations would be terribly biased and

contrive to send a favorable outcome just to

ensure that they are paid for their efforts. The

parents in USA now doubt the vaccines safety.

JayaJan Pharmaceuticals is an accredited research

organisation. However whether international

protocols are adhered to during clinical trials

in India has always been a contentious issue.

Kindly read the article in full to know about the

" mercky " word of vaccine politics. It reflects on

the fact that patients interests and patient

safety are not issues high on the priority list

while launching new drugs or vaccines. As

knowledgeable patients should we not strive to

protect our own interests? Can we depend upon the

" healthcare system " that we have blindly believed in and trusted for centuries?

My own experience says we cannot.

This vaccine is targeted towards young women who

may suffer cervical cancer due to the Human

Papilloma Virus as a result of sexual

misadventures. The vaccine does not ensure

protection against all strains of the virus. The

parents in USA are concerned that this vaccine

will make their daughters lower their guard and

become promiscuous. They are also worried that

the vaccine is targeting women in the

reproductive age. It also contains a large amount

of aluminum, the required three shots would

introduce 675 mcg of the toxic metal which

adversely affects the muscles, tissues, nerves

and brain. Instances of Alzheimers, a crippling

brain disorder which may be caused by aluminum,

has already skyrocketed in the US.

Very strangely this vaccine is also being

recommended for boys, again in the reproductive

age. " To further protect the girls " is the

explanation being offered. I feel this is a good ploy to increase sales.

The vaccine, which is being made mandatory in

some states of the US,. will soon find its way

here with authorities tom tomming the fact that

it has been tested in India. This will increase

the vaccine burden on Indian children who are

already reeling from the after effects of 30

vaccine shots. The new vaccines waiting in the

wings are Flu, Pnemococcal, Meningococcal,

Rotavirus, IPV and of course the HPV. A five in

one vaccine has already been launched last year.

I do not no whether it is being given. Then there

is the JE vaccine which killed 54 children and

hospitalised 750 last year. And we do not know

how many and which vaccines are being tested on our children on the sly.

If your child is offered a " new and promising "

vaccine with a number rather than a name then

please make proper inquiries before you allow the

injection or drops. And besides we know now that

the Govt of India does not want children to be

subjected to more than the six vaccines included

in the Universal Immunisation Program.

Regards,