HPV vaccine Gardasil underwent clinical trials in India.

[Guest guest]

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,Jagannath.http://www.inthesetimes.com/article/3057/hpv_vaccine_betting_on_a_mercky_record/Views > February 27, 2007HPV Vaccine: Betting on a Mercky RecordBy Terry J. AllenMerck

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 Perry 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 (Perry is a pro-abstinence Christian

Conservative), and speed of Perry’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 Perry’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

Perry’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

Karen Smith-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. Allen at tallen.

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[Guest guest]

> Beside this a report came out today that showed tyre of Hpv virus

that this protected against had a relatively low occurence> Article

in Jama

 

> 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