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Incog4
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Re: Requiring HPV-Shots for schoolgirls is a CORRUPT FINANCIAL SCAM!
Another "Hurrah" is in order!
Things are looking very good for the Public, but very bad for Merck and the corrupt politicians.
A 119 to 21 votes victory in Texas' House not only ensures that its Senate will follow suit, but also that Gov Perry doesn't stand a chance of a successful veto of the nullifying measure.
IOW, his executive order is now dead meat!
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3/13/2007, 10:08 pm
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Joseph Sarandos
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Re: Requiring HPV-Shots for schoolgirls is a CORRUPT FINANCIAL SCAM!
Sorry for going offline before you did last night, A/G.
You're right that this was a big victory in Texas. But, the story doesn't end there. Now it's important to "trace the ripple effects" into the other states that were considering similar legislation.
Let's hope that they take the right lesson from the Texas results and voluntarily back down from their own plans.
J/S
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3/14/2007, 10:45 am
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insider3
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Re: Requiring HPV-Shots for schoolgirls is a CORRUPT FINANCIAL SCAM!
Joseph,
I've been loosely trying to follow the "ripple effects" in other states following the dismal failure of the attempt to make Merck's vaccine mandatory by law in Texas.
As I understood you, there were least 20 other states in which such mandatory vaccinations of young schoolgirls with Merck's "Gardasil" were under consideration by the legislatures, the most imortant of which were California, New York, Illinois and Florida.
The news coverage of progress in those states has been "low key" and "back burner," except for the revelations of Merck's multi-million-dollars investments in questionably legal lobbying and politician-bribing in New York, and except for the announcement that the proposed bill in California has been withdrawn by its author and co-sponsors.
Also, there have been articles and reports issued by reputable individuals and organizations, harshly questioning Merck's claims, promises and testing-procedures with regard to its brand of HPV vaccine, along with religious and parental-rights groups "slamming" the implications of forcing such inoculations upon pre-pubescent schoolgirls, even in doubts that such early vaccinations would last long enough to protect girls if and once they do become sexually promiscuous in their late teens and early 20's, which might require second rounds of those highly expensive series of shots.
But, there have not been "blaring" headlines with regard to whether or not the bulk of those other states have totally abandoned their efforts to MANDATE such inoculations.
Perhaps they are waiting to see if the Texas SENATE will follow the lead of its House of Representatives in "veto-proofing" Governor Perry's executive order, or maybe they are waiting to see how much cheaper or more expensive will be the competitive vaccine by Glaxo once it becomes cleared by the FDA (which should happen soon).
Do YOU have any predictions or educated guesses as to what might be happening quietly during this "news-suspense" period?
Curious Bob
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3/21/2007, 10:53 am
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Joseph Sarandos
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Re: Requiring HPV-Shots for schoolgirls is a CORRUPT FINANCIAL SCAM!
Dear "curious" (lol),
You've laid out the current situation as clearly as I could have.
Like you, and like my private feedback sources, I am left at the mercy of the mainstream press for pertinent updates to the "quiet" goings-on in the state legislatures.
However, there are rumblings to the effect that the Federal government is considering denying funding to states that tie-together mandatory requirements for and availability of HPV vaccines. IOW, that the Fed will pick up the tab for making such vaccine available to indigents via healthcare clinics, while keeping a "hands-off" attitude with regard to those who are willing and able to purchase the vaccine through private doctors and/or the private insurers who are willing to cover the costs of it.
Such actions by the Fed, if taken, would surely kill-off any attempts at the states-level to mandate such inoculations, since it would be at their own expense without even matching-funds from the Fed.
That's all I have at the moment, Bob.
Joseph
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3/21/2007, 11:24 am
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Joseph Sarandos
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Re: Requiring HPV-Shots for schoolgirls is a CORRUPT FINANCIAL SCAM!
Here are some details about the possible (more probable) likelihood that the Federal government will step in to discourage states from enacting mandatory programs for inoculating schoolgirls against HPV.
Separately, it appears that Merck might have “legally bribed” some members of the FDA to vote in favor of approving its Gardasil, and that such practices by the Drug Companies might be common in that agency, since there is now a movement underway to investigate it. I’ll post an article about this immediately below.
Joseph
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http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=43628
Friday, March 16, 2007
National Politics & Policy
Rep. Gingrey Introduces Bill That Would Prohibit Federal Funds From Being Used for State HPV Vaccination Mandates
Rep. Phil Gingrey (R-Ga.) on Thursday introduced a bill (HR 1153) that would prohibit federal funds from being used by states to make human papillomavirus vaccination mandatory, the Washington Times reports.
The bill would not prohibit states from enacting mandatory vaccinations, but it would inhibit states' ability to use federal Medicaid or education funds to ensure children from low-income families receive the vaccine, the Times reports (Lopes, Washington Times, 3/16).
Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. GSK in April plans to file for FDA approval of Cervarix, and it expects approval by the end of this year. CDC has added Gardasil to its Vaccines for Children Program, which provides no-cost immunizations to children ages nine to 18 covered by Medicaid, Alaska Native and American Indian children, and some uninsured and underinsured children (Kaiser Daily Women's Health Policy Report, 3/15).
According to Gingrey spokesperson Becky Ruby, Gingrey will attempt to attach the bill as an amendment to the 2008 spending bill for HHS. According to the Times, although there is little chance that Congress will approve Gingrey's measure as a "stand-alone" bill, appropriations bills often include multiple proposals that are difficult for lawmakers to notice or block. "I can't think of a single Democrat who will push to move the bill," an unnamed House staffer said, adding, "But putting it in an appropriations bill will make for an interesting floor vote."
Lawrence Gostin, director of the Center for Law and the Public's Health at Johns Hopkins and Georgetown universities, said, "If this bill were enacted, it would signal the end of state vaccine mandates (for HPV)." He added, "No state could forgo the considerable federal funds" (Washington Times, 3/16).
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3/23/2007, 8:08 am
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Joseph Sarandos
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Re: Requiring HPV-Shots for schoolgirls is a CORRUPT FINANCIAL SCAM!
http://www.nytimes.com/2007/03/22/washington/22fda.html?_r=1&th&emc=th&oref=slogin
F.D.A. Limits Role of Advisers Tied to Industry
By GARDINER HARRIS
Published: March 22, 2007
WASHINGTON, March 21 — Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.
Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.
A “significant number” of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many. The rules are among the first major changes made by Dr. Andrew C. von Eschenbach since he was confirmed as commissioner of food and drugs late last year.
Advisory boards recommend drugs for approval and, in rare cases, removal, and their votes can have enormous influence on drug company fortunes.
“The $50,000 threshold is something that we think strikes an appropriate balance between” getting smart advisers and reassuring the public that their advice is not tainted, Dr. Lutter said.
The changes are intended to respond to a growing chorus of critics who contend that drug and device makers have hijacked the Food and Drug Administration’s approval process by paying those who serve on the agency’s advisory panels.
In one famous example, 10 of the 32 advisers who voted in 2005 to allow the painkiller Bextra to remain on the market and the painkiller Vioxx to return to the market despite safety worries had taken money from the drug makers. Under the new rules, their votes would not have counted and the committee would have voted to keep both drugs off the market.
In the end, the F.D.A. removed Bextra from the market anyway, and Vioxx has never returned. But the controversy surrounding that panel’s vote, and similar ones, tarnished the process and provided new fodder for critics in Congress.
Representative Maurice D. Hinchey, Democrat of New York, said he was delighted with the change, which will not become final until the end of a 60-day comment period.
“So many lives have been lost as a result of the failure of the F.D.A. to review drugs properly,” said Mr. Hinchey, who for two years has proposed legislation to ban agency advisers from having financial conflicts of interest. “The F.D.A. is now moving back to where it was supposed to be, a principled agency that protects the people.”
But Representative Rosa DeLauro, Democrat of Connecticut and chairwoman of a subcommittee that has oversight over the F.D.A. budget, said there might be undisclosed loopholes that make the new rules toothless. “I am skeptical, given their recent track record of putting political and corporate interests above science,” Ms. DeLauro said.
With the change in the leadership of Congress, Mr. Hinchey’s legislation had better prospects of passage. Daniel E. Troy, a former F.D.A. general counsel, said the new rules were an effort to pre-empt the Hinchey bill.
“F.D.A. is trying to strike a balance here,” Mr. Troy said, “and they would rather strike it themselves than have it struck for them.”
Drug makers routinely hire doctors as consultants for marketing and research. The New York Times reported on Wednesday that records in Minnesota show that at least 20 percent of licensed physicians in the state received money from drug makers between 1997 and 2005 — an average of $10,000.
While there were some conflicts under the old rules that led to outright exclusions, like a prohibition on advisers holding $100,000 or more in stock in the company at issue, the agency could waive almost any other financial conflict, including tens of thousands of dollars in income.
The announcement of waivers was becoming so common at the start of advisory committee meetings that they took on the feel of fast-talking car commercials, but because of confidentiality rules, the conflicts underlying the waivers were generally not disclosed. The public did not know whether the conflicted experts got $10 or $10,000.
The agency has long defended its process of selecting expert advisers, and some in the agency’s drug center opposed in internal deliberations strict rules that would have prevented them from picking the experts they wanted.
Waivers to that rule are still possible under the present system, but only the commissioner can approve them, something Mr. Lutter said would probably be rare.
Some conservatives were not happy with the new rule
“There are going to be more good people who can’t get over the hurdles, and I don’t think that’s a good thing,” said Jack Calfee, a resident scholar at the American Enterprise Institute. But Dr. Peter Lurie of Public Citizen, an advocacy group often critical of the F.D.A., praised the new rules.
“I think it’s likely to improve the quality of the recommendations, remove the taint of the recommendations and improve the credibility of the recommendations,” Dr. Lurie said.
The Pharmaceutical Research and Manufacturers of America said it was still studying the new rules.
Advisory panels are important to the F.D.A. not so much because they provide the agency with expert advice — the F.D.A. can get that privately any time — but because they serve to increase public confidence in the agency’s decisions.
F.D.A. officials have long said that such panels help the public better understand the many factors it must weigh in its decisions. Advisory panels are a crucial means by which the agency pulls back the curtain on its decision-making, so declining confidence in the panels seriously undercuts their utility to the agency.
Although the new rules would most likely lead some of the agency’s present advisers to drop off their committees, many advisers are likely to welcome the greater clarity that the new rules bring. Under the old system, committee members rarely knew what kind of conflicts would lead to problems.
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3/23/2007, 8:24 am
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Joseph Sarandos
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Re: Requiring HPV-Shots for schoolgirls is a CORRUPT FINANCIAL SCAM!
Mandatory HPV vaccine push ends in Texas
Governor Rick Perry gives in after state legislature overturned his order for statewide vaccine.
May 8 2007: 6:02 PM EDT
AUSTIN (Reuters) -- Texas Gov. Rick Perry said Tuesday he is backing down in his effort to require that pre-teen girls be vaccinated against a virus known to cause cervical cancer after the state's legislature overturned his order.
The February order would have made Texas the first U.S. state to require that girls receive the Merck & Co. Inc.'s vaccine against human papillomavirus (HPV) so they can enroll in sixth grade, when most students are 11 or 12 years old. But social conservatives opposed it, saying it would lead to sexual promiscuity.
The Republican-majority Texas Legislature passed a bill last month contravening the order by preventing the vaccination program for at least four years. Several other states are also considering requiring the vaccine.
Perry announced Tuesday he would not veto that bill, meaning it will become law. Perry said a veto was futile because the legislature would vote to override it. He blasted the legislature for its decision.
"They have sent me a bill that will ensure three-quarters of our young women will be susceptible to a virus that not only kills hundreds each year but causes great discomfort and harm to thousands more," said an emotional Perry.
Perry, a Republican with close ties to the religious right, surprised observers when he issued the order in February.
The girls would have been vaccinated with Merck's Gardasil, which won U.S. approval last June as the first vaccine to prevent cervical cancer, a disease that kills about 300,000 women worldwide each year.
The vaccine, which targets four HPV types believed to cause more than 70 percent of cervical cancer cases and 90 percent of genital warts, is cleared for use in girls and young women aged 9 to 26. In clinical trials, Gardasil was shown to be 100 percent effective against two of the most common HPV strains.
Find this article at:
http://money.cnn.com/2007/05/08/news/companies/bc.h
ealth.vaccine.texas.reut/?postversion=2007050818
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5/11/2007, 8:33 pm
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