Merck and the Feds…follow the money

Mandatory Childhood Vaccine Legislation Ignores The Contaminated Culture That Created It

By Pam Martens

A national furor has erupted over another executive order. This time, it’s not the President of the United States bypassing the legislative branch of government to pass laws, it’s the Governor of one of the three most populated states in the country. Rick Perry, Governor of Texas, has signed an order making it mandatory for 11 and 12 year old girls to be injected with a 3-shot regimen vaccine that’s been on the market less than 9 months. Ostensibly, the vaccine is to prevent some strains of human papillomavirus (HPV) that may cause cervical cancer, a cancer that occurs annually in less than one-tenth of one percent of women in the U.S.

The clinical trials for these 11 and 12 year old girls were limited to a few hundred individuals of this age group and tested only for immune response, not the efficacy of the drug in preventing the virus or cervical cancer.

The vaccine comes from the big pharmaceutical maker, Merck, which is currently facing down 27,400 lawsuits (as of 12/31/2006 according to its own SEC filings ) over another of the drugs the company touted as safe, Vioxx, just before it was taken off the market due to cardiovascular risk. The lawsuits allege, and produce damaging internal emails to back their assertions, that while Merck was telling the public and the Food and Drug Administration (FDA) about the safety of Vioxx, internal correspondence at the company was confirming it knew that Vioxx was causing heart attacks, essentially brushing it off as the cost of doing business and telling its sales force to “DODGE” questions arising from doctors about these risks.

According to the Wall Street Journal, this is a direct quote from an internal email from Dr. Edward Scolnick, chief of research for Merck at the time of the Vioxx subterfuge: In Vioxx, he wrote, “We have a great drug and like angioedema with Vasotec and seizures with Primaxin and myopathy with Mevacor there is always a hazard. The class will do well and so will we.” Experts now believe that as many as 140,000 individuals suffered heart attacks, strokes and other serious medical complications as a result of taking Vioxx. This business model of injury and suffering to some for the benefit of “the class” could certainly be challenged on many ethical fronts. But only a fool or a conflicted regulatory body would fail to see it as a cautionary red flag in the implementation of a vaccine for children for a disease they stand a 1 in 15,000 chance of getting later in life, with no clinical evidence that the duration of the vaccine will even last that long.

The adequacy of Merck’s internal ethical culture to market vaccines for children was further called into question in May 2005 when Congress released Merck’s training manuals for its sales force. The manuals gave the impression of being authored by a psychotic intelligence operative who moonlighted as a used car salesman. [*]

While this latest vaccine, which goes by the proprietary name Gardasil, was being fast tracked for review at the FDA, another government agency, the IRS, was fast tracking charges that Merck owed the Federal government over $2 Billion in back taxes. The amount Merck is anticipated to have to pay out for Vioxx lawsuits and back taxes could wipe out its cash reserves without an immediate infusion of big sales from some other blockbuster drug. Enter Gardasil, whose 3-dose regimen will cost a minimum of $360 per student.

With the stakes this high, Merck reached out to a non-profit group called “Women in Government,” a group funded by it and other drug companies that stand to benefit from the sale of Gardasil through the use of co-licensing agreements and royalty payments. On May 18, 2006, when the FDA held its hearing on whether to approve Gardasil, Kathryn Guccione, an employee of Women in Government, appeared at the hearing to ask the FDA to approve the vaccine. (Of the 9 public groups that spoke at the hearing, 6 received financial support from Merck.)

While acknowledging to the FDA that her organization received funding from Merck, Ms. Guccione also indicated that her group was responsible for recently getting 39 states to formally introduce legislation or resolutions calling attention to preventing cervical cancer. As more and more states jumped on this fast moving train, Women in Government, which had an executive from Merck sitting on its Business Council last year, rolled out the second phase of the project once Gardasil was approved in June 2006. The second phase was for their members, female state lawmakers across the country, to introduce the actual legislation that would mandate that six grade girls receive the Gardasil vaccine in order to enter school. At least 20 states now have this legislation pending, most of it introduced by members of Women in Government.

I sent an email to Women in Government asking for the specific dollar amount of funding they had received from Merck. Ms. Guccione responded in an email: “We leave it up to our supporters if they wish to share specific funding information.” The organization’s 990 tax form that is publicly available shows it has received over $5.7 million in total funds for the period 2002 through 2005. It does not list its donors’ names or the amount they have given.

But Women in Government was the tip of the iceberg. Merck was spending tens of millions of dollars funding other non profits (who engaged high profile celebrities), TV advertising and PR firms to create a saturated public climate ready to embrace a new mandatory vaccine.

And then there were Merck’s acknowledged lobbyists. The Associated Press has reported that one of Merck’s lobbyists in Texas, Mike Toomey, is the former chief of staff to Governor Rick Perry. This might help explain why a conservative Republican Governor would risk a tidal wave of conservative backlash by skirting the legislative branch to pass an order that is highly questionable on both a medical basis as well as parental rights.

The real clue may be buried in the hundreds of pages of documents related to Gardasil that reside on the FDA’s web site. On June 8, 2006, the FDA sent a letter to Merck approving its license for Gardasil. But there was a caveat. The FDA wanted more safety information gathered in a new study of 11 and 12 year old girls. The letter said: “…a sufficient number of children 11-12 years of age will be studied to permit an analysis of safety outcomes. The final study protocol will be submitted by December 31, 2006. Patient accrual will be completed by December 31, 2008.” This meant that Merck was going to need to enroll a large number of 11 and 12 year old girls and get the willing and informed signatures of parents who didn’t know about Merck’s history with Vioxx before December 2008. Enter the mandatory order from the Texas governor requiring mandatory vaccinations of sixth grade girls entering school in September 2008. On its face, this could be interpreted as a mandatory clinical trial on orders from the Governor of Texas to augment the inadequate one conducted by Merck.

As jaded as this chronology appears, an equally questionable role was played by the government agencies mandated to protect the public health.

The day after the FDA held its hearing on Gardasil, it met again to discuss its future mandates with outside experts. A transcript of that meeting quotes an FDA associate director of research, Dr. Kathryn Carbone, as follows: “When I arrived here 10 years ago, in fact, I was instructed never to mention the word ‘research’ and FDA in the same sentence.” A slide presented as part of this meeting now lists two goals for the FDA: (1) “Ensure the safety and efficacy of vaccines and related biological products for human use;” and (2) “Facilitate the development, evaluation, licensure and use of new vaccines and related products that positively impact the public health.”

Why should the FDA be concerned with licensing products for big pharma? Aside from the stated goal of ensuring the public health, it’s also big bucks for government workers.

According to the federal government’s Office of Technology Transfer at the National Institute of Health (NIH), researchers working for the FDA or NIH and are credited with an invention can “receive the first $2,000 received from a licensee. Next, they receive 15 percent of royalties received above $2,000 up to $50,000. Finally, they receive 25 percent of royalties in excess of the first $50,000 received each year. Each inventor cannot receive more than $150,000 in royalty payments for a calendar year.”

So the question arises: if you’re a government employee at the FDA and you know your government colleagues could earn millions over a lifetime for a drug invention, are you going to shoot down their license application; especially when your agency is strapped for funds and intramural grants from these sister agencies are keeping you afloat?

According to the Office of Technology Transfer, it collected $82.7 million in royalty payments from 882 license agreements or amendments in fiscal year 2006.

And guess where Gardasil originated; in a lab at a federal agency. According to an Office of Technology Transfer document, “The underlying technology for the vaccine originated in the laboratories of Drs. John Schiller and Douglas Lowy of the NIH National Caner Institute (NCI)…Working with the NCI technology transfer office, the NIH Office of Technology Transfer (OTT) oversaw the patenting of the VLPs. OTT then sought a suitable [emphasis added] company with the necessary resources to formulate the vaccine and to conduct clinical trails. The technology was licensed to Merck….”

And this answers one more question: why was GlaxoSmithKline also funding Women in Government. It has its own competing vaccine in the pipeline. According to Merck’s SEC filings (and backed up by NIH documents) “In February 2005, the Company announced that it and GlaxoSmithKline (GSK) entered into a cross-license and settlement agreement for certain patent rights related to HPV vaccines. Pursuant to the agreement, GSK will receive an upfront payment and royalties from the Company based upon sales of Gardasil….)

If ever there was a message of hope to those downtrodden FDA whistle blowers and public citizens calling for an investigation of the regulatory structure of the FDA, surely this is it. And, hopefully, it comes before a pack of callous corporate owners of underwater stock options and Washington bureaucrats stick it to our Nation’s children.

Pam Martens is an independent writer living in New Hampshire.

[*] Merck’s sales force training manuals and related documents: