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Chapter 18

The FDA, CDC, Media and Politicians Receive Money from Vaccine Makers.

The FDA and CDC Get Money from Vaccine Makers

The agencies and people who approve and make vaccines mandatory for the U.S. have received money from vaccine manufacturers.

Think about this and how this corrupts what you are told about vaccines. Where are the news reports on this?

The Federal Offices Over Vaccine Policy

The Department of Health and Human Services (HHS) is a Cabinet Level Department in the Federal Government. HHS has a $1.2 trillion dollar budget. It is over the National Institute of Health (NIH), the CDC and the FDA. The FDA approves vaccines and when the CDC adds them to the schedule, they become mandatory.

The FDA Receives Money from Vaccine Makers

Before a vaccine is put on the vaccination schedule by the CDC, it first has to be approved by the FDA. However, the FDA receives money from pharmaceutical companies in order to function.

For example, the FDA budget for 2019 was $5.7 billion. About 55 percent, or $3.1 billion, of the FDA’s budget was provided by federal budget authorization. The remaining 45 percent, or $2.6 billion, was paid for by industry user fees.  The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products.  Vaccines are “biological products.”

The virginity was lost in ’92,” said Dr. Jerry Avorn, a professor at Harvard Medical School. “Once you have that paying relationship, it creates a dynamic that’s not a healthy one.”

According to an investigative report from ProPublica entitled: “FDA Repays Industry by Rushing Risky Drugs to Market”:

  • In 2017, pharmaceutical companies paid 75% ($905 million) of the agency’s scientific review budgets for branded and generic drugs, compared to 27% in 1993.
  • Industry also sways the FDA through a less direct financial route. Many of the physicians, caregivers, and other witnesses before FDA advisory panels that evaluate drugs receive consulting fees, expense payments, or other remuneration from pharmaceutical companies.
  • “You know who never shows up at the [advisory committee]? The people who died in the [clinical] trial,” lamented one former FDA staffer, who asked not to be named because he still works in the field. “Nobody is talking for them.”

Another investigation from Science was entitled “Investigation Examines Big Pharma Payments to FDA Advisers.”  It found:

  • Forty of 107 physician advisers on the FDA committees examined “received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms.” Of those forty, 26 snagged more than $100,000 and seven of those gained $1 million or more.
  • Seventeen top-earning advisers benefitted from more than $26 million in research assistance or personal payments from industry companies.
  • Yale University physician Robert Steinbrook, editor at large for JAMA Internal Medicine, told Science, that such payments are “troubling” and raises ethical concerns.

Conflicts of Interest and FDA’s Approval of Rotashield

The FDA was not doing its due diligence when it approved the rotarvirus vaccine (“Rotashield”).

In June 2000, the Committee on Government Reform looked at the approval of this vaccine. It was made by Merck and it was approved for use by the FDA in August 1998. It was recommended for universal use by the CDC in March 1999. Children were soon injured or killed by it. The Congressional investigation found numerous examples of people who sat on FDA committees to approve the vaccine had financial ties to the vaccine manufacturer (Merck).

For example, Congress found:

  • “Members, including the chair of the FDA and CDC advisory committees who make these [vaccine] decisions own stock in drug companies that make the vaccines.”
  • “Individuals on both advisory committees own patents for vaccines under consideration, or affected by the decisions of the committees.”
  • “Three out of the five of the members of the FDA’s advisory committee who voted for the rotavirus vaccine had conflicts of interest that were waived.”
  • “Dr. John Modlin served for 4 years on the CDC advisory committee and became the chair in February 1998. He participated in the FDA’s committee as well. He owns stock in Merck, one of the largest manufacturers of the vaccine, valued at $26,000. He also serves on Merck’s immunization advisory board.”
  • “Dr. Patricia Ferrieri, during her tenure as chair of the FDA’s advisory committee, owned stock in Merck valued at about $20,000 and was granted a full waiver.”
  • “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.”

The CDC Both Pays and Receives Money from Vaccine Makers

The CDC decides what vaccines are put on the pediatric vaccine schedule and therefore what is mandatory in the U.S. The CDC has a number of financial ties to the pharmaceutical industry.  For example:

Under a 1980 law, the CDC currently has 28 licensing agreements with companies and one university for vaccines or vaccine-related products. It also has eight ongoing projects to collaborate on new vaccines.

Here are 43 vaccine related technologies currently available for license from the CDC.

In addition, the CDC holds patents on the vaccines that they approve and mandate American children must take.

How is this possible?

The NIH uses taxpayer money to fund research.  When that research leads to something that can be sold, NIH patents it and then licenses the patent to pharmaceutical companies.

Nine NIH Institutes or Centers (ICs) transfer NIH and CDC inventions through licenses to the private sector for further research and development and eventual commercialization.”

HHS then gets a cut of the profits.

You can read the actual licenses that HHS uses here.  In this example “IC” is the HHS Institute or Center.  It can be the CDC or another subdivision of HHS.  The Licensee is whomever is permitted to use the invention. It is usually a pharmaceutical company.

Here’s just an excerpt:

PUBLIC HEALTH SERVICE PATENT LICENSE-NON-EXCLUSIVE

This Agreement is based on the model Patent License Non-exclusive Agreement adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of the PHS within the Department of Health and Human Services (“HHS”).

ROYALTIES AND REIMBURSEMENT

6.1 The Licensee agrees to pay the IC a noncreditable, nonrefundable license issue royalty as set forth in Appendix C.

6.2 The Licensee agrees to pay the IC a minimum annual royalty as set forth in Appendix C.

6.3 The Licensee agrees to pay the IC earned royalties as set forth in Appendix C.

6.4 The Licensee agrees to pay the IC benchmark royalties as set forth in Appendix C

APPENDIX C – ROYALTIES

Royalties:

I. The Licensee agrees to pay to the IC a noncreditable, nonrefundable license issue royalty in the amount of _______ Dollars ($X) within sixty (60) days from the effective date of this Agreement.

II. The Licensee agrees to pay to the IC a nonrefundable minimum annual royalty in the amount of _______ Dollars ($X) as follows:

(a) The first minimum annual royalty is due within sixty (60) days of the effective date of this Agreement and may be prorated according to the fraction of the calendar year remaining between the effective date of this Agreement and the next subsequent January 1; and

(b) Subsequent minimum annual royalty payments are due and payable on January 1 of each calendar year and may be credited against any earned royalties due for sales made in that year.

III. The Licensee agrees to pay the IC earned royalties of ___ percent (X%) on Net Sales by or on behalf of the Licensee.

IV. The Licensee agrees to pay the IC Benchmark royalties within sixty (60) days of achieving each Benchmark.

In addition, under the Vaccines For Children (VFC) Act, funding for new vaccines or new recommendations occurs through a vote of the CDC’s Advisory Committee on Immunization Practices (ACIP). When ACIP votes to add a vaccine to the schedule it can also have it covered by VFC.

The CDC “automatically covers vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) and approved by the CDC.”

Due to the Vaccines for Children (VFC) program, the Federal government of the United States currently purchases between 52 and 55 percent of childhood vaccines administered in the United States.

This means that the CDC mandates that a vaccine must be purchased, licenses some vaccines, and then purchases billions of dollars worth of vaccines with taxpayer money. The CDC does this through “bulk purchase[s] of vaccine through CDC’s contracts…”

This also means that this one committee (ACIP) has the power and authority to add benefits to an entitlement program.  This is very unusual. After ACIP passes a VFC resolution for a vaccine, the federal government establishes a contract with the relevant manufacturer. Funding is approved by the Department of Health and Human Services and the Office of Management and Budget without the need for additional Congressional appropriations.

The CDC-Vaccine Maker Connections

So the CDC’s ACIP committee is essentially the gateway by which vaccine makers make multi-billion dollar sales.

This means that the government can create a vaccine with our tax money, license it to a drug company, approve it, make it mandatory, buy it (with our tax money), and profit from it. This is called self-dealing. It is usually illegal but in the world of vaccines, it’s not.

Conflicts of Interest and CDC’s Mandating of Rotashield

Not surprisingly, members of (ACIP) have received money from vaccine manufacturers. Relationships have included: sharing a vaccine patent; owning stock in a vaccine company; receiving payments for research; getting money to monitor manufacturer vaccine tests; and funding academic departments.

In June 2000, the Committee on Government Reform looked at the Rotashield vaccine. It found:

  • “Members, including the chair of the FDA and CDC advisory committees who make these decisions own stock in drug companies that make the vaccines.”
  • “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.”
  • “Dr. Paul Offit disclosed that he holds a patent on a rotavirus vaccine and receives grant money from Merck to develop this vaccine. 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 program.”
  • “Dr. Neal Halsey, who serves as a liaison member to the CDC committee on behalf of the American Association of Pediatrics, and is a consultant to the FDA’s committee, has extensive ties to the pharmaceutical industry, including having solicited and received startup funds from industry for his Vaccine Center.”

Glance at the ACIP Committee Today

This was in 2000.  What about now? Even a quick look at the current members of the CDC’s Vaccine Advisory Committee is revealing.

The Media Gets Money from Vaccine Makers

When you see drugs being advertised on TV this is called “Direct to Consumer Advertising” or DTC.  The U.S. is one of only two countries that permit drug makers to advertise their products directly to consumers (the other is New Zealand). And their favorite way to do that has been through TV.

The media receives billions from the pharmaceutical industry. In 2018, the pharmaceutical industry spent $3.79 billion on TV advertising in the U.S.

Other sources say the number is even higher.  Money spent on DTC (mostly TV commercials) went from $2.1 billion in 1997 to $9.6 billion in 2016.

If you add in healthcare advertising, the number is even bigger.  According to Medical Marketing and Media, Pharma and healthcare ad spending is projected to hit nearly $11.3 billion this year and $12 billion in 2020, with TV making up the largest share, according to October data from WARC.

Who benefits from all this drug company spending?  The big TV broadcasters and cable companies. The mass media is receiving billions in pharmaceutical advertising dollars.  Why would they anger their pay masters by reporting on the dangers of vaccines?  If fact, it make sense that the media would do the opposite and offer phama information to the public without any critical analysis. Pharma helps pay the media’s bills.

Politicians Get Money from Vaccine Makers

Big pharmaceutical companies spend more on federal campaign contributions and lobbying then almost any other industry.  Every year, around $40 million is given in donations to politicians and another $233 million is spent on lobbying.

For example:

This observational study, which analyzed publicly available data on campaign contributions and lobbying in the US from 1999 to 2018, found that the pharmaceutical and health product industry spent $4.7 billion, an average of $233 million per year, on lobbying the US federal government; $414 million on contributions to presidential and congressional electoral candidates, national party committees, and outside spending groups; and $877 million on contributions to state candidates and committees. Contributions were targeted at senior legislators in Congress involved in drafting health care laws and state committees that opposed or supported key referenda on drug pricing and regulation.

Massive Money Machine

Drug companies spend those types of dollars because it’s the cost of doing business.  There’s more money to be earned. The global vaccine market is expected to reach total revenues of 59.2 billion by 2020. By 2020, the total market size for vaccines in the United States will generate $18 billion.

To keep those profits flowing, the pharmaceutical industry have created a massive money making machine which ensnares government offices, politicians, doctors, scientists and the media.  Even the Academy of Pediatrics is involved. This article was published by CBS News in 2008.  Here’s an excerpt:

“The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters. The totals are kept secret, but public documents reveal bits and pieces.”

Money, unfortunately, is always a corrupting influence.