April 25, 2002

Jim Rarey is a freelance writer based in Romulus, Michigan. He is a former newspaper editor and investigative reporter, a retired customs administrator and accountant, and a student of history and the U.S. Constitution.

Now comes a new “cooperative” effort to provide protection against “bio-terrorism.” But this one is quite different from Homeland Defense. It is a merging of government and the “private sector.” Announced quietly without fanfare (the reader will soon understand why), the first notice was the appearance of a new website appropriately named HomelandHealth.com ¹⁾ The website explains that the U.S. Department of Health and Human Services (HHS) has joined with the pharmaceutical industry to develop defenses against biological threats.

Aside from the involvement of for-profit companies in the effort, another major difference from Homeland Defense is that the man in charge is not a part of the government.

The nominal head of the industry’s effort comes through its trade association Pharmaceutical Research and Manufacturers of America (PhRMA). However, PhRMA’s president Alan F. Holmer announced that Dr. Michael Friedman would be the association’s Chief Medical Officer for Biomedical Preparedness and lead the initiative.

Friedman will interface with a number of government agencies, including HHS, The Dept. of Defense, the FDA, NIH, and the CDC, and oh yes, Homeland Security. Holmer did not say whether Friedman would be making use of the association’s lone consultant (as listed on its webpage) Arthur Andersen, LLP.

Friedman himself is a 30-year veteran of government service in public health. He was a leader in the FDA, and at one time, its acting commissioner. Friedman was the FDA official who gave the Department of Defense the go ahead to use the anthrax vaccine in the Gulf war even though the FDA had not found it to be safe or effective against inhalation anthrax.

But Friedman is no longer in government. He is currently a senior vice president of the pharmaceutical giant Pharmacia Corporation, from which he will be drawing his paycheck (and bonuses and stock options?). Many, including this writer, would predict that the recommendations and agenda of Pharmacia might carry more weight with Friedman than those from the others. So what is Pharmacia, and who runs it?

In April 2000, three well-known companies combined to form the Pharmacia Corporation: Pharmacia and Upjohn Laboratories, which acquired Monsanto (chemical) Company. The combined companies have a pipeline of new drugs, a $2 billion research and development budget and a leading sales force in the U.S. market. Additionally, with the acquisition of Monsanto’s agriculture division, about 90% of the world’s genetically engineered foods will contain a Pharmacia (Monsanto) gene.

The current Chairman of the Board and CEO of Pharmacia is a Pakistani named Fred Hassan. Hassan was President of Pharmacia-Upjohn at the time of the merger with Monsanto, and moved into his current position after Monsanto’s CEO had served an interim 18-month period as head of the combined companies.

There are a couple of well-known names on the Pharmacia Board of Directors, and one whose name has only recently come into the public consciousness.

William Ruckelshaus is a Harvard-trained lawyer who came out of the Justice Department to become the first administrator of the new Environmental Protection Agency (EPA) in 1970. He served another three-year term as EPA administrator during the Reagan administration. Ruckelshaus is currently a principal in the Madrona Investment Group.

Michael (Mickey) Kantor is a close confidante of Bill Clinton and served in his administration first as the United States Trade Representative (USTR). Kantor took over as Commerce Secretary following the controversial death of Ron Brown. Kantor was one of the point men involved in blunting some of the Clinton personal scandals, including the Kathleen Willey affair.

Dr. Philip Leder, although a virtual unknown outside of medical circles, has impressive credentials. He is Chairman of the Department of Genetics at Harvard Medical School and a Senior Investigator for the Howard Hughes Medical Institute (HHMI). He was a contemporary of Dr. Don C. Wiley at Harvard. Wiley, who had made a breakthrough in genetic research, died in a mysterious plunge from a bridge in Memphis, Tennessee that was ruled an accidental death. Wiley also was funded as an investigator by HHMI.

Perhaps the most controversial member of Pharmacia’s board is Frank Carlucci. Carlucci is Chairman of the Board and CEO of the Carlyle Group, which describes itself as a “merchant bank.” However, its portfolio ranks it as one of the major defense contractors in the country.

The Carlyle board of directors reads like a class reunion of former cabinet members from past Republican administrations. However, Carlucci himself seemed equally at home under Democrat and Republican presidents during his checkered career in public service.

In the 1950s and 1960s, Carlucci was a foreign service officer ostensibly in the State Department, although some alleged that was cover for his CIA activities. Indeed, he served as Deputy Director of the CIA in the Carter administration. He served in foreign posts in the Congo and Brazil when Communist or pro-Communist governments were overthrown, as well as ambassador to Portugal when that government fell.

Carlucci held several sub-cabinet level positions in the Nixon Administration. As Deputy Secretary of Defense under Caspar Weinberger in the Reagan administration, he was responsible for development and procurement of new weapons. In that post, he formed a number of associations that would prove to reap rewards for the Carlyle Group. He later was elevated to Secretary of Defense, where he worked closely with the Chairman of the Joint Chiefs of Staff, Admiral William Crowe. Crowe would become the “front man” in the takeover by the el Hibre family of the State of Michigan laboratory producing the only anthrax vaccine approved by the FDA.

Although Pharmacia will likely be first among equals in influencing PhRMA’s involvement in bioterrorism, there are plenty of other big shooters (don’t take that literally) in the association. Virtually all of the American and foreign pharmaceutical giants are members, along with some smaller companies and subsidiaries of the giants.

Numbered among the 66 members is Bayer, the German firm that returned to profitability through the surge in sales of its antibiotic Cipro following the mailed anthrax incidents last year.

Surprisingly, none of the companies involved in direct manufacture of anthrax and smallpox vaccines to be sold to the U.S. Government is a member of PhRMA. Currently, Bioport in Michigan produces the only FDA-approved anthrax vaccine. Acambis, supported by Baxter investments, will be the supplier of a new smallpox vaccine. The FDA is said to have promised quick approval of Acambis’ vaccine, shortcutting the normal approval cycle.

However, under the radar of the Pharmaceutical Research and Manufacturers of America PhRMA umbrella there is a web of interlocking agreements, partnerships and alliances among members, for profit non-members, and tax-exempt foundations involved in bioweapon research and production. Ostensibly searching for defenses against biological attacks, the threats must be produced to measure the effectiveness of vaccines and antibiotics.

A common thread in the fabric of this web is the presence of two giant foundations; Battelle Memorial Institute (BMI) and the Howard Hughes Medical Institute (HHMI). Billions of dollars have been funneled through these institutes to universities, private companies and individual researchers in the bio-genetic field of scientific effort. The money comes from government grants, contracts with various government agencies and from their own huge endowments. Both have extensive ties to the CIA and other government agencies involved in classified operations.

In a three part series (Anthrax, GOCO’s and Designer Germs) this writer detailed Battelle’s management, or co-management, of four super-secret government installations, one of which (Dugway, Utah) stockpiles and has produced weaponized anthrax.

Researchers Leonard Horowitz and Patricia Doyle have catalogued the extensive involvement and control by HHMI of research on the human genome. At least six microbiologists in that field with ties to HHMI have been murdered or died mysterious deaths (five since 9/11/01).

One of the undercurrents in the development of the ability to change genes is the documented effort by scientists in several countries (including the U.S.) to turn the science into production of deadly designer diseases that attack only specific segments of the population.

According to an undercover FBI informant, American scientist Larry Ford (who had ties to the CIA) designed an agent for the South African bioweapon program that would affect only blacks. Ford later was considered a suspect in the attempted murder of his business partner, and died from a shotgun blast that was ruled a suicide.

One of the concerns of researchers, including this writer, is that such bioweapons may have been perfected and the spate of some 14 or 15 scientists’ deaths is merely a cleanup operation eliminating those who know too much or are potential whistle blowers.

A second concern is with the vaccines and other “defensive” agents being hastily contrived. Could any of them actually contain dangerous designer genes? As states adopt the model emergency health legislation, combined with the 1996 interstate emergency assistance compact, procedures will be in place to compel vaccinations under threat of detention in a different state.

These (unconstitutional) “emergency” procedures only require the declaration of any emergency by states’ governors. In the case of a health emergency, only a perceived threat is necessary, not an actual outbreak. And who will announce the existence of a “threat”? Odds are it will be Homeland Health. ²⁾

Biological Weapons Experts Call for Revisions to BioShield II Legislation October 25, 2005 For more information contact: Alan Pearson, apearson@armscontrolcenter.org

FOR IMMEDIATE RELEASE Press Contact: Alan Pearson Phone: 202-546-0795 x107 email: apearson@armscontrolcenter.org

Washington, DC (October 25, 2005)

Biological weapons experts at the Center for Arms Control and Non-Proliferation called yesterday for changes in the BioShield II legislation currently making its way through the U.S. Senate (S. 1873 - the “Biodefense and Pandemic Vaccine and Drug Development Act”) that would increase transparency and international cooperation in U.S. biodefense.

In a letter distributed to all U.S. Senators, Alan Pearson, Director of the Center’s Program on Biological and Chemical Weapons Control, and Lynn Klotz, a biotechnology consultant and former biotechnology executive who is Senior Science Fellow at the Center, noted that the legislation “laudably seeks to correct weaknesses in the Project BioShield Act of 2004.” However, they said, it “falls short. In particular, …[it] fails to address two key aspects of our biosecurity.”

According to Pearson and Klotz, “biosecurity at home relies on biosecurity throughout the world. Epidemics and pandemics of naturally occurring disease outside our borders can be a major threat to the U.S., as could a biological weapons attack.” They noted that the current legislation “fails to … include provisions for enhancing international cooperation and public health, such as strengthening and integrating international infectious disease surveillance.”

Pearson and Klotz also said that the legislation “mandates secrecy in areas where transparency is both appropriate and necessary for the public’s health and security.” In particular, they pointed to language which exempts the newly envisioned Biodefense Advanced Research and Development Agency from the Freedom of Information Act (FOIA). The said that “all information relating either directly or indirectly to this new agency could be withheld from public disclosure unless the Secretary of Health and Human Services or the Director of the Agency specifically determines, on a case by case basis, that such disclosure would not pose a threat to national security.” Pearson said that “this stands FOIA on its head.”

In their letter, Pearson and Klotz wrote that such “secrecy is inappropriate when developing [drugs and other] countermeasures for natural infectious disease. … Robust and effective countermeasure development can take place only in a climate of timely and free exchange of materials and information.” They continued “public accountability is essential for ensuring that the activities envisioned in [this legislation] … meet our nation’s biodefense and public health needs.” Yet, “if enacted as is, this legislation will dramatically reduce the level of public accountability for” such efforts. They noted that “recent concerns about FDA regulatory oversight … clearly demonstrate the importance of transparency and accountability for public health.”

Pearson and Klotz noted that lack of transparency can also fuel “suspicions on the part of nation’s about the intent of each other’s biodefense activities. … A high level of transparency in biodefense activities can reduce suspicions, thereby reducing the risk of an international [biological weapons] arms race.”

In their letter to the Senators, Pearson and Klotz concluded that “our biosecurity will be better served if public disclosure of all information related to … the BARDA is mandated, except in special circumstances where the Secretary [of Health and Human Services} or Director [of BARDA] determines that disclosure would be an obvious threat to our national security.” Tying transparency to international cooperation, they noted that “international cooperation in the form of consultation, oversight, and co-development of countermeasures implicitly contributes to transparency.” ³⁾

See also-“Even intelligence agencies and the Defense Department do not have blanket exemptions from FOIA” - Nick Schwellenbach of the Project on Government Oversight. See a statement on the POGO blog here -

S. 1873 Biodefense and Pandemic Vaccine Drug Development Act of 2005

(Bio)Shielding Industry

This Tuesday, October 18, a Senate committee moved a bill forward that would create a new agency within the Department of Health and Human Services (HHS). This new agency would help spur private industry to develop and manufacture medical countermeasures for bioterrorism agents and natural outbreaks such as a possible avian flu pandemic. But the bill also makes oversight and accountability of much of America's biodefense efforts nearly impossible.

S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, exempts industry from liability and a new agency within HHS, the Biomedical Advanced Research and Development Agency (BARDA) from the Freedom of Information Act (FOIA), the Federal Advisory Committee Act (FACA) and parts of the Federal Acquisition Regulations (FAR). Here's the October 17, 2005 text of the legislation (pdf).

Global Security Newswire lists other questionable aspects of the bill, such as forbidding government purchases of generic drugs thus tying the government's hands.

Several groups such as the National Vaccine Information Center and the Center for Justice and Democracy are opposed to the indemnification of industry. And we at POGO don’t see how exempting BARDA from FOIA, FACA and FAR cost/accounting standards can even be justified.

BARDA would be responsible for handling the $5.6 billion Project Bioshield initiative to create a new biodefense industry with government incentives and contracts. Exempting BARDA would mean congressional and public oversight of the agency and its important activities would be severely curtailed. A less effective agency and an American public more vulnerable than it should be are the likely results of this erosion of transparency. ⁴⁾