Since Burlington Free Press Reporter Tim Johnson appropriately headlined the hearing on vaccine regulations today at the Health Department, "Foes of mandatory vaccination speak out at hearing today," I thought I would share further background and information on the subject of conflict of interest in Federal Vaccine Policy. The following information was originally posted at www.vaccinationnews.com. Although the original publication is 13 years old (and the vaccine schedule has ballooned since then), the information is still very much relevant today.
For more background on conflict of interest in our national vaccine policy, see also: Money Magazine article from 1996.
Presentation by Kristine M. Severyn, R.Ph., Ph.D.
56th annual meeting, Association of American Physicians and Surgeons
Coeur d'Alene, Idaho, October 14, 1999
I wish to thank you for the kind invitation to speak here today. I consider it a great honor to have been invited. Since 1993 I have followed news accounts of your organization. At that time my family was living for ten months near Washington, D.C., where I daily devoured The Washington Post and The Washington Times. News of the AAPS lawsuit to open up Hillary Clinton’s Health Care Policy Task Force caught my eye; I still have the news clippings. At the time I thought, “This is really one great group of physicians.” I also purchased, for a dollar, from the Wright State University Medical School Library a used copy of the 1973 AAPS book, Medicine and the State. Dr. Orient tells me that it is one of the few original bound copies left.
Earlier this year I had the privilege of having dinner with Dr. Orient and other distinguished AAPS members while Dr. Orient was in Dayton, Ohio for, among other things, a book signing. I purchased and read an autographed copy of her book, Your Doctor Is Not In, and in the process became better educated about the perils of managed care. I continue to recommend the book to countless others.
When Dr. Orient was in Dayton, our organization was in the midst of opposing a hepatitis B vaccine mandate for kindergartners across Ohio. The mandate was tagged onto a hazardous waste bill in 1998 (1), through direct lobbying of the Ohio House and Senate health committees by the two manufacturers of hepatitis B vaccine, Merck and Smith Kline Beecham. In an effort to reverse the mandate, I wrote an op-ed column about the shady manner in which the mandate was passed (2), mailed it to all 300-plus newspapers across the state, and met with the head of the House Health Committee. Surprisingly, he introduced legislation to rescind the mandate, and eventually reversed his original support of vaccine mandates (3).
Since Ohio was the first state to have such a bill introduced and have legislative hearings scheduled to rescind a hepatitis B vaccine mandate (4), well-funded organized opposition to our efforts descended from across the country on the statehouse in Columbus, Ohio. A representative of a public relations firm from New York City, hired by the American Academy of Pediatrics and the vaccine manufacturers to deal with hepatitis B vaccine dissent, flew back and forth from New York to Columbus for the hearings. A representative from the CDC (Centers for Disease Control and Prevention) flew up from Atlanta to testify. Two out-of-state parents testified in support of the mandate. (I later saw these same two parents give identical testimonies at the May 18th, 1999 congressional hepatitis B vaccine hearings in Washington, D.C..) Representatives from the American Academy of Pediatrics and the Cleveland Clinic testified. We were definitely outgunned, financially and otherwise.
Public opinion appeared to be on our side, however, reflected in five daily newspapers who questioned mandatory hepatitis B vaccine mandates for schoolchildren and a Chicago Sun-Times telephone poll where 83 percent of those voting stated they did not want their children vaccinated against hepatitis B (5). Our members and other Ohio citizens flooded the House Health Committee with letters opposing the hepatitis B vaccine mandate (6). We also gathered 25 letters from physicians in and out of Ohio, who questioned the vaccine mandate (7). Several of these letters came from Dr. Orient and other AAPS members. AAPS was the only medical organization which had the courage to oppose the hepatitis B vaccine mandate. For this, I will always be grateful.
Unfortunately, we lost the vote. We do have in our state, however, a rather liberal religious exemption for those parents who do not want their children to receive hepatitis B vaccine (8). These exemptions are not available, however, for college students or adults who work in professions which require the shots.
I brought copies of a letter summarizing our efforts to rescind the hepatitis B vaccine mandate in Ohio (9), as well as copies of my op-ed column on the issue, which appeared in newspapers across the state (2).
Until the recent removal of rotavirus from the market, the federal government had recommended eleven vaccines administered in multiple doses by the age of 2 years. (Slide of Recommended Childhood Immunization Schedule, United States, January-December 1999) How did organized medicine get to such a point where informed consent, a basic tenet of ethical medical practice, gets thrown out the window, under the guise of “disease prevention?” Those who are not vaccinated face societal punishment, for example:
- Children may not attend school (10);
- Their parents may be accused of child abuse (11);
- Families may have their welfare benefits slashed (12);
- Adults may not attend college (10);
- Adults may be forbidden from working in selected professions (13).
For the remainder of my presentation, I have prepared a brief history of mandatory vaccination policy in the United States. For those interested, I will leave a more detailed printed copy of this presentation, including references, with Dr. Orient.
Jacobson v. Massachusetts
Mandatory vaccination laws are made in state legislatures. The precedent for such laws goes back to a 1905 U.S. Supreme Court decision, Jacobson v. Massachusetts (14, 15). Mr. Jacobson, an adult resident of Cambridge, Massachusetts, refused to be vaccinated, opposing a 1902 Cambridge Board of Health mandate “that all inhabitants of the city...be vaccinated...” Jacobson claimed that he had “suffered seriously from previous vaccination,” as did his son. All adults over 21 years of age who refused vaccination were fined $5.00.
The U.S. Supreme Court affirmed the right of a state legislature to enforce mandatory vaccination, claiming it a proper exercise of the state’s police power to enact “health laws” reflecting dominant medical beliefs and those of the majority of society. Thus, the opinion of the minority should not subvert the opinion of the majority, or “the interests of the many [should not be] subordinated to the wishes or convenience of the few.”
Noting the controversial nature of vaccination, the U.S. Supreme Court stated, “...in a free country, where the government is by the people...what the people believe is for the common welfare must be accepted as tending to promote the common welfare, whether it does in fact or not” [emphasis added]. This means that until public opinion changes, with subsequent changes in state vaccination laws, the courts will not condiser challenges to state vaccination laws.
State vaccination laws
In 1904 only 11 out of then 45 U.S. states had compulsory vaccination laws, with 13 states excluding unvaccinated children from public schools. No state employed “forcible vaccination” (15). With the licensing of the Sabin live oral polio vaccine in 1960, the drive to enforce vaccination as a prerequisite for school admission accelerated across the country.
In March 1962, President John F. Kennedy submitted the Vaccination Assistance Act of 1962 to Congress, which provided three years of federal assistance to states and local departments of health. The first grants were awarded in June 1963, with grantees having the option of receiving vaccines or personnel in lieu of cash payments (16).
This 1962 legislation represented an important milestone for the CDC in that its immunization personnel (federal civil service workers) could now infiltrate local and state health departments around the country, transforming them into satellites of the CDC in Atlanta. Prior to this, CDC personnel worked only in local and state sexually transmitted disease control units. All 50 states have such federal civil service CDC workers in their state capitals and/or local communities. For example, the Immunization Program Director at the Ohio Department of Health (ODH) is a federal civil service CDC employee, whose desk is at ODH. This explains how federal vaccine recommendations are incorporated so quickly into state laws, based on easy access to state legislatures.
Current exemptions to compulsory vaccinations
State legislatures have granted three types of exemptions from compulsory vaccination, with the availability of each type varying depending on the state. Such exemptions are not absolute in that if the local department of health declares a public health emergency, the exemptions can be canceled (17).
Every state provides a medical exemption. Religious exemptions are available in 47 states, some requiring that a person’s religion be disclosed, while others are worded more liberally. Mississippi and West Virginia provide no religious exemptions, only medical exemptions. While Minnesota provides no religious exemption, it provides a philosophical exemption (15).
The third type of vaccine exemption is the so-called “philosophical exemption,” which, depending on the state, allows objections ranging from “personal,” “philosophical,” or “moral” beliefs, or “other.”
As recently as 1990, 22 U.S. states provided philosophical exemptions for vaccines. However, encouraged by state departments of health, whose immunization departments are usually staffed and/or funded by the CDC, several state legislatures have deleted philosophical exemption provisions in their state codes. Where no organized citizen opposition exists, the exemptions have been lost. But, where citizen opposition was present, legislative attempts to delete the exemptions were defeated (15). Currently, the following states have philosophical exemptions for vaccines: AZ, CA, CO, ID, LA, ME, MI, MN, NM, ND, OK, PA, UT, VT, WA, and WI (10).
Interestingly, even with the availability of vaccine exemptions, few families take them. Across the U.S. less than 2 percent of students in each state take any type of exemption. A September 5, 1997 report of the National Vaccine Advisory Committee stated:
- “There appear to be no correlation between states which allow philosophical exemptions and immunization coverage...”, and
- “Given the small percentage of children who are currently exempted... philosophical exemptions do not appear to have a major detrimental impact on child health and well-being in the United States...” (18).
Dr. Alan Hinman
One of the most influential persons in pressing for mandatory vaccination laws was Dr. Alan Hinman. In 1996 the CDC gave Dr. Hinman a lifetime achievement award for his 24-year career at the CDC, part of which he served as head of the Division of Immunization (now the National Immunization Program). During this time Dr. Hinman “directed the efforts to assure that state immunization laws were established and enforced in every state throughout this country” (19).
After Dr. Hinman retired from the CDC in 1996, he went to work for the Carter Center in Atlanta, in the same city as the CDC. At the Carter Center, which advocates former President Jimmy Carter’s and his wife’s social change projects, Dr. Hinman works for All Kids Count and The Task Force for Child Survival and Development. Since 1991 All Kids Count has worked on establishing government vaccine registries (aka: Immunization Information Systems), which track children’s, and eventually will track all persons’ vaccination records by Social Security numbers in government computers. A past CDC director and deputy director of CDC, Dr. William Foege and Mr. Bill Watson, also work with Dr. Hinman at All Kids Count in the Carter Center. I detailed the government’s vaccine tracking activities in my October 1998 newsletter, “Vaccine Tracking: Big Brother is Watching You!” (20).
State vaccination laws essentially federal mandates
While there is technically no federal mandate for vaccines, except for vaccines mandated in the military, the Department of Health and Human Services (HHS) requires that all recipients of federal vaccine grants must have “a plan to systematically immunize susceptible children at school entry through vigorous enforcement of school immunization laws” (21). Since, on the average, 60-75 percent of each state’s immunization programs are funded by the CDC, state departments of health do what the CDC tells them to do.
CDC places great importance on enforcing its vaccine recommendations. At the 1997 CDC National Immunization Conference, the director of CDC’s National Immunization Program, Dr. Walter Orenstein, described mandatory vaccinatoin laws as “our nation’s public health safety net.” Vaccines must be mandated, says Dr. Orenstein, because, “After all...[vaccines] are not 100 percent effective. A few vaccine failures or a few unvaccinated children are protected by high immunization levels...It is good for the health of all that we have uniformly high immunization coverage rates throughout our country” (22).
Are vaccine mandates scientifically based?
Americans naively assume that CDC’s vaccine policies are backed by numerous medical studies proving that vaccines always work and are safe. Nothing could be further from the truth. Vaccine recommendations for rubella (German measles are a prime example.
CDC experts admit there really is no evidence supporting the current requirement that seventh-graders and/or college students in most states receive a second dose of rubella vaccine. In February 1996 the director of CDC’s National Immunization Program, Dr. Walter Orenstein, even commented, “We don’t have the data to support a second dose of rubella, but we hate to go back” (23). Nevertheless, to facilitate measles outbreak control, students across the U.S. must receive, upon CDC urging, a second dose of the combination vaccine MMR (measles, mumps, rubella), in lieu of monovalent measles vaccine, before attending classes. Meanwhile, the federal Vaccine Injury Compensation Program has payed out injury claims to MMR vaccine victims.
Worse yet, CDC targets adult females for additional rubella vaccination, even though this group is historically at significantly higher risk for temporary or permanent adverse reactions. To bolster its utilitarian view that rubella vaccine is harmless, CDC cites studies funded by rubella vaccine manufacturer Merck and Co..
Conflict of Interest and CDC Cover-up
The way CDC currently withholds information, circles its wagons, and cites only the studies which support its views, ignoring those studies that don’t, one would think that the letters CDC stood for Cover-up, Distortion, and Coercion. Another favorite of mine is Coercion, Distortion, and Conflict of Interest.
The CDC committee which sets national vaccine policy, the Advisory Committee on Immunization Practices, whose recommendations are routinely mandated by state legislatures, until 1997 operated for more than 20 years without making verbatim transcripts of its meetings available to the public. Virtually all federal advisory committeess, vaccine or otherwise, make available verbatim transcripts of their meetings about one month after the meeting. Meeting far away from Washington, D.C. at CDC headquarters in Atlanta, ACIP instead chose to make available only heavily-edited minutes. For some meetings, it took more than a year for CDC to make meeting minutes available to the public; at least six months was the norm. ACIP policies were put into effect across the U.S. while the public remained in the dark about how vaccine recommendations were made at ACIP meetings.
In my January 1997 and June-July 1998 newsletters (24), I discuss at length my battle to make ACIP meeting transcripts public. This battle involved letters to the CDC, meetings with two congressmen and a senator in Washington, D.C., and many hours and late nights writing reports and letters.
CDC did not give up easily. When months of negotiations between Congress and CDC failed, Congress added a statement in July 1997 to CDC’s 1998 appropriations, i.e., the agency’s operating budget language from Congress, instructing CDC to make the transcripts available. Backed into a corner, the CDC relented. At the beginning of the October 22, 1997 ACIP meeting it was announced that verbatim transcripts would now be available, in his words, “...for reasons I won’t go into here...”
Except for the higher ups at CDC, those attending that meeting may never know that CDC was essentially forced by Congress to begin preparing and providing verbatim transcripts of ACIP meetings. But, you and readers of my newsletter know. My only concern now is that more work will be conducted behind closed doors.
My fears are not without basis. Just last month at the National Vaccine Advisory Committee meeting, which I attended on September 16th while Hurricane Floyd passed over Washington, D.C., Dr. Hinman and HHS attorney David Benor told committee members how they could get around the Federal Advisory Committee Act and not be bothered with public meetings to enact public policy (25).
ACIP conflict of interest
Conflict of interest among ACIP members and vaccine manufacturers is quite common. While federal law (18 U.S.C. section 208) prohibits members of federal advisory committees from participating in matters in which he/she, wife, or child, or organization has a financial interest, the conflict of interest can be waived if “the need for the individual’s services outweighs the potential for a conflict of interest created by the financial interest involved” (26).
I was told last week by a CDC official who helps manage the conflict of interest waivers for ACIP members that all ACIP members serve under waivers (27).
Indeed, past Assistant Secretary for Health, Dr. James Mason, implied that if the government did not use such individuals to advise them, we’d have no vaccine experts (28).
When I alerted my congressman a few years ago to problems of conflict of interest on ACIP, he wrote then Secretary of HHS Louis Sullivan, who turned over the problem to Dr. Mason, who turned over the problem to the CDC ACIP staff, the HHS lawyers who advise them (Office of General Counsel), the CDC Deputy Ethics Officer, and Executive Secretaries for “several CDC advisory committees [who] met to discuss procedure for addressing potential conflicts of interest in all CDC advisory committees.” What do you think they decided?
According to a letter from Dr. Mason to my congressman (29):
“The group strongly reaffirmed the appropriateness of including individuals as members of advisory groups based on their expertise. Federal advisory committees do not exclude from memberhip university investigators who have consulted for or have conducted studies funded by pharmaceutical companies. A policy that excludes such scientists would eliminate many university investigators knowledgeable about vaccines.”
Dr. Mason continued to describe how HHS complies with “requirements for disclosure of potential conflicts of interest on an annual update of Health and Human Services Form No. 474 (Confidential Statement of Employment and Financial Interest)...” Each Form No. 474 is “reviewed and signed by the Executive Secretary for the Advisory Committee [a U.S. Public Health Service, CDC employee] and by the Deputy Ethics Officer fo CDC.”
In a nutshell, Dr. Mason told my congressman not to worry because CDC’s SOP’s (standard operating procedures) were in place which CDC established to define conflicts of interest and keep specific details about conflicts of interest secret from the public. Since a system to monitor conflict of interest was in place, the agency was technically in compliance with the law. In essence, “Buzz off.”
The Catch 22 in all of this is that financial disclosure forms are confidential. If citizens request these forms, they are told by the Freedom of Information Officer at CDC that the forms “are exempt under the provisions of 5 U.S.C. 552(b)(3) of the Freedom of Information Act, which permits nondisclosure of records exempted by other statutes. In this case, the Ethics in Government Act prohibits the disclosure of “financial disclosure documents.”
In addition, citizens are told that release of financial disclosure forms “constitute(s) a clearly unwarranted invasion of personal privacy,” per U.S.C. 552(b)(6) and “the Department’s [HHS] implementing regulation 45 CFR 5.67” (30).
Recognizing that the waiver policy might obstruct implementing CDC policy, the ACIP charter was recently changed to temporarily deputize non-voting ex-officio members from various government agencies, e.g., Food and Drug Administration, National Institutes of Health, Vaccine Injury Compensation Program, Department of Defense, to voting members (31).
I witnessed this process used for five votes at the February 1999 ACIP meeting in Atlanta. So many ACIP voting members had conflict of interest that a quorum could not be reached. Consequently, ex-officio members from government agencies were deputized to facilitate the votes. Needless to say, all votes favored CDC policy (32).
Vaccine policy top secret
Citizens are also confronted with similar obstacles when they try to research how vaccine policy is formulated. When the CDC is questioned about the rationale behind its vaccine recommendations, which one assumes would be public information, citizens find that the agency treats formulation of national vaccination policy as a top military secret. Instead of being honest, CDC hides behind an obscure provision in the federal Freedom of Information Act that exempts it from releasing such information (33). According to the U.S. Department of Justice, this loophole is necessary so as not to “stifle honest and frank communication within the agency.” Consequently, the public is left in the dark about the scientific validity behind various CDC vaccine recommendations.
Thus, U.S. families must live with a government vaccine policymaking bureaucracy which is accountable to no one but itself. The agency, CDC, who determines U.S. vaccination policy is the same agency who determines whether or not a conflict of interest is significant. When the public tries to find out just how significant a conflict is, the CDC tells them that the degree of conflict of interest is confidential. When the public questions how a policy is formulated, the CDC tells them that is also confidential. The U.S. Public Health Service says, “Trust us, we know best.”
Institute of Medicine
Who sets priorities for vaccine development?
A division of the National Institutes of Health, the National Institute of Allergy and Infectious Diseases (NIAID), works in conjunction with other branches of government and industry to determine future vaccine development (34, 35). The Institute of Medicine (IOM), a division of the prestigious National Academy of Sciences, receives government contracts to evaluate which vaccines should be put on the fast track. Six of the 14 vaccines so recommended in IOM’s 1985 report (36) have since been licensed and, in some states, mandated for school or daycare (acellular pertussis, Hemophilus influenzae type B, hepatitis A, hepatitis B, varicella, rotavirus).
In April 1999 the IOM released a second report (37) which sets vaccine research priorities in this country for the next 20 years. One of the seven vaccines in the “most favorable” category is “influenza vaccine given to the general population.” (The 1985 IOM report likewise recommended developing a live influenza vaccine, but recommended it only for high risk populations.) As you may have read, the government is only a year or two away from licensing a live, nasal flu vaccine. It looks like the vaccine will be mandated for school admission, not to protect children, but to protect so-called high risk individuals for whom influenza can have serious complications. Considering the poor track record of inactivated influenza vaccines in protecting recipients from influenza (38), it’s no wonder the government is trying to research something better. But, you won’t hear anything negative from the government about current flu shots until there is something ready to replace them.
In the next most favorable category of the 1999 IOM study, which cost taxpayers more than $1 million dollars, four of the nine recommended vaccines are sexually- transmitted diseases (chlamydia, herpes, human papillomavirus, and gonorrhea), specified for administration to all 12-year-olds to prepare them for teenage fornication.
IOM evaluates vaccine safety
The National Childhood Vaccine Injury Act of 1986 specified that IOM be contracted to conduct studies on vaccine safety. These studies, which cost taxpayers nearly $2 million, were released in 1991 (39) and 1994 (40). While both studies acknowledged the scarcity of research which would determine the degree of vaccine safety, the 1991 IOM study was used by the Department of Health and Human Services in its 1992 proposal to redefine pertussis vaccine injury (41). This change in criteria to grant award payments under the Vaccine Injury Compensation Program (VICP) effectively eliminated 90 percent of pertussis vaccine damage claims submitted at that time, pertussis vaccine damage representing almost three-fourths of all VICP claims.
IOM conflict of interest
While IOM is described as an independent scientific body, conflict of interest betrays its independence. IOM’s corporate donor list reads like a Who’s Who of the medical industrial complex, including nearly all major drug and vaccine manufacturers, health insurance companies, health maintenance organizations, Monsanto, the American Medical Association, the American Hospital Association, the World Health Organization, the March of Dimes, blood bank industry trade groups, and the American Red Cross (42).
An article in the February 1994 Scientific American (43) likewise cited concerns about the “impartiality and independence” of NAS studies and the NAS’s “cozy relations with external parties.”
In congressional hearings leading to passage of the 1986 National Childhood Vaccine Injury Act, which protects vaccine manufacturers from lawsuits, one vaccine manufacturer testified in 1984 that his company “among others, made a major financial contribution to support the IOM study,” which subsequently recommended in 1985 (44) that “political decision makers...develop a compensation system for vaccine-related injury.” The U.S. taxpayer now funds vaccine makers’ liability expenses. This misguided piece of legislation was a cash cow for vaccine manufacturers, giving them all incentive to research and market new vaccines, with little incentive to improve existing products (45).
Members of IOM committees are not without conflict of interest, some obvious, like employees of pharmaceutical companies. IOM claims privacy rights when requests are made to reveal less public conflict of interest involving other members.
In 1997 various groups affected by IOM decisions won lawsuits in federal court challenging the IOM’s status as an independent body, and claiming that IOM should be covered by the Federal Advisory Committee Act (46). Things were looking quite bleak for IOM until its friends in Congress, plus President Clinton, passed legislation to undo the court decisions (47).
Cocaine vaccine for all children?
As if venereal vaccines for all 12-year-olds weren’t bad enough, the government is developing a cocaine addiction vaccine (48). If the suggestion by Peter J. Cohen, of the National Institute on Drug Abuse, National Institutes of Health, “to analogize cocaine addiction to an infectious disease...”, is predictive of what we can expect, we may have reason to worry. In 1997 Cohen suggested giving a future cocaine addiction vaccine to all children, so that cocaine addicts are not stigmatized (49).
A discussion about mandatory vaccines would not be complete without mentioning the anthrax vaccine controversy in the military. While the military continues to courtmartial and discharge military service personnel who refuse anthrax vaccine, government health officials know deep down that the vaccine leaves much to be desired. At the December 1998 meeting of the Advisory Committee on Childhood Vaccines, I heard one U.S. Public Health Service officer describe the current anthrax vaccine as a “terrible “ and “primitive” vaccine which incorporates “old technology.” Since the anthrax vaccine manufacturing facility was unable to supply enough vaccine for the entire military, the company took stockpiles of outdated vaccine and, with permission of the Food and Drug Administration, put new expiration dates on the outdated vaccine (50).
In addition to these problems, the anthrax production facility in Michigan is shrouded with potential conflict of interest involving its Department of Defense contracts. Past Chairman of the Joint Chiefs of Staff, Admiral William J. Crowe, is on the board of directors of Bioport, the sole supplier of anthrax vaccine. Congress held hearings on the anthrax vaccine controversy earlier this year (51), and two bills have been introduced which would make the vaccine voluntary and stop the program until more studies are conducted (52).
Recent press reports allege that the military discourages reporting of anthrax vaccine adverse reactions to VAERS (Vaccine Adverse Events Reporting System). There may be some truth to the reports. On September 17, 1999 an army lieutenant colonel who helps manage the anthrax vaccine program spoke to the National Vaccine Advisory Committee, which I attended. During the public comment time I asked if military personnel are each given the phone number of VAERS to facilitate reporting of anthrax vaccine reactions directly, as is the case in the civilian sector with Vaccine Information Statements. During the meeting he stated that VAERS information was not given to military recipients of anthrax vaccine during the first three months of the anthrax vaccine program, but that since then, vaccine recipients have been given a vaccine information sheet which includes the VAERS phone number (52).
The following morning the same army lieutenant colonel left a message on my home voice mail at 8:00 a.m., that he had given me erroneous information at the NVAC meeting the day before, and that in fact military personnel were not currently given information on how to directly report vaccine adverse reactions to VAERS (53). With this in mind, is it any wonder that so few anthrax vaccine adverse reactions are reported?
More conflict of interest
While I briefly touched on the problem of conflict of interest, time does not permit me to fully discuss this topic now. The author of the 1906 novel The Jungle, Upton Sinclair, reportedly observed, “It is difficult to get a man to understand something when his salary depends on his not understanding it.” By way of note, Sinclair’s detailed account of the turn-of-the-century meatpacking industry prompted President Theodore Roosevelt’s administration to enact pure food and drug laws. I gave a presentation detailing conflict of interest issues in U.S. vaccination policy at a Michigan vaccine conference on October 2nd. The presentation will be available in my newsletter or posted on our organization’s website. Dr. Orient has also asked me to submit an article documenting conflict of interest in vaccine policy for Medical Sentinel, which I plan to do after this conference.
I thank you all for your attention, and welcome any questions.
- Amended Substitute Senate Bill 153, Ohio 122nd General Assembly, 1997-1998.
- Severyn, K.M., Hepatitis B vaccine for Ohio’s kindergartners unnecessary, wasteful, The Cincinnati Enquirer, January 15, 1999, p. A23; Severyn, K.M., Has Ohio’s vaccine policy gone too far?, Dayton Daily News, January 27, 1999, pg 9A; and others.
- Ohio House Health, Retirement, and Aging Committee, May 5, 1999 Vote on House Bill 200, Amendment 123-0758.
- House Bill 200, Ohio 123rd General Assembly, 1999-2000.
- Hepatitis shots should be OK’d by parents. Dayton Daily News, January 27, 1999, p. 8A; Hepatitis B vaccine to get its hearing in Ohio after all, Dayton Daily News, March 29, 1999, p. 6A; R
- Lawmakers consider easing hepatitis mandate, Delphos (Ohio) Herald, (Associated Press), April 29, 1999.
- Vaccine rule may bite dust, Dayton Daily News, April 29, 1999, p. 3B.
- Ohio Revised Code 3313.671.
- Letter to Vaccine News recipients and VPI contacts, from Dr. Kristine Severyn, Re. Ohio's hepatitis B vaccine legislation--update, May 1999. (Available from: Vaccine Policy Institute, 251 W. Ridgeway Dr., Dayton, OH 45459.)
- State Immunization Requirements 1996-1997. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention.
- In the Matter of Christine M., 595 N.Y.S.2d 606,607 (1992).
- Severyn, K.M., Concerned parents unfairly shut out of congressional hearings on vaccinations, Dayton Daily News, May 28, 1993, p. 15A.
- "All dentists and dental health care workers must show evidence of immunity to or immunization against the hepatitis B virus when such immunization does not threaten their health and well-being" Ohio Administrative Code 4715-20-01 (A). The Ohio State Dental Board "determines [if a] waiver [from hepatitis B vaccination] is justified" (OAC 4715-20-01 (C)).
- Jacobson v. Massachusetts, 197 U.S. 11 (1905).
- Severyn, K.M., Jacobson v. Massachusetts: Impact on Informed Consent and Vaccine Policy, J. of Pharmacy and Law, 5(2): 249-274, 1996.
- Hinman, A., Acceptance speech for lifetime achievement award, Centers for Disease Control and Prevention's 30th National Immunization Conference, First General Session, Washington, D.C., April 9, 1996.
- Dover, An Evaluation of Immunization Regulations in Light of Religious Objections and the Developing Right of Privacy, 4 U. Dayton L. Rev. 401 (1979).
- National Vaccine Program Office, Centers for Disease Control and Prevention, 1600 Clifton Rd., N.E., Mailstop D-66, Atlanta, GA 30333.
- Orenstein, W.A., Opening speech, Centers for Disease Control and Prevention's 30th National Immunization Conference, First General Session, Washington, D.C., April 9, 1996.
- Severyn, K.M., Vaccine Tracking: Big Brother Is Watching You, Vaccine News, October 1998, Vaccine Policy Institute, 251 W. Ridgeway Dr., Dayton, Ohio 45459.
- 42 CFR 51b.204 (Title 42, Public Health, Chapter I, Public Health Service, Department of Health and Human Services, Part 51b--Project Grants for Preventive Health Services--Subpart B--Grants for Childhood Immunization Programs).
- Orenstein, W.A., Presentation to 31st Centers for Disease Control and Prevention National Immunization Conference, Detroit, Michigan, May 19, 1997.
- Rubella Elimination Working Group, meeting proceedings, Centers for Disease Control and Prevention, February 13, 1996.
- Vaccine Policy Institute, 251 W. Ridgeway Dr., Dayton, Ohio 45459.
- Transcripts available from National Vaccine Program Office, 1600 Clifton Rd., N.E., Mailstop D66, Atlanta, GA 30333.
- 18 U.S.C. section 208 (b)(3).
- John Livengood, M.D., Medical Officer, Director of Epidemiology and Surveillance Division, Centers for Disease Control and Prevention, 1600 Clifton Rd., N.E., Mailstop E61, Atlanta, GA 30333. See also, "Financial Conflicts of Interest and 208 (b)(3) Waivers," which describes how CDC incorporates 18 U. S. C. section 208 into establishing conflict of interest waivers for Advisory Committee on Immunization Practices (ACID) members. The following ten items are defined/described: Prohibition, inherent potential, waivers, integrity of committee, scope of waivers, current direct financial interest, disclosure not required--uncontrolled interests, de minimus financial interests--honoraria and travel support for scientific interchange, voting restrictions, and financial disclosure by members. See also, blank waiver form given to the Deputy Ethics Counselor, CDC from the ACID Executive Secretary, regarding Conflict of Interest Waiver for Participation on the ACID. (Faxed on December 11, 1996 from Dr. Dixie Snider, Executive Secretary, ACIP.)
- Letter to Jeffrey H. Schwartz, Dissatisfied Parents Together, from James O. Mason, M.D., Dr. Ph.H., Assistant Secretary for Health, U.S. Department of Health and Human Services, July 10, 1991. "Limited funding is available from the Government for applied research on vaccine immunogenicity and efficacy; therefore, such research is generally funded by pharmaceutical companies. A policy that excludes such scientists would eliminate many university investigators knowledgeable about vaccines."
- Letter to Congressman Bob McEwen from James O. Mason, Assistant Secretary for Health, July 21, 1992.
- Letter to Joanne Hatem, M.D. from Donald A. Berreth (signed by Laura Leather), Centers for Disease Control and Prevention Freedom of Information Ofcer, Director, Office of Public Affairs, October 30, 1990.
- Charter, Advisory Committee on Immunization Practices. Centers for Disease Control and Prevention. (distributed at October 1998 meeting) Available from: National Immunization Program, Centers for Disease Control and Prevention, 1600 Clifton Rd., NE., Mailstop E05, Atlanta, GA 30333.
- Transcripts available from Centers for Disease Control and Prevention National Immunization Program, 1600 Clifton Rd., N.E., Mailstop E05, Atlanta, GA 30333.
- Maida, P. (ed), Freedom of Information Act Guide and Privacy Act Overview, September 1995 edition, Office of Information and Privacy, U. S. Department of Justice, Washington, D.C. 20530. ISBN 0-16-048375-1, p. 179.
- Folkers, G.K., and Fauci, A.S., The role of U.S. government agencies in vaccine research. Nature Medicine (Vaccine Supplement), 4(5) May 1998, 491-494.
- Gellin, B. (ed), The Jordan Report: Accelerated Development of Vaccines. Bethesda, Maryland: National Institute of Allergy and Infectious Diseases, 1998.
- New Vaccine Development: Establishing Priorities. Volume I, Diseases of Importance in the United States. National Academy Press, Washington, D.C. 1985.
- Vaccines for the 21 st Century: A Tool for Decisionmaking. National Academy Press, Washington, D.C., 1999. (National Institute of Allergy and Infectious Diseases, National Institutes of Health contract #NO1-AI-45237, issued for three years in 1994, $1,213,900.00.)
- Severyn, K.M., Flu Shots: Do They Really Work, Vaccine Policy Institute, 251 W. Ridgeway Dr., Dayton, OH 45459.
- Howson, C.P., Howe, C.J., Fineberg, H.V. (eds), Adverse Effects of Pertussis and Rubella Vaccines. National Academy Press, Washington, D.C. 1991. (Section 312 study: DHHS contract #95041, September 27, 1989 December 31, 1991, $728,151.00)
- Stratton, K.R., Howe, C.J., and Johnston, R.B., Jr., (eds), Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. National Academy Press, Washington, D.C. 1994. (Section 313 study: DHHS contract #15130 from June 30, 1991 - June 30, 1994, $1,085,860.00)
- 57 Fed Reg. 36,878-36,885, August 14, 1992.
- Institute of Medicine, National Academy of Sciences, Reports and Information Office, 2101 Constitution Ave., N.W., Washington, D.C. 20418, (202) 334-2352, May 1, 1994.
- Alberts, B.M., Laid-Back Leader Rattles the Academy, Scientific American, February 1994, 34-35.
- Vaccine Supply and Innovation, National Academy Press, Washington, D.C., 1985.
- Severyn, K.M., New Vaccines Plentiful and Profitable: Lack of Liability Stimulates Research and Marketing, Vaccine News, June-July 1998, p. 3. Vaccine Policy Institute, 251 W. Ridgeway Dr., Dayton, OH 45459.
- Kaiser, J., Judgent Pries Open Expert Panel, Science (275), January 17, 1997, p. 297; Court Invalidates Expert Panel Report, Science (275), March 14, 1997, p. 1560; Suplee, C., Court Orders Public Access at National Academy of Sciences, The Washington Post, May 7, 1997, p. A19; NRC Tries to Ease Customer Worries, Science (276), June 27, 1997, p. 1959; Greenwood, M.R.C. Raiders of the Last Bastion? Science (277), July 11, 1997, p. 163; Wade, N., Academy of Sciences, Fighting to Keep Its Panels Closed, Is Rebuffed by Supreme Court, New York Times, November 4, 1997.
- Lawler, A., House OK's Compromise on Panel Meetings, Science (278), November 14, 1997, p. 1219; President to Ink Cliffhanger NAS Bill, Science (278), November 21, 1997, p. 1389.
- Vaccine for cocaine addicts in the works, The Washington Times, September 16, 1999, p. B9, col. 2.
- Cohen, P.J., Immunization for prevention and treatment of cocaine abuse: legal and ethical implications. Drug and Alcohol Dependence 48 (1997) 167-174.
- Transcripts available from: Advisory Commission on Childhood Vaccines, Division of Vaccine Injury Compensation, Parklawn Building, Room 8A-46, 5600 Fishers Lane, Rockville, MD 20857.
- Hearings available at: www.house.gov/shays. Click onto National Security Subcommittee.
- Maier, T. W., A dose of Reality, Insight, September 20, 1999, p. 10-12 + 20; Maier, T.W., Why BioPort Got a Shot in the Arm, Insight, September 20, 1999, p. 13-15.
- Telephone message from Lt. Col. John Grabenstein, September 18, 1999.