Extended from remarks given by Karen Vanderhoof-Forschner, BS, MBA, CPCU, CLU to the Food and Drug Administration's Vaccine Advisory Committee Meeting 11/28/01

©2002 LDF

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I am Karen Vanderhoof-Forschner, a mother whose child was born with, handicapped by, and died from Lyme disease. In 1988, before he died, I cofounded the Lyme Disease Foundation (LDF), a national nonprofit dedicated to finding solutions to all tick-borne disorders. The LDF is a team of distinguished scientific, business, government and public leaders who trailblazed into a world unaware of Lyme disease and within two years our efforts made "Lyme disease" a household term. The LDF has always fostered the development of a LD vaccine and one of our Board members was the first to patent a Lyme vaccine.

I have always appreciated the value of how vaccines help prevent terrible illnesses. My son had received his childhood vaccines, and my daughter is current in her vaccinations. My great-aunt had lifelong crippling effects from polio, so I am grateful a polio vaccine was available for my generation. I take the flu vaccine every year. My pets (dogs, cats, horse) have always been fully vaccinated.

Most of you may remember me from the 1998 Vaccine Advisory Committee (VAC) meeting where the VAC recommended approval for the SmithKline Beecham (SKB) LYMErix vaccine. I was the only person from the "public" who spoke during the public forum. I am back.

As background, the Lyme vaccine was made from a lipidated piece of the outer surface protein A (OspA) of the Lyme pathogen, Borrelia burgdorferi. Also important is understanding that the same OspA piece has been linked to causing treatment-resistant arthritic damage in a genetically vulnerable population. These vulnerable patients have a common HLA molecule pattern (HLA-2/HLA-4). HLA molecules reside on immune cells throughout the body and determine which antigens (e.g. foreign invaders) cause reactions. The binding of the patient's own antibodies, which are fighting the foreign antigen OspA, with their own HLA cells, is the autoimmune problem. Exhibit 7, p 632.

Based on the new data I am presenting I believe the OspA-vaccine represents an imminent and substantial hazard to the public health and needs to be immediately recalled.

The Lyme vaccine trial and approval process have been seriously flawed, vital information has been withheld from the Vaccine Advisory Committee and the FDA, and experts who could have helped provide critical analysis were never invited to participate ... enough to compromise all trial data and cast doubts on the integrity of all involved.

This is a wake-up call that the FDA and its Vaccine Advisory Committee, need to demand that manufacturers fully complete all safety and efficacy studies, and never again let them promise you a study tomorrow, for approval today. The FDA's decisive action to pull this product will help restore the public's dwindling trust in the FDA.

The series of events and information presented here underscores the increased need for stronger public oversight of and input into government activities that affect the public's health.

Let me cover the issues in several sections.

As early as 1988, scientific publications reported that the Lyme bacteria's OspA (including a vaccine) could cause chronic disease in genetically vulnerable individuals. Scientific literature demonstrated potential OspA-related cross-reactions with nerve cell axons, joint synovia, and heart & skeletal muscle protein could result in an autoimmune disease. Exhibit 1.

In 1993, Steere reported on the real potential for cross-reaction of OspA and HLA-2 &/or HLA-4 in patients. Exhibit 2.

• He stated that in Lyme disease, " the synovial lesion ... [presents] a histological picture that is suggestive of a delayed hypersensitivity immune response." He attributed this to the autoimmune reaction sparked by OspA. Which means the vaccine could also cause similar problems. Were the vaccine volunteers told?
• He continued, "B. burgdorferi is a potent inducer of interleukin 1 (IL-1), a cytokine with proinflammatory effects ... that may lead to destruction of cartilage and bone." This is important to understand when designing OspA vaccine trials and monitoring for adverse reactions. Worse yet, when you get to the patent, remember, that there was a test to determine both levels of protection and levels of autoimmunity - were they used in vaccine volunteers? Please note that this is a test performed in the safer OspA Tufts patent. Exhibit 10.
• "To learn whether genetically determined variations in the host immune response might account for such outcomes we determined the immunogenetic profiles of 130 patients..." As a result of the studies he determined, "These observations suggest that certain class II major histocompatibility genes determine a host immune response that results in a chronic arthritis and lack of response to antibiotic treatment." At this point scientists knew there was a genetically vulnerable population. This is one major group that is coming forth with damage relating to the OspA vaccine.

In 1994, Marks, a Connaught researcher, co-published on the Connaught Lyme vaccine trial results and described finding a correlation in volunteers with adverse reactions to HLA types 2 and 4. He stated, "five of the eight volunteers who experienced joint pain were HLA-DR4 positive..." The others were HLA-2. If they knew this, why weren't all patients checked in advance for their HLA typing in all future trials? Exhibit 3.

May 31,1995, Steere, Principle Investigator on the SmithKlineBeecham OspA vaccine trial, wrote a letter to the National Institutes of Health Lyme Project Officer commenting on his OspA vaccine concerns, "A small percentage of patients have developed joint pain or arthritis following vaccination. I continue to be concerned about this phenomenon." Did he tell his Internal Review Board? Did he tell the vaccine trial Data Safety Monitoring Board (DSMB)? Since Dave Dennis, MD, Centers for Disease Control Lyme Officer, was a member of SKB's private DSMB, did he alert any government officials? Did the National Institutes of Health Lyme Project Officer alert anyone? Did anyone tell the patients? Did anyone tell SmithKline Beecham? Who knows? At this point, the trial should have been stopped and the patients informed and treated. Exhibit 4.

In 1997, Philipp reported on his SKB-funded vaccine research, finding that the OspA-vaccinated monkeys were not completely protected and contracted a low-level of Lyme disease infection. The information, although given to the Food and Drug Administration, was not taken seriously. Exhibit 5.

In 1998, Steere publishes his finding that a human component, LFA-1 is an autoantigen to OspA of the Lyme bacterium. Despite this, the vaccine is approved. Exhibit 6.

In 1998, an article in Science states, "why is the inflammation confined to the joints, while hLFA-1 is found on cells all over the body?" Good question. The adverse event data has focused only on the arthritic problems. An accompanying article stated that the vaccine was, "made from the very same spirochete protein linked to autoimmune arthritis by the Steere and Huber team. In theory, the protein might provoke autoimmunity in some people who receive the vaccine..." Exhibit 7.

In October, 2000 the first proved vaccine-related events are presented at the American College of Rheumatology. None of the these researchers are invited to the 2001 Lyme vaccine meeting to provide expert advice. I know some VAC members do not know about this publication. Exhibit 8.

Since the trial began, adverse events have continued to mount. Media reports of patient abuse and potential abandonment abound. Trial information discloses that patient adverse events had not been reported by some investigators. Other investigators found loop-holes to avoid reporting adverse events. Yet, other patients could not find a way to report their adverse events directly to government officials.

In November of 2001, the Journal of Rheumatology published proved the first vaccine adverse events. Exhibit 9.

In November 2001, Forschner found the World Trade Patent, filed on 3/21/00 by Steere's Tufts collaborators, that details the autoimmune mechanism as reality, not theory. This document patents a genetically-modified OspA that is characterized as causing LESS autoimmune reaction than the current OspA. Based on conversations with the FDA and VAC members, none of this was disclosed to them, as of 11/01. Since this was based on extensive research, the investigators had to have concluded their research proving that OspA was dangerous, sometime in the fall of 1999. Exhibit 10.

The patent covers the following issues:

The OspA vaccine-induced autoimmunity due to homology (almost identical match) with human cells is no longer "theoretical" but proven by animal and human testing. This similarity then caused one's own antibodies to be programmed to attack a foreign substance so closely matching our own tissue, that it does attack ones-self, setting in place an autoimmune disease. [The research for this patent, NIH-funded research, had to be complete by the winter of 1999.] Tuft's states, "..the invention is characterized by a novel modified OspA polypeptide which elicits in treated animals the formation of an immune response, without causing the induction of an autoimmune reaction in certain populations, individuals expressing the HLA-DRB1*0401 allele." Patent, Pg 9.

• The patent proves that Tuft's researchers had very detailed information about how the OspA vaccine does its damage in humans. And, these Tuft's patent-holders are colleagues of the SKB Principle Investigator (Steere) and co-published with Steere on this NIH-funded research. The patent presents detailed human and animal experiments using a genetically modified OspA to develop a less dangerous vaccine! It would have been nice for anyone to have told the FDA, VAC, patients, or patient's doctors. SKB knew about this new "safer" vaccine in 2000, yet failed to mention it to the FDA.

The researchers explained that they have proven that the Human leukocyte function-associated antigen 1 (hLFA-1aL332-340) IS a cross-reactive auto-antigen match for OspA165-173. Tuft researchers developed and patented a less reactive vaccine that causes less binding (autoimmunity) in human patients. Patent, FIG. 1

• This patent compares the human reaction to OspA vs. Tufts modified FTK-OspA. This shows the regular OspA vaccine causes more autoimmune reaction by: increased self-binding (Pg 7, Fig 1), significantly higher human T-cell proliferation response (Pg 7, Fig 2), and increased human cytokine production of both human interferon-gamma and human interleukin 13 (Pg 7, Fig 3A, 3B).
• The patent repeatedly states that there is a Scientific Need and Urgency for a safer vaccine than the current OspA. But, who ever bothered to tell the patients? These are quotes from the patent.

• "Preferred modified OspA polypeptides are characterized by modifications which diminish and/or abate their ability to bind the human MHC allele DRB*0401." Patent, Abstract.
• "... there exists a continuing urgent need for an improved vaccine for the prevention for Lyme disease." Patent, pg 5.
• "... the increased frequency of the HLA-DRB1*0401 allele in these patients suggest an autoimmunity etiology" - 1993 Publication and "unpublished data". Patent, pg 4.
• "... the use of protective immunogen in vaccines may be associated with the induction of an autoimmune reaction in certain populations, including [Ed. but not limited too] individuals expressing the HLA-DRB1*0401 allele." Patent, pg 5.
• "... it would be highly desirable to generate modified OspA polypeptides with diminished or no binding to the HLA-DRB1*0401 allele". Patent, pg 5,6.
• ??Tufts "OspA causes diminished binding to HLA-DRB1*0401 allele". Patent, pg 6, multiple times.

This proves that we are now past a package insert or labeling change issue. The vaccine is now known to cause serious damage in some people. It is time for a recall and to inform the public of the real trial results and potential dangers.

Steere presented the vaccine trial "Entry" and "Exclusion Criteria" at the 5/26/98 FDA VAC meeting. These were the strict criteria that MUST be met in order to conduct a proper trial. People were screened before entry into the trial to ensure proper enrollment. Exhibit 11. The following is taken from the material.

• "Entry Criteria: Healthy and 15 - 70 years
• Exclusion criteria: active Lyme disease, recent Lyme disease, or if volunteers had other illnesses that might interfere with the assessment of Lyme disease, including those associated with joint swelling or musculoskeletal pain. "
  

According to SKB documents, the LYMErix OspA vaccine trials were so popular that enrollment was achieved in 6 weeks. The trials were so popular, that investigators could be very picky about who they included, in order to ensure a proper trial. Exhibit 12.

Unfortunately, investigators ignored both entry and exclusion criteria. A 7/7/98 FDA internal memo, (referring to intake forms of volunteers) "2,028 subjects had a history of musculoskeletal conditions at study entry." This means that about 20% of the volunteers were entered into the study with the investigators knowing (before enrollment) that the patients were in violation of the protocol! These patients had no idea that they were not eligible for the vaccine trials, putting them at increased risk for adverse events and ensuring lack of informed consent. Exhibit 13, pg 10; Exhibit 16, pgs 5, 13; Exhibit 18.
The FDA writes:

• "Note: With regard to musculoskeletal conditions, individuals who 'had current disease associated with joint swelling or diffuse joint or muscular pain' or 'physician diagnosed chronic joint illness related to Lyme disease' were to be excluded from the study, but as is noted in item #18 below, this exclusion was not uniformly applied." Exhibit 16, pgs 5 & 13.
• "Materials provided by SKB caused CBER not only to note the protocol violations..." Exhibit 18.

In reviewing the FDA documents we find a sample of known preexisting conditions that should have been excluded, included volunteers with: Osteoarthritis (incl. hands, spine); hip replacement; clinical depression (suicidal); knee surgery; arthritic degeneration; pains in joints, elbows, knees; diabetes; malignant fibrohistiocytoma; neurogenic bladder; Lyme disease with bell's palsy; Lyme meningoencephalitis and facial palsy; Parkinson's disease; abnormal movement disorder; inflammatory and toxic neuropathy; multiple sclerosis; and other extrapyramidal disease. What were the investigators thinking? These people had no business being included in ANY trial - for their own safety and the safety of those who rely on the credibility of the data.

How might this affect the study? It skewed the data. By reviewing the Freedom of Information request I received from the FDA, anytime a vaccine recipient had an adverse event that could be attributed to any preexisting condition, it was! This totally undermines the validity of the study. Only those adverse events that occurred in healthy people, were attributed to the vaccine ... and then the term "possibly" was used.

Sample OspA Vaccinee Evaluations:

Prior: Heart attack, migraines, laminectomy Event: Pain in hands, elbow, shoulder, feet (polyarthritis)

Declared: Not related

Prior: Menopause Event: Arthritis, hands, fingers, hip

Declared: Possibly related

Prior: Arthroscopy, rheumatic heart disease Event: Arthroscopy left knee (inflamed, swelling)

Declared: Not related

Prior: LD, seizure disorder, clinical depression Event: Arthroscopic removal of cartilage/arthritic polyp knee

Declared: Not related

Prior: Back surgery Event: Hip replacement due to osteoarthritis
Declared: Not related

What about neurologic events? The FDA states, "A similar analysis is provided for 27 subjects who had a 'neurological condition' at study entry."

 

This means there are a number of questions that need to be answered:

• Was each participating institution's Internal Review Board told about each and every protocol violation?
• Was there a report issued about the violations? Is this available to the public or VAC?
• Which sites and physicians were involved?
• Why was the pharmaceutical allowed to move forward despite this?
• Were patient rights of informed consent violated?

III. SERIOUS PROTOCOL CONCERNS FROM THE FDA FOI MATERIAL

Please read Exhibits 16, 17, 18 to understand the scope of the problems with data reporting and patient handling. Serious ethical concerns stand out, including the failure of investigators to deliver proper testing and treatment to seriously ill volunteers. I have discussed this with VAC members and found they are completely unaware of any of the data disclosed in this document.

The Data Safety Monitoring Board had serious failings during the trials - including in its monitoring function and analysis of reported adverse events. This is very problematic, as these "experts" are the ones who are the "independent" experts expected to provide a safety factor for the public. It is important to note that Dave Dennis, MD, the Lyme Office for the Centers for Disease Control and Prevention and coauthor of the CDC's vaccine use guidelines, was a member of SKB's private Data Safety Monitoring Board. Exhibit 16, pg 4. Exhibit 18, pg 3, 5. And, during the 2001 reevaluation of the vaccine adverse event data, he and others at Ft. Collins, were once again used as an "independent" source of review of the FDA's Lymerix vaccine adverse events. How did the hiring of the CDC's own employees facilitate the vaccine approval process? More will be included on this in a future update.

The vaccine trial published information shows that only two patients had neurologic Lyme disease - one in the placebo (bell's palsy) and one in the vaccine group (bell's palsy). But, this public information does not accurately reflect the real data.

FDA FOI information revealed that there were other patients with facial palsy, Exhibit 16, page 22. This section also states there were 8 other vaccinees with facial palsy.

Stunningly, there was a trial design failure that lead to a major underreporting of neurologic cases. An additional 414 cases of facial palsy were reported weeks before the final vaccine approval. These were not originally reported because the sponsor "found they had not included a code for facial nerve disorder." Exhibit 18, page 3. And, investigators limited their descriptions of facial palsies to only those occurring with EM rash. Exhibit 18, pg 3. Exhibit 16, pg 12.

Trial mistakes have not been publicly disclosed - such as one patient who was given a vaccine instead of placebo. Exhibit 16, page 22. Was the IRB notified? Was the patient notified? Were report forms submitted anyplace?

The study had a lot of data errors in reporting. In this exhibit, there were too many to summarize here. Exhibit 15 - read the whole exhibit.

There were protocol loop-holes that resulted in the data misrepresenting the trial results to the public. This included nine neurologic LD cases (Bell's palsy, radiculopathy, meningitis/encephalopathy, meningoencephalitis) that were not reported as "Definite LD", because the investigators declined to do the necessary testing (lumbar puncture, EMG) to qualify the cases as definite LD neurologic cases. The investigators decided they "were not medically necessary." They were reported as EM rash & laboratory positive. The FDA writes "It is not possible to assess whether or not there was a 'medical indication' to perform an EMG because the protocol did not specify clinical criteria that would trigger such an evaluation." SKB confirms this. Exhibit 17, pg 8 & 10.

Additional data indicated that the standard of care for diagnosis was not met. Three patients were diagnosed with Lyme meningoencephalitis, but the investigator failed to do spinals - hence they did not meet the case definition to be reported as "Definite LD". The FDA writes, "It is not possible to assess whether or not there was a 'medical indication' to perform a lumbar puncture because the protocol did not specify clinical criteria that would trigger such an evaluation." According to medical experts, the standard of care to make this diagnosis requires a spinal tap. SKB confirms the protocol problem. Exhibit 17, pgs 8 & 10.

One patient was hospitalized with diagnosed Lyme meningitis and had a spinal tap. But, the investigators declined to run a LD test on the spinal fluid. The patient was NOT reported as a "Definite" case of neurologic LD. This is a clear issue of the investigators failing to meet the standard of care for diagnosis of Lyme disease. Exhibit 16, pg 22.

The FDA writes that at least one meningoencephalitis patient was "not given the optimal antibiotic regimen." This poor patient was given several weeks of oral medicine. While saving money for the pharmaceutical, it is unclear if the patient ever received the proper medical treatment. Exhibit 17, pg 8. This is a clear case of failure of SKB's investigators to provide the standard of care for appropriate treatment.

Deviations from the protocol and failure to report cases are throughout Exhibits 16 and 17. One surprise was that a patient with a positive Lyme culture (grew the organism), some positive tests, Lyme neurologic symptom of radiculopathy (with no EMG test) was reported as an Ehrlichia positive. Exhibit 17, pg 3.

Two vaccinee's experienced hemiparesis (brain-caused one-sided paralysis). No placebo's experience this. These were determined to not be related to the vaccine. This should be reevaluated. Exhibit 16, pg 15.

The FDA's internal analysis of those with a history of LD, those with prior arthritic conditions, and individuals having prior positive blood tests show each group individually had an increased risk of adverse events. Each formed a subpopulation that when separated from the group, had significant adverse events.

• " SKB reports, Individuals with a history of specified musculoskeletal conditions at baseline or with a prior history of LD had a significantly higher risk of experiencing such adverse events, both early and late." Exhibit 16, pg 27.
• Comparing those patients with a history of prior LD "for early AE's, there was an increased incidence of musculoskeletal symptoms in vaccinees with a history of LD compared to vaccinees with no history of LD (20% vs. 13%)." Exhibit 16, pg 27.
• FDA finds on their analysis: "Note: A safety analysis is provided comparing (only) vaccinees who were WB positive (N=124) or WB negative (N=5345). Statistically significant differences (p<.05) were found in multiple categories for incidence of late AE's including: skin and appendage disorders, musculoskeletal system disorders, central and peripheral nervous system disorders, autonomic nervous system disorders, psychiatric disorders, gastrointestinal disorders, white cell and RES disorders, and resistance disorders." Exhibit 13, page 10.

IV. VACCINE ADVISORY COMMITTEE (VAC)

Was the FDA and the VAC given the available and necessary information to make their analysis and provide for the public welfare? No. The FDA failed to include in their deliberations academically-based Lyme vaccine researchers who had published on OspA vaccines problems.

These researchers may be available for OspA vaccine analysis:

• Don Marks, MD, PhD, who helped conduct the Connaught OspA vaccine trials, is the first to publish (in1994) about a possible link of HLA-types to OspA vaccine-related adverse events. Exhibit 3.
• James Miller, PhD, a UCLA researcher, has published on research supporting concerns about the OspA vaccine, including delayed autoimmunity and potential masking of low-level infection. Exhibit 19, 20, 21.
• Ronald Schell, PhD, a University of Wisconsin researcher, has published on his animal studies of OspA-induced autoimmune reactions - the issue at the very heart of the OspA vaccine. Exhibit 22, 23.
• Steve Callister, PhD, a Gunderson Medical Foundation researcher, has published on his animal research on OspA vaccine-induced Lyme arthritis. Exhibit 22, 23.
• Dave Dorward, PhD, a National Institutes of Health researcher, has been investigating other vaccine candidates and was the first to express the real concern that Lyme bacteria can enter human blood serum cells, be protected from the immune system response, and produce infection later. Exhibit 24.
• Carlos Rose, MD, a duPont Hospital for Children researcher, is the first to co-present (2000) and co-publish (2001) on SmithKline OspA vaccine-induced adverse reactions in adults and children. Exhibit 8, 9.
• Paul Fawcett, PhD, a duPont Hospital for Children researcher, is the first to co-present (2000) and co-publish (2001) on SKB's OspA vaccine-induced adverse reactions in adults and children. Exhibit 8, 9.

This information from the Tuft's patent, freedom of information material from the FDA, data on the pediatric vaccine trials, NIH/CDC-internal memo's, and vaccine press releases were not shared with the VAC. Some of this material was withheld from the FDA. This hiding of information prevented the VAC from properly performing its duties. And, as a result meant they failed to give fully-informed recommendations to the FDA regarding the LYMErix vaccine. This includes:

1. Tuft's patent of a safer modified OspA-vaccine, filed in March of 2000. Almost a year BEFORE the 2001 FDA vaccine meeting to discuss concerns about the SKB data. None of the patent information was disclosed to anyone. And, this information was critical to the decisions made. Tufts is the SKB OspA vaccine's Principle Investigator's institution, and the publications I have included show he collaborated on the patent-grant with the patent holders.

2. SKB protocol violations: a 20% intentional violation of enrollment Entry-Exclusion criteria, lack of reporting neurologic Lyme involvement, failure to provide the standard of care of proper diagnosis and treatment, and failure to report adverse events.

3. Pediatric data was available, but not shared. Adverse events for this was higher than for the adult trial.

4. Connaught's vaccine data was available, but not shared. Including early studies showing a potential link to OspA-induced autoimmunity. And, since this vaccine did not use an adjuvant, the placebo data would provide a control for the SKB's placebo group. As you may know, the SKB placebo group had many components, including the adjuvant.

5. SKB stated there was a "Harvard" study (done about 1997) on vaccinee bloods looking for a link to autoimmune arthritis. Despite repeated requests from the LDF, SKB has declined to release the data.

6. SKB disclosed that they can determine which vaccine recipients will develop an immune response as early as right after the first vaccine dose. Then, why give the non-responding population the additional doses? Why not test for a response, limiting human OspA exposure?

7. In July, 2001 it was disclosed that there was an additional phase III OspA trial that was awaiting the FDA's approval to start vaccinating 10,000 - 15,000 people with a new OspA vaccine. Exhibit 25.

 

V. ADDITIONAL ISSUE OF QUESTIONABLE SCIENCE

 

A. The OspA vaccine "mechanism of action" in the tick.

1. Promotional pieces (e.g. package insert) falsely state that the vaccines "mechanism of action" is that the vaccinated host's antibodies kill the Lyme bacteria in the tick before they are transmitted to the host. This is a false conclusion from the article. Exhibit 26, 27.

2. The 1992 Fikrig, et al ["paid advertising"], "Elimination of Borrelia burgdorferi from vector ticks feeding on OspA-immunized mice." This states that the tick must feed to completion (which takes 3-4 days), drop off, and sit for ten additional days before the tick is free of Borrelia burgdorferi. Nymphs transmit disease is 24 -48 hours of feeding. So, in this case, disease transmission would have already occurred. The false statement on clearing out the infection is left to stand and is repeatedly cited. Exhibit 28.

Another concern is that patient bloods were taken during the trial, not for trial use, but for personal gain, without patient informed consent. Three examples are attached: Yale (promotional material), Mayo Clinic (patent), and Immungen (personal communication with SKB). Exhibit 29, 30, 31.

The FDA's responsiveness to the Freedom of Information process was poor. The FOI was sent to the FDA on 11/27/00. The LDF asked for all information on the vaccine trials. We received limited, heavily redacted internal letters. Nothing from the manufacturer. The FDA stated, "a preliminary review of the records indicated that the deleted material is not required to be publicly disclosed." There was no rule to prevent the disclosure, so the FDA voluntarily whited-out most of the material. This prevents public watchdog efforts. Exhibit 32.

A. Recall the LYMErix vaccine. This is no longer a labeling issue.

B. Make sure this never happens again, by adding a breath of experts to the Vaccine Advisory Committee.

C. The FDA should never let a pharmaceutical get away with promising studies tomorrow, for approvals today.

D. Federal employees should never be allowed to consult in areas where they set Federal Policy.