VITAL info- TB skin testing a Trojan Horse?

August 4, 2006

I suggest sharing this with your doctors, your hospitals, any health care

worker that you know.

Get them to realize the danger to themselves and organize to stop this.

Also have heard of autistic kids who are healing, regressing after TB test

http://www.nccn.net/~wwithin/TBtest.doc

(nice formatted Word Doc)

Sheri

" The exact number of doses sold in the US annually is apparently a guarded

secret (personal communication, Aventis Pasteur, Sept 12, 2003). "

" Recommendations

Immediate suspension of mandatory TB skin testing policies of HCWs is

reasonable considering the lack of clinical efficacy of testing or

subsequent treatment of LTBI. A review of current local and state public

health records could be undertaken to determine a) the incidence of TB skin

test reactivity amongst HCWs, the true risk of TB disease in the skin

reactive HCWs who fails to receive prophylaxis for LTBI and c) the outcome

analysis of the HCWs placed on preventative drug therapy and finally d) the

review or performance of pertinent toxicology studies on Tubersol that

establishes this agent as safe. "

-

From: RadPoke@... [mailto:RadPoke@...]

Sent: Saturday, March 27, 2004 4:11 PM

Subject: TB skin testing a Trojan Horse?

I am a physican and have written a short essay regarding the illogical

utilization of TB skin testing, which is being pushed upon hospital

employees and now high school and college students. After learning the

truth about the vaccine industry, i revisited TB skin testing policies and

have concluded that there is really very little science in support for

testing, especially in low risk populations. In fact, routine testing in

high risk populations has been challenged. In spite of this our government

and its regulatory agencies have poured millions of our dollars into

building the TB testing infrastructure and in my opinion, is serving

purposes other than reducing the incidence of TB in the US. With mandatory

policies (our department technicians cannot continue working without annual

testing), we are in my opinion, programming our population to accept

whatever the government deems appropriate. Although I have not discovered

any healthcare risks from TB skin testing agents, the potential (phenol) is

there and the health risks are in my opinion, unknown. This is not as

serious as the vaccine-mercury-autism link, for example, but I wanted to

pass on the results of my research and review to you. Feel free to use

this, pass it on, etc., no restrictions to its use.

Ayoub. MD

Dept Radiology

Southern Illinois University School of Medicine

*******

http://www.nccn.net/~wwithin/TBtest.doc

(nice formatted Word Doc)

The Rationale for TB Screening of Healthcare Workers (HCWs) and Other

Low-risk Populations:

A Critical Review of CDC Policy

or

The Emperor Has No Clothes, Cough or Fever

Summary:

1) Healthcare workers(HCWs) are identified by the CDC as a high risk group

for development of TB; however, no current clinical data exists that

supports that contention. The overwhelming majority of TB, as with most

infectious diseases, occur in individuals with compromised immune systems.

2) Targeted TB testing in HCWs is only recommended by the CDC; however,

local facilities have often initiated mandatory testing policies amongst

employees, subject to employment termination for refusal.

3) According to the CDC, initiation of chemoprophylaxis in the TB positive

HCW is not mandatory in circumstances of negative health exam, negative

chest radiograph and absence of additional risk factors. The overwhelming

majority of HCWs who test positive have normal clinical exams and radiographs.

4) Current randomized studies of chemoprophylaxis in the TB skin test

positive, healthy HCWs do not exist. Some randomized studies in AIDS

patients show TB disease occurs with higher incidence in those receiving

therapy for latent TB compared with those receiving no therapy.

5) One analysis showed no benefit to treatment of LTBI in all non disease

states despite risk factors. Risks associated with chemoprophylaxis for TB

may outweigh potential benefits.

6) TB skin test is inaccurate but yet is considered the gold standard to

diagnose infection. Because there is no better method to diagnose

infection, its actual test accuracy is unknown.

7) Phenol, a component of Tubersol, is a highly toxic industrial chemical

with numerous known health risks yet this is a component of Tubersol.

8) The CDC claims that the TB skin test is safe, yet the manufacturer

states that NO known carcinogenicity studies have been performed. In fact,

phenol, when injected intradermally, is associated with skin cancer

development in test animals.

9) The CDC states that TB skin testing is safe in pregnant women yet

manufacturers have NOT performed mutagenicity testing. This is alarming in

consideration that phenol, a component of Tubersol, is a known mutagen.

Summary: TB skin testing should not be required of otherwise healthy HCWs

unless safety and efficacy studies have proven a benefit in this low risk

population. The FDA should halt the use of Tubersol pending the standard

and usual safety testing has been performed, including carcinogenicity and

mutagenicity testing.

INTRODUCTION

The following document is a review of current TB screening policies for

HCWs. This includes an analysis of two published documents. First, " The

Core Curriculum on Tuberculosis " (4th edition, 2000), published by the U.S.

Department of Health and Human Services and The Centers for Disease

Control. The second, a joint statement published in the MMWR, June 2000,

represents the works of the American Thoracic Society and the CDC.

After anti-TB medications became available in the 1940's, a gradual decline

of the number of TB cases were reported from 1953 until about the mid

1980's when there was a 20% increase from 1985 through 1992 (1, p. 16).

According to the CDC, the major factors for this rise were 1) a

deterioration of TB public health infrastructure, 2) HIV/AIDS epidemic, 3)

immigration and 4) transmissions in congregate settings. (It would seem

most logical that, since HIV increases the risk of TB by as much as

100-fold, and AIDS was an entirely new disease entity coinciding with this

period of TB resurgence, that HIV would be the most likely contributing

factor for rising cases of TB.) The CDC claims that the deterioration of

the TB public health infrastructure was a major factor for TB resurgence,

yet, the CDC publication offers no supportive evidence of this conclusion.

If this were true, there would be an increase in the incidence of TB

amongst healthy HCWs. Data to this effect is absent. In fact, I have not

discovered any published data that proves the hypothesis that the neglect

in screening programs resulted in more cases of TB during this era.

It is interesting to note that the incidence of TB in the US has declined

steadily since the 1900's. This decline was noted in spite of the fact that

pharmaceutical therapies were unavailable for nearly five decades. How did

the incidence of TB decline in the absence of TB screening programs and

chemoprophylaxis? The CDC's contention that the small TB spike occurring in

the late 1980's was the result of deteriorating TB control infrastructure

seems very questionable.

The unrealistic goals of the CDC

In 1989, the CDC announced the goal of eliminating tuberculosis from the US

by 2010. Plans and task forces were then established to accomplish this

goal. To apparently help achieve this goal, the CDC now concludes that

healthcare workers are part of a " targeted " population of individuals who

are at high risk for developing the infection (TB skin tested positive)

and developing subsequent clinical disease of tuberculosis. Institutional

TB skin testing is recommended for the staff of healthcare facilities (1,

p. 25;90-91).

Elimination of TB is unachievable and unrealistic. First, our government's

open door immigration policy allows countless high risk individuals into

the US undetected on a daily basis. How can those individuals be screened

when our government refuses to identify illegal aliens and allows them

access to the healthcare system? Secondly, since the majority of TB occurs

in the immune compromised host, how will the disease be irradicated unless

the coexisting conditions are eliminated. AIDS, cancer and chemotherapy

populations grow each year. Thirdly, false negative skin testing alone will

bypass significant numbers of infected individuals (even one case missed in

screening is significant when the goals are 100% eradication and the CDC

claims a 23% transmission rate!) .

CURRENT POLICIES

Risk analysis for TB and the rationale to screen HCWs

There are an alleged 10-15 million infected (skin test positive) persons in

the US (1, p20:no source given). Of these, if not detected and no

preventative treatment is initiated, the CDC states that 10% will develop

TB at some point, 5% within the first 1-2 years, in spite of normal immune

system (1, page 7; (2) page 8). The primary source of this data is not

referenced in the CDC publications. Accurate natural historical data is

critically important in order to support screening of asymptomatic HCWs. A

study recently published in JAMA (3) challenges the CDC report and showed

that of the estimated worldwide TB infection (TB test positive) rate of

32%, only 7.96 million cases of disease were reported in 1997, or a TB

disease incidence of less than 0.2% amongst infected individuals (assuming

a 6 billion world population). This is far less than the 5-10% rates quoted

in the CDC publications and are consistent with the general concept that TB

is a disease of opportunity, generally harmless to the immune competent

host. This data alone should challenge the wisdom in screening otherwise

healthy populations.

In addition, the CDC quotes a transmission rate of 21-23% (ref 1, page 6):

this seems alarmingly high (referenced from " CDC Program Management

Report " -unavailable). This implies that 21-23% of all contacts with a TB

patient will develop the infection or disease! Demographic data simply does

not support this alarmingly high rate.

Summary of CDC's High Risk Groups for Developing TB (modified from 1, p 8)

HIV/AIDS

Silicosis

Substance abuse

Hematological and reticuloendothelial disease

Chronic malabsorption and malnutrition

Diabetes Mellitus

Prolonged steroid therapy

Solid organ transplantation

Cancer of head and neck

Chronic renal failure

Low body weight

Healthcare workers

Table 3 in Ref 2 (p 9) assigns relative risk values for many of these

groups; however, missing in this table are relative risk data of HCWs with

healthy immune systems!

DISEASE Relative Risk

Silicosis 30

Diabetes mellitus 2-4.1

Chronic renal failure/hemodialysis 10-25.3

Gastrectomy 2-5

Jejunoileal bypass 27-63

Solid organ transplant

renal 37

cardiac 20-74

Carcinoma of head or neck 16

The HCWs receiving mandatory yearly testing should be informed of his

relative risk to develop TB disease. With the sole exception of the HCWs,

all individuals designated in the CDC publications as high risk are those

with abnormal systemic or pulmonary immune defenses. But is this proven? Is

it possible that, as with many other diseases, the integrity of the host

immune response system is of far greater importance than the presence of

mere exposure to microorganisms? In fact, if HCWs were not at higher risk

than the general population, unless they had additional medical risk

factors, screening of HCWs would be no more valid than screening 100% of

the population.

Although historical studies showed higher infection and disease rates in

HCWs in an era when the prevalence of TB was higher, modern era data

suggests this is no longer the case. McKenna, et al (4) concluded that the

" overall case rate of tuberculosis in healthcare workers was slightly lower

than the natural rate....most healthcare workers do not appear to have a

risk of clinically active tuberculosis greater than the general

population " . This conclusion has been confirmed in other recent studies (5).

TESTING AND THERAPY

The TB skin test

Tubersol, manufactured by Aventis, is comprised of a purified protein

derivative of the organism M. tuberculosis. Its efficacy as a screening

test is derived from the delayed hypersensitivity response in the infected

host after intradermal injection. The exact number of doses sold in the US

annually is apparently a guarded secret (personal communication, Aventis

Pasteur, Sept 12, 2003).

False negatives are thought to occur frequently. Listed causes (6) include

anergy, recency of exposure, viral infections, various vaccinations,

overwhelming infection, various drugs(steroids) and malignancies and any

condition that can impair the cell mediated immune response (sarcoid,

malnutrition) . False positives include nontuberculous infections and BCG

vaccine state. In spite of these inaccuracies, the CDC states that for

persons with latent TB infection who have a normal immune system, test

sensitivity approaches 100% ( 2, p 11). This statement is ridiculous for

several reasons. First, the TB skin test is the gold standard, so it is not

possible to accurately gauge the incidence of false negative exams. The

sensitivity of this test , in actuality, remains unknown. Secondly, false

negative exams occur in the groups who are at the very highest risk for

disease in the first place, meaning that the false negative tests weigh

heavily against the efficacy of screening in the most important risk

groups-the one's most likely to develop disease in the first place!

Compounding the inaccuracies of the TB skin test is the revelation that

only one in three positive reactions are correctly classified as positive

by screen test interpreters (7).

Serious untoward reactions to the Tuberculin substance have been reported.

Adverse reactions include local skin reactions (vesicles, ulcers, necrosis,

scarring), rashes, and anaphylaxis.

Shockingly, in spite of its widespread use, the manufacturer's insert 6)

states that Tubersol has not been evaluated for its carcinogenic or

mutagenic potentials or influence on fertility. This is surprising

considering the widespread use and frequent repetition intervals of

administration, particularly to the long term HCWs employee. It is also

irresponsible for the CDC to state that tuberculin is safe and reliable

throughout the course of pregnancy (1, p. 29). This is in direct opposition

with the manufacturers statement that Tubersol is NOT tested for

mutagenicity. It is a fact that a declaration of safety without testing is

a declaration of assumed safety, not a proven scientific fact.

What can we gather from the toxicology of its components? Tubersol contains

0.28% phenol(5), which is known to be highly toxic to humans (8). The 1969

American Heritage Dictionary defines phenol as a " caustic, poisonous,

white, crystalline compound...derived from benzene and used in various

resins, plastics, disinfectants, and pharmaceuticals. Phenol is also known

as 'carbolic acid.' " Amongst the known adverse reactions to phenol are:

-irritating to skin, eyes, mucous membranes in humans

-ingestion in humans may cause death, paralysis, weakness, seizures, coma,

respiratory collapse

-animal testing has shown severe toxicity

-limited data available on the chronic effects in humans, but in humans has

caused dermal inflammation and necrosis, arrhythmia's, hepatic enlargement

and dysfunction.

-animal studies have shown chronic exposure effects the CNS, respiratory,

renal and cardiovascular systems

-no human development and reproduction studies have been performed BUT...

-animal studies have shown reduced weight, growth retardation, abnormal

development, increased maternal mortality and decreased maternal weight gain.

-no studies have been done in humans with regards to carcinogenicity BUT...

- animal studies show phenol applied to skin is a skin carcinogen in mice!

These findings should be embarrassing to the FDA and shocking to recipients

of the TB skin test. The CDC has no supportive data to state unequivocally

that this test agent " is both safe and reliable throughout the course of

pregnancy " (1, p 29) when animal studies exist to the contrary and

demonstrate that one of its constituents is a skin carcinogen! How did the

FDA approve this agent for use in the tuberculin skin test? Without

testing, no conclusions can be made as to the safety of Tubersol,

regardless of what comments critics might offer such as, for example,

" ....but it is such a small dose " . Has Aventis proven that Tubersol is

safe? The FDA, CDC and Aventis simply cannot answer that question with

available scientific data.

The myth of screening and prophylactic therapy for the skin test positive

HCWs- is there any proof of benefit?

With regards HCWs, a 1992 survey of 210 hospitals in the U.S. calculates

the tuberculin reactivity rate of only 0.64% (9). This rate would even be

expected to be lower today with falling prevalence of TB. Is it really

worth screening 156 health HCWs in order to discover one positive

convertor? In turn that convertor invariably will have a negative clinical

exam and radiograph.

Cost benefit analysis was studied at a time when the tuberculin agent was

$10. The costs of screening was $4,500 per person eligible for treatment

and and $350,000 per case of TB prevented (10). The current cost of

tuberculin is $18. It is particularly disappointing that as few as 25% of

treated individuals actually are able to complete therapy.

Do local TB statistics support screening studies? Illinois Department of

Public Health Statistics (11) compiling TB disease in all counties between

1990-2001 reveals that 86% of 104 counties reported on average fewer than

two TB cases per year and 67% as few as one case annually! How can

screening healthy HCWs in those counties with such low disease prevalence

be justified? It simply cannot.

Inconsistencies within the CDC guidelines are easily found. First, the CDC

publications do not support blanket chemoprophylaxis for all TB skin

positive individuals with normal health exams and radiographs, yet one

wonders how the CDC could NOT suggest therapy if the CDC believes their own

statistic that 10% of these individuals really were destined to developed

disease. If a subsequent TB positive test results in a negative clinical

exam and chest radiograph and a decision NOT to treat, why not replace the

risky, inaccurate TB test with a clinical exam and an employee radiograph?

The decision to test SHOULD be a decision to treat.

Secondly, in order to justify chemoprophylaxis, outcomes studies must show

proven safety, efficacy and long term benefit. If there were no proven

benefits to the treatment group over non treated individuals, then the

screening program would be without merit. Are there studies that support

better outcomes in the treated group vs. untreated group in healthy HCWs?

This author has discovered no such literature. Other studies challenge the

supposition of beneficial chemoprophylaxis.

In Ref 2 (pg. 12), there is an allusion to seven trials in the 1950's -60's

which demonstrated reduction of TB disease in the 25-92% range with

chemoprophylaxis. Since these studies were done in the decades when TB was

significantly more prevalent, approximately 50 years ago, they are no

longer valid. Secondly, these studies almost exclusively involved non-US

participants in countries where environmental and health issues were

substantially different than in the US. This is not applicable to the

current issue of treatment outcomes in healthy US HCWs treated for LTBI.

The MMWR report (2, p 13) also refers to the IUAT trial which indicated a

reduction of LTBI by 65-75%. Unfortunately, this trial was also performed

in non-US individuals, all of whom had abnormal chest radiographs. This is

a significantly different population than the typical US HCW who rarely

displays an abnormal radiograph (2, pg. 11, and personal experience). The

MMWR report attempts to further inflate these success statistics by quoting

a 69-93% efficacy in " compliant " participants, a statistic that has little

significance in real-life clinical outcomes. A closer look at the success

rates shows they are quoted in meaningless percentages (if i bought three

lottery tickets instead of one, does the 200% improved chance of winning

mean anything in the real world?) Where is the statistical proof (for CDC

authors, that would be the " p " values)? For the group with fibrotic lesions

< 2 cm (the group closest to the most typical HCWs), there was NO

STATISTICALLY SIGNIFICANT DIFFERENCE in placebo treatment and 12 week, 24

week and 52 week regimens. In addition, these trials were conducted from

1969-1977, over 30 years ago when TB rates were generally higher than today.

The MMWR report reviewed randomized treatment of LTBI in HIV positive

individuals in seven studies from 1980-1997, although only one was strictly

in the US (2,p 16). These results were decisively mixed, with some studies

actually demonstrating higher TB rates in groups receiving isoniazid than

nontreated groups! If benefit of prophylaxis is at best equivocal in high

risk individuals, on what basis does the CDC use to justify prophylaxis in

the healthy HCWs?

In a more recent study involving a New York area population of HIV-positive

patients with anergy, there was a no significant difference in TB rates in

those receiving anti-TB prophylaxis with INH compared with placebo (12).

Once again, if efficacy of therapy for LTBI in the highest risk group is

unproved, how can we justify prophylaxis in low risk HCWs with an intact

immune system?

In order to answer these questions more completely with regards to the low

risk HCWs, Tsetat et. al. (13) performed a decision analysis of screening

test positive adults and concluded that " from the perspective of the

individual adult with a positive skin test for TB, we cannot make a case

for INH therapy " . Furthermore these authors distinguished TB mortality

rates from individuals dying with their disease rather than because of

their disease and calculated lower TB mortality rates than earlier authors.

With this factored into the risk-benefit analysis they further concluded

that " it does not matter how high the rate of developing TB is-the

preferred strategy is always " NO INH " . These authors do not recommend

therapy unless active TB disease is detected.

The FDA safety record with anti-tuberculous drugs

The 2000 MMWR report states:

" In 1965, when Isoniazid was first recommended in the United States for

treatment of LTBI , it was not thought to cause severe toxicity. However

studies in the late 1960's suggested that isoniazid did cause

hepatitis....It was not until the 1970's that when several persons

receiving isoniazid for LTBI died from hepatitis that the likelihood of

isoniazid hepatitis was understood " (2, p 15-16).

Most clinicians are now very aware of the dangers of INH therapy and the

need for careful clinical evaluation of all patients receiving therapy for

LTBI. Unfortunately, this failure of the CDC/FDA to detect toxicity in

recommended drug therapies prior to their widespread use and acceptance was

not an isolated incidence.

The CDC manual published in 2000 (1, pg. 78) did not discuss potential

hepatotoxicity of two additional anti-TB drugs, rifampin and pyrazinamide.

In 2003, the CDC published a retraction of the recommendation of these

drugs for LTBI based on the discovery of 48 cases of severe liver injury

and 11 related deaths (14). An alarming 5% of patients who started this

therapy did not complete the regimen due to hepatic toxicity. With these

high percentages of complications it is difficult to comprehend how such

severe adverse reaction rates were not discovered in pilot studies before

the CDC issued widespread recommendations for their use in LTBI.

Understandably, the FDA's and CDC's track record in TB drug safety testing

would leave one even more concerned of their widely held opinion of the

untested but assumed safety of the phenol containing skin testing agent

Tubersol.

When recommendations become mandatory

According to the CDC, the " risk assessment should identify which HCWs have

the potential for exposure and the frequency with which the exposure may

occur. This information can then be used to determine which HCWs to include

in the skin testing program and the frequency with which they should be

tested " (1, p 91). This site or occupation-specific risk assessment of all

HCWs is a targeted testing program. It is uncertain how individual

institutions implement targeted testing. Radiology technicians currently

undergo mandatory yearly testing at Memorial Medical Center and Springfield

Clinic. It is my understanding that employment can be terminated in HCWs

refusing to be tested.

The FDA and CDC: conflicts of interest

The following was published in the Washington Free Press as the results of

an UPI investigation(15).

In the year 2000, the U.S. House of Representatives Committee on Government

Reform held hearings to examine conflicts of interest in the two official

panels that control vaccine policy in the U.S. (there is one panel at the

Centers for Disease Control and one at the FDA). Among the committee's

findings were widespread conflicts of interest among panel members in the

form of financial ties to pharmaceutical companies who manufacture vaccines

that the panels oversee. Following is a summary of the committee findings,

assembled by Dr ph Mercola.

* The CDC routinely grants waivers from conflict of interest rules to

every member of its advisory committee.

* CDC advisory committee members who are not allowed to vote on certain

recommendations due to financial conflicts of interest are allowed to

actively participate in committee deliberations and advocate specific

positions.

* The chairman of the CDC's advisory committee until recently owned 600

shares of stock in Merck, a pharmaceutical company with an active vaccine

division.

* Members of the CDC's advisory committee often leave key details out

of their financial disclosure statements, and are not required to provide

the missing information by CDC ethics officials.

* Three out of the five FDA advisory committee members who voted to

approve the rotavirus vaccine in December 1997 had financial ties to the

pharmaceutical companies that were developing different versions of the

vaccine. The vaccine was recalled a few years later after numerous public

complaints of serious bowel obstruction due to the vaccine.

* Four out of the eight CDC advisory committee members who voted to approve

guidelines for the rotavirus vaccine in June 1998 had similar financial ties.

In a USA Today report of conflicts of interest on the 18 advisory

committees established by the FDA, the following was reported (16).

* 54% of the experts hired to advise the government on safety and efficacy

policies had financial relationships with the pharmaceutical companies that

would be directly affected by their opinions

* since 1988, the FDA has waived on more than 800 occasions the federal

law that would have other wise prohibited use of experts with financial

conflicts

* 92% of FDA advisory meetings had at least one member with a conflict of

interest

* 55% of FDA advisory meetings were held when at least half of the

committee members had conflicts

* in 102 FDA advisory meetings dealing with the fate of a specific drug,

33% of the experts had a financial conflict.

The pharmaceutical industry enjoys the benefits of increased revenue when

government regulatory bodies pass favorable legislature promoting use of

its products. The influential power of this industry has been subject to

much criticism.

According to Public Citizen's report (17)

Drug industry lobbying ranks include 26 former members of Congress. All

told, 342 lobbyists (51 percent of those employed by the industry) have

" revolving door " connections between K Street and the federal government.

The Pharmaceutical Research & Manufacturers of America (PhRMA), which

represents more than 100 brand-name prescription drug companies, shelled

out $14.3 million last year, a 26 percent increase from 2001 and nearly

double what the group spent in 2000. PhRMA hired 112 lobbyists in 2002, 30

more than the year before.

Brand-name drug manufacturers spent more than 20 times as much on lobbying

as generic drug-makers - $76 million versus $3.4 million. And they employed

seven lobbyists for every one hired by their generic counterparts.

Biotechnology companies spent $12 million on lobbying.

Since Public Citizen began tracking the drug industry's lobbying activities

in 1997, the industry has spent nearly $478 million lobbying the federal

government. In that same period, the top 25 pharmaceutical companies and

trade groups gave $48.6 million to federal campaigns. Well over $100

million more went to paying for issue ads, hiring academics, funding non

profits and other activities to promote the industry's agenda in

Washington. All told, the drug industry has spent nearly $650 million on

political influence since 1997.

Drug company profits have been staggering.

*By comparison, all companies in the Fortune 500 suffered a combined loss

of 66.3 percent in profits from 2001 to 2002. The pharmaceutical industry

soared past other business sectors - raking in profits five-and-a-half

times greater than the median for all industries represented in the Fortune

500.

*17% profit (as a percent of revenue) far outpaces the 3.1% median value

for all other Fortune 500 industries.

*Profits registered by the 10 drug companies on the list were equal to more

than half the $69.6 billion in profits netted by the entire roster of

Fortune 500 companies - when all losses are subtracted from all gains.

The dollars available to the drug companies for influencing industry

agencies are staggering. There is no question that the CDC's policy of

widespread use of Tubersol for testing HCWs has widely increased the market

for their product. National advisory committees have been an essential and

necessary part of healthcare policy in this country but has been also

linked to significant conflicts of interest, as reported in JAMA (18). In a

review of of doctors involved in establishing national guidelines on

disease treatment, they found that :

85% of guideline authors have some sort of relationships with drug

companies, and they are often not disclosed

38% of respondents said they had served as employees or consultants for

drug companies; 58% received research money

59% had links with drug companies whose medications were considered in the

particular guidelines they authored, almost all cases predating the

guideline creation process

These numbers may be even greater, as only 52% of authors responded

These are disturbing revelations. Questions must be asked regarding the

establishment of national TB skin testing policies for healthy HCWs. First,

to what degree has Aventis benefited from the expansion of mandatory

testing to healthy HCWs in the United States? Secondly, did advisory

committee members who established TB skin testing policies have financial

ties with Aventis?

Conclusions

There is no clinical scientific evidence that the healthy HCW is at higher

risk than the general population. Furthermore, even in positive TB

reactors, there is no modern scientific evidence that would support benefit

of chemoprophylaxis for LTBI in healthy HCWs. The Tubersol agent in use has

not been adequately tested for safety and its accuracy is questionable and

unproveable. The TB skin testing policy for LTBI in the typical HCW is of

doubtful efficacy and benefit and of unknown risk to the individual HCW.

Mandatory testing is unsupported. Most tragically, our government health

agencies have a tract record of errors in drug safety testing and these

same agencies have conflicts of interest that raise serious questions of

the mechanisms that healthcare policies are established.

Recommendations