Congressman Paul Answers our Health Freedom Questions

November 3rd, 2007

November 3, 2004

Here are the questions we asked of each Presidential candidate on our Health Freedom Scorecard. To date, only Dr. Ron Paul (R-TX) has provided his answers to those questions.

We urge all candidates for the office of President of the United States take the time and effort necessary to consider, and answer,

HFUSA: The FDA current Good Manufacturing Practices (cGMP) Final Rule
Do you support the FDA cGMP Final Rule for dietary supplements, issued on June 22, 2007, requiring the batch testing of all food dietary supplements although
– Supplements have an enviable safety record
– The FDA’s own economic analysis of the impact of the cGMP shows that it will drive a significant number of small and medium size manufacturers out of business?

Dr. Paul: I oppose all federal regulations that burden dietary supplement manufacturers. There is no need for the federal nogovernment to impose “Good Manufacturing Practices” on the dietary supplement industry. In addition, the federal government lacks constitutional authority to create standards for the supplement industry.

HFUSA: The FDA draft Guidance on Health Claim substantiation
A. Are your aware of the FDA draft guidance on Health Claim substantiation, issued this summer, which mandates an unreasonably high “Significant Scientific Agreement” standard instead of the FTC “competent and reliable scientific evidence”, as proposed in HR 2117, The Health Freedom Protection Act?

Dr. Paul: I oppose the CAM Regulation draft guidelines and submitted comments to the FDA in opposition to the CAM regulations.


HFUSA: Do you support HR2117 {Health Freedom Protection Act]?

Dr. Paul: I introduced HR 2117, and oppose all FDA actions that in any way infringe on the First Amendment rights of consumers to learn about the health benefits of dietary supplements.

HFUSA: Protection of Dietary Supplements
Do you support continuing strong protection for Dietary Supplement Health and Education Act (DSHEA) products?

Dr. Paul: I support DSHEA.

HFUSA: Bio-Identical Hormones
Do you support the right of men and women to use supplemental Bio-identical Hormones such as DHEA and progesterone to support normal function during change of life and premature aging in preference to less effective, dangerous and more expensive prescription drugs if they prefer bio-identical hormones?

Dr. Paul: The federal government has no constitutional authority to stop Americans from using bio-identical hormones.

HFUSA: Compounding Pharmacies
Do you support the right of Compounding Pharmacists and licensed physicians to continue to provide compounded medications, on a doctor’s prescription, for special needs and choices of individuals, communicating their availability to the public, as permitted by the landmark Supreme Court case of Thompson vs. Western States Medical Centers?

Dr. Paul: The federal government has constitutional authority to restrict the operations of compounding pharmacies.

HFUSA: A. Trilateral Cooperation Charter/North American Union/Security and Prosperity Partnership
A. Do you support the “North American Union” and its companion “Security and Prosperity Partnership” which were created without Congressional debate and approval?

Dr. Paul: A. I am the leading Congressional opponent of the North American Union and the Security and Prosperity Partnership.

HFUSA: B. Do you support FDA’s policy of “harmonization” of regulations with those of Mexico and Canada through the North American Union and the already-operating Trilateral Cooperation Charter which fuses the national health departments of all three countries into a single entity without Congressional oversight or authorization of any entity?
Dr. Paul: B. I oppose all efforts to harmonize American law with the law of other countries and I have taken the lead in working to mobilize congressional opposition to the Trilateral Cooperation Charter.

HFUSA: C. Do you support such executive agreements without Congressional debate and approval?
Dr. Paul: C. No; I do not support allowing the President to erode our freedom and threaten our sovereignty by executive agreement.

HFUSA: D. If elected, do you pledge to use the power of the Executive Branch of Government to overturn or reverse the North American Union, Security and Prosperity Partnership and the Trilateral Cooperation Charter?
Dr. Paul: D. As President, I will withdraw the United States from the North American Union, the Security and Prosperity Partnership, and the Trilateral Cooperation Charter.

HFUSA: HARMonization of FDA regulations with international and foreign agencies and entities
A. Do you support FDA?s policy of ?harmonization? of regulations with those of the European Union, under executive agreement?

Dr. Paul: A. I oppose harmonization. Centralization of power and control breeds oppression.

HFUSA:B. Do you support FDA?s policy of ?HARMonization? of regulations with the standards and guidelines of the Codex Alimentarius when those texts are created through the US efforts on behalf of industrialized food supply constituents and degrade and render toxic the US and global food supplies?
Dr. Paul: B. I am the leading Congressional opponent of CODEX.

HFUSA: C. If elected, what steps do you pledge to take to end these HARMonization activities of the FDA, USDA, FTC and EPA?

Dr. Paul: C. I will seek to stop US participation in the Codex process and make it clear to the UN and the WTO that my administration will not change one comma in American law to make the bureaucrats at Codex happy.

HFUSA:Anti-HARMonization Statute
Do you support strict enforcement of the Anti-Harmonization Statute, 19 USC 3512, which prohibits such harmonization with respect to the US food supply and those foods known as Dietary Supplements?

Dr. Paul: I was instrumental in drafting the anti-harmonization statute, so, yes; I supported strict enforcement of it.

HFUSA: FDA HARMonization with international standards
A. Are you aware and do you support the FDA’s announced policy of “harmonization” with International Standards, even where those standards are not finalized: “In a notice published in the Federal Register of October 11, 1995 (60 FR 53078), FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines? – http://www.cfsan.fda.gov/~lrd/fr970707.html ?

Dr. Paul: A. As stated before, I am strongly opposed to harmonization.

HFUSA:B If elected, what steps do you pledge to take to reign in such HARMonization and return the US to regulatory sovereignty?
Dr. Paul: B. please see my previous answers.

HFUSA: World Trade Organization and similar international bodies
A. Do you support harmonizing America’s legal structure and freedoms to international restrictions through participation in bodies such as the World Trade Organization?

Dr. Paul: A. No; I oppose harmonizing American laws with those of foreign countries to satisfy the WTO or any other international regime.

HFUSA: B. Do you support withdrawing from the World Trade Organization?
Dr. Paul: B. Yes; as a Congressman, I took advantage of the clause in the WTO enabling legislation that allows any member of Congress to introduce legislation withdrawing the United States from the WTO. In fact, by twice introducing WTO withdrawal legislation, I twice forced Congress to vote on withdrawing the United States from the WTO.

HFUSA: C. Do you support withdrawing from the United Nations?
Dr. Paul: C. Yes; I have introduced legislation to withdraw from the UN (HR 1146).

HFUSA: Divesting the FDA of food regulatory authority
A. Since nutrient and natural health products are regulated as Food in accordance with US law, do you support a division of the FDA into two separate agencies, one focusing on Foods (including dietary supplements and all natural or non-pharmaceutical health products) and the other finally focusing on protecting the safety of the public with regard to dangerous drugs and invasive medical devices?

Dr. Paul: A. No; I favor reducing the power of the FDA, not “rearranging deck chairs on the Titanic” by dividing the FDA bureaucracy.

HFUSA: B. Do you support the FDA’s approval of genetically modified foods in the absence of any safety testing, requiring only a patent before the genetically modified food can be admixed with the food supply?
Dr. Paul: B. Consumers should have the right to choose whether or not to use genetically modified food without having the FDA deny them that choice.

HFUSA: C. Do you support the FDA’s position that since the FDA has declared genetically modified foods equivalent to natural ones in the absence of any testing to demonstrate that to be the case and its stated understanding that the public would reject genetically modified foods if they knew what they were buying and eating, that it would be false and misleading if genetically modified foods were identified as such so their labeling is prohibited?
Dr. Paul: C. Consumers have every right to demand that genetically-modified food be labeled as such.

HFUSA: Compulsory medical treatment
A. Do you support the use of the State’s powers to compel compulsory mental health or other screening, forced drugging or other medical treatment under any circumstances?

Dr. Paul: A. No; I oppose compulsory medical treatment.

HFUSA: B. Do you support removing children from parental custody when parents refuse to use medication for alleged “mental health problems” in their children?
Dr. Paul: B. The federal government has no authority to remove children from their parents’ custody because those parents have refused to medicate their children according to federal edicts.

HFUSA: C. Do you support removing children from parental custody when parents refuse to use medication for the allopathic (pharmaceutical) treatment of life threatening diseases such as cancer?
Dr. Paul: C. The federal government has no constitutional authority to remove a child from a parent’s custody because of that parent’s refusal to seek state-ordered medical treatments for their child.

HFUSA: D. Do you support the forced use of pharmaceutical or other medical treatment in adults under any circumstances?
Dr. Paul: D. I have a difficult time imaging a scenario where I would support forcing medical treatment on someone against their will, especially in my capacity as a federal elected official.

HFUSA: E. Do you support the right of parents or adult persons to chose natural medical treatments over pharmaceutical ones if they desire?
Dr. Paul: E. Of course; I support the right of adults to choose natural medical treatments. I have consistently cosponsored legislation in Congress to protect this right.

HFUSA: Mandatory screening
A. Do you support mandatory mental health or other health screening?
Dr. Paul: A. I am the leading Congressional opponent of Mandatory Mental Health Screening.

HFUSA: B. Do you support the use of Federal funds for such screening?
Dr. Paul: B. I have introduced the Parental Consent Act (HR 2387), which forbids federal funds for mandatory mental health screening of children without parental consent. I oppose any use of funds for mandatory mental health screening.

HFUSA: C. Do you support the use of Federal funds to pay for forced drugging of children or adults?
Dr. Paul: C. Yes, I oppose the use of federal funds to pay for forced medicating of children (or adults).

HFUSA: Natural Health Options
Do you support the use of Federal funds for natural medical and health therapy services and treatments on a par with pharmaceutical and other allopathic treatments, at the discretion of the patient?

Dr. Paul: As long as the federal government is financing health care, it should allow the beneficiaries to choose to use their federal funds for alternative treatments.

HFUSA: Vaccination
A. Do you oppose mandatory vaccination under all circumstances?

Dr. Paul: A. It is difficult for me to imagine a scenario where I could support forced vaccinations, especially in my capacity as a federal elected official.

HFUSA: B. Do you support continuing the pharmaceutical industry’s exemption from legal responsibility for injuries caused by vaccinations?
Dr. Paul: B. No, I do not believe the pharmaceutical industry should be protected from paying compensation to those harmed by their vaccines.

HFUSA: C. Do you support continuing the pharmaceutical industry’s exemption from legal responsibility for injuries caused by drugs approved for any indication?
Dr. Paul: C. No, the pharmaceutical industry should not be protected from being held accountable to those injured by their products.

HFUSA: . Reproductive Autonomy
A. Do you support a woman’s right to control her reproductive life without interference from the Federal government?

Dr. Paul: A. As a physician, I oppose abortion. I believe this should be dealt with by state and local governments; it is not a federal issue.

HFUSA: B. If elected, what will you pledge to do to protect the reproductive autonomy of women?
Dr. Paul: [No Answer provided]

HFUSA: Freedom Plank
How soon can the American public expect a formal Health Freedom Plank in your campaign platform?

Dr. Paul: There is further information on my position on health freedom on my website at http://www.RonPaul2008.com.

Findings, HR 2387, the Parental Consent Act of 2007

October 4th, 2007

Here are the Findings listed at the beginning of HR 2387, introduced on May 17, 2007 into the House of Representatives by Congressman Ron Paul:
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) The United States Preventive Services Task Force (USPSTF) issued findings and recommendations against screening for suicide that corroborate those of the Canadian Preventive Services Task Force. `USPSTF found no evidence that screening for suicide risk reduces suicide attempts or mortality. There is limited evidence on the accuracy of screening tools to identify suicide risk in the primary care setting, including tools to identify those at high risk.’.
(2) The 1999 Surgeon General’s report on mental health admitted the serious conflicts in the medical literature regarding the definitions of mental health and mental illness when it said, `In other words, what it means to be mentally healthy is subject to many different interpretations that are rooted in value judgments that may vary across cultures. The challenge of defining mental health has stalled the development of programs to foster mental health (Secker, 1998). . . .’.
(3) A 2005 report by the National Center for Infant and Early Childhood Health Policy admitted, with respect to the psychiatric screening of children from birth to age 5, the following: `We have mentioned a number of the problems for the new field of IMH [Infant Mental Health] throughout this paper, and many of them complicate examining outcomes.’. Briefly, such problems include:
(A) Lack of baseline
(B) Lack of agreement about diagnosis.
(C) Criteria for referrals or acceptance into services are not always well defined.
(D) Lack of longitudinal outcome studies.
(E) Appropriate assessment and treatment requires multiple informants involved with the young child: parents, clinicians, child care staff, preschool staff, medical personnel, and other service providers.
(F) Broad parameters for determining socioemotional outcomes are not clearly defined, although much attention is now being given to school readiness.
(4) Authors of the bible of psychiatric diagnosis, the Diagnostic and Statistical Manual, admit that the diagnostic criteria for mental illness are vague, saying, `DSM-IV criteria remain a consensus without clear empirical data supporting the number of items required for the diagnosis. . . . Furthermore, the behavioral characteristics specified in DSM-IV, despite efforts to standardize them, remain subjective. . . .’ (American Psychiatric Association Committee on the Diagnostic and Statistical Manual (DSM-IV 1994), pp. 1162-1163).
(5) Because of the subjectivity of psychiatric diagnosis, it is all too easy for a psychiatrist to label a person’s disagreement with the psychiatrist’s political beliefs a mental disorder.
(6) Efforts are underway to add a diagnosis of `extreme intolerance’ to the Diagnostic and Statistical Manual. Prisoners in the California State penal system judged to have this extreme intolerance based on race or sexual orientation are considered to be delusional and are being medicated with anti-psychotic drugs. (Washington Post 12/10/05)
(7) At least one federally-funded school violence prevention program has suggested that a child who shares his or her parent’s traditional values may be likely to instigate school violence.
(8) Despite many statements in the popular press and by groups promoting the psychiatric labeling and medication of children, that ADD/ADHD is due to a chemical imbalance in the brain, the 1998 National Institutes of Health Consensus Conference said, `. . . further research is necessary to firmly establish ADHD as a brain disorder. This is not unique to ADHD, but applies as well to most psychiatric disorders, including disabling diseases such as schizophrenia. . . . Although an independent diagnostic test for ADHD does not exist. . . . Finally, after years of clinical research and experience with ADHD, our knowledge about the cause or causes of ADHD remains speculative.’.
(9) There has been a precipitous increase in the prescription rates of psychiatric drugs in children:
(A) The use of antipsychotic medication in children has increased nearly fivefold between 1995 and 2002 with more than 2.5 million children receiving these medications, the youngest being 18 months old. (Vanderbilt University, 2006)
(B) More than 2.2 million children are receiving more than one psychotropic drug at one time with no scientific evidence of safety or effectiveness. (Medco Health Solutions, 2006)
(C) More money was spent on psychiatric drugs for children than on antibiotics or asthma medication in 2003. (Medco Trends, 2004)
(10) A September 2004 Food and Drug Administration hearing found that more than two-thirds of studies of antidepressants given to depressed children showed that they were no more effective than placebo, or sugar pills, and that only the positive trials were published by the pharmaceutical industry. The lack of effectiveness of antidepressants has been known by the Food and Drug Administration since at least 2000 when, according to the Food and Drug Administration Background Comments on Pediatric Depression, Robert Temple of the Food and Drug Administration Office of Drug Evaluation acknowledged the `preponderance of negative studies of antidepressants in pediatric populations’. The Surgeon General’s report said of stimulant medication like Ritalin, `However, psychostimulants do not appear to achieve long-term changes in outcomes such as peer relationships, social or academic skills, or school achievement.’.
(11) The Food and Drug Administration finally acknowledged by issuing its most severe Black Box Warnings in September 2004, that the newer antidepressants are related to suicidal thoughts and actions in children and that this data was hidden for years. A confirmatory review of that data published in 2006 by Columbia University’s department of psychiatry, which is also the originator of the TeenScreen instrument, found that `in children and adolescents (aged 6-18 years), antidepressant drug treatment was significantly associated with suicide attempts . . . and suicide deaths. . . . ‘. The Food and Drug Administration had over 2000 reports of completed suicides from 1987 to 1995 for the drug Prozac alone, which by the agency’s own calculations represent but a fraction of the suicides. Prozac is the only such drug approved by the Food and Drug Administration for use in children.
(12) Other possible side effects of psychiatric medication used in children include mania, violence, dependence, weight gain, and insomnia from the newer antidepressants; cardiac toxicity including lethal arrhythmias from the older antidepressants; growth suppression, psychosis, and violence from stimulants; and diabetes from the newer anti-psychotic medications.
(13) Parents are already being coerced to put their children on psychiatric medications and some children are dying because of it. Universal or mandatory mental health screening and the accompanying treatments recommended by the President’s New Freedom Commission on Mental Health will only increase that problem. Across the country, Patricia Weathers, the Carroll Family, the Johnston Family, and the Salazar Family were all charged or threatened with child abuse charges for refusing or taking their children off of psychiatric medications.
(14) The United States Supreme Court in Pierce versus Society of Sisters (268 U.S. 510 (1925)) held that parents have a right to direct the education and upbringing of their children.
(15) Universal or mandatory mental health screening violates the right of parents to direct and control the upbringing of their children.
(16) Federal funds should never be used to support programs that could lead to the increased over-medication of children, the stigmatization of children and adults as mentally disturbed based on their political or other beliefs, or the violation of the liberty and privacy of Americans by subjecting them to invasive `mental health screening’ (the results of which are placed in medical records which are available to government officials and special interests without the patient’s consent).
SEC. 3. PROHIBITION AGAINST FEDERAL FUNDING OF UNIVERSAL OR MANDATORY MENTAL HEALTH SCREENING.
(a) Universal or Mandatory Mental Health Screening Program- No Federal funds may be used to establish or implement any universal or mandatory mental health, psychiatric, or socioemotional screening program.
(b) Refusal to Consent as Basis of a Charge of Child Abuse or Education Neglect- No Federal education funds may be paid to any local educational agency or other instrument of government that uses the refusal of a parent or legal guardian to provide express, written, voluntary, informed consent to mental health screening for his or her child as the basis of a charge of child abuse, child neglect, medical neglect, or education neglect until the agency or instrument demonstrates that it is no longer using such refusal as a basis of such a charge.
(c) Definition- For purposes of this Act, the term `universal or mandatory mental health, psychiatric, or socioemotional screening program’–
(1) means any mental health screening program in which a set of individuals (other than members of the Armed Forces or individuals serving a sentence resulting from conviction for a criminal offense) is automatically screened without regard to whether there was a prior indication of a need for mental health treatment; and
(2) includes–
(A) any program of State incentive grants for transformation to implement recommendations in the July 2003 report of the President’s New Freedom Commission on Mental Health, the State Early Childhood Comprehensive System, grants for TeenScreen, and the Foundations for Learning Grants; and
(B) any student mental health screening program that allows mental health screening of individuals under 18 years of age without the express, written, voluntary, informed consent of the parent or legal guardian of the individual involved.

Dangerous “Mental Health” Drugs Damage Unborn Babies: Pregnant Mothers To Be Screened and Drugged Under “New Freedoms Initiative”, 2004 US Law

October 4th, 2007

Women Not Warned About SSRI-Related Lung Birth Defects

By Evelyn Pringle

October 2, 2007

A study of nearly 500,000 women by researchers at the University of Pittsburgh Medical Center, in the September 18, 2007, Annals of Internal Medicine, found that nearly 50% of women taking a prescription drug that could cause birth defects did not receive warnings to avoid pregnancy. The authors note that the pregnancy risks of a drug should be discussed with women before they begin taking it.
Experts say the seriousness of a life-threatening lung disorder found six times more often in infants born to mothers who take antidepressants during pregnancy is not being adequately conveyed to women while they are considering whether to use the drugs.

The disorder, persistent pulmonary hypertension (PPHN), occurs when a newborn does not adjust to breathing outside the womb. PPHN refers to high pressure in the lungs’ blood vessels which prevents the body’s oxygen-poor blood from entering the lungs to absorb oxygen, and leaves the infant with not enough oxygen into the bloodstream.

On July 19, 2006, the FDA ordered a PPHN warning for the labels of the selective serotonin reuptake inhibitor antidepressants (SSRI’s), based on a February 9, 2006 study in the New England Journal of Medicine, and issued a Public Health Advisory that stated:

“A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRI’s) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

Two week later on August 1, 2006, the American College of Obstetricians and Gynecologist issued a press release warning that the use of SSRI’s and selective norepinephrine reuptake inhibitors (SNRI’s) during pregnancy should be individualized based on their respective risks and benefits, and specifically warned that Paxil should be avoided due to the potential risk of fetal heart defects, PPHN and other negative effects.

SSRI’s sold in the US include Paxil marketed by GlaxoSmithKline, Prozac by Eli Lilly, Zoloft by Pfizer, and Celexa and Lexapro sold by Forest Laboratories, along with various generic versions of the drugs. The closely-related class of SNRI antidepressants also carry birth defects warnings and include Wyeth’s Effexor and Lilly’s Cymbalta.

In any given year in the US, at least eighty-thousand pregnant women are prescribed SSRI’s, according to a study in the May 2005, Journal of American Medical Association. The CDC recently reported that antidepressants were the most prescribed class of drugs in the country in 2005. The fact that the overall prescribing rate is higher than for any other drugs indicates that a large number of pregnant women may be taking antidepressants without knowledge of the risks to the unborn fetus.

Overall, respiratory failure affects nearly 80,000 newborns per year, and it is responsible for as many as half of all infant deaths. Nearly one-third of all newborns with respiratory failure are born at term or near-term, and are at risk for PPHN, according to the April 2007 article, “Pulmonary Hypertension, Persistent-Newborn,” by Dr Robin Steinhorn, head of the Division of Neonatology at Children’s Memorial Hospital in Chicago and Professor at Northwestern University Medical School, in eMedicine from WebMD.

Dr Steinhorn also notes that an increased incidence of PPHN is reported for mothers who use SSRI’s during the last half of their pregnancies.

As recently as 15 years ago, the reports says, the mortality rate for PPHN infants reached 40%, and the prevalence of major neurologic disability was 15-60%. However, the introduction of extracorporeal membrane oxygenation (ECMO) and other new therapies has had a major effect on reducing the mortality rate, yet the prevalence of major neurologic disabilities among surviving newborns remains approximately 15-20%.

Dr Steinhorn reports that Glass and colleagues compared the neurodevelopmental outcome of 103 neonates following ECMO and 37 without ECMO at age 5 and states:

“Major disability, which was defined as mental disability, motor disability, sensorineural impairment, or seizure disorder, was present in 17 of children in whom ECMO had been used. The mean full-scale, verbal, and performance intelligence quotient (IQ) scores of children who received ECMO treatment were within the normal range; however, as a group, the scores were significantly lower than in children who had not had ECMO (96 vs 115).”

According to the report, infants who survive following ECMO have a higher rate of re-hospitalization for non-pulmonary and surgical conditions, and the rate of sensorineural disabilities in infants who survive averages 6% and developmental delay occurs in 9%.

Because the prevalence of hearing loss is high, the report recommends that an automated hearing test should be administered before discharging the baby and hearing should be reassessed when he or she is 6-months-old and again, as the results indicate.

Dr Steinhorn also notes that an increased frequency of social problems, academic difficulties at school age and higher rates of attention deficit disorder are reported in children who received ECMO.

Although the actual FDA warning about PPHN was not added to the antidepressant labels until August 2006, the drug makers were well aware of the risk of this birth defect for more than a decade, due to a long and steady line of studies that linked the drugs to serious respiratory problems in newborns dating back to 1996.

A study in the October 3, 1996, New England Journal of Medicine, lead by Dr Christina Chambers of the Department of Pediatrics at the University of California-San Diego, reported that PPHN developed in 2.7% of a group of infants whose mothers took Prozac throughout their pregnancy.

From 1989 through 1995, the California Teratogen Information Service and Clinical Research Program received approximately 1,500 calls requesting information on the potential teratogenic effects of Prozac (fluoxetine), and an estimated one-third of the calls were made by pregnant women who were currently taking Prozac.

For their study, the researchers selected 228 of these women. Because they hypothesized that birth size, gestational age, and neonatal adaptation were influenced by exposure to Prozac late in pregnancy, the women were divided into two groups.

One group was referred to as the exposed-early group because the women discontinued Prozac in the first or second trimester, and another group was referred to as the exposed-late group because the women continued to take Prozac in the third trimester.

A third group of 254 pregnant women who called the same California Information Program between 1989 through 1995, but with questions about other drugs and procedures that were not considered teratogenic, was enrolled as a control group.

The researchers determined that 73 infants in the exposed-late group had higher rates of premature delivery, admissions to special care nurseries, and poor neonatal adaptation, including respiratory difficulty, cyanosis on feeding and jitteriness. Birth weight was also lower and birth length shorter in the exposed-late infants, they found.

The study authors noted their concern over the 15.5% incidence of three or more minor anomalies in some infants exposed to Prozac in early pregnancy. “The combination of any three minor anomalies in a single child is an unusual finding,” they wrote.

The 15.5 percent incidence, they said, indicates that exposure during the first trimester has an effect on embryonic development. “This finding raises the possibility of an associated defect in the development of the central nervous system that may become evident when the infant is older,” the authors wrote.

In January 1998, a study in the international journal of medical science and practice, The Lancet, explained that the lungs act as a reservoir for antidepressants and this study suggests that SSRI’s could play a pivotal role in infant respiratory conditions, such as PPHN. Another study, in the April 2002 Journal of Laboratory and Clinical Medicine, investigated the effects of SSRI’s on pulmonary circulation and found that SSRI’s affect the pulmonary smooth muscle cells and aggravate pulmonary hypertension.

In June 2004, a study in Prescrire International also reported that newborns exposed to SSRI’s toward the end of pregnancy showed signs of altered muscle tone, breathing and suction problems, and agitation, with an estimated 20% to 30% of the infants affected.

The next month, after receiving hundreds of adverse event reports over a decade, in July 2004, the FDA finally revised the labels for all SSRI’s and SNRI’s, warning that some newborns exposed to the drugs had developed problems requiring prolonged hospitalizations, respiratory support and tube feeding.

Less than a year later, a study in the May 2005 Journal of the American Medical Association reported that women who took SSRI’s or SNRI’s late in pregnancy were at a 3 times higher risk of giving birth to infants suffering from serious respiratory problems, jitteriness and irritability. Lead author, Dr Eydie Moses-Kolko, reported that serious respiratory problems developed in about one out of every 100 infants.

According to Dr David Healy, a leading expert on pharmacology and author of “The Antidepressant Era,” the doctors who prescribe SSRI’s are often not able to spend enough time with patients to discuss their emotional issues in depth. “For some doctors,” he notes, “SSRI’s may appear to provide a quick solution for patient problems arising from normal life events such as bereavement, work stress, or marital conflict.”

However, he says, a review of the actual SSRI studies shows that only one patient in 10 responds to these drugs, and he attributes the massive prescribing to successful marketing rather than benefits.

“Through educational and marketing campaigns,” Dr Healy says, “the SSRI makers have produced a situation where people who would never have been given an antidepressant in the 1960s, 1970s and 1980s, are now given one after cursory questioning by a physician.”

Another leading expert, Dr Peter Breggin, founder of The International Center for the Study of Psychiatry and Psychology (ICSPP), a nonprofit research and educational network, and the journal Ethical Human Sciences and Services, also says a thorough review of all the studies submitted to the FDA for the approval of the SSRI’s showed that, when taken as a whole, the drugs do not work.

Dr Breggin also agrees that the high rate of prescribing to women indicates that women who may be experiencing minor symptoms of distress common with daily living are being convinced that they have a mental illness that requires drugs, most frequently an SSRI.

Proponents for the drug makers claim that depression itself poses a greater risk to the fetus than SSRI’s. “The problem with this claim is that there is no consideration for the health of the baby and the immense stress a mother has to endure when her baby is sick,” states Kate Gillespie, a Paxil injury lawyer from the Baum Hedlund law firm.

“Not to mention, the far greater stress that is created by having to constantly deal with life and death health issues, like the respiratory problems of an infant, that are caused by SSRI-induced PPHN,” she adds.

“For these women,” Ms Gillespie says, “it is clear that the risks far outweigh any benefit.”

An August 2006 study in the Archives of General Psychiatry compared babies born to depressed mothers treated with SSRI’s to those born to mothers who were not treated, and found a significantly greater incidence of respiratory distress, 13.9% vs 7.8%, and longer hospital stays for the infants exposed to SSRI’s.

Another study, in the August 2007 American Journal of Psychiatry, examined the effects of depression and antidepressant use on fetal age and the risk of preterm birth with 90 women and found the drugs, rather than depression, to be associated with lower fetal age and an increased risk of preterm birth. The researchers noted that the presence of depression per se during pregnancy did not adversely affect outcomes.

According to Dr Breggin, SSRI’s should never be used during pregnancy. “If pregnant women feel anxious or sad,” he says, “they should seek counseling or family therapy involving the child’s father, along with other sources of emotional support.”

Families seeking legal advice regarding SSRI-antidepressant birth defects can contact the Baum, Hedlund, Aristei & Goldman Law Firm at: (800) 827-0087 ; http://www.baumhedlundlaw.com/

(Written by Evelyn Pringle as part of the Antidepressant Birth Defect Litigation Monthly Round-Up, Sponsored by Baum Hedlund’s Pharmaceutical Antidepressant Litigation Department)
www.paxilbirthdefect.com/
www.pphnlawyers.com

(Evelyn Pringle is a regular columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America)

Microsoft HealthVault Preserves Doctor-Patient Confidentiality: Good for Microsoft!

October 4th, 2007

This morning, tech giant Microsoft Corporation will tell America that health
technology CAN protect privacy and ensure informed consent when they announce
the launch of HealthVault, an electronic health record system. Patient
Privacy Rights founder, Dr. Deborah Peel, will be standing with Microsoft to
talk about HealthVault’s privacy protections.

Microsoft has sought advice from Patient Privacy Rights about building privacy
protections into HealthVault. Today, the bar for privacy in electronic health
records has been raised exponentially: guaranteeing informed consent is NOT a
nuisance or impossibility BUT a requirement. We challenge other technology
companies to also give patients real control of their personal health
information.

Why would Patient Privacy Rights support an electronic health record?

* HealthVault requires consumers to give informed consent before any use or
disclosure of personal health information. No one: not insurers, employers,
hospitals, application partners, advertisers, data miners, or even Microsoft
will be able to access consumers’ electronic health accounts without consent.
* Microsoft has committed to independent third party audits to verify their
pledge to protect privacy.
* Microsoft is the first major multinational technology corporation to
collaborate with Patient Privacy Rights and use the 2007 Privacy Principles
created by the bi-partisan Coalition for Patient Privacy as the basis for the
consumer controls of health data stored in HealthVault.
* Microsoft’s application partners are held to the same privacy standards as
HealthVault.
* Advertisers are contractually required to protect any data transferred from
HealthVault.
* HealthVault’s privacy policies are simple and easy to understand.
* Microsoft’s new health search engine is not data mined and allows people to
search for health information anonymously.

While Microsoft assured Patient Privacy Rights that HealthVault’s privacy
protections are solid, no one should feel pressured to use HealthVault, or any
other electronic health record. You and you alone should have the right to
decide whether you are comfortable storing and sharing your health information
To learn more you can read Patient Privacy Rights’ Press Release and explore
Microsoft’s HealthVault.

Source: Ashley Katz
Patient Privacy Rights.org

Dr. William Rea’s Letter to His Patients

September 24th, 2007


Environmental Health Center – Dallas
WIlliam J. Rea, M.D.
FA.C.S., F.AA.E.M.,
FA.C.N., FA.C.P.M.,
FA.CA., F.R.S.M.
Board Certified in
Thoracic and Cardiovascular Surgery
Abdominal and General Surgery
Environmental Medicine

8345 Walnut Hill Lane – Suite 220, Dallas,Texas75231 · Telephone:(214)368-4132- Facsimile: (214) 691-8432
Website: www.ehcd.com E-mail: inform@ehcd.com

September 18, 2007
Dear Patients:
This letter is being sent to you so that we may provide information about a
potential serious potential threat to your choice of medical care. To put it bluntly,
there is currently an organized nation-wide effort to destroy the specialty of
Environmental Medicine and to eliminate from practice physicians who diagnose
and treat patients suffering from chemical sensitivities.
Since October of 2005 the Texas Medical Board has been investigating me on
charges of providing substandard care and “endangering public health.” An
anonymous third party complaint was made to the board against me, citing five
specific patients as being mistreated. You may ask “What is an anonymous third
party complaint?” This type of complaint is made to the board without the
knowled2:e or consent of the patient. The complaint against me was almost
certainly made by United Health Care/Oxford. All five patients cited in the
complaint had no knowledge that they or their information was being used in this
way. Further, none of the patients are alleging mistreatment or malpractice against
me and all five are still under my care. Additionally, these patients have all
written to the Texas Medical Board and informed them that they are not part of
this complaint and they are not making any allegations against me of any kind.
Two of the patients have stated that I saved their lives.
The Texas Medical Board has dismissed the protests of these patients and
continues to pursue charges against me. Further, the board refuses to officially
reveal who made the complaint, what I am alleged to have done, or what evidence
was presented against me. They continually maintain that this information is
protected and does not have to be revealed.
However, we are almost certain that United Health Care/Oxford is behind the
complaint. All five patients were from Manhattan (New York City), New York
and all had the same insurance company – United Health Care/Oxford. As you
know, our clinic does not take insurance, so all patients file claims directly with
their respective insurance companies. We therefore do not have any direct
connection with this insurance company. Evidence showing these facts was
supplied to the Texas Medical Board, but was apparently disregarded as they have
decided to pursue the charges despite the evidence.
The board has conducted an anonymous so-called peer review of the five patient’s
medical records and the treatment they received, again without the permission of
these patients. A peer review of a physician’s action can be undertaken for a
variety of reasons but there is always one common factor in the process.
September 18, 2007
Page Two
That common factor is that the reviewer is required to be both knowledgeable about and a
practitioner of the specialty that is being reviewed. Thus, the reviewer is a “peer” of the
physician being reviewed.
In my case the Texas Medical Board chose a reviewer who does not specialize in Environmental
Medicine, and who is in fact an allergist. This reviewer, who was anonymous, gave a negative
review of the treatment of the five patients, despite the fact that all have improved, several of
them substantially so, while under my care. I had 17 actual peers, physicians who practice
Environmental Medicine, review all five of these cases as well. To a person these 17 reviewers
found that my treatment of these patients was not only adequate, but that it met or exceeded the
standard of care for treatment in our specialty. Further, the reviewers also noted that the state
board reviewer was UNINFORMED about the specialty of Environmental Medicine, clearly did
not understand the complex nature of the diagnosis and treatment of patients who suffer from
chemical sensitivities, grossly misunderstood many of the facts in the medical records, was
antagonistic towards and biased against the specialty of Environmental Medicine, and was
clearly unqualified to conduct such a review due to lack of experience, knowledge, and
expressed biases. The board has chosen to dismiss the review done by 17 actual peers and has
chosen to support the conclusion of their one unqualified reviewer.
Based on secret evidence provided by an anonymous accuser and supported by and anonymous
reviewer the board has recommended that my license to practice medicine be placed in jeopardy.
Currently, the Texas Medical Board is one of the most difficult for physicians to deal with in the
entire country. It is particularly noted for not treating physicians fairly and denying their basic
constitutional rights. Pleased be assured that I still have my license, that I am fighting the
charges, that the Environmental Health Center is still open, and we are still seeing patients and
plan to continue doing so.
Unfortunately, my case is not unique. Recently across the United States there has been an
organized attempt to deprive citizens of their choice in individual health care by attempting to
have the licenses of doctors who are deemed to practice “alternative” medicine revoked. This
campaign has been going on for at least 10 years now and is being led primarily by health
insurance companies. These efforts are also being supported by a small group of individuals (and
other groups) working for or associated with the National Council Against Health Fraud in
Allentown, Pennsylvania.
The typical pattern in these attacks is to single out physicians they do not like and file
anonymous complaints against them with different state medical boards. For example, over the
past 10 years the number of physicians who are willing to diagnose and treat Lyme Disease has
dropped sharply, while cases of Lyme disease have skyrocketed. This is because several health
insurance companies have systematically targeted the doctors who specialized in treating that
illness. Many of these physicians have had complaints made against them in exactly the same
manner that they have been made against me. These same types of complaints have been made
— —-
September 18, 2007
Page Three
against doctors who treat patients for chemical sensitivities, mold exposure, for Gulf War
Syndrome, and now possibly against physicians who are treating patients who were injured in
the 9/11 tragedy.
You may ask why this campaign is taking place. It appears that quite simply the health insurance
companies want to be the sole arbiter of what types of treatments are available to patients, and
thus what they will be required to pay. They clearly do not want new diagnoses and treatments
established because they will then have to pay for these. Finally, many of us who have been
turned in to state medical boards do not take insurance assignment. We do this so that we can
provide treatment to our patients without insurance company interference. In recent years the
health insurance carriers have tried to automate their claims processing procedures. When claims
are denied, they then have to be handled by a human and this costs money. When physicians do
not accept insurance assignment, the claims submitted by their patients often have a higher
denial rate. This results in higher processing costs for the insurance companies. If these carriers
can eliminate the independent physicians with higher denial rates they can potentially save a lot
of money. Certain state medical boards appear to agree with this strategy and cooperate in the
process.
Of course, these attempts are also being made in order to try and standardize treatments and
make all patients fit into one “box.” Americans need more choices in health care, not fewer. We
hope you, as an informed citizen, want to be part of an effort to help preserve freedom of choice
in health care. Insurance carriers and a small group of “Quack busters” should not be allowed to
decide what type of health care is available in this country.
It is unconscionable that the Texas Medical Board would want to limit freedom of choice in
health care, and allow insurance carriers to interfere with the doctor-patient relationship. Please
join our effort for freedom of choice in health care and write your protest to members of the
Texas Legislature. You can also copy your protest to members of the Texas Medical Board. If
you do not know who your representatives are, go to the following website to find out:
http://www.fyi.legis.state.tx.us/
If you are out of state, you can contact Texas State Senator Jane Nelson and Representative Fred
Brown, both of whom have taken an interest in recent activities of the Texas Medical Board. You
can also send letters of protest to the Executive Director of the Texas Medical Board, Donald
Patrick, M.D., J.D., bye-mail, phone, or fax. Please petition the elected officials to:
1. Support the dismissal of the anonymous complaint made against Dr. Rea, or at
the very least the revelation of who made the complaint and what evidence was
presented against him.
— —-
September 18, 2007
Page Four
2. Prohibit the Texas Medical Board from conducting anonymous peer reviews by
unqualified reviewers, or using reviewers with a bias or conflict of interest.
3. Prohibit the Texas Medical Board from accepting and pursuing complaints in
such a way that they deprive physicians of their constitutional rights and their
ability to defend themselves.
4. Strongly oppose the anonymity given to billion dollar insurance compames
when making state board complaints against physicians.
5. Urge the Texas Legislature to hold hearings on the Texas Medical Board and
their seeming cooperation with health insurance companies’ attempts to delicense
physicians in specialties that they do not like and the board’s denial of
due process to accused physicians in direct contradiction to the due process that
the board claims that it provides.
Thank you very much for your help. Together, we can stop the Texas Medical Board and other
state medical boards from unfairly targeting physicians that outside interests do not like. We can
also expose the despicable tactics of the insurance companies in their efforts to control all
aspects of healthcare.
r!!::J~ President
Environmental Health Center-Dallas
Texas Leeislators:
Texas Senator Jane Nelson
Chair of the Senate Health and Human Services Committee
P. O. Box 12068
Austin, TX 78711
512/463-0112
j ane.nelson@senate.state.tx.us
— – — –
September 18,2007
Page Five
Representative Fred Brown
Room CAP GWA
P.O. Box 2910
Austin, Texas 78768
(512)463-0698
(512) 463-5109 Fax
Members of the Texas Medical Board:
Correspondence to the Board Members can be sent to:
Texas Medical Board
P. O. Box 2018
Austin, Texas 78768
TEL: (512) 305-7030
FAX: (512) 305-7051
Donald W. Patrick, M.D., J.D. (Executive Director)
Lawrence LaZelle Anderson, M.D. (Dermatology)
Tyler
Michael Arambula, M.D. (Psychiatry)
San Antonio
Julie Attebury (Public Member)
Amarillo
Jose M. Benavides, M.D. (Internal Medicine)
San Antonio
Patricia S. Blackwell (Public Member)
Midland
Melina S. Fredricks (Public Member)
Conroe
Manual G. Guajardo, M.D. (Obstetrics/Gynecology)
Brownsville
— – — – – – – — – – — —
September 18, 2007
Page Six
Roberta M. Kalafut, D.O. (Physical Medicine and Rehabilitation)
Current board President
Abilene
Amanullah Khan, M.D. (Oncology)
Dallas
Melina McMichael, M.D. (Internal Medicine)
Austin
Margaret C. McNeese, M.D. (Pediatrics)
Houston
Charles E. Oswalt, III,M.D. (Trauma Surgeon)
Waco
Larry Price, D.O. (Cardiovascular Diseases)
Current Board Vice President
Temple
Annette P. Raggette (Public Member)
Austin
Paulette B. Southard (Public Member)
Alice
Timothy J. Turner (Public Member)
Current Secretary-Treasurer
Houston
Timothy Webb (Public Member)
Houston
Irvin E. Zeitler, Jr., D.O. (Family Practice)
San Angelo
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