Psychiatrist Warned by FDA
Mar 16th, 2010
Miami Herald
March 16, 2010
MENTAL HEALTH
The psychiatrist who treated the Broward foster child who killed himself last year is now in hot water with the FDA.
BY CAROL MARBIN MILLER
A South Florida psychiatrist who was treating a 7-year-old foster child before the boy committed suicide last year has received a warning from federal drug regulators who say he failed “to protect the rights, safety and welfare” of children enrolled in clinical drug trials.
In a strongly worded letter dated Feb. 4, regulators at the U.S. Food and Drug Administration said Dr. Sohail Punjwani over-medicated children who were enrolled in clinical trials for undisclosed drugs. One girl, the letter said, slashed her wrists while hallucinating.
Another, a 13-year-old, “experienced sedation and dizziness during the study,” the letter said.
The warning letter, a harsh and rare form of discipline by the agency, says Punjwani failed to “adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.”
“Your failure to conduct the requisite safety measures contributed to the unnecessary exposure of pediatric subjects to significant overdoses, which jeopardized the subjects’ rights, safety and welfare,” the letter says.
Punjwani did not return calls from The Miami Herald seeking comment.
Punjwani, who practices in Tamarac and has offices elsewhere in South Florida, was treating 7-year-old Gabriel Myers when the boy hanged himself with a shower cord in a Margate foster home. The boy’s death prompted a yearlong probe by a Department of Children & Families task force, as well as proposed legislation before the Florida Senate.
Before Gabriel’s death, Punjwani had prescribed several powerful mental health drugs — some of which had not been approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children.
Punjwani also was sued last summer by a Tamarac mother who claims her son, 16-year-old Emilio Villamar, died after being over-medicated with a group of mental health drugs at a Fort Lauderdale psychiatric hospital.
The letter mailed to Punjwani does not specify the names or types of drugs the doctor was testing, and a spokeswoman for the FDA, Sandy Walsh, said such details are kept confidential to protect drug companies.
Walsh said the FDA does not send out such warning letters often, and the agency considers breaches of its regulations to be “very serious.” The letter was signed by Leslie K. Ball, a doctor who heads the compliance office of the Division of Scientific Investigations, and Constance Cullity, a doctor who is also a compliance officer.
For years, drug makers did not study most medications on children, largely due to ethical concerns over using kids as test subjects. More recently, however, Congress passed laws to encourage pharmaceutical companies to test their drugs for safety and efficacy with children by extending patents on drugs approved for adults.
In a trial for one drug that was not identified, Punjwani gave one child dosages “in excess of… specified limits,” the letter says.
The child was discontinued from the trial before it was completed, the letter says, “due to worsening auditory hallucinations that apparently caused the subject to lacerate her wrists.” The girl was “overdosed” on the drug for more than two weeks.
The letter says Punjwani submitted a corrective action plan to the FDA and revised his procedures to better protect his research subjects from dosing missteps. “However,” the letter says, “we are concerned that the response is not adequate to prevent future recurrence of the violation.”
The clinical trials for a different drug were to adhere to a series of protocols that specified what dosage of the drug was to be used, depending on the child’s weight, the letter states. But for six of seven children — chosen at random — who received one of the tested drugs in Punjwani’s study, the dosage exceeded what was spelled out in the protocol.
One child who weighed 103 pounds, for example, “was overdosed on study medication for 20 consecutive days while participating in the study,” the letter states. The child is identified only as “Subject 1001.”
A child identified as “Subject 1003,” who was 15 at the time of the trials, “was overdosed on study medication for 21 consecutive days while participating in the study,” the letter says. “Subject 1004,” a 16-year-old, “received doses in excess of the maximum target dose for 3 consecutive days while participating,” the letter says.
A 10-year-old, identified as “Subject 1007,” was “overdosed” for nearly two weeks while on the study, the letter states.
Department of Children & Families Secretary George Sheldon, who appointed a task force last year to study Gabriel’s death, said Monday he is asking the FDA to compare a list of Florida foster children with lists ofchildren enrolled in Punjwani’s clinical trials. Sheldon said he was acting on concerns that children in state care may have been involved in clinical trials, which is against state law.
The FDA letter, Sheldon said, “raises clear ethical issues and judgment issues that we need to clearly understand.” If foster kids were enrolled in clinical trials, he said, “we will need to take it to another level.”
This is why foster kids are lab rats:
OUR MOST PRECIOUS TREASURE
By Beverly Tran
May 3, 2007
“The state must declare the child to be the most precious treasure of the people. As long as the government is perceived as working for the benefit of the children the people will happily endure almost any curtailment of liberty and almost any deprivation.”
Adolph Hitler, 1943
There have been much heated discussions in the area of the psychological well-being of children. Children are time and time again found in our government’s rhetoric as the most precious resource of our nation, and this responsibility of protecting children is entrusted in our government.[i] Unfortunately, attention is strictly focused on the aftermath of adopting these policies for mandatory psychological screening, evaluation, and the medication of children. Diatribes from supporters for mandatory psychotropic medication of children (i.e. pharmaceutical industries, psychiatrists, social workers, educators) are embroidered on waving banners in the lobbying charge on legislatures promising the glorious victory of children growing up to better function in society. The other voice in the battle against mandatory psychotropic medication of children hails from the parents. Parents cry out their stories of horror of watching their children mentally and physically deteriorate, to the point of life long suffering and even death, from the side effects of these medications, and in many cases, unnecessary and overmedication of our children. The time has come for both professionals and families to reconcile for the “best interests of the child” and redirect national perspectives to preserve the “best interests of the family”.
The genus of the “best interests of the child” philosophy has classified federal policy into a taxonomic category of ranked organisms, where these “ranked organisms” are better understood as federal agencies.
FEDERAL RANKED ORGANISMS
The Task Force on Environmental Health Risks and Safety Risks to Children[ii] and Interagency Forum on Child and Family Statistics[iii] were created to co-integrate federal statistic and research agencies to produce an “annual compendium” of the most important indicators of the well-being of the Nation's children and families to be published by the Forum in collaboration with the National Institute of Child Health and Human Development. Since then, the Task Force added environmental health in schools and coordinated federal efforts to highlight the importance of protecting children's health during Children's Health Month in October 2002.
National Children's Study and Children's Health Month were incorporated into its interagency activities. The National Governor's Association (NGA) Center for Best Practices, supported by the Center for Disease Control and Prevention (CDC), examines the relationship between smart community design and improved public health. With Environmental Protection Agency (EPA) support, NGA is building on this work to help strengthen the connection between state smart growth initiatives and the protection of children's environmental health.
In an unexpected move, the Office of Children’s Health Protection was dismantled and reorganized as a “national security and intelligence”[iv] operation in the new reorganization under the regulatory authority of the Environmental Protection Agency under the auspices of the environmental education bureau.
The creation of the “national security and intelligence” function was soon to be placed within the Office of Homeland Security to advise the Administrator and other senior EPA officials on matters related to national security and intelligence; to serve as the principal Agency liaison to the U.S. intelligence community; and to coordinate with EPA programs and Regions on matters related to classified and other sensitive information. This expanded regulatory authority through these federal mandates in the states, for the issue of child abuse and neglect. In Michigan, this protective obligation was assigned to the Department of Environmental Quality, Environmental Science Board and the Department of Community Health, now, a state agency of Michigan Homeland Security[v].
THE FALLACY OF PARENTAL AUTHORIZATION
As parents and caregivers, it is a falsely assumed that parental authorization of medical care is an inherent, fundamental right. Federal policy for the Protection of Children From Environmental Health Risks and Safety Risks supra, was formulated from a body of scientific knowledge that comported with abuse and neglect polices. It was at this point that the design of future child protection policies was to assume the nurturing role of the parent. Concerns of health and safety risks were broadly determined to be “attributable to products or substances that the child is likely to come in contact with or ingest (such as the air we breath, the food we eat, the water we drink or use for recreation, the soil we live on, and the products we use or are exposed to.) Under this interpretation, states have been able to usurp parental authorization under the guise of functioning for the well-being of children.
The federal government went a step further in circumventing parental authorization by allowing Institutional Review Boards to establish certain protocol for conducting human research on children. If a parent does not give consent for medication, waiver mechanisms are substituted for parental authorization. These mechanisms are to be found in policies of child protection as conditions of future risk of abuse and neglect. This means that if a parent does not consent to the medication of his and/or her child, there is nothing they may do about it because it would be considered an act of placing the child at risk of future health and environmental harms.
Children who are wards of the state, agency, institution, or entity, where entity has been identified as schools, camps, hospitals, or similar settings in which the majority of children involved as subjects are not wards, can be participants in human subject research without notification or authorization of parents. Authorization is then assigned, as previously stated as waiver mechanisms, to an institutional guardian. As stated in the Code of federal Regulations Title 45, Public Welfare, Department of Health and Human Services, Part 46, Protection of Human Subjects, 2003, requirements for permission by parents or guardians and for assent by children has made it possible to authorize and approve alternative mechanisms to obtain permission from an adult who would better represent the child’s interests, “The inability of obtaining permission from a parent or guardian could not be basis for excluding a child from research that held out the prospect of benefit to the child.” Simply put, there is nothing a parent can do but watch his and/or her child become a human guinea pig, if the parent is even lucky enough to be told what is happening.
REDIRECTION OF DISCUSSIONS
Instead of pitting the government’s side of “preventing future risks” against the parents’ and caregivers’ side of “present harms” of the children, we, as a nation, need to come to a general consensus and begin to address how the nation has been allowed to usurp the fundamental rights of parents in “the best interests of the child”. Children are not the most precious resources of a nation; children are the most precious treasures of OUR families. Until we, as citizens of the United States of America, stand up and hold our elected officials accountable for such egregious violations of the Constitution, the only ones to blame for the unnecessary death and medical torture of our children, is ourselves.
This article is dedicated to the brave souls of children who have lived the torture and life long suffering from unnecessary psychiatric medication mandated by our government.
Adrian survived. Richmond did not.
[i] State of Michigan. Children's Memorial Day.
Whereas, Each day in America many children young people under age 20 commit suicide, are victims of violence, or are lost as a result of accidents or illness; and,
Whereas, Now, more than ever, when violence and tragic events are taking place in our schools with increased frequency, we should all reflect on our children and ourselves; and,
Whereas, We hold sacred the trust of our nation's most valuable resource, our children; and now therefore be it,
Resolved, That I, Jennifer M. Granholm, Governor of the State of Michigan, do hereby proclaim April 27, 2007, as Children's Memorial Day. Pursuant to Public Act 213 of 2003, I call upon the citizens of Michigan to recognize Children's Memorial Day as a day to remember those children we have lost this past year.
[ii] Executive Order 13045 of April 21, 1997. Protection of Children From Environmental Health Risks and Safety Risks.
1-102. Each independent regulatory agency is encouraged to participate in the implementation of this order and comply with its provisions.
Sec. 2. Definitions. The following definitions shall apply to this order.
2-201. ``Federal agency'' means any authority of the United States that is an agency under 44 U.S.C. 3502(1) other than those considered to be independent regulatory agencies under 44 U.S.C. 3502(5). For purposes of this order, ``military departments,'' as defined in 5 U.S.C. 102, are covered under the auspices of the Department of Defense.
2-202. ``Covered regulatory action'' means any substantive action in a rulemaking, initiated after the date of this order or for which a Notice of Proposed Rulemaking is published 1 year after the date of this order, that is likely to result in a rule that may:
(a) be ``economically significant'' under Executive Order 12866 (a rulemaking that has an annual effect on the economy of $100 million or more or would adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities); and
(b) concern an environmental health risk or safety risk that an agency has reason to believe may disproportionately affect children.
2-203. ``Environmental health risks and safety risks'” mean risks to health or to safety that are attributable to products or substances that the child is likely to come in contact with or ingest (such as the air we breath, the food we eat, the water we drink or use for recreation, the soil we live on, and the products we use or are exposed to).
Sec. 3. Task Force on Environmental Health Risks and Safety Risks to Children.
3-301. There is hereby established the Task Force on Environmental Health Risks and Safety Risks to Children (``Task Force'').
3-302. The Task Force will report to the President in consultation with the Domestic Policy Council, the National Science and Technology Council, the Council on Environmental Quality, and the Office of Management and Budget (OMB).
3-303. Membership. The Task Force shall be composed of the:
(a) Secretary of Health and Human Services, who shall serve as a Co-Chair of the Council;
(b) Administrator of the Environmental Protection Agency, who shall serve as a Co-Chair of the Council;
(c) Secretary of Education;
(d) Secretary of Labor;
(e) Attorney General;
(f) Secretary of Energy;
(g) Secretary of Housing and Urban Development;
(h) Secretary of Agriculture;
(i) Secretary of Transportation;
(j) Director of the Office of Management and Budget;
(k) Chair of the Council on Environmental Quality;
(l) Chair of the Consumer Product Safety Commission;
(m) Assistant to the President for Economic Policy;
(n) Assistant to the President for Domestic Policy;
(o) Assistant to the President and Director of the Office of Science and Technology Policy;
(p) Chair of the Council of Economic Advisers; and
(q) Such other officials of executive departments and agencies as the President may, from time to time,
designate.
Members of the Task Force may delegate their responsibilities under this order to subordinates.
3-304. Functions. The Task Force shall recommend to the President Federal strategies for children's environmental health and safety, within the limits of the Administration's budget, to include the following
elements:
(a) statements of principles, general policy, and targeted annual priorities to guide the Federal approach to achieving the goals of this order;
(b) a coordinated research agenda for the Federal Government, including steps to implement the review of research databases described in section 4 of this order;
(c) recommendations for appropriate partnerships among Federal, State, local, and tribal governments and the private, academic, and nonprofit sectors;
(d) proposals to enhance public outreach and communication to assist families in evaluating risks to children and in making informed consumer choices;
(e) an identification of high-priority initiative that the Federal Government has undertaken or will
undertake in advancing protection of children's environmental health and safety; and
(f) a statement regarding the desirability of new legislation to fulfill or promote the purposes of this
order.
3-305. The Task Force shall prepare a biennial report on research, data, or other information that would enhance our ability to understand, analyze, and respond to environmental health risks and safety risks to children. For purposes of this report, cabinet agencies and other agencies identified by the Task
Force shall identify and specifically describe for the Task Force key data needs related to environmental health risks and safety risks to children that have arisen in the course of the agency's programs and activities. The Task Force shall incorporate agency submissions into its report and ensure that this report is publicly available and widely disseminated. The Office of Science and Technology Policy and the National Science and Technology Council shall ensure that this report is fully considered in establishing research priorities.
3-306. The Task Force shall exist for a period of 4 years from the first meeting. At least 6 months prior to the expiration of that period, the member agencies shall assess the need for continuation of the Task Force or its functions, and make appropriate recommendations to the President.
Sec. 4. Research Coordination and Integration.
4-401. Within 6 months of the date of this order, the Task Force shall develop or direct to be developed a review of existing and planned data resources and a proposed plan for ensuring that researchers and Federal research agencies have access to information on all research conducted or funded by the Federal Government that is related to adverse health risks in children resulting from exposure to environmental health risks or safety risks. The National Science and Technology Council shall review the plan.
4-402. The plan shall promote the sharing of information on academic and private research. It shall include recommendations to encourage that such data, to the extent permitted by law, is available to the public, the scientific and academic communities, and all Federal agencies.
Sec. 5. Agency Environmental Health Risk or Safety Risk Regulations.
5-501. For each covered regulatory action submitted to OMB's Office of Information and Regulatory Affairs (OIRA) for review pursuant to Executive Order 12866, the issuing agency shall provide to OIRA the following information developed as part of the agency's decisionmaking process, unless prohibited by law:
(a) an evaluation of the environmental health or safety effects of the planned regulation on children; and
(b) an explanation of why the planned regulation in preferable to other potentially effective and reasonably feasible alternatives considered by the agency.
5-502. In emergency situations, or when an agency is obligated by law to act more quickly than normal review procedures allow, the agency shall comply with the provisions of this section to the extent practicable. For those covered regulatory actions that are governed by a court-imposed or statutory deadline, the agency shall, to the extent practicable, schedule any rulemaking proceedings so as to permit sufficient time for completing the analysis required by this section.
5-503. The analysis required by this section may be included as part of any other required analysis, and shall be made part of the administrative record for the covered regulatory action or otherwise made available to the public, to the extent permitted by law.
Sec. 6. Interagency Forum on Child and Family Statistics.
6-601. The Director of the OMB (``Director'') shall convene an Interagency Forum on Child and Family Statistics (``Forum''), which will include representatives from the appropriate Federal statistics and research agencies. The Forum shall produce an annual compendium (``Report'') of the most important indicators of the well-being of the Nation's children.
6-602. The Forum shall determine the indicators to be included in each Report and identify the sources of data to be used for each indicator. The Forum shall provide an ongoing review of Federal collection and dissemination of data on children and families, and shall make recommendations to improve the coverage and coordination of data collection and to reduce duplication and overlap.
6-603. The Report shall be published by the Forum in collaboration with the National Institute of Child Health and Human Development. The Forum shall present the first annual Report to the President, through the Director, by July 31, 1997. The Report shall be submitted annually thereafter, using the most recently available data.
Sec. 7. General Provisions.
7-701. This order is intended only for internal management of the executive branch. This order is not intended, and should not be construed to create, any right, benefit, or trust responsibility, substantive or procedural, enforceable at law or equity by a party against the United States, its agencies, its officers, or its employees. This order shall not be construed to create any right to judicial review involving the compliance or noncompliance with this order by the United States, its agencies, its officers, or any other person.
7-702. Executive Order 12606 of September 2, 1987 is revoked.
[iii] Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks, September 2, 1987
[iv] CFR TITLE 45, PUBLIC WELFARE, DHHS, PART 46, PROTECTION OF HUMAN SUBJECTS Effective June 23, 2005
(iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in §46.408.
§46.408 Requirements for permission by parents or guardians and for assent by children.
(a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A.
(b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405. Where research is covered by §46.406 and §46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
(c) In addition to the provisions for waiver contained in §46.116 of subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
(d) Permission by parents or guardians shall be documented in accordance with and to the extent required by §46.117 of subpart A.
(e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
§46.409 Wards.
(a) Children who are wards of the state or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is:
(1) Related to their status as wards; or
(2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.(b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
[v] FR: February 6, 2006 (Volume 71, Number 24), Rules and Regulations, Page 6137-6178 and EPA, 40 CFR Parts 9 and 26 [EPA-HQ-OPP-2003-0132; FRL-7759-8], RIN 2070-AD57, Protections for Subjects in Human Research. The final rule also: (1) Categorically prohibits any EPA research involving intentional exposure of human subjects who are pregnant women or children to pesticides or any substances; and (2) adapts regulations of the Department of Health and Human Services providing additional protections beyond those of the Common Rule to pregnant women and children as subjects in EPA observational research--i.e., research which does not involve intentional exposure to any substance. (Research conducted by EPA is referred to as ``first-party'' research, and ``second-party'' research refers to research supported by EPA but performed by others.) Finally, this rule forbids EPA to rely, in its actions under the pesticide laws, on intentional-exposure human research that either involves pregnant women or children or is otherwise considered unethical, except in narrowly defined circumstances. For example, if children were at risk from unsafe exposure to a substance, the Agency would be permitted to rely on otherwise unacceptable research to justify setting a more restrictive standard to protect them. Proposed Sec. 26.408 adopted, essentially verbatim, the text of the HHS regulation in 45 CFR 46.408 establishing special requirements for obtaining permission by parents or guardians and for assent by children. Among other provisio
Last year, a 7-year-old foster boy named Gabriel Myers committed 