14 July 2005

Mr. Lester M. Crawford                         

Acting Commissioner                   

Food and Drug Administration

5600 Fishers Lane , Rm 1471, HF-1

Rockville , Maryland 20857  

RE:  STIMULANT DRUG AND ANTIDEPRESSANT WARNINGS

Dear Mr. Crawford

We are writing to support several recent submissions to the FDA regarding the increased need for more stringent warnings about the stimulant drug and antidepressant side effects. Recent media shows that a group of doctors and several actresses, Ms. Kelly Preston and Ms. Kirstie Alley, have called on the FDA to be more vigilant about drug adverse reaction monitoring and to ensure doctors report all incidents of violence and suicide by patients prescribed stimulants and antidepressants.

Our organization, which represents hundreds of parents who have faced the dilemma of being coerced into placing a child on one or more of these potentially dangerous drugs, applaud Ms. Preston and Ms. Alley who have championed the rights of parents for many years.

That a body of doctors has also spoken out about this issue shows the level of growing concern among medical professionals.

Further, the Citizens Commission on Human Rights, which provided us with a copy of their submission to Mr. Jan N. Johannessen Ph.D. from your Office of Science and Health Coordination, raised an important issue that we wish to bring directly to your attention.  Hundreds of parents contacting us have said that they agreed—often with tragic results—to medicating their child with a stimulant drug, antidepressant or antipsychotic drug because they were led to believe that their child’s “mental condition,” behavioral or learning problem, were neurobiologically-based or caused by a “chemical imbalance” that the drug would normalize.

As some of the doctors prescribing these drugs are also family physicians and pediatricians, it seems that they, too, are being marketed this claim when the medical literature does not support with replicable study, results that such a chemical imbalance exists. They deserve the facts too.

Representatives of the American Psychiatric Association, in their recent media interviews, have promoted the existence of chemical imbalance in relation to mental illness.  Their website says that “bipolar” is a “brain disorder”, that the “brain chemistry of a person with major depression is different from a non-depressed person, and medication can be used… to bring the brain chemistry back to normal.”

Even going to manufacturers’ websites, this is presented as fact.  “Common questions about Zoloft” says it works “to correct a chemical imbalance in the brain which may be related to symptoms of depression and anxiety.”  For Prozac, it says that a “growing amount of evidence supports the view that people with depression have an imbalance in the brain’s neurotransmitters… Prozac may help to correct this imbalance….” Under Paxil CR, it says “disorders like depression may be caused by a chemical imbalance in the brain.”

While the manufacturers use modifying words such as “may”, this gets lost. Even the media miss this, reporting that a "chemical imbalance" is a fact. There needs to be more responsible promotion/advertising regarding such claims. It sends a very misleading message to parents, violating our “informed consent” rights.

We try to provide information to parents who come to us for help, and it is our understanding that while studies may suggest brain differences or “chemical imbalances”, there is no conclusive evidence (yet still the APA and manufacturers’ websites imply otherwise). Additionally, isn’t it the case that the majority, if not all studies suggesting this, have involved subjects that had previously taken psychiatric drugs, making the outcomes questionable at best?

In 2003, Jonathan Leo, Professor of Anatomy at the Western University of Health Sciences and Professor David Cohen of the School of Social Work at Florida International University , reviewed 33 of the most recent brain-imaging studies of ADHD-diagnosed subjects.  They confirmed that every study involved medicated kids, a major variable, because stimulant drugs “cause very persistent changes in the brain.”  They also reviewed a 2001 National Institute of Mental Health study that included unmedicated subjects and had claimed that unmedicated ADHD children had significantly smaller brains. This somehow was seen as supporting the idea that ADHD exists as a neurobiological disorder.  However, as Professor Leo and Cohen determined, the comparison group was two years older, so naturally the younger children had smaller brains.

Commissioner Crawford, the FDA is now issuing the warnings that mental health practitioners have failed to give us for years. The “black box” label on antidepressants, the recent warnings about pediatric stimulant drug use and antidepressant use in adults, along with the directions to manufacturers regarding antipsychotic drugs, are so vitally needed and welcomed.

However, this should be the start only. In order to make a truly informed decision about the healthcare needs of our children, we must have correct information about the factual status of such claims as those made above about chemical imbalances and neurobiological causes.

One of our advisory board members, Dr. William Glasser, a psychiatrist of over 43 years, has pointed out that with insurance coverage for drugs so easily available, psychiatrists are quick to grab for their prescription pads. Yet, the drugs are not prescribed for an illness based on pathology, but to suppress or provide relief for unwanted symptoms.

Surely, this is information that should be made known to consumers and parents. Surely, there can be some direction regarding advertising—similar to side effects being a requirement of an advertisement—that when the drug is prescribed for a “mental disorder” it must state that the disorder is “not a chemical, neurobiological, or physical illness and is prescribed to relieve symptoms only.”

Our members have nurtured and helped their children through the most grueling prescribed psychiatric drug experiences, including withdrawal—something that no parent should have to go through. Some parents have been threatened with charges of medical neglect if they chose to take their child off such a drug.  This was so abusive that we reported this to our congressmen and to the Speaker of the House, Mr. Dennis Hastert, meeting with some of his staff.  This ultimately led to passage of an amendment to IDEA in December that now prohibits students being forced onto these controlled substances as a requisite for their schooling.

The bottom line is that the risks parents are taking when consenting to these drugs can all be reduced if they were provided with accurate and complete information, not with just what “sells.”

Therefore, I am requesting a private meeting with you to discuss how the FDA may further assist parents and others to receive the best possible information about these drugs and the conditions for which they are approved and prescribed.  I am sure that this will be of mutual benefit.  We can certainly have one of the many doctors that we consult attend this meeting and would also like to approach either Ms. Preston or Ms. Alley (or both)to also participate, given their long history of speaking out on this issue as a voice for parents and children.

Yours sincerely

Mrs. Patricia Weathers

President

845-677-4118

Mrs. Sheila Matthews

Vice President

203-966-8419

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