ADDerall

Adderall for Attention Deficit Disorder

Adderall is a stimulant medication used in the treatment of attention deficit disorder in both children and adults.

Made from a combination of four amphetamine compounds, Adderall is useful because it covers a broad range of attention deficit disorder symptoms, and because it is a "one a day" dosing. A child with attention deficit disorder usually has to take only one dose of adderall per day to get through school and get his homework done.

ADDerall

Adderall is a "cocktail" drug, or a mixture of four drugs, all from the amphetamine family. As a result it has a broad spectrum of symptom coverage. It also tends to last for about six hours per dose, so it can cover the entire school day.

It can be less "harsh" than Ritalin. ADDerall might be worth talking to your doctor about as either the first or second medication to try.

ADDerall tablets come in 5, 10, 20, and 30 mg doses offering great flexibility to a physician in targeting the optimum dose for any patient. Even greater flexibility is offered because the tablets are double-scored so they can be accurately split into halves or quarters. This means that ADDerall can be administered in increments as low as 1.25 mg, or adjusted in 1.25 mg increments.

ADDerall begins to work more gradually than Ritalin, or Dexedrine, and the "drop-off" slope is also much more gradual, meaning that there is less of a "trough" time at the end of the dose.

Expectations and Drawbacks of Adderall

ADDerall can be expected to work very well for the "space cadet" ADHD kids. Stimulants (including caffeine) are great for "inattention" or "brain fog" symptoms. We would estimate that 70% of Attention Deficit Disorder - ADHD Inattentive Type kids would respond to Adderall very nicely. For them, Adderall is a very easy treatment intervention.

Hyperactive-Impulsive kids respond less well to the stimulants. Maybe 60-65% will benefit.

Kids with impulsivity or temper outbursts either do very well, or they do very poorly.

These kids may also need something like Extress for temper, or Clonadine for extreme outbursts. We recommend the Extress nutraceutical medicine first. We have seen Extress work very well in reducing temper outbursts. You can buy it at from VAXA International. The Clonadine is like a "sledgehammer," but use it if you need to.

For the best results using a natural homeopathic medicine see our Specific Treatment Strategies, and use "Attend".

The main drawbacks of Adderall that we have observed are loss of appetite (feed a protein shake twice a day to help keep weight up), some irritability or anger (as when you have had too much caffeine), possible short term growth inhibition (though long-term this may not be a problem). Remember, every medication has possible bad side effects, so always closely monitor your child when taking medications!

If there is a problem, don't give the next dose, and call your doctor right away.

Adderall Side Effects

All stimulants have side effects, and the side effects from Adderall can be serious.

Any amphetamine can be over used and result in drug addiction.

Because Adderall is made from amphetamine, it can cause your child's heart to race, elevate heart rate to dangerous levels, and raise blood pressure to dangerous levels.

Adderall side effects include overstimulation of the central nervous system, dizziness, difficulty sleeping, tremors, headaches, hyperactivity, and tics or Tourettes Syndrome.

A common Adderall side effect is a dry mouth, a bad taste in the mouth, diarrhea, constipation, upset stomach, and loss of appetite.

Children often lose weight when taking stimulants.

Stimulants may reduce growth rates in children.

Sexual dysfunction is a common problem in adults using stimulants.

How effective is stimulant medication when compared to alternative treatments for ADHD?
See here.

Read FDA WARNINGS on Adderall

Clearly stimulants like Adderall work. But Adderall can also have serious side effects.

Alternative medicines like ATTEND also work, but without the side effects. They only drawback to ATTEND is that it takes about 30 days to really do the job, while stimulants begin working right away.

ADHD Stimulant Medication and ER Visits

ADHD Stimulant Medication and ER Visits for Heart Problems in Children

Are the risks of heart problems greater in children who are prescribed stimulant medications for ADHD than for children who are not taking such medications? The University of Florida researched this question and published their results in the journal Pediatrics in December, 2007.

What they found was that the use of stimulant medication for ADHD in children and teenagers may be the cause for an increased number of emergency room visits, or visits to the doctor’s office, because of cardiac symptoms such as a racing heart or increased blood pressure. But the study also found that deaths, or serious heart complications, are rare.

The researchers looked at the records of over 50,000 children and teenagers who had ADHD, and were treated with stimulants such as Ritalin and other Methylphenidate compounds, Dexedrine, and Adderall. Then they compared the findings from this group to a database of over 2 million children and teenagers to see if there were any differences.

What they found was the children and teenagers treated with stimulants for ADHD were about 20 percent more likely to have to go to a doctor’s office or emergency room with cardiac symptoms than children and teens that were not taking stimulant medications. In other words, for every 100 children or teens who have to go to the ER or doctor's office for scary heart symptoms, there are 120 children or teens who take stimulant medication who have to go to the ER.

However, rates of death or admissions to a hospital were no different that the rates among those not being treated with stimulant medications.

ADHD Medication and FDA Warnings

There is an ongoing controversy within various committees in the FDA about whether stimulant medications should carry a “black box” warning label. In 2006 the FDA added the “black box” warning to the labels of ADHD medications warning of possible heart risks from the medications. The warnings on the label included possible sudden death in patients who have heart problems or heart defects, stroke and heart attack in adults, and increased heart rates and increased blood pressure.

The authors note that they do not know the long-term implications of increased heart rate and blood pressure in children and teens treated with stimulant medications. They also noted that about 25 percent of children and teens treated with stimulants were also prescribed either an antidepressant medication or an antipsychotic medication, which can also impact the heart and blood pressure.

Read more about the study from the University of Florida.

Ampakine CX717 Trials Rejected -Press Release

Editor: Background information from wikipedia on Ampakine:
Ampakines are a new class of modified benzamide compounds known to enhance attention span and alertness. Their action is theorized to be due to facilitation of transmission at cortical synapses that use glutamate as neurotransmitter. This in turn may promote plasticity at the synapse, which could translate into better cognitive performance. The ampakines take their name from the glutamatergic AMPA receptor, which they strongly interact with.

Unlike earlier stimulants (e.g. caffeine, methylphenidate (Ritalin®), and the amphetamines), ampakines do not seem to have unpleasant, long-lasting side effects such as sleeplessness. They are currently (2005) investigated as potential treatment for a range of conditions involving mental disability such as Alzheimer's disease, Parkinson's disease, schizophrenia or neurological disorders as Attention Deficit Hyperactivity Disorder (ADHD), among others. In a 2006 study they were shown to have an effect after they had left the body, continuing to enhance learning and memory. Some examples include: CX-516 (Ampalex), CX546, CX614 and CX717.

FDA’s Psychiatric Division has Rejected Cortex’s Request to Study CX717 in Phase IIb ADHD Study

— Company plans to focus on Alzheimer’s disease PET scan study and the treatment of acute respiratory depression with CX717 —

Irvine, CA (October 11, 2007) – Cortex Pharmaceuticals, Inc (AMEX:COR) was informed on Wednesday, October 10, 2007, that the Food and Drug Administration (FDA) would soon be sending it formal notice that the agency would not approve Cortex’s Investigational New Drug Application for a Phase IIb study of CX717 in attention deficit hyperactivity disorder, or ADHD. The denial is based on results of animal toxicology studies filed by Cortex. As a result, the company has requested that the Division of Psychiatry Products (DPP) of the FDA inactivate its IND Application for ADHD.

The company has chosen at this time to not formally withdraw the IND Application in order to evaluate the formal response from the FDA. It will weigh the potential for providing additional data if the potential exists for re-activating the IND at a later date. While the company will need some time to review the specifics of the FDA’s written concerns, at this time Cortex does not believe it likely that a resubmission will occur.

However, Cortex clearly intends to continue its plans to develop CX717 for the acute treatment of respiratory depression (RD) and continue its study of CX717 in its Alzheimer’s disease PET scan study. Cortex believes that the IND application previously filed with the Division of Neurology Products of the FDA for the treatment of Alzheimer’s disease will not be affected by the actions of the DPP.

Cortex believes that by developing an acute use for CX717, such as treatment of respiratory depression, the risks perceived to be associated with higher chronic doses required for ADHD can be mitigated. Additionally, the risk/benefit ratio for the treatment of patients with life-threatening respiratory depression is substantially different than for the treatment of ADHD. Also, Cortex’s preclinical data for improvement of memory and cognition in animals consistently shows that the dose level of CX717 is 5-10 fold less than that required in animal models of ADHD. Hence, either lower dosage levels for chronic administration and/or acute uses are possible options for the continued development of CX717.

Finally, Cortex is committed to continuing the development of other compounds such as CX701, which the company believes will go into Phase I clinical trials shortly, and other low and high impact Ampakine® compounds which are currently in the preclinical pipeline. While this decision by the FDA represents a significant setback for the company, Cortex has a broad-based technology platform that is currently producing several other significant future clinical candidates.

Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. Cortex is pioneering a class of proprietary pharmaceuticals called Ampakine compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer’s disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain's neurotransmitter system. These imbalances may be improved by using the Ampakine technology. Cortex has an alliance with N.V. Organon for the treatment of schizophrenia and depression. In December 2006, Cortex terminated the research collaboration with Servier enabling Cortex to pursue the use of Ampakine compounds in the treatment of neurodegenerative diseases on a global basis. Servier retained the right to select up to three compounds developed during the collaboration for further development for the treatment of neurodegenerative diseases. Cortex may receive additional milestones and royalties if either Organon or Servier is successful in developing and commercializing Ampakine compounds. For additional information regarding Cortex, please visit Cortex Pharmaceuticals’ Website at www.cortexpharm.com.

Forward-Looking Statement
Note – This press release contains forward-looking statements concerning the Company’s research and development activities. The success of such activities depends on a number of factors, including the risks that the Company’s proposed compounds may at any time be found to unsuitable for moving into clinical studies or be unsafe or ineffective for the indications under clinical test and that pre-clinical and clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company’s Securities and Exchange Commission filings, the Company’s proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. Ampakine compounds are investigational drugs and have not been approved for the treatment of any disease.

CDC Reports that Cough and Cold Medicines Send 7,000 Children to Hospital Each Year

The Associated Press is reporting that the Center for Disease Control (CDC) is estimating that each year cough and cold medicines send about 7,091 children to hospital emergency rooms.

Of these 7,000 cases, about two-thirds of the cases were children who took the medicines unsupervised. Of the remaining 2,600 cases, about 1,600 were were children under the age of 2 years old who were given over-the-counter cough and cold medicines that the FDA considers to be too dangerous for such young children.

However, about one-quarter involved cases in which parents gave the proper dosage and an allergic reaction or some other problem developed, the study by the U.S. Centers for Disease Control and Prevention reported.

CDC researchers gathered case reports of children 11 and under who had taken cough and cold medications and wound up in 63 hospitals studied in 2004 and 2005. They used that number to come up with the national estimate.

"The main message is no medication left in the hands of a 3-year-old is safe," said the CDC's Dr. Melissa Schaefer.

Many of the ER case reports were not specific about symptoms, and the researchers did not follow cases through to conclusion. So they did not know if — or how many — deaths resulted, said Schaefer, an epidemiologist who was the study's lead author. For the children whose symptoms were reported, allergic reactions like hives and itching were most common, and neurological symptoms like drowsiness and unresponsiveness were next, she said. Most of the medicines involved were liquid combinations of cough and cold treatments, CDC researchers said.

The study was published online Monday. It will appear in the April issue of Pediatrics, a journal of the American Academy of Pediatrics.

Concerta Approved for Adult ADHD

The FDA was busy last week as it approved two drugs for use in adult disorders. The FDA approved the drug Concerta for use in adult ADHD, and approved the first generic versions of Risperdal (risperidone) tablets to treat schizophrenia, bipolar disorder, and other psychiatric conditions. Here we will focus on the approval of Concerta for adults with ADHD.

Concerta is a CNS stimulant medication is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and now adults up to the age of 65. It is thought that stimulants work by helping to increase dopamine and norepinephrine, and perhaps blood flow, in the brain.

Concerta is a timed-release form of methylphenidate (Ritalin is made from methylphenidate). This is why people like it. Instead of having to take two or three doses of Ritalin each day, with the Ritalin “ups” and “downs” through the day, they can get roughly the same benefits all day long from one Concerta dose in the morning. Concerta has a half-life of 3.5 hours, which is about twice as long as Ritalin.

It is recommended that children and teenagers begin Concerta with just a small dose (18 mg/day), but the FDA is permitting adults to start with either 18 mg/day or 36 mg/day. We are not medical doctors, so we don’t want to say anything more on this than that you should always start with a small dose and see how you do before jumping to a bigger dose of a medication for ADHD. We’d say this for any stimulant, but especially a methylphenidate product.

By the way, the 18 mg/day dose of Concerta is equivalent to a 5 mg dose of Ritalin, twice or three times per day.

Besides, there are differing opinions by doctors on what the optimum dosage for adults actually is, or even how to figure it out. Some doctors will just stay with the recommended formulas used for children, and figure “x mg of methylphenidate per each kg of body weight.” But this ignores the fact that a teenager’s metabolism is different from a child’s, and certainly an adult’s metabolism is different from either a teenager’s or a child’s. So I’m not sure that the standard formulas used for children are helpful for adults. Often adults need far less medication, per kg of body weight, than children require for an optimal dose.

This is where tools like the TOVA test are extremely helpful, as an adult can take the medication, wait a few hours, and be tested on the TOVA to see if he/she is a responder to the medication, and if that particular dose was “optimal” or not. These computerized testing tools are about 20 years old now, and yet few practices use them still. Too bad.

Although Concerta is more convenient than Ritalin, you will still have to be careful. Here are the official precautions to consider:

WARNINGS AND PRECAUTIONS

• Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.
• Increase in Blood Pressure: Monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic.
• Psychiatric Adverse Events: Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or eacerbation of symptoms in patients with pre-eisting psychiatric illness. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
• Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures (5.3)
  Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
• Long-Term Suppression of Growth: monitor height and weight at appropriate intervals in pediatric patients
• Gastrointestinal obstruction with pre-eisting GI narrowing
• Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy

Adverse Reactions

• The most common adverse reaction in double-blind clinical trials (>5%) in children and adolescents was abdominal pain upper.
• The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, aniety, dizziness, weight decreased, irritability, and hyperhidrosis.
• The most common adverse reactions associated with discontinuation (t1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased.

Daytrana

What is DAYTRANA?

Is the "Daytrana patch" a Good Choice for You?

Last summer Shire Pharmaceuticals came out with their new version of methylphenidate, called DAYTRANA. It is the first and only patch, or transdermal medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD).

DAYTRANA is methylphenidate (generic name for Ritalin) in a patch, which makes it a very convenient delivery system (one a day dosing).

The response from parents has been mixed.

Parents, and patients, like the convenience of a patch. And they also like the fact that children don’t have to swallow a pill.

But the patch can cause side-effects. Skin rashes, sleeplessness, stomach aches and motion sickness are commonly cited. Some parents also complain that they have to fight with their kids to put the patches on, and it leaves a “goo” after taken off.

You can learn more about DAYTRANA at its website.

As always, parents should know that DAYTRANA is a Schedule II controlled substance.

Daytrana Side Effects

It was generally well tolerated in clinical studies, but some subjects had side effects. As with other products containing methylphenidate the common side effects reported in children who received DAYTRANA were

• decreased appetite,
• insomnia,
• nausea,
• vomiting,
• weight loss,
• tics,
• affect lability (mood swings).

It is the same list of side effects one would see with Ritalin in any of its forms.

The manufacturer warns that Methylphenidate should never be taken by children with:

• significant anxiety,
• agitation,
• extreme temper outbursts,
• glaucoma,
• tics or Tourette's syndrome, or family history of Tourette's syndrome,
• current/recent use of MAO inhibitors (a type of antidepressant),
• problems with alcohol or drugs,
• has had depression,
• abnormal thoughts/behaviors,
• visual disturbances,
• seizures,
• high blood pressure,
• heart conditions including structural abnormalities.

The manufacturer warns that abuse of methylphenidate may lead to dependence.

As always, tell your doctor immediately if any of these unlikely but serious side effects occur: blurred vision, uncontrolled movements (twitching, shaking), uncontrollable outbursts of words or sounds (e.g., Tourette's syndrome), unexplained weight loss, mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts, hallucinations).

Daytrana Drug Interactions

Your doctor or pharmacist should already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before or after treatment with this medication.

In some cases, a possibly fatal drug interaction may occur.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this medication. Or better yet, just don’t use this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription herbal products you may use, especially of: "blood thinners" (e.g., warfarin), clonidine, guanethidine, drugs that can increase blood pressure (e.g., epinephrine, phenylephrine), anti-seizure drugs (e.g., phenobarbital, phenytoin, primidone), tricyclic antidepressants (e.g., imipramine, desipramine), SSRI antidepressants (e.g., fluoxetine, sertraline), other stimulant medications (e.g., amphetamines).

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with methylphenidate such as bupropion, isoniazid (INH), phenothiazines (e.g., thioridazine), or theophylline, among others. Consult your doctor or pharmacist for details.

Check the labels on all your medicines/herbal products (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure (e.g., pseudoephedrine, phenylephrine, ephedra/ma huang). Ask your pharmacist about the safe use of these products.

Daytrana: Our Thoughts

We are not opposed to Daytrana, or Ritalin, or Methylphenidate in any of its forms, provided that the “alternative” options have been tried, and have failed.

We are referring to ADHD diet interventions, Attend and other amino acids such as Extress or Memorin, essential fatty acids (omega oils), and perhaps EEG Biofeedback training.

DAYTRANA Risks

Is methylphenidate over-prescribed? Is it over-used?

Probably. But the reason why Ritalin is used so much is that it works. Think about it. No one would use it if it didn’t make a positive improvement in the life of their child.

But Ritalin, DAYTRANA, and all the other forms of methylphenidate (in fact, all the other forms of prescription treatments for ADHD) come with the problem of potential side effects. And some of these side effects are severe.

So, please try our recommended ADHD eating program plus the specific Attend treatment strategies first. Consider EEG Biofeedback training if you can afford it.

Try these “alternatives” first if you can and see if they work. If they do not work for you or your child, then by all means carefully consider the use of prescription stimulants.

See our comparison of the effectiveness of your treatment options.

A Parent's Comment on Daytrana

This comment was posted on our ADHD Newsletter website by a parent in February, 2007 following the posting of the above article on Daytrana.

"This patch has been a god send for us!!! If our child washes the glue off and moisturizes the skin area there are very few problems other than decreased appetite."

Parents, share your experiences with Daytrana below.

Dexedrine

Dexedrine (Dexamphetamine or Dextroamphetamine)

Dexedrine is a central nervous system stimulant used in the treatment of ADHD.

It is from the amphetamine family, and is manufactured in 5mg, 10mg, and 20mg pills, and 5mg, 10mg. or 15mg capsules. Dexedrine comes in a very effective Spansule formula for a longer effective dose (one dose a day gets you through school).





It is very similar to Ritalin in its benefits to individuals with ADHD. It can be less harsh, as it seems to start more gradually, and come to the end of its dose without the harsh "crash" or "trough period" of Ritalin.

Here is an alternative to Dexedrine to consider. In the chart below compare the effectiveness of Stimulant medication (most of the subjects were using Ritalin, but many were using Dexedrine or Adderall in the study, and all were lumped together into the category of "stimulants") with ATTEND natural homeopathic medicine with specific amino acid combinations. You will find that the ATTEND is as powerful as the stimulants, but is much easier to tolerate, has fewer side effects than Dexedrine or other stimulants, and is much healthier.

Dexedrine Side Effects

Even though Dexedrine can be helpful in the treatment of ADHD, the list of drawbacks, or Dexedrine side effects, is very long.

Read the list below, and then consider ATTEND the alternative to Dexedrine.

FDA Warnings on Dexedrine

Do not take monoamine oxidase inhibitors with this drug. Check with your physician if you are taking any of the following: Chlorpromazine, ethosuximide, haloperidol, antihypertensive, medications, meperidine, norepinphrine, phenytion, propoxphene, any beta blocker, digitalis, or thyroid hormones. A variety of neurological toxic effects can occur, sometimes with fatal results.

AMPHETAMINES HAVE HIGH POTENTIAL FOR ABUSE. USE OF AMPHETAMINES FOR A PROLONGED PERIOD OF TIME MAY LEAD TO DRUG DEPENDENCE.

The habit-forming potential is high. Psychological and physical dependence is possible. Addiction is rare in children but a problem with adults.

Long-term effects on children have not been well established (might be a problem). Children who take this drug on a long-term basis should be examined every four to six months.

The physician should:

• monitor height and weight to see if growth is being inhibited as feared might happen,
• check for the presence of tics which may start after using stimulants,
• measure blood pressure and pulse which may elevate unacceptably with stimulant use,
• and ask about other Dexedrine side effects.

Do not take this drug if you are pregnant or if planning to become pregnant. Do not take if you are breast-feeding.

Do not give this drug to children under the age of three.

Do not drink alcohol while taking this drug.

Do not use if: You had negative reactions to this or any other amphetamine in the past. If you have a history of drug alcohol abuse. If you have a psychotic disorder of any type.

Inform your Doctor if:

• You had negative reactions to this or any other amphetamine in the past.
• If you have epilepsy, glaucoma, heart / blood vessel disease.
• If you have high blood pressure, or a history of Touette's syndrome.
• If you are taking any other prescription or nonprescription drug.
• If you will have anesthesia or any surgery in the next few months.
• If you will be undergoing any medical tests.
• If you have a history of drug or alcohol dependence.

Dextroamphetamine ( Symptoms or Effects )

Pretty Common Dexedrine Side Effects include : Nausea, diarrhea, loss of appetite and weight loss, difficulty sleeping, restlessness, and anger.

Less Common, but Serious Dexedrine Side Effects include : Abdominal pain, headache, loss of appetite and weight loss, mood changes, increased temper outbursts, lack of coordination, tics or other unusual movements, Tourette's Syndrome, irritability, dizziness, difficulty sleeping, nervousness, skin rash, hives, blurred vision, sexual problems, or paranoia. If any of these start, SEE YOUR PHYSICIAN ASAP.

Beware of: Nausea, diarrhea, loss of appetite, difficulty sleeping, drowsiness, dizziness, or restlessness. SEE YOUR PHYSICIAN ASAP.

Stop taking the Dexedrine, and see your physician NOW: Abdominal pain, headache, lack of coordination, tics / unusual movements, skin rash, hives, or paranoia.

Why Not Try ATTEND first?

ATTEND is a powerul, safe, and healthy alternative to Dexedrine without the potential Dexedrine side effects.

Keywords: Dexedrine Side Effects and an Alternative to Dexedrine

FDA Black Box Warning Labels on ADHD Medications

After much debate the following medications carry the "black box warnings" on the labels of the bottles. These are the strongest warnings that the FDA requires, a step away from pulling the medications.

• Adderall Tablets (mixed salts of a single entity amphetamine product)
• Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine hydrochloride) Tablets Label (will be updated soon)
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
• Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine hydrochloride) Capsules

Warnings for Amphetamine, Dextroamphetamine, Lisdexamfetamine dismesylate, Methamphetamine, Mixed Salts of a Single Entity Amphetamine Products

Adderall, Adderall XR, Desoxyn, and Dexedrine (SR)

• High abuse/diversion potential: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.
• Drug dependence: Administration of amphetmaines for prolonged periods of time may lead to drug dependence and must be avoided.
• Serious Adverse Events: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events

Warnings for Dexmethylphenidate, and Methylphenidate Medications

Ritalin, Ritalin LA, Ritalin SR, Concerta, Daytrana, Desoxyn, Focalin, Metadate, Methylin

All Dexmethylphenidate, Methylphenidate Products

• Chronic abusive use can lead to a marked tolerance and psychological dependence with varying degree of abnormal behavior
• Frank psychotic episodes can occur, especially with parenteral abuse.

Methylphenidate Products: Concerta, Metadate, Ritalin, Daytrana
Dexmethylphenidate Products: Focalin

• Should be given cautiously to patients with a history of drug dependence or alcoholism.
• Careful supervision required during drug withdrawal from abusive use since severe depression may occur.
• Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Methylphenidate Products: Methylin Products

• Should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
• Careful supervision required during drug withdrawal, since severe depression as well as the effects of chronic over-activity can be unmasked.
• Long term follow-up may be required because of the patient's basic personality disturbances.











Strattera Atomoxetine

Strattera Suicidal Ideation in Children and Adults



• Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with attention-deficit/hyperactivity disorder (ADHD).
• Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need.
• Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior.
• Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Largest Study Ever of Heart Risks with ADHD Medications

AHRQ and FDA To Collaborate in Largest Study Ever of Possible Heart Risks with ADHD Medications

Press Release Date: September 17, 2007

Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

Researchers supported by the Agency for Healthcare Research and Quality (AHRQ) and the U.S. Food and Drug Administration (FDA) will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications.

The planned analysis follows an FDA-sponsored preliminary study that compiled information from large health care databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes, including death. Based on that effort, researchers identified people who took ADHD drugs during a 7-year period ending in 2005. AHRQ, which sponsors research on clinical effectiveness and safety, will team with FDA to complete the analysis of the data.

"This study highlights one of AHRQ's most important missions: to collect and analyze scientific evidence that will help patients, policymakers, and clinicians make the best possible decisions," said AHRQ Director Carolyn M. Clancy, M.D. "This partnership with the FDA is a great way to move closer to answering important clinical questions that affect children and adults who have ADHD."

"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment," said Gerald Dal Pan, M.D., director of FDA's Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question."

The study will be coordinated by Vanderbilt University researchers on contract through AHRQ's Effective Health Care program. Data analysis will be performed by researchers at Vanderbilt, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, as well as from FDA and AHRQ. The analysis will include all drugs currently marketed for treating ADHD. The study will analyze the risks of all the drugs as a whole, and risks of the drugs grouped by class.

The analysis will take about 2 two years to complete. Results are expected to be important not only to patients, their families and health care providers, but also to government insurance programs. Medicaid, Medicare, and the State Children's Health Insurance Program provide reimbursement for drugs prescribed for ADHD. This information could also be used to inform product labeling, which is used by health care providers when making treatment decisions.

ADHD is a behavioral disorder that, in many patients, causes hyperactivity, and may have a significant impact on school performance and social functioning. According to the National Institute of Mental Health, ADHD affects approximately 3 percent to 5 percent of school-age children and about 4 percent of adults.

Use of ADHD drugs has increased in recent years among children and adults. A recent AHRQ analysis of medication expenditures found three ADHD drugs—Concerta, Strattera, and Adderall—ranked among the top five drugs prescribed for children ages 17 years and younger. About $1.3 billion was spent on those drugs in 2004, the study estimated. Adult use is also believed to be increasing.

In May 2006, based on a review of anecdotal reports of heart attack, stroke and sudden death among patients taking usual doses of ADHD medications, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse events. Drug manufacturers have created patient Medication Guides for individual products to help patients understand risks.

FDA and AHRQ recommend that individuals using or being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current health status, particularly for cardiovascular and psychiatric problems, including assessment for a family history of such problems.

Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2007/adhdmedpr.htm

Parents Caught in the Middle as FDA Committee Debates

FDA Hearings on Ritalin: Black Box Labeling Recommendation for ADHD Medications in Debate

On February 9, 2006, the FDA’s standing Drug Safety and Risk Management Advisory Committee was tasked for the morning to study ADHD medications to see if there was a link between the stimulant medications and an increased risk of sudden death or serious cardiovascular problems from taking the medications.

The FDA also tasked the Committed with considering ways of studying the drugs without putting patients at risk.

This FDA advisory committee is a standing committee that studies all types of medications and products. Members of the committee have a broad range of experiences and education, and report on a range of agenda items through the year. The information below comes from sources ranging from news reports to the FDA Advisory Committee’s own website.

As the committee considered ADHD medications, after some discussion, the Committee took action and voted 15-0 to recommend that the FDA require a “medication guide” for parents and patients to read for all prescriptions of ADHD medications. Good thinking and common sense applied.

However, some members of the Committee got off task immediately and began to debate the link between the medications and 25 reported deaths of patients who had been taking ADHD medications over a four-year period of time (1999-2003). Many of these patients had pre-existing heart problems.

The FDA’s Dr. Kate Gelperin, who is a medical officer in the Office of Drug Safety, joined the conversation and reported to the Committee that an analysis of the reports of death and injury suggest a possible link between the drugs and cardiovascular problems, but that it is not “conclusive” that a link exists, it is just a possible link. Nor is it clear that there is actually an increased incidence of death or serious injury from taking ADHD medications. “This is really a question that we would like to have answered,” said Dr. Gelperin, referring to the Committee’s reason for existence.

An previous FDA review found less than one death, or serious injury, per 1 million prescriptions filled for ADHD medications.

Some members of the Committee then changed the subject, stopped talking about safety, and charged that ADHD medications are seriously “over-prescribed.”

Cardiologist Steve Nissen, a consultant to the Committee, stated that there was an out of control growth in the rate of ADHD medications being prescribed to adults, and stated, “We have to elevate the level of concern” about the “out-of-control use of drugs that [may] have profound cardiac effects.”

Dr. Nissen pushed for a “black box” warning label on all ADHD medications. Over-prescription, rather than safety, now became the issue under debate. The “black box warning,” normally a response to a safety issue, would now be recommended to slow the rate of growth in prescriptions.

The committee never considered the possibility that the reason for the increase in the use of ADHD medications is that they actually work, and that people might refill their prescriptions for the medications because they may actually improve the quality of their lives.

After debate, the Committee voted 8-7 to recommend the most serious type of warning, a “black box” warning label, for ADHD medications because of “potential cardiac risks” (not mentioning that they were really more concerned about the rate of growth in the use of the medications).

March 23, 2006. Following the actions of the Drug Safety and Risk Management Advisory Committee, the FDA had asked their Pediatric Advisory Committee to also study the issue, and they met to make their recommendations.

The Pediatric Advisory Committee rejected the recommendation from the Drug Safety and Risk Management Advisory Committee that medications used to treat ADHD should have the strongest type of warning, called a “black box” warning. The Pediatric advisory committee did recommend adding more information to the labels of these medications for doctors, patients, and parents.

The FDA must now consider the recommendations of both advisory committees and determine what, if any, action to take regarding ADHD medications. No one knows for certain how many children and teens are prescribed these medications for ADHD, but estimates range from 2 million to 3.3 million in the United States alone.

It is important to understand that all stimulants have potential side-effects, including loss of appetite, increased heart rate, and less commonly a risk of seizure, heart attacks, hallucinations, and more. People with heart conditions should not take or use any stimulants, from caffeine (Starbucks coffee, Mountain Dew, Diet Pepsi, or even chocolate) to medications.

The medications can be controversial. For example, Health Canada had pulled Adderall from the market in Canada last year, but then found that there really was very little evidence linking the medication to these serious problems. Adderall was returned to the market after a few months. The Health Canada report can be read online.

Strattera already has a “black box” warning in the U.S. that it may cause suicidal thoughts in children. It also carries a similar warning in Canada.

About the debate, it is important to understand that the Drug Safety and Risk Management Advisory Committee is composed largely of Risk Management specialists. None of the members treat children or teens for ADHD, and only know of the issue second hand. According to the FDA Advisory Committee web site the Committee is composed of 2 Internal Medicine MDs, 1 Ambulatory Care and Prevention MD, 6 PhD’s or equivalent in Pharmacy or Pharmaceuticals, 1 Lawyer, 1 Pharmaceutical Industry Representative, 0 Pediatricians, 0 Psychiatrists, and 0 Family Practice Docs.

After the Drug Safety and Risk Management Advisory Committee voted 8-7 for the “black box” warning on ADHD drugs, the FDA asked the Pediatric Advisory Committee to examine the same issues. This committee was composed largely of Pediatricians and Child Psychologists who actually treat children for a living, and often prescribe medications for ADHD patients. A list of the members of this Committee can be found at the advisory committee website.

The Pediatric Advisory Committee concluded that, “Potential episodes of psychosis, aggression and cardiac events with attention deficit drugs in children do not warrant a black box warning.”

The committee felt that the cardiovascular events were not of a similar risk in ADHD children as adults, except for those with cardiovascular abnormalities. The committee also declined to endorse a black box for psychiatric events, including aggression, and risk of suicide, according to the FDA Advisory Committee’s web site.

Also parents should understand that the News Media loves the debate, and loves the idea that a medication that is being prescribed to perhaps 3 million children and teens might be forced to wear a “black box” warning on the label. This is the kind of news that sells newspapers.

Physicians, patients, and parents must understand that there are risks to stimulant medications. But they are rare. Stimulant medications do have their place, and when needed should be considered. Stimulant medications should be prescribed with care, and parents should understand that they are not toys, vitamins, or over the counter remedies. The medications used for ADHD are powerful, usually effective, but can sometimes cause serious problems.

There are alternatives that can also be effective without the potential of dangerous side-effects, including diets for ADHD, the nutraceutical Attend’s specific treatment strategies, and EEG Neuro-feedback training.

We have always recommended trying the alternatives (1) diet and (2) Attend strategies before considering medications. Together they are statistically as effective as medications in the treatment of ADHD. Should these interventions not provide the patient with the benefits that he needs, the patient should then consider the available medications for ADHD.

Pill Pushers: Pharmaceutical Marketing in an Overmedicated Nation

This interview appeared in the Multinational Monitor about a month ago, and I thought it was one of the most interesting interviews I had ever read. It is an interview with journalist Melody Petersen of the New York Times, who has just written a book about pharmaceutical companies. It is an interesting read, and is reprinted here with the permission of the editor. --DC

Melody Petersen covered the pharmaceutical beat for The New York Times for four years. In 1997, her investigative reporting won a Gerald Loeb Award, one of the highest honors in business journalism. She is the author of Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (2008).

Multinational Monitor: There is a long history of pharmaceutical companies hawking remedies to the broad population. What’s different about the current era?

Melody Petersen: It’s much more aggressive. Many companies have even put their marketers in charge of their laboratories. At Pfizer, there was a program called CRAM, which stood for Central Research Assists Marketing. The name made it clear that the marketers were in charge.

The whole focus of the industry has changed. The drug companies center their efforts on medicines for chronic conditions that affect large portions of the American public — and therefore have vast potential markets — things like heartburn, depression, allergies, blood pressure. Even inside the labs, the scientists are told to focus only on drugs that could become billion-dollar sellers. That’s why we have six drugs to lower cholesterol that all work in the same way. And yet millions of very sick patients have no treatments.

MM: What are the key themes of drug company marketing campaigns to consumers?

Petersen: There are two different ways the companies use the ads to get you to go to the doctor. One way is to trade in fear about a disease. These ads have taglines like, “What you don’t know could kill you” or the ominous, “All it may take is the formation of one clot.” Those are attempts to make you fearful that, if you don’t take a pill, you could die.

The second way they use the ads is to show wonderful scenes of people running on the beach, hiking in the woods, dancing at a party. In those ads, they’re not really selling medicines, they’re selling things like youth and happiness and friends and beauty and sex. This is how marketers sell a whole host of different products. The underlying message is that this medicine will bring you a sort of personal transformation. You’ll be envied, you’ll be more lovable, if you take the advertised medicine.

MM: Besides overt ads, what do the companies do to market to consumers?

Petersen: The companies do most of their promotion from behind the scenes. If a company needs a group of patients or doctors to stand up and be advocates for its drugs, it may simply create a group that looks like a cancer society or a heart association, but is really nothing more than the creation of a PR firm working for the drug company.

If they want a news story about their medicine, a PR firm calls up reporters and works to get stories placed, often successfully.

When I was at the New York Times, I would get calls from the public relations staff of a drug company offering me what they called “an exclusive” story. They had one of the best doctors in the country ready to talk to me about a new medicine that was going to be on the market. They had patients who wanted to tell me how this drug had changed their lives. They even had a survey that said a large percentage of the American public suffered from this particular disease. It was clear I wouldn’t have to do much work for this story. It was all written out in the press release.

I could never get myself to do these stories, but if you read the newspaper, you will find stories like this that have come from a public relations person. They describe what sounds like a wonder drug.

The drug companies are experts at knowing how to put their words in the mouth of someone who appears to be independent, so the public accepts their promotional message as the truth.

MM: One noteworthy phenomenon you document is the marketing of pharmaceuticals to children.

Petersen: The companies are creating cartoon characters and giving kids free gifts. They’re trying to reach young consumers who may go on to take their medicines for decades.

For instance, AstraZeneca has created a creature named Pulmi. He kind of looks like a frog. He’s animated. He looks like he could be a character in a Disney movie. And the kids can go online and watch funny videos of Pulmi dancing and blowing his horn. He’s advertising a drug for asthma called Pulmicort. He’s also making drugs fun for kids.

This type of promotion is very dangerous because it can mislead children and their parents into believing these drugs are safer than they actually are.

Kids don’t buy drugs, but they’re very persistent. If the child has asthma and the doctor thinks a drug other than Pulmicort might be better for the child, the doctor might be up for a fight.

MM: The industry has also created or expanded markets for drugs for kids, notably to treat Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD).

Petersen: ADHD is a condition defined by certain behavioral symptoms a child displays.

What the drug companies have been able to do is sell more of their medicines by marketing the disease. They’ve promoted the disease to parents, taught parents about it through their websites and by handing out brochures in schools and through doctors.

At the same time, they now aggressively advertise drugs like Concerta and Adderall for ADHD. You can open up Ladies Home Journal and see ads for these drugs tucked in amongst the ads for cold cuts and cereals.

MM: How important are industry efforts to create or dramatically expand the population understood to have diseases, or redefine problems to be perceived as diseases needing treatment?

Petersen: I was very surprised about this. One day I was at a conference where drug executives were giving speeches. I looked down the agenda, and there was an executive from one of the biggest drug companies planning to give a speech about how he and his drug company had “created a disease.” At the time I didn’t understand that the drug companies could do this. But, indeed, he got up on stage and through his slide presentation went point by point how he and his company had created the disease of “overactive bladder.”

In essence, they went to some of the top urologists in the world, put them on their payroll as consultants, and gathered these doctors together in meetings where the expenses were paid by the drug company. At these meetings, the company and its physician consultants laid out how they thought the disease of overactive bladder should be defined. The company then paid some of these doctors to write articles about this new disease and how the company’s drug Detrol worked to remedy it. The company then paid to publish those articles in a medical journal. It’s as simple as that.

MM: What do you mean they paid to publish those articles in a medical journal?

Petersen: In this case, the company paid a journal called “Urology.” The journal published a supplement, and the manufacturer, Pharmacia, paid Urology to publish these articles. It said at the beginning of the supplement that these articles were generated from a meeting Pharmacia had sponsored in London where a group of urologists had gathered to talk about overactive bladder. It sounds, and it actually was, simple.

These first articles were then used as the source of even more articles in other medical journals. And the company paid some of its physician consultants to give lectures to other physicians about this new “disease.”

The company then taught consumers about this new disease through millions of dollars of TV ads. It also hired celebrities like Debbie Reynolds to talk to women about why they should be worried about their overactive bladders.

Today, Detrol, the company’s drug for overactive bladder, is a billion-dollar seller.

MM: Most people in the United States are much more aware of drug company marketing directed to consumers than the marketing directed to doctors. What’s the relative importance of those two things for the industry?

Petersen: Most of the drug companies’ marketing dollars actually go to physicians. The drug companies do this because once physicians played a very important role in our drug safety system.

In 1951, Congress decided that we must get a prescription for certain drugs. Before that law, we could go into the pharmacy and get whatever we wanted. Congress wanted the physician, who was independent and well educated and had the best interests of the patient at heart, to make sure we didn’t take drugs that could harm us more than help us.

But now, virtually all physicians in America take cash or gifts from the drug companies. A recent survey said 94 percent of physicians took something of value from the drug companies. Some doctors take hundreds of thousands of dollars a year from these companies, and there’s no law that says they can’t. So we’ve lost a key part of our drug safety system: the independent physician. This safeguard has disappeared.

MM: What are the ways the industry can transfer such significant sums to doctors?

Petersen: The drug companies hire thousands of physicians to be their consultants or advisors. They hire doctors to give lectures to other groups of doctors. Some doctors take money from two dozen drug companies at the same time.

I had no idea this was so extensive until one day I was writing a story about Celebrex and Vioxx — this was before Vioxx was taken off the market. The story was about the marketing battle between these two pain drugs. I called one of the large societies of rheumatologists and asked for an expert on arthritis. I specifically said I needed an expert who was not being paid as a consultant to one of the manufacturers of these drugs. A staff person said, “We have lots of people you can talk to, but all of these doctors are consultants to one or both of the drug companies.”

MM: What kind of “consulting” can so many doctors be doing?

Petersen: The drug companies will invite physicians to a dinner or a weekend retreat where they hear a lecture from another doctor. That lecture is being paid for by the drug companies. The physicians who are invited will get a nice meal, but they’ll also be paid for serving as a consultant.

I’ve read agreements that these doctors sign and it’ll often say that “For your work as a consultant, we will pay you $500 for this evening.” There’s also a confidentiality agreement. This is why so few patients understand that this is going on. The doctor signs an agreement where he agrees not to tell others what went on at this dinner.

There are more than 500,000 of these dinners or events in America every year. This is a huge part of how drug companies market their drugs.

MM: Could you say more about how the marketing push affects the science that the companies are doing?

Petersen: This is one of the most frightening things about the way drugs are marketed in America today. The drug companies have learned to use science as a marketing tool. They have a standard marketing technique that they call “publication planning.” They want to saturate the medical literature with articles about their new drug that will get doctors to prescribe it. They will hire a Madison Avenue ad agency, or a smaller marketing firm, to draft these articles. But the name of the ad firm rarely appears in the article. Instead, they hire a physician or a group of physicians to put their names on as “authors,” although these doctors may do little or none of the work.

Our medical literature has become so distorted by the industry’s influence that some scientists say it is little more than corporate propaganda. This is frightening. It means that even if you have one of the few doctors who ignore the sales reps and read medical journals to find what is best for patients, that physician is still getting little more than an advertisement.

MM: What is Neurontin?

Petersen: Neurontin is a drug for epilepsy. It’s not a very good drug for epilepsy. It was a drug that Wall Street wasn’t excited about because it really didn’t have much of a future.

Warner-Lambert, which sold Neurontin, decided they were going to change that. They decided to sell the drug for more than a dozen other medical conditions for which it wasn’t approved. They had little or no science to back the use of Neurontin for these conditions. They sold it for things like bipolar disorder, migraines, attention deficit disorder in children.

It is illegal for a drug company to sell a drug for indications that the FDA hasn’t approved. But doctors can prescribe a drug for whatever they see fit, and that’s the loophole that this company set out to exploit.

MM: Was there some basis or intuitive reason to believe that it would be helpful for these varied conditions, or did Warner-Lambert just make this stuff up?

Petersen: In some cases they had some limited research where they believed it might help. Neurontin was eventually approved to treat certain types of pain. But for some other conditions, like bipolar disorder, the company actually had studies that showed it didn’t work. That didn’t stop doctors from prescribing Neurontin to hundreds of patients suffering from that mental illness.

MM: Based largely on whistleblower efforts, you have a rich account of what the company was doing internally and how it was marketing. Ultimately, Warner-Lambert paid $430 million in a criminal and civil settlement over its off-label promotion.

Petersen: It’s really a story about a scientist, David Franklin, who went to work for a big drug company believing that he could help people get the medicines they needed. He was quickly horrified by what he found going on inside that company.

The company got doctors to prescribe the drug for all these experimental uses by paying them. They paid physicians to give speeches to other physicians at restaurants or hotels or resorts. The doctors not only enjoyed a nice meal or a weekend vacation, they often also received a $500 check for attending. The physicians giving lectures at these parties were often trained by the drug company’s ad firm to describe how Neurontin could work for conditions like bipolar. The whistleblower, David Franklin, told me that he was saddened by how many doctors seemed eager to help the company succeed with this deception.

The company tracked the doctors’ prescriptions before and after these dinners or weekend retreats. The executives saw how well it worked.

MM: One thing that’s very striking about this story was how the deceptive marketing scheme was a central part of the company’s business model.

Petersen: The plan for selling Neurontin was actually approved by the highest level of management. I’ve looked at thousands of internal documents that became public as part of the lawsuit and you can see how top level executives were involved. They were excited by the enormous sales potential of what was really a mediocre drug for epilepsy.

MM: The pharmaceutical industry is very much on the defensive politically. Do you see meaningful reforms likely in the near future?

Petersen: The drug industry has enormous political power in Washington. The companies have been able to defeat proposed reforms again and again. Then, add the power of the American Medical Association and physicians and you can see how hard it is to get new laws to protect patients. Americans need to rise up and say they’ve had enough. They really need to start a revolution. So many people are needlessly dying because of the industry’s relentless marketing tactics.

MM: You are very critical of pharmaceutical marketing. The industry says it is providing information to consumers and doctors and that people are better off for knowing about treatments that can help them. How do you respond?

Petersen: The bottom-line point of my book is that it’s not the medicines that are the problem. Medicines can help you if you get the right drug at the right time. The problem is the marketing.

The marketing is distorting the information that we, as patients, read and understand. The marketing makes these drugs appear to be much more helpful and a lot less risky than they actually are. There really isn’t any place for marketing in medicine. Patients need honest and objective information about these products and they simply can’t get that today.

MM: Should drug companies be prohibited from advertising to patients?

Petersen: I wish we could prohibit them from advertising to patients, but I don’t think that we can. They have a First Amendment right to get their information out there. But, at the same time, they don’t have a right to hurt patients with their ads.

We should go back to the rules before 1997, when ads weren’t allowed on television. Let the drug companies publish print ads in black and white with basic, truthful information about drugs. The ads should include the price of the drug and also information on how patients could find relief through changes that do not involve taking a prescription drug. For instance, if the drug is for Type II diabetes, the ad should describe how many patients can cure themselves through diet and exercise. We need to get away from the images of people having a good time on the beach or at a party. That shouldn’t be allowed in the ads.

MM: What about drug company payments to doctors?

Petersen: We have a law in America that says radio disc jockeys can’t take cash from music companies. But when it comes to something like medicines — which mean life or death for people — doctors can take as much money as they want from the drug companies. We need a law to stop that.

MM: One of your book’s recommendations that may surprise people is a call for more autopsies. Why is there a need for more autopsies?

Petersen: We really have no idea how many people are dying from prescription drugs in America. It’s clear that most of these deaths are not being attributed to the medicines on the death certificate. One reason for that is that doctors and hospitals no longer do autopsies. The autopsy rate has fallen to less than 10 percent of all deaths in the country. Doctors are guessing at what people actually died from. If there were more autopsies, we could learn which drugs were excessively dangerous and which ones were beneficial. Doctors would stop making the same deadly mistakes.

MM: You suggest that one hidden toll of taking “Our Daily Meds” is a massive, underappreciated impact of drug-induced injury and death.

Petersen: We only have estimates of how many people are dying from prescription drugs. The study that the FDA often cites estimated that more than 100,000 Americans die every year from prescription drugs they took just as their doctor recommended. These aren’t situations where a doctor made a mistake, or a pharmacist made a mistake, or the patient accidentally took too much. This is where, supposedly, everything went right.

There’s been disaster after disaster caused by aggressively-promoted medicines. Just look at Vioxx. More than 20 million Americans took Vioxx before it was taken off the market in 2004 because it doubled the risk of heart attack or stroke. A government scientist estimated that this single drug might have led to the deaths of 40,000 Americans. This was a devastating tragedy.

Far too many physicians are ignoring the deaths caused by the prescriptions they write. It’s as if they read about cases like Vioxx, shrug their shoulders, and think, “Oh well.” They like the current profit-driven system that puts money in their pocket. They don’t want anything to change.

ProDrugs: The Next Generation of ADHD Medications?

Just as 2006 and 2007 saw an increase options for delivery systems of medications for ADHD, the next generation of medications for ADHD may be just around the corner in 2008 and 2009. These NextGen medications are known as ProDrugs, and they have the potential to change the way medications are prescribed to individuals with ADHD.

Since there has been a recent explosion of new ADHD drugs such as Strattera, or new delivery systems such as Daytrana, or “old drugs in new dresses” such as Concerta, why in the world is it necessary to develop any more new drugs for ADHD? Why should we care?

To the extent that new drugs are just “old drugs in new dresses” for a pharmaceutical company to make money, we don’t care. But to the extent that this NextGen of ProDrugs might actually make a difference in people’s lives, we are very interested in learning more.

And given that between 30% and 40% of patients cannot tolerate the side-effects of current stimulant medications, and given that today’s ADHD medications range from about 60% effective (Strattera) to 80% effective (Ritalin), there is a lot of room for improvement in this field. This is why we like Attend, which is not a drug, but is about 70% effective and with few or no side-effects. It is just not well known.

ProDrugs: The Next Generation of ADHD Medications

By developing this next generation of drugs, pharmaceutical companies are betting huge sums of monies that they can develop ADHD drugs that are more efficient for a given individual, and with fewer side-effects. Since there are different types of ADHD, different types of drugs, or drugs that will work on different parts or systems of the brain, will be more efficient than just broad acting CNS stimulants.

What is a ProDrug?

A ProDrug is an inactive precursor of another drug, an inactive precursor to a particular pharmacologic agent. It is a drug that is given in an inactive, or greatly less active form. But once taken, the person’s body metabolizes it into an active form. The person’s body becomes the “delivery system.”

A ProDrug is designed to be more efficient in treatment, by being better absorbed and better utilizied by the body, with less side-effects.

The goal of ProDrugs is for the drug to be highly targeted to a specific system or region of the body, a specific site of action, rather than just impact the entire body or CNS.

Shire Pharmaceuticals, a company that we have been very critical of in the past, is one of the companies leading the way in ProDrug development. Well, actually they are not, but they did by New River Pharmaceuticals for $2,600,000,000 (yes, that is 2.6 Billion dollars). And New River Pharmaceuticals was leading the lay in ProDrug development for ADHD with their drug Vyvanse (lisdexamgetamine dimesylate). The FDA approved Vyvanse as a “novel treatment” for ADHD in February of 2007, and the DEA will classify it as a Schedule II controlled substance.

See http://newideas.net/adhd/medication/vyvanse_shire

From the Shire press release of Feb. 2007:

“VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

The big selling point of Vyvanse is that it may reduce the potential for abuse, as ProDrugs are not favored by those intending to abuse stimulants.

In regards to ADHD ProDrugs, admittedly Vyvanse is the only ProDrug that I have heard any lectures on or read anything about, but I don’t want to assume that it is the only ProDrug in development for ADHD. In the studies on Vyvanse, the researchers found that among all of the subjects, the ProDrug was metabolized very consistently in terms of time to optimum therapeutic levels in the body, and in terms of the predictability of the degree to which the ProDrug was utilized by the body.

To put it better, put ten kids in a room who each weigh 100 pounds. Let’s say that they each need treatment with methylphenidate (Ritalin, et al.). The variety of optimal doses in those ten children could range from 5mg per dose to 40mg per dose. But with the ProDrug, the study indicates that nearly everyone of that body weight will be taking the same size does to get the optimum dose.

To put it even more simply, it will be easier for doctors who aren’t paying attention well to get the right dose for the right child the first time. And the response to the drug will be more predictable. Everything will operate more efficiently with a more efficient drug.

In addition to ProDrug development, look for the use of various “Alpha-2 Noradrenergic Receptor Agonists” for the treatment of ADHD in the near future. Tenex (guanfacine) is already in use for ADHD, as well as being an anti-hypertesive and blood pressure medication, but more will be on the way. We will look at this class of medications, and their potential for ADHD treatment, in the near future.

QA: Adderall XR Question

Adderall XR

Question from a Reader:

This summer I took my child off XR adderall, he is not growing and his weight is below average. He is not moody any longer, the ticks are going away and he told me he is not having problems like before with attention. I do not wish to return him to meds.

How can I help him when it comes to school and behavior?

Answer from Editor:

Most of what you mention are things that you have to discuss with your doctor. But I'll do what I can to help you. You may be aware of this week's headlines about stimulants "stunting growth" in kids. I haven't yet read the study yet, but I will soon and it seems that you should too.

Regarding the "tics" that you mention, it is possible that your son suffers from Tourettes Syndrome, perhaps instead of ADHD. People with TS can have the same symptoms of ADHD, but with tics, especially when using stimulant medications. You'll have to check this out with your doctor.

What to do next?

Well, I'd recommend that you use our eating program for about two months
http://newideas.net/adhd/adhd-diet

and Attend and Extress for about two months
http://newideas.net/adhd/attend
http://newideas.net/adhd/different-types-adhd
http://www.vaxa.com/26462/index.cfm?page=636.cfm

and also check to make sure there are no environmental allergens or toxins around that
might be involved:
http://newideas.net/adhd/differential-diagnosis/mercury-chemical-toxicit...

also begin learning about Tourettes Syndrome. I like the old book Tourettes Syndrome and
Human Behavior, by David Commings at the City of Hope (City of Hope Press). Your local
library should have a copy. Its a huge book, but very readable, with about 1/3 of the
book on TS, 1/3 on ADHD, and 1/3 on the brain and treatment options. Again, it is old, so
the medication options have changed. But it is a great place to begin learning to see if
that's really what's going on with your son.

Does this help? I hope so. Please stay in touch.

Doug Cowan Psy.D.

Adderall XR Question

Report Card on ADHD Medications

Hayes Evaluates Test and Treatment Options For Attention-Deficit Hyperactivity Disorder

Press Release: 19 August 2008
More clinical research needed to recommend most ADHD treatments Stimulant drugs and atomoxetine show promise in relieving symptoms in children

Hayes Inc., an industry leader in providing independent, unbiased analyses of healthcare technologies, today announced that it has completed an exhaustive study of a wide range of medications to treat attention-deficit hyperactivity disorder (ADHD). The study was undertaken in response to significant customer interest in gaining a better understanding of those treatments that really work to relieve symptoms in ADHD sufferers.

ADHD is a common disorder of childhood and adolescence that may persist into adulthood and is characterized by symptoms of inattention and/or hyperactivity/impulsivity with symptoms lasting for at least 6 months and to an extent that is inconsistent with development level. It is estimated that up to 5% of the world’s population suffers from ADHD.

Over the past three months, Hayes medical research analysts have reviewed the clinical evidence regarding a range of ADHD treatments for adults and children, including the use of stimulants, antidepressants, antihypertensives, and atomoxetine, a nonstimulant drug approved for treatment of ADHD. The results are not promising. Of the treatments evaluated, only one type of drug, stimulants, was given an “A” Hayes Rating for use in children and a “B” Rating for use in adults. One other drug, atomoxetine, was given a “B” Rating for use in children.

The Hayes Rating is a proprietary rating system with each rating reflecting the strength and direction of the evidence regarding the safety and efficacy of a medical technology (procedure, test, device, biologic, or drug), its impact on health outcomes, indications for use, patient selection criteria, and comparison with other technologies. Ratings are scaled A, established benefit, through D, no proven benefit and/or not safe.

Elisabeth Houtsmuller, PhD, Medical Research Analyst for Hayes, Inc., directed the evidence analysis for the ADHD project, and notes that “Healthcare payers and providers are grappling with the best techniques for treating ADHD as knowledge of this disruptive and sometimes debilitating disease spreads. Unfortunately, in most cases, current evidence is limited and further studies are needed before these drugs can be unequivocally recommended for use.”

In addition, Hayes reviewed the effectiveness of neuropsychological testing for diagnosis of ADHD, finding that these tests do not have strong predictive value for ADHD diagnosis. Accordingly, neuropsychological testing was rated “D” for ADHD.

Houtsmuller added, “Unfortunately for sufferers of ADHD and their families, there are few clear conclusions that can be drawn from the research to date on the best treatment options. In the case of stimulant treatment for children, clinical studies do demonstrate short-term relief, but many families have concerns about administering stimulants to children. In these cases, atomoxetine represents a good option, with clinical evidence demonstrating some effectiveness.”

Hayes conducts its research by thoroughly analyzing all peer-reviewed clinical studies and determining if studies were designed appropriately, if enough patients were involved, and if the studies answered critical questions about whether the treatments work or improve patient care.

About Hayes, Inc.
Hayes, Inc. provides unbiased, evidence-based research and analysis to help insurers, hospitals, and policy makers make informed healthcare decisions. The company’s conclusions are independent, impartial, and objective, formulated by an international staff of medical analysts drawn from a range of healthcare disciplines.

Hayes research products and advisory services are used by some of the world’s leading healthcare organizations. More than 65% of U.S. healthcare insurers serving approximately 150 million lives depend on Hayes research when developing coverage policies. In addition, Hayes research also supports hospitals making health technology acquisition decisions and employers helping employees make better informed healthcare choices.

Hayes, Inc. was founded by Winifred S. Hayes, PhD, in 1989 and is headquartered in suburban Philadelphia.

For more information go to www.hayesinc.com.

Press Contact:
Joe Crivelli
Gregory FCA
27 West Athens Ave.
Ardmore, PA 19003
610-642-8253 ext. 123

Company Contact:
Karen Matthias
Hayes, Inc.
157 South Broad Street.
Lansdale, PA 19446
215-855-0615

Risperdal for ADHD?

Is Risperdal a medication that is used to treat ADD/ADHD? What are the mental illnesses that it is used for?

Risperdal would not typically be used to treat ADHD, and I have never heard of it being a first drug to try. I suppose there might be reasons if there were a lot of symptoms of anxiety, obsessive-compulsive symptoms, or explosive temper or irritability. Or if the doctor thought that it was really tourettes syndrome, or schizophrenia just breaking out.

It is an interesting question that you ask...

Here are some websites with general information that would be more helpful to you than any answer I might give:

http://www.janssen.com/janssen/products.html
http://www.drugs.com/risperdal.html
http://en.wikipedia.org/wiki/Risperdal
http://www.fda.gov/foi/warning_letters/archive/g4628d.htm

Talk with your doctor and your PHARMACIST if you have more questions.

Doug Cowan

The ADHD Information Library at http://newideas.net
Over 500 Classroom Interventions at http://www.ADDinSchool.com

The information in this email is not to be considered medical advice. Always
consult your own physician or health care provider. The information at the ADHD
Information Library and from its staff is for educational purposes only.

Ritalin

Just the mention of the name "Ritalin" can cause a wide variety of emotional reactions among people.

Some love Ritalin, as they have seen it help a loved one, and will defend it forever.

Others hate it, and see it as a part of the plan of evil psychiatrists to try to drug children and take over the world (yes, really!). They will attack it whenever they can.

Most people simply don't know what to think.

Ritalin for ADHD

Ritalin is a "brand-name" for a medication made from Methylphenidate. Methylphenidate (MPH) is a stimulant used to treat Attention Deficit Hyperactivity Disorder, or ADHD, in both children and adults.

Ritalin, or one of its Methylphenidate cousins, may also be used to treat symptoms of traumatic brain injury, narcolepsy, and even chronic fatigue syndrome (though many other treatments are far better).

Other Methylphenidate-based medications are also discussed in this section, and they include:

• Concerta
• Focalin
• Metadate
• Daytrana

Ritalin as a "brand-name" medication comes in three forms, and in various doses:

• Ritalin: 5 mg, 10 mg, and 20 mg tablets;
• Ritalin SR: 20 mg tablets;
• Ritalin LA: 10 mg, 20 mg, 30 mg, and 40 mg capsules;

Ritalin in the Treatment of ADHD

Stimulants have been around for about 50 years. Overall, they work very well. Ritalin and Dexedrine are moderately beneficial, or very beneficial, for about 70% to 75% of those who try them.

There is an unbelievable amount of research done on children and Ritalin, less with Dexedrine, ADDerall, and Cylert. We have heard that Ritalin is the most widely studied medication prescribed to children in the world, and we would not dispute that claim. It seems that every doctoral candidate writing his dissertation for psychology does something with Ritalin.

Stimulants, whether Ritalin or the amphetamines such as Dexedrine or ADDerall, all have benefits for children and adults with Attention Deficit Hyperactivity Disorder - ADD ADHD.

Ritalin will increase the brain's ability to inhibit itself. This allows the brain to focus on the right thing at the right time, and to be less distracted, and less impulsive. Ritalin will increase the "signal to noise ratio" in the brain.

Ritalin will also increase both gross motor co-ordination and fine motor control. For several years the sales brochure for Ritalin simply had pictures of children's handwriting before Ritalin, and with 10 mg of Ritalin in their system. The changes were dramatic, and physicians wrote a lot of prescriptions for Ritalin.

Ritalin may be "over-prescribed" in America, it may not be. But if it is "over-prescribed" it is because it actually works! If it didn't work, sometimes dramatically, it wouldn't be "over-prescribed."

Are we great advocates for the use of stimulant medications?

No. We would prefer that patients at least try the nutritional medicines like ATTEND and Extress, or EEG Biofeedback training first. However, there is a time and a place for the use of Ritalin. And we want you to have accurate information.

Getting the Most out of Ritalin

Ritalin is a pretty good medication. We have seen hundreds of kids benefit greatly from Ritalin. But doctors and parents must be observant and conservative.

We have also seen some horror stories with Ritalin. It must be used carefully, and started slowly and cautiously. It is not a toy.

Ritalin can cause serious side-effects. Read about Ritalin side-effects here.

We have found that the short-acting pill is better than the timed-release pill. Patients report that the timed-release pill seems to "release" whenever it feels like it, rather then when the patient expects it. So using the short-acting pill gives most patients greater control with the Ritalin.

We have found that the brand name “Ritalin” is much superior to the generic “Methylphenidate.” Generic pills can vary is dosage as much as 20% either way, stronger or weaker. For example, what is a 10 mg Ritalin pill in the generic form may be effectively as little as 8 mg or as much as 12 mg, a 50% potential variation. Always begin your "trial" of medication with the real Ritalin. If that works, then feel free to see if the generic will work as well as the “real stuff.”

Ritalin begins to work in about 15 or 20 minutes. It peaks in effectiveness at 1.5 to 2.5 hours, and lasts for about 3.5 to 4.0 hours.

Some kids have "withdrawals" or a “trough period” from coming off of the dose at about the 4 hour mark. They may "crash" and become irritable, tearful, emotional, or bratty. This lasts for 15 to 30 minutes, and tends to be worse with doses of 15 mg. or more.

The best remedy for this that we've found is a 12 oz. Mountain Dew at about the 3.0 hour mark. The caffeine "deflects" or "flattens out" the angle of withdrawal. This trick works well.

Ritalin Myths

Statements often heard about Ritalin, but are not supported by research, include:

• "Drug treatment should not and need not be indefinite and usually may be discontinued after puberty."

  Most children with ADD ADHD will still benefit from medications through their teenage years, and more than 50% of children with Attention Deficit Hyperactivity Disorder will still benefit from stimulant medications into adulthood.

• "Start with 5 mg twice daily, before breakfast and lunch."

  Studies show that the medications work better if taken with or after meals. Just be consistent as to when you take it.

• "Administration of amphetamines for prolonged periods may lead to drug dependence and must be avoided."

  While this is one aspect of treatment to be concerned about, another side of this is that studies show, over and over again, that (1) ADD ADHD kids who are never treated will have higher rates of drug use than non-ADHD kids, (2) ADD ADHD kids that ARE treated, whether with medications, or biofeedback, or with anything, will have LOWER rates of drug us than non-ADHD kids.

  There is no evidence that using stimulant medications increases rates of drug use among adolescents or adults. Rather, the opposite is true.

FDA Hearings and Warnings About Ritalin

We have lots of discussion about the recent FDA hearings on Ritalin and other stimulant medications that we want you to read and become familiar with.

We also have the "black box warnings" for you to look over.

It is an issue of "full disclosure" to you. These medications can be very helpful. But we recommend that you try Attend, Extress, and the ADHD diet first. They also work well without the potential side-effects of Ritalin.

Ritalin: Side Effects and an Alternative to Ritalin

Ritalin Side Effects

Ritalin (Methylphenidate)

It has been our opinion for years that Ritalin is a good medication. But it can cause problems, sometimes serious side effects, and must be used with caution.

Recent FDA warnings are starting to make us wonder about recommending Ritalin these days. The evidence seems to be mounting against it.

Our Clinical Director Dr. Cowan has worked with over 1,000 children and teens with ADHD over the past 20 years, and hundreds of those ADHD patients were treated with Ritalin.

For about a third of those patients Ritalin made a "day and night" difference. For another third Ritalin was "helpful." For the rest, Ritalin either didn't help significantly, or it actually caused problems. For a few ADHD kids there were significant side effects ranging from loss of appetite, to seizures.

Most of the Ritalin side effect problems observed over the years were due to physicians not being careful with the prescriptions, and prescribing too much Ritalin per dose, especially when first beginning treatment.

Other problems were observed when parents would continue to give the Ritalin to their ADHD kid even when they saw that the medication was causing the child problems. Ritalin is a powerful tool and must be used carefully, if used at all.

Tip for Parents: The short-acting pill is better than the timed-release pill. Also, the brand name "Ritalin" is much superior to the generic "Methylphenidate." Always begin your "trial" of medication with the real stuff. If that works, then feel free to see if the generic will work as well as the "real stuff." Ritalin begins to work in about 15 or 20 minutes. It peaks in effectiveness at 1.5 to 2.5 hours, and lasts for about 3.5 to 4.0 hours.

More Ritalin Side Effects

Some kids have "withdrawals" or a "trough period" from coming off of the Ritalin dose at about the 4 hour mark.

They may become irritable, tearful, emotional, or bratty. This lasts for about 15 minutes, and tends to be worse with Ritalin doses of 15 mg. or more.

The best remedy for this that we've found is a 12 oz. Mountain Dew at about the 3.0 hour mark. The caffeine "deflects" or "flattens out" the angle of withdrawal. This trick works well.

We have seen hundreds of kids benefit greatly from Ritalin. But doctors and parents must be observant and conservative. We have also seen some horror stories with Ritalin. Start slowly and cautiously. It is not a toy. And remember, there are other things that you can do that work as well as Ritalin, and are healthy for you!

Is Ritalin Dangerous?

Here is a link to a site that is strongly opposed to Ritalin use, as the author, Mr. Lawrence Smith, states that his child died as the result of its use.

He claims that there are about 20 deaths reported each year to the FDA's MedWatch program from Ritalin. Although it is hard to believe everything that is on the internet, I do think that you should at least take a minute to look over his site and consider the information.

Here is a copy of the email that Mr. Smith sent to me in 2002.

There are Other Choices

Look at this chart comparing Ritalin to ATTEND and to EEG Biofeedback treatment...

Ritalin is very effective. Ritalin works somewhat differently in the brain than do the amphetamines like Dexedrine or ADDerall. Ritalin seems to primarily impact on longer term vesicular storage of Dopamine, while amphetamines primarily impact the pool of newly synthesized Dopamine. It also has a different effect on Norepinepherine.

Attend is also effective. It has amino acids, essential fatty acids, phospholipids, homeopathic medicines, and more. It is healthy and effective. And it does not require a prescription, and comes with a no-risk trial policy second to none. It either works - or it is free. More information on the natural remedy ATTEND. Here to order ATTEND from VAXA International.

The main side effects of Ritalin that we have observed are loss of appetite (feed a protein shake twice a day to help keep weight up), some irritability or anger (as when you have had too much caffeine), possible short term growth inhibition (though long-term this may not be a problem). Remember, every medication has possible bad side effects, so always closely monitor your child when taking medications!

If there is a problem, don't give the next dose, and call your doctor right away.

Storm in a Western Pill - Fear and Empowerment in ADHD Drug Treatment

Our guest author is Shane Wong. Mr. Wong is the Editor-in-Chief for Juxtaposition Global Health Magazine, a student-run publication based at the University of Toronto. According to the author: "This article will explore how ADHD medication can empower diagnosed patients, and why fears towards such drugs and the pharmaceutical industry persist across North America."

"Ritalin, Ritalin, seizure drugs, Ritalin.” Such is the lunchtime rhyme for a typical school nurse in the U.S. as she trots from class to class, dispensing pills into outstretched hands of young children (01/18/99 - New York Times).

Welcome to the uniquely North American psychotropic environment. A continent featuring a prescription drug market for attention-deficit hyperactivity disorder (ADHD) worth over 2-billionUS annually, and where the number of prescriptions have grown four-fold in 20 years and over 90% of prescriptions worldwide originate.

But when patients as young as two-years-old are prescribed drugs that a government puts in the same category as morphine and cocaine, controversy concerning the use of drug treatment for ADHD is bound to arise. This article will explore how ADHD medication can empower diagnosed patients, and why fears towards such drugs and the pharmaceutical industry persist across North America.

ADHD Diagnosis

Attention Deficit Hyperactivity Disorder (ADHD) is among the most commonly diagnosed behavioural disorder in school-aged children, with prevalence rates ranging from 2% to 7%.

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), the standard diagnostic manual for all North American mental health professionals, ADHD is differentiated into two clusters of behavioural symptoms: inattention, as well as hyperactivity and impulsivity.

Problems with attention primarily involve lack of sustained focus, which can manifest as a rapid shift between toys when young children play or a lack of persistence shown by older children during tasks that lack intrinsic appeal or immediate reward. Additionally, children may also have trouble controlling impulsive behaviour, such as speaking out irrationally or engaging in unnecessary risk-taking behaviour. Finally, hyperactivity includes a tendency to fidget excessively, making it often the most obvious feature in young children.

Burden of Disease: In the Classroom

These tendencies naturally contribute to problems in a variety of domains for many children classified as having ADHD. Academically, children with ADHD are more likely to be expelled or suspended, and 25% of ADHD children develop learning disabilities that range from reading disorders to dyscalculia, a very specific math related disorder where individuals have trouble manipulating simple calculations and numbers. Consequently, it is no surprise that researchers found that ADHD is associated with lower rates of high school graduation and post-secondary education.

Burden of Disease: Outside the Classroom

Apparently the sing-song echo of kids in the playground, “sticks and stones may break my bones, but words will never hurt me”, is only partly true. ADHD children not only have higher rates of accidents, but they have a lower sense of self-esteem and self-efficacy due to frequent negative feedback in academic and social settings.

More troublingly, one study found that 30% of ADHD youth also suffer from anxiety disorders, while 11% experience major depression. Due to their often unrestrained and overbearing social behaviour, ADHD children are also less popular among their peers. Using their classmates’ ratings, researchers found that only 1% of 7-9 year-old children with ADHD were of ‘popular’ status, while 52% fell into the ‘rejected’ category.

A Childhood Syndrome?

Contrary to popular belief, many of the symptoms of ADHD remain present throughout an individual’s lifetime. With growing attention towards adults with ADHD, researchers have found many negative outcomes associated with ADHD that are exacerbated in adulthood as individuals are gaining increasing responsibility and autonomy.

Adults with ADHD generally face greater marital and drug abuse problems, and become involved in more serious accidents. For instance, a unique German study revealed that nearly 45% of inmates in a prison facility suffer from ADHD, suggesting an increased risk of run-ins with the law. Furthermore, at the workplace, ADHD adults display lower work ratings and often change jobs more frequently.

Ritalin: An Empowerment Tool?

Given the negative health, social and academic outcomes associated with ADHD, psychostimulant medications such as Ritalin and Adderall offer the potential to empower children and adults by reducing the risk of negative consequences. In a landmark study lasting over 18 years, researchers at the famed Mayo Clinic found that ADHD medication was associated with improved long-term academic success in children with ADHD. Compared to untreated children diagnosed with ADHD, medication improved reading achievement scores, decreased absenteeism, and decreased the likelihood for a child to be retained in a grade. More specifically, children were able to handle general tasks and manage requests better, while increasing academic productivity.

Outside the classroom, treatment with psychostimulants also reduced the risk of substance abuse by about half compared to children without treatment. The growing research into the benefits of psychostimulant treatment suggest that current ADHD medications can empower individuals to achieve success in academic, employment, self-care and social relationships.

Yet, how does this ‘magic’ pill work? With advances of brain imaging technology, researchers have made tremendous progress in illuminating how medication ‘empowers’ at a neurochemical level. Contrary to one of the first coherent descriptions of ADHD in 1902, which attributed the disorder to an “abnormal defect in moral control,” current drug treatments have actually uncovered a characteristic difference in the brains of patients with ADHD, which stems from a lack of dopamine receptors in the attentional network.

Therefore, ADHD psychostimulant treatments, like Ritalin, actually work by increasing dopamine in the brain by blocking re-uptake transporters, in a fashion analogous to a powerful brick that blocks a drainage pipe, preventing neurochemicals from being flushed away. According to our knowledge of dopamine, the enhancement of dopamine signals in the brain helps patients focus and learn.

One theory that can explain the lowered risk of drug abuse, hypothesizes that an increased dopamine signal lengthens ‘the temporal window’ for associating behaviours to consequences, leading to more effective extinction of impulsive behaviours. Psychostimulants were also shown to increase dopamine in brain regions known as the attentional network, leading to a greater level of attention and focus. Based on these findings, psychostimulant treatments appear to empower patients by reducing symptoms at a neurochemical level and minimizing the risks of negative outcomes associated with ADHD.

Long Term Effects of Psychostimulants: Dependency?

Despite the demonstrated benefits of drug treatment, there remain uneasy fears towards the ADHD medication as a result of its potential side-effects. According to fundamental neurobiological principles, the brain will compensate for the artificial changes in brain chemistry caused by drugs.

This suggestion was confirmed in a 2001 brain imaging study that found three months of
psychostimulant treatment in ADHD children significantly reduced the number of dopamine receptors in the attentional network, the very deficit characterizing ADHD brains in the first place. In other words, if children are taken off the medication, it is likely that their ADHD symptoms will worsen, at least in the short-term. Currently, ADHD medication labelling warns for the risk of sudden death in children and adolescents with structural cardiac abnormalities or other serious heart problems, and psychotic symptoms such as hallucinations and delusions.

For Every Action, There is a Reaction: Abuse and New Formulations of Medication

There are also fears directed towards the potential abuse of psychostimulant medication. In 2001, the Journal of the American Medical Association published an article titled: “Pay Attention: Ritalin Acts Much like Cocaine”, confirming that the clinical effects of ADHD drugs are indistinguishable
from cocaine if both are similarly administered. Furthermore, psychostimulants have been abused by students needing to stay awake and study, or hoping to lose weight. As quoted in the New York Magazine, “You swallow Adderall to study, and snort it for fun”.

One survey examining the prevalence of ADHD drug abuse found that more than 16% of students at a liberal arts college had tried Ritalin recreation