The Shortage of Adderall

The Shortage of Adderall

Earlier this year, reports began emerging in various cities in the United States, that a shortage of the drug Adderall was occurring.  Just today, November 22, 2011, I was called by the first family to find that their pharmacy was out.

Adderall is the brand name for the drug amphetamine, which is used by many people to treat ADHD.

There are other forms of amphetamine available that are not in shortage (Vyvanse, amphetamine), and other related medications that treat ADHD (Ritalin, Concerta, Methylin, Metadate, Focalin), but for those being treated with Adderall, the shortage is of concern.  

The reasons for the shortage are not entirely clear, not even what forces are driving it.

The manufacturer is making as many doses as it usually does, and doctors are prescribing it at relatively steady rates.

A curious feature of the stimulant drug market has emerged as this issue has been looked at.  The stimulants are all variations of the street drug amphetamine, which is illegal to use without a prescription.  Therefore, the use of amphetamines is tightly monitored by two major Federal agencies, the FDA (Food and Drug Administration) and the DEA (Drug Enforcement Agency).  Each prescription for any stimulant is monitored and the government works hard to detect any trend towards illegal use.  This is why prescriptions for stimulant medications cannot be called in and why, at the pharmacy, refills cannot be authorized.

As part of the government's effort to allow the use of legally prescribed stimulants but bad the use of illegally non-prescribed stimulants, the FDA sets a total amount of drug that can be manufactured in the US.  That amount is set by the number of prescriptions.  So, if in the US, say some number of tons of Adderall are prescribed each year, the FDA will allow the manufacturer to produce that number of tons, with some extra to make sure the supply meets the demand.

Officials at the FDA are clear that they have continued to allow the amount of Adderall to be manufactured that will meet the demand as defined by the number of prescriptions written.  The manufacturer disputes this.

And so we have a situation in which families go to their pharmacy and find the pharmacy is out of Adderall, and cannot get more.

Possible reasons include:

1. The government has it wrong, prescriptions are up and manufacture is not.
2. The government has it right and there is enough being made but not enough reaches the drug stores
1. A problem with distribution has occurred with problems in shipping or stocking causing the shortage
2. Manufacturers are allowed to make enough but for some reason enough batches have gone bad to affect availability
3. Manufacturers are making enough and distributing it well, but illegal use could be exploding, diverting the limited supply to those not prescribed the medication.

We do not know the reason at this time.

But, if you are on Adderall and find you cannot get the medication, try various pharmacies as your first step.

Consider mail order of the prescription as well.

If you are part of the Advanced Pediatrics practice, call our office to inquire about other approaches to helping your child with ADHD, including use of related medications that are not in shortage, non-medication options for therapy, and use of non-stimulant medications.

Happy Thanksgiving,
Dr. Arthur Lavin

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*Disclaimer* The comments contained in this electronic source of information do not constitute and are not designed to imply that they constitute any form of individual medical advice. The information provided is purely for informational purposes only and not relevant to any person's particular medical condition or situation. If you have any medical concerns about yourself or your family please contact your physician immediately. In order to provide our patients the best uninfluenced information that science has to offer,we do not accept samples of drugs, advertising tchotchkes, money, food, or any item from outside vendors.

Don't Spank- The Controversy has Led to Tragedy

Don't Spank- 

The Controversy has Led to Tragedy

Recent news reports bring to light the fact that 3 children have been killed by parents following the advice of a preacher in Tennessee whose book that calls for parents to use beating to discipline children has sold over 600,000 copies.

http://www.nytimes.com/2011/11/07/us/deaths-put-focus-on-pastors-advocacy-of-spanking.html

The preacher is Michael Pearl and he promotes a religiously informed conviction that an essential tool in teaching children rules and how to follow them is to beat them.  He goes so far as to call for children to be trained just as mules are trained, and his book recommends the type of instruments that are best to use when hitting your children.

Clearly, this call for hitting children is an extreme, but it taps into a controversy that all parents in America face- is spanking a good tool for teaching kids rules and encouraging them to do so?

To my mind, it is a controversy that is worth our attention about as much as arguing if the earth is flat.  This question has actually been measured and studied, and in every instance the studies find the same conclusion:

Spanking does not work.

What does that really mean?  The facts are dramatic:

• Kids who are spanked do not behave better than kids who are not.
• Kids who are spanked are not more likely to follow the rule the spanking was meant to teach
• Kids who are spanked are more likely to have trouble in their life than similar kids who are not spanked.  Spanked kids tend to be more likely:
• To be more violent
• To have more trouble having healthy relationships
• To hit their children

So, not only does spanking fail to teach kids to behave well, it also actually hurts children.

If a drug failed this miserably and hurt people this much it would be off the market very rapidly.

This makes the attraction of hitting kids in today's climate all the more striking, and yet hitting kids has become a politically sensitive subject with some constituencies taking on the use of spanking and corporal punishment as important actions to support for a variety of reasons.

This news story reminds us that it is important, from time to time, to look at the facts when it comes to how we teach our children.  There may be religious or philosophical concepts that promote the idea of hitting children, but the facts establish that it doesn't work and it causes harm.  The tragedies of these three families should bring that message home quite forcefully.

Bottom Line

Spanking is a nice word for hitting our kids.  

It turns out that hitting kids does not work, it does not help control behavior and it fails to teach kids rules.

Further, hitting kids can cause harm, at the time, and later in life.

We strongly urge all families to be careful not to hit their children.

Dr. Arthur Lavin

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*Disclaimer* The comments contained in this electronic source of information do not constitute and are not designed to imply that they constitute any form of individual medical advice. The information provided is purely for informational purposes only and not relevant to any person's particular medical condition or situation. If you have any medical concerns about yourself or your family please contact your physician immediately. In order to provide our patients the best uninfluenced information that science has to offer,we do not accept samples of drugs, advertising tchotchkes, money, food, or any item from outside vendors.

Screening for cholesterol and lipids in childhood

Screening for cholesterol and lipids in childhood

On November 13, 2011, three major medical societies announced new recommendations for screening children for elevated cholesterol levels.

Major medical societies are endorsing the concept of treating elevated cholesterol levels with powerful medications at younger and younger ages.

In this instance, the American Academy of Pediatrics, the American Heart Association, and the National Heart, Blood, and Lung Institute (part of the NIH), all are agreeing that drugs such as Lipitor should be used in children before puberty.

There are several reasons to agree with these recommendations, but one reason suggests the recommendations are flawed and should not be followed, yet.  What is missing is any evidence that treating high cholesterol at young ages leads to longer or better life later on.  

Does lowering cholesterol at age 10 help someone be healthier at age 50 than lowering cholesterol at age 20?

This is important, because if someone starts a drug like Lipitor at age 10, they will have daily exposure to that drug during the critical years of puberty, and, compared to starting such treatment at age 20, will have 10 extra years of drug exposure.

Elevated cholesterol has been an interest of mine for many years.  In the late 1980's, I practiced in Boston, and led a cholesterol screening clinic there.  I helped form the New England Pediatric Preventive Cardiology Network, which came to include such clinics at Harvard, Yale, Dartmouth, and Brown.  We eventually published our experiences in Boston.

http://www.ncbi.nlm.nih.gov/pubmed?term=lavin%20AND%20newburger

Why look at cholesterol in childhood?

I got interested in this issue because it is well known that the arteries begin to clog with fat deposits as early as 2 years of age.  So it made sense to stop the clogging before the arteries get clogged.  It still makes sense to do that.  The key question is what actually succeeds in keeping the vessels from clogging?

With that goal in mind, we drew lipid panels on every child whose family had a history of heart attack or bypass surgery prior to age 55-60 years old.  We were able to find close to 100 children, some as young as 2-3 years old, with quite elevated cholesterol levels, sometimes as high as 400!

So we had a purpose in mind, stop arteries from clogging early.  We had a way to find those at highest risk, those with a positive family history of early age heart attacks or clogging.  And, we did succeed in finding children with very seriously elevated cholesterol levels.

Why not look at cholesterol in children?

But then we found the problem.    Here we had several dozen young children with very high cholesterols in whose families many people had suffered serious heart attacks in young adulthood.  It was obvious this group could benefit from treatment, right?  Not so.

First we attempted to lower cholesterol by strict dietary control:  no cholesterol, very low fat, high fiber, in the diet.  Every family consulted with a skilled dietician, but even with extremely strict diets, we could not lower cholesterols more than 10%.  That meant a child with a cholesterol of 290 could not get below 260 with diet alone.

Then we tried a variety of relatively safe medications, like cholestyramine, that bind cholesterol but do little to interfere with the body's chemistry.  These drugs had little impact.

The only class of drugs left that would make a real difference were statins, like Lipitor.  But these drugs are very powerful, could have significant side effects.  It was not clear then that it would be safe to put a 3 year old on them for their entire childhood.  

When all was said and done, we had created a group of children whose families now knew their cholesterol was dangerously high, but but nothing to do to really help.

Thoughts on Effective Screening Programs

What I learned from this experience is that a good screening program really has to fulfill all steps of being useful to really be useful. Those steps are:

1. The condition being screened has to be important.  No sense in screening for how long your hair can grow, finding that out does not improve anyone's health.
2. The condition being screened for must have a treatment that makes a difference, and a treatment that is safe and available when the test comes back abnormal.  This is where our clinic in Boston ran into an obstacle.
3. The timing of treatment should make a difference in actual outcome.  It makes little sense to screen if treating the condition leads to the same outcome whether one treats early in the course or later in the course of the condition.

When it comes to cholesterol, only one of the three key criteria for a good screening program is present- a high cholesterol is an important problem.

But the safety of treating young children with a very powerful category of medications, statins, is simply not yet known.

And perhaps most worrisome, no one actually knows if treating someone for high cholesterol at age 10 will indeed lead to a better or healthier life than starting treatment at age 20.

For both these reasons, it seems like a bad idea to screen young children for cholesterol elevations much before puberty- we do not know if the key drugs used are safe at this age, and we do not know if someone is better off starting treatment at the earlier age.

Bottom Line

• A major recommendation came out Sunday, November 13, 2011- young children should be screened for high cholesterol and if found to be high enough, start the powerful drugs in the category of statins.
• Proof of safety of statins in young children is not established, so starting such a drug will commit a child to taking a potentially dangerous drug every day for many, many years, during development.
• Most importantly, because it is not known at all whether starting treatment for high cholesterol in childhood yields a healthier adulthood, we do not even know if any benefit comes from starting statins as such early ages.
• Therefore, Advanced Pediatrics is not recommending that young children be screened for high cholesterol or other lipid abnormalities.  Clearly if a specific child has a problem requiring a look at the lipid profile, such testing makes good sense, but not as a test required of all children.

Dr. Arthur Lavin

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*Disclaimer* The comments contained in this electronic source of information do not constitute and are not designed to imply that they constitute any form of individual medical advice. The information provided is purely for informational purposes only and not relevant to any person's particular medical condition or situation. If you have any medical concerns about yourself or your family please contact your physician immediately. In order to provide our patients the best uninfluenced information that science has to offer,we do not accept samples of drugs, advertising tchotchkes, money, food, or any item from outside vendors.

Good news on Urinary Tract Infections

Good news on Urinary Tract Infections:

UTI's in Childhood Cause no Harm to Adult Kidney Function

Over the last 50 years there has been a very disturbing idea put forward that urinary tract infections (UTI's) in children, given the right complications, could cause damage to kidneys that could cause kidney problems later in adult life.

This idea has fueled a great deal of worry and a lot of studies, the most uncomfortable of which is the VCUG, a test involving catheterization of the bladder.

The idea was based on the observation that children who have both a UTI and urinary reflux [this is when urine flows up to the bladder towards the kidneys, not just out of the bladder when one urinates] can develop scars in their kidneys, and that scars appear to be associated with the need for dialysis later in life.

The good news it that over the last year or so, important research has tested this idea, and found that it is not true.

Most recently, a very important study was reported in our lead journal, Pediatrics (128(5) Nov 2011, 840) where 1,576 cases of chronic renal disease in adults were reviewed.   In no instance could a clear connection to a UTI in childhood be linked to the cause of the adult chronic renal disease.  An accompanying editorial puts the matter very clearly:  "It's a Myth--UTI Does Not Cause Chronic Kidney Disease."

So now, we can safely say that a UTI is like most any other infection, worth treating to become more comfortable, but not an infection that puts one at risk later in life.

And, it means that the use of VCUG's in childhood is going to drop quite a bit, which is comforting news.

Bottom Line:

Urinary tract infections in children do not cause problems with kidney function later in life if the kidneys were normal to begin with.

UTI's should be diagnosed and treated to help your child feel better, not to prevent a danger.

If your child has UTI's that are severe or frequent enough to cause concern, a renal ultrasound is still a good idea to be sure the kidneys are normal, but the VCUG study will no longer be used routinely.

Dr. Arthur Lavin

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*Disclaimer* The comments contained in this electronic source of information do not constitute and are not designed to imply that they constitute any form of individual medical advice. The information provided is purely for informational purposes only and not relevant to any person's particular medical condition or situation. If you have any medical concerns about yourself or your family please contact your physician immediately. In order to provide our patients the best uninfluenced information that science has to offer,we do not accept samples of drugs, advertising tchotchkes, money, food, or any item from outside vendors.

Cough- When to Worry, What to Do

Cough- When to Worry, What to Do

Cough is one of the most agonizing experiences a healthy person can have.

More than runny nose or itchy eyes, a cough really causes a lot of suffering.

The sound is irritating, and coughing whenever you breathe is exhausting, robs you of sleep, and hurts.

Also, cough, more than most problems, can keep happening.  Some people can cough every day for months and months.  But even a few weeks of coughing is enough to create tremendous discomfort. 

And yet, cough is one of the most common experiences of humanity.  Everyone coughs at some time in their life.

Here we have a problem that everyone experiences, literally everyone, so how can a parent tell if there child's cough is different from what we all see come and go without any harm done.

So what is a cough, when is it a problem, what helps?

What is a Cough?

A cough is a sharp exhalation, really an explosion of air out of the chest.

Coughs occur always in response to an irritation in the airway, and typically an irritation somewhere in the throat, vocal cord area, and/or lungs.

There are only a small number of causes of the irritations that cause us to cough:

• Viral infection (tend to last no more than a few days or weeks)
• Bacterial infection (tend to make one rapidly ill with high fever and getting sicker every hour or day)
• Allergy (may go on with no change in intensity for months)
• Irritation (such as smoke)

So coughs can cause a great deal of suffering, and last for many weeks and months, but the number of types of causes of cough is actually fairly small.

When to Worry?

Most of us get worried about a cough if it sounds bad, lasts too long, or is bothersome.
One would think these are good signs to watch for, but it turns out that these clues tend not to help figure out if you are in trouble.

Keeping in mind that a cough almost always is a sign that the lining of the airway is inflamed, the key thing to worry about with a cough is if it indicates that the inflammation is serious enough to interfere with air coming in and out of the body.

Here is another way to think about this.   The air moves in and out of our body via a set of hollow tubes.  Every one of those tubes has a living lining.  That lining often gets inflamed, meaning it can get swollen, make lots of mucus, and get very tender.  If the lining of a tube gets swollen and makes mucus, the whole tube gets more narrow.  If the tube gets narrow enough, air does not pass in and out of the tube very well.

So, a cough is a clear sign that the tubes that carry air in the body are inflamed.  So now the key question becomes: how inflamed are the tubes?  Are they inflamed enough to interfere with air flow or not?  If so, then we have a serious problem, a potentially dangerous problem.  If not, then the cough is a sign of an inflammation that is harmless and will go away.

This leads us to the key signs that someone with a cough is of concern:

• Most Important:  Do you have any trouble breathing when not coughing?
• The best indicators of trouble breathing are:
• breathing rapidly
• tugging or working hard to get air in or out of the chest (not nose)
• skin on the chest tightening with each breath
• grunting with breaths
• if the child says they are having trouble getting air in and out of the chest

If none of these symptoms are present, and your child looks very comfortable breathing when not coughing, then the tubes carrying the air are likely not too swollen, and the inflammation is very likely mild and harmless.

If ANY of these symptoms are present, you should call for medical attention.

How to Get Rid of Cough?

The next question when it comes to cough is how to get rid of it.

That all depends on the cause:

• Bacterial infections are best treated with antibiotics, and antibiotics are only helpful for this cause.
• Allergic reactions are best treated with antihistamines and inhaled steroids
• Irritations are best treated by removing the irritation.
• Viral infections are incredibly resistant to all known drugs.  There are no drugs yet invented that can significantly reduce the inflammation caused by viruses.  This includes cough syrups.  No cough syrup has yet been shown to decrease the number of coughs one has per hour or days one coughs.   In fact, the FDA launched an investigation of over 500 cold remedies in March of 2011 with an eye towards exposing which  are frankly ineffective and/or fraudulent.

Bottom Line

• Cough means the airways are inflamed.
• The causes are usually one of four causes
• The best indicator that a cough is worrisome is how you are breathing when not coughing.
• The cough itself can be quite agonizing even if the underlying condition is harmless
• Coughs caused by viruses (colds, flus) cannot be stopped by any known medication, including cough syrups and antibiotics.
• If you think your child is having any trouble breathing, getting air in and out of their chest, call for medical help immediately

Dr. Arthur Lavin

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*Disclaimer* The comments contained in this electronic source of information do not constitute and are not designed to imply that they constitute any form of individual medical advice. The information provided is purely for informational purposes only and not relevant to any person's particular medical condition or situation. If you have any medical concerns about yourself or your family please contact your physician immediately. In order to provide our patients the best uninfluenced information that science has to offer,we do not accept samples of drugs, advertising tchotchkes, money, food, or any item from outside vendors.