SCIENTIFIC AMERICAN ONLINE
Comment on this article at ScientificAmerican.com/sep2012

This article was originally published with the title Safer Drugs for Kids.

8 Comments

1. 1. SteveCurry 02:40 PM 8/16/12

   I once heard a somewhat less charitable explanation for the lack of drug safety and effectiveness testing in children. It is hearsay and it may not be true. I would be interested if anyone can confirm or deny it. I heard that the six month extension of patent rights beyond the normal termination date is available for drug companies that need the time to complete safety and effectiveness testing in children. Consequently, it would be to the company's financial advantage to postpone that testing until the patent is about to run out in order to qualify for the extension. This would be a powerful motivation for a drug company to *delay* testing in children for as long as possible.

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2. 2. CalifBillR 01:56 PM 8/17/12

   This article contradicts a later article about 'Can We Keep Getting Smarter'. In fact, it suggests we are getting dumber. In only one place does this article actually mention in passing the real problem: "...in part because of the difficulty of finding enough patients to enroll in them". Do the authors actually imagine that any parent would willingly enroll their child/baby in an experimental drug program??? In the latest legislation requiring pediatric studies for certain drugs (for children), the FDA Safety and Innovation Act, exactly how are they going to force parents to allow drugs to be tested on their children? Will they fine them $2000/year if they don't comply as per the current government medical insurance plan? The comment above from SteveCurry shows how well the public has been trained to give a knee-jerk response to these issues - it's always the drug companies greed. In fact, I'm sure most drug companies would willingly test the drugs on children given the parents permission. Would SteveCurry or the authors of this article allow their children to be used in these trials? I highly doubt it. It is clear that information is needed in dosing children but this kind of nonsense reporting doesn't address the problem. I would very much like to hear from the authors how they plan to have children enrolled in these studies!!

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3. 3. voxfuror 03:52 PM 9/14/12

   It is always illegal to prescribe any medication for off-label use under Medicaid funded service delivery but that has certainly stopped very few doctors or organizations from doing so. Until there is a much higher level of accountability and culpability for these crimes against citizens there is little incentive to stop them and much to gain from these practices.

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4. 4. Charlie Taylor PhD in reply to SteveCurry 06:49 PM 9/14/12

   The truth is that drug trials are not safe in the early stages, and it is generally thought that conducting all the early safety and also efficacy/safety trials is more ethical in adults who can give informed consent than in children.
   
   There are no "evil thoughts" from the drug companies to delay testing in children...it's just that they don't want to expose kids to experimental medicines before they know they are relatively safe in adults. In some cases, it may not be ethical to do trials in kids, and specialized pediatricians have been doing great medicine for dozens of years using meds that were never approved for children.

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5. 5. kaebomb 12:00 PM 9/19/12

   I'm the parent of a 10-year-old child who was prescribed Ritalin. More than one doctor told him that his reported side effects were "all in his head" because they weren't on the list of side effects. When he stopped taking it however, his "imaginary" side effects went away. The carelessness in the medical field extends way beyond the drug companies...

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6. 6. tmorr01 in reply to voxfuror 10:19 PM 10/13/12

   It is not illegal to prescibe drugs for off label use under Medicaid guidelines. Medicaid does not presume to dictate medical care. It may be illegal to try to collect reimbursement for off label treatment. However, without reimbursement, where is the incentive for all these "gains". Actually, the incentive is successfully treating a patient with a drug that has a positive effect. An illegal act under Medicaid guidelines and a criminal act against the public are two different issues and are covered under different bodies of law.

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7. 7. tmorr01 in reply to kaebomb 10:27 PM 10/13/12

   If you had volunteered your son for the clinical trials for Ritalin, his "side effects" would have been included on the list. Would you have been willing to do so? Herein lies the major defect, as mentioned above, of the whole idea of clinical trials in children.

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8. 8. Generalwutangcharleschang 08:57 PM 3/1/13

   I'm flabbergasted by the innocuous attitude of pharmaceutical companies who should be doing more to improve safe drugs for kids, and human beings in general rather than screwing America's young-ins with doctored excuses. I understand from a research lab p.o.v. that there are certain "unique" challenges when conducting pediatric trials, re: complexity and cost, adding on the plausible disadvantage or "difficulty of finding enough patients to enroll...". However, we are talking about a gazillion-ba-billion-ten X a million and forty million pennies-industry (here). Spend the money on improving and making safer pediatric drugs; stop using economic justifications to overshadow morally reprehensible attitudes toward the priority level status of children. So what is the plan? We screw up them up before they even hit the ground as fully functioning human adults then we prescribe more shoddy, crappy, 1,000+1 side-effected drugs to keep the money wheel rolling. Orwellian epic here.

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