Showing posts with label Drug Safety. Show all posts
Showing posts with label Drug Safety. Show all posts

Tuesday, October 9, 2012

It's Official: Doctors Prescribe Adderall to Help Kids Get Higher Grades at School

Dr. Michael Anderson, a pediatrician for many poor families in Cherokee County, north of Atlanta, routinely prescribes Adderall to kids who get poor grades in school. To do that, he first must commit fraud: submit a false diagnosis of attention deficit/hyperactivity disorder (ADHD) to Medicaid and/or private insurer.

The doctor admitted his fraudulent activity in a story published in today's New York Times (here). “I don’t have a whole lot of choice,” said Dr. Anderson. “We’ve decided as a society that it’s too expensive to modify the kid’s environment. So we have to modify the kid.”

He does this believing in his heart of hearts that ADHD is “made up.” His excuse? To prescribe the pills to treat what he considers the children’s true ill — poor academic performance in inadequate schools.
Dr. Anderson’s instinct, he said, is that of a “social justice thinker” who is “evening the scales a little bit.” He said that the children he sees with academic problems are essentially “mismatched with their environment” — square pegs chafing the round holes of public education. Because their families can rarely afford behavior-based therapies like tutoring and family counseling, he said, medication becomes the most reliable and pragmatic way to redirect the student toward success.
This is wrong on so many levels. For one thing, who made Dr. Anderson and other physicians who feel the same way judge and jury regarding what school is "adequate" or "inadequate"?

That, of course is not the main problem, which is prescribing a dangerous, additive drug to children who have no real medical need. This is clearly a case where a drug's benefit does not justify the risks that the patients are subject to. "Reported side effects of the drugs have included growth suppression, increased blood pressure and, in rare cases, psychotic episodes," says the NY Times.

Not mentioned by the Times is the dangers of addiction. ABC News recently ran a story documenting this problem: Dangers of Adderall Addiction Among Moms (see here or view the embedded video below).



If moms can become addicted to Adderall, their children can also become addicted. When they can no longer get Adderall, they will try other drugs easily available from physicians or on the street (see, for example,

This is so egregious that I must ask if Dr. Anderson has received payments from Shire Pharmaceuticals, which sells Adderall XR (the extended release version of Adderall, which Shire sold to Teva Pharmaceuticals). Unfortunately, Shire does not publicly disclose such payments. According to its compliance Web site (here), Shire only reports spending on HCPs (healthcare providers) to a "limited number of states as required by the individual state laws."

Related posts:

Thursday, September 6, 2012

FDA Caught Speeding. Puts Public Safety at Risk.

"An FDA effort to speed approval of new medicines allowed drugs for stroke prevention, cancer and multiple sclerosis onto the market without proper safety analysis, according to two drug-safety experts," reports the Wall Street Journal in a review (here) of a "viewpoint" recently published in JAMA.

Peter Pitts of Drug Wonks says: "As usual, Janet Woodcock [Director of the Center for Drug Evaluation and Research at FDA] places the matter in the appropriate perspective. 'I'd like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,' Dr. Woodcock said. "The cancer community in particular says we haven't used accelerated approvals enough.'" Pitts adds this zinger:

"Here’s the truth -- there is no such thing as a 'safe' drug. It's the patient who must understand the risks required to achieve the benefit. That’s why the patient voice must be heard during all phases of the regulatory review process."

Unfortunately, I don't think Pitts actually read the piece in JAMA. The drug safety expert authors of that piece (Thomas J. Moore and Curt D. Furberg) did not claim that drugs approved by the FDA should be "safe." They made the argument that accelerated approval by FDA of several powerful drugs with UNKNOWN safety issues were no better at improving outcomes than drugs currently on the market whose safety issues are well-known.

"Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal," said Moore and Furberg, "the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered."

The authors cite several specific drugs that were fast-tracked for approval without adequate safety information available. I'd like to focus on one: Dabigatran for prevention of stroke. Dabigatran is marketed as Pradaxa by Boehringer Ingelheim (BI).

According to Moore and Furberg, Pradaxa benefited from "3 different FDA policies promoting innovation. This drug received both Fast Track and Priority Reviews and was studied in a single large phase 3 trial rather than in at least 2 pivotal trials, as normally required...Within less than a year of approval, 1 survey showed that dabigatran accounted for more serious adverse drug events reported to the FDA during the second quarter of 2011 than any other regularly monitored drug. Risk of hemorrhage was prominent in older patients (median age, 80 years), a subgroup for whom declining kidney function or other factors may have increased bleeding risk. Both a manufacturer package insert revision and the European Medicines Agency have called for closer monitoring of kidney function, a needed step because even moderate kidney impairment increases dabigatran levels more than 2-fold. In addition, unlike warfarin, no antidote is available for use in bleeding emergencies related to dabigatran. Evidence was beginning to emerge that dabigatran-related bleeding— whether from trauma or as an adverse effect—may be more difficult to treat than warfarin-related bleeding."

Couple this safety issue with the promotion of Pradaxa in the media as a "super pill" and a "revolutionary drug" (see "Bad Journalism or Bad Pharma?") and you end up with a real public safety issue that patients should be concerned about. BI itself stoked this Pradaxa-mania (read, for example, "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons" and "Full BOEHR(inger) Social Media Reporting of RELY Trial Results").

Sadly, Woodcock may have heard from "patient advocates" paid by pharma companies to testify before the FDA, but who advocates for the patients harmed by drugs like Pradaxa? Their stories are locked in the FDA's adverse event database, which is not generally cited during drug approval Hearings at the FDA.

Not to mention the impact of DTC advertising on the public's willingness to accept greater risk: