Posts tagged “drugs”

The Ranbaxy Boondoggle

Cover-ups. A corporate culture not only lacking ethics but endorsing and encouraging amoral behavior. Unfettered greed. And excellent reporting by Katherine Eban at Fortune on Ranbaxy’s atrocious behavior. I remember not long ago reading about how much of a boon Ranbaxy could be for PEPFAR and for getting good medicines to those most in need.

Shameful behavior and a slow and unacceptable response from the US FDA. Kudos to the employees and auditors who brought the abuses to light.

The two men strolled into the hall to order tea from white-uniformed waiters. As they returned, Kumar said, “We are in big trouble,” and motioned for Thakur to be quiet. Back in his office, Kumar handed him a letter from the World Health Organization. It summarized the results of an inspection that WHO had done at Vimta Laboratories, an Indian company that Ranbaxy hired to administer clinical tests of its AIDS medicine. The inspection had focused on antiretroviral (ARV) drugs that Ranbaxy was selling to the South African government to save the lives of its AIDS-ravaged population.

As Thakur read, his jaw dropped. The WHO had uncovered what seemed to the two men to be astonishing fraud. The Vimta tests appeared to be fabricated. Test results from separate patients, which normally would have differed from one another, were identical, as if xeroxed.

Thakur listened intently. Kumar had not even gotten to the really bad news. On the plane back to India, his traveling companion, another Ranbaxy executive, confided that the problem was not limited to Vimta or to those ARV drugs.

“What do you mean?” asked Thakur, barely able to grasp what Kumar was saying.

The problem, said Kumar, went deeper. He directed Thakur to put aside his other responsibilities and go through the company’s portfolio — ultimately, every drug, every market, every production line — and uncover the truth about Ranbaxy’s testing practices and where the company’s liabilities lay.

Nature, Nurture, Medication, Arrogance

A pretty terrifying article from the NYT about prescriptions of psychotropics - regardless of ADHD diagnosis - in school age children. I couldn’t read the article in any light but one of utter disbelief; I’m not sure if that’s me imposing my bias on it or if its actual paints the practice as problematic.

Some excerpts below, but read the whole thing.

Although A.D.H.D is the diagnosis Dr. Anderson makes, he calls the disorder “made up” and “an excuse” to prescribe the pills to treat what he considers the children’s true ill — poor academic performance in inadequate schools.

“I don’t have a whole lot of choice,” said Dr. Anderson, a pediatrician for many poor families in Cherokee County, north of Atlanta. “We’ve decided as a society that it’s too expensive to modify the kid’s environment. So we have to modify the kid.”

The Drug Enforcement Administration classifies these medications as Schedule II Controlled Substances because they are particularly addictive. Long-term effects of extended use are not well understood, said many medical experts. Some of them worry that children can become dependent on the medication well into adulthood, long after any A.D.H.D. symptoms can dissipate.

According to guidelines published last year by the American Academy of Pediatrics, physicians should use one of several behavior rating scales, some of which feature dozens of categories, to make sure that a child not only fits criteria for A.D.H.D., but also has no related condition like dyslexia or oppositional defiant disorder, in which intense anger is directed toward authority figures. However, a 2010 study in the Journal of Attention Disorders suggested that at least 20 percent of doctors said they did not follow this protocol when making their A.D.H.D. diagnoses, with many of them following personal instinct.

You can argue either way about this — that helping struggling students perform is a good thing; that riddling younger kids with drugs that we know are addictive AND for which we don’t know the long-term side effects of is insane. I tend toward two seemingly sensical principles here — 1) the precautionary principle, something largely eschewed in this country and 2) finding better ways to engage students in school beyond medication. Medication is appropriate when the prescription is made with a valid medical diagnosis. In some of the cases described, however, the diagnosis is flimsy, the ethics questionable, and the end-result hardly what we want, as a society, for our youth. I can’t help but think there must be another way.

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