Generic Drugs Are Actually Not the Same as Name-Brands, Thanks to FDA Malfeasance

ProPublica / by Charles Seife, Bob Garver

The FDA failed to address compromised lab tests suggesting generic drugs are more similar to name-brands than they really are.

April 24, 2013  |  

 

 

 

 

Andrew Richards remembers that he had just sat down in front of the TV when the lightning bolt struck. “It was almost like it went through my ear because I could hear it. It was kind of like, ‘fwomp,’ right through my head,” he says.

Stunned and disoriented, Richards tried to get up, he says, but spasms rumbled through his torso and his back; his muscles kept clenching and relaxing. He doesn’t recall falling. “It was almost like a little piece of time was missing, almost like a record skipped ahead a little bit,” he says, “like I was sitting on my couch and time had moved forward and I was on the floor.”

The next thing Richards remembers was calling out to his wife, who scooped him up and drove him to the emergency room. He would soon discover that the lightning bolt that struck him down was an electrical storm taking place entirely in his brain: a seizure. Less than a year later he was in court, contending that his seizure — and the spasms that he says still plague him — were caused by a faulty generic medication.

Generic medications are generally safe and effective, because the Food and Drug Administration mandates tests to show that they are equivalent to the name-brand originals. But in 2011, the Food and Drug Administration determined that a major laboratory had committed such “egregious” research violations that years’ worth of its tests — many comparing generics to name-brand drugs — were potentially worthless. The FDA has required drug manufacturers to redo many of the tests from that lab, owned by the now-defunct Cetero Research. But a  ProPublica investigation shows that the agency took little action to prevent consumers from taking medicines the FDA no longer knew for sure were safe or effective.

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Finger nail creatinine and its role in confirming chronicity of renal failure

SJ Jessy¹, RK Visweswaran², B Sulekha^3
1 Department of Biochemistry, Government Medical College, Trivandrum, Kerala, India
² Department of Nephrology, Ananthapuri Hospitals and Research Institute, Trivandrum, Kerala, India
³ Department of Biochemistry, SUT Academy of Medical Sciences, Trivandrum, Kerala, India

Indian Journal of Nephrology http://www.indianjnephrol.org/article.asp?issn=0971-4065;year=2013;volume=23;issue=2;spage=114;epage=118;aulast=Jessy

Abstract

It is often difficult to differentiate acute renal failure (ARF) from chronic renal failure (CRF) when the patient presents with advanced uremia for the first time. Assessments of kidney size, history of nocturia, and pallor are used as indirect indicators of CRF. Some investigators have proposed an estimation of finger nail creatinine concentrations to differentiate between ARF and CRF, as patients with CRF have higher nail creatinine concentrations. Measurement of creatinine in the nail can be performed easily in a biochemistry laboratory. The nail clippings are cleaned, dried, pulverized and creatinine extracted from the powdered nail to be assessed biochemically. By standardizing the methods, the biochemistry laboratory can provide the results within 48 hours. In this study, we analyzed the nail clippings of 49 normal subjects, 50 cases of known acute kidney injury (AKI), and 50 cases of known CRF on follow-up at the Nephrology Clinic, Medical College, Trivandrum between December 1999 to November 2000. Forty-nine normal individuals were selected from healthy bystanders of respective patients. On study, it was revealed that patients with ARF had a mean fingernail creatinine level of 30.9 mg/100 g of nail as against 30.1 mg/100 g of nail in normal controls. There was no difference between the controls and ARF patients.Patients with known CRF had a mean fingernail creatinine level of 69.2 mg/100 g. There was a significant increase in the level of nail creatinine in patients with known CRF versus ARF patients and normal controls. The measurement of nail creatinine is useful, easy and can be standardized and performed in a biochemistry laboratory. This simple investigation can help in solving the question of ARF versus CRF in a given case. From this study, it is concluded that the result of creatinine concentrations of nail clippings can indicate chronicity of renal failure.

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