Fire Alarm Companies

It seems like only yesterday (but it wasn't -- it was actually June 28th) that we were discussing the pharmaceutical industry and its general abuse of numbers to keep itself afloat. (In a pool full of money.)

Some more drug company ugliness has surfaced in a report published in the Archives of Internal Medicine . To examine documents, uncovered during the Franklin v. Pfizer Case, researchers came in detail a marketing ploy as a phase IV study with gabapentin, a drug for treatment of seizures and neurological pain disguised:

"The study of Neurontin: titrate to effect profiles of Safety (STEPS)" study was a so-called seeding trial in which the stated goal was to assess the safety and efficacy of gabapentin, but the real goal was to increase the prescription drug by duping highly recruited physicians to the \ behavior "trial" after three medicolegal consultant involved in litigation against the drug 's manufacturer.

The STEPS study recruited 772 doctors Parke-Davis prescribe Neurontin (gabapentin) and titrate the dose upward in patients whose partial seizures were completely controlled by other drugs. The pharmaceutical company specifically recruited "site investigators with little or no experience from clinical studies [and] provided insufficient training," and the registration is limited to the approximately four patients per investigator.

The study design was uncontrolled and not blinded, and their rigid titration protocol led to the exclusion of 87% of study participants. Be an Institutional Review Board, which declared twice rejected STEPS application to their medical center that \ Parke-Davis collected the field, "the entry criteria and outcome measures are too vague, in order to reach a scientific conclusion to be [ed]. \ Are" performed recorded and individual subject data. In a clear example of data manipulation, not only epilepsy patients, some 'doctor visits (under the guise of "shadow" the doctor), but also actively promoted the use of Neurontin and blocks the use of competing drugs, in particular, lamotrigine (Lamictal ), in these visits. In addition, investigators involved rewarded with free lunches and dinners.

Beyond (!), Around the manipulation of data, exclusionary tactics, unethical recruitment practices and low-level bribery, the researchers also found that Parke-Davis '(a subsidiary of Pfizer) own internal documents STEPS as "a marketing strategy called "and that the study 's findings were secondary to" increase in market share in new prescriptions':

"Mr. Krumholz and his co-authors clearly show that present the true intention of planting a new product studies and induce clinicians to use it is," said Dr. G. Caleb Alexander. As others have noted, is "Deception is not only an incidental part of a seeding study, but the success of the study will depend on such deception, there were few institutional review boards, researchers, clinicians or patients to participate intentionally, in a study of marketing objectives and little or no scientific value, wrote, "Dr. Alexander in comments to the report.

If his ethics violation (an understatement along the lines of "Titanic \ contacted 's hull breach"), Pfizer spokesman Christopher Loder responded with a can reply that he might right Neurontin \ off copied' s (gabapentin) advertising Brochure:

"Neurontin is an important FDA-approved drug that doctors prescribed to treat millions of patients safely and effectively. Neurontin was often studied for more than two decades and there is a large body of publicly available literature on its safety and its use. "

True that, I think. But at this point you can add "and a growing number of published literature about their unethical testing procedures and another in a long line of black eyes for the pharmaceutical industry 'at the end of this little blurb whenever you want, Chris. "Now" would be good.

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