According To Pfizer, A Clinical Trial Is A 'Marketing Strategy'
from the our-regional-sales-rep-will-help-you-gather-your-data dept
Some more drug company ugliness has surfaced in a report published in the Archives of Internal Medicine. Examining documents uncovered during the Franklin v. Pfizer case, researchers came across details of a marketing ploy disguised as a Phase IV trial of gabapentin, a drug used for treatment of seizures and neurological pain:
"The Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS)" study was a so-called seeding trial, in which the stated objective was to assess the safety and efficacy of gabapentin, but the actual aim was to increase prescribing of the drug by duping the very physicians recruited to conduct the "trial," according to three medicolegal consultants involved in litigation against the drug's manufacturer.In addition(!) to the data tampering, exclusionary tactics, unethical recruitment practices and low-level bribery, the researchers also found that Parke-Davis' (a subsidiary of Pfizer) own internal documents referred to STEPS as "a marketing strategy" and that the trial's findings were secondary to "increasing market share in new prescriptions":
In the STEPS trial, Parke-Davis recruited 772 physicians to prescribe Neurontin (gabapentin) and titrate the dose upward in patients whose partial seizures were not completely controlled by other drugs. The drug company purposefully recruited "site investigators with little or no clinical trial experience [and] provided insufficient training," and limited enrollment to about four patients per investigator.
The study design was uncontrolled and unblinded, and its rigid titration protocol led to the exclusion of 87% of the study subjects. One institutional review board that twice rejected the STEPS application to be conducted at their medical center stated that "the entry criteria and outcome measures are too vague to allow any scientific conclusions to be reach[ed]." Parke-Davis sales representatives collected and recorded individual subject data. In a clear example of data tampering, they not only attended epilepsy patients' office visits (under the guise of "shadowing" the clinician), but also actively promoted the use of Neurontin and blocked the use of competing medications, particularly lamotrigine (Lamictal), at those visits. They also rewarded participating investigators with free lunches and dinners.
"Mr. Krumholz and his coauthors clearly demonstrate that the true intent of seeding trials is to introduce a new product and induce clinicians to use it," according to Dr. G. Caleb Alexander. As others have noted, "Deception is not just an incidental part of a seeding trial, but rather the very success of the trial depends on such deception, since few institutional review boards, investigators, clinicians, or patients would willfully participate in a study with marketing objectives and little or no scientific value," Dr. Alexander wrote in commentary accompanying the report.When contacted about its ethics breach (an understatement along the lines of the "Titanic's hull breach"), Pfizer spokesman Christopher Loder responded with a canned response that he quite possibly copied right off Neurontin's (gabapentin) promotional pamphlet:
"Neurontin is an important FDA-approved medicine that physicians have prescribed to treat millions of patients safely and effectively. Neurontin has been widely studied for more than 2 decades and there is an extensive body of publicly available literature on its safety and its use."True that, I suppose. But at this point you can add "as well as a growing body of publicly available literature on its unethical testing procedures and another in a long series of black eyes for the pharmaceutical industry" to the end of that little blurb any time you want, Chris. "Now" would be good.