"Illegal Promotion of Neurontin"

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HREF="id59.htm" TARGET="_top" TITLE="RSD Hope Quilt Information"><U><B>PROJECT</B></U></A><FONT SIZE="3" COLOR="#FFFFCC" FACE="Burlesque" >.</FONT></div> <div>  </div> <bR> <bR> <bR> </td> <td valign="top" BGCOLOR="#000000" TEXT="#F7F7FF"> <bR> <div> <B><U>"Illegal Promotion of Neurontin"</U></B></div> <bR> <div> <B>Neurontin</B></div> <div> <B>Update on the Illegal Promotion of Gabapentin (NEURONTIN)</B></div> <div> <B>Return to Top</B></div> <bR> <div> <B>In the May 2002 issue of Worst Pills, Best Pills News, we wrote about</B></div> <div> <B>Neurontin, a drug approved by the Food and Drug Administration (FDA) for</B></div> <div> <B>treating seizures, a somewhat limited potential market, that was illegally</B></div> <div> <B>transformed into a “blockbuster” drug with sales approaching $1.5 billion in</B></div> <div> <B>2001. The metamorphosis was accomplished by fabricating a number of uses for the</B></div> <div> <B>drug that are not FDA approved. These included bipolar disorder, attention</B></div> <div> <B>deficient disorder, and migraine. The use of a drug that is not approved by the</B></div> <div> <B>FDA is referred to as an “off-label” use.</B></div> <bR> <div> <B>The May article was based on New York Times reporting and documents from</B></div> <div> <B>the U. S. District Court for the District of Massachusetts. This court recently</B></div> <div> <B>released new documents that for the first time gave the public an inside picture</B></div> <div> <B>of the lengths to which a pharmaceutical company will go to sell a drug even</B></div> <div> <B>when there is no evidence that it is safe or effective for the uses being</B></div> <div> <B>promoted.</B></div> <bR> <div> <B>This article is based on allegations made in recently released court</B></div> <div> <B>documents.</B></div> <bR> <div> <B>Neurontin was originally produced by Parke-Davis, which was acquired by</B></div> <div> <B>Pfizer, Inc, of New York in 2000. The only FDA approved use for Neurontin at</B></div> <div> <B>that time was as an add-on treatment for epilepsy. This is a very limited market</B></div> <div> <B>with little upward potential for sales. The new court documents allege that</B></div> <div> <B>Parke-Davis knew that pain management, psychiatric disorders, anxiety and</B></div> <div> <B>depression were immense markets which, if tapped, could yield enormous profits</B></div> <div> <B>from sales of Neurontin</B></div> <bR> <div> <B>The Decision to Promote Gabapentin for Unapproved Uses</B></div> <bR> <div> <B>Documents revealed that after an extensive economic analysis, senior</B></div> <div> <B>officials at Parke-Davis determined that it was not sufficiently profitable for</B></div> <div> <B>Parke-Davis to obtain FDA approval for Neurontin's alternative uses mentioned</B></div> <div> <B>above by doing the types of studies necessary for approval. Instead, company</B></div> <div> <B>officials developed a strategy that would allow Parke-Davis to avoid the costs</B></div> <div> <B>of proving Neurontin’s safety and effectiveness for these other uses, while</B></div> <div> <B>allowing the company to enter the lucrative off-label markets.</B></div> <bR> <div> <B>Taking advantage of a loophole in the FDA’s off-label marketing rules,</B></div> <div> <B>Parke-Davis decided to employ a “publication strategy” that would allow it to</B></div> <div> <B>promote Neurontin by the massive distribution of publications supposedly written</B></div> <div> <B>by independent researchers who purportedly described the scientific evaluation</B></div> <div> <B>of Neurontin. Another advantage of this strategy, from the company’s</B></div> <div> <B>perspective, was that it could be done immediately. There was no need to wait</B></div> <div> <B>for the results of scientifically conducted clinical trials to determine if</B></div> <div> <B>Neurontin was actually effective in the treatment of these conditions and submit</B></div> <div> <B>them to the FDA for approval.</B></div> <bR> <div> <B>Payment to Doctors to Increase Gabapentin Prescriptions</B></div> <bR> <div> <B>The company’s “publication strategy” required doctors to perform the work</B></div> <div> <B>normally performed by the company’s sales force in order to promote Neurontin.</B></div> <div> <B>This necessitated that Parke-Davis make tens of thousands of payments to the</B></div> <div> <B>doctors who would act as a surrogate sales force as well as to the practicing</B></div> <div> <B>physicians who would receive the message. In other words, adoption of the</B></div> <div> <B>“publication strategy” required the company to pay physicians to either</B></div> <div> <B>recommend the prescription of Neurontin or to order Neurontin, in violation of</B></div> <div> <B>the federal anti-kickback regulations, according to the newly released court</B></div> <div> <B>documents.</B></div> <bR> <div> <B>A description of the various programs Parke-Davis used to make these</B></div> <div> <B>payments to physicians follows.</B></div> <bR> <div> <B>Consultants’ Meetings</B></div> <div> <B>A common trick used by Parke-Davis to funnel illegal payments to doctors</B></div> <div> <B>to encourage them to prescribe Neurontin off-label was through “consultants’”</B></div> <div> <B>meetings. Under this front, Parke-Davis invited doctors to dinners or</B></div> <div> <B>conferences and paid them to hear presentations about off-label uses of the</B></div> <div> <B>drug. Under the guise that these doctors were acting as consultants, Parke-Davis</B></div> <div> <B>sometimes, but not always, had the doctors sign bogus consulting agreements. At</B></div> <div> <B>these meetings, the company would give these doctors lengthy presentations</B></div> <div> <B>relating to Neurontin, particularly regarding off-label usage. Presentations</B></div> <div> <B>would be made by Parke-Davis employees or physician speakers hired by the</B></div> <div> <B>company for the purpose of promoting Neurontin, and questions relating to the</B></div> <div> <B>use of Neurontin would be solicited and answered. At some conferences, the</B></div> <div> <B>sponsoring organization or Parke-Davis intentionally posed questions to the</B></div> <div> <B>speakers about off-label use to insure that the doctors were exposed to such</B></div> <div> <B>information.</B></div> <bR> <div> <B>Parke-Davis would routinely analyze whether the consultants’ meetings were</B></div> <div> <B>successful in getting doctors to change their prescription writing practices. At</B></div> <div> <B>some meetings, the so-called consultants were asked directly if they would write</B></div> <div> <B>more Neurontin prescriptions as a result of the meeting. This question would</B></div> <div> <B>have been irrelevant if the actual purpose of the meeting was to receive the</B></div> <div> <B>consultants’ advice. Parke-Davis also routinely tracked consultants’ Neurontin</B></div> <div> <B>prescription writing practices after these meetings. Parke-Davis actually</B></div> <div> <B>analyzed whether the doctors they had paid had in fact written more Neurontin</B></div> <div> <B>prescriptions after the meeting, using market data purchased from third parties.</B></div> <bR> <div> <B>Medical Education Seminars</B></div> <div> <B>The court documents revealed another platform used by the company to pay</B></div> <div> <B>kickbacks to doctors to hear off-label promotion of Neurontin. These were</B></div> <div> <B>programs billed as Continuing Medical Education (CME) seminars. These</B></div> <div> <B>conferences and seminars were set up to appear to qualify for an exception to</B></div> <div> <B>the FDA’s off-label marketing restrictions which permits doctors to learn about</B></div> <div> <B>off-label uses of drugs at independent seminars. Such seminars, however, must be</B></div> <div> <B>truly independent of the drug companies. The companies may make “unrestricted</B></div> <div> <B>grants” for the purpose of a seminar, but may not be involved in formulating the</B></div> <div> <B>content of the presentations, picking the speakers or selecting who attends the</B></div> <div> <B>seminars. Parke-Davis retained third party companies to present seminars while</B></div> <div> <B>in fact retaining control of virtually every aspect of these events. The seminar</B></div> <div> <B>companies obtained Parke-Davis’ approval for all content presented at the</B></div> <div> <B>seminars. Parke-Davis also paid all expenses, including all the seminar</B></div> <div> <B>companies’ fees.</B></div> <bR> <div> <B>The company designed and approved the seminars, hand-picked the speakers,</B></div> <div> <B>approved the seminar presentations, previewed (in most cases) the contents of</B></div> <div> <B>the seminars prior to a presentation, selected the attendees based on their</B></div> <div> <B>ability and willingness to prescribe high quantities of Neurontin, evaluated the</B></div> <div> <B>presentations to make sure Parke-Davis’ “message” was appropriately</B></div> <div> <B>delivered, black-listed presenters whose presentations were not</B></div> <div> <B>sufficiently pro-Neurontin, and monitored the prescribing patterns of the</B></div> <div> <B>physicians who attended.</B></div> <bR> <div> <B>Grants and Studies</B></div> <div> <B>Parke-Davis also made outright payments, in the form of grants, to reward</B></div> <div> <B>demonstrated Neurontin advocates. Company sales managers identified key doctors</B></div> <div> <B>who actively prescribed Neurontin or programs which were willing to host</B></div> <div> <B>Neurontin speakers and encouraged such persons or programs to obtain</B></div> <div> <B>“educational grants” from the company. Parke-Davis’ sales people informed</B></div> <div> <B>leading Neurontin subscribers that significant advocacy for Neurontin would</B></div> <div> <B>result in the payment of large grants. These studies did not involve significant</B></div> <div> <B>work for the physicians. Often they required little more than collating and</B></div> <div> <B>writing up office notes or records. Parke-Davis frequently hired technical</B></div> <div> <B>writers to write the articles for which the “authors” had been given grants.</B></div> <bR> <div> <B>Payments to “Authors” of Ghost-Written Articles</B></div> <div> <B>Another method of paying off doctors for backing Neurontin was to pay</B></div> <div> <B>honoraria for the use of their names on scientific articles intended for</B></div> <div> <B>publication in various neurology and psychiatry journals, but actually</B></div> <div> <B>ghost-written by technical writers hired by Parke-Davis, which retained control</B></div> <div> <B>of all such articles. In 1996 Parke-Davis paid for at least 20 such articles,</B></div> <div> <B>most of which dealt with off-label use of Neurontin, and were placed according</B></div> <div> <B>to the company’s “publication strategy.” Naturally, Parke-Davis paid all</B></div> <div> <B>expenses in connection with these articles.</B></div> <bR> <div> <B>Once Parke-Davis and the technical writers conceived the articles, the</B></div> <div> <B>company and its outside firms attempted to find recognized Neurontin prescribers</B></div> <div> <B>whose names could be used as the authors of these articles. In some cases,</B></div> <div> <B>drafts of the articles were completed even before an “author” agreed to place</B></div> <div> <B>his or her name on the article. This even occurred in connection with case</B></div> <div> <B>histories that purported to describe the “author’s” personal treatment of actual</B></div> <div> <B>patients. The “authors” were paid an honorarium of $1,000 to lend their names to</B></div> <div> <B>these articles, and also were able to claim publication credit on their</B></div> <div> <B>professional resumes.</B></div> <bR> <div> <B>Speakers’ Bureau</B></div> <div> <B>Parke-Davis also formed a Speakers’ Bureau, another tactic to make large</B></div> <div> <B>and numerous payments to doctors who recommended Neurontin at teleconferences,</B></div> <div> <B>dinner meetings, consultants meetings, educational seminars, and other events.</B></div> <div> <B>These speakers repeatedly gave short presentations relating to Neurontin for</B></div> <div> <B>which they were paid anywhere from $250 to $3,000. Some speakers received tens</B></div> <div> <B>of thousands of dollars annually in exchange for recommending to fellow</B></div> <div> <B>physicians that Neurontin be prescribed, particularly for off-label uses.</B></div> <div> <B>Speakers who most zealously advocated Neurontin were hired most frequently for</B></div> <div> <B>speaking events, regardless of the fact that many of these events were billed as</B></div> <div> <B>independent medical education seminars where objective information was supposed</B></div> <div> <B>to be delivered.</B></div> <bR> <div> <B>Circumstantial and some direct evidence over the years suggests that the</B></div> <div> <B>behavior of Parke-Davis in the off-label promotion of Neurontin is not isolated,</B></div> <div> <B>but rather an integral part of the pharmaceutical industry’s marketing</B></div> <div> <B>practices. However, in the Health Research Group’s experience, the Neurontin</B></div> <div> <B>episode is the most complete and well documented case of off-label promotion to</B></div> <div> <B>ever come into public view. Because of the detail of fabrications, pay-offs,</B></div> <div> <B>manipulation, and their effect on Neurontin sales some widely held myths have</B></div> <div> <B>been shattered.</B></div> <bR> <div> <B>First, and perhaps the most important to the health and safety of</B></div> <div> <B>patients, is the belief that doctors are not fooled or influenced by drug</B></div> <div> <B>company promotional ploys such as gifts to attend medical meetings or expensive</B></div> <div> <B>meals. The evidence presented in the court documents unambiguously shows that</B></div> <div> <B>such schemes work. Congress recognized 40 years ago that a large proportion of</B></div> <div> <B>physicians in everyday practice have neither the training nor the background to</B></div> <div> <B>differentiate between a useful drug and a harmful one. This is why Congress</B></div> <div> <B>created a process by which the FDA approves drugs based on validated science—to</B></div> <div> <B>protect patients from worthless or dangerous drugs. But this says nothing about</B></div> <div> <B>the apparently substantial number of doctors who accepted kickbacks or bribes to</B></div> <div> <B>prescribe Neurontin for uses that had not been proven. The memorable words of</B></div> <div> <B>the inspector in the movie Casablanca—”I am shocked—shocked!” come to mind.</B></div> <bR> <div> <B>Second, the sacrosanct position of peer reviewed medical literature as a</B></div> <div> <B>vehicle for scientific exchange has been seriously damaged. The manipulation of</B></div> <div> <B>information about Neurontin that Parke-Davis exercised would astonish George</B></div> <div> <B>Orwell. In defense of the many physicians who try their best for patients by</B></div> <div> <B>diligently keeping up with the medical literature, there is no way for a doctor,</B></div> <div> <B>scientist, or medical journal editor to know if a study is a fabrication.</B></div> <bR> <div> <B>There are major differences between the way the FDA reviews clinical</B></div> <div> <B>trials as part of the new drug approval process and the process used by a peer</B></div> <div> <B>reviewed medical journal to accept a study for publication. The FDA bases its</B></div> <div> <B>drug approval decisions on its own review of the actual data submitted by a</B></div> <div> <B>manufacturer, not on published journal articles. The agency has a staff of</B></div> <div> <B>highly trained statisticians who do their own analyses of the manufacturer’s</B></div> <div> <B>data, thus ensuring that approval decisions are based on valid data. Also, the</B></div> <div> <B>agency has authority to inspect clinical sites in order to keep investigators</B></div> <div> <B>honest.</B></div> <bR> <div> <B>On the other hand, the editor of a peer reviewed medical journal must</B></div> <div> <B>accept the veracity of a study submitted for publication. The editor will send</B></div> <div> <B>the study to several peer reviewers for their recommendations, but these people</B></div> <div> <B>have other things to do, and may spend only a few hours on their review. Peer</B></div> <div> <B>reviewers also must accept the veracity of the underlying data presented in the</B></div> <div> <B>study. The journal editor has neither the authority nor the resources to inspect</B></div> <div> <B>clinical sites. This is a system that can be “gamed,” as documented in the court</B></div> <div> <B>papers about Parke-Davis’ Neurontin publication strategy.</B></div> <bR> <div> <B>The message for patients is that if you have been prescribed a drug for an</B></div> <div> <B>off-label use, the evidence supporting such a use may be good or it may be</B></div> <div> <B>fabricated. The doctor prescribing the drug may have based the decision to use</B></div> <div> <B>the drug on an expensive dinner, received a kickback or was bribed, or was</B></div> <div> <B>simply fooled by a fabricated medical journal article.</B></div> <bR> <div> <B>What You Can Do</B></div> <bR> <div> <B>If you or a family member receive Neurontin for a use not listed in the</B></div> <div> <B>FDA approved professional product labeling, discuss with your doctor the</B></div> <div> <B>continued need for taking Neurontin.</B></div> <bR> </td> </tr></table></body>