1. Provide the title of your story or series and the names of the journalists involved.
Series of three related breaking news stories from BioPharmInsight.com/Pharmawire.com [a national/international wire service/website headquartered in New York]:
1. Pfizer receives FDA warning letter for repeated GCP concerns in clinical trials
2. K-Force said to be contractor involved in Pfizer trials prompting GCP warning letter
3. Pfizer's warning letter for pediatric Geodon trials could impact patent extension
2. List date(s) this work was published or aired.
1. 20 April 2010
2. 21 April 2013.
3.Published first on Pharmawire.com on 23 April 2010 and subsequently on our parent publication FT.com on 24 April 2010, [provided by Pharmawire.com]
3. Provide a brief synopsis of the story or stories, including any significant findings.
1. Kirsty first broke the news to the world that Pfizer, the world's largest pharmaceutical company, had been officially slapped down by the FDA for repeated failures in conducting some of its clinical trials according the required regulations over a number of years. The article reports that Pfizer had received a warning letter from the government agency that it had yet to disclose publically, and provided specific details of the cited violations, including the names of certain drugs and the fact that some of the experiment violations involved psychiatric medication for children.
2. The second story updates the situation to identify K-Force as the contractor, hired by Pfizer to provide staff to oversee the conduct of the clinical trials and ensure that they are being run according to standard. This vindicates an earlier story published by Kirsty in November 2009 after she first uncovered systemic problems in the conduct and monitoring of a large number of Pfizer's clinical trials that were utilising K-Force contractors, in addition to the failure of in-house Pfizer staff to keep a tight rein on the K-Force staff. It was reported based on high level sourcing that this inadequate clinical trial conduct could expose Pfizer to future regulatory issues, as proved true in the issuance of this FDA warning letter.
3. The third article follows up on the situation to present further key non-public details uncovered by Kirsty and puts the warning letter into a business/financial perspective for Pfizer, presenting a new and unique angle to bring the story forward beyond the newswire reports in terms of potential materiality and outcome, for this particular drug approval application as well as its approval applications for future new drugs. It is also the only story that puts the FDA's action into context in terms of the bigger picture for the industry, highlighting how the FDA are now taking GCP issues such as this very seriously. The story provides recent case examples of this (also first reported by Kirsty on Pharmawire) and demonstrates how this news service has been ahead of the game in its reporting on these business topics and has continually highlighted the potential for such regulatory issues to seriously impact the companies involved.
4. Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The "Pfizer series" was generated when Kirsty was working during a period from Pharmawire's headquarters in New York and she connected with a longstanding source who provided her with a series of confidential documentation that detailed the correspondence between Pfizer and the FDA in addition to the actual warning letter itself, that she obtained before its issuance was made public. Once the warning letter was made public, certain key details were blanked out preventing their release to the public although Kirsty's documentation had all details still intact, hence she had access to the whole picture.
5. Explain types of human sources used.
Kirsty interviewed a high level source close to the situation under the cover of anonymity, who was able to put the contents of the documents in her posession into perspective and clarify any outstanding questions to ensure the reporting of the situation was accurate. Kirsty also interviewed longstanding FDA regulatory sources known by her to be familar with the situation to provide additional clarity and context for the articles and cross check all the information she had obtained. To the best of her knowlege Kirsty ensured that her human sources had provided her with accurate information without bias.
6. Results (if any).
1. Within hours after Kirsty broke the first story it was picked up and had sparked coverage by all other major news services (according to a Google snapshot taken at the time there were nearly 400 news reports replicated on the subject).
2. When the second report linking K-Force to the warning letter first broke, it generated a high volume of interest amongst Pharmawire subscribers, many whom had noted the earlier prediction in Pharmawire reports that a situation of this nature could arise between Pfizer and K-Force. It is still being referred to as an example of high level business intelligence by K-Force rivals.
3. When this article was published on FT.com [provided by Pharmawire] Pfizer_s share price dropped USD 3bn with a 25% increase in trading within the hour. This is tangible evidence of the impact of the non-public details provided in the third, follow-up article and the forward looking angle focusing on the potential fallout for Pfizer. Since the publication of the _Pfizer series_ in April 2010, Pfizer is now acutely aware of our news service and has changed the way in which it responds to requests for comment from our organization. Pfizer now takes our requests very seriously and responds in a timely fashion with a comment that directly addresses the situation in question, in contrast to the past where often it would ignore our requests for comment.
7. Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
When Kirsty contacted Pfizer with the information she had obtained for each article to be published, Pfizer made some acknowledgements of the story contents being true as reflected in its right of reply and there were no challenges to accuracy.
8. Advice to other journalists planning a similar story or project.
Treat your sources with utmost respect _ prove to them you can be trusted to handle sensitive documents/information responsibly and report the situation in a way that reflects the contents of the documents accurately without jeopardizing the identity of your source. If you demonstrate integrity and build trust it is more likely that the source will continue to provide you with new information on the situation as it evolves and put you in a position to be on top of reporting fresh, insightful updates on the situation as I was able to do in the Pfizer series. Be persistent and continue to follow up on the situation until you have exhausted all possible material angles and take note of what the newswires have picked up on and pursue a different angle that provides a value-add for the reader, not just a regurgitation of the same facts. Do your homework – If you obtain confidential documents be sure to put them into perspective by fact checking and cross checking the details with experts rather than just taking them at face value and making your own assumptions about what they mean or what might happen. Always question whether your sources have any ulterior motivation for the information they provide you with. Race against the clock! In this case I knew that some of the information in the documents I had would soon be released to the public so I pulled out all the stops to make sure I released my stories prior to this and scooped the situation. Be sure to disclose to the company involved as many details possible about the information you have obtained and what you intend to publish so that the company has adequate opportunity to comment and can prepare itself accordingly for when the news breaks so that there can be no backlash from the company at a later date.