Is Bluebird Preventing Patients from Speaking Publicly? No.

There have been some concerns and rumors that Bluebird has a "gag order" on patients going through trials. This is not the case, as we can see from the FAQ section of the Northstar study.
http://northstarstudy.com/commonquestions.html

Q.
Can I tell people I am participating in this study?

A.
That is completely up to you. We encourage you to discuss the specifics of this study with your primary care doctor, as well as your spouse or family members, prior to deciding to join the study.

Of course, Bluebird does have concerns about information being released prematurely and the potential for patients to not fully understand what they are going through in the study. Bluebird has prepared a long explanation of their policies and reasons for these policies.

 
So, even though we absolutely understand the appeal of communicating the personal story of a study participant, there are a number of reasons why it is not common practice for sponsor companies like us to support premature, anecdotal public disclosure by patients who are active participants in ongoing clinical trials. (“Active” and “ongoing” being key words here.) These reasons include clinical trial data bias, FDA, SEC, and patient privacy considerations.
               
Clinical Trial Data Bias Considerations
As the sponsor of the LentiGlobin Study, bluebird bio is responsible for minimizing the potential for bias in our clinical trial results that could undermine their validity and interpretability. Especially with open label clinical trials (where tools to prevent bias, such as randomization, cannot be employed), sponsors must strive to reduce potential patient and investigator bias in the perception and reporting of trial results.
When patients speak publicly in an uncontrolled setting about their clinical trial experience, their words may have unintended impact, even subconsciously, on how other subjects or even investigators report the ongoing results of the clinical trial. This has the potential to bias the data collected. Although a single incident of a patient sharing data may not bias an entire clinical trial, supporting one patient sharing his or her experience creates an environment in which other patients feel encouraged by the sponsor or investigator to speak publicly, thereby increasing the risk of bias and the potential to undermine the trial.
The Center for Information and Study of Clinical Research Participation has a website with educational videos explaining some of the consequences when a patient in a clinical trial speaks publicly: https://www.ciscrp.org/primer/index.php.
 
Food and Drug Administration (FDA) Considerations
21 CFR 312.7(a): “A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”
If anyone (the company, a company employee, an investigator or a patient) speaks about or otherwise signals information about the effectiveness of a treatment under clinical trial investigation and the company is supportive of that speech or action, there is a risk that the employee, investigator or patient can be construed as acting on behalf of the sponsor company in a promotional context. The FDA has taken enforcement action against these types of activities by sponsors and investigators.
 
Securities and Exchange Commission (SEC) / Public Company Considerations
bluebird bio is a public company and is subject to a number of laws governing public disclosure that are enforced by the SEC and the NASDAQ stock market.
The main requirements of these laws in the context of clinical data disclosures are:
                                                               i.      Material clinical trial information should be disclosed promptly and accurately and widely disseminated when disclosed. bluebird bio addresses this requirement by accumulating the efficacy and safety data for a number of patients over time and then publicly presenting it in a comprehensive and balanced manner at peer-reviewed medical meetings and then publicly disclosing it in a press release and a public conference call to answer questions.
                                                             ii.      Data should be disclosed in a fair, balanced and non-misleading way to investors. In practice, this means data from single subjects in ongoing clinical trials should not be highlighted but should be disclosed in the context of the experiences of other participants in the trial.
                                                            iii.      Although a single patient is not a representative of the company, if the patient were to speak or answer questions about his or her current clinical status (e.g. hemoglobin levels, time since last transfusion, side effects), it may be material information about the LentiGlobin Study that bluebird bio would then need to promptly disclose so as to not have a market impact (positive or negative), and such disclosure would be at risk of being misleading as it would not be balanced by data from other patients in the trial.
 
Patient Privacy Considerations
As the sponsor of the LentiGlobin Study, bluebird bio is required by US, international law, IRB requirements, our contracts with each clinical site and our informed consent forms signed by patients to respect the privacy of the patients participating in our clinical trials and the personal health care data that is being generated over the course of the trial. Although patients are free to share their private information as they choose, the perception that bluebird bio is associated with promoting the public dissemination of this private information may undermine future patients’ trust in bluebird bio and our commitment to patient privacy.
In addition, due to increased investor and press interest in bluebird bio, LentiGlobin and gene therapy, there is a risk that publicly-identified patients in the LentiGlobin Study will be contacted directly by investors, research analysts and the press regarding their experiences. This attention may be unwanted and potentially invasive, and can quickly become beyond the control of bluebird bio, the patient and their treating physician.
 
As a company, we operate in a highly regulated environment, and particularly in the early (“active” and “ongoing”) stages of clinical development for a new therapeutic, when the risk-benefit assessment is incomplete, it is important that clinical data are presented in a balanced and scientifically rigorous manner to avoid generating misleading or erroneous conclusions that could have counter-productive clinical, regulatory and legal consequences. Generally, as you know, we make these data releases at scientific meetings like EHA where we can present all of the data in a comprehensive, unbiased manner.
 
Once our LentiGlobin clinical program has progressed further, and more complete clinical data are available for study participants, we would welcome the opportunity to work with the patient community to have a broad discussion around the experience of patients who have undergone gene therapy in bluebird bio clinical trials—ideally with patient speakers who have completed their study participation.

There is nothing wrong with Bluebird policy here. This is a proprietary asset for Blue, they have every right to defend it.

Thanks for sharing Andy.

Could it be that members of this forum participate in the study and we don't know it? 

sofear,

I do not know of any member from this forum participating, but they could be and keeping it confidential.


If anyone does not understand why Bluebird is so strict about how they release information, very basically, the SEC watches these companies very very closely. If anything could be construed as an attempt to manipulate stock prices, a company could face heavy penalties. Bluebird is dedicated to their end goal and in no way do they want information made public before any official release and before they have data to back up the information. Bluebird has made great efforts to ensure that all employee contracts are written so that no one has any control over selling shares of stock on their own. They will make their money when this is further down the line and they stand to make a big payday, but in the meantime, they are being extremely careful and very wise about what they say publicly. Patients currently in trials may not completely understand everything and are not the best source of information. Next time I talk to Bluebird, I will address this again and ask if there is any way for them to have patients make statements through Bluebird, so nothing incorrect is said, while still giving us the opportunity to get some information about the general health of patients and their own reactions to what they have observed.