What would you think if the package insert for your new medication said the following?
Our company, Drugs4All has tested this medication in 20,000 people and collected copious data about its effects. But we made a promise to Drugs4All shareholders that we will not let anyone see that data unless they can demonstrate that they will use it to promote the well being of our company.
Therefore, we’ve created a two-step process for access to the data. If you’d like to learn about the safety of this medication please complete the application attached and explain your commitment to the well being of Drugs4All. Please include the your name and the names of anyone you have ever associated with. A committee will review your ideological commitment to the well being of Drugs4All to be sure that you will not use the data to harm our interests.
If you meet with our approval you will be eligible to see our safety data. That’s step 1. In step 2 you must sign our non-disclosure agreement promising not to share the data with anyone else under the pain of legal penalties.
We’re sorry for any inconvenience, but our first commitment is naturally to our shareholders, not to our customers.
Your first assumption might be that Drugs4All withheld the safety data from the public because it shows that the drug is not safe. Therefore, they must restrict access to the data to those who can demonstrate in advance that they are committed to the interests of Drugs4All and have instituted penalties to be sure that no one else sees it.
Evidently not. This the procedure that the Midwives Alliance of North America (MANA), the official organization of homebirth midwives, has instituted to protect the safety data they have gathered in the past decade. In periodic public announcements over the past few years, MANA has announced the existence of the data and promised that it will be the largest and most extensive database of its kind.
Unfortunately for MANA, though, it does not show what they want it to show. Since their first commitment is to homebirth midwives, not their patients, they have publicly announced that only those who pass an ideological litmus test and sign a legal non-disclosure agreement will be allow access to the data.
[MANA} is responsible for representing the midwifery community in its relationship with investigators…Therefore [MANA] expects all investigators interested in collaboration with this community to consider how they can cooperate … and to describe how they intend to do so in their request for data access.
Upon approval of a research application, access will be predicated on the signing of a … a Confidentiality and Non-Disclosure Agreement…
It is difficult to imagine a more unethical procedure for gaining access to the database. MANA has made several things clear.
1. It’s first priority is the benefit of its shareholders.
2. MANA does not believe that patients have any right to know the truth about homebirth safety
3. The data is potentially so damaging to homebirth midwives that it must not be allowed to get out to anyone who hasn’t been vetted in advance and promised to keep it secret from the public.
It does not take a rocket scientist to surmise that MANA’s own data show that homebirth with an American homebirth midwife is not safe. Withholding that information from patients is both unethical and immoral.
MANA should publicly release all their available safety data immediately. Will that hurt the employment prospects of homebirth midwives? Probably, but that’s just too bad.
No one can make an informed decision about homebirth without access to information. But I guess that’s the point. An informed patient might not become a customer, and as MANA has helpfully informed us, representing the interests of homebirth midwives is its most important priority.