The Vicissitudes of Kong

There's a scene in Peter Jackson's version of King Kong where the girl, Ann, (Naomi Watts) has been carried off by Kong, and somehow manages to escape. She then comes face to face with a T-Rex. Kong shows up, angry that she's run off, but willing to fight to save her, and there's a split second where she has to make a choice between the two, and it's completely clear to both Ann and the audience who she's better off with. Because Kong, as big and scary and destructive as he may be, is not actually trying to hurt her. Whereas good 'ol T-Rex wants only to kill and devour her for lunch.

This is kind of how I feel about insurance companies vs. Big Pharma. Insurance companies can only survive by charging outrageous premiums and then denying coverage. The harm is innate. But I truly believe that if pharmaceutical companies could produce drugs that were always helpful and never harmful, they would flourish and be pleased as punch.

Here is where my analogy falls apart, because Kong is in love with the girl, and I attribute no such caring and altruism to Big Pharma. And while some drugs are unquestionably helpful, and others are questionably helpful, none are free of adverse effects.

In that vein, there's been a lot of online chatter about a recent panel discussion that took place in Brussels, about the potential for conflict between public health and commercial confidentiality in clinical trials run by pharmaceutical companies. See, for example, this post on 1 Boring Old Man, or this one on DavidHealy.org. The ongoing issue is, of course, data transparency.

For some reason, I'm having trouble embedding the video, but here's a link:

Session 3: Balancing Public Health and Commercial Confidentiality

The video is almost an hour long, and since time is a limited commodity, and Breaking Bad and Dexter have only a couple more episodes, each, priorities need to be established.

But I'll give you the gist of it, as well as a transcript of a brief section.

The panel members, from various agencies, I believe, including the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), speak about how important it is for companies to maintain confidentiality in their clinical data, so they can't be scooped by competitors. The claim is that this benefits the public, and public health, because it allows the companies to continue to pursue the noble goal of discovering, producing, and selling new drugs.

One of the panel members is Neal Parker, a US lawyer and representative of AbbVie, a spinoff of Abbott Pharmaceuticals, and makers of Humira. AbbVie has already taken action in the courts to prevent the European Medicines Agency from releasing data on Humira to a rival company. It won an interim judgment preventing release of this data on April 30th of this year.

Parker emphasized the importance of confidentiality, and included adverse events as potential data to be kept from the public. There were several responses to this from the audience.

Hans Georg Eichler, the EMA’s senior medical officer, said, “I have been a regulator for many years and I am totally flabbergasted.”

And Aginus Kalis, head of the Dutch Medicines Evaluation Board, asked, “Are you aware you are working in the healthcare industry, with patients and human beings?”

While I agree with these sentiments, I think the outrage is counterproductive in this setting. It makes Eichler and Kalis look like histrionic foils to Parker's man of reason. And the last thing I want is for people to buy into Parker's rhetoric.

Because, overall, he is reasonable. He says that AbbVie will consider revealing data on a drug by drug basis, and that as long as the purpose of the revelation is for the scientific community to learn from it, and as long as appropriate safeguards are put in place so the lucky scientists don't go running to AbbVie's competitors in Bangladesh, there's no reason they won't share their information.

One audience member asked if these scientists would be free to share the data with clinicians. I don't quite recall what the response was, and this may be an indication that some double-speak was going on.

Later in the session, a woman in the audience asked Parker to give an example of an adverse event that AbbVie would not release to the public. He told her he couldn't think of a case where AbbVie wouldn't be willing to share this information. She said, "But it's happened before." And he responded with something like, "I can only speak for AbbVie." The subtext: I can't talk about SSRIs and suicidality.

Since most people reading this are not going to watch the whole megillah, I want to point you in the direction of what I thought was the most telling of Neal Parker's comments. Parker is responding to a question from an audience member, asking about why it's so important to maintain this confidential data, when presumably, the interprative analysis gleaned from the data is already available to the public in the discussion and conclusion sections of the product label information.

It runs from minutes 19:41 to 20:47, and this is my transcript:

The detail of the give and take of the problem solving which is reflected in the narratives of some of these clinical study reports is internal sensitive information which is nowhere reflected in the label.

A company’s,...the process of getting these products approved with the regulatory agencies is a give and take of issues, challenges, um, reworking of data in response to regulators’ concerns or concerns that we have identified and raised ourselves, which needs to be explained and articulated in documents that we submit to regulators to get products approved. And if I’m a competitor to Abbvie, and I’m in a competitive landscape, where there are a lot of products on the market, and I want to enter that market, the first thing I want is Abbvie’s clinical study report, ‘cause I want to know what problems I am gonna have to confront when I try to get a product approved, and that is a competitive advantage, and that’s why we consider this information, depending on the circumstances, CCI (confidential clinical information).
(Boldface mine)

It’s the “reworking of data” that no one outside the company has access to that really worries me.

What, Exactly, Is HIPAA?

The term, "HIPAA" gets thrown around in relation to patient confidentiality, so I thought it might be useful to clarify exactly what HIPAA is.

My understanding of a HIPAA-covered entity, at least for private practice, has been that you're a HIPAA Covered Entity if you bill electronically. End of story. Here's a government chart to corroborate my opinion.

Specifically:

I don't bill electronically, therefore, I am not a HIPAA Covered Entity.

Now, if you do bill electronically, or work with a billing service, then you are a HIPAA Covered Entity. But again, you are restricted in terms of the billing, not other areas.

This is a link to a useful fact sheet from HHS. Some key points:

Health Insurance Portability and Accountability Act (HIPAA) does not require patients to sign consent forms before doctors, hospitals, or ambulances can share information for treatment purposes.

So you can share patient information with other health care providers without the patient's consent.

I think it's still a nice idea to get consent, anyway, but you are not in violation of HIPAA if you don't have it.

HIPAA does not cut off all communications between providers and the families and friends of patients

You can share needed information with family, friends, or caregivers, as long as the patient doesn't object. And if the patient is unable to indicate a preference, you can do what you think is best.

So let's get something straight once and for all. HIPAA is not a catchall term that describes all legal issues surrounding patient privacy and confidentiality. It's about billing electronically.

The next time you hear someone try to reassure you by saying he or she is restricted from revealing patient information because of HIPAA, Uh-Uh.

If you're a HIPAA covered-entity, you need to give your patients forms indicating how their information may be used. And you need to make a good faith effort to get them to sign a form acknowledging receipt of these forms. What you don't need to do is get the patient to consent to the release of information. And in fact, these forms are more about the ways in which the patient's information lacks privacy.

The sample Patient Privacy Notice from NYU Langone includes the following ways a patient's health information may be used, without consent:

Treatment
Payment
Business Operations
Appointment Reminders
Fundraising
Education
Business Associates
Electronic Communications
Research
Public Need

Doesn't sound all that private, to me.

There are non-HIPAA laws regarding patient privacy, doctor-patient privilege, and confidentiality, and these vary by state. I'll go into more detail in a future post.

But for now, PLEASE read Shrink Rap's post on KevinMD for a description of what can happen to privacy under the auspices of "HIPAA".