This morning, I posted an item about Centocor’s documentary INNERSTATE and reported that SEIU Local 32BJ filed a lawsuit against J&J claiming that the company used pricing and marketing practices that lead to excessive reimbursements by Medicare, private insurers, and patients. (see “The Innerstate DVD. Is TV Next?“). I also implied that Centocor “hid” this fact and referred to a Local 32BJ protest at a screening of INNERSTATE as merely a labor issue.

I’d like to make some corrections and also add a bit to the story.

First, a spokesperson for the union wrote me an email and clarified who initated the law suit:

“I write to correct today’s entry, which says SEIU Local 32BJ filed a lawsuit against J&J. The plantiffs in the case include the federal government, various states, and other entities, but NOT Local 32BJ. We just reported on it based on court filings.”

Michael Parks, Centocor’s Director of Public Relations, and Executive Producer of INNERSTATE, made this further clarification:

John, always enjoy reading your posts and I personally appreciate your diligence in seeing a topic through.

That said I want to take an opportunity to clarify some of the statements made in your most recent post.

We have been sending out free DVD’s since the premiere in New York City to anyone who requests a copy. As you know, this film had a limited release and will only be screened in 14 cities. Therefore, we felt it was important that we made the film readily available by DVD for the majority of people who lived beyond the area of the screenings and for those who simply could not attend.

With respect to your question about InnerState appearing on TV, I regret to inform you that we have no plans to take it to take it there.

Regarding your “protest”, it is important that you understand the full picture before jumping to conclusions. As you know, the pharmaceutical industry must adhere to very rigorous regulatory standards that have been put in place by the Food and Drug Administration (FDA). Adherence to these standards is something Centocor takes very seriously and we go to great lengths to ensure it is done properly. InnerState is no exception. These standards are often open to interpretation by regulators and they can apply these standards in a way that is not obvious to the general public. In order to fully disclose our role in the film and to ensure that we are delivering a very responsible and fair public health message, we made the decision to include the statements by Dr. Schaible and to include the Medication Guide for REMICADE in the DVD packaging. The Medication Guide is a risk management document for patients and is mandated by FDA regulation. A substantial majority of the information you describe discusses appropriate risk information and encourages viewers to have informed conversations with their doctors.

Lastly, you are correct that Service Employee International Union (SEIU) Local 32BJ demonstrated at the King of Prussia screening of InnerState. However, SEIU has not filed suit against Centocor or its parent company and demonstrations remain related to a labor issue with one of Centocor’s third party contractors. SEIU states on their own fliers “SEIU Local 32BJ has a dispute with [named company, not Centocor] and no other employer”. As I stated to you before, Centocor cannot and will not take a position on this matter.

I hope this offers some context around the issues you raise in your post.

I regret the confusion I may have caused.

Regarding the Medication Guide in the DVD package, I will take Mr. Parks at his word when he says Centocor included it to “fully disclose our role in the film and to ensure that we are delivering a very responsible and fair public health message.” Certainly, they are not hiding the fact that Remicade is the “biologic therapy” in quetion. The main point is that the circle connecting the unbranded movie to the branded message is now closed.

Since the DVD was released at the same time the movie came out, I suppose my little analogy with Hollywood films is now null and void! The fact that the movie will NOT make it to TV puts more holes in the analogy. O well!

SEIU Local 32BJ Protests INNERSTATE to FDA and PhRMA
But Local 32BJ still protests INNERSTATE and has sent letters to the FDA and PhRMA complaining that Centocor is violating PhRMA’s Guiding Principles on DTC advertising. I reproduce the bulk of that letter here:

May 21, 2007
PhRMA Office of Accountability
950 F Street, NW, Suite 300
Washington, DC 20004

VIA FASCIMILE: (202) 775-0258

Dear Sir or Madam:

We write to express our dismay at the release and marketing of Centocor’s movie, Innerstate, which features individuals with conditions treated by the company’s drug, Remicade. Centocor is a subsidiary of PhRMA member Johnson & Johnson (“J&J”). While Centocor labels Innerstate a documentary, Remicade’s dominant market position and materials distributed at Innerstate screenings suggest that the movie serves as a promotional vehicle for the company’s product. In light of this, we believe PhRMA should investigate whether J&J has violated the Guiding Principles on direct-to-consumer (“DTC”) marketing to which PhRMA members have agreed, and take appropriate action.

Innerstate as DTC advertising
PhRMA’s guidelines on DTC advertising are aimed at television and print advertising. DTC television advertising is defined in the guidelines as “a portion of television air time on broadcast or cable television that is bought by a company for the purpose of presenting information about one or more of the company’s medicines.” Although Innerstate has so far only been shown in movie theaters, we believe the spirit of the guidelines should cover such a project, whose screenings are paid for by Centocor and which will also be released on DVD. Indeed, one reason the PhRMA guidelines do not explicitly cover movies may be that their authors never envisioned the existence of a film like Innerstate. According to the New York Times, industry experts “could remember no other documentary conceived of and financed start-to-finish by a drug maker.”

Another criterion for DTC advertising is the presentation of medication information. While Innerstate does not specifically mention Remicade or Centocor, Centocor distributed a Viewer’s Guide to the film at its King of Prussia, Pennsylvania, screening on April 28, 2007 that did. The Viewer’s Guide profiles the three patients featured in the film, and states in each profile that the patient was treated with Remicade. Following the patient profiles is an essay titled “A Message from Centocor” by the company’s Vice President of Medical Affairs, which reveals that Centocor makes Remicade, and discusses many of the drug’s possible side effects. Centocor also included the entire Medication Guide for Remicade in the booklet.

No other biotech drug was mentioned in the Viewer’s Guide.

At the screening, Centocor also distributed a survey form with an offer for a DVD of Innerstate. The fine print gives Centocor and other Johnson & Johnson affiliates the right to send to survey participants information about their products “and the conditions they are approved to treat,” as well as experiences of patients treated by those products. Centocor did not offer to provide information on competing drugs or treatments.

It is important to note that there is no other way to watch the movie at this time than to attend a Centocor-sponsored screening, and the DVD is available only to attendees after talking to a member of the event staff.

In light of the above, SEIU Local 32BJ believes that the Viewer’s Guide and survey form distributed at the Innerstate screening constitute DTC print advertisements, and the movie a DTC broadcast advertisement. We do not appear to be alone in this view. The New York Times called the movie “an unusual form of soft-pedal marketing of a blockbuster drug, Remicade.” The Philadelphia Inquirer reported that “even without naming Remicade, Centocor stands to gain from increased disease-awareness because, as the market leader, it tends to capture most new prescriptions.”

Centocor would have us believe that it aims “to elevate the voices, stories and successes of patients, as well as to broaden awareness of immune-related diseases.” But the promotional materials given at the screenings suggest an ulterior motive. Dr. Jerry Avorn, a Harvard Medical school professor and author of Powerful Medicines, commented that Innerstate “is a whole new dimension in direct-to-consumer advertising. What makes me edgy about it is if it is going to be a commercial, you should know it’s a commercial. I’m very troubled by the blurring of the lines between advertising and patient education.”

PhRMA’s Guidelines as Applied to Innerstate
Since Innerstate is clearly, in our view, a DTC advertisement, Centocor should follow PhRMA’s Guiding Principles on such advertisements. But Centocor appears to have violated several of the guidelines.

Principles #3 and #4 ask companies to educate consumers about the medicine being advertised, and to indicate if it is a prescription drug. Innerstate, by contrast, does not mention the name of the drug, and even the name of the film’s producer, Centocor, is not revealed until the last line of the credits.

PhRMA should also investigate whether Centocor has complied with
Principle #2 on presenting a “balance of risks and benefits” about the advertised drug;
Principle #11, that “risks and safety information .. should be presented in clear, understandable language, without distraction from the content”; and
Principle #15, on providing information “about help for the uninsured and underinsured.”

[Some stuff about prior history omitted; you can read the entire letter here.]

We ask that PhRMA thoroughly investigate Innerstate and Centocor’s marketing of the movie, and pursue all appropriate remedies that address the practices of its member Johnson & Johnson and its subsidiary Centocor.

Good luck with that! First, PhRMA’s Office of Accountability has not been very effective in enforcing its DTC Guidelines (for more on that, see “Adventures of PhRMA Intern!“).

I wasn’t at the King of Prussia showing of INNERSTATE and I cannot verify that the Medication Guide I received with the DVD is the same as the Viewer’s Guide mentioned in the Local 32BJ letter to PhRMA. All I can say is that if the two are the same, then the movie should be considered part of a branded campaign. If so, Centocor did include enogh information about side effects, etc. to comply with FDA regulations and PhRMA DTC Guidelines.

The question is NOT did Centocor violate FDA or PhRMA Guidelines. Rather, should INNERSTATE be considered branded or unbranded promotion?