NOTE: Please see the follow-up post, “Innerstate: A Correction and Further Criticisms.”

Depending upon how well a Hollywood movie does at the box office, it usually takes six months or more before the DVD version is released and maybe a year before you can see it on paid TV channels like HBO.

By that standard, Centocor’s 58-minute disease awareness documentary INNERSTATE must not be doing too well in theaters: less than three months after the movie debuted in New York City, the INNERSTATE DVD arrived in my mailbox. I had signed up to attend a live presentation of the movie at the King of Prussia Mall in Pennsylvania, but decided not to go. After all, I already had a private screening (see “Innerstate Private Screening: Philadelphia Style“).

INNERSTATE is about patients suffering from psoriasis, Crohn’s disease, and rheumatoid arthritis, which, coincidentally (not), are three of the indications for Centocor’s biologic drug Remicade. The drug name is not mentioned in the movie, which is considered a “disease awareness” promotion by Centocor. As with all such disease awareness programs, INNERSTATE is designed to fit into an overall marketing strategy whose goal is to increase sales of product. I’ll explain below how Centocor links the movie to the product.

Some might argue that pharma companies have limited time to make hay out of their promotional efforts before patent expiry of their products and therefore you cannot compare Hollywood blockbuster movie time lines with Rx drug blockbuster time line. However, Hollywood movies have even shorter shelf lives than Rx drugs. [In case you are interested in more comparisons between Hollywood movie production and promotion and blockbuster drug production and promotion, please see “Movies and Drugs: Same Blockbuster Mentality“.]

INNERSTATE — The TV Show?
Any way, if the analogy with blockbuster movies holds, I expect to see INNERSTATE on TV in the fall. Probably on PBS. Recall that other pharmaceutical companies have provided educational grants to independent producers to support disease education documentaries on PBS. GSK, for example, provided funding for the PBS show “Fat: What No One is Telling You.” GSK is marketing the over-the-counter weight loss product Alli (see “Alli Oops! I Just Pooped Myself!“).

[I think it’s interesting that FDA approved GSK’s “Alli” but balked at Sanofi-Aventis’ use of “Acomplia” as a name for its drug. I guess a drug can be your “ally” but not promise that such an alliance will “accomplish” much. The best analogy I can use is the alliance between the US and UK in Iraq, in which endeavor France was definitely not an ally.]

Will the INNERSTATE movie appear on European TV first?
According to a recent article in the Guardian:

“Four of the world’s biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. Pharma TV would be a dedicated interactive digital channel funded by the industry with health news and features but, at its heart, would be detailed information from drug companies about their medicines.”

Under the proposals, viewers could use their remote control to click on treatment options and read what manufacturers have to say about the latest branded drugs.

The four companies are Johnson & Johnson (parent company of Centocor), Pfizer, Novartis and Procter & Gamble.

Centocor already has devised a way to link the unbranded movie INNERSTATE with branded information about Remicade, although not in the high-tech fashion proposed for “Pharma TV’ (maybe that’s in the cards for the EU version).

Finally, the DTC Advertising is Delivered!
The INNERSTATE DVD came with a letter from Thomas Schaible, VP of Medical Affairs at Centocor. Dr. Schaible urges me to “talk to a doctor to learn if biologic therapy is an appropriate treatment option.”

None of this — not the movie, not the DVD, and not the letter — is considered direct to consumer (DTC) advertising and none of it is subject to FDA regulation. That’s because no brand name drug is mentioned. Although not required by law, the movie does mention side effects of “biologic treatments.”

Side effects are a major focus of the product labeling for Remicade. I discovered the Remicade labeling, which was a huge sheet of paper (about 13″ x 30″) covered front and back with small print, in the DVD box. It includes a “black box” warning, which tells of possible side effects of treatment, including “serious infections leading to hospitalization or death,’ tuberculosis, and heptasplenic T-cell lymphoma (cancer).

At first, I was surprised to see the product labeling in the DVD box because neither the movie nor the cover letter mention Remicade by name. Therefore, no product labeling is required. But then I looked more closely at the 41-page “Viewer’s Guide” that also came with the DVD. More than half of this booklet is devoted to a “Remicade Medication Guide.” This glossy bit of collateral closes the circle between the “disease awareness” movie and branded DTC advertising.

The Protest
Unfortunately, I missed a bit of entertainment by deciding not to view the movie at the King of Prussia Mall — and I’m not talking about the movie itself. Apparently, protesters demonstrated at this showing as they have been doing at other showings of the movie in other states.

These protests are carried on by Service Employees International Union Local 32BJ, which also has filed a lawsuit against J&J that charges the company used pricing and marketing practices that lead to excessive reimbursements by Medicare, private insurers, and patients. In documents filed in connection with the case, J&J admitted to publishing “average wholesale prices” (AWP) that are above the real cost of medications.

The union claims that the artificially high AWP means that they end up paying 30% more for Remicaid than physicians.

One Little Disappointment: Lack of Transparency
When I inquired about the protest at the King of Prussia showing, a Centocor spokesperson shrugged it off as merely a union “labor issue” that had nothing to do with the movie or Remicade. He did not bother to mention the law suit and did not open the discussion on average wholesale pricing and the profits that physicians can reap merely by prescribing the product.

No wonder Centocor did not have to pay physicians to appear in the movie or to show up at the screenings!