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LIVING PROOF is a biographical account of Dr. Dennis Slamon's discovery and invention of a new class of oncology drugs and, in particular, trastuzumab (HER-2). Trastuzumab is an antibody used for curing breast cancer. First, let us look at the regulatory aspects of this film. Then, let us look at the emotional aspects of the movie.
REGULATORY ASPECTS. The viewer will learn about inclusion criteria for a clinical trial. We learn that a subject must have breast cancer, and that the tumor cells must be HER2 positive. We learn that the goal of Phase I trials is to characterize safety ("side-effects"). We also learn about exclusion criteria from this movie, for example, the exclusion criterion of the study subject having had too many rounds of prior chemotherapy. This movie shows one of the characters being refused entry into the Phase II trial because she failed to satisfy this particular criterion. Also, we learn that funding for any particular clinical trial can be a start-and-stop activity. In this movie, we learn that where GENENTECH decided not to fund the study, another company, REVLON stepped in and provided money. Another take-home lesson, is that clinical trials require regulatory approval from the FDA, and that clinical trials need to be designed by physicians who actually have experience in trial design (just because you are a doctor who discovers a new drug does not mean that you have the slightest clue in trial design). The movie shows Dr. Shamon being told that "his" clinical trial will be taken over by physicians who actually have experience in trial design. Also, relating to concept of regulatory approval, we see a cancer victim who had been approved for entry into a Phase III trial, begging a receptionist to be given drug right away, "I only have a day to live, I need the drug right now, I can't wait until next week." We learn of the concept "quality of life," which is an issue for most clinical trials for chronic, debilitating diseases. Quality of life in these clinical trials is always measured by a special questionnaire called, "Health Related Quality of Life instrument." LIVING PROOF teaches us all of these lessons. These lessons, as taught by LIVING PROOF, can be understood by children of the ages 8-12, by teenagers, and by adults.
EMOTIONAL ASPECTS. To cut to the chase, this movie requires a collection of Kleenex tissues or handkerchiefs. We see various examples of emotional dispair, where is woman is being denied entry into a clinical trial, because she does not meet the entry criteria (inclusion criteria). The result is that she dies leaving behind a family and children (Kleenex #1). Another character turns down a marriage proposal, because she believes that she will eventually die of her breast cancer (Kleenex #2). There are other scenes of emotional triumph, which also require the handkerchief. One of the characters has reached the point of despair, and decides to live out her final days in Mexico, sipping margueritas on a relaxing beach, instead of vomiting from chemotherapy. But then, she gets persuaded to enter Dr. Slamon's trial, and at the end of the movie, she is declared totally cancer-free (Kleenex #3, #4, and #5).
THE BAD GUY. One unusually interesting theme in this story concerns an employee at Genentech known as "Reinhart." He is portrayed as the bad guy in this movie, apparently because of his expertise in trial design, in contrast to Dr. Slamon's lack of expertise in this skill. Even though it is not certain why "Reinhard" is the bad guy, any viewer of this movie will sense that something good has occurred when Reinhard is taken off of the trial. While I do not know if "Reinhard" corresponds to a real person, it is often the case that, in management, people with Reinhard-like characteristics are encountered. This particular Reinhard had characteristics that were both good and bad.
SUMMARY. The movie sticks to events relating to the various phases of this drug -- research, funding, regulatory approval, enrollment, adverse drug reactions ("side effects"), trouble getting enough patients enrolled, and efficacy. The movie does disclose some of the outside activities of all the characters, for example, a courtship between an African-American woman and a Caucasian man (happy ending), Christmas party not attended by dead mother, and fact that Dr.Slamon did not have time to be a devoted "family man," that is, to attend school functions of his daughter. But these outside activities merely act as a cementing substance to the "bricks" of this movie, namely, the steps required to get regulatory approval. The movie emphasizes the issue of femininity, for example, where the soundtrack plays Dionne Warwick's, "I SAY A LITTLE PRAYER," at which point the film dwells on each cancer victim, that is, on her activities in grooming, lipstick, womanly shoes, skirts, and so on.
CRITICISM. I only have one critisism. The movie does not mention that Phase II trials and Phase III trials are usually randomized (placebo versus study drug). However, it is quite possible that the HERCEPTIN clinical trials only contained one arm (study drug only). But it is also possible that the movie failed to mention randomization, in order not to scare away the viewers of this movie (to scare them away from participating in clinical trials). FIVE STARS for LIVING PROOF.
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