Aromin, Paula Benilda C.

MPM-HG Cohort C 2019 HTAREG

Critique Paper on the film, “Bleeding Edge”

“New is not necessarily better.”

The film “Bleeding Edge” is a thought-provoking, nerve-wracking Netflix

documentary, directed by Kirby Dick (“The Invisible War,” “The Hunting Ground”) alongside
his creative producing partner Amy Ziering, which premiered on the online streaming site in
July 27 of 2018 and has garnered a lot of praises in reviews. In business, bleeding edge 1
refers to “a product or service that is new, experimental, generally untested and carries a
high degree of uncertainty.Bleeding edge is mainly defined as newer, more extreme, and
riskier than technologies on the cutting or leading edge.” Since it is innovative, more radical
and even precarious than technologies on the cutting or leading edge, some companies
prefer to hedge one's bets by promoting products that comprise the category of bleeding
edge as cutting edge instead which is how it was depicted at the start of the movie. The
word "bleeding" also has much more negative connotations than leading. Cutting edge
refers to a technology that is able to outmaneuver or outpace its competitors, inclines to
communicate a better sense of trustworthiness, thorough experimenting, and
appropriateness.

Bleeding edge in business aims to gain first-mover advantage but it is risky because
it portrays a product or service that is advanced and potentially make significant changes to
how things are done but may malfunction or ever create adequate exigency in the market to
realize middle-of-the-road success. This is not only the issue rendered by the movie
because it is only about the business aspect of technological innovations. The bigger issue
here is that these technologies, portrayed as leading or cutting edge but they are not, were
applied on enhancing the well-being of humans that breaks the ethical boundaries of health
technologies regulations. The movie was about purportedly hazardous, dangerous medical
devices, how they were entered into the market, and how challenging, arduous, grueling it
is to take them outof the market and the people involved.

The movie tackled the problem of faulty medical devices by means of the personal
accounts of the sufferers, noting medical, economic, personal, and social impacts. The
primary devices taken up were the Essure birth control implants (recently withdrawn from
the market due to very low sales), the gynecological mesh (which is currently the subject of
multiple class-action and individual lawsuits), and the recounted cobalt poisoning from
artificial hips. There were fleeting remarks in the film on the inferior vena cava (IVC) filter,
breast implants, morcellators, and the da Vinci surgical robot. The primary concern alluded
to with da Vinci is what is illustrated as vague and wooly training and experience
prerequisites sooner than it can be used with a degree of safety, efficacy, or proper
functioning of the device. The training part of how soon it can be learned, how many
exercises do you have to do before you become excellent or skillful, the amount of actual
experience needed, is one thing that gets little consideration in surgery and implantation.
1
https://www.investopedia.com/terms/b/bleeding-edge.asp
 Moreover, the film delved into the two major pathways by which the US Food and
Drug Administration (FDA) approves medical devices – the traditionalpre-market approval
(PMA) process that has been in place since 1976, requiring at least one trial, and the less
stringent 510(k) corridor that was conceived shortly thereafter, allowing manufacturers to
have devices “cleared” by demonstrating that their device is "substantially equivalent" to
devices that are already marketed for the same use. The film also criticized how all the
devices mentioned (except Essure and current breast implants) arrived in market,
the510(k), for the lack of acceptable pre-market testing. The film remarked an oddity of the
510(k) process is that a recalled device can serve as a ground for clearance. It was also
mentioned that there is the apparent disconnect between assertions that manufacturers
often make on their product’s safeness or efficacy and what is actually experienced,
especially in the insufficient or the lack of premarket testing and only short-term monitoring
or follow-ups.

On the other hand, Essure manufacturer, Bayer, has recalled the sale of the product
but it had released a fact-check on the movie saying, “the only FDA-approved non-
incisional form of permanent birth control” and that the movie “lacks scientific support,
despite the fact that Bayer provided the producers with extensive scientific information on
Essure before the completion of the film. The film presents an inaccurate and misleading
picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a
predetermined conclusion, ignoring the full body of scientific evidence that supports the
Food and Drug Administration's (FDA) determination that Essure's benefits outweigh its
risks and disregarding the appropriate warnings that accompany the device.” I’d say that
the mere fact that Essure promotes inflammation in the fallopian tube is already a cause for
concern to claim it is non-incisional and that is based on science. In addition, it is not fair to
say the movie relied anecdotes and cherry-picked data when the movie represented the
women’s group supporting the victims of the failure or Essure and that FDA had received
26,773 medical device reports related to Essure as of December 31, 2017.

Johnson & Johnson asserted that it is their top priority to deliver safe and effective
products that is the rationale behind them voluntarily recalling the ASR Hip System in 2010
after reviewing new data as part of the company's ongoing surveillance of post-market data
they conduct for all of their devices. This is very positive, and they claimed accountability
and ownership.

The Advanced Medical Technology Association’s statement saying that the film
rendered, “a disservice to the hundreds of millions of patients worldwide who have
benefited from medical technology” is stifling and it is like barking at the wrong tree so to
speak as the film was not criticizing the benefits of innovation but the direct impact of
bleeding edge technologies in the near- or long-term and is so neoteric and experimental
that it has not been fully tested and, consequently, may be untrustworthy but they were
guised as cutting or leading edge on human life that is why the movie was titled as such.

With regards to the FDA about the film, they said that they have provided extensive
responses to the filmmaker’s queries. It emphasized, under the Center for Devices and

Critique Paper on the film, “Bleeding Edge” PBCA Page 2 of 4 amdg†

Radiological Health (CDRH), the mission of the agency is assuring “the patients and
providers have timely and sustained access to high-quality, safe, and effective medical
devices and safe radiation-emitting products.” However, it also said, “Regardless of
which process is followed, the FDA strives to permit marketing of only those devices with a
favorable benefit-risk profile. However, not all information regarding benefits and risks for a
given device are generally known before the device reaches the market.” The FDA wants
the best regulation for the public but there’s a caveat to it?

With all things said and done, the following are my recommendations to the CDRH
and Philippine FDA, namely:

1. Maintain the traditional, rigorous pre-market approval (PMA) clearance corridor

for new technological devices and abolish the exit door 510(k). Since the risk
assessment could not be established prior to clearing a new technology, the
device should be held in abeyance until such risk assessment could be
accurately and completely determined. We haveto understand that strict
regulation would lead to obstruction BUT too lenient regulation would lead to
turmoil, or basically inefficiency and ineffectiveness.

2. To gather more information about the pros and cons for a device and, at the
same time, strike a balance to effective regulation and speed of clearing into the
market, the agencies should bring more scientific data and studies and
experts/resource people and leave the cost-benefit to the businesses because
the only reason why they innovate is to gain first-mover advantage over their
competitors. There is no problem if the device is not medically related or health-
related like a new telecom gadget or kitchen utensil. However, if the device deals
directly with the human body and its components as in the case of the movie, that
is a different story. Protection of the human life takes utmost importance over
profit. Just because you have a new know-how doesn’t mean it’s modernization
or advancement. It must be verified and proven safe and effective with minimal, if
not none, risk for the patients. Patients, as shown in the film, have morbidities
already and seek medical help. It would be a paradox to have them suffer further
for an unproven, untested, and uncertain technology and no accountability.

3. To propose to the lawmakers criminalizing the lobbying for such new devices to
be cleared into the market and people who are found to have conflict of interest.
Moreover, people who leaves the agency must agree not to disclose, consult or
advise any entities directly and indirectly related to medical technologies.

4. The film was short in saying the acceptable magnitude of device complications or
side-effects. In my opinion, using statistics, there should be an acceptable risk
factor of 0.01% of the total studies actually conducted for critical conditions and
less stringent of 0.05% for non-critical conditions because we are dealing with
people and peopleseek treatment and physicians offer treatment because the
patients aresuffering – eitherthere is a pain, disability, or a risk ofdeath – and

Critique Paper on the film, “Bleeding Edge” PBCA Page 3 of 4 amdg†

 obviously some of these devices are not really treating critical conditions, but are
trying to improve something.

Critique Paper on the film, “Bleeding Edge” PBCA Page 4 of 4 amdg†