As you probably have heard by now, biotech giant Genzyme is having some manufacturing difficulties at its Allston plant (pictured on the left). The issues started when the plant had to be shut down over the summer due to a viral contamination problem and continued last week when shards of steel and rubber were discovered in some of the Company’s vials.
The second manufacturing defect only impacted about one percent of the vials leaving the plant and with proper precautions, should have minimal patient impact. It was a relatively minor incident. But you wouldn’t know it if you looked at some of the sensational headlines coming out that proclaimed “garbage” was found in Genzyme drugs. That’s because this is a situation where perception has become reality. Even though the most recent slip up should not trickle down to patients, when it comes on the heels of a 3-month plant shut down that caused the drugs for orphan diseases to be rationed, you are certainly in the midst of a communications crisis.
The thing about crisis communications is it should never sneak up on you, especially in a highly regulated industry such as pharma. It should be an integral part of any public relations plan developed for a pharmaceutical or biotech company. This plan should address the decision-making process and authority during a crisis, the primary messages that need to be communicated (i.e. patient safety), a philosophy around transparency and an approval process of official communications. With all of this in place, you should never feel stifled by a crisis.
This isn’t to say every hiccup can be predicted and a specific plan should be in place for each possible scenario. That’s neither feasible nor productive. However, there should be a clear framework in place that allows you to take quick and decisive action in times of crisis. Your ability to minimize the damage posed by a crisis communications situation comes down to your decision-making framework.
This is where a concept such as Return on Health (ROH) is particularly useful. If the patient is at the forefront at all times, including during a crisis, your actions will certainly reflect that. In the case of Genzyme, the first course of action would be to acknowledge the problem. In evaluating the responses from the day the news broke of the second problem at the Allston plant, it appears the company was open and available to speak to the press. That is a good thing. Perhaps it was a lesson learned from the plant shutdown when the company took some heat for waiting two to three days to disclose the viral contamination. While the company contended that it needed to get its messages aligned with the FDA before making any public disclosure and technically abided by all laws covering the dissemination of that type of information, it sent the wrong message.
When you look like you are covering something up, people are inclined to assume that you are. In the case of Genzyme, it would have been better to immediately acknowledge the problem and commit to releasing another official statement once it discussed next steps with the FDA. In doing so, you go on record as admitting a problem once it occurs and making an effort to solve that problem as quick as possible. Patients and the general population are apt to forgive a manufacturing error; they are not likely to forgive an attempt at covering up that error. With ROH at the center of your decision-making process, this becomes a simple course of action. Patients feel it is their right to know when their health could be affected. As soon as you know, they feel they should know. If ROH is your guiding principle, you inevitably get out there early and often to minimize the patient impact of any problem. The problem for Genzyme was that even though it probably had the best of intentions, a certain amount of skepticism had already developed once they did acknowledge the problem.
That skepticism resulting from the first incident is what the Company is currently experiencing. The fact is: the most recent incident is fairly benign. However, because it is the second in a short period of time and the perceived lack of response during the last situation, it is being overly scrutinized. Genzyme has landed in the crosshairs of both the FDA and the public.
Genzyme is doing the right thing by not hiding from this problem. As mentioned earlier, company spokespeople seem open to addressing this problem with the media. However, the message in that communication largely seems to downplay the significance of this event. The tone and tenor of the remarks is to justify what happened as a normal part of operating procedure in a very complex manufacturing process. Commentary from company executives has addressed that a 1 percent contamination rate is well within the industry norm and that the company already suggests doctors filter the drug before infusion (consistent with the FDA’s recommendation to combat the issue). This approach may work if it were the first instance of a problem, but because it is the second; it does not display the right amount of patient empathy.
And while everything the company has discussed to date is accurate, I would take a different approach. Because they are battling a perception problem, defending this manufacturing blip as something that happens across the industry doesn’t evoke the type of accountability patients are seeking. Rather than justification, I would counsel Genzyme to tackle the problem head on right from the outset.
Here is what I would counsel Genzyme to say if I were handling its communications: “At Genzyme, we are in the business of developing drugs that treat orphan diseases. There are few alternatives to our medications. It is unacceptable that anything stands in the way of that commitment to get our patients treatment. This latest manufacturing error does not meet the standard of excellence that we hold ourselves to as a Company. And although only 1 percent of our vials have been impacted, we strive to lead the industry, not fall within the norm. We will make every effort to ensure that this does not happen again and that our patients continue to get the treatment they deserve.”
What have we achieved with this approach? Shown empathy, not defense. Patients, and health care professionals for that matter, don’t want to hear how hard it is to manufacture drugs. They want to hear that a commitment has been made to their health. The difference is that this message not only conveys empathy but it also displays a human side. Genzyme would be able to illustrate that it understands the impact its drugs have on patients and that it holds itself to a higher standard because of that impact.
Too risky you say? Admitting to a problem would cause the stock price to plummet you argue? Maybe so. But I would also remind you that Genzyme’s stock plummeted about 7 percent immediately following the disclosure of this incident. Certainly the current approach did not protect the stock price so why make decisions based on what the street wants to hear? Why not instead make decisions geared toward the stakeholders that will drive your long-term value—patients?
The problem many companies make in a crisis situation is to attempt to solve it or downplay it one barrage of messages. But that’s impossible to achieve. A crisis communications situation is more about being part of the solution and conversation than it is about solving it right at the outset.
Genzyme has done a great job of not running from the issue at hand—now it simply needs to tweak its message and focus on the impact it has on the patient.
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