Kent Sepkowitz is a CNN medical analyst and a physician and infection control expert at Memorial Sloan Kettering Cancer Center in New York. The views expressed in this commentary are his own. View more opinion at CNN.
(CNN)More than 80 years ago, the American salesman extraordinaire, Elmer Wheeler, introduced his “Five Wheeler Points” to help his brethren boost sales of whatever it was they were selling. The first Point, later immortalized by an episode of Seinfeld , was this: “don’t sell the steak — sell the sizzle.”
Giroir: We do not have a safe, effective vaccine yet 03:38This adage seems to have been adopted by the some in the Trump administration as they still, seven months in, try to find their footing on the federal response to the Covid-19 pandemic. We have seen a lot of sizzle — lots of happy talk about game-changers and breakthroughs and miracle treatments. The zenith thus far has been the recent rise and fall of a touted natural cure from a plant (Nerium oleander) that was cheap and available, and pushed very strongly by Mike Lindell, the MyPillow CEO.In early September, it was brought to light that the FDA had recommended against approval of the product as a dietary supplement ingredient weeks prior. The August 14 FDA letter said the agency had “significant concerns” about safety evidence concerning oleandrin’s use as a supplement.The Nerium oleander “cure” — like so many other just-around-the-corner Covid fixes, such as hydroxychloroquine and warm weather — is all sizzle. The goal of pushing theories of their effectiveness seemed less related to trying to cure someone than to generate a good feeling, an excitement, some buzz, good ratings. As for the steak itself… let the buyer beware, at least till after the election. Read MoreWhich brings us to our current sizzlemanship (a Wheeler term) for the greatest vaccine ever (specific vaccine to be named later), something the President continues to suggest might be ready for the public by election day. He has even suggested his director of the Centers for Disease Control and Prevention, Dr Robert Redfield, was “confused” when he indicated otherwise. Never mind that some of the steak-seekers, those sober scientists, have pointed out that there is little chance that an approved pandemic-flattening vaccine will be near readiness for wide use in 2020 — much less an approved pandemic-flattening vaccine that most Americans would willingly take so that lives might be saved and herd immunity established. The admonishment to not cut corners in vaccine development is founded on several concerns. A few years ago, CanSinoBIO, a company in China, received global kudos for moving an Ebola vaccine from first idea to approval in just over 3 years. Among vaccinaologists, this is a blistering pace — and the time is not spent making claims and pushing headlines but rather on seemingly endless arduous work. All this activity is necessary in assuring safety and appropriate production of an immune response first in small animals then, usually, in primates, then in a few human volunteers. When can a Covid-19 vaccine really be ready?Any early volunteers are monitored stringently for side effects and toxicities, as well as for a lab test-based signal that the vaccine is interacting with the immune system as hoped. Then months later come more volunteers and testing. Only then — if everything looks good — they proceed on to the large Phase 3 trial that a handful of Covid-19 candidate vaccines currently have reached. Running a study across dozens of sites with 30,000 patients who must be monitored for safety with serial blood tests and examinations, as well as longer term follow-up to make certain there are no unexpected problems, all while demonstrating a detectable health benefit, is a high-wire act that simply cannot be hurried, lest the acrobat crash to the ground. Nevertheless, the administration persists — perhaps because of jealousy. After all, leaders in Russia (Vladimir Putin)and China (Xi Jinping) have already gotten their sizzle. Their vaccines are being actively administered. Who knows if they work or are safe — as per Elmer Wheeler, that isn’t the point. Of course, misleading salesmanship or at least its gentler relative, selective emphasis, is part of everyday life — and nowhere more so than in politics. We expect it. The Wheeler Word Laboratory was the prototype not just for the Don Draper generation but the entire semi-hidden universe of political consultants. Its intrusion into the world of vaccines, however, creates a major problem, well beyond the usual minor distrust and eye-rolling at a sales pitch. No one enjoys receiving vaccines, either for themselves or their family members — they hurt, they can make your arm sore the next day, they can cause fever. But they can prevent death and paralysis and some cancers so the decision to take the vaccine is easy — for most people. Still, there has been a strong anti-vaccination movement that dates back to the moment Sir Edward Jenner lanced the first cowpox pustule. Then, there was a concern, which proved unfounded, that somehow, live cowpox injected into a human would result in cow-like features, literally and figuratively. Now the concerns range from autism to weakened “natural immunity” and much else. The CDC, the World Health Organization and various independent groups have debunked such fears multiple times.Worse, for many people, the attitude against vaccination is not vaccine-specific but rather an all or none proposition. A concern about measles vaccine may lead to rejection of the vaccine against hepatitis or influenza. Get our free weekly newsletter
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So, the public health consequences of a hurried, poorly studied vaccine — even against a disease as feared as Covid-19 — likely will result in a grimmer situation than simple confusion about the impact on the target infection. If indeed people develop side effects after their injection, the vaccine program it also runs the risk that those just barely accepting of the American vaccine program will be scared away from other already safe vaccines that that have saved countless lives. We could come out of the Covid-19 experience an even less healthy and less sensible nation than we are today. Thus far, the Trump administration has created just one memorable “product” in the fight against Covid19 — the term “Warp Speed” to indicate the resolute, forward-thinking, take-no-prisoners focus of the American scientific efforts against the pandemic. The additional promises are just hot air distractions and unpleasant noise.In other words, they have prepared one first-rate sizzle. It is the steak however that will save lives — but thus far, our plate remains empty.
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