controlled tests of slight revisions to existing vaccines.
PPhoto: PeopleImages.com - Yuri A/Shutterstock
Placebo effects have been in the news lately because the U.S. Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., announced a new policy requiring placebo controlled studies for vaccines before they can be approved. Several online sources have covered the story. Some writers criticize the new policy (e.g., Paul Offit's Substack and this entry from factcheck.org) and some writers praise the decision.
I'll pull quotes from the BBC's coverage, since the BBC is considered a middle-of-the-road news source (according to allsides.org).
Here's the new policy:
The top US health department plans to require placebo testing for all vaccines in an effort to offer "straightforward" public health information, but experts say such testing could limit availability and raise ethical concerns.
In a statement first given to the Washington Post, the Department of Health and Human Services (HHS) said this week, "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices".
On the face of it, it makes sense that any new drug or vaccine should be compared to a placebo--after all, it's the best way to determine if it is effective and safe.
For example, in 1955 when the polio vaccine was first developed, scientists randomly assigned children to receive the true vaccine and others to receive a placebo shot. They found that children who received the real polio vaccine were less likely to become infected with, paralyzed by, or die from polio (it's fun to read the original 1955 press release here). In addition, children who received the real vaccine had no more side effects than kids in the placebo condition. The vaccine was both effective and safe.
Despite the intuition that placebo controlled studies are necessary, there are good reasons for concern with the HHD's new policy.
For one, the BBC story pointed out an inaccuracy in the HHS statement:
The [new HHS] statement said none of the childhood vaccines recommended in the US - except the Covid shot - had undergone "inert placebo" testing, meaning "we know very little about the actual risk profiles of these products".
But public health experts say the statement is misleading, as childhood vaccinations, including ones for Hepatitis A and B, rotavirus, polio and the mumps, were all initially tested against a placebo. In fact, all new immunizations already go through the trials - a type of random testing where one test group receives the immunization, and the other gets a placebo, like a saline shot.
In addition, modern public health policy does not require placebo controls after a vaccine has been shown to be effective. That is, most scientists and public health experts agree that we should approach placebo testing differently when an already-effective vaccine is only slightly changed (a vaccine might be slightly changed to respond to changes in flu or COVID viruses from year to year).
... newer versions of the shots may not go through the same process, because it is considered unethical to withhold a shot known to be safe from a particular group, and because the shot is only being tweaked in a minor way, vaccine experts said.
a) In Chapter 4 you read about three core ethical principles: Respect for Persons, Beneficence or Concern for Welfare, and Justice. Review these principles and what they mean. Then decide which one of them applies to the concern above (that " it is considered unethical to withhold a shot known to be safe from a particular group")
Here's another, more practical concern about the new policy:
Requiring companies to conduct placebo tests for simple upgrades of established vaccines would be costly - and the drug makers could ultimately decide to forgo making the newer, more effective versions of the vaccine altogether, said Dr Lurie.
b) When psychology researchers test new psychotherapies for efficacy, they may also use placebo control therapies in their studies, such as a supportive conversation with no therapeutic structure. Do you think this is ethical? Why or why not? How might your answer change depending on whether the therapy is brand new, or a revision of an existing therapy?
c) Psychology researchers might, instead of using a placebo therapy, use a "wait list design" in which people are randomly assigned to either receive they new psychotherapy right away or assigned to wait, say 6 to 8 weeks, before starting their therapy. Both groups are tested for symptom severity (say, anxiety or depression levels) at the end of the 6 to 8 week period. What do you think of the ethics of this design? Does it seem better or worse than the placebo design? Explain your thinking.