Mifepristone Shakes the Abortion Landscape
Editor’s Letter
Dear readers,
I would like to apologize for the skipped postings these past 2 months. The articles were written both of the times that we skipped posting, but I neglected to schedule the newsletter and did not realize it until the middle of the week. Going forward, I am going to set more alarms and aim to schedule the newsletter earlier so that there will not be any more skipped weeks.
Sorry again,
Shean Fu
Mifepristone Shakes Abortion Landscape with Conflicting Rulings
In a groundbreaking decision, a federal judge in Texas has suspended the FDA's approval of the abortion drug mifepristone, but delayed implementing the ruling to give the Biden administration time to appeal. The decision could have far-reaching consequences on medication-assisted abortions, particularly as the drug has become increasingly important since the Supreme Court overturned Roe v. Wade last year.
Simultaneously, a federal judge in Washington state ruled that the FDA must continue to supply the drug in 12 liberal states that sought to expand access to mifepristone. This ruling, however, only applies to the 18 states that sued.
U.S. District Judge Matthew Kacsmaryk sided with the anti-abortion group Alliance for Hippocratic Medicine, which argued that the drug's approval in 2000 was rushed and that the agency neglected requests for judicial review. The Department of Justice, President Joe Biden, and Danco Laboratories (which manufactures mifepristone) all signaled their intent to appeal the decision.
If the suspension of the FDA's approval goes into effect, mifepristone would no longer be available in the U.S., leaving only surgical procedures or off-label use of misoprostol as options for terminating pregnancies in states where abortion is legal. Misoprostol, not affected by the injunction, is not FDA-approved for terminating pregnancies on its own, and the one-drug approach has been shown to be less effective than the two-pill regimen.
The Alliance for Hippocratic Medicine sued in November, claiming the government inadequately assessed the drug's safety and should not have made it accessible via telehealth during the pandemic. They sought an injunction to halt the use of mifepristone nationwide while the case plays out.
The case could ultimately be decided by the Supreme Court, testing the Court's pronouncement last summer that it was leaving the issue of abortion to states and other branches of government to decide as a policy question. The votes of Justice Brett Kavanaugh and Chief Justice John Roberts, who voted against overturning Roe, could be crucial.
Reactions to the decision have been mixed. Vice President Kamala Harris stated that the ruling undermines the FDA's ability to approve safe and effective medications based on science, not politics. Erik Baptist, senior counsel for the Alliance Defending Freedom, called it a significant victory for doctors, medical associations, and women's health and safety. Nancy Northup, president and CEO at the Center for Reproductive Rights, disagreed, saying the decision "has no basis in law or fact."
The lawsuit alleges that medication abortion has potentially serious and life-threatening effects, but studies have shown that when mifepristone and misoprostol are used together under doctors' supervision, the regimen successfully terminates pregnancies up to 99.6% of the time and has a 0.4% risk of major complications.
The FDA has argued that it extensively reviewed the scientific evidence and determined that mifepristone's benefits outweigh any risks. It also called the lawsuit "extraordinary and unprecedented." There is little legal precedent for a court to overturn an FDA approval of a drug.
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Solving The Puzzle Of How Cells Select Their Identity
It is well known now that stem cells formed during human development have the ability to become any cell in the body, but how do these cells know what type of cell to form? Now that is a much bigger mystery. We know that all cells have the same DNA and therefore a muscle cell has the same DNA as a cell in your brain but clearly they express different genes which gives them their unique forms and functions.
Our understanding of how every cell knows what to do has been quite limited so far. We previously identified Hox genes and determined that they helped define what area of the body is to become what (like limbs, torso, etc). More recently though, we’ve discovered polycomb proteins complexes. These proteins restrict the set of genes a cell can access and thus serve as a mechanism to restrict cells from expressing genes that they are not supposed to, for example, a heart cell should not be making antibodies, which is a function of a B-cell.
At the Trinity college in Dublin, researchers added to this body of knowledge and found that polycomb complexes can be used as a way to treat cancer, specifically PRC1 and PRC2. There are two forms of PRC2 but they have the same function, so the need of two different proteins to do the same function has been a puzzle to scientists. The researchers were able to finally answer that question, PRC2 has two forms because it has to recruit two different versions of PRC1 in order to function.
This discovery is very important in understanding how the mechanics of these proteins and therefore, how mutations in them can lead to cancer. The easiest way to envision this would be a non-functioning PRC which allows a cell to express a gene it shouldn’t be expressing.
There is still a long way to go in developing a therapeutic application that exploits this mechanism and perhaps stop the expression of cancer causing genes but now that we have a basic understanding of it, we can start working towards harnessing it as a therapeutic method.
Featured Fake News
In a clip posted on Instagram a bio-energetic chiropractor (we have no idea what that means) claims that annual mammograms for a 10-year period expose patients to Hiroshima levels of radiation.
This is completely false. According to a paper in the Journal of Breast Imaging titled “Radiation Doses and Risks in Breast Screening” mammograms expose patients to 0.36 millisieverts (mSv) per screening. According to the author of the paper, annual screenings over 10 years is in fact, just 10 times that amount, something anyone should be able to calculate with basic arithmetic.
Therefore, a total of 3.6 mSv is how much radiation a patient would be exposed to, and this is over the course of a decade, unlike an atomic bomb. In the 1-mile radius of the atomic bomb dropped on Hiroshima the radiation dosage was between 2250-2530 mSv. 3.6 mSv over 10 years is not comparable at all.
However, even if you are in the camp that no radiation is better than some radiation, you should know that mammograms are the most highly correlated reason behind the reduction and in breast cancer deaths.