The short answer to that question is: probably not but we cannot be certain.

            Let me beg your indulgence in an explanation about why that is the only honest answer I can give you.

            The “gold standard” in assessing the risks and benefits of any medication is the “controlled trial”. In such a trial, a large group of people are randomly assigned to drug A or drug B or to Drug A or placebo. This tends to ensure that differences in outcomes between the people taking one treatment or the other are due to the treatment and not to the characteristics of the people taking them. With a large enough group and truly random assignment, differences among the subjects are assumed to be evenly spread.

            Historically, drug trials have excluded pregnant women because the trial sponsors worried that they would be sued for any bad birth outcomes. While this did protect the trial sponsors, it meant that most of the time, we were totally in the dark about the safety and efficacy of drugs when prescribed to pregnant women.

            The fallback has been the “observational trial.” You look at a group who took a given drug and compared their outcomes to a group who did not.

            The enormous problem with observational trials is that they are often comparing apples to oranges. People who take a medicine on their own are not the same as those who do not.

            Let us take acetaminophen as an example. We know that about 60% of women take it during pregnancy. Most of the trials that report more neurodevelopmental disorders (autism, ADHD) in acetaminophen users compare women who used it with those who did not.

            What is the commonest reason for acetaminophen use? It is fever. Thus, acetaminophen users are much more likely to have had febrile illnesses than those who did not use it. If there is an increased incidence of autism among users, the culprit might just as easily be the febrile illness, not the drug.

            Until someone – and realistically it will have to be the NIH, as no commercial firm will pay for it – does a controlled trial comparing pregnancy outcomes among women who take acetaminophen with those who take a placebo, we will be offering advice either way with imperfect data.

            The closest I can find to a good study is one out of Sweden that used successive pregnancies of women who had more than one child, comparing the siblings and looking at acetaminophen use. This study found no increase in autism, ADHD or learning problems caused by acetaminophen use. Again, though, this was an observational study.

            Given this, what is the best advice you can take?

            First, as is true for all medications, take medication only when you need it. A temperature of 99.6 does not need treatment. A temperature of 102 is harmful to the fetus and should be treated. If you have a backache that can be relieved with heat or a backrub, skip the pills. If you are very uncomfortable, acetaminophen is clearly safer than anti-inflammatories such as ibuprofen or naproxen, that are known to cause fetal malformation, or narcotics.

            Second, try to take it for as short a time as possible. The limited data we have suggests that chronic use is worse than occasional use, and that makes physiological sense.

            Edward Hoffer MD is Associate Professor of Medicine, part-time, at Harvard.

What Does The Doctor Say?

By Dr. Edward Hoffer

            This week in Revolutionary War History, let’s discuss what was going on 250 years ago in and around the colonial Province of Massachusetts Bay.

            Last week was busy: Washington attempted to maintain his land claims to nearly 20,000 acres in what would become Ohio; Washington works with Nicholas Cooke to permit merchants in Providence to buy arms and powder in the Caribbean; a mutiny aboard the American schooner the Hannah occurred, leading to the flogging of 13 and fines for another 21 sailors; and finally, the Continental Congress began to amass resources to get the army through the encroaching winter.

            On September 24, 1775, Washington’s General Orders, following the court martial of Major Scarborough Gridley for “being deficient in his duty upon the 17th June last, the day of the Action upon Bunkers-hill,” declare the desire to name and index all soldiers in the army, per request from the Massachusetts House of Representatives. The main information needed by the governing body is troop count in order to ascertain supply needs for the winter. They need to know who is stationed around Boston, who is heading north to Quebec, and who is dead.

            Of the voyage to Quebec, Colonel Benedict Arnold writes to Washington on September 25, telling the general of their arrival to Fort Weston, District of Maine (near Augusta). This same day further north, Ethan Allen, hero of Fort Ticonderoga and a leader of the Green Mountain Boys, is captured following his defeat at the Battle of Longue Pointe just outside Montreal. Allen would remain a prisoner aboard British ships until a prisoner exchange nearly three years later in 1778.

            The next day, Nicholas Cooke of Rhode Island cautions against future trips to Bermuda for arms and powder. He instead re-emphasizes the proposition discussed last week of sending ships to Bayonne, France to pick up from friendly merchants. He states he will forward this plan to the Continental Congress in Philadelphia. His writings also highlight the importance of Falmouth, being the origin point of more possible supply trips to Bermuda.

            On September 28, the Canadian Brigantine Dolphin is found anchored off Thatcher Island near Gloucester. The Gloucester Committee of Safety writes to Washington to inform him the ship was carrying 68 sheep and 45 oxen, a gift to British soldiers stationed in Boston from merchants in Quebec. A few days later, he would order the Dolphin to be seized, and cargo sold by the committee.

            Also on September 28, Washington writes to the Massachusetts General Court informing them of communications he’s received from the Oneida tribe, a member of Haudenosaunee (Iroquois Confederacy). He states of a visiting representative, “his tribe has been very friendly to the cause of the united colonies.” Washington emphasized this meeting’s importance to the court and urges further cooperation to sway the people into joining the conflict more directly.

            On September 29, Nicholas Cooke writes to Washington to inform him that the 74 men stationed on Block Island have observed “six transports, with some ships of war, are now in the Vineyard Sound, designed, without doubt, to procure another supply of fresh stock.” The British ships are patrolling the waters, looking to raid and capture provisions and livestock.

            On September 30, Washington’s General Orders highlight the postponement of a court hearing between surgeons and Chief Physician & Director General Benjamin Church of Newport. Doctor Church, the day prior, had been found to have “carried on with the enemy” following the deciphering of his letters. His trial would be discussed at an official Counsil of War on October 3.

This Week In Revolutionary History…

By Sam Bishop