Dank journal oct nov 2016

Page 11

OCTOBER/NOVEMBER 2016

Trials from page 10 dom of France and imposed substantial fines for counterfeiters. Good connections at Versailles were often a critical asset in securing a monopoly. In a premodern parallel to concerns over collusion between political elites and today’s pharmaceutical industry, one royal physician, Claude Jean-Baptiste Dodart (1664–1730), felt pressured to recommend privileges for the medical favorites of powerful officials and members of the royal family. In 1728, Dodart decided to share the responsibility of evaluating new drugs with an expert committee of physicians, surgeons, and apothecaries. The committee was tasked with assessing whether drugs were truly novel, and it screened for thinly disguised variants of drugs already in the “public domain” of the pharmacopoeias (the “me-too” drugs of the 18th century). Dodart’s reforms did not last long, however. One of his successors, the royal physician Jean-Baptiste Sénac (1693–1770), was widely believed to approve drugs in exchange for money, regardless of the opinions of the commissioners.4 The testing of drugs to support the granting of monopoly privileges was sometimes closely linked to military procurement. State officials recognized that diseases — typhus, typhoid fever, malaria, and dysentery — often killed more soldiers and sailors than did actual combat, and they looked to civilian contractors to supply them with critical drugs. Among the most famous drugs to be tested for both monopoly privilege and military use in 17th-century France was the dysentery remedy of the Dutch-born physician Adrien Helvétius (1662–1727). The drug’s principal ingredient was ground ipecacuanha root (ipecac) from Brazil. It was prepared using Helvétius’s secret technique to moderate its powerful emetic properties so that it would pass into the digestive tract, where its “specific virtue” could act against dysentery. To guarantee the efficacy of the drug, Louis XIV’s naval secretary ordered

German - American Journal

Helvétius to undertake trials in Parisian hospitals under the supervision of two practitioners from the royal household. The hospitals were not necessarily interested in cooperating with ambitious medical entrepreneurs, however, and Helvétius faced resistance from the spiritual director and nursing sisters when he tried to remove four men from the Hôtel-Dieu in order to isolate and better supervise the trial at a private residence. He turned to his royal patrons to expedite matters, and they ordered the hospital to accede to the king’s wishes and comply with Helvétius. The trial was successful, and in 1688 Helvétius was granted a legal monopoly over the production and sale of his drug.5 Similar military-led efforts were undertaken in the Holy Roman Empire, and the English navy famously tested remedies for scurvy in the 18th century. Research has demonstrated that successful trials — supervised by practitioners close to the monarch and conducted in animals as well as in human patients — furnished critical evidence for officials who granted pharmaceutical monopolies between 1500 and 1800. The application and testing processes remained enmeshed, however, in the overarching structures of patronage and power that governed early modern states. Today, our understanding of pharmaceutical intellectual property tends to start with the patent as conceived from the 1790s onward. Before that point, monopolies on a given drug’s sale were granted as a gift from the monarch rather than being a right of the entrepreneur. By the end of the Enlightenment, new liberal notions of intellectual property would redefine citizen-inventors’ ability to profit by their inventions as a right rather than a privilege. Such new beliefs would also demand public disclosure of knowledge, time limits on monopolies, and their management through government patent offices. But the older, absolutist form of intellectual property had already mobilized pharmaceutical trials in relation to statesanctioned monopolies.

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