Who will Check the Medicine?

By Yoel Donchin
haaretz.com

History books mention the German company IG Farben as the manufacturer of Zyklon B, which was used in the gas chambers of extermination camps. The firm employed forced prison labor in this process. However, in the wake of the First World War, the company's scientists actually developed chemicals used to dye textiles. After a number of compounds were found to bind well with the protein fibers of the cloth, it was decided to study the extent to which the dye could bind to the outer wall of bacterial cells, and thereby destroy them.

In 1927, a physician and microbiologist by the name of Gerhard Domagk was appointed to find a compound that could fight the bacterial infection responsible for the deaths of thousands in Europe during the period between the two world wars. The experiments began by introducing various dyes to bacterial cultures. Afterward, tests were carried out on animals infected with the bacteria, and finally, without any need for approval or oversight, the substances were injected into human subjects.

One day, Domagk was testing a chemical compound intended for dyeing leather, and found that it did not delay the growth of bacteria outside the body. Nevertheless, mice injected with fatal quantities of streptococcus bacteria and treated with this dye were found in their cages alive and healthy the next day. After further tests, it turned out that a specific component of the dye was the chief killer of the bacteria. A short while later, Domagk's daughter became dangerously ill with a bacterial infection. In a desperate attempt to save her life, he injected her with a little of this sulfa, and she recovered completely. (The dye did turn her skin reddish, but that was a small price to pay to save her life.)

In 1936, the 21-year-old son of President Franklin D. Roosevelt suffered a serious sinus infection, accompanied by respiratory difficulties and a high fever. The family doctor prescribed a sulfa injection, the president's son was cured in short order, and the drug subsequently won wide recognition throughout the United States.

The potential for enormous profit was not lost on the chief chemist of a small American pharmaceutical company by the name of Massengill. He believed that the medicine would be more widely used if it could be ingested orally, and therefore decided to dissolve it in a material known as ethylene glycol, which leaves a sweet aftertaste and is known as an anti-freeze for car batteries. The medicine was marketed throughout the U.S., without any efficient safety or monitoring methods.

Tragedy soon followed. Between September and October 1936, more than 100 children died throughout the U.S. after having taken the drug. Yet the authorities were unable to put the manufacturer on trial because no suitable law existed. One of the company's directors committed suicide, and finally, the manufacturers were charged with selling a prohibited material, because they had given the drug an illegal name. It was this tragedy that led Roosevelt to enact the law establishing the Food and Drug Administration (FDA).

The law requires the government to test every food and drug to be marketed, to assure that it meets the toughest standards. It protects the public from charlatans and greedy companies that want to hasten a drug's marketing without sufficient testing or oversight.

The need for this kind of agency was best illustrated in 1957, when a German company launched a huge publicity campaign for a new drug, Thalidomide, intended to reduce patient anxiety. The FDA director of that time, Dr. Frances Kelsey, did not rely on the reports and studies she received from the European manufacturers, and adamantly refused to approve the import of the drug.

Meanwhile, Thalidomide was marketed in Britain and Germany by means of an extensive PR campaign. The results were grave: The first babies born to mothers who had taken the drug while pregnant did not have limbs and suffered from numerous other birth defects. Later it turned out that the drug also harmed mice and other laboratory animals. However, no animal testing had been conducted prior to its release. There were only two such cases in the U.S. - in both of which the women had purchased the drug in Europe.

Today, every drug company knows that there is no chance of marketing a drug that does not have FDA approval. The approval process is long and stringent, and every researcher knows the protocol: Every research stage must be repeated twice, to clearly prove that the benefit of the drug is greater than any damage it could cause. In addition, experiments have to be carried out on human subjects who understand the risk involved.

The FDA stamp of approval also extends to medical equipment, ensuring that it meets safety standards and does not endanger patients; it tests stents and pacemakers, measures the accuracy of devices to determine bloodsugar, the amount of radiation emitted by medical equipment, etc.

In recent years, with an increased awareness of the possibility of errors in administering drugs, the agency has insisted that every new drug be given a completely different name, at least in a number of syllables, from existing drugs on the market, to prevent confusion among buyers.

The FDA wields tremendous power in the U.S. For us, as a small country, its test results are important. There is no point in discussing the introduction of a new drug or device to Israel before the FDA has considered it. Nevertheless, the Israeli government must also test drugs and equipment before they enter the country, because sometimes data exists that was unavailable to the American agency.

However, adding to the other privatizations that are the result of the state's disengagement from its responsibility for public health, this week we learned that the Health Ministry may divest itself of the need to test and approve drugs for import ("Hospitals seethe as ministry decides to quit overseeing some drug imports," Ran Reznick, Haaretz, July 27).

Instead, the hospital director or the importer will be responsible for the safety of dangerous materials. To save money, the health-care system is absolving itself of the most basic responsibility for the public's wellbeing. It is renouncing the need for an independent body that will prevent the recurrence of instances like the sale of sulfa, which contained poison, or the marketing of Thalidomide, which harmed babies.

No wonder hospital directors and the Israel Medical Association are horrified by the regulation now being cooked up by the government, and no wonder the finance and health ministries are adopting this economizing step. However, the individuals working in these ministries are not immune to the poisons that will be brought into Israel; they should remember that the craving to save money, which is devouring them, might one day harm them, their families, their children, and the entire structure that has been built over the years with great effort, whose goal is to protect the public. Be warned, the above stories are not fables; they are fact.

The writer is the director of the Patient Safety Unit at Hadassah University Hospital, Jerusalem.

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