Thalidomide is a synthetic drug developed in 1954 by German pharmaceutical company, Chemie Grünenthal, for use as a sedative in the treatment of insomnia and anxiety. Because of its purported atoxic nature, the use of this “wonder drug” quickly became widespread all over Europe. It was initially used to treat conditions like colds, headaches, and depression.
Problems began to arise in 1957 after the drug was remarketed for treatment of morning sickness in pregnant women. Over the next few years, doctors noted an influx of pregnancy complications, miscarriages, and birth defects. It wasn’t until 1961 that doctor Widukind Lenz of Germany connected this to the use of thalidomide during pregnancy. However, According to BBC News, when the drug was withdrawn, over 10,000 babies had been already affected. Complications included limb malformations, heart disease, facial malformations, and delayed mental development – all irreversible defects that the victims and their families would have to live with for the remainder of their lives.
Thanks to the meticulous work that Dr. Frances Kelsey carried out at the Food and Drug Administration (FDA), the approval of thalidomide was barred in the United States, thus sparing the country the disastrous effects of thalidomide.
The Thalidomide Scandal was not only a tragic medical mishap but also an extremely relevant event in the matter of corporate social responsibility. There are a series of reasons for which the actions of Grünenthal can be considered as the quintessence of irresponsible corporate behavior:
Inadequate Testing – Though Grünenthal had carried out some research on product safety, they failed to place any focus on gestation and effects on fetal development. The company did not give adequate consideration to the predictability issue, which is a matter of crucial importance whenever a new drug is released. Luckily, specific and stringent research practices that must be carried out in order for a pharmaceutical product to enter the market are currently implemented in many countries.
Wrongful Denial – For years, Grünenthal denied claims of thalidomide’s teratogenic properties despite concerns of neuropathy and congenital defects. Rather than issuing a recall while looking into its potential dangers, the company simply dismissed any claims. It was not until 2012, fifty years after the tragedy unfolded, that the company issued a formal public apology.
Research Manipulation – Grünenthal attempted to disrupt the scientific process by threatening the individuals raising concerns about its product. Private detectives were hired to spy on doctors and scientists. It also blocked the publishing of scientific journals addressing the negative effects of thalidomide, while bribing other journalists to praise its effectiveness. The company needed published articles testifying to the utility of the drug, so it used corrupt practices to obtain them. For instance, in Spain, a doctor declared he was prepared to write a short report whereby he would leave it to the company to “revise” the final draft. In the United States in 1959, Grünenthal and the American distributor of the drug, WM. S. Merrell, “convinced” Dr. Ray O. Nulsen, a Cincinnati physician, to publish a paper promoting Thalidomide safety during late pregnancy. In reality, as it eventually emerged, the article had been written by the medical director of the drug company.
Employee Selection – Grünenthal also showed irresponsibility in its employment process. Its affiliation with the Nazi party made it somewhat of a refuge for party members post-war. Dr. Heinrich Mückter, responsible for lethal testing of vaccines on prisoners, was appointed chief of research and production at Grünenthal during the development of thalidomide. Otto Ambros, Nazi war criminal guilty of mass murder, was appointed head of the advisory board.
Insufficient Compensation –Finally, the judicial ruling allowed Grünenthal to escape responsibility for their misconduct. After a 972-page bill of indictment was brought against the organization, the case settled out-of-court under terms of recompensation to the victims and their families. Sadly, surviving Thalidomiders are now entering late middle age, and many find their physical condition deteriorating. As a result, original compensation deals made in the 1970s are no longer enough to pay all the bills. Although, legally speaking, the likelihood of a successful legal challenge against the firm – already judged once and so long ago – seems next to zero. The lack of will to offer additional economic support to the victims denotes for the umpteenth time Grünenthal’s corporate irresponsible behavior.
Despite the heartache thalidomide has caused, it has made its way back into the pharmaceutical industry for treatment of leprosy, multiple myeloma, and other conditions. With the drug’s reinstatement, national health departments took measures to ensure history would not repeat itself. This requires collaboration between patients, physicians, regulators, manufacturers, distributors and pharmacists.
Although national health administrations must take responsibility in preventing further distress, pharmaceutical companies play a crucial role and can foster the adoption of more effective regulatory instruments. A glaring example is represented by Celgene, which followed such a direction in the United States by developing the STEPS programme to monitor the use and distribution of thalidomide. The protocol requires thorough education for all parties involved, contraceptive counseling for both men and women, frequent pregnancy testing for women of childbearing age, and the patient’s informed consent distributed to all necessary parties. Additionally, the STEPS programme implements a managed distribution system limiting the amount prescribed/dispensed at a time, and a mandatory registry to monitor patient and physician information and compliance.
However, due to the presence of regulatory double standard around the globe, some pharmaceutical companies may tend to consider in an irresponsible way the profit versus safety tradeoff. Such a risk is particularly relevant in developing countries. Where domestic regulations are inadequate, corporations should take it upon themselves to limit the distribution of drugs because they are aware of the potentially tragic consequences arising from the absence of safety guidelines. Although these steps may result in loss of revenue, it will ultimately benefit the company as it avoids legal liabilities that may arise, as well as builds a strong reputation in both the regulators and consumers’ eyes for making morally and ethically sound decisions.
Brazil’s current situation is a prime example of the necessity for stricter health regulations. Thalidomide was removed from the Brazilian market in 1965 for a brief period, but was never fully out of circulation. It was rapidly reinstated later that decade following the revelation of its effectiveness in treating leprosy.
For many years, there was no adequate legislation in place in the country. It wasn’t until 2011 that Claudia Marques Maximino, in association with the Brazilian Association of Thalidomide Syndrome Victims, sought and achieved approval of four main stipulations to thalidomide regulation: education; no administration to women of childbearing age; national register of physicians and patients; criminal charges for misuse.
Though these standards have been successful in reducing Brazil’s overall risk to the fetus, there’s still roughly four million thalidomide tablets being administered yearly, meaning the risk is still very present. As a matter of fact, today, Brazil is still highly susceptible to the negative effects of thalidomide because of its high prevalence of leprosy and its poverty crisis. There is a large population in need of treatment, but a great percentage cannot afford it. As a result, restrictions and costs encourage consumers to obtain the drug through other means. So it is not surprising that a scientific study has recently indicated that thalidomide is still causing congenital disabilities in Brazil.
India is the only country that surpasses Brazil in number of leprosy cases, with Indonesia falling in third. However, it’s been many years since India has reported any new victims of Thalidomide. While Brazil’s new regulation has made a great difference, a few more measures can be adopted from India’s healthcare system. First, it would be beneficial for the Brazilian Ministry of Health to make thalidomide analogs and safer drug alternatives available for its patients. Secondly, India utilizes a hospital administration system for thalidomide. To combat illegal dealing and drug sharing, Brazil may consider implementing this method of administration to ensure the correct patient is receiving the correct dosage, thus eliminating risk of unintended users.
The thalidomide scandal has taught us important lessons we must not forget. The existence and implementation of sound legislation are vital in medicine. This requires collaboration between patients, physicians, pharmacists, manufacturers, regulators, and non-government organizations. But, most importantly, in the absence of adequate regulations, pharmaceutical companies must exercise a greater level of corporate social responsibility because of the inherent nature of their business operations, which directly impact the lives of millions.