Holly Kelly Ennis
Bayer's History of Malfeasance
Although the atrocities of the Essure device cannot be understated, Essure is one just facet in the long immoral history of the Bayer Corporation. Bayer AG was founded in 1863 in Barmen, Germany. Its first and best known product was aspirin. Few, however, may realize that in 1898, Bayer trademarked the name Heroin for the drug diacetylmorphine and marketed it as a cough syrup to children and as a non-addictive pain killer. By 1900, due to Bayer’s intensive marketing campaign, Heroin was Bayer’s number one product. However, in 1912 The Hague Opium Convention required the legal control of narcotics and Heroin was on the way out. 1
By 1915, Bayer found a new way to make money at the expense of others. During World War I, Bayer supplied over 700 tons of chemicals to the front lines. This included over 170 tons of chlorine gas used in battle, in violation of the Hague Convention, which had banned chemical warfare. Carl Duisberg of Bayer was present during the testing of the gases. Under Duisberg’s leadership, Bayer developed and sold increasingly lethal chemical weapons, including phosgene and mustard gas. These gases killed nearly 60,000 people as a result of the gas warfare started by Germany and from which Bayer profited immensely. 2
Bayer’s Role in the Holocaust
However, none of Bayer’s actions are as morally reprehensible as those which occurred during World War II and Bayer’s affiliations with the Nazis and the Holocaust. In 1925, a syndicate of six chemical companies was formed to create the chemical and pharmaceutical conglomerate, IG Farben. These six companies included, among others, Agfa, BASF, Bayer and Hoechst (now Sanofi-Aventis). 3 This conglomerate became the largest company in Germany and worked closely with the Nazis. IG Farben used slave labor in many of its factories and mines, picked from the various surrounding concentration camps. IG Farben’s largest plant was, not surprisingly, built in Auschwitz with an endless supply of slave labor readily available.
It is estimated that more than 83,000 forced laborers and death camp inmates worked in the IG Farben factories. Otto Armbrust, the IG Farben employee responsible for the projects, advised his colleagues, “Our new friendship with the SS is a blessing. We have determined all measures integrating the concentration camps to benefit our company.” IG Farben paid 100,000 reichsmarks each year to the SS and was assured a continuous supply of fresh slave labor.4 Additionally, an IG Farben subsidiary, Degesch, manufactured and supplied Zyklon B to the SS. IG Farben held the patent for this cyanide based gas, used during the Holocaust to annihilate more than a million people in the Auschwitz and Majdanek concentration camps. 5
Perhaps the most disturbing of all Bayer’s immoral actions during World War II, was Bayer’s participation in the medical experiments conducted at Auschwitz. Dr. Victor Capesius and Dr. Helmuth Vetter, an IG Farben employee and SS major, participated in medical experiments, along with the infamous Dr. Joseph Mengele, by order of Bayer Leverkusen. 6 Many people were infected with various diseases in order to test potential medications to be later marketed by Bayer. After the war ended, correspondence was discovered in the Auschwitz files between the camp commander and Bayer Leverkusen dealing with the sale of 150 women to be used in experiments:
“With a view to the planned experiments with a new sleep-inducing drug we would appreciate it if you could place a number of prisoners at our disposal (…)” – “We confirm your response, but consider the price of 200 RM per woman to be too high. We propose to pay no more than 170 RM per woman. If this is acceptable to you, the women will be placed in our possession. We need some 150 women (…)” – “We confirm your approval of the agreement. Please prepare for us 150 women in the best health possible (…)” – “Received the order for 150 women. Despite their macerated condition they were considered satisfactory. We will keep you informed of the developments regarding the experiments (…)” – “The experiments were performed. All test persons died. We will contact you shortly about a new shipment (…)” 7
During the Nuremberg Trials, an SS physician Dr. Hoven testified that, “It was clear that the experiments in the concentration camps with IG preparations only took place in the interests of IG….It was not the IG’s intention to make any of this public, but rather to put up a smoke screen around the experiments so that (…) they could keep any profits to themselves. Not the SS but the IG took the initiative for the concentration camp experiments.” 8 A classic example of one of the IG Farben employees convicted in the Nuremberg Trials was Bayer executive Fritz Ter Meer. Meer was responsible for the over-seeing the construction of the IG Farben factory in Auschwitz. He was found guilty of plunder, slavery and mass murder and was imprisoned until 1952. By 1956 he had become the chairman of the supervisory board of Bayer, a position he held until 1964. 9
From War Crimes to a Blood Bath
As Bayer transitioned into pharmaceuticals and medical devices marketed in the United States, the reprehensible behavior continued. From 1970 through 1985, Bayer’s Cutter Laboratories was the primary producer of the medication, Factor VIII, for hemophiliacs. Although at that time, there was no test for HIV, certain individual donors such as homosexuals, I.V. drug users and incarcerated individuals had a significantly higher HIV rate, and as such were NOT acceptable blood and plasma donors. In an effort to cut costs, Cutter purchased the blood to produce Factor VIII from the Arkansas Department of Corrections for $7 per pint of blood, which sold on the plasma market for over $50 per pint. Even worse, Cutter mixed this tainted blood with over 10,000 other donors infecting the entire blood supply. 10
Cutter Biological began manufacturing a heat-treated version of Factor VIII-which eliminated the infections in the blood in February 1984. However, even after it began selling the new product, it continued making and selling the old medicine until July 1985, as the company had several fixed-price contracts and knew the old product would be cheaper. Bayer then knowingly sold the tainted products for over a year, marketing them in Asia and Latin America. 11 This misconduct violated basic principles of medical and business ethics. When Bayer's Cutter Laboratories realized that their blood products, Factor VIII and IX or antihemophiliac factor (AHF), were contaminated with human immunodeficiency virus (HIV), the financial investment in the product was considered too high to destroy the inventory. As a consequence, hemophiliacs who infused the HIV-contaminated Factor VIII and IX tested positive for HIV and developed AIDS.12
It is impossible to ascertain how many thousands of victims received tainted blood and died from HIV illness. In the Spring of 1984, the CDC reported that 74% of hemophiliacs who used the unheated concentrate tested positive for HIV. 13 However, Cutter Biological collaborated with the FDA in order to keep the incident quiet. Dr. Harry M. Meyer, Jr., the FDA’s regulator of blood products requested that the issue be “quietly solved without alerting Congress, the medical community and the public,” showing both the FDA’s and Bayer’s desire to keep the scandal a secret. 14 Bayer later commented that it had, “behaved responsibly, ethically and humanely” in selling the old medication overseas, even though a much safer version was available. Bayer later sold drugs like IVIG and Mycelex to treat the very people they likely infected. Bayer has paid over $600 million in settlements for the damages caused by the tainted Factor VIII products.
Bayer Fined for Improper Activities
Bayer’s conduct has not only hurt thousands of individuals, but it has cheated the U.S. government as well. In 1995 Bayer conspired with Kaiser Permanente and broke the law by agreeing to sell Kaiser Permanente the antibiotic Cipro for less than it charged Medicaid, which was illegal. Bayer tried to simply re-label the drugs with Kaiser’s name and a different drug identification number. Bayer pled guilty and paid $257 million, the largest Medicaid fraud settlement in history at the time.15 Bayer also ponied up another nearly $100 million to the Justice Department to settle allegations that it paid kickbacks to a number of diabetic suppliers and caused those suppliers to submit false claims to Medicare from 1998-2002.16 According to the website Violation Tracker, Bayer has paid over $550 million in fines and penalties since 2002. 17
Bayer's Birth Control Failures
Although Bayer has exhibited improper conduct in marketing many of its pharmaceuticals, including Trasylol and Baycol, both of which have been removed from the U.S. market, no discussion of Bayer’s atrocities can be compete without discussing its Triple Crown failure in women’s birth control: Yaz, Mirena and Essure. Bayer very aggressively marketed the Yaz birth control pill and was fined by the FDA for false and misleading advertising.18 The Yaz products are the only group of oral contraceptives that combine estrogen with the synthetic hormone, drospirenone. Drospirenone has been linked to serious side effects including blood clots, stroke, pulmonary embolism, deep vein thrombosis and heart attacks. A government-funded study showed that oral contraceptives containing drospirenone increased blood clot risks by 75 percent. Studies in Germany and Great Britain showed the health risks from taking Yaz, Yasmin or Ocella are nearly double those of other birth control pills. Despite these findings and thousands of lawsuits, Bayer continued to market and sell these oral contraceptives, earning billions in sales. The FDA issued a series of warnings regarding the products and ultimately mandated labeling changes. Bayer paid over $1 billion dollars to settle thousand of Yaz birth control cases.
Mirena was approved by the Food and Drug Administration (FDA) as a contraceptive in 2000 and again in 2009 for the treatment of heavy menstrual bleeding. The IUD is a small t-shaped plastic device, which is inserted directly into a woman’s uterus to prevent pregnancy for up to five years. The device then releases a continuous low dose of levonorgestrel (hormone to prevent pregnancy) into the uterus. Mirena has been repeatedly linked to several significant side effects, including: perforation of the uterus, Pelvic Inflammatory Disease, intestinal obstruction and/or perforation, infertility, abscesses, erosion of adjacent areas such as the vagina, ectopic pregnancy and embedment in the uterus. Some or more of these injuries occur because the device may become dislodged and perforate or imbed itself into the uterus. It may also travel outside of the uterine cavity, which can cause scarring, adhesions, or more devastating, infertility. In 2009, the FDA issued a warning letter to Bayer after finding that its promotions of Mirena overstated the efficacy of the device and minimized its risks. 19 Bayer has also resolved most of the pending Mirena claims.
The Essure device was approved for use in the U.S. on November 4, 2002. Essure is a permanent birth control device consisting of a four-centimeter coil placed into each fallopian tube to prevent pregnancy by causing severe inflammation creating a total blockage of the fallopian tubes. The coil contains nickel, which some women are unknowingly highly allergic. The coil also contains polyethylene (PET) fibers, which irritate and inflame the tubes, causing scar tissue to form over the coils, blocking subsequent fertilization. Unfortunately the PET fibers which create the irritation to form the scar tissue, often cause the body to fight what it deems to be an infection or foreign body, creating a host of other problems from autoimmune disorders, neurological problems, kidney, adrenal and thyroid disorders and even cancer. The coils often become dislodged, perforating the fallopian tubes, uterus, colon or other internal organs.
Currently, there are nearly 20,000 Essure lawsuits pending in various jurisdictions around the country by women who were injured by the device and forced to undergo removal surgeries, including hysterectomies to remove the defective devices. Bayer has announced it would no longer sell the device after December 31, 2018. Bayer needs to do the right thing and resolve the cases for the thousands of women whose lives have been so adversely affected by this device. Bayer can expect the victims of Essure to continue to cause it pain that its aspirin can’t fix.
Bayer’s malfeasance continues with its recent purchase of Monsanto. Many atrocities have been committed by Bayer’s CropScience division, which will be the focus of an upcoming separate article. The ethical shortcomings of this company are many and varied. When will enough be enough?