Bayer Group is a huge company with a long history and only one part of it is devoted to pharmaceuticals. That one part, though, has played an important role in the development and manufacturing of over the counter and prescription medications. It continues to create and develop drugs that both make a positive difference in people’s lives and cause some serious harm and complications.
Most famous for aspirin, Bayer has also been responsible for a number of medications that have led to major complications and side effects. Birth control devices and drugs like Yaz, Essure, and Mirena, the blood thinner Xarelto, and even heroin have all come from Bayer and have caused real harm to patients. Several of these have also led to lawsuits and harsh criticisms against the company.
Bayer Group – Overview
Bayer is one of the most recognizable pharmaceutical companies in the world, largely in part to its development of aspirin in the early 1900s. The Bayer group is a huge company, with over 100,000 employees and locations all around the world. The company includes divisions devoted to agricultural products, material science, business and technology services, and of course health care.
Under its health care division Bayer researches, develops, and sells prescription drugs, over the counter drugs, and medical devices. The health care division is further divided into animal health, medical care, consumer care, and pharmaceuticals. The pharmaceutical division is the part of the company that focuses on medical devices and prescription drugs. Some of Bayer’s prescription medications include Levitra for erectile dysfunction, Nexavar for treating cancer, Betaferon for multiple sclerosis, and several devices and drugs for contraception, including Yaz, Essure, Mirena, and Skyla.
Bayer is one of the oldest drug companies in the world. It was founded by two friends, Friedrich Bayer and Johan Friedrich Weskott in Germany in 1863. They began the company to research and sell synthetic dies, but soon after the founding also began to develop drugs. Bayer led the way in researching and developing new medications and produced its first drug, aspirin, in 1899.
Bayer grew by leaps and bounds, but was temporarily interrupted by the start of World War I. After the war Bayer became a part of IG Farben, a large chemical conglomerate, and didn’t become a separate company again until the 1950s. From that point on Bayer grew, making more new products and acquiring smaller companies. Bayer celebrated its 150th anniversary in 2013.
This drug, which is illegal classified as a schedule I controlled substance by the Drug Enforcement Administration, was created by Bayer in the early 1900s as a cough suppressant and painkiller. It was hoped that heroin could replace morphine and be less addictive, but this didn’t turn out to be the case. Bayer stopped making heroin after it caused a number of cases of addiction and after sending hundreds of people to the hospital for abuse of the drug.
Essure and Mirena
Essure and Mirena are both IUDs, inter-uterine devices, used to prevent pregnancies. Companies like Bayer have worked to develop these implantable, permanent or semi-permanent types of birth control to increase effectiveness and to make birth control more convenient for women. Essure is a device that was designed to be permanently implanted in the fallopian tubes. There it causes scar tissue to form that prevents eggs from being able to move from the ovaries to the uterus.
Many women have had success with Essure, but others have experienced complications including excessive bleeding, pelvic and back pain, organ perforation, unintended pregnancies, migration of the device, and allergic reactions. Some women have even had such serious damage that they required surgery to correct it, and even hysterectomies, or the complete removal of the uterus.
In addition to the problems with Essure, Bayer may not have acted completely ethically in the testing of the device and publishing results. Some experts claim that the company has overstated the device’s effectiveness. The FDA required Bayer to continue testing Essure after approving it, but the company delayed publishing troubling results of that study for several years.
Bayer also developed Mirena, a temporary implanted birth control device. This one is inserted into the uterus, where it releases hormones for up to three years. It can be removed at any time. As with Essure, there have been reports of serious problems with Mirena, including migration and perforation of organs, embedment in the uterine wall, and ectopic pregnancies. The FDA warned Bayer that its advertising for Mirena was misleading and overemphasized benefits while minimizing risks.
In addition to the devices, Bayer also developed an oral contraceptive called Yaz, which has caused a number of problems for many women. One of the biggest issues with Yaz has been the risk of developing blood clots. Blood clots can be fatal because they may travel to the lungs, heart, or brain and cause blockages that lead to heart attacks or strokes.
The FDA spent a lot of time investigating Yaz and its risks, ultimately deciding to leave it on the market. The drug does, though, come with a serious warning about the fact that it can increase the risk of blood clot formation by as much as three times. While Yaz was extremely popular when it first came out, and Bayer pushed it hard in marketing, it is now a much less popular choice for contraception.
Another big seller with some potential problems for Bayer is Xarelto. This medication belongs to a newer class of blood thinners, designed to be safer and more effective than older drugs like warfarin. Xarelto is used to prevent the formation of blood clots in people at risk for them. One of the biggest safety issues with any blood thinner is the possibility of excessive bleeding. Unlike warfarin, Xarelto does not have an antidote and cannot be reversed. Another problem with Xarelto is that it increases the risk of developing infections after surgery.
Bayer has faced serious scrutiny over Xarelto because it was found that the company left out important clinical trial data that demonstrated how dangerous it can be. Bayer is being accused of doing this intentionally in order to boost sales.
Bayer has faced a number of lawsuits because of problematic medications and medical devices. Practices like unethical advertising and hiding or delaying the release of trial data has made the company more vulnerable to lawsuits. Unfortunately in the case of Essure, Bayer has been protected from lawsuits. Some women have still attempted to file suits, in spite of this special preemption.
Yaz has been a major source of lawsuits facing Bayer, mainly over the risk of blood clots. In addition to the risk, Bayer has been accused of misleading advertising for the medication. To date the company has paid over $1 billion in fines and settlements related to Yaz. Lawsuits over Xarelto have been filed and accuse the company of hiding risk data, marketing the drug knowing of the risks, and overstating the effectiveness of the drug in preventing clots.