Shire Pharmaceuticals is a global specialty biopharmaceutical company headquartered in Ireland with branches worldwide. The company was founded in 1986 by four entrepreneurs in the United Kingdom: Geoff Hall, Peter Moriarty, Gary Stafford, and Dennis Stephens. The company’s initial products included calcium supplements to treat osteoporosis. As the company acquired other businesses and developed as a biotechnology company, it specialized in medications and other treatment interventions for rare conditions.
Shire Pharmaceuticals markets products in more than 100 countries. The main offices for Shire Pharmaceuticals in the US are in Cambridge, Massachusetts, and Chicago, Illinois.
Available Medications in the United States
According to the company’s product website, Shire Pharmaceuticals offers a number of medications that are available in the United States. Some of these medications are detailed below:
- Adderall XR (amphetamine/dextroamphetamine) is a stimulant medication primarily prescribed for the treatment of attention deficit hyperactivity disorder (ADHD). It is a Schedule II controlled substance, according to the United States Drug Enforcement Administration (DEA), and also a major drug of abuse, particularly by younger individuals. Dexedrine/Dextrostat (dextroamphetamine) is a component of Adderall that is a separate stimulant medication that may also be used to treat ADHD and narcolepsy.
- Advate, Adynovate, and Hemofil‐M (antihemophilic factor) are blood clotting agents that have a number of uses, including treating disorders like hemophilia.
- Agrylin (anagrelide) is used to prevent blood clotting and to treat a number of disorders, including bone marrow issues.
- Aralast NP (alpha 1‐proteinase inhibitor) is used to treat respiratory disorders, such as emphysema.
- Buminate and Flexbumin (albumin human) increases protein and plasma levels in the blood.
- Ceprotin (protein c) is used to treat individuals who have severe blood clotting disorders.
- Elaprase (idursulfase) is used in the treatment of Hunter’s syndrome, a condition where the body lacks certain enzymes that break down proteins and sugars. These substances can build up and lead to potentially toxic conditions.
- Feiba NF and Feiba VH (anti‐inhibitor coagulant complex) is used in controlling bleeding during surgery, particularly in individuals with disorders that inhibit blood clotting.
- Firazyr (icatibant) is used to treat the complications associated with the immune system disorder hereditary angioedema.
- Gammagard (immune globulin) and Hyqvia (hyaluronidase/immune globulin) are anti-bodies that are used to strengthen the immune system.
- Gattex (teduglutide) is a medicine that helps to build up tissue in the gastrointestinal system, particularly the intestines, and is used to treat disorders like short bowel syndrome.
- Glassia (alpha 1‐proteinase inhibitor) is used to treat respiratory issues.
- Intuniv (guanfacine) is a medication that is used with other medications to treat ADHD. Intuniv is not a stimulant medication, but it is often used in conjunction with stimulant medications.
- Kalbitor (ecallantide) is used in the treatment of the immune system disorder hereditary angioedema. It is recommended for use in individuals over the age of 16.
- Lialda (mesalamine) is used for the treatment of ulcerative colitis.
- Natpara (parathyroid hormone) is used in conjunction with vitamin D to treat conditions that result in low calcium levels in the body, such as osteoporosis.
- Obizur, Recombinate (antihemophilic factor), and Rixubis (coagulation factor ix) are blood clotting agents used to treat conditions where individuals have disorders that reduce their ability to form blood clots (e.g., hemophilia A) or during surgery.
- Oncaspar (pegaspargase) is used in the treatment of lymphoblastic leukemia.
- Onivyde (irinotecan liposomal) is a medication that is used to limit the spread of cancer cells in the body and often used to treat pancreatic cancer.
- Pentasa (mesalamine) is used to treat the inflammation associated with ulcerative colitis.
- VPRIV (velaglucerase alfa) is used to treat a rare disorder known as Gaucher’s disease, a hereditary condition that leads to the buildup of certain fats and other substances in the body that can be toxic if not removed.
- Vyvanse (lisdexamfetamine) is a different central nervous system stimulant used in the treatment of ADHD. The DEA lists it as a Schedule II controlled substance.
- Xiidra (lifitegrast) eye drops are used to treat dry eye disease, a condition where individuals do not produce tears in their tear ducts.
As can be seen from the partial list of medications available in the United States, Shire Pharmaceuticals lives up to its goal to develop medications for a number of rare and specialized conditions. This includes medications used in the treatment of ADHD, which are also potential medications of abuse.
Some Legal Issues Associated with Shire Pharmaceuticals
All of the big pharmaceutical conglomerates have legal issues regarding their marketing practices and associated with some of the medications they distribute. Shire Pharmaceuticals is no exception to this.
- Some of the largest legal scandals associated with Shire Pharmaceuticals have to do with its marketing practices for its medications for ADHD. For instance, in 2014, the company was fined over $56 million for claiming that its drug Adderall would “normalize” children with ADHD. This is both an inaccurate and ridiculous claim. In addition, the company made unsubstantiated claims that use of Adderall could improve academic performance and reduce criminal behaviors in individuals who took the drug. Again, these are unsubstantiated claims and illustrate the lengths to which many pharmaceutical companies go to promote their drugs.Another questionable marketing practice used by the company occurred in 2016, when the company made claims that a drug still in clinical trials, labeled SHP465, was effective in treating ADHD in children and adolescents. While a drug is still in Phase III clinical trials, it cannot be released to the market until these trials are completed, and its status as a safe and effective medication is still questionable. This particular drug is another stimulant medication, and there were legitimate concerns regarding how this drug actually adds any treatment utility to the stimulant medications used to treat ADHD that are already on the market.
- Numerous lawsuits have been filed against Shire Pharmaceuticals regarding the side effects that are associated with children and adolescents who use Adderall. The company has agreed to continue clinical trials to identify these long-term and short-term side effects; however, it remains resistant to putting a black box warning on the drug for parents. Some of these lawsuits involve issues with the potential of the drug to produce addiction in individuals who misuse it.
- Shire Pharmaceuticals has also been involved in more than one lawsuit regarding false claims for its ADHD medications and some of its other medications to treat ulcerative colitis. For example, in 2014, the company paid a $565 million settlement to resolve false claims regarding these medications. In 2017, the company was forced to pay a $350 million settlement regarding false claims and unfair market practices (e.g., bribes, special favors, etc., to physicians) regarding a number of different medications. Of special interest here are the claims that Shire Pharmaceuticals engaged in unethical practices in an attempt to monopolize the market for its ADHD medications. A class action lawsuit alleges that Shire Pharmaceuticals attempted to delay the release of generic forms of Adderall presumably to maintain its market share for the product.
Shire Pharmaceuticals is a large biopharmaceutical company with locations around the world. It specializes in developing medications for rare conditions and to treat ADHD. The company provides a number of medications that are useful in the treatment of these rare conditions; however, it has also attempted to monopolize its hold on the medications used to treat ADHD. The company has engaged in several instances of unethical marketing practices regarding its ADHD medications and some of its other medications and continues to be the focus of litigation. In addition, the company has been the focus of numerous legal actions regarding the side effects of its stimulant medications.