Bristol-Myers Squibb is an American, New York-based, but also international pharmaceutical company. It researchers, develops, and makes drugs that treat type 2 diabetes, autoimmune disorders, liver conditions, cancer, genetic disorders, and HIV. The company continues to grow and profit, but it has also paid out billions of dollars in fines and lawsuit settlements. Some of its drugs have proven to be dangerous. If you have been harmed by drugs like Farxiga, Byetta, or Eliquis, you may be able to make a case to get compensation.
Bristol-Myers Squibb – Overview
Bristol-Myers Squibb is one of the largest pharmaceutical companies in the world. With a focus on both research and development and manufacturing, the company makes some of the most important drugs for patients. These include medications for type 2 diabetes, Eliquis, a new-generation blood thinner, Baraclude, which treats hepatitis B, Orencia for rheumatoid arthritis, and many others.
The company was only created in 1989, but it was the result of the merging of two older businesses: Squibb and Bristol-Myers, both of which had been producing pharmaceuticals for more than 100 years. While the company has seen much success and continues to grow, it has also had setbacks. Findings of fraud, dangerous drugs, and clinical trial errors and cover ups have marred some of the success, but has not stopped the company from growing and making profits.
The history of Bristol-Myers Squibb is really of two companies, which merged in 1989 to create one of the biggest pharmaceutical companies in the world. Squibb was founded in 1858 by Dr. Edward Robinson Squibb, a U.S. Navy doctor unimpressed with the medications available at the time. He founded his company to research and develop better drugs in Brooklyn. Squibb provided the medications used during the Civil War.
Bristol-Myers was founded in 1887 when William McLaren Bristol and John Ripley Myers invested in a failing pharmaceutical company. The first successful Bristol-Myers product was a salt laxative called Sal Hepatica. Eventually, Bristol-Myers developed and manufactured many more pharmaceuticals including penicillin during World War II and other antibiotics.
When the two companies came together in 1989, Bristol-Myers Squibb was the second-largest pharmaceutical company in the world. Today the company is headquartered in New York City, but employs thousands of workers around the world and takes in several billions of dollars in annual revenue. Sales in 2015 were $16.6 billion, and over $4 billion was put back into research and development.
Eliquis is a newer type of blood thinner, developed jointly by Bristol-Myers Squibb and Pfizer to be safer and more effective than older blood thinners, like warfarin. As with all blood thinners Eliquis carries a serious risk of causing excessive bleeding. The drug companies claimed that this risk was lower with Eliquis as compared to warfarin, but evidence later showed that they may have made mistakes in clinical trials and then covered them up.
The clinical trials were supposed to prove the claim that Eliquis was safer and more effective than warfarin and other blood thinners. That may have been proven, but several issues were found with how the trials were conducted. Misconduct was found in several trials conducted in China, including cover ups of violations. Another issue was that a mistake in the trials meant that the researchers couldn’t say for sure that the patients got the medications they were supposed to receive. All of this delayed approval of Eliquis by almost a year and cast doubt on the effectiveness and safety claims.
Byetta and Bydureon
Byetta and Bydureon are injectable incretin mimetics, drugs used to treat type 2 diabetes by lowering blood sugar. Since being approved for this use, several problems have come to light. In 2007 the FDA issued a warning that Byetta may increase the risk of pancreatitis and pancreatic cancer in patients. Although no official warning has been made, there is also evidence that these two drugs may increase the risk of developing thyroid cancer.
Farxiga is another type 2 diabetes drug, belonging to the class called SGLT2 inhibitors. It was created through a partnership between Bristol-Myers Squibb and AstraZeneca. Since they first came on the market in 2013, SGLT2 inhibitors have been found to increase the risk of bladder cancer. There may be other concerns too, but the medications are too new to know for sure. The FDA has required that companies like Bristol-Myers Squibb continue trials to determine the safety of Farxiga and other drugs.
Although developed by Japanese pharmaceutical company Ostuka, Bristol-Myers Squibb partnered with the company to market this antipsychotic. Approved to treat schizophrenia and bipolar disorder, Abilify has been put under scrutiny for some unusual side effects. There have been many reports that it can increase the risk of developing a compulsive gambling or eating disorder in patients who take it.
Bristol-Myers Squibb has also come under fire for the way it marketed Abilify. The company marketed the drug for off-label uses, including treating psychiatric disorders in children and in older adults with dementia. While doctors may prescribe drugs off-label, it is illegal for companies to market drugs for any use not approved by the FDA.
Fraud and FDA Warnings
Bristol-Myers Squibb has made a few missteps over the years, and have been caught in some cases and charged with fraud. In one instance the company was accused of channel stuffing, a type of accounting fraud that involves convincing customers to buy more product than they need just to meet sales goals. In 2001 the company was accused of doing this to the tune of $2 billion. Investigations by the U.S. Department of Justice and Securities and Exchange Commission resulted in fraud charges and fines over $800 million.
Other fraud charges resulted in more than $500 million in fines and payments for Bristol-Myers Squibb between 1994 and 2005. Some of these charges included overcharging the government for drugs, paying kickbacks and consulting fees to doctors and other health care professionals to induce them to prescribe their drugs, misreporting the best price for an antidepressant called Serzone for Medicaid, and inflating the prices on oncology and other drugs for government health care programs.
Bristol-Myers Squibb has faced a number of lawsuits over the years, and if you have been harmed by one of their drugs, you too could file a lawsuit and seek compensation. For off-label marketing of Abilify the company had to pay over $515 million in settlement fees and fines. Byetta and Bydureon have triggered individual lawsuits from patients who claim the company did not adequately warn of the risks of pancreatitis and pancreatic cancer. Lawsuits over Eliquis claim that there were not adequate warnings about the risk of excessive bleeding and the fact that there is no antidote to reverse the action of the drug.
In addition to the lawsuits over dangerous drugs, Bristol-Myers Squibb has faced suits brought by the government over a number of fraud charges. The company was found guilty in most of these and has had to pay the federal government several hundreds of millions of dollars for overcharging, misrepresenting prices, and other fraud offenses and unethical practices. In spite of all the problems it has faced, Bristol-Myers Squibb has a strong research core and continues to grow and profit.