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Johnson & Johnson’s Drug Manufacturing Business

One of the biggest healthcare companies in the world, Johnson & Johnson, got its start in 1886 in New Brunswick, New Jersey, where Robert, Edward, and James Wood Johnson set up shop. Today, the organization is a global leader in healthcare products, innovation, biotech, and pharmacology, as over 250 companies work under the Johnson & Johnson umbrella in more than 60 countries around the world.

Notable Accomplishments

Johnson & Johnson is responsible for innovations in sterile surgery with the introduction of sterile sutures and white absorbent cotton, as well as public healthcare for the sale and mass distribution of dental floss, first aid kits, disposable sanitary napkins, baby powder and shampoo, the invention of Band-Aid brand adhesive bandages and waterproof duct tape, and the introduction of tamper-resistant medication containers and disposable contacts that can be worn as long as a week.

Johnson & Johnson entered into the drug manufacturing business in 1931 as their operating unit Ortho Products produced the first contraceptive gel (Ortho-Gynol). About 30 years later, Ortho Pharmaceuticals introduced oral contraceptives (Ortho-Novum), which played a large role in the revolution of widespread birth control pill use in the United States.

Johnson & Johnson’s pharmaceutical arm develops and produces many important medications. In 1959, they acquired both the European Cilag Chemie and the US company McNeil Laboratories. McNeil is responsible for the development of the popular over-the-counter and first aspirin-free pain medication Tylenol (acetaminophen).

The pharmaceutical companies of Johnson & Johnson, including Cilag AG and Janssen, make the healthcare magnate one of the biggest manufacturers of pharmaceuticals in Switzerland. Dr. Paul Janssen, an innovative scientist, founded Janssen Pharmaceutica N.V., a research laboratory in Beerse, Belgium, in 1953. In 1961, Janssen Pharmaceuticals became a part of Johnson & Johnson. Janssen put themselves on the map in 1960 with the discovery and production of Haldol (haloperidol), an antipsychotic medication for the treatment of schizophrenia that made it possible to treat the debilitating disorder outside of a mental institution.
Janssen is a pharmaceutical leader, and today, it has eleven drugs on the World Health Organization’s WHO Model List of Essential Medicines. Along with Johnson & Johnson, Janssen focuses on healthcare treatments in five main therapeutic areas:

  • Neuroscience
  • Oncology
  • Immunology
  • Infectious diseases and vaccines
  • Cardiovascular and metabolism

Legal Troubles of Johnson & Johnson

Failure often lurks behind major success, and large companies are rarely without legal entanglements. Johnson & Johnson and their pharmaceutical subsidiaries are no exception to this rule.

In the early 1980s, several people died in the Chicago area after ingesting Tylenol capsules that had been tampered with and had cyanide inside of them. While Johnson & Johnson was not considered to be at fault, they did swiftly recall the medication, which is manufactured by their subsidiary McNeil Consumer Products Company, and remade it into a tamper-resistant capsule form, setting a new standard for the industry. The New York Times publishes that Johnson & Johnson settled the lawsuit and agreed to pay the families retribution almost a decade after the deaths. This was not the end of lawsuits and legal troubles surrounding Tylenol, however.

In 2010, Johnson & Johnson was forced to recall more than 40 non-prescription medications, including Children’s Tylenol, after reports of bacterial contamination and quality-control failures. The Chicago Tribune reports that to date, this was the single biggest recall of children’s medications in the history of the U.S. Food and Drug Administration (FDA). While admitting no wrongdoing, Johnson & Johnson paid out a nearly $23 million settlement amid accusations of trying to suppress publicity about the issues.

In 2009, the FDA released warnings connecting high doses of acetaminophen (the active ingredient in Tylenol) to liver damage, stating that taking the drug beyond the recommended amounts could result in severe damage to the liver. Many lawsuits have been brought over the years against makers of Tylenol that are related to liver damage and injury. Tylenol and Johnson & Johnson took another hit in 2012 when around a half-million bottles of Infants’ Tylenol were recalled due to dosing problems.

Nearly 60,000 bottles of the anti-seizure medication Topamax (topiramate), made by the Ortho-McNeil Neurologics division, were recalled in 2011 due to odor issues and concerns over quality, CNN Money publishes.

Risperdal (risperidone), an antipsychotic drug used to treat schizophrenia and bipolar disorder, has also been under fire. In August 2004, the FDA forced Janssen Pharmaceuticals to place warning labels on Risperdal telling patients of the risk for diabetes and hyperglycemia associated with taking the drug. In 2012, Johnson & Johnson was fined over $1 billion, the biggest fine of its kind up to that date, for failing to disclose (potentially knowingly) the dangers of Risperdal for increasing rates of weight gain and thus diabetes in elderly patients for the 10 years it was on the market before the label changes, CorpWatch reports.

In 2016, Johnson & Johnson and its subsidiary DePuy Orthopaedics were ordered to pay more than $1 billion in damages to individuals who were implanted with defective Pinnacle hip implants made by the company, The New York Times publishes. More claims are sure to follow. Several years earlier, Johnson & Johnson and Depuy recalled several artificial hip replacement products after reports of them failing within a few years, NPR reports.

Though Johnson & Johnson has taken several hits over the years, the company has had many successes. It is widely considered a leader in the healthcare and pharmaceutical industry.

Nucynta

In addition to having several pharmaceutical subsidiaries, Johnson & Johnson also partners with other companies to develop and produce new products. In collaboration with Grunenthal GmbH, Ortho-McNeil-Janssen Pharmaceuticals, Inc. co-developed the analgesic opioid pain medication tapentadol (brand-name Nucynta), and immediate-release formulations became available in the United States in 2009. Tapentadol was discovered by Grunenthal as a prescription-based pain reliever for moderate to severe acute pain. Tapentadol is the first update and new molecular entity of its kind for opioid pain relief in more than 25 years, PR Newswire reports. It is a centrally acting opioid drug that blocks pain sensations and slows down some of the autonomic functions of the central nervous system, like respiration, blood pressure, and heart rate.

In 2015, Johnson & Johnson sold the rights to Nucynta to California-based company Depomed for just over $1 billion, Bloomberg reports. A specialty pharmaceutical company Depomed, Inc. is most widely recognized for their anti-seizure drug Gralise (gabapentin). Depomed currently markets both the immediate-release formulation of Nucynta and Nucynta ER, which is an extended-release formulation that provides around-the-clock relief for chronic pain.

Tapentadol was placed into the Schedule II classification as a controlled substance by the Drug Enforcement Administration (DEA) in June 2009. As a Schedule II drug, Nucynta is considered to have a high potential for diversion, abuse, and addiction. Opioid drugs are highly addictive, and regular use, or misuse, may lead to drug dependence and compulsive use. The FDA warns that Nucynta may be chewed, crushed, snorted, or injected when abused and has an abuse potential similar to that of hydromorphone. Abusing Nucynta may lead to overdose and death.

About 2 million Americans struggled with addiction involving prescription opioid drugs in 2015, the American Society of Addiction Medicine (ASAM) publishes. Opioids can create a pleasurable euphoric sensation when abused, which can lead to drug-seeking behaviors. Drug dependence may set in quickly, leading to significant emotional and physical withdrawal symptoms when the drug processes out of the body. For this reason, Nucynta should not be stopped suddenly. Often, medical detox and a slow and controlled tapering schedule are optimal for stopping use of the drug. Specialized addiction treatment after detox is needed to prevent relapse and promote long-term recovery.

Concerta

Janssen Pharmaceuticals also distributes the prescription drug Concerta (methylphenidate), which is a once-a-day, long-acting medication for the treatment of ADHD (attention deficit hyperactivity disorder). Methylphenidate is a stimulant drug that helps individuals who suffer from AHDH to focus their attention and concentrate better, helping to improve performance at work, school, and home, thus improving quality of life.

As of 2011, the Centers for Disease Control and Prevention (CDC) estimates that as many as 11 percent of children (between the ages of 4 and 17) have been diagnosed with ADHD in their lifetime. When used as directed, Concerta may be a very helpful tool in managing the disorder.

It is classified as a Schedule II controlled substance by the DEA because it is not always used as directed. It is regularly diverted and abused, and addiction to the drug is possible. In fact, the DEA reports that around 5 million Americans over the age of 12 have used methylphenidate for nonmedical purposes at some time in their lives. It is often heralded on college campuses as a “study drug,” as it can promote greater focus and help students to stay awake for long hours to complete projects or study for tests. It may also be abused as a weight loss supplement as the drug suppresses appetite.

Similar to the effects of cocaine on dopamine and norepinephrine levels in the brain, methylphenidate can also produce euphoria and is abused as a “party drug.” Concerta is often mixed with alcohol, which can increase the risk for life-threatening alcohol poisoning and issues related to polysubstance abuse.

Concerta can be habit-forming and lead to drug dependence and addiction, as individuals may struggle to control their dosage and use patterns. As a stimulant drug, the brain may stop making brain chemicals that are needed to feel happiness due to the continued presence of the drug. Motivation, concentration, and energy levels may drop; sleep may be disturbed; appetite levels can increase; and moods can become depressed after stopping Concerta use once dependence has formed with regular use or abuse. It can be difficult to stop taking Concerta without professional help, and it is not recommended to stop taking the drug “cold turkey.” Medical detox and a comprehensive addiction treatment program are needed to safely stop Concerta abuse.

When used in conjunction with therapeutic methods, Concerta can be a beneficial medication for those suffering from ADHD; however, the drug can have multiple negative consequences for people who do not have a medical need for it.

In Summary

Despite some issues throughout the years with particular medications, devices, and practices, Johnson & Johnson remains a leader in the medical, pharmaceutical, and consumer goods world.
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