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J&J Accused of Ghostwriting Campaign to Tout Risperdal's Off-Label Benefits

  • Jan 15, 2014
  • Kevin Pflug
  • What You Need To Know

Here at ClassAction.org, we are constantly combing through newly-filed lawsuits and court documents to uncover information that is valuable to our readers. What we found when reading through some of the court documents in the Risperdal personal injury lawsuits filed against Johnson & Johnson was, to say the very least, shocking. 

This practice, known as ghost writing, is purposefully calculated to create a positive buzz.

It’s typical for defective drug lawsuits to contain allegations that a drug company knew a drug was dangerous and released it anyway, or even that the company failed to properly test a product before it was sold to patients; however, it seems that the lawsuits involving Risperdal go one step further.

Attorneys representing Risperdal victims have alleged that the pharmaceutical giant hired other companies to ghostwrite scholarly articles proclaiming Risperdal to be a wonder drug. The articles, the attorneys claim, were written to encourage doctors to prescribe Risperdal for uses that had not been approved by the FDA. J&J is said to have been specifically targeting children and nursing home residents as patients who should be given Risperdal.

Regular readers of this blog will recall that J&J has been on the receiving end of a number of high-profile lawsuits. The company is set to pay out billions to settle lawsuits involving allegedly defective hip implants, is defending lawsuits filed by 11,500 women who claim they were injured by J&J’s Gynecare transvaginal mesh products - which the company was able to sell by exploiting a loophole in the FDA’s approval process - and has been accused of engaging in a multi-decade strategy of downplaying the risks of liver failure associated with Tylenol.

In the midst of all these allegations of improper behavior swirling around J&J, the lawsuits filed by Risperdal patients contain startling claims of corporate misconduct that truly shock the conscious, even against the backdrop of the shady behavior described above. 

How Did A Drug Only Approved to Treat Schizophrenia and Major Psychological Disorders Become the Seventh Best Selling Drug in America?

The master complaint, filed in court 2010 by attorneys representing patients who suffered severe side effects after taking Risperdal, details the health problems many patients experienced after taking the medicine. These serious side effects include gynecomastia (abnormal development of breasts in males), pituitary tumors, breast cancer, and rapid weight gain. As reported in the New York Times, Risperdal may have contributed to the deaths of 31 children since it went on the market in 1993.

According to the master complaint, Johnson & Johnson hired Excerpta Medica to develop a publication strategy whereby Excerpta would create favorable articles about Risperdal, including its prohibited, off-label uses. Circumventing federal regulations designed to prevent drug companies from writing these types of articles, the studies would appear as if they were conducted and written by doctors unaffiliated with Johnson & Johnson, when in fact they were undertaken by Excerpta and paid for by Johnson & Johnson, the complaint alleges.

To effectuate this strategy, Excerpta allegedly employed other medical marketing companies, doctors, and ghostwriters to publish “seemingly unbiased and independent publications regarding Risperdal.”

Johnson & Johnson paid Excerpta Medica to create a portfolio of articles to be published in medical journals that promoted Risperdal.  As stated in the lawsuit, the articles were:

“Written by medical writers or educators in the employ of Excerpta Medica, then academic authors were approached by Excerpta Medica to become the named ‘authors’ of such articles. This practice, known as ‘ghost writing,’ is purposefully calculated to create a positive ‘buzz’ in the medical community that appears to emanate from an unbiased perspective, giving the article and the glowing conclusions about Risperdal stated therein, false credibility. Accordingly, psychiatric thought was ‘shaped’ through the academic arena to create dissatisfaction in the market, and to establish a ‘need’ for and create a desire for Risperdal.”

As alleged in the master complaint, Excerpta had exclusive responsibility for drafting and revising the articles. In many instances, the doctors whose names appeared as the authors of these articles were not even allowed to see the data from the clinical trials or provide any meaningful input into the writing of the articles, according to the complaint.

One of the purposes of this ghostwriting campaign allegedly was to establish Risperdal as an attractive medicine for a much larger customer base. The campaign worked. As described by investigative reporting website Truthout, “How else do you explain a drug for schizophrenia (1 percent of the population), bipolar disorder (2.5 percent), and autism-related irritability in children 5 to 16 years old (less than 1 percent of kids) becoming the seventh best-selling pharmaceutical in the world in 2007?” Risperdal proved to be a blockbuster for Johnson & Johnson. It was the company’s best-selling drug in 2007 and generated worldwide sales of $24.2 billion from 2003 to 2010.

Ghostwriting by the pharmaceutical industry may be a widespread problem and the controversial practice is starting to receive congressional scrutiny. A report published in June of 2010 by Senator Charles Grassley’s office, entitled “Ghostwriting in Medical Literature” found that “the role of pharmaceutical companies in medical publications remains veiled or undisclosed” and that “detection of ghostwriting by medical schools is limited.”

Doctors For Hire

Johnson & Johnson also allegedly hired doctors to speak about the off-label benefits of Risperdal by paying Excerpta to produce and offer Continue Medical Education (“CME”) programs for doctors. For example, Excerpta conducted CME programs entitled:

  • Broadening Horizons: Advances in Understanding the Etiology, Effect and Treatment of Anxiety Disorders
  • Treating Anxiety: Current Therapies and Beyond
  • Atypical Antipsychotic Drug Augmentation in Resistant Major Depression Disorder.

Although Risperdal had not been approved to treat anxiety disorders or major depression disorders, doctors were allegedly receiving large checks from Johnson & Johnson to appear at these seminars and tell other doctors about how Risperdal is a wonderful drug to treat these disorders.

One doctor reportedly on Johnson & Johnson’s payroll was particularly effective in convincing the medical community that Risperdal could safely be used to treat broad groups of patients, including pre-school age children who had been diagnosed with bipolar disorder. The master complaint highlights the work of Dr. Joseph Biederman, a professor at Harvard Medical School and the director of the Pediatric Psychopharmacology Unit and Massachusetts General Hospital. Dr. Biederman is alleged to have received hundreds of thousands of dollars in contracts and funding from Johnson & Johnson to promote Risperdal as an effective treatment of bipolar disorder and other mental illnesses in children as young as two years old, as well as promoting the use of Risperdal in treating various mental illnesses in children and adolescents. This allegation is particularly troubling in light of the drug’s propensity to cause adolescent males to grow breasts.

The master complaint notes Johnson & Johnson’s approval of and enthusiasm for Dr. Biederman’s program at a pediatric seminar attended by more than 1,000 doctors where he advocated for the off-label use of Risperdal in children. According to the New York Times, Dr. Biederman “is the world’s most prominent advocate of diagnosing bipolar disorder in even the youngest children and of using antipsychotic medicines to treat the disease, but much of his work has been underwritten by drug makers for who he privately consults.” The New York Times observed that, “his work [funded by pharmaceutical companies] helped fuel a rapid rise in the use of these medicines in children.” To secure funding from Johnson & Johnson, Dr. Biederman reportedly told the company, before even conducting any clinical trials, that the results of his study would prove the drug to be effective when used on preschool age children. So much for the scientific method.

We will continue to cover the Risperdal lawsuits as they proceed. Given Johnson & Johnson’s recent history of settling lawsuits rather than facing victims in court, it is my belief that the Risperdal cases will eventually settle. In the meantime, if you or a loved one have taken Risperdal and suffered adverse side effects, you should talk to an experienced defective drug attorney as soon as possible to learn if you can participate in the pending litigation against Johnson & Johnson. 

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