BOSTON- The U.S. Attorney's office filed a complaint in January 2010 against Johnson & Johnson for violating the anti-kickback statute and False Claims Act. Allegedly, J & J paid kickbacks for five years to Omnicore Inc, a long term care pharmacy, to increase the number of elderly patients taking the antipsychotic Risperdal and several other medications.
Omnicare, due to its contract with J & J, sent faxes to thousands of doctors asking them to switch their dementia patients to Risperdal. Between the years of 1999 though 2004, Johnson & Johnson's annual sales jumped from $100 million dollars to more than $280 million. The pharmacy's annual purchase of Risperdal rose to more than $100 million, according to the complaint filed.
Risperdal is approved by the Food and Drug Administration to treat schizophrenia and bipolar disorder, it is not specifically approved to treat behavioral problems in elderly people with dementia. In fact, in 2005 the FDA required that Risperdal carry the black box warning label. It warns that elderly people treated with this drug had an increased risk of death compared to those taking placebo.
Regulations, enforced by the government, are in place to protect residents in nursing homes from medication mismanagement. However, the outside consulting pharmacists in charge of reviewing the patient's medication once a month may be involved. They have the authority to recommend that a physician remove, change or add medications to the patient's drug regimen. The government complaints that the very people entrusted with safeguarding the integrity of nursing home drug prescriptions are the ones guilty of corporate gain.
Day after day, pharmaceutical companies betray proper business ethics for financial gain. Therefore, more Certified Product Safety Specialists and Legal Nurse Investigators are needed to help the victims on these cases.
Certified Product Safety Specialists (CPSS)
are responsible for minimizing the risks in the product safety industry by identifying, screening, reviewing and reducing potential problems. A CPSS can develop reports regarding damages and injuries potentially caused by a product. The CPSS course was developed for the staff of a multi-billion dollar pharmaceutical company. With the many products that are under scrutiny, the need for this type of new age specialty is at its highest! The concern of product safety has become a worldwide issue. Consumers are more educated now than ever before. No longer are they relying on what the doctor ordered. Products are being advertised on television, in magazines, in newspapers and even on billboards. The product industry is leading the world's income. There is an alarming increase in the number of lawsuits against product manufacturers, importers and distributors. Pharmaceutical companies are being hit the hardest. The media becomes involved with increasing the awareness of many products once they are suspected of causing harm to the consumer.
Denise Lavoie and Linda Johnson-www.news.yahoo.com
Natasha Singer- www.nytimes.com