In July, it was reported in
newspapers and TV news that GlaxoSmithKline LLC (GSK)
agreed to plead guilty and to pay $3 billion to resolve its criminal and civil
liability arising from the company’s unlawful promotion of certain prescription
drugs including
Paxil and Welbutrin, its failure to report certain
safety data about
Avandia, and its civil liability for alleged false
price reporting practices. The
resolution is the largest health care fraud settlement in U.S. history and the
largest payment ever by a drug company. Among
the unlawful promotion activities were providing hunting trips and Madonna
concert tickets for doctors.
In fact the GSK guilty plead was
only one of such settlement cases. What
was special was the escalating amount paid setting a new record of $3 billion. In January 2009, Eli Lilly and Company paid
1.4 billion for the criminal charges and civil liabilities of the off-label
marketing of the drug Zyprexa. In September
2009, Pfizer pleaded guilty to a felony violation of
the Food, Drug
and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Then $2.3 billion was paid to for the criminal
offences and the civil settlement. In
April 2012, Johnson & Johnson agreed to paid $1.2 billion for minimizing or
concealing the dangers associated with Risperdal. In May 2012, Abbott Laboratories Inc. pleaded
guilty and agreed to pay $1.5 billion to resolve its criminal and civil
liability arising from the company’s unlawful promotion of the prescription
drug Depakote for uses not approved as safe and effective by the Food and Drug
Administration (FDA).
What
had happened to these drug giants? What
were the unique features of these cases? Would these cases affect our practices? The following are my observations:
- There were criminal charges. It was the government against drug firms and there were vast investigatory power and resources. In May 2009, the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative was announced. The GSK case, for example, was investigated by agents from the Office of Inspector General of the U.S. Department of Health & Human Services (HHS-OIG), the FDA’s Office of Criminal Investigations, the Defense Criminal Investigative Service of the Department of Defense, the Office of the Inspector General for the Office of Personnel Management, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the Office of Inspector General for the U.S. Postal Service and the FBI.
- For the criminal charges, apart from fines, the drug firms had to enter into Corporate Integrity Agreements to “behave themselves” and the directors would be held responsible for further offences.
- Of course there were civil claims. Because of the contingency fee arrangement and the availability of class actions, product liability and personal injury cases were big money in the US. Fascinating stories had been written by John Grisham on those lawyers with private jets launching advertisements to recruit clients. For the current cases, there had been a new frontier of attack. Under the qui tam provisions of the False Claims Act, private citizens are allowed to bring civil actions on behalf of the United States and share in any recovery. The purpose is to encourage individuals to come forward and identify companies and individuals that defraud the government. For example, in the Eli Lilly case, the whistle blowers were its former sales representatives and they shared in 18%, or $78,870,877, of the federal share of the (civil) settlement.
- For your information, The Law Reform Commission published a report on 28 May 2012, proposing that a mechanism for class actions should be adopted in Hong Kong. The proposal was put forward after the Commission’s consultation paper in 2009.
- Although in these cases, it was admitted that free lunches and all kinds of benefits were provided to doctors to “encourage” them to prescribe those drugs in an off-label manner, the blame did not fall on the medical profession too much. The main reason was that drug firms with money, assets and insurance coverage were targeted. Doctors did not have deep enough pockets. Moreover, doctors were also cheated as the drug firms admitted withholding important research results and information, and at the same time falsifying data of researches.
- However, the images of doctors were affected. At least they were not independent professionals putting patients’ safety and well being as the first priority. Also, their abilities in critically appraising studies and evidence were doubted. For a lay citizen, it was easy to figure out a doctor prescribing just according to a casual chat from a drug representative who provided free lunches and Madonna concert tickets.
- All the cases were more or less on the off-label use of medicines. By definition, any use outside those approved by the FDA is off-label use. It can be about the indications, the dosages, the duration of use, and the use in specific groups of patients such as children and pregnant women.
- With these cases and judgments, doctors might need to be more careful on the off-label use of medicines. It does not mean that all off-label use of medicine should be prohibited or avoided. In fact off-label use of medicine is very common. However, certain points need to be remembered. First, the doctor needs to know that he is using the medicine in an off-label manner. Second, he has to be able to justify the use. He can either support it with data or studies. Exhaustion of available treatments may be another justification. Third, he should try to communicate with patients about the off-label use and to keep records of such communication. Of course, all these are easily said than done. At least, we should have the word “justification” in mind.
(Source: HKMA News July 2012)
