Does Aggressive and Sometimes Illegal Pharmaceutical Marketing Pay Off?
Early in the last decade the federal government began paying substantial attention to the marketing of drugs by manufacturers. Investigations and eventual settlements with Tap Pharmaceuticals ($875 million) and AstraZeneca ($350 million) paved the way for compliance guidance by CMS Office of Inspector General (OIG) published in 2003.
The guidance addressed potentially illegal marketing practices and the connection between marketing practices, kickbacks and false claims. The fraud related to the reporting of pricing by manufacturers to the government as well as the enabling of providers to charge for drugs given to them for free. The kickback issues related to all manner of gifts, grants, research monies paid to physicians to induce them to prescribe particular drugs as well as rebates, unreported discounts on drug products administered by physicians. The investigations and guidance led to a number of changes in the marketing practices of manufacturers to attempt to avoid kickback prosecutions. At the core, bribing doctors, in various ways to write prescriptions for your drugs became dangerous.
Apparently, the message did not get through all the way. Recently there have been a number of settlements and even guilty pleas by pharmaceutical manufacturers, including AstraZeneca ($550 million), Pfizer ($2.3 billion) and Eli Lilly ($1.4 billion) related to other unlawful marketing practices. However, these cases involved the promotion of so called “off label” uses for their drugs, with some allegations kickbacks as well. The Pfizer settlement stems from an investigation instigated by six whistleblowers, who received $102 million from the settlements. The complaint charged that Pfizer sent doctors on all-expense-paid trips to resorts, gave out free massages, and paid kickbacks to doctors, to provide incentives to the doctors for them to prescribe drugs for off-label uses.
There is a question of how effective current marketing efforts are without resorting to outright bribing of physicians to prescribe drugs. In an interesting article, available here, suggests that the current marketing by manufacturers worldwide is not particularly effective, even with increased marketing budgets. Also, the drug industry as a whole is headed for financial trouble with price controls which are likely inevitable. Therefore, it leads to the question of whether some of the discarded and potentially unlawful methods will be finding their way back into use with fines and settlements merely being the cost of doing business.
“Pharmaceuticals Out Of Balance - Reaching the tipping point” is available for download, click here.
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Increasingly the manner in which the government promotes its law enforcement efforts in the Medicare arena sound more and more like military operations or even Saturday morning cartoons. The creation of the “Strike Force” known as HEAT, Health Care Fraud Prevention & Enforcement Action Team, sounds a lot more like commandos than lawyers and agents arresting doctors and white collar criminals. In the press releases you see the use of the words “combat” and “battle” and now the battle also has phases: Miami (Phase One), Los Angeles (Phase Two), Detroit (Phase Three), and Houston (Phase Four).
In one of the recent pleas related to the government’s new focus on Medicare fraud in Detroit, a physical therapist and two others pleaded guilty to approximately $2.5 million in Medicare Fraud related to physical and occupational therapy services. Click
A Jacksonville physician, Janet Johnson-Hunter, pleaded guilty to altering medical records to justify ambulance transportation of patients. Rather than have the case presented to a grand jury and require the government obtain an indictment, Dr. Hunter-Johnson waived that right and instead pleaded guilty to an information, available
In an interesting suit filed against Amgen, the maker of Epogen, as well as two large dialysis clinic chains, Fresenius and Davita, a whistleblower alleges that salespeople for the drug company told clinic operators and physicians working there to prescribe specific dosage levels of the drug Epogen for patients based upon the maximum reimbursement under Medicare for the drug rather than actual patient needs.
