In a complaint unsealed last week in US District Court in Boston, prosecutors allege that New York-based Forest Laboratories Inc. illegally marketed the drugs Celexa and Lexapro for use in children by paying kickbacks, including lavish meals and cash payments disguised as grants and consulting fees, to induce doctors to prescribe the drugs. They also say the company misled doctors and the public by failing to disclose the results of a negative study.
In the 34-page complaint, prosecutors said that from 1999 to 2006, Dr. Jeffrey Bostic, director of school psychiatry at the hospital, gave more than 350 Forest-sponsored talks and presentations in 28 states, many of which addressed pediatric use of Celexa and Lexapro.
"Forest also paid Dr. Bostic to meet other physicians in their offices in order to ease their concerns about prescribing" the drugs, the complaint said. Doctors are allowed to prescribe children drugs not approved by the FDA for pediatric use, a practice called "off label" use.
The government said that Bostic became "Forest's star spokesman in the promotion of Celexa and Lexapro for pediatric use" and that the company paid him more than $750,000 between 2000 and 2006 for his presentations. The complaint quotes an unnamed Forest sales representative as saying, "Dr. Bostic is the man when it comes to child psych."
Bostic declined to be interviewed, but the hospital gave the Globe a statement describing him as a "highly regarded practitioner and educator in the field of psychiatry." The hospital said Bostic cooperated with the government, providing investigators with information about his speaking engagements.
"The United States complaint is brought against Forest Laboratories, not Dr. Bostic," the statement said. "The complaint consists of characterizations and allegations by the United States, not established facts. In those speaking engagements, Dr. Bostic talked to fellow physicians about the treatment of patients with various mental health conditions, not about one or two specific drugs."
On his Mass. General website on school psychiatry, Bostic outlines several treatments for depression in children and teenagers, including counseling and cognitive behavior therapy, as well as antidepressants. He mentions Lexapro and Celexa along with several other medications, and says, "There is no best medicine to treat depression."
Dr. Michael Jellinek, president of Newton-Wellesley Hospital and chief of child psychiatry at Mass. General, said he has known Bostic for years. "He has absolute integrity," Jellinek said. "I have seen no bias in terms of any choice of treatment or particular medication."
The allegations against Forest are part of a legal and political backlash against potential conflicts of interest in medicine, particularly in psychiatry. US Senator Charles E. Grassley, Republican of Iowa, has accused another Mass. General child psychiatrist, Dr. Joseph Biederman, of failing to tell Harvard Medical School until last March about most of the more than $1.5 million that the pharmaceutical industry paid him in consulting and speaking fees between 2000 and 2007. Biederman has said in statements and letters to the Globe that he has been conscientious about requirements that he disclose payments to his employers and that drug company money has not biased his research.
Harvard would not comment on whether Bostic disclosed his speaking fees, saying faculty disclosure forms are confidential.
In a statement, Forest said it "is committed to adhering to the highest ethical and legal standards, and off-label promotion and improper payments to medical providers have consistently been against Forest policy."
Pharmaceutical Bribing
Violating the anti-kickback statute, 42 U.S.C. & 1320a-7b (b) of 1987 is a serious issue. The statute is regulated by the Department of Health and Human Services (DHHS, www.hhs.gov), and their Office of The Inspector General (OIG), led by Daniel Levinson. Drug companies violate the False Claims Act (F.C.A.) with their marketing activities often by fracturing this statute.
This can result in causing the submission of false claims in the form of prescriptions to government health care programs. The company knowingly causes to be presented to the Fed. Govt. false/fraudulent claims for payment/approval.
Or the company knowingly causes to be made or used a false premise to get a false or fraudulent claim approved or paid by the Federal Government. Drug companies pay doctors to have them write more prescriptions for their promoted products.
And this violates this statute. Fed. Health care programs will not pay claims that were induced by kickbacks. This is knowingly and willfully paying of remuneration to induce others to refer or arrange for a health care item that is reimbursable under federal health care programs. It is a prerequisite to payment of federal health care funds, so kickbacks are F.C.A.s.
The company, by violating the anti-kickback statute, knowingly and willfully acts with deliberate ignorance and reckless disregard of the public's health. This marketing is offending to many, yet not many know about its frequency. Sales reps. constantly try to make health care providers favor and utilize their drugs for their patients, and these drug reps are often told by their employers that bribing them is the most effective tool in making this happen.
A useful prosecutorial tool is this anti-kickback statute, yet it is not a deterring statute, so it seems. Whoever knowingly and willingly offers or pays remuneration directly or indirectly, overtly or covertly, in cash or in kind to another in order to induce the prescriber, is now guilty of a felony. This crime could lead to a fine of 25,000 dollars, and less than 5 years in prison.
It is illegal criminal commercial bribery that prevents health care providers from fully acting in the best interest of public health with many of these providers, because the bribes potentially cloud their clinical assessment of patients. The drug companies often bribe those prescribers who write prescriptions in high volume.
Examples of those who have been caught utilizing this inducement:
:Forest Pharmaceuticals, Feb. 2009-
Paid kickbacks to induce health care providers to prescribe their drugs by providing these prescribers with various forms of illegal remuneration, such as high cash payments and valuable goods and services.
Sept. 2007: BMS- 515 million-
“Knowingly and willfully paid illegal remuneration to physicians and other health care providers to induce them to purchase BMS drugs. BMS paid the illegal remuneration in the form of consulting fees and expenses to physicians and other health care providers to participate in various consulting programs, advisory boards, and preceptorships. By paying this illegal remuneration, BMS knowingly caused the submission of false and fraudulent claims to the federal health care programs.
“Illegal drug marketing schemes will be vigorously persued by OIG”--- Daniel Levinson, HHS Inspector General: “We are committed to ensuring that others are not taken advantage of by those engaging in unscrupulous practices”.
11-08: Bayer- 100 million
Paid others to use their products overtly. “Those who pay illegal kickbacks should expect to be held -accountable.” --- Daniel Levinson
8—06: S Plough 435 million.
Kickbacks to insurers. “health care corruption erodes public confidence and affects both patients and doctors.” --- Daniel Levinson
2008:
Biovail 25 million for paying thousands of doctors 1000 dollars each to enroll 13 patients to place on their drug cardizem.
2-08: Merck 650 million:
Paid illegal remuneration to health care providers to induce them to prescribe merck’s products. Multiple programs were implemented by their sales reps. To induce health care providers to prescribe their products. This included excess fees to health care providers that were illegal kickbacks intended to induce the purchase of merck products.
2-11-2005:
Novartis pays about 50 million for eluding and impeding federal audits, as well as violating the fed. Anti-kickback statute by giving free medical equipment to potential clients. DOJ never did a press release. St. Louis Post Dispatch, and Bloomberg were only sources that reported this event.
90 percent of new health care fraud enforcement actions were initiated by whistleblowers. Less than 10 percent are sales representatives. One third of prosecuted schemes were illegal marketing, inappropriate financial relationships, and kickbacks.
Dan Abshear
Posted by: Dan | March 26, 2009 at 12:13 PM