Novartis Accused of Paying Kickbacks to Boost Exjade Sales

Novartis Accused of Paying Kickbacks to Boost Exjade Sales
By Christie Smythe
Bloomberg Business Week
January 08, 2014

A Novartis AG (NOVN) unit was accused by the U.S. and a group of states of paying kickbacks to a specialty pharmacy to boost sales of Exjade, an iron-control drug that can cause kidney and liver failure.

U.S. District Judge Colleen McMahon in Manhattan today unsealed a complaint filed against Novartis Pharmaceuticals Corp. by the U.S., 26 states and the District of Columbia alleging that the drugmaker had paid kickbacks to BioScrip Inc. (BIOS:US) to encourage patients to refill prescriptions.

Separately, federal and state officials announced that the Elmsford, New York-based specialty pharmacy agreed to pay $15 million to resolve the claims against it.

Federal and state officials alleged that government health programs Medicare and Medicaid paid tens of millions of dollars in reimbursements based on false claims for the drug.

“This arrangement between Novartis and BioScrip was dangerous for patients and is against the law,” New York Attorney General Eric Schneiderman said in a statement. “Our lawsuit against Novartis and our agreement with BioScrip send a clear message: Drug companies cannot pay pharmacies to promote drugs directly to patients.”

Kickbacks, Calls

According to the complaint, Novartis paid kickbacks to BioScrip from February 2007 to May 2012 in the form of patient referrals and rebates. To hold up its end of the bargain, BioScrip made tens of thousands of calls to patients to try to convince them to keep taking the drug, federal and state officials alleged.

Julie Masow, a spokeswoman for Basel, Switzerland-based Novartis, said in an e-mailed statement that the company disputes the allegations in the complaint related to its interactions with BioScrip and intends to defend itself.

The company “is dedicated to improving patient health and supports patient medication adherence programs,” including outreach by pharmacies, Masow said.

Exjade was approved by the U.S. Food and Drug Administration in November 2005 to treat chronic iron overload due to blood transfusions, according to the complaint. In January 2010, the agency required the drug to feature a “black box” warning highlighting the potential for kidney failure, liver failure and gastrointestinal hemorrhage that in some cases were fatal, according to the complaint.

Increasing Refills

Novartis wanted to increase the refills of the drug because “its own market research had shown that a significant percentage of physicians and patients were opting to discontinue Exjade therapy” because of side effects, the officials said in the complaint.

In late February 2007, Novartis told BioScrip that because it generated lower levels of refills compared with other pharmacies, it had been placed on a “performance improvement plan,” according to the complaint.

Novartis “expects that the specialty pharmacies it works with conduct vital patient outreach in a manner wholly consistent with NPC’s commitment to patient care,” Masow said. “BioScrip reached out to patients using its own protocols to provide education, counseling and information about proper administration of the medicine and to fulfill prescriptions that have been prescribed by a patient’s treating physician.”

Officials are seeking triple damages against Novartis and civil penalties under the False Claims Act.

The case is ABC v. DEF, 1:11-cv-08196, U.S. District Court, Southern District of New York (Manhattan).

San Diego Pharmacy to Pay $11.4M to Settle Kickback Allegations

See other posts about doctors bought by insurance companies.

SD Pharmacy to Pay $11.4M to Settle Kickback Allegations
Alleged kickbacks included tickets to sports events, spa, golf and ski outings and expensive dinners
NBC 7
Dec 28, 2012

The U.S. Justice Department says a specialty pharmacy based in San Diego has agreed to pay about $11.4 million to resolve allegations it used kickbacks to induce doctors to write prescriptions for its products.

The Justice Department says under an agreement announced Thursday, Victory Pharma Inc. agreed to pay a criminal forfeiture of $1.4 million to resolve anti-kickback statute allegations and more than $9.9 million to resolve false-claims allegations.

The alleged kickbacks included tickets to sports events, concerts and plays, spa, golf and ski outings, expensive dinners and other events.

Authorities also say Victory encouraged sales representatives to schedule paid "preceptorships" in which they shadowed doctors in their offices to induce them to prescribe Victory's products.

A company phone listing could not be immediately located.

This San Diego doctor accepts checks from drug company representatives

I had an interesting experience on July 24, 2012 when I drove a friend to the doctor.

The receptionist said the doctor doesn't accept checks, so my friend paid with a credit card.

Then I saw one of those drug company representatives walk through the door. If you don't know what I mean, then you might have a particularly ethical doctor. The representatives are young and good-looking. This one was a man in a suit with the posture as straight as a marine's. He strode in pulling his black case on wheels, and was immediately ushered inside.

In my experience, the representatives are more often very attractive young women.

As I was leaving, I noticed a check lying on the receptionist's desk. I saw it was for $30.00. Apparently the doctor does accept checks--from drug representatives. I assume he was being paid to listen to the agent.

The receptionist saw me looking at the check, and she grabbed it quickly, then she couldn't seem to think of any good place to hide it, so she set it back down.

Years ago I had a neighbor who was prescribed an off-label drug (meaning used for a condition for which it was not approved by the FDA) she didn't need. That doctor's office was crawling with representatives almost all the time. Both the drug company and the doctor got in trouble with the law.

I wonder if my friend's doctor will prescribe unnecessary drugs after his discussion with the drug company agent.

Dr. Drew Pinsky responds to allegations he received GlaxoSmithKline payments

Dr. Drew Pinsky responds to allegations he received GlaxoSmithKline payments
By Michelle Castillo
July 4, 2012
(CBS News)

After being accused of taking payments from GlaxoSmithKline to promote the antidepressant Wellbutrin, Dr. Drew Pinksy told CBS News everything he said was in accordance with the law and accurate according to his medical experience.

"In the late 90s I was hired to participate in a 2-year initiative discussing intimacy and depression which was funded by an educational grant by Glaxo Wellcome," Pinksy told HealthPop in a statement. "Services for the non-branded campaign included town hall meetings, writings and multimedia activities in conjunction with the patient advocacy group the National Depresive and Manic Depressive Association (NDMDA). My comments were consistent with my clinical experience."

Pinsky - a board-certified internist, addiction medicine specialist, and radio and television personality - was mentioned in a complaint filed by the U.S. government against the pharmaceutical company, according to the Forbes.

The document states that Pinksy allegedly received two payments in March 2009 and April 2009 from GlaxoSmithKline totaling $275,000 to promote Wellbutrin SR. The Wall Street Journal reported in June 1999, he made statements on "Loveline," a television and radio show he co-hosted, saying that he prescribed Wellbutrin to depressed patients because it "may enhance or at least not suppress sexual arousal" as much as other antidepressants are known to do. Pinsky was also reported to have made comments on other media, including another national radio program called "David Essel - Alive!," Forbes added. In both instances, he did not disclose that he was paid by the company to do so, and he promote uses of Wellbutrin that had not been approved by the Food and Drug Administration.

GlaxoSmithKline recently plead guilty and had to pay $3 billion in the largest settlement of health care fraud in U.S. history, HealthPop reported. The company was charged with unlawful promotion of certain prescription drugs.

Do doctor-payment sunshine laws work?

Since the disclosure of information was to state agencies, not the general public, the state laws were less likely to influence doctors' behavior, one expert not involved in the research noted.

Do doctor-payment sunshine laws work?
By Andrew M. Seaman
Jun 4, 2012
(Reuters Health)

The mere passage of a law that requires drug companies to disclose how much money they pay doctors may not change physician prescribing practices, suggests a new study.

In two states that passed so-called sunshine laws requiring drugmakers to disclose payments, doctors' choices of which drugs to prescribe for their patients did not differ much from those of peers in states without such a law.

However, since the disclosure of information was to state agencies, not the general public, the state laws were less likely to influence doctors' behavior, one expert not involved in the research noted.

"It was a way of doing a quick analysis to even see if there was an impact we could measure," said Kavita Nair, the study's senior author and a associate professor at University of Colorado School of Pharmacy in Aurora.

Nair and her colleagues said they were trying to gauge the potential effect of a nationwide disclosure requirement.

The Affordable Care Act -- the broad overhaul of the U.S. healthcare system passed in 2010 -- includes a provision that requires drug companies to report certain payments made to doctors. Drug companies may pay doctors for, among other things, consulting, speaking fees or travel.

The reasoning behind disclosure requirements, according to the researchers, is that doctors will shy away from taking money or gifts that might influence their prescribing choices if the information is reported publicly.

In a letter to the Archives of Internal Medicine, Nair's team said they decided to look at the experiences of Maine and West Virginia -- states that each enacted sunshine laws in 2004...

Overall, "there were negligible to small effects of the disclosure laws in Maine and West Virginia for both statins and SSRIs," Nair's group concluded...

"This doesn't even present a bird's-eye view," said Charles Ornstein, who has looked at the issue of payments to doctors at ProPublica, a non-profit investigative news organization in New York.

Ornstein told Reuters Health that both Maine and West Virginia do not make their disclosures available online. And, he added, companies did not start disclosing how much they paid doctors until 2009 (the end of Nair's study period)...

"I think as more companies report, and this information has been out there a little longer, you'll see studies that are done with a little more robustness than this one," said Ornstein.

Dr. Jerome Kassirer, a distinguished professor at the Tufts University School of Medicine, said the information also needs to be accessible to researchers.

Kassirer, who has looked at the relationships between doctors and big business, told Reuters Health that the debate comes down to a conflict of interest.

"If I'm going to take advice form a doctor on a new drug or any kind of procedure, I'd like the advice from someone who is not conflicted," said Kassirer...

US to Force Drug Firms to Report Money Paid to Doctors

US to Force Drug Firms to Report Money Paid to Doctors
January 17, 2012
by: Robert Pear
The New York Times News Service

To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.

Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.

The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.

Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.

The Obama administration estimates that more than 1,100 drug, device and medical supply companies will have to file reports, generating “large amounts of new data.” Federal officials said they would inspect and audit drug company records to make sure the reports were accurate and complete.

Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.

Top executives are potentially liable because a senior official of each company — the chief executive, chief financial officer or chief compliance officer — must attest to the accuracy of each report.

The new requirements, or something very similar, will take effect soon; in fact, they are overdue. Under the new health care law, the administration was supposed to establish payment-reporting procedures by Oct. 1, 2011. The public will have until Feb. 17 to comment on the proposals, which are broadly consistent with the expectations of industry and consumer groups. After considering the comments, Medicare officials will issue final rules with the force of law.

Consumer advocates have long demanded details of the financial ties between doctors and drug and device companies.

Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts, said: “Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with a pharmaceutical company, but they are often uncomfortable asking the doctor directly.”

In an introduction to the proposed rules, the Obama administration says that patients can benefit when doctors and the industry work together to develop life-saving drugs and devices. But, it said, these relationships can also “lead to conflicts of interests that may affect clinical decision-making” and “threaten the underlying integrity of the health care system.”

The administration does not try to define the difference between proper and improper payments. It says simply that public reporting of the financial ties between doctors and drug and device companies “will permit patients to make better-informed decisions when choosing health care professionals and making treatment decisions.”

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul.

“The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

Christopher L. White, executive vice president of the Advanced Medical Technology Association, which represents makers of medical devices, said the payment data could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers.

“Some companies fear that doctors may no longer want to engage in consulting arrangements, and such reluctance could chill innovation,” Mr. White said.

Matthew D. Bennett, a senior vice president of the Pharmaceutical Research and Manufacturers of America, said the industry “supported transparency of physician payment information.” However, he said, it is important that payment data be presented in a proper context, emphasizing that interactions between doctors and drug companies played a critical role in improving care, educating doctors and fostering appropriate use of medicines.

Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices.

Although the Congressional Budget Office does not predict immediate savings, it has said that, “over time, disclosure has the potential to reduce spending,” by reducing instances of overprescribing.

The law also requires drug and device companies to report the amount of “any ownership or investment interest” held by doctors or their immediate family members, other than holdings of publicly traded stocks.

The administration intends to apply the same disclosure requirements to doctor-owned companies that distribute medical devices. Such companies allow doctors to benefit financially from sales of devices they use in surgery.

Influential research misses financial conflicts

Influential research misses financial conflicts
By Frederik Joelving
Mar 9, 2011
Reuters

Scientists who review large sets of drug trials for medical journals often ignore financial conflicts that might warp the evidence, according to a study out Tuesday.

That's more than just an academic problem, experts say, because the reviews are considered just about the strongest evidence that medical science can muster.

"It influences how physicians make decisions and how guideline panels come up with their guidelines," said Brett D. Thombs, of McGill University and the Jewish General Hospital in Montreal, whose findings are published in the Journal of the American Medical Association (JAMA).

Thombs' team found that of 29 reviews, or "meta-analyses," of earlier drug trials -- culled from top journals like JAMA and The Lancet -- only two reported who had funded the original trials included in the review.

And none of the reviews mentioned whether the authors reporting on those trials had been paid by drugmakers.

Such financial ties have been linked to research inflating the benefits of new drugs and downplaying the risks, said Thombs.

For instance, according to a 2008 report, only half the trials on antidepressants sent to the U.S. Food and Drug Administration, which approves new drugs, got a positive review by the agency.

By contrast, from the medical literature it appeared that more than 90 percent of the trials favored the drugs, because the majority of those that were unfavorable simply never got published...

U.S. doctors still too cozy with drug industry: report

U.S. doctors still too cozy with drug industry: report
By Julie Steenhuysen
Nov 9, 2010
Reuters

Doctors in the United States are still too cozy with drug companies, although they have managed to break some of those ties, U.S. researchers said on Monday.

The team at Harvard University and Massachusetts General Hospital did a national survey of 1,900 primary care doctors in 2009 about their contacts with drug companies.

They found 84 percent reported some type of relationship with drug companies, compared with 94 percent in 2004.

About two thirds accepted drug samples, 70 percent accepted food or beverages from drug companies and 14 percent accepted payment in exchange for their professional services, they reported in the Archives of Internal Medicine.

"We found a significant decline overall in the percentage of physicians who have relationships with industry," Eric Campbell of Massachusetts General, who led the study, said in a telephone interview.

In the team's first study of industry ties in 2004, getting drug samples or accepting lunches or other food from drug company salespeople were most common, followed by payments from drug companies for attending medical meetings or continuing education seminars.

Since then, several government and academic groups have pressured doctors to sever their ties to drug companies.

Members of Congress, including Senator Charles Grassley, an Iowa Republican, have been pushing to limit the influence of drugmakers over the practice of medicine after a probe showed a noted Harvard neuroscientist had failed to disclose payments from drug companies...

Drug Companies Hire Troubled Doctors As Experts

October 19, 2010
Drug Companies Hire Troubled Doctors As Experts
NPR Staff and ProPublica

Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of the companies' drugs.

But an investigation by ProPublica has uncovered hundreds of doctors receiving company payments who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.

To vet the industry's handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8 million in payouts since 2009 for speaking, consulting and other duties. The companies include Lilly, Cephalon, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer.

Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.

That is something not all companies do.

"Without question, the public should care," said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. "You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn't displayed good judgment in the past?"...

Was Dr. Nemeroff bought off by drug makers?

In the following case, I'm more disturbed about the doctor being bought by drug companies than by his failure to report income to the IRS.

Emory Psychiatrist Dr. Charles B. Nemeroff Did Not Report Drug Income
LINK
By Jenny Huntington
October 4th 2008

"Congressional investigators have revealed that Dr. Charles B. Nemeroff of Emory University, one of the nation’s leading psychiatrists, has failed to report income of more than $1.2 million, thus violating federal regulations.

"The money, which came from consulting arrangements with drug makers, has been earned by Nemeroff over a period of seven years, from 2000 to 2007. The total amount has been estimated at about $2.8 million..."