Kickbacks to Physicians/Pharmacies
The $300-per-person, 'doc-in-a-box' dinners that put Salix on DOJ's naughty list
Need more evidence that pharma’s fancy dinners with doctors don’t automatically count as educational events? Check out the details behind Valeant Pharmaceuticals’ recent settlement with the Justice Department, over its Salix unit’s gastrointestinal drug marketing.
According to the whistleblower complaint joined by the U.S. Attorney’s Office, Salix sales staff stepped over multiple lines when entertaining physicians on behalf of a range of brands, including the irritable bowel syndrome drug Xifaxan and the constipation med Relistor.
They spent far more on food and drinks than the “modest” amount allowed--$200 to $300 per person, in some cases--and gave short shrift to the educational program purportedly at the center of each event.
Sales managers pressured reps to set up more events and expected the sales force to “spend, spend, spend, spend, spend, spend,” one former rep is quoted as saying. And as one sales manager’s email stated, the guests were expected to be people who’d deliver “ROI” down the road, the lawsuit says.
Live speakers spent little or no time talking about the drugs involved, the lawsuit says. Slide presentations weren’t shown in full, and sometimes weren’t shown at all. The guest lists sometimes included people without “legitimate interest” in the topic at hand, such as doctors’ spouses.
When it came time to fill out paperwork afterward, Salix employees responsible for certain programs added names to the guest list, to spread out a big restaurant tab over more guests than actually attended. That way, they could fudge the per-head cost to avoid raising red flags to their higher-ups. Some reps reserved the most lavish meals for doctors who delivered the most scripts for Salix products.
For Xifaxan alone, Salix spent about $20 million on honoraria and meals. For all six of the GI products involved, the tally was 10,000 speaker programs at a cost of about $25 million, the lawsuit states.
These details are mostly familiar to readers of the DoJ’s lawsuits against drugmakers, even down to the names of the high-restaurants Salix reps and their doctor guests frequented. Nobu and Le Bernardin in New York, for instance.
One departure from the norm: Salix not only paid live speakers, but shelled out for physicians to create video presentations for speaker events. They were dubbed “doc-in-the-box” programs, and they were easily dispensed with. When the group didn’t want to take the time to view a program, the laptop or iPad would be set aside to run the presentation unheeded.
All of these details add up to the DoJ’s case against Salix, which Valeant acquired in a 2015 buyout. The allegations run from January 2009 to December 2013, so they pre-date Valeant’s ownership. Salix agreed to pay $54 million to federal and state governments to resolve allegations under the Anti-Kickback Statute and False Claims Act.
Another semi-unusual aspect of this settlement: Salix “made extensive admissions regarding its conduct,” the Justice Department said in a statement. For instance, it acknowledged that it paid doctors to serve as quote-unquote speakers at events that were a., essentially social events, and b., included little or no time for medical talk.
“With today’s settlement, Salix has taken responsibility for its conduct and agreed to pay a significant financial penalty,” said Manhattan U.S. Attorney Preet Bharara, who’s been prosecuting a variety of pharma marketing cases. “This action and settlement is part of our continuing effort to pursue health care providers who put their profits ahead of patient safety.”
- see the court document
- read the DoJ release
Source : FiercePharma (June 2016)
Doctors Got $6.5 Billion From Drug, Device Makers in U.S.
U.S. doctors and teaching hospitals got $6.49 billion from drug and medical-device makers in 2014, according to new government data on the financial links between the companies and the people who prescribe their products.
The data released Tuesday range from the royalties paid to hospitals to help develop products to fees provided to medical experts to speak at a dinner with colleagues. The payments are listed in two broad categories: money to fund research and payments to entertain doctors or compensate them for consulting or other non-research purposes.
By disclosing information on the payments, the U.S. is seeking to bring transparency to the financial relationships between drugmakers and health care providers. Those ties can influence how physicians practice, even if they aren’t aware of it, said Jason Dana, a professor at Yale School of Management who studies decision-making.
“If we have a financial incentive to believe something or conclude something, we kind of trick ourselves into thinking it’s true,” he said. “And we’re not always aware we’re doing it.”
The Centers for Medicare & Medicaid Services created a website, called Open Payments, to let people search for data on their medical providers.
The disclosures cover payments to about 607,000 doctors and 1,121 teaching hospitals. Overall, companies made $3.23 billion in payments for research and $2.56 billion for other purposes, according to a summary posted on the website. The data also include ownership interests of $703 million.
Pfizer, MerckPfizer Inc., the biggest U.S. drugmaker, reported at least $234 million in research payments and $53.3 million in general outlays. Merck & Co. said it paid at least $97.7 million for research and made at least $27.5 million in general payments. AstraZeneca Plc spent at least $85.7 million on research and $72.5 million on general payments.
Quirks in the data make it difficult to get accurate totals for manufacturer payments. Many companies reported payments under various subsidiaries, which may not be apparent at first glance. For example, Johnson & Johnson has 32 reporting subsidiaries, according to spokesman Ernie Knewitz. Merck reported some payments under Comsort Inc.
“We appropriately compensate doctors and institutions for their work to enroll patients and collect clinical trial data,” Pfizer spokesman Dean Mastrojohn said in an e-mailed statement.
“Merck is committed to the discovery and development of important new drugs and vaccines through collaboration with scientific leaders,” Merck spokeswoman Lainie Keller said in an e-mail. AstraZeneca had no immediate comment.
More AccurateThe U.S. released more limited data last year and updated it Tuesday. In the last five months of 2013, doctors and hospitals got about $3.43 billion from device and pharmaceutical firms.
The government has pushed to make the data more accurate by letting doctors and hospitals look over their records before they’re made public. CMS said today that payments accounting for about 30 percent of the total were reviewed.
More TransparencyPresident Barack Obama’s administration has been working to increase transparency in health care since the 2010 passage of the Patient Protection and Affordable Care Act. In addition to the payments posted Tuesday, the law has also led to the disclosure of how much doctors across the U.S. are paid by Medicare.
“We have to know where the money is going to really understand the problem, to develop policy,” Dana said. “No pharma companies spend this kind of money in a disinterested way.”
Some companies began voluntarily disclosing the payments in 2010 after the Affordable Care Act was signed. A similar disclosure requirement begins next year in Europe, while U.K. firms began posting the information in 2013.
The Advanced Medical Technology Association said Tuesday that feedback from doctors helps device makers improve their products. The group, which represents device and diagnostics firms, said it supports the disclosures.
Drug industry group Pharmaceutical Research and Manufacturers of America said collaboration between doctors and drugmakers helps lead to medical breakthroughs and can improve patient care.
The American Medical Association, which represents doctors, said the government should work to make it easier for health-care professionals to verify the data.
Source : Bloomberg (June 2015)
Huge Prescriber of Risky Antipsychotic Drug to Plead Guilty to Taking Kickbacks
Dr. Michael Reinstein has been the subject of two ProPublica investigations. For years, even while under federal investigation, he prescribed more of the drug clozapine than any other doctor in the United States.
A former Chicago psychiatrist who was the nation's top prescriber of the most powerful and riskiest antipsychotic drug intends to plead guilty to a federal felony charge of taking kickbacks from its manufacturer in exchange for prescriptions, court records show.
The U.S. Attorney for the Northern District of Illinois filed a single felony charge against Dr. Michael Reinstein this week for taking $2,000 in November 2009 from drugmaker Teva "in return for Reinstein's referrals of patients" for clozapine prescriptions.
Clozapine, also known as Clozaril and FazaClo, is approved to treat schizophrenia patients who don't respond to other medications. But it can have dangerous side effects, including seizures, inflammation of the heart muscle, and a drop in white blood cells. The drug is considered particularly risky for elderly patients.
A note in court records says that Reinstein intends to plead guilty at his arraignment next Friday. The action was first reported by the Chicago Tribune.
Reinstein's prescribing patterns have been detailed in two ProPublica reports.
In 2009, ProPublica and the Chicago Tribune reported how in one year Reinsteinprescribed more of the antipsychotic clozapine to patients in Medicaid's Illinois program than all doctors in the Medicaid programs of Texas, Florida and North Carolina combined. Autopsy and court records showed that at least three patients under Reinstein's care had died of clozapine intoxication. At that time, Reinstein defended his prescription record, arguing that clozapine is effective and underprescribed.
Then, in 2013, as part of a ProPublica investigation into Medicare's failure to monitor problem prescribers, we reported that Reinstein prescribed even more clozapine in Medicare's prescription drug program for seniors and the disabled. Medicare continued to let him prescribe in the program even after the U.S. Department of Justice accused him of fraud and Illinois' Medicaid program suspended payments to him.
The U.S. Attorney's office declined to discuss Reinstein's upcoming plea. Reinstein's attorney, Terence Campbell, did not immediately return a phone call from ProPublica seeking comment. He told the Tribune on Thursday that Reinstein was "working toward resolving the issues raised by the government and hopes to put this episode behind him soon."
The Tribune reached Reinstein, as well, yesterday. He would not discuss the criminal case but denied any payments from Teva, clozapine's manufacturer, were for prescribing the drug. The doctor instead said the money was for lectures he gave.
In November 2012, the federal government filed a civil fraud lawsuit against Reinstein, saying he "received illegal kickbacks from pharmaceutical companies and submitted at least 140,000 false claims to Medicare and Medicaid for antipsychotic medications he prescribed for thousands of mentally ill patients in area nursing homes."
Last August, Illinois medical regulators indefinitely suspended Reinstein's medical license after determining that Reinstein received " illegal direct and indirect remuneration" from the maker of generic clozapine, did not consider alternative treatments for his patients, and disregarded patients' well-being. In response to the medical board's accusations, Reinstein's lawyers invoked his right against self-incrimination.
Early last year, Teva Pharmaceutical Industries Ltd., the maker of generic clozapine, agreed to pay more than $27.6 million to settle state and federal allegations that it induced Reinstein to prescribe the drug.
Reinstein's prescribing of clozapine appears to have declined after our 2009 articles about him. From 2007 to 2009, he wrote an average of 20,000 Medicare prescriptions annually for clozapine and the brand-name version, FazaClo. That figure dropped to about 8,000 in 2012, according to data obtained by ProPublica.
Check out how your doctor's prescribing within Medicare compares to others in his or her specialty in your state. Visit our Prescriber Checkup tool.
Source : ProPublica (Feb 2015)
Vying for Market Share, Companies Heavily Promote ‘Me Too’ Drugs
For more than five decades, the blood thinner Coumadin was the only option for millions of patients at risk for life-threatening blood clots. But now, a furious battle is underway among the makers of three newer competitors for the prescription pads of doctors across the country.
The manufacturers of these drugs --Pradaxa, Xarelto and Eliquis — have been wooing physicians in part by paying for meals, promotional speeches, consulting gigs and educational gifts. In the last five months of 2013, the companies spent nearly $19.4 million on doctors and teaching hospitals, according to ProPublica's analysis of federal data released last fall.
The information, from a database known as Open Payments, gives the first comprehensive look at how much money drug and device companies have spent working with doctors. What it shows is that the drugs most aggressively promoted to doctors typically aren't cures or even big medical breakthroughs. Some are top sellers, but most are not.
Instead, they are newer drugs that manufacturers hope will gain a foothold, sometimes after failing to meet Wall Street's early expectations.
"They may have some unique niche in the market, but they are fairly redundant with other therapies that are already available," said Dr. Joseph Ross, an associate professor of medicine and public health at Yale University School of Medicine. "Many of these, you could call me-too drugs."
In almost all cases, older, cheaper products are available to treat the same conditions. Companies typically try to differentiate the new drugs by claiming they are easier to use; carry fewer side effects; work faster than competitors; or have medical advantages.
The makers of Pradaxa, Xarelto and Eliquis, for example, say their drugs are at least as effective as Coumadin for certain conditions but do not require routine blood tests or limitations on what patients can eat. (Patients taking Coumadin, also known as warfarin, shouldn't eat grapefruit or cranberries and have to limit green leafy vegetables in their diet.)
Officials at the Centers for Medicare and Medicaid Services, which administers Open Payments, and the Pharmaceutical Research and Manufacturers of America, the drug industry trade group, said they had not analyzed the data in order to rank spending by drug.
When told of ProPublica's analysis, John Murphy, PhRMA's assistant general counsel, said drug makers' spending should be seen not only as a marketing strategy, but also as a way of ensuring the best treatment options for patients. "On paper, a drug may not look like it is monumentally better than another drug, but to an individual patient, it might be," Mr. Murphy said.
According to ProPublica's analysis,Victoza, a diabetes medication made by Novo Nordisk, was the drug associated with the most payments to doctors, by dollar amount. The company spent more than $9 million on physician interactions related to Victoza in the last five months of 2013, excluding research payments and royalties, which relate more to drug development than marketing. (ProPublica created a tool that lets you look up any drug, device or company and compare it with any other.)
Victoza, through a once-a-day injection, helps lower blood sugar among diabetics, but researchers and advocacy groups have said drugs of its class carry an increased risk of thyroid cancer and pancreatitis. Dr. Todd Hobbs, chief medical officer of Novo Nordisk in North America, said the company's spending reflected Victoza's newness and the need to address such safety concerns.
"We just received a huge amount of interest and questions and need for education," Hobbs said, referring to inquiries by health care professionals, particularly primary care doctors. "You see the fruits of that in this report."
Eliquis, the anticoagulant jointly marketed by Bristol-Myers Squibb and Pfizer, ranked second in its link to spending on physicians, with nearly $8 million, our analysis showed. In a statement, the companies said their spending helps ensure physicians understand the appropriate use of Eliquis. Because the drug is prescribed by physicians in different specialties, the statement said, "it is critical to have a speaker program that adequately provides robust education to these physicians."
The drug associated with the third-most payments to doctors was Brilinta, a different type of blood thinner made by AstraZeneca that vies for sales with Plavix, which is now available generically. In an email, AstraZeneca said it had identified Brilinta as one of its "key platforms for growth" and increased speaker and research spending on it. "Physicians are also indispensable partners in our efforts to bring new medicines to patients," the company said.
ProPublica has tracked drug companies' payments to doctors since 2009 through a searchable database called Dollars for Docs. But this covers only 17 companies, most of which have been compelled to release this information under legal settlements with the government. It has no information from medical device makers.
The list of most promoted drugs featured many recent arrivals: 14 of the top 20 were approved by the Food and Drug Administration since 2010. Some treat similar conditions, including diabetes, schizophrenia and chronic obstructive pulmonary disease, so the competition among them is fierce. "They're fighting over the same doctors, I guarantee you," said Rhonda Greenapple Simoff, founder of a consulting firm that advises pharmaceutical companies in Bernardsville, N.J.
Largely absent from the top of the list were drugs that cure disease, such as a new class of hepatitis C treatments, or those that significantly extend life, particularly for cancer patients. If a drug is either the first to treat a disease or is much better than existing drugs, said Dr. Sidney Wolfe, the founder and now senior adviser to Public Citizen's Health Research Group, "they 'sell themselves' on the merits of their unique benefits."
According to ProPublica's analysis, a few of the most heavily promoted drugs, includingSamsca, which treats low sodium levels in the blood, have serious side effects that came to light after their approval by the federal government. The manufacturers of several others, including Copaxone, Latuda, Xarelto,Daliresp and Humira, have been faulted by the F.D.A. for improper promotion.
Subsys, approved in 2012 to treat cancer pain, ranked 23rd in spending on doctors. It's often prescribed for off-label, or unapproved, uses; in November, The New York Times reported that some of the doctors paid the most to promote the drug had disciplinary or legal troubles. In a statement to The Times, Insys Therapeutics, the drug's maker, said its marketing of Subsys was appropriate.
The medical device associated with the most payments to doctors was Intuitive Surgical'sda Vinci surgical robot system, which the company has marketed as an effective, less invasive option for an array of procedures. Critics have complained that the device is needlessly expensive and overused, and say it has been linked to patient complications and deaths.
Intuitive spent nearly $12.8 million on physician interactions to promote the robot in the last five months of 2013, not including royalties and research. The spokeswoman Paige Bischoff said in an email that about half of the company's outlays for education and training were "pass through" spending: Surgeons or hospitals paid the company for services, and the company, in turn, paid doctors to provide them.
Dr. Robert Takla, an emergency room physician in the Detroit area, earned about $75,000 in the last five months of 2013 by delivering promotional talks about several of the most heavily marketed anticoagulants and blood thinners, particularly Brilinta, according to Open Payments.
He said he enjoys speaking on behalf of companies and thinks he offers a different perspective than cardiologists and internists — the usual prescribers of the drugs — because he treats complications of blood clots in the emergency room.
Dr. Takla said he reviews clinical studies before deciding to speak for a drug and turns companies down when he isn't impressed. He said he no longer spoke on behalf of Pradaxa because of what he characterized as public backlash against it, driven by a spate of lawsuits against its manufacturer, Boehringer-Ingelheim. (The company agreed to pay $650 million last year to settle the suits.) He accepts fees to speak about Xarelto, a drug he has taken himself for a deep vein thrombosis.
"It's a very fertile and very robust marketplace right now," he said of the anticoagulants.
News applications developer Mike Tigas contributed to this report.
Methodology: How we calculated company payments to doctors
Source : Propublica
Link to Source + graphs (Jan 2015)
UK doctors paid $64 million by drug companies in 2013
Doctors in Britain were paid 38.5 million pounds ($64 million) by drugmakers last year, slightly less than 2012, according to new data underscoring the links between the pharmaceutical industry and prescribers.
Industry payments to doctors have come under increased scrutiny following a number of scandals over sales practices, notably in the United States, and concerns that such ties could put commercial interests ahead of the best outcome for patients.
The figure, announced by the Association of the British Pharmaceutical Industry (ABPI) on Thursday, was slightly down on the 2012 level of 40 million pounds.
Criticism of the close relationship between doctors and drug firms has prompted some companies to rethink how they operate. GlaxoSmithKline said in December it would stop paying doctors to promote its drugs, though it will still pay fees for clinical research and advisory work.
A number of other firms have also taken more limited steps to curb physician-related marketing practices, including AstraZeneca, which said in 2011 it was scrapping payments for doctors to attend international congresses.
Under U.S. healthcare law, drug companies are now forced to disclose payments to doctors, while in Europe firms will be required to make public the names of individual doctors they have paid from 2016.
In the interim, the ABPI is providing aggregate figures based in information from 34 out of the top 40 drug companies operating in Britain.
The overall payments to doctors last year comprised 27.7 million pounds for consultancy services and 10.8 million in sponsorship to attend third party meetings, the trade group said.
Source : Reuters (April 2014)
Big Pharma pays record money to medical doctors
Spending by major pharmaceutical companies to U.S. doctors exceeded $1 billion in 2012, according to some newly released figures.
The new data has been compiled by the consultancy firm PharmaShine for the Financial Times. The figure in excess of $ 1 billion is considerably greater than the figure for 2011 although this may relate to a number of pharma firms are revealing their payments for the first time.
The new information from several companies about payments is in preparation for the Sunshine Act, which comes into force in the next few months within the U.S., mandating pharma to disclose all of its payments to doctors.
It is estimated that around half a million doctors received payments. There are different reasons why a pharmaceutical company pays a medical doctor. This can include including a particular new medicine in a clinical trial. Other reasons include entertaining and travel. The risk is that some members of the public could regard the payments as buying influence to promote particular medicines. However, as a rejoinder, the company Merck said in a press statement: “Consulting engagements conducted with external eSMerck and in the broader scientific community and ultimately help benefit human health.”
In terms of the pharmaceutical companies involved, according to Pharma Times, Merck tops the list with payments of $226 million in 2012, followed closely by Lilly with $219m and Pfizer with $162 million. Despite the forthcoming Act, the drugs firms Sanofi, Roche, Bayer and Amgen have each decided against releasing their payments for 2012.
Source : Digital Journal
Link to Source
U.S. sues Novartis, alleging kickbacks to pharmacies
The U.S. government filed a civil fraud lawsuit against Novartis AG on Tuesday, accusing a unit of the Swiss drug maker of causing the Medicare and Medicaid programs to pay tens of millions of dollars in reimbursements based on fraudulent, kickback-tainted claims.
U.S. Attorney Preet Bharara in Manhattan said Novartis Pharmaceuticals Corp had since 2005 induced at least 20 pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic from
competitors' drugs, in exchange for kickbacks disguised as rebates and discounts.
He said Novartis tried to conceal the scheme by omitting the agreements from rebate and discount contracts with pharmacies.
In one alleged case, Novartis offered a Los Angeles pharmacist a "bonus" rebate of 5 percent of that pharmacist's annual Myfortic sales, or several hundred thousand dollars, to switch as many as 1,000 patients to Myfortic.
"Novartis co-opted the independence of certain pharmacists and turned them into salespeople," Bharara said in a statement.
The lawsuit was filed in U.S. District Court in Manhattan, and seeks civil penalties and triple damages from Novartis for violating the federal False Claims Act.
Novartis disputes the claims and will defend itself, spokeswoman Julie Masow said in an email.
Novartis is "committed to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products," Masow said.
Myfortic net sales totaled $579 million in 2012, up 12 percent from a year earlier, according to Novartis' annual report. The Novartis Pharmaceuticals unit has offices in East Hanover, New Jersey.
In his announcement, Bharara called Novartis a "repeat offender," referring to a settlement of health care fraud charges based on kickbacks less than three years ago.
Novartis in September of 2010 agreed to pay $422.5 million to resolve criminal and civil liability over its marketing of several drugs, including the epilepsy drug Trileptal. (here)
The company violated a federal anti-kickback statute, "choosing instead to put sales growth and profits before its duty to comply with federal law," according to the new complaint.
The federal anti-kickback statute prohibits paying people to buy drugs or services that Medicare, Medicaid or other federal healthcare programs cover, according to the complaint.
The scheme has been highly lucrative for Novartis, according to the complaint, resulting in "rapid, sometimes exponential growth in Myfortic sales."
A pharmacy in Arkansas, for example, increased its annual sales of the drug to more than $1 million from $100,000 over four years, according to the complaint.
The lawsuit also claims a Novartis account manager admitted the kickback scheme generates "an ongoing stream of revenue" for Novartis "as long as the patient is still living and using (Myfortic)."
These types of cases "are one of the highest priorities of the FBI's health care fraud program," FBI Assistant Director Ronald Hosko said in a statement.
The case is U.S. v. Novartis Pharmaceuticals Corp, U.S. District Court, Southern District of New York, No. 11-08196.
(Reporting by Jonathan Stempel and Bernard Vaughan in New York; Editing by Gary Hill, David Gregorio and Tim Dobbyn)
Source : Reuters
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German doctors shaken by corruption allegations
The German Medical Association has investigated nearly 1,000 cases of corrupt doctors over the past few years, according to its president, Frank Ulrich Montgomery.
Dr Montgomery told Der Spiegel that more than half of the case involved alleged bribes from an Israeli pharmaceutical company, Ratiopharm. The doctors were paid for prescribing its drugs to their patients. This was “clearly prohibited”, says Dr Montgomery.
“The Medical Association punished 163 Ratiopharm doctors after state prosecutors made the files available to us,” said Montgomery. He wants the government to pass legislation which would permit the Medical Association itself to conduct searches and confiscate files.
However, this is opposed by health insurance companies. “Corruption is not a minor offence which doctors can regulate amongst themselves,” said an industry spokesman.
Montgomery’s comments highlight a crisis in the German medical profession which has become so dramatic that a legislation has been mooted to beef up professional ethics. “This ongoing corruption debate is a thorn in our flesh which is massively damaging the reputation of my profession,” Montgomery told Der Spiegel.
The problem is most acute for transplant surgeons. Two senior doctors in Leipzig have been suspended after an investigation showed that they had manipulated records to push 38 liver patients up the waiting list for organs. Similar cases have been reported in Göttingen, Munich and Regensburg.
The government and the Medical Association has reassured the public that corruption in the transplant waiting list has been eradicated. But the media seems convinced that public confidence in the integrity of the transplant system has been shaken. The Frankfurter Allgemeine Zeitung writes:
"The damage done is immense. That is obviously not just true of patients on the waiting list for donated organs who were cheated. That is also true of all patients who see themselves as being literally helpless. And it is true of donors, whose mistrust grows with each case of manipulation. The number of donor organs began dropping last year just as the first cases of deceit became public. Last but not least, such cases also hurt transplant doctors, whose own area of specialization has been plunged into disrepute. And the disappearance of trust in how livers, hearts and kidneys are handled hurts the standing of all doctors. As such, it is all the more in their interest to combat this growing damage to their image."
Source : BioEdge
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Massachusetts House tries to repeal gift ban again
The Massachusetts gift ban got another thumbs down in the state legislature. House members voted to repeal the ban, passed in 2008, with a 128-22 split. Lawmakers say that the law, which prohibits drugmakers from entertaining doctors and handing out promotional freebies, has hurt the local economy.
But the decision doesn't necessarily mean that the ban will be lifted. The House voted last year to repeal it, too, by adding the measure to an economic development bill, the Boston Globe reports. But the Massachusetts Senate blocked the repeal. This time, the ban repeal is attached to the House's budget bill; the Senate is working on its own budget proposal, expecting to vote next month.
Critics of the ban say that it hasn't helped to control healthcare costs--but it has curbed pharma spending at restaurants and has hurt Massachusetts convention centers. "We need every opportunity possible in order to generate revenue for our economy," Rep. Todd Smola said (as quoted by State House News Service).
Supporters, however, say that the state hasn't suffered from the ban. Proceeds from meal taxes have grown, they say, and there are plans to expand the Boston Convention and Exhibition Center. "The only thing that's being hurt is the ability of the drug industry to market their high-priced drugs by wining and dining doctors at our expense," Brian Rosman of the consumer group Health Care for All told the Globe.
Source : Fierce Pharma
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St Jude Medical will pay 16Million USD
St. Jude Medical will pay $16 million as part of a settlement with the Justice Department to resolve allegations it used post-market studies and a registry to pay kickbacks to physicians who would then implant the company's pacemakers and defibrillators.
The settlement is the second in eight months over allegations the company paid kickbacks to those who used its products. The company is the world's second-biggest maker of heart-rhythm devices, after Medtronic, Bloomberg notes. St. Jude agreed in June to pay $3.7 million to resolve a separate case over claims it made illegal payments to hospitals in Kentucky and Ohio that used the company's heart devices.
The roughly five-year-old dispute stemmed from lawsuit filed by former employee Charles Donigian. He accused the company of paying kickbacks to doctors, hospitals and other healthcare providers in the form of travel and tickets to sporing events to encourage them to prescribe certain St. Jude products, thus causing the providers to submit requests for payment to government programs. Donigian will receive $2.64 million for his part in the case.
"Medical device and pharmaceutical companies can use post-market studies legitimately to obtain information about how their products work in the field, but they cannot use those studies, and the honoraria associated with them, to induce physicians to select their products," U.S. Attorney Carmen Ortiz says in a statement. "Cardiologists and electrophysiologists should make their decisions on which pacemaker or defibrillator to implant in a patient based on their independent medical judgment, not based on how much the manufacturer is paying them to implant the device."
Last August, U.S. District Judge Douglas Woodlock in Massachusetts granted a government request to join the suit. Although the government had declined to join the suit in December 2009, Ortiz wrote that it had "good cause" to intervene following additional witness interviews and document reviews, according to a Reuters article.
In a statement, the company says its post-market studies and registries are legitimate and designed to gather important scientific data. It also denies any wrongdoing but entered into a settlement agreement to avoid the potential costs and risks associated with litigation.
The company's shares fell 0.2 percent in after-hours trading from Thursday's close of $42.20, Dow Jones reports.
- check out the St. Jude statement
- read the Justice Department statement
- get more from Dow Jones
- read more from Bloomberg
St. Jude ($STJ), DOJ may be close to resolving kickback dispute
St. Jude, Justice in talks in kickbacks case
FDA: St. Jude illegally promoted ablation device
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