Case against Merck allegedly providing false data on vaccine efficacy allowed to advance

Antitrust, FCA Claims On Merck Mumps Vaccine To Advance
By Dan Packel

Law360, Philadelphia (September 05, 2014, 6:12 PM ET) — Two lawsuits accusing Merck & Co. Inc. of lying about the efficacy of its mumps inoculation in order to keep competitors from bringing their own versions of the vaccine to market will move forward, after a Pennsylvania federal judge ruled in favor of whistleblowers and direct purchasers Thursday.
U.S. District Judge C. Darnell Jones II ruled that the whistleblowers had sufficiently pled that Merck might have provided false statements to the government and that the direct purchasers had shown enough evidence to establish that these falsehoods could have helped the company gain a monopoly. The judge did ax breach of contract and unjust enrichment claims against the pharmaceutical giant.

“We are pleased that the court has upheld our federal antitrust claim in this important case. While Merck has enjoyed an exclusive monopoly on the sale of mumps vaccine in the United States, mumps outbreaks continue to occur because, as we allege in our lawsuit, Merck has misled the public about the vaccine’s efficacy,” Kellie Lerner of Robins Kaplan Miller & Ciresi LLP, representing the direct purchasers, said in a statement. “This decision brings us one step closer to shining a light on Merck’s deceptive business practices so that new and more effective vaccines will ultimately be developed in the future.”

Since 1967, Merck has been the sole pharmaceutical company in the U.S. licensed to produce mumps vaccine, and the company has long represented that the vaccine is 95 percent effective in preventing the disease.
The whistleblowers, two individuals who worked as virologists in a Merck lab performing efficacy tests, claimed that after the company’s tests showed the vaccines slipping below the 95 percent threshold, it changed its methodology and falsified results but kept reporting to the Food and Drug Administration that the drug was 95 percent effective.

They claimed in their lawsuit, unsealed in June 2012, that Merck violated the False Claims Act by billing the Centers for Disease Control and Prevention for the vaccine while they were aware of its diminished efficacy and by falsifying and manipulating data that should have been shared with the government. They claimed that, as a result, the government had spent hundreds of millions of dollars on ineffective medicine. Continue reading “Case against Merck allegedly providing false data on vaccine efficacy allowed to advance”

Off-Label Marketing Puts Novartis in Hot Water – Sold to Children and is a Carcinogen

Off-Label Marketing Puts Novartis in Hot Water

By ROSE BOUBOUSHIAN

(CN) – Novartis Pharmaceuticals must face claims that it promoted the use on infants of a drug that U.S. regulators have deemed harmful, a federal judge ruled.

While working as a senior sales consultant for Basel, Switzerland-based Novartis in its dermatology and respiratory division, from 2001 through 2006, Donald Galmines marketed and sold the atopic dermatitis drug, Elidel.

The Food and Drug Administration had authorized the marketing of Elidel as a second-line treatment for patients aged 2 and older after it found that the drug posed safety risks to infants in December 2000.

Though regulators refused to approve the drug for patients older than 3 months of age, Galmines said Novartis soon began marketing Elidel as safe for children under the age of 2 and as a first-line treatment.

This marketing allegedly continued even after the FDA revealed in 2005 that the drug increased the risk of cancer in animals and respiratory infections in children younger than 2.

Galmines said Novartis trained him and paid Dr. Lawrence Eichenfield, a pediatric dermatologist, to convince doctors that Elidel was safe for infants.

The drugmaker also allegedly funded and publicly touted Dr. Alexander Kapp’s report that Elidel was safe for children over 3 months old.

Galmines said Novartis created visual aids for him and other sales reps to engage in off-label marketing of the drug and had him host and pay for $1,000 dinners for doctors who prescribed high amounts of Elidel for chronic use. Novartis also allegedly had Galmines use “preceptorships” in which he followed a doctor for a few hours and paid him or her for prescribing the drug.

A federal judge unsealed the 2006 whistle-blower complaint Galmines filed against Novartis under the False Claims Act (FCA) in Philadelphia after the government declined to intervene.

Novartis responded with a 295-page motion to dismiss in May 2011, but U.S. District Judge Gene Pratter preserved some claims on Thursday.

“The first amended complaint plausibly suggests that at least some of the claims submitted to government healthcare programs for Elidel prescriptions were not reimbursable, because it also alleges that these programs do not pay for drugs that are ‘not prescribed for a medically accepted indication,’ and that at least 1.2 million Elidel prescriptions were written off-label in a manner that put the health of the children receiving those prescriptions at risk,” Pratter wrote. “Therefore, Mr. Galmines has sufficiently pled that false claims for Elidel prescription reimbursements were submitted to the government.”

Though another pair of former Novartis employees, Gina Moyer and Judith Shelton, also brought a 2005 qui tam action over Elidel in Michigan, the court found that the first-to-file rule bars only Galmines’ claims of kickbacks. He can still pursue claims over off-label-marketing because the Moyer complaint discusses the allegedly unlawful promotion of Elidel for psoriasis and seborrhea, and Galmines “makes almost no allegations about these diseases.”

“Mr. Galmines has injected precision into his off-label marketing allegations by pleading a myriad of details about how such marketing occurred,” Pratter wrote. “The first amended complaint details with specificity how Novartis trained its personnel to engage in off-label marketing, how it equipped those personnel with reports and visual aids to support such marketing, how it used medical experts to promote the off-label use of Elidel, and how Mr. Galmines was reprimanded when he declined to market Elidel for such uses. These allegations, together with the first amended complaint’s allegation that at least 1,218,000 off-label prescriptions were written for Elidel, ‘are sufficiently specific both to inform [Novartis] of the “precise misconduct” charged, and to make it unlikely that [Mr. Galmines] has commenced this action in bad faith.’ Therefore, the court will not dismiss the first amended complaint under Rule 9(b).”

Novartis reported nearly $56.7 billion in net sales for 2012

U.S. sues Novartis over kickbacks, 2nd case this week : The $10,000 Dinner for 3

Source: Reuters – Fri, 26 Apr 2013 08:44 PM

Author: Reuters

* Second civil fraud lawsuit by U.S. in four days

* U.S. says Novartis sought to boost sales of drugs

* Dinners held at pricey Chicago, D.C. restaurants

* Novartis disputes claims, says will defend itself

By Jonathan Stempel

NEW YORK, April 26 (Reuters) – The U.S. government on Friday announced its second civil fraud lawsuit against Novartis AG in four days, accusing a unit of the Swiss drugmaker of paying multimillion-dollar kickbacks to doctors in exchange for prescribing its drugs.

Authorities said the Basel-based company for a decade lavished healthy speaking fees and “opulent” meals, including a nearly $10,000 dinner for three at the Japanese restaurant, Nobu, to induce doctors to prescribe its drugs.

They said this led to the Medicare and Medicaid programs paying millions of dollars in reimbursements based on kickback-tainted claims for medication such as hypertension drugs Lotrel and Valturna and the diabetes drug Starlix.

The charges are detailed in a whistleblower lawsuit first filed against Novartis Pharmaceuticals Corp by a former sales representative in January 2011 and which the U.S. government has now joined.

Twenty-seven U.S. states, the District of Columbia and the cities of New York and Chicago are also plaintiffs in the lawsuit, which seeks triple damages under the federal False Claims Act.

“Novartis corrupted the prescription drug dispensing process,” U.S. Attorney Preet Bharara in Manhattan said in a statement. “For its investment, Novartis reaped dramatically increased profits on these drugs, and Medicare, Medicaid, and other federal healthcare programs were left holding the bag.”

On Tuesday, the government accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts.

Novartis spokeswoman Julie Masow said the company disputes the claims in both lawsuits and will defend itself. She also said physician speaker programs are “an accepted and customary practice” in the industry.

People who file whistleblower lawsuits, sometimes known as “qui tam” lawsuits, on behalf of the government under the False Claims Act share in recovered damages.

The United States does not participate in all such lawsuits, but often joins cases it believes have greater merit.

The original lawsuit against East Hanover, New Jersey-based Novartis Pharmaceuticals was filed by Oswald Bilotta, who now lives in North Carolina. He did not immediately respond to a request for comment.

“We believe that Novartis’ alleged payment of kickbacks is yet another example of abuse in the pharmaceutical industry that contributes to skyrocketing medical costs,” James Miller, a partner at Shepherd, Finkelman, Miller, and Shah in Chester, Connecticut representing Bilotta, said in a statement.

A $9,750 DINNER

According to the complaint, from January 2002 to November 2011, Novartis often paid doctors to speak about its drugs and programs that were supposed to have educational purposes, but which in reality were often social occasions or not held at all.

Authorities said that for Lotrel, Valturna and Starlix alone, the company spent nearly $65 million and conducted more than 38,000 speaker programs over the decade.

The complaint describes a variety of alleged improper programs, including seven at Hooters restaurants that Novartis sales representatives attended, and pricey meals to which Novartis allegedly treated doctors.

Among these meals were dinners at high-end Chicago restaurants such as Japonais and L20, a $2,016 dinner for three at Smith & Wollensky in Washington, D.C. and the $9,750 dinner for three at Nobu in Dallas in December 2005.

Satow, the Novartis spokeswoman, said speaker programs are “promotional programs” designed to inform physicians how to use the company’s medicines.

Novartis “invests significant time and resources to help ensure these programs are conducted in an ethical and responsible manner,” she said. “We are dedicated to doing it right.

Bilotta filed his lawsuit four months after Novartis in September 2010 agreed to pay $422.5 million to resolve criminal and civil liability over its marketing of several drugs, including the epilepsy drug Trileptal.

The case is U.S. ex rel. Bilotta v. Novartis Pharmaceuticals Corp, U.S. District Court, Southern District of New York, No. 11-00071.

http://www.trust.org/item/20130426204414-nx7or/?source = hpbreaking

 

Feds Accuse Novartis of Kickback Drug Scheme

 

 

 

MANHATTAN (CN) – Novartis Pharmaceuticals cost Medicare and Medicaid tens of millions of dollars by paying kickbacks to pharmacies to switch transplant patients to one of its drugs instead of cheaper generics, federal prosecutors say.

The United States unsealed a four-count complaint against Novartis on Tuesday, accusing it of unjust enrichment, False Claims Act violations and conspiracy. It seeks treble damages, penalties and restitution for “a Novartis-orchestrated kickback scheme.”

“Under this scheme, Novartis paid kickbacks to pharmacies in exchange for the pharmacies switching transplant patients to the Novartis drug Myfortic, or continuing to recommend and dispense Myfortic instead of cheaper, generic competitor drugs. As part of the scheme, Novartis has also knowingly caused the pharmacies to submit false claims to Medicare and Medicaid that were tainted by kickbacks, causing these programs to pay tens of millions of dollars in reimbursements that should not have been paid,” the complaint states.

Novartis paid more than 20 pharmacies kickbacks from 2005 until today, knowing it was violating the federal anti-kickback law, the U.S. attorney says in the complaint. It “disguised these kickbacks as ‘performance’ rebates or discounts,” and “these pharmacies agreed to disregard their professional independence, and use their influence to switch patients to Myfortic,” according to the complaint.

“For example, in early 2011, the owner of Twenty-Ten Prescription Pharmacy in Los Angeles told Novartis that, in exchange for ‘5 percent more’ in rebates, Twenty-Ten would ‘do all the conversions’ requested by Novartis. Similarly, Novartis agreed to a kickback arrangement with Transcript Pharmacy in Flowood, Mississippi, after Transcript promised to recommend moving patients to Myfortic ‘only if’ Novartis allowed Transcript to participate in the kickback scheme.” (Citations omitted.)

Novartis and the pharmacies concealed the scheme from doctors, patients and the government, prosecutors say.

“As Novartis and the pharmacies profited from their kickback scheme through, respectively, escalating levels of Myfortic sales and ongoing flows of kickback payments, Medicare and Medicaid were made to bear the financial cost of this corrupt scheme. All of the pharmacies receiving kickbacks from Novartis submitted claims to Medicare and Medicaid. Further, in seeking Medicare and Medicaid reimbursement, neither these pharmacies nor Novartis disclosed their quid pro quo arrangements. The Myfortic kickback scheme, in short, resulted in the submission of tens of thousands of false Medicare and Medicaid claims.

“These false claims, in turn, caused Medicare and Medicaid to disburse tens of millions of dollars in reimbursements that should not have been paid. Specifically, Novartis data shows that the total amount of Myfortic sales by pharmacies receiving kickbacks was well in excess of $100 million; and, according to a ‘payer mix’ analysis that Novartis received in 2011, reimbursements by Medicare and Medicaid accounted for 47 percent of the total Myfortic sales through those pharmacies and their peers. Thus, Novartis has, through its kickback scheme, caused tens of millions of dollars in losses to those federal health-care programs.”

Novartis stock closed at $73.23 on Tuesday, up 62 cents from Monday.

Novartis paid $420 million in civil and criminal penalties in 2010 to resolve similar allegations about it epilepsy drug Trileptal. In that case, it paid the kickbacks to doctors.

Novartis sued Teva Pharmaceuticals two years ago, to try to block it from introducing a generic form of Myfortic.

Although government fines in these cases may look stiff, they typically amount to a small percentage of the profits big pharmaceutical companies make by illegally marketing their drugs.

http://www.courthousenews.com/2013/04/24/56981.htm

$11.4 Million for Drug Kickbacks : Naproxen, Xodol, Fexmid, Dolgic

 

 

 

SAN DIEGO (CN) – San Diego-based Victory Pharma will pay $11.4 million in civil and criminal fines for paying kickbacks to doctors who prescribed its drugs, federal prosecutors said.

Victory entered a deferred-prosecution agreement, agreed to pay a criminal forfeiture of $1.4 million and another $9.9 million to resolve False Claims Act allegations, the U.S. Attorney’s Office said.

It paid kickbacks to doctors who prescribed its Naprelan (Naproxen), Xodol (acetaminophen with hydrocodone), Fexmid (cyclobenzaprine, a muscle relaxant), and Dolgic (acetaminophen with butalbital, a barbiturate). Some of the patients were on Medicare.

“The kickbacks included tickets to professional and collegiate sporting events, tickets to concerts and plays, spa outings, golf and ski outings, dinners at expensive restaurants, and numerous other out-of-office events,” the U.S Attorney’s said in a statement. “Victory also encouraged its sales representatives to schedule paid ‘preceptorships,’ which involved sales representatives ‘shadowing’ doctors in their offices. The settlement also resolves allegations that Victory improperly used these preceptorships to induce doctors to prescribe Victory’s products.”

The prosecutions began when a former Victory sales rep, Chad Miller, filed a qui tam whistleblower complaint. Miller will get $1.7 million from the settlement.

The Justice Department said it has recovered $13.9 billion under the False Claims Act since January 2009, $10.1 billion of it from health care fraud

http://www.courthousenews.com/

Pfizer can do no wrong, or at least not enough to get found guilty ( Off-guideline does not equate to off-label )

Suit Over Pfizer Lipitor Labels Gave Judge ‘Paine’

By ADAM KLASFELD

BROOKLYN, N.Y. (CN) – A federal judge invoked Thomas Paine’s “Common Sense” in dismissing allegations that Pfizer illegally marketed its cholesterol-fighting drug Lipitor.

In her fifth complaint against Pfizer under the False Claims Act, former employee Dr. Jesse Polansky faulted the pharmaceutical company for encouraging doctors to overprescribe the drug for patients not at risk for heart disease.

U.S. District Judge Brian Cogan dismissed the fifth amended complaint on Thursday.

In his 13-page order, Cogan said that Lipitor’s 2005 and 2009 labels rivaled the length of Paine’s 1776 pamphlet “Common Sense,” and that they were too technical to mislead consumers.

“This is not the piece of paper affixed to the outside of a pill bottle, or one of the accordion-style informational attachments a pharmacist attaches to the pill canister when he fills the prescription,” the order states. “The 2009 label, for example, which is the shorter of the two, has over twenty single-spaced pages of small font- approximately the same length as Thomas Paine’s ‘Common Sense.’ Indeed, outside of the pharmaceutical industry, it would more properly be characterized as a pamphlet or a brochure. Among a wealth of other information, it describes the drug’s chemical structure, its active mechanism, its ‘pharmacodynamics,’ ‘pharmacokinetics,’ and the results of various clinical studies. Although a consumer (who probably never sees it) might be able to understand parts of the label, much if not most of the document is only within the ken of a doctor, pharmacist, or biochemist.” (Parentheses in original.)

Cogan described the allegation that Pfizer illegally urged doctors to prescribe it for patients who did not meet the National Cholesterol Education Program, or NCEP, guidelines for its use.

“Thus, if a Pfizer representative told a doctor that he should prescribe Lipitor to any of his patients who smoke and have a bad family cardiac history (i.e., two risk factors) and LDL levels of 131 mg/dL or more, that advice would be proper because that patient falls within the Guideline range,” the order states. “However, change the number in the sales pitch to 125 mg/dL, or even 129mg/dL, and any prescription issued by a doctor who relied on that advice, and which Medicare or Medicaid subsequently reimbursed, would constitute a false claim. Of course, plaintiff’s alleged ‘false statements’ are not as de minimis as this illustration, but there is no logical place to draw a line on plaintiff’s theory. According to plaintiff, any marketing of the drug for patients outside the guidelines’ range is ‘off-label marketing,’ resulting in the filing of false claims under the False Claims Act.”

Ultimately, the judge explicitly deferred to Pfizer’s argument.

“Defendant puts its [sic] best: Off-guideline does not equate to off-label. Having determined that the NCEP Guidelines in the 2005 label, and the passing reference to them in the 2009 label, were merely informational and advisory rather than restrictive limitations, I hold that defendant has not engaged in off-label marketing, and has therefore not violated the [False Claims Act],” the order states.

Polansky’s lawyer did not immediately respond to a request for comment

http://www.courthousenews.com/2012/11/16/52360.htm

Merck Accused of Faking Mumps Vaccine Data

Couthouse News Service Site 27 JUN 201

PHILADELPHIA (CN) – Merck has known for a decade that its mumps vaccine is “far less effective” than it tells the government, and it falsified test results and sold millions of doses of “questionable efficacy,” flooding and monopolizing the market, a primary caregiver claims in a federal antitrust class action.

Alabama-based Chatom Primary Care sued Merck on Monday, the week after the unsealing of a False Claims Act complaint two relators filed in 2010.

Those relators, Stephen Krahling and Joan Wlochowski, were Merck virologists who claim in their unsealed complaint that they “witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings.”

Krahling and Wlochowski claimed Merck’s scheme caused the United States to pay “hundreds of millions of dollars for a vaccine that does not provide adequate immunization.”

“As the largest single purchaser of childhood vaccines (accounting for more than 50 percent of all vaccine purchases), the United States is by far the largest financial victim of Merck’s fraud,” according to the 2010 False Claims Act complaint. “But the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection. And while this is a disease that, according to the Centers for Disease Control (‘CDC’), was supposed to be eradicated by now, the failure in Merck’s vaccine has allowed this disease to linger, with significant outbreaks continuing to occur.”

The United States told a federal judge in April that it did not want to intervenein the False Claims case, but reserved the right to do so later.

Chatom says in its antitrust complaint that Merck falsely claims its mumps vaccine is 95 percent effective.

That claim “deterred and excluded competing manufacturers,” who would enter the risky and expensive vaccine market only if they believed they could craft a better product, Chatom says in its complaint.

Merck is the only manufacturer licensed by the FDA to sell the mumps vaccine in United States, and if it could not show that the vaccine was 95 percent effective, it risked losing its lucrative monopoly, according to the complaint.

That’s why Merck found it critically important to keep claiming such a high efficacy rate, the complaint states.

And, Chatom claims, that’s why Merck went to great lengths, including “manipulating its test procedures and falsifying the test results,” to prop up the bogus figure, though it knew that the attenuated virus from which it created the vaccine had been altered over the years during the manufacturing process, and that the quality of the vaccine had degraded as a result.

Starting in the late 1990s, Merck set out on its sham testing program with the objective of “report[ing] efficacy of 95 percent or higher regardless of the vaccine’s true efficacy,” the complaint states.

Chatom says Merck initially called its testing program Protocol 007.

Under Protocol 007, Merck did not test the vaccine’s ability to protect children against a “wild-type” mumps virus, which is “the type of real-life virus against which vaccines are generally tested,” the complaint states.

Instead, Chatom says, Merck tested children’s blood using its own attenuated strain of the virus.

“This was the same mumps strain with which the children were vaccinated,” the complaint states.

That “subverted” the purpose of the testing regime, “which was to measure the vaccine’s ability to provide protection against a disease-causing mumps virus that a child would actually face in real life. The end result of this deviation … was that Merck’s test overstated the vaccine’s effectiveness,” Chatom claims.

Merck also added animal antibodies to blood samples to achieve more favorable test results, though it knew that the human immune system would never produce such antibodies, and that the antibodies created a laboratory testing scenario that “did not in any way correspond to, correlate with, or represent real life … virus neutralization in vaccinated people,” according to the complaint.

Chatom claims that the falsification of test results occurred “with the knowledge, authority and approval of Merck’s senior management.”

And as Merck’s vaccine is the only game in town, the vaccine’s “significantly degraded” quality means “there has remained a significant risk of a resurgence of mumps outbreaks,” Chatom says in its complaint.

It claims that the degraded quality of the Merck vaccine played a role in a 2006 mumps outbreak in the Midwest, and in another outbreak in 2009.

Those outbreaks caused the Centers for Disease Control to push back its target date for eradicating the disease from 2010 to no earlier than 2020, the complaint states.

“But no amount of extra time or dosages will be enough to eliminate the disease when the vaccine does not work as represented in the labeling,” the complaint states. “It will merely allow Merck to continue to misrepresent the vaccine’s efficacy and thereby maintain its exclusive hold on the relevant market with an inadequate vaccine.”

Merck spokesman Ron Rogers told Courthouse News in a statement that the False Claims lawsuit “is completely without merit,” and that Chatom’s lawsuit is merely derivative of that case.

“Merck has presented information that demonstrated to the United States Department of Justice that these allegations are factually false, and after the Department conducted its own two-year investigation, it decided not to pursue this lawsuit,” Rogers said.

In addition, he said, the U.S. Food and Drug Administration “previously examined the issues raised in the lawsuit, and they were resolved to the agency’s satisfaction.”

Chatom seeks to represent the class of all those who bought Merck’s mumps vaccine from Jan. 1, 1999 to today.

It seeks damages for monopolization under the Sherman Act, violation of state consumer protection laws, unjust enrichment and breach of warranty.

Chatom is represented by Richard Golomb of Golomb & Honik, in Philadelphia

Evil: Well Putting Children in Harms way for Profit. As well as possibly causing the spread of engineered viruses, that only its vaccine worked against….

More on legal remedies for ghostwriting

In an Essay that expands on a previous proposal to use the courts to prosecute those involved in ghostwriting on the basis of it being legal fraud, Xavier Bosch from the University of Barcelona, Spain and colleagues lay out three outline specific areas of legal liability in this week’s PLoS Medicine.

First, when an injured patient’s physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors (including “guest” authors), can be held legally liable for patient injuries, says the article. Second, guest authors of ghost-written articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label drugs articles may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses. Finally, the authors argue, paying guest authors of ghostwritten papers—which may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit— can mean that both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.

Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the authors say, the US Supreme Court has firmly held that the First Amendment does not shield fraud.

In the previous proposal, published in PLoS Medicine in August 2011, Simon Stern and Trudo Lemmens from the Faculties of Law and Medicine at the University of Toronto, Canada argued that it is irrelevant whether publications with academic guest authors are factually accurate. Rather, ghostwriting of medical journal articles raises serious ethical and legal concerns, bearing on the integrity of medical research and scientific evidence used in legal disputes. Furthermore, the false respectability afforded to claims of safety and effectiveness through the use of academic investigators risks undermining the integrity of biomedical research and patient care—an integrity that also underpins the use of scientific evidence in the courtroom.

According to these authors, medical journals, academic institutions, and professional disciplinary bodies have failed to enforce effective sanctions. Some journals, such as PLoS Medicine, have called for bans on future submissions by authors who act as guests, formal retraction if unacknowledged ghostwriting is discovered after publication, and reporting of authors’ misconduct to institutions. Although the authors agree that such actions may have an impact on academics concerned about their status and future publication options, they say that it is unclear whether journals can adequately monitor the practice.

They made the case for more effectively deterring the practice of ghostwriting through the imposition of legal liability on the ”guest authors” who lend their names to ghostwritten articles. The authors say: “We argue that a guest author’s claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act [RICO].”

The authors said: “The same fraud could support claims of ”fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This claim also appropriately reflects the negative impact of ghostwriting on the legal system.”