PharmaGossip

FDA's New Stance on Antibiotics Use Could Be Too Little, Too Late - Alice G. Walton - Health - The Atlantic

2012-01-28T16:21:00.001Z

A father’s anguish: Military killed my son with prescription pad | The Daily Caller

2012-01-28T08:43:00.001Z

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A generic photo of prescription drugs taken March 20, 2009 for files. (PAUL J. RICHARDS/AFP/Getty Images)

A father who has lost two sons to war told The Daily Caller that the U.S. Central Command’s policy of allowing troops to deploy with a 180-day supply of the antipsychotic Seroquel has contributed to the deaths of troops and veterans. Seroquel, he said, has tragic side effects that military leaders have ignored in their quest to combat insomnia and post-traumatic stress disorder (PTSD) among fighting men and women.

The father, West Virginia school principal Stan White, said there are better ways to treat troops and veterans who suffer from PTSD. But because the maker of Seroquel, London-based AstraZeneca, has so much influence over Congress and the military, he insisted, that peer counseling and other treatment options are being shoved aside in favor of low doses of the drug.

White’s suspicions are slowly being validated by a series of studies, legal settlements, and military rulings — including a recommendation from the Department of Defense’s own advisory body on pharmaceuticals.

“I think AstraZeneca is so strong and has so much power that no one can speak out,” said White, who has remained stoic despite his losses. “Money talks. I truly believe AstraZeneca and other big pharma companies have control over Congress.”

His first son, Army Sgt. Robert White, died in combat in Iraq. When Robert’s younger brother Andrew returned from his own tour in the Middle Eastern country, a Veterans Administration doctor prescribed a combination of Seroquel and antidepressants for his PTSD.

Andrew died at home, and the state of West Virginia ruled that an accidental medication overdose was to blame.

But his father believes the “dangerous” pill cocktail killed him. And he told TheDC that he has identified 300 other soldiers and veterans who died from sudden cardiac arrest while taking Seroquel and antidepressants in combination.

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Evidence supporting his theory has continued to accumulate, including a September 2011 study from the European Society of Cardiology which linked the “combined use of antipsychotic and antidepressant drugs” with an increased risk of sudden heart attacks.

Seroquel has been on the market since 1997, and in that time doctors have widely experimented with prescribing it for “off-label” purposes that the FDA has not approved. The drug, a mood stabilizer, is approved to treat schizophrenia and bipolar disorder, but it has also been used to treat insomnia in Parkinson’s disease patients, dementia in adults of all ages, and a variety of disorders in children.

Doctors have free rein to prescribe medications for off-label uses, and the FDA’s ever-growing avalanche of advisories sometimes makes it difficult for physicians to know what has been approved and what has not.

A 2009 University of Chicago national survey of physicians, for instance, found that one in eight doctors thought Seroquel was approved for treating dementia, even though the FDA had issued a specific warning against it.

Drug marketers, however, are forbidden to promote their products for any purpose not approved by the FDA.

In April 2010 AstraZeneca conceded that it had crossed that line, agreeing to pay the U.S. government $520 million to settle claims related to its illegal promotion of Seroquel for off-label uses.

NEXT: A massive increase in government spending on Seroquel
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Senate Watchdog Targets High-Prescribing Medicaid Docs - ProPublica

2012-01-28T02:43:00.001Z

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Bydureon, a Diabetes Drug from Amylin, Wins F.D.A. Approval - NYTimes.com

2012-01-28T01:58:00.001Z

Analysts expect annual sales of Bydureon to eventually exceed $1 billion. But they are less enthusiastic than they once were, in part because of safety concerns involving thyroid cancer and pancreatitis.
David Kliff, publisher of Diabetic Investor, an electronic newsletter following the diabetes industry, said a once-weekly self-injection could make Bydureon an alternative for many patients to multiple insulin injections or even to multiple pills every day.

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Harvard doctor calls for greater supplement regulation in NEJM | Drug Store News

2012-01-27T19:07:00.001Z

WASHINGTON — The New England Journal of Medicine on Thursday published an opinion online that called for more rulemaking to govern dietary supplements in an effort to reign in the criminal activity of illicit prescription drug manufacturers that openly disregard the laws currently in effect.

Author Pieter Cohen, author of the opinion and an assistant professor of medicine at Harvard Medical School, in his opening paragraph pointed to the recent recall of the product Zotrex. Marketed as a dietary supplement, the product reportedly contained the fictitious ingredient "Ophioglossum polyphyllous," but in actuality contained a drug analogue of the active ingredient in the erectile dysfunction pharmaceutical Viagra (sildenafil).

Following a Food and Drug Administration investigation of NovaCare, the company that distributed that product online, the U.S. Attorney's Office in September 2011 revealed a 31-count indictment alleging NovaCare proprietor Kelly Dean Harvey purposefully thwarted FDA regulations after the agency first started warning consumers about NovaCare products in 2009 (the product at the time was called "Stiff Nights"). Charges against Harvey include one count of conspiracy, 12 counts of wire fraud, nine counts of mail fraud and nine counts of money laundering, according to reports. He pleaded not guilty to those charges in November.

"Although Zotrex represented a particularly brazen violation of the law," wrote Cohen, an assistant professor of medicine at Harvard Medical School in the opening paragraph, "surprisingly, many new supplement ingredients are introduced into the market as [those found in Zotrex were], without any regulatory oversight." Specifically, Cohen calls for clinical trials establishing safety be a pre-requisite for new dietary ingredients to reach the market.

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James Murdoch’s departure rings in changes to GSK’s board | InPharm

2012-01-27T13:03:00.001Z

GlaxoSmithKline has announced that after nine years with the firm, Sir Crispin Davis, Sir Robert Wilson and Larry Culp will stand down from the board.

In addition, the UK firm said that James Murdoch has decided not to stand for re-election.

Sir Christopher Gent, chairman of GSK, said: “James Murdoch has decided to stand down from the board with effect from this year’s AGM.

via inpharm.com

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MeReC Bulletin – Implementing key therapeutic topics: 1

2012-01-27T11:18:00.001Z

The National Prescribing Centre has published a MeReC Bulletin (PDF), the first in a series of three, that focuses on the therapeutic areas of the QIPP agenda.

The topics covered in this bulletin are:

Non-steroidal anti-inflammatory drugs

Antibiotic prescribing - especially quinolones and cephalosporins

High dose inhaled corticosteroids in asthma

For each of the therapeutic topic areas the evidence base is summarised and current prescribing data are reviewed.

via prescriber.org.uk

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EDITORIAL Of doctors and drug makers - latimes.com

2012-01-27T03:47:00.001Z

Did your doctor prescribe that expensive drug solely because you need it, or in part because she has friendly feelings toward the pharmaceutical company that makes it, which treated her to a Hawaiian vacation-cum-"medical conference"? Patients may get some insight into such questions thanks to a lesser-known but important provision of the 2010 healthcare reform law that requires the makers of drugs and medical devices to disclose most payments and gifts to physicians.
The proposed regulations, which are going through a period of public comment, are appropriately strict in ways that would both protect patients and reduce medical costs. The payments and gifts would be available on a searchable public website. Free samples of drugs would be exempt from reporting, but otherwise, anything worth more than $10 total for the year would have to be disclosed.
Of course, many doctors are motivated only by the well-being of their patients, and there are times when drug company payments are appropriate and beneficial to medical research. But pharmaceutical companies are known for underwriting luxurious medical meetings for doctors that are more about play than work, and for paying physicians hefty sums to pitch their drugs to colleagues, often at lunches also paid for by the companies. Doctors with the best intentions can be influenced, consciously or not, by relentless marketing, especially when it's done by their peers.

Physicians who received research funding and other payments from pharmaceutical companies have sat on advisory boards for the U.S. Food and Drug Administrationand have recommended drugs made by those companies. A survey published in the Annals of Internal Medicine in 2010 found that 71% of doctors had accepted food from drug companies, and that doctors who took payments were more likely to prescribe those companies' expensive brand-name medications rather than cheaper generics. Fourteen percent of doctors had been paid to serve on advisory boards and enroll patients in clinical trials — and that number was half what it had been in 2004, before the practice came under greater scrutiny. Some drug companies recently began voluntarily reporting payments and gifts to doctors.
In other words, the website will be a force for good even if few patients examine it. Watchdog organizations and news reporters will use it. For many doctors and pharmaceutical companies, the knowledge that their actions will be held up to public light is enough to curb the potentially troubling behavior.

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Using Symptom Checklists to Sell Drugs

2012-01-26T17:35:00.001Z

via well.blogs.nytimes.com

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BBC News - Bid to stop doctor gagging orders

2012-01-26T17:29:00.001Z

Doctors are being told they can no longer sign contracts that contain gagging orders, in new guidance issued by the medical regulator.

The General Medical Council advice states medics should not enter contracts or deals that seek to stop them raising concerns about poor care.

The guidance also makes clear that doctors have a duty to act if they believe care is being compromised.

It is the latest in a series of attempts to encourage whistle-blowing.

Evidence has been emerging in recent years of trusts restricting the ability of staff to raise the alarm about bad practices.

via bbc.co.uk

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Obamacare!

2012-01-26T17:10:00.000Z

Join a FREE Online Health Community

2012-01-26T16:53:00.001Z

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Forget sponsorship and free trips—welcome to Pharmacare | BMJ

2012-01-26T12:29:00.001Z

via bmj.com

Ray Moynihan, author, journalist and conjoint lecturer, University of Newcastle, Australia

Ray.Moynihan@newcastle.edu.au

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Tales From the PMPCA contd. - The Case of the Botox Tweet

2012-01-26T09:52:00.001Z

An anonymous, non-contactable complainant alleged that a tweet sent by an Allergan employee to a patient organisation and an individual representing that organisation was in breach of the Code. The tweet referred to Botox and stated ‘… we could do something around stroke rehab …’. Botox was indicated, inter alia, for certain spasticity associated with stroke in adults.

The detailed response from Allergan is given below.

The Panel noted Allergan’s submission that its employee had used a personal Twitter account to respond to a tweet from a friend who worked for an agency that worked for the patient organisation. The tweet referred to Botox and rehabilitation in stroke. The Panel noted that although the tweet was intended to be a private message to a friend, tweets were much more public and so in that regard it considered that a prescription only medicine had been advertised to the public. A breach of the Code was ruled as acknowledged by Allergan. High standards had not been maintained. A further breach of the Code was ruled.

The Panel noted that the tweet was sent in error by an individual using a personal account and without the knowledge or authority of Allergan. Pharmaceutical company employees needed to ensure that business relationships and personal relationships were kept very separate particularly when such business relationships were subject to the Code. In the Panel’s view pharmaceutical company employees needed to be extremely cautious when using social media. Allergan’s company policy clearly stated no Allergan employee might comment in a social media forum about an Allergan product or business activity. The Panel thus noted that Allergan had a policy in place which should have prevented the tweet being sent. The Panel considered that Allergan had been badly let down by its employee. Nonetheless the Panel did not consider that this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and reserved for such. No breach of that clause was ruled.

via pmcpa.org.uk

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What we need now is a banker behind bars - Telegraph

2012-01-26T07:24:00.001Z

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Risperdal Whistleblower: J&J Credo Is ‘Empty Words’ // Pharmalot

2012-01-26T05:49:00.001Z

Last week, Johnson & Johnson agreed to pay $158 million to settle a lawsuit filed by the Texas attorney general, who charged the health care giant had orchestrated a controversial program that was designed to boost the use of the Risperdal antipsychotic in the public sector throughout the country (back story). The charges stemmed from a whistleblower lawsuit filed in 2004 by a Pennsylvania state investigator named Allen Jones, who uncovered the program, known as the Texas Medication Algorithm Project. J&J had been accused of surreptitiously creating and funding TMAP, and relied on various state officials and academics to develop and sell the program as a policy tool. Jones was fired for his trouble, but his efforts laid the groundwork for numerous federal and state investigations - J&J has reportedly reached a tentative deal to pay up to $1 billion to settle a federal probe into Risperdal marketing and resolve civil charges, and also agreed to a misdemeanor charge over the same issues. We spoke to Jones, a 57-year-old who divides his time between litigation consulting and stone masonry, about the recent trial and what this has meant…

via pharmalot.com

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U.S. settles with drugmaker Ranbaxy over violations | Reuters

2012-01-25T23:13:00.001Z

(Reuters) - The U.S. Department of Justice said it had reached an agreement with generic drugmaker Ranbaxy Laboratories Ltd (RANB.NS
) to resolve the company's manufacturing violations.
The United States said Ranbaxy had "numerous problems" at its facilities in the United States and in India, such as not keeping written records and not preventing contamination of sterile drugs.
The government also said Ranbaxy submitted false data in applications to the Food and Drug Administration.
Ranbaxy cannot manufacture drugs for the U.S. market at some of its facilities until it resolves the problems, the government said.
Ranbaxy originally announced the agreement with the U.S. government in December but did not provide details about its violations. It set aside $500 million for any liabilities related to the case.

via in.reuters.com

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TYWKIWDBI ("Tai-Wiki-Widbee"): The double tragedy of Sarah Burke

2012-01-25T23:09:00.001Z

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Abbott to cut 700 jobs, most in Chicago area - Chicago Sun-Times

2012-01-25T19:27:00.001Z

Medical device and drugmaker Abbott Laboratories says it will lay off 700 employees, most in the Chicago area, as part of ongoing restructuring efforts in its medical device and diagnostic businesses.

A company spokeswoman says most of the layoffs involve employees who manufacture the company’s heart stents and diagnostic tests. Abbott expects a decline in orders for stents later this year after the expiration of a supply agreement with medical device maker Boston Scientific Corp. Abbott currently sells a version of its Xience stent to Boston Scientific, which pays a 40 percent royalty on sales. Boston Scientific recently replaced that device with its own in-house stent, Promus Element.

About 500 of the eliminated positions are related to stents, with the remaining 200 from the company’s diagnostic business.

via suntimes.com

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Novartis to pay $99 M to settle overtime lawsuit - AP

2012-01-25T19:15:00.001Z

A U.S. division of Swiss drugmaker Novartis AG will pay $99 million to settle a class-action lawsuit about overtime pay for U.S. sales representatives.
The nationwide case involves about 7,700 current and former sales representatives who claim the company owes them overtime for hours worked outside the normal business day, said David Sanford, an attorney for the representatives. He says the claims date back to 2000.
A federal judge gave the settlement preliminary approval Tuesday. Both sides say final approval could take months.
Sanford said in a joint statement with Novartis Pharmaceuticals Corp. that he was pleased to have secured compensation for sales reps for years of overtime pay. Novartis said the deal was in the best interests of the company and its employees. It also said it had been litigating the case for nearly six years, and it was time to resolve the claims.
The U.S. Supreme Court in April will hear arguments on a similar case involving another drugmaker, the U.K.'s GlaxoSmithKline plc. Sanford is assisting on that case too. He said in a phone interview that the Supreme Court has to decide whether the representatives are subject to overtime exemptions under federal and state labor law or if they are marketers or promoters who should be paid overtime.
Sales reps meet with physicians to encourage them to prescribe a company's medicine.
Novartis said it is confident the sales representatives should be classified as exempt from overtime because their autonomy and incentive compensation are typical of exempt employees.
Morningstar analyst Damien Conover, who covers the pharmaceutical industry, said he thinks the Supreme Court will likely decide that sales representatives are exempt from overtime. If it doesn't, any fees the industry has to pay to make up for past overtime will likely amount to just a small percentage of earnings.

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Compare Prescription Drug Prices - Buy Drugs Online - Save Over 70%!

2012-01-25T15:17:00.001Z

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PLoS Medicine: Challenging Medical Ghostwriting in US Courts

2012-01-25T02:54:00.001Z

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Challenging Medical Ghostwriting in US Courts

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Xavier Bosch¹^*, Bijan Esfandiari², Leemon McHenry³
1 Department of Internal Medicine at the Hospital Clínic and the Institut d'Investigacions Biomèdiques August Pí i Sunyer, University of Barcelona, Barcelona, Spain, 2 Law Firm of Baum, Hedlund, Aristei & Goldman, Los Angeles, California, United States of America, 3 Department of Philosophy, California State University, Northridge, California, United States of America

Citation: Bosch X, Esfandiari B, McHenry L (2012) Challenging Medical Ghostwriting in US Courts. PLoS Med 9(1): e1001163. doi:10.1371/journal.pmed.1001163
Published: January 24, 2012
Copyright: © 2012 Bosch et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: No specific funding was received for writing this article.
Competing interests: BE has participated as an attorney in litigation involving Prozac, Paxil, and Avandia and other pharmaceutical products. LM is a member of Healthy Skepticism and research consultant for the law firm of Baum, Hedlund, Aristei & Goldman, Los Angeles, California. He has participated in litigation involving Prozac, Zoloft, Paxil, Avandia, and other pharmaceutical products. All other authors have declared that no competing interests exist.
Abbreviations: FCA, False Claims Act; KOL, key opinion leader
* E-mail: xavbosch@clinic.ub.es
Provenance: Not commissioned; externally peer reviewed.

Summary Points

Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.

In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.

For example, 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.

In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.

Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, 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 US Supreme Court has firmly held that the First Amendment does not shield fraud.

Introduction Top
Complaints about the ethics of medical ghostwriting have increased in the last decade, but little has changed [1]–[14]. Corruption of the scientific literature through ghostwriting persists in medicine due to the enormous profits for all stakeholders [15], including the pharmaceutical industry that creates the publication strategy, academic researchers acting as key opinion leaders (KOLs) for industry, universities employing KOLs, medical journals and their proprietors, including medical societies and publishers, and medical communication companies employing ghostwriters.

Ghostwriting openly infringes academic standards and, in many cases, as recently argued by Stern and Lemmens in PLoS Medicine, contributes to fraud [16]. Typically, the practice involves industry-financed writers generating articles that either promote the sponsor company's products or discredit competing ones, with eventual authorship credited to academic researchers who provide little or no input, thereby concealing industry involvement and contributing to distorted drug profiles. In the United States, cases relating to gabapentin [17], rofecoxib [2], paroxetine [7], sertraline [18], fenfluramine/phentermine (fen-phen) [19], and Prempro [3] are well documented, while many others, relating to rosiglitazone, olanzapine, quetiapine, valdecoxib, and celecoxib, remain under seal by the courts. These cases demonstrate the dangers inherent in permitting pharmaceutical companies to maintain the status quo.

Some editors, fully aware that ghostwritten manuscripts are submitted to their journals, refuse to police their content [20]. Although other journals, most notably PLoS Medicine, as well as several editors' associations have produced policies against the practice, in some cases adopting clear and visible positions, little has changed [1],[6],[11],[21]–[23]. In addition, despite efforts to reinforce authorship and publication requirements, journals' responses to ghostwriting remain unsatisfactory, as shown by a recent study of 630 articles from six high impact medical journals [24]. In 2008, the overall prevalence of articles with honorary authorship, ghost authorship, or both, was 21.0%, which represented a decline from 29.1% in 1996. Although the prevalence of ghost authorship showed a significant decline, there was no change in the prevalence of honorary authors relative to 1996 [24]. This study concluded that inappropriate authorship remains a significant problem in high impact biomedical publications.

Indeed, even the policies adopted by the International Committee of Medical Journal Editors have failed to clarify how the corruption of medical literature could be curtailed [14]. Substantial contribution to manuscript design or drafting is of little significance when marketing messages are planted in the ghostwriter's first draft well before a nominal author is selected. Authors may give approval when the paper is submitted for publication, but this only occurs after the sponsor company has ensured the manuscript meets its marketing goals and the legal department has transferred ownership to the submitting author. The manuscript and message are therefore controlled by the company rather than the nominal authors [3],[7].

Since self-regulation has not produced results and the government has failed to have any significant impact, we argue that the only remaining option is the legal system. Building upon the recent Stern and Lemmens article that proposed viewing ghostwriting as fraud [16], this Essay expands on the possible legal remedies for medical ghostwriting that can help outlaw a practice that has long tainted journal content and jeopardized patient safety.

Legal Remedies for Medical Ghostwriting Top
Stern and Lemmens recently advanced various legal theories under which “guest authors” can be held accountable, including filing an action under the Racketeer Influenced and Corrupt Organizations Act (RICO) [16]. They opined that monetary damages could include a reduction in the subscription value of the journal publishing ghostwritten articles. They concede individual damages would be nominal but suggest that potential liability and reputational harm may curb ghostwriting. We endorse this novel theory and the other theories (i.e., fraud on the court) Stern and Lemmens advance. We question, however, whether a law firm would undertake the Herculean task of filing RICO actions against guest authors when the potential of recovery (even if aggregated and trebled) would be, in litigation values, fairly modest and nominal. In reality, the transactional costs of such an endeavor, the novelty of the theories, and the nominal damages at issue would likely discourage law firms from prosecuting such cases.

We fully agree with Stern and Lemmens that the legal system could be effective in curbing ghostwriting, and suggest the following models of liability.

Personal Injury and Wrongful Death Damages Caused by the Guest-Authors' Misrepresentations Top
Guest authors lending their names to ghostwritten articles touting the safety and efficacy of a drug have an independent duty to exercise ordinary care and prevent injury to others as a result of their conduct [25]. As the influential Justice Benjamin Cardozo noted long ago: “It is ancient learning that one who assumes to act, even though gratuitously, may thereby become subject to the duty of acting carefully, if he acts at all.” [26] When US courts have considered misrepresentations that implicate a risk of physical harm to others, they have often looked to the rules set forth in the Restatement Second of Torts, sections 310 and 311 [27].

Sections 310 and 311 of the Restatement allow injured third parties to recover from a person who has made an intentional and negligent misrepresentation inducing action that involves a risk of physical harm [28]. The Restatement emphasizes that liability “extends to any person who, in the course of an activity which is in furtherance of his own interests, undertakes to give information to another, and knows or should realize that the safety of the person or others may depend on the accuracy of the information” [29].

The following hypothetical case, which is applicable to many real world events, illustrates how liability can be established: A drug manufacturer conducts a study whose primary endpoints show the study drug poses serious risks and is not effective. The drug manufacturer manipulates the data and creates post hoc secondary and tertiary endpoints to create favorable outcomes. Once a favorable outcome is created, the manufacturer hires a ghostwriting firm to draft an article falsely touting the purported benefits of the drug and failing to disclose the side effects. The manufacturer then retains various KOLs and reputable university professors to lend their names and credentials to the drafted article. The article is published in a widely read medical journal and physicians begin to prescribe the drug in reliance on the article's claims and the “authors'” reputations. Placebo responses help mask efficacy issues, but some patients begin to suffer from the undisclosed side effects—which in many cases cause serious and fatal injuries. Under these circumstances, the injured patients and their families sue the manufacturer for injuries and death caused by the drug's side effects. The guest authors, however, are never named as defendants. We argue that when an injured patient's physician directly or indirectly relied upon a journal article containing false/manipulated safety and efficacy data, then pursuant to the legal authority outlined above, the authors of that article, including guest authors, are legally liable for patient injuries and could be named as defendants.

Accordingly, guest authors should know that the information to which they have affixed their name (and purportedly “authored”) will be relied on by other medical professionals to make treatment decisions and that, should the information be false, the patients receiving the drug are placed in peril. Guest authors cannot claim immunity from the law by stating that they relied on data summaries presented by the pharmaceutical company. Such facts would fall squarely within the elements of liability outlined in Sections 310 and 311 of the Restatements discussed above. Even if the prescribing physician never actually read the ghostwritten article but its messages were relayed to him or her by colleagues, under established case law, the prescriber can be deemed to have relied on the ghostwritten article [30]. We therefore recommend that in cases where patients are harmed as a result of a pharmaceutical manufacturer's fraudulent representations involving ghostwritten articles, serious consideration should be given to naming as defendants the guest authors who lent their names to the misrepresentations.

In a few current pending pharmaceutical mass-tort litigations, plaintiffs' lawyers have begun naming ghostwriting firms such as Excerpta Medica, Inc. and Elsevier, Inc. as defendants [31], although we are aware of no published decisions or cases in which guest authors have been named as defendants. The transactional costs involved in naming guest authors as defendants are minimal given that a suit will already be pending against the manufacturer. The potential damages at issue can be significant and will depend on the plaintiff's injury and the egregious nature of defendants' conduct. Such potential liability serves four purposes. First, guest authors will be held accountable for their fraud and negligent conduct. Second, they will be confronted with the consequences of their actions and will have to answer at pre-trial depositions and at trial. Third, this will, we hope, force guest authors to review the data and independently confirm the conclusions prior to lending their names to articles drafted for them by manufacturers. Finally, once guest authors realize they could be personally liable for the bodily injuries resulting from their misrepresentations, they and other potential guest authors will be deterred from engaging in such unethical and illegal behavior.

False Claims Act Top
In addition to the claims for personal injuries caused by the guest authors' fraud, should the article constitute illegal off-label promotion by the pharmaceutical company, then the guest author may be held liable potentially as a conspirator under the federal False Claims Act (FCA) [32]. The FCA has effectively been used by private persons and the federal government to prohibit off-label promotion when company representations encouraged health care professionals to submit false payment claims to government health care programs. As recently reported by Kesselheim et al. [33], private individual actions under the FCA (also known as qui tam actions) allow company insiders and others with special knowledge of potential violations to initiate legal actions, which the government may join or take over. In particular, the FCA qui tam provision permits a private person, known as a relator, to file a lawsuit on behalf of the US government, on grounds that he or she has information that the named defendant has intentionally submitted, or instigated the submission of, false or fraudulent claims to the United States [34]. The relator, who need not have been personally affected by the defendant's demeanor, stands to receive a portion (usually about 15%–25%) of any recovered damages. A qui tam suit initially remains under seal for at least 60 days, during which the Department of Justice can investigate and decide whether to join the action.

This bounty system has acted as a powerful enticement in a variety of health settings, leading to a wellspring of FCA litigation [35], and such claims have become a usual feature of trials for off-label promotion [36],[37].

The Food, Drug, and Cosmetic Act (FDCA) governs drug safety; under it, manufacturers are forbidden from directly marketing a drug for a use other than the FDA-approved indication [38]. Under the FCA, lawsuits have been brought for FDCA violations against drug companies, based in part upon the company's utilization of ghostwritten articles to support illegal off-label use that induces physicians to prescribe medication for unapproved uses. In 2004, Pfizer pleaded guilty to charges that its Warner-Lambert unit flouted federal laws (FDCA and FCA) by promoting non-approved uses for a drug, alleging it used an illegal marketing strategy to drive up sales. Pfizer paid US$430 million in settlement, including US$24.6 million to the whistleblower who first reported the marketing manipulations. The lawsuit alleged that the Neurontin (gabapentin) marketing campaign included compensating doctors for putting their names on ghostwritten articles, paying them hefty speakers' fees, and covering the costs of “educational” trips at lavish resorts [39],[40].

Obtaining formulary coverage for off-label drug uses in the US can be especially hard, but approval can be advanced by articles supporting off-label use. If ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals are used as clinical evidence to establish medically accepted indications for off-label drugs, they are arguably inducing prescriptions to be written and paid for by the US government under false pretenses. The ghostwritten articles may then form the basis for FCA claims [41],[42].

FCA inflicts civil liability against persons or entities presenting false payment claims or using false records or statements to get claims paid or approved or causing third parties to do so. Statutory damages include up to US$11,000 per false claim submitted (i.e., per each reimbursement submitted for an off-label indication), plus 3-fold damages for the government [43]. If the ghostwritten article causes physicians to prescribe a drug for off-label use to patients on government assistance, the prices paid by the government for these off-label prescriptions can be obtained as damages (and trebled) in a successful FCA prosecution. The potential that participating in a ghost authored article can result in liability for conspiracy under the FCA may be another deterrent to the unethical practice of guest authorship.

Liability under the Anti-Kickback Statute Top
If it is established that, in consideration of prescribing the manufacturer's drug, the manufacturer agreed to the naming of the physician as a guest author, such arrangements would violate the federal Anti-Kickback Statute [44], the primary federal law governing physician-manufacturer consulting provisions. Enacted to protect Medicare and Medicaid programs against inappropriate use of services and unnecessary expenditures, it criminalizes suppliers inducing the use of products or services by providing remuneration to ordering physicians who knowingly offer, pay, solicit, or receive remuneration (in cash or kind, directly or indirectly, overtly or covertly) to induce (or in exchange for) the prescribing, purchasing, or recommending of goods or services reimbursable by any federal health care program [45].

Since paying physicians to become honorary or guest authors of a ghostwritten paper may influence their clinical judgment, subsequently increasing product sales (and government health care costs), and putting patients at risk by misrepresenting risk-benefit, both physicians and sponsor companies may be legally liable. The FCA, in conjunction with the Anti-Kickback Statute, can also be utilized to curb unethical ghostwriting. Via the FCA, a claim can be filed on behalf of the government by anyone possessing information regarding the anti-kickback violation and, if successful, the claimant or “relator” can share in any damages collected on behalf of the government. In addition, once the government is apprised of a kickback violation, the Department of Justice may bring criminal actions against violators of the Anti-Kickback Statute. Classified as a felony, the maximum individual punishments are fines of up to US$250,000 and imprisonment for up to five years [46]. Furthermore, individuals guilty of violating the statute can be excluded from participation in government programs such as Medicare and Medicaid [47]. The threat of civil and potential criminal prosecution is another potential manner of curbing guest authorship, especially when it is the result of reciprocal agreements between physicians/guest-authors to prescribe the drug and manufacturers promising to use the physician as a guest author.

No Recourse to the First Amendment Top
In their defense, guest authors and pharmaceutical defendants may try to argue they have a First Amendment right to participate in ghostwriting. The US has a rich history of protecting anonymous speech, especially in the area of political speech [48]. However, the same level of protection does not apply to commercial speech, i.e., speech promoting the safety/sale of a drug. Moreover, the US Supreme Court has firmly held that “the First Amendment does not shield fraud” [49] and courts have consistently rejected such First Amendment arguments in cases in which drug companies have been sued for fraudulent or off-label promotion [50]. Accordingly, the First Amendment should not provide any sanctuary to guest authors and pharmaceutical companies engaged in fraudulent commercial speech.

Conclusion Top
In addition to openly infringing academic standards and contributing to fraud, the crisis of credibility resulting from medical ghostwriting persists in published reports on the efficacy and safety of proposed treatments. The situation is so dire that the public is forced to seek judicial intervention to curb dangerous, unethical medical ghostwriting. Stakeholders, including universities, journals, pharmaceutical companies, and academic KOLs, have largely failed to heed public calls for honesty in reporting clinical research. Since these complaints have fallen on deaf ears, we believe the courts now have the task of restoring the integrity of the medical literature.

Acknowledgments Top

We wish to thank Michael Baum for suggestions on style. We also thank Trudo Lemmens for the invitation to BE and LM to present parts of this paper at “The Ethics of Ghost Authorship in Biomedical Research: Concerns and Remedies,” Faculty of Law, University of Toronto, May 4, 2011.

Author Contributions Top
Conceived and designed the experiments: XB BE LM. Analyzed the data: XB BE LM. Wrote the first draft of the manuscript: XB BE LM. Contributed to the writing of the manuscript: XB BE LM. ICMJE criteria for authorship read and met: XB BE LM. Agree with manuscript results and conclusions: XB BE LM. Jointly developed the structure and arguments of the paper: XB BE LM. Made critical revisions and approved final version: XB BE LM.
References Top
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Johnson & Johnson Takes $3 Billion Charge for Hip Recall - NYTimes.com

2012-01-25T02:49:00.001Z

Johnson & Johnson took quarterly charges of more than $3 billion, largely related to the recall of artificial hips, and gave a 2012 earnings forecast below analysts’ estimates on Tuesday.

via nytimes.com

The company’s DePuy Orthopaedics unit issued an extensive recall of its “metal-on-metal” hip replacement devices in 2010 after they shed metal fragments, causing disabling injuries.

The fourth-quarter charges will allow money to be set aside for patients and lawyers involved in product liability litigation.

“The hip recalls worry me because their eventual costs are unknown,” said Jeff Jonas, an analyst at Gabelli & Company, who noted that the fourth-quarter charges included $800 million for medical costs of the recall.

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OxyContin: Purdue Pharma's painful medicine - Fortune Features

2012-01-24T19:40:00.001Z

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Paula Deen Publicist, Nancy Assuncao Sanchez, Reportedly Quit Over Novo Nordisk Deal

2012-01-24T19:17:00.001Z

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