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Anti-fraud Laws in the Pharmaceutical & Health Care Sectors "Qui Tam Provisions"

#1 User is offline   hukildaspida 

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Posted 02 May 2011 - 10:42 PM

"Implementing US style Anti-fraud laws in the Australian Pharmaceutical and Health care sectors."


http://www.mja.com.a...au11387_fm.html


A couple of small excerpts from this article which is just as relevant to New Zealand as the same Pharmaceutical Companies are involved.

Abstract

*

This article critically analyses the prospects for introducing United States anti-fraud (or anti-false claims) laws in the Australian health care setting.
*

Australian governments spend billions of dollars each year on medicines and health care. A recent report estimates that the money lost to corporate fraud in Australia is growing at an annual rate of 7%, but that only a third of the losses are currently being detected.
*

In the US, qui tam provisions — the component of anti-fraud or anti-false claims laws involving payments to whistleblowers — have been particularly successful in providing critical evidence allowing public prosecutors to recover damages for fraud and false claims made by corporations in relation to federal and state health care programs.
*

The US continues to strengthen such anti-fraud measures and to successfully apply them to a widening range of areas involving large public investment.
*

Australia still suffers from the absence of any comprehensive scheme that not only allows treble damages recovery for fraud on the public purse, but crucially supports such actions by providing financial encouragement for whistleblowing corporate insiders to expose evidence of fraud. Potential areas of application could include direct and indirect government expenditure on health care service provision, pharmaceuticals, medical devices, defence, carbon emissions compensation and tobacco-related illness.
*

The creation in Australia of an equivalent to US anti-false claims legislation should be a policy priority, particularly in a period of financial stringency.

AND


1 Types of fraudulent and false claims successfully prosecuted under the United States False Claims Act*

*

Billing for goods and services never delivered or rendered; marketing and lobbying; inappropriate or unnecessary medical procedures; work or tests not performed; inferior equipment as premium equipment; automatic laboratory tests based on range not request; patented drugs when generic drugs were provided; unlicensed or unapproved drugs; research that was never conducted.
*

Billing at doctors rates for work by a nurse, resident or intern.
*

Billing to increase revenue not for actual work performed.
*

Double billing for the same goods or service.
*

Unbundling — using multiple billing codes instead of one billing code for a drug panel test in order to increase remuneration.
*

Bundling — billing for a panel when a single test was ordered.
*

Upcoding — inflating bills by using diagnosis billing codes that suggest a more expensive illness or treatment.
*

Charging for employees who were not actually on the job, or billing for made-up hours to maximise reimbursements.
*

Failing to report known product defects in order to be able to continue to sell or bill the government for the product.
*

Falsifying research data paid for by the government.
*

“Lick and stick” prescription rebate fraud and “marketing the spread” prescription fraud (lying to the government about true wholesale price of prescription drugs).
*

Pumping, mining or harvesting more natural resources from public lands than is actually reported to the government.
*

Not reporting overpayment by the government.
*

Misrepresenting the value or origin of imported goods.
*

Falsely certifying that a contract falls within certain guidelines (ie, the contractor is part of a minority group or is a veteran).
*

Submitting false performance records or samples.
*

Presenting broken or untested equipment as operational.
*

Certifying a product as having passed a test when it has not.
*

Yield burning — skimming profits from sale of municipal bonds.
*

Winning a contract through kickbacks or bribes.
*

Prescribing a medicine or recommending a type of treatment or diagnosis regimen to win kickbacks from hospitals, laboratories or pharmaceutical companies.
*

Forging physician signatures when such signatures are required for reimbursement from Medicare or Medicaid.

* Source: False Claims Act Legal Center website at http://www.taf.org/legalupdate.htm.
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#2 User is offline   hukildaspida 

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Posted 03 October 2012 - 10:50 PM

https://www.mja.com....and-health-care

Implementing US-style anti-fraud laws in the Australian pharmaceutical and health care industries
Thomas A Faunce, Gregor Urbas and Lesley Skillen
Med J Aust 2011; 194 (9): 474-478.

Abstract

This article critically analyses the prospects for introducing United States anti-fraud (or anti-false claims) laws in the Australian health care setting.

Australian governments spend billions of dollars each year on medicines and health care. A recent report estimates that the money lost to corporate fraud in Australia is growing at an annual rate of 7%, but that only a third of the losses are currently being detected.

In the US, qui tam provisions — the component of anti-fraud or anti-false claims laws involving payments to whistleblowers — have been particularly successful in providing critical evidence allowing public prosecutors to recover damages for fraud and false claims made by corporations in relation to federal and state health care programs.

The US continues to strengthen such anti-fraud measures and to successfully apply them to a widening range of areas involving large public investment.

Australia still suffers from the absence of any comprehensive scheme that not only allows treble damages recovery for fraud on the public purse, but crucially supports such actions by providing financial encouragement for whistleblowing corporate insiders to expose evidence of fraud. Potential areas of application could include direct and indirect government expenditure on health care service provision, pharmaceuticals, medical devices, defence, carbon emissions compensation and tobacco-related illness.

The creation in Australia of an equivalent to US anti-false claims legislation should be a policy priority, particularly in a period of financial stringency.

Government expenditure on medicines and health care in Australia runs to billions of dollars annually. Federal expenditure on the Pharmaceuticals Benefits Scheme (PBS) increased from A$3.2 billion in the 1998–99 financial year to A$8.3 billion in 2009–10.1 In 2008, the federal government spent A$45 billion on health care and state governments spent A$26 billion.2 Federal expenditure on health care in general is expected to be over A$70 billion in 2011 and will increase partly as a result of projected changes to federal–state administrative arrangements.3 Per capita yearly government expenditure on health (calculated using the average exchange rate) is about US$4000 in Australia and US$7000 in the United States.4

Risks of corporate fraud in Australian health care

In the US, the health sector is a major target for fraudulent corporate activities, such as reporting false claims or costs, billing for services or procedures not performed or medically unnecessary, hiding improper financial arrangements with health care goods and service providers, as well as promoting off-label uses to physicians, lying about the true wholesale price and submitting false performance records5 (Box 1).

In Australia, a recent representative proceeding (class action) in the Federal Court found that Merck Sharpe and Dohme trained its representatives to minimise physician concerns about adverse cardiovascular effects of Vioxx (rofecoxib). The company even created a publication called the Australasian Journal of Bone and Joint Medicine, which was neither peer-reviewed nor independent, to advertise a product subsequently found under the Trade Practices Act 1974 (Cwlth) to be defective (s 75AD) and not reasonably fit for purpose (s 74B) or of merchantable quality (s 74D).6 This heightens concerns that the Australian pharmaceutical market is unlikely to be immune from US-style false claims and fraud, if only because most of the major drug companies proven to have engaged in such conduct against the US government also dominate the Australian market (Box 2). A report by the University of Melbourne and KPMG estimated that the total amount of money lost to corporate fraud in Australia, including in the health care sector, was about A$350 million in 2010 and growing at an annual rate of 7%, with only a third being detected.7

Under the Medicare Australia Act 1973 (Cwlth), Medicare is empowered to monitor payments on claims paid for both Medicare and the PBS for fraud. It does this through a program of audits as well as sophisticated methods of data analysis. Under the Health Insurance Act 1973 (Cwlth), civil penalties can be imposed on providers of pathology or diagnostic services for asking for or accepting prohibited benefits (s 23DZZIK), offering or providing prohibited benefits (s 23DZZIL) and making threats to induce the above conduct (s 23DZZIM) (Box 3). Within 6 years of a wrongdoer contravening a civil penalty provision, the Chief Executive Officer of Medicare Australia may apply on behalf of the Commonwealth to the Federal Court for an order that the wrongdoer pay the Commonwealth a pecuniary penalty (s 125A(1)). In the 2006–07 financial year, Medicare pursued 499 individuals for A$3.4 million in “incorrect payments” and 550 investigations into fraudulent claiming were begun, with 79 referred to the Commonwealth Director of Public Prosecutions, who successfully prosecuted 56 individuals to recover A$312 927.8 Yet in Australia (unlike the US) large-scale anti-fraud and anti-competitive prosecutions in the pharmaceutical sector have been rare. One example was the 2001 Australian Competition and Consumer Commission prosecution in the Federal Court of Roche Vitamins Australia (A$15 million penalty), BASF Australia (A$7.5 million) and Aventis Animal Nutrition (A$3.5 million), in connection with a global price-fixing cartel supplying vitamins A and E in animal feeds, which inflated general food prices.9

Comparison with the anti-fraud measures in the US health care sector


The False Claims Act (31 US Code ss 3729-3733) (FCA) began during the US Civil War and was substantially amended in 1986 by the Reagan administration, and in 2009 by the Obama administration. It now imposes liability upon anyone who knowingly or with “deliberate ignorance” or “reckless disregard” of the truth submits, or conspires with another to submit, a false claim or related false record:

for payment from the US Government or from an entity administering government funds; or

to avoid or decrease an obligation to pay the US Government.

Qui tam provisions are a component of these false claims laws that have proved extremely effective in encouraging whistleblowers to provide (in a private–public enforcement partnership) crucial “insider” evidence about corporate fraud in a wide range of settings (Box 1). The words qui tam are an abbreviation of a Latin legal maxim broadly meaning “he who sues on behalf of himself also sues on behalf of the state”. Qui tam laws allow private citizens (relators) the right to provide documents establishing fraud or false claims (the terms are generally interchangeable in this context) upon the government to a no win–no fee lawyer who, if convinced of the merits, will fund and file with a Department of Justice office a lawsuit under seal (not initially disclosed to the defendant) (s 3730(B)). Whistleblowers are rewarded with between 15% and 30% of whatever proceeds the government recovers from the civil suit (ss 3729(a), 3730(d)(1), 3730(d)(2)).10 The prospects of success are greater if federal or state justice department officials can be convinced to join the case.11 In such instances, the qui tam relator and his or her counsel act as force multipliers for the often cash-strapped public prosecutors, contributing valuable human and financial resources to the action.

Qui tam whistleblower suits constitute about 80% of all false claims actions and have been very successful in achieving substantial recoveries from corporations in the health service, pharmaceutical, education, defence, and oil and gas sectors.12 In 2010, recoveries from pharmaceutical and medical device companies accounted for 65% of the US$2.5 billion recovered from health care fraud claims.13 Qui tam actions against pharmaceutical companies are now the most successful type of anti-false claims litigation14 (Box 4). In recent years, nearly half of all US states have enacted their own anti-false claims statutes.

Treble damages, civil penalties and criminal offences

In addition to prosecution for criminal offences and penalties, since 1986, the FCA has provided for treble damages, which the US Supreme Court has held to be largely compensatory or remedial rather than punitive.15 Treble damages give public law enforcement agencies a substantial financial incentive to undertake protracted investigations and actions, while the potential to receive 15%–30% of that amount creates a critical incentive for corporate insiders to overcome their concerns about the risks associated with whistleblowing (such as intimidation, loss of livelihood, friends and family, and mental anguish).16 Civil fines of about US$11 000 per claim (eg, per billing item) are also imposed. Companies convicted of offences under the FCA can be barred from involvement in government programs, though some companies appear to have circumvented this by shifting liability to subsidiary corporate entities.

The expanding scope of the FCA


The range of fraudulent activities in health care covered by the FCA is fairly broad and extends to prohibited conduct prescribed in other federal statutes, such as the Anti-Kickback Statute of 1972, the Anti-Self Referral (“Stark”) Law of 1995, the Fraud Enforcement and Recovery Act 2009 and the Patient Protection and Affordable Care Act 2010. False claims liability was an important public interest protection built into the financial sector bailouts of the Troubled Asset Relief Program under the Emergency Economic Stabilization Act 2008.

Although the FCA traditionally did not apply to taxation, in the circumstances specified in the Tax Relief and Health Care Act 2006 (s 406), treble damages and whistleblower awards of 15%–30% of the amount recovered by the Internal Revenue Service apply if the tax, penalties and interest in dispute exceed US$2 million. It is even arguable that anti-false claims actions may be available under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) 2009, by which the US Food and Drug Administration specifies criteria for manufacturing, registration and marketing approvals for tobacco products (including receiving all relevant corporate research [s 904]), among other reasons to restrain government payments under Medicare and Medicaid for tobacco-related illness.

In the words of the US Supreme Court, “the [FCA] was intended to reach all types of fraud, without qualification, that might result in financial loss to the Government.”17 The enforcement partnership has proven extremely cost-effective, recouping US$15 for every US$1 spent on qui tam investigations and litigation.18 Qui tam laws can act as potent deterrents for fraudulent activities as they amplify the threat of detection and prosecution, and create incentives for compliance with government requirements and conditions. The relevant government law enforcement body retains control. Where the government decides to intervene in the action, it takes over the prosecution of the claim, and the relator must tender full cooperation, or the government may compel the court to limit the relator’s role in litigation (ss 3730(B)(4), 3730©(1), 3730©(2)(B), 3730©(2)©). Even if the government refuses to intervene, allowing the relator to proceed with the lawsuit on the government’s behalf (s 3730(B)(4)(B)), it still actively monitors the case and has a right to review all pleadings and to later join the case where good cause is shown (ss 3730(B)(3), 3730©(3)). As such, fears about perverse incentives driving enforcement19 or over-enforcement,20 are unfounded.
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#3 User is offline   hukildaspida 

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Posted 03 October 2012 - 10:51 PM

https://www.mja.com....and-health-care

Checks and balances against inappropriate claims

Frivolous or parasitic qui tam claims are curtailed not only by the large amounts that plaintiff lawyers acting for “relators” must pay up-front and by scrutiny of the case by Department of Justice officials, but by statutory bars to individuals who have made no material contribution to uncovering the fraud or providing the factual basis of the claim.12 In a recent case where the relator could not identify each false claim the defendant had submitted to US Medicare and Medicaid, the court found that the relator’s allegations were sufficiently particular because they identified the providers whom the defendant had caused to submit false claims, the dates of the claims, the monetary amounts, and the number of claims.21

The 2009 amendments to the FCA clarified that, while a relator cannot base a qui tam action on publicly disclosed allegations (already in a government report, hearing, audit or investigation or in the media), a court may still have jurisdiction if the Attorney General nonetheless decides to bring the action, or if the relator is the original source of that information (s 3730(e)(4)(A)). Original source is defined as “an individual who has direct and independent knowledge of the information on which the allegations are based” (s 3730(e)(4)(B)).

Implementing qui tam legislation in Australia


A comparison with the situation in the US strongly suggests that one reason for the lack of large-scale anti-fraud and anti-false claims actions in the pharmaceutical and health care sectors in Australia may relate to the lack of insider information from private corporations provided to law enforcement officials. Whistleblowing is an infrequent phenomenon from within the Australian health care sector; it is not encouraged, rewarded or adequately protected.22 In 1989, a federal committee recommended that qui tam laws were incompatible with accepted practice in the Australian legal system.23 By 2011, however, significant progress has been made in Australia towards a uniform legislative regime for protecting whistleblowers from unjust reprisals.24 The potential application of US qui tam laws to facilitate whistleblowing about fraud and false claims from within the Australian private corporate health care and pharmaceutical sectors again has been suggested to the Australian Government (T A F, invited oral testimony to the Australian House of Representatives Standing Committee on Legal and Constitutional Affairs,18 Sep 2008). Given the scale of public investment in the Australian health care service, pharmaceutical, medical device and other health-related industries, we believe that an anti-fraud regime based on that of the US should be introduced in Australia. Such laws comport with developing Australian legal principles and are likely to prove as effective here as they have been in the US.

Over the past 20 years, anti-competitive behaviour has increasingly been regarded as a serious crime by Australian regulators. No win–no fee advertising is now common, and litigation funding companies are permitted to back public interest class actions.25 The Australian High Court has now supported the right of any person to seek injunctive relief for a breach of specified provisions of the Trade Practices Act against a corporation.26 It has also upheld the capacity of a plaintiff to bring an action, not to vindicate a private right, but to prevent the violation of a public right or to enforce the performance of a public duty.27,28

Litigation-funding companies in Australia already accept the risk of paying the other side’s costs if a case fails, in return for a set share of the proceeds if it succeeds. These arrangements have withstood challenges in Australian courts, in part because they fulfil public policy imperatives such as access to justice, particularly in public health-related class actions.25While some Australian courts may consider the treble damages provided for under the FCA to be an extraordinary remedy, appropriate only in cases of truly outrageous conduct,29 others are likely to agree with US courts that treble damages in qui tam actions are primarily remedial in nature10 or even justifiably punitive.30 Moreover, treble damages have been considered previously as a deterrent for insider trading, and Australian regulators have generally been in favour of them.31 Considerable financial benefits would arise from applying such damages even to existing penalties under, for example, the Health Insurance Act (Box 3). The recently announced Tobacco Plain Packaging Bill 2011 could include provisions establishing an anti-fraud system related to industry claims required to be made under government regulation of the manufacture and marketing of tobacco (including mandatory disclosure of tobacco industry research about the harmfulness or addictiveness of its products).

The key strengths of the US qui tam anti-fraud regime, particularly in a period of financial stringency, lie in its recovery of large amounts of public monies, its encouragement of good corporate practice, the incentives it provides and the protection it affords whistleblowers from within the private sector, and its various checks and balances to ensure that only presumptively meritorious claims are processed. If designed carefully, Australian qui tam anti-fraud laws may provide a mechanism for sustained and diligent oversight of claims by health care services, the financial sector, and the pharmaceutical, medical device, defence and fossil fuel industries on the public purse without significantly impeding their growth. Australian qui tam legislation could also play a significant role in reducing fraud and false claims in relation to other large investments or redistributions of public monies in public health-related fields such as carbon emissions compensation and the costs of treating tobacco-related illness.
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#4 User is offline   hukildaspida 

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Posted 03 October 2012 - 10:54 PM

https://www.mja.com....and-health-care

Box 1 – Types of fraudulent and false claims successfully prosecuted under the United States False Claims Act*

Billing for goods and services never delivered or rendered; marketing and lobbying; inappropriate or unnecessary medical procedures; work or tests not performed; inferior equipment as premium equipment; automatic laboratory tests based on range not request; patented drugs when generic drugs were provided; unlicensed or unapproved drugs; research that was never conducted.

Billing at doctors rates for work by a nurse, resident or intern.

Billing to increase revenue not for actual work performed.

Double billing for the same goods or service.

Unbundling — using multiple billing codes instead of one billing code for a drug panel test in order to increase remuneration.

Bundling — billing for a panel when a single test was ordered.

Upcoding — inflating bills by using diagnosis billing codes that suggest a more expensive illness or treatment.

Charging for employees who were not actually on the job, or billing for made-up hours to maximise reimbursements.

Failing to report known product defects in order to be able to continue to sell or bill the government for the product.

Falsifying research data paid for by the government.

“Lick and stick” prescription rebate fraud and “marketing the spread” prescription fraud (lying to the government about true wholesale price of prescription drugs).

Pumping, mining or harvesting more natural resources from public lands than is actually reported to the government.

Not reporting overpayment by the government.

Misrepresenting the value or origin of imported goods.

Falsely certifying that a contract falls within certain guidelines (ie, the contractor is part of a minority group or is a veteran).

Submitting false performance records or samples.

Presenting broken or untested equipment as operational.

Certifying a product as having passed a test when it has not.

Yield burning — skimming profits from sale of municipal bonds.

Winning a contract through kickbacks or bribes.

Prescribing a medicine or recommending a type of treatment or diagnosis regimen to win kickbacks from hospitals, laboratories or pharmaceutical companies.

Forging physician signatures when such signatures are required for reimbursement from Medicare or Medicaid.

* Source: False Claims Act Legal Center website at http://www.taf.org/legalupdate.htm.

Box 2 – Eight Australian Pharmaceutical Benefits Scheme (PBS) suppliers with highest market share and representative United States False Claims Act (FCA) actions against their related companies in the US

Box 3 – Offences with penalties under the Health Insurance Act 1973 (Cwlth) that could also allow governments to recover treble damages if qui tam statutes were enacted in Australia

Prohibition of certain medical insurance (s 126).

Preclusion on agreements to assign Medicare benefits (s 127).

Offences in relation to tax returns (s 128).

False statements relating to Medicare benefits (s 128A).

Knowingly making false statements relating to Medicare benefits (s 128B).

Charging fees for provision of public hospital services to public patients (s 128C).

Making false statements (s 129).

Bribery in relation to admissions to private hospitals (s 129AA).

Box 4 – Prominent qui tam claims in the United States pharmaceutical industry, 2001–2010
Provenance:

Commissioned; externally peer reviewed.
Received
27 Nov 2010,
accepted
3 Apr 2011
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#5 User is offline   hukildaspida 

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Posted 02 January 2013 - 09:58 PM

Please be mindful this article is from 2009.

It would be of interest how much has changed since these facts were published.

It would also be interesting to see how New Zealand compares and how it will compare in a years time after ex http://www.acc.co.nz Dr Jan White
has been in her new role with Pharmac and the same with ex http://www.acc.co.nz Medical Advisor Dr Kevin Morris in his role at the Medical Council,
to see what if any influence they have over ensuring accountablity & integrity in the Pharmacuetical industry.


Drug companies censured over lavish doctors' seminars

by: Adam Cresswell, Health editor
From: The Australian
March 28, 2009 12:00AM

http://www.theaustra...6-1225692038865

GRAPHIC: The medicinal train

DRUGMAKERS are under fire for "profoundly excessive" spending on educational events for doctors that include weekends costing more than $300,000 at five-star hotels.

Despite a ban on "lavish" hospitality, the latest six-monthly report by the drug industry's peak body, Medicines Australia, shows a significant number of the educational events cost the sponsoring companies six-figure sums.

In one case, drug giant Pfizer -- the maker of anti-impotence drug Viagra -- spent $206,155 last July putting up nearly 200 doctors at Sydney's five-star Sheraton on The Park to tell them about erectile dysfunction in diabetes patients.

The cost, which equates to $1057 per person, covered 10 hours of educational content, accommodation for 168 doctors, air travel for 19, transfers for 75 and dinner and parking for 195.

In another case, Pfizer spent $291,916 to host 210 doctors at the Crowne Plaza at Surfers Paradise for a nine-hour "cardiovascular forum", equal to $1390 per head.


Some of the highest per-capita spending was racked up by Merck Sharp & Dohme, which spent $337,169 to put up 136 hormone specialists at the Westin Hotel in Sydney ($2479 per head), and Schering-Plough, which spent $311,599 to host just 75 rheumatologists at the Westin in Melbourne ($4154 per head).

AstraZeneca spent $22,052 on flights and accommodation for 38 GPs at the Shangri-La Hotel in Cairns, which claims on its website that it "sets the standard for contemporary luxury and service in one of Australia's most beautiful seaside destinations". The report is the third six-monthly breakdown of the details of seminars, conferences and other educational meetings funded by drug companies since the Australian Competition and Consumer Commission forced the industry to be more transparent about its spending in 2007.

The report shows the number of events has risen fast to 18,060, up 23.4 per cent on the same time of last year.

The number of doctors attending also rose, by 15.4 per cent from 385,221 to 444,724. The average cost of events per person fell, from $80.50 to $67.67.

Drug companies last night defended the spending, but Ian Kerridge, associate professor in bioethics at the Centre for Values, Ethics & Law in Medicine at the Sydney University, said the sums involved were "profoundly excessive" and the system of self-disclosure had failed to impose restraint.

"They are all fairly swanky events, fully catered -- I had three invitations this week, all offering airfares and accommodation for a weekend in Melbourne or the Gold Coast," said Associate Professor Kerridge, who is also a haematologist at Sydney's Westmead Hospital.

"It does raise questions about the adequacy of these (Medicines Australia) processes."

Professor Kerridge said while dancing girls were a thing of the past, drug companies had instead become adept at playing on doctors' fears their medical knowledge might fall behind that of their peers.

One common technique was to fly out international experts to give talks, creating considerable peer pressure to attend, he said.

"They have become much more sophisticated at blurring the boundary between education and influence. You can't clearly say these events have no educational value, because they do.

"But the program is restricted, and the way it's restricted will inevitably reflect the interests of the sponsor."
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#6 User is offline   hukildaspida 

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Posted 06 January 2014 - 12:54 PM

Drug companies accused of holding back complete information on clinical trials
MPs voice concern after report into decision to stockpile Tamiflu finds discussions about effectiveness hampered by practice

*
Rajeev Syal
*
* The Guardian, Friday 3 January 2014


http://www.theguardi...clinical-trials

Clinical trial results are being routinely withheld from doctors, undermining their ability to make informed decisions about how to treat patients, an influential parliamentary committee has claimed.


MPs have expressed "extreme concern" that drug manufacturers appear to only publish around 50% of completed trial results and warned that the practice has "ramifications for the whole of medicine".

Their conclusions have emerged in a public accounts committee report which examined the Department of Health's decision to spend £424m on stockpiling the flu drug Tamiflu, before writing off £74m because of poor record keeping.

The MPs found that experts failed to agree on how well Tamiflu works, but discussions were hampered because important information was held back.

Richard Bacon, a senior member of the committee, said the practice of holding back results was undermining the ability of doctors, researchers and patients to make informed decisions about treatments. "Regulators and the industry have made proposals to open up access, but these do not cover the issue of access to the results of trials in the past which bear on the efficacy and safety of medicines in use today," he said. "Research suggests that the probability of completed trials being published is roughly 50%. And trials which gave a favourable verdict are about twice as likely to be published as trials giving unfavourable results.

"This is of extreme concern to this committee. The department [of health] and Medicines and Healthcare products Regulatory Agency [MHRA] must make sure, prospectively and retrospectively, that clinical trials are registered and the full methods and results of all trials are available for independent wider scrutiny by doctors and researchers."

The committee noted that an NHS National Institute for Health Research review in 2010 estimated that the chance of completed trials being published is roughly half. Trials with positive results were about twice as likely to be published as trials with negative results.

Dr Fiona Godlee, editor-in-chief of the British Medical Journal,
told the MPs that the pharmaceutical industry published more positive results than negative ones from their trials. She noted that the journal had published very clear summaries of systematic reviews of data on individual medicines or classes of medicines where, "when you add together the published and unpublished evidence, you get a very different picture of the quality and effectiveness of those drugs".

A review by the non-profit Cochrane Collaboration into 20 existing studies into Tamiflu found it "did not reduce influenza-related lower respiratory tract complications" but did induce nausea.

It is now receiving full clinical study reports from manufacturer Roche, which are being used to complete a further review of the effectiveness of Tamiflu. The results of that should be used by government, the MHRA and the National Institute for Health and Care Excellence to review the drug's use, MPs said.

They also called on ministers to take action so that full trial results are available to doctors and researchers for all treatments currently being prescribed and carry out regular audits of how much information is being made available.

Bacon added: "There is still a lack of consensus over how well the antiviral medicine Tamiflu, stockpiled for use in an influenza pandemic, actually works. The lack of transparency of clinical trial information on this drug to the wider research community is preventing proper discussion of this issue among professionals. We are disturbed by claims that regulators do not have access to all the available information.

"The case for stockpiling antiviral medicines at the current level is based on judgment rather than on evidence of their effectiveness during an influenza pandemic. Before spending money in future to maintain the stockpile, the department needs to review what level of coverage is appropriate. It should look at the level of stockpiling in other countries, bearing in mind that the patent for the medicine runs out in 2016."

An MHRA spokesman said the body would work with partners in the UK and in the EU to ensure greater transparency in the dissemination of clinical trials information.
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#7 User is offline   hukildaspida 

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Posted 06 January 2014 - 04:08 PM

Please click on the link to read the links within this article and for the readers comments.


It's a scandal drug trial results are still being withheld

Doctors like me can't give an informed view on the benefits of any treatment, let alone Tamiflu, because drugs firms aren't publishing all the evidence



* Ben Goldacre
*
o
Ben Goldacre
o
o The Guardian, Sunday 5 January 2014 20.30 GMT

http://www.theguardi...doctors-tamiflu



The Commons public accounts committee's report into the government's handling of the UK's £424m stockpile of the influenza drug Tamiflu, published last week, was damning. But starting from this narrow remit, the committee also stumbled – with palpable amazement – into a far wider problem.

Nobody can give you a fully informed view on the benefits of any treatment, let alone Tamiflu, because the results of clinical trials are being routinely and legally withheld from doctors, researchers and patients. As the committee pointed out, government agencies around the world disagree on whether Tamiflu reduces your chances of pneumonia and death, but we can have no idea who is right, because we can't see the evidence. Astonishingly, in withholding this information for five years, Tamiflu's makers, Roche, have broken no law – and it is only an accident of history that this drug has become the poster child for change.

The first study on the problem of missing results was published in 1986. A 2010 review article by the NHS's own research body summarises the results of a dozen more studies on the same subject: this found that, overall, the chances of a completed trial being published are roughly 50%. This undermines our ability to make informed decisions on everything from surgical techniques to drugs and devices. Unsurprisingly, trials with positive results are twice as likely to be published as those with negative results, so the evidence we do see is potentially biased. Large studies from the past two years, chasing up results from huge registries of completed trials, report similar results. Information isn't just passively left unpublished: it is actively withheld when requested by researchers.

Doctors like me cannot possibly make informed decisions about which treatment is best when the information we rely on has been distorted in this way. The problem is endemic, has a serious impact on public health, and has been well documented for over two decades. How can this have been allowed to happen?

It's tempting to fall back on crude fairytales of evil corporations, and there is no doubt that industry has lobbied hard against change. Secret internal memos, leaked in 2013, showed the US and EU industry representative bodies discussing their "advocacy strategy" against transparency, including a plan to "mobilise" the patient representative groups the industry often generously funds.

But the real scandal lies with the very people we expect to protect us. It seems some civil servants at medicines regulators still wish for a quiet life, where they can ruminate on secret data behind closed doors, with no or limited academic or public scrutiny over their decisions. This is particularly dangerous when you consider that some of the biggest medical scandals of the past few years – problems with the evidence for Vioxx, Avandia and Tamiflu, for example – were only spotted by independent researchers and academics, often after a long fight for access to information on clinical trials.

The medical profession, until recently, has been supine. In 2012 the medical royal colleges, societies and even the Department of Health signed up to a bizarre set of documents – apparently orchestrated by industry – claiming there is a "robust regulatory framework" ensuring access to trial results. Not only does this give false reassurance on a vitally important matter of public safety, but the signatories refused to answer even the simplest questions about how they came to sign such peculiar statements.


Now, all that has changed. Some 130 patient groups, representing more than 100 million patients, have signed up to All Trials, a campaign I co-founded with the BMJ and other groups a year ago. Others supporting the campaign include Nice, the Medical Research Council and GlaxoSmithKline one of the biggest drug companies in the world.

The final frontier is delay and denialism at the Medicines and Healthcare Products Regulatory Agency, the Department of Health and the government. David Cameron, when asked about missing trial results and Tamiflu, at prime minister's questions, explained that he took this problem seriously, and suggested new EU legislation will fix it. This is untrue. New EU legislation – which the industry have been lobbying desperately against – only requires better sharing for trials starting after 2014. Even if it passes, this will do nothing to improve the evidence base for the decisions made in clinics around the world today. The overwhelming majority of treatments prescribed by doctors right now – the everyday drugs for blood pressure, cholesterol, ulcers and more that are taken by millions – all came on the market over the past two decades, not the past seven days. That is the era of evidence that patients need.

Government should ride the wave we have created, and act. There has been more progress on trials transparency in the past 12 months than in the past 25 years. Proposals from industry and regulators are riddled with loopholes so huge they exempt the vast majority of trials on the medicines we use today: but these loopholes are finally being called out.The net is tightening for those who belittle this problem, or pretend it has been fixed, and it's almost painful to see how easy it was for patients and doctors to have such an impact. We should have acted sooner, but we have an unprecedented opportunity for change. Anyone undermining the case for transparency will find themselves on the wrong side of patients and the wrong side of history. Medicine relies on evidence: future generations will look back on us tolerating withheld results in the same way we look back on medieval blood-letting.
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#8 User is offline   hukildaspida 

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Posted 11 April 2014 - 06:22 PM

Please click on the link to read another interesting piece by Ben Goldacre about Tamiflu

What the Tamiflu saga tells us about drug trials and big pharma
We now know the government's Tamiflu stockpile wouldn't have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there's a lot we don't know about other medicines we take


http://www.theguardi...ials-big-pharma


Ben Goldacre
Ben Goldacre
The Guardian, Thursday 10 April 2014
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Today we found out that Tamiflu doesn't work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.
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#9 User is offline   hukildaspida 

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Posted 11 April 2014 - 06:25 PM

The drugs don't work: Britain wasted £600m of taxpayers' money on useless flu pills stockpiled by Government in case of pandemic


http://www.independe...ic-9249396.html


Steve Connor
Thursday 10 April 2014
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#10 User is offline   hukildaspida 

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Posted 14 April 2014 - 12:48 PM


Who's Paying Your Doctor?


Image for Who's Paying Your Doctor?
Not currently available on BBC iPlayer

http://www.bbc.co.uk...rammes/b041drpn

Duration: 30 minutes

With the NHS drug bill topping £10 billion in 2013, this investigation examines the tactics employed by drug companies to tap into that lucrative market and influence which medicines your doctor prescribes.

Strict rules govern drug company spending in the UK, but still they pay out millions to doctors to attend and speak at conferences. Panorama goes undercover to see this subtle persuasion at work and asks whether you should have the right to know who is paying your doctor.

And as Britain's most profitable drug company, GlaxoSmithKline, waits to hear whether it will face criminal charges following allegations of bribery in China, the programme reveals new evidence that GSK was recently paying doctors to boost prescriptions much closer to home, in Europe.  Show less

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BBC OneMon 14 Apr 2014 20:30 BBC One

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#11 User is offline   hukildaspida 

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Posted 17 April 2014 - 12:20 PM

Growing concern over medical freebies
NIKKI MACDONALD
Last updated 05:00 12/04/2014

http://www.stuff.co....edical-freebies

Doctors and nurses accepted drug company-funded trips, meals and gifts worth almost $170,000 last year amid growing concern about the freebies' potential to influence medical decisions.


District health board gift registers obtained under the Official Information Act show health workers accepted 109 drug company "gifts", including overseas trips flying business class.

The largest gift, from Novartis to an Auckland doctor, was $13,500 in flights and accommodation to attend a four-day osteoporosis meeting in Rome.

Drug companies also hosted meals, including Roche and Gilead spending $6400 for two "educational dinners" for 35 Auckland haematology staff.

One Wellington intensive care doctor was paid a $2500 honorarium for one day's work advising Baxter Healthcare. The declared gifts are likely to be only a fraction of the total spent by pharmaceutical companies, as gift registers do not cover private doctors.

Despite Health Minister Tony Ryall's 2012 assurances that DHBs would standardise their approaches to declaring drug company gifts, policies still vary widely.


Some DHBs had no gift register. Others had registers, but with nothing declared. Waitemata DHB's 6800 staff declared just one "gift" in 12 months - a tapa cloth given to its chief executive.

Countries are now demanding greater transparency of payments to doctors as research has shown drug company largesse influences medical decisions.

Australia's pharmaceutical industry body Medicines Australia now declares how much it spends on hospitality and advisory boards.

Medical Association president Mark Peterson supported a similar public national register here.


"To say you're not influenced at all by drug company behaviour is a bit naive. . . . The key point is openness and the declaration of any interest."


However, he would not advocate banning doctors and nurses from accepting drug company sponsorship.

IN THE MONEY

Auckland:17 drug company* gifts declared, worth $32,592. The only health board to identify recipients.

Counties Manukau:29 drug company gifts declared, worth $45,809. Two gifts were declined.

Waikato: One policy outlaws gifts, such as free air travel or accommodation. Another says drug firms commonly provide subsidised travel and such "outside" work must not interfere with DHB duties.

Bay of Plenty:1 drug company gift declared, worth $50.99.

Hawke's Bay: Gifts must be reported but no register is kept.

Mid Central: No register kept. Staff required to "decline gifts or benefits that place oneself under any obligation or perceived influence".


Hutt Valley:1 drug-company gift declared, worth $750.

Capital & Coast:7 drug company gifts declared, worth $9445.

Canterbury: Staff must file conflict of interest forms, but no log kept.

West Coast: No register kept.

Southern:56 drug company gifts declared, worth $80,690.

Northland, Waitemata, Tairawhiti, Lakes: Some gifts declared but none from drug companies.

Taranaki, Whanganui, Wairarapa, Nelson-Marlborough, South Canterbury: No gifts declared.

* "Drug company" includes medical device makers
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#12 User is offline   unit1of2 

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Posted 17 April 2014 - 02:49 PM

OH and what about all the free oversea's trips etc etc etc that the Medical Reps get.. !!!! Yeah they do... fact..
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#13 User is offline   hukildaspida 

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Posted 07 May 2015 - 05:24 PM

Drug company treats to doctor should be public - experts

By Martin Johnston
1:33 PM Friday Mar 27, 2015

http://www.nzherald....jectid=11424060

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Doctors receiving payment, overseas holidays and generous hospitality from medical suppliers should be under public scrutiny, say some health and science experts.
A group of health and science experts have concerns about medical suppliers paying doctors to influence their prescribing of medicines. Photo / Thinkstock A group of health and science experts have concerns about medical suppliers paying doctors to influence their prescribing of medicines. Photo / Thinkstock

Medical suppliers' treats and payments to doctors should be opened to public scrutiny under American-style "sunshine" legislation, say a group of health and science experts.

The United States law led to the disclosure of payments of US$3.5 billion ($4.61 billion) made to more than 500,000 doctors and 1360 teaching hospitals in five months of 2013.

Professor Cindy Farquhar, of Auckland University, and her colleagues say in today's NZ Medical Journal the law is needed to counter the "increasingly close relationship" between suppliers and health practitioners.

Read also:
• Cost to develop a new drug more than doubles
• Make TPP details public - doctors

" ... it is not uncommon for doctors and researchers to receive payment for membership of advisory boards, speaking at industry sponsored symposia, or sponsorship of travel and accommodation to conferences which often incorporate generous hospitality events and may not include any speaking commitment."

They acknowledge that state-owned Pharmac's role as the main buyer of drugs - and its expansion into the devices market - but worries remain about drugs outside the agency's funding.

"Certainly the industry is still actively promoting new medicines in New Zealand, and so there are concerns about payments to doctors influencing their prescribing," the authors say.

Professor Farquhar said she accepted a number of engagements funded by the medicines industry - including a speaking at an Australian conference and being able to take her family for a week - following her appointment as a senior lecturer in obstetrics and gynaecology in 1989. But she stopped the practice in 1998 after becoming concerned about her conflicts of interest.

The journal paper says the transtasman code of conduct adopted by pharmaceutical companies in 2011 does not include a requirement to disclose payments to doctors and institutions and there had been "no visible change in the practices".

We will have no influence on the decision made for a physician to get medical education or attend a conference...We are trying to remove any perception of influence.
Anna Stove, general manager GlaxoSmithKline New Zealand

Medicines NZ chairwoman Heather Roy said it would be unlawful under the Privacy Act for companies to name doctors without their consent.

"Our preference would be industry self-regulation and we already have a rigorous code of practice."

Drug company GlaxoSmithKline's New Zealand general manager Anna Stove said it typically spent less than $250,000 a year on health care professional education. Globally the company has decided that from next January it will make such payments only to institutions and no longer to individuals.

"We will have no influence on the decision made for a physician to get medical education or attend a conference," Ms Stove said. "We are trying to remove any perception of influence."

The Medical Association's deputy chairman, Dr Stephen Child, said it supported greater transparency but if individual doctors were to be named, the information on payments would have to be accompanied by details such as whether they were for an overseas holiday, which would be inappropriate or for something innocuous like a drug company pen.

Health Minister Jonathan Coleman said, "There are a number of existing guidelines and standards in New Zealand which cover this. There are no plans to develop legislation in this area."

- NZ Herald

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