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Mob rule

MagazineDecember 2013 (Vol. 24 Issue 9)Mob rule

One of the founders of the Cochrane Collaboration saysthat the pharmaceutical industry uses tactics to sell its products thatresemble those of the Mafia

One of the founders of the Cochrane Collaboration says that the pharmaceutical industry uses tactics to sell its products that resemble those of the Mafia.

The most scathing attack on the drug industry to date comes from a former company insider who unabashedly compares drug companies with the Mafia, stopping at nothing-bribery, embezzlement, extortion, fraud, obstruction of law enforcement, political corruption and even death threats-to ensure the successful marketing of their products.

The latest canary is Peter Gotzsche, presently head of the Scandinavian arm of the Cochrane Collaboration, an independent research and information centre that evaluates the scientific evidence for most treatments in mainstream medicine.

"The main reason we take so many drugs is that drug companies don't sell drugs, they sell lies about drugs-blatant lies that-in all the cases I have studied-have continued after the statements were proven wrong,"says Gotzsche.

Poacher turned gamekeeper

A medical doctor and epidemiologist, Gotzsche got his start as a drug salesman and then as a drug researcher, eventually heading up the medical department at Astra-Syntex, overseeing both clinical trials and registration applications for new drugs.

Gotzsche was so scandalized by what he saw on the inside that he went on to help found the Cochrane Collaboration, the first group to champion the notion of 'evidence-based' medicine-that is, medicine supported by scientific proof that it works and works safely.

His latest book, entitled Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare (Abingdon, UK: Radcliffe Publishing, 2013), is nothing less than an outraged litany of drug-company misdeeds.

"We now suffer from two man-made epidemics, tobacco and prescription drugs, both of which are hugely lethal," he writes in his introduction. "In the United States and Europe, drugs are the third leading cause of death after heart disease and cancer."

Gotzsche is fearless in wielding his broom in front of Big Pharma. When asked to speak at a Danish Society of Rheumatology event, tactfully entitled 'Collaboration with the drug industry. Is it THAT harmful?', Gotzsche's opening gambit was to name and shame each of the five sponsors in turn. Pfizer had been fined $2.3 billion in the US for promoting off-label use of four drugs, while Merck, the sponsor the year before, had been responsible for more than 60,000 deaths by hiding information about the risks of thombotic events with the Cox-2 arthritis drug Vioxx.

Turning a negative into a positive

The book's lengthy catalogue of drug-company sins is breathtaking, but the most extraordinary aspect of the book is Gotzsche's ability as a highly experienced medical researcher and statistician to walk the reader through the various stages by which unfavourable results quickly disappear and flawed studies make it into print.

Even what is widely regarded as the world's most prestigious journal, The New England Journal of Medicine, is not immune to data massage. In a Cochrane review of two studies that had appeared in NEJM comparing Pfizer's antifungal drug voriconazole (Vfend) with amphotericin B, Gotzsche and his colleagues discovered that one study gave one group of patients voriconazole for 77 days while the other group received amphotericin B for only 10 days-clearly an unfair comparison.

The other study, meanwhile, omitted the fact that voriconazole was significantly inferior to amphotericin B and that more patients had died in the voriconazole group. Manipulated data made it falsely appear that the drug had a significant benefit in terms of fungal infections and kidney toxicity.1

Medical journals for sale

Drug companies are a medical journal's lifeblood not only because of advertising, but also through mass reprints of studies. Any studies shown to be favourable to a drug are highly valuable to a drug company because they can then be passed on in the tens of thousands to doctors, who rely on such information to inform their daily prescribing habits.

Gotzsche quotes a 2012 survey showing that The Lancet journal typically received a median order of lb287,353 for reprints, with a maximum order of up to more than lb1.5 million.2 Small wonder that drug companies can threaten to pull advertising when a peer review is too critical, or even attempt to 'buy' the peer-reviewed journals outright.3

A US congressional investigation of spinal device products revealed in 2009 that Thomas Zdeblick, an orthopaedic surgeon, has received more than $20 million in patent royalties and more than $2 million in consulting fees from Medtronic as editor-in-chief of the Journal of Spinal Disorders & Techniques.4 Not surprisingly, papers on Medtronic devices appeared in every issue, none of them unfavourable.

Gotzsche's premise and the whole of his polemical book is no surprise to anyone who has got close to the industry. His book is being championed by the editors of two medical journals-Richard Smith, former editor of the British Medical Journal, who agreed to write the book's foreword, along with Drummond Rennie, the deputy editor of the Journal of the American Medical Association.

Besides such blatant instances of fraud, say Smith, Gotzsche "shows too how the industry has bought doctors, academics, medical journals, professional and patient organizations, university departments, journalists, regulators

and politicians. These are the methods

of the mob."

Among countless cases, Gotzsche describes how Pfizer agreed to pay $60 million to settle a US federal investigation into bribery overseas in 2012 after being accused of bribing doctors as well as hospital administrators and drugs regulators in several countries in Europe and Asia.

Doctors on the payroll

In Denmark, drug companies are required to list on a website how many doctors work for them in some capacity; in 2010, 4,036 doctors were listed in the top 10 firms, which means that one in every five doctors is being paid by a drug company in a country that is considered one of the least corrupt societies in the world.5

The corruption also runs to medical schools. Gotzsche quotes a 2005 survey showing that 80 per cent of medical schools would allow an agreement that grants data ownership to sponsors, while 50 per cent would allow sponsors to write up the results for publication and let the investigators review the manuscript and 'suggest' revisions.6

Drug company influence on medicine is insidious, says Gotzsche, through scholarships and journalistic awards sponsored by the companies themselves, and through organizations such as patient groups like Mental Health America, half of whose funding has come from drug companies, including more than $1 million apiece from Bristol-Myers Squibb, Eli Lilly and Wyeth.

Regulatory corruption

Gotzsche's cri du coeur is being echoed by an increasing number of leading academics. In a recent article in Harvard's Journal of Law, Medicine & Ethics entitled 'Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs,' authors Donald W. Light from the Edmond J. Safra Center for Ethics and two colleagues from York University and Harvard Law School argue that institutional corruption is also rife on three levels: by large-scale lobbying and political contributions that influence Congress to pass favourable and light legislation, so compromising the mission of the Food and Drug Administration (FDA); through Congress, which now underfunds FDA enforcement capacity by allowing industry-paid 'user fees' to underwrite the staff ostensibly to speed up the approval process; and by 'commercializing' the role of doctors.7

In fact, the most shocking of all the book's disclosures concerns the FDA, which has a culture of deceit that now simply mirrors the drug industry's. Former FDA scientist Ronald Kavanagh is quoted as saying that he and his colleagues were reprimanded for asking questions that might delay or prevent a drug's approval.

Sometimes they were told to confine their examinations of drug trials to small summaries and to accept drug company claims without examining the actual data, which he discovered on multiple occasions directly contradicted the summary document. At other times he was ordered not to review certain sections of the submission-"invariably where the safety issues would be".

When Kavanagh went to Congress to report these issues, his office was broken into and his computer tampered with. One FDA manager even threatened his children, then aged four and seven.

Like Gotzsche, Light and his colleagues charge that the industry is flooding the market with drugs that are of little benefit, and many major drug categories are under fire.

Gotzsche's specific targets include statins, NSAIDs, diabetes drugs and most psychiatric drugs, all of which have been sold based on highly manipulated data and rationales for their use, he charges. "It has never been documented that any of the large psychiatric diseases is caused by a biochemical defect," he says.

But his greatest scorn is saved for companies like GlaxoSmithKline (GSK), which manipulated findings through tortured data massaging to hide the fact that its drug increased the risk of suicide in children.8

The business of illness

Some new categories of conditions, Gotzsche suggests, such as 'bipolar II', may simply be fallout from drugs.

Currently, one in four children in America is taking drugs for attention-deficit/hyperactivity disorder (ADHD) or other psychiatric 'illness', and both selective serotonin reuptake inhibitors (SSRIs) and ADHD drugs cause

bipolar illness in up to one in every

10 young people.

Like Gotzsche, Light, Smith and many others believe that the solution needs to be far-reaching: drug testing must be nationalized or carried out by independent institutes separate from the pharmaceutical industry; regulatory agencies have to be overhauled and publicly funded; all clinical data should be made available to the public; drug marketing should be banned; and doctors must be prohibited from participating in events sponsored by industry.

But perhaps the greatest challenge is reforming the very culture that institutionalizes crimes against humanity as the acceptable face of 'doing business'.

Gotzsche quotes Peter Rost, a former global vice-president of Pfizer, who once wrote, "It is scary how many similarities there are between this industry and the mob . . . The difference is, all these people in the drug industry look upon themselves . . . as law-abiding citizens

. . . However, when they get together as a group and manage these corporations, something seems to happen . . . It's almost like when you have war atrocities; people do things they don't think they're capable of. When you're in a group, people can do things they otherwise wouldn't because the group can validate what you're doing as okay."

It's time for more insiders like Gotzsche to break this conspiracy of silence by standing up for the fact that this is not now, and never has been, okay.

MAIN TEXT References

1

Cochrane Database Syst Rev, 2006; 1: CD004707

2

BMJ, 2012; 344: e4212

3

BMJ, 2005; 330: 9; www.the-scientist.com/?articles.view/articleNo/27383/title/Elsevier-published-6-fake-journals/

4

BMJ, 2010; 340: c495

5

Ekstra Bladet, June 24, 2010

6

N Engl J Med, 2005; 352; 2202-10

7

J Law Med Ethics, 2013; 14

8

Account Res, 2001; 18: 45-54

The cost of doing business

Most of the billions paid out as fines by the drugs industry for flouting the law are thought of as 'the cost of doing business', says Richard Smith. Here are some of the biggest cases of what Gotzsche calls Big Pharma's 'Hall of Shame':

Pfizeragreed to pay $2.3 billion in 2009 , the largest healthcare fraud settlement in the history of the US Department of Justice at the time, after a Pfizer subsidiary pleaded guilty to illegally promoting four drugs, including anti-arthritis drug Bextra (valdecoxib), now withdrawn from the market and Geodon (ziprasidone).1

Novartispaid $423 million in 2010 after illegally marketing Tripleptal (oxcarbazepine), an epilepsy drug, and making false claims about it.2

Sanofi-Aventispaid more than $95 million to settle a fraud charge in 2009, in which the company overcharged US and local health agencies for drugs for indigent patients. The firm deliberately misquoted the prices, underpaid rebates to Medicaid and overcharged public health agencies.3

GlaxoSmithKlinepaid $3 billion in 2011, the largest healthcare fraud settlement in US history after pleading guilty to having marketed a number of drugs illegally for off-label use.4

AstraZenecapaid $520 million in 2010 to settle a fraud case by illegally marketing one of its bestselling drugs, the antipsychotic Seroquel (quetiapine) to children, the elderly, veterans and inmates for unapproved uses.5

BOX References

1

BMJ, 2009; 339: b3657

2

www.justice.gov/opa/pr/2010/September/10-civ-1102.html

3

www.sourcewatch.org/index.php?title=Sanofi-Aventis

4

www.nytimes.com/2011/11/04/business/glaxo-to-pay-3-billion-in-avandia-settlement.html?_r=0

5

BMJ, 2010; 340: c2380

Lynne McTaggart


Mob rule

An old dog with new tricks

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