Big pharma: prosecutions for discounting, bribery and ‘education’

Today, Euronews reports from Croatia that pharmaceutical company Farmal, and 364 individuals, have been charged with bribery and abuse of office. Farmal allegedly ran a network of doctors, giving them gifts in return for prescribing the company’s products

Only two days ago Andrew Jack reported that US fines from whistleblower and government prosecutions against the pharmaceutical industry reached $20bn in the period 1991-2010. In less than three years since then, companies have been given further penalties totalling more than $13bn.

Jack cited four examples:

• Last year, Eli Lilly paid $29m to the US Securities and Exchange Commission after evidence showing it offered discounts to fund bribes to win business in Brazil and Kazakhstan.

• Pfizer was fined $60m for activities including “incentive trips” to Greece for Bulgarian doctors who agreed to meet prescription targets for its drugs.

• Johnson & Johnson  channelled more than $100,000 through a subsidiary company to a sympathetic nurse in order to boost prescriptions of Natrecor, a heart medicine; she spoke favourably about the drug in talks, trained colleagues in its use and put her name on an article in a medical journal to boost sales. J&J paid a $2.2bn fine in November for practices stretching back over a decade – the latest in an escalating series of penalties against the pharmaceutical industry for the way it markets its products.

• In China, GlaxoSmithKline has been accused of paying up to $500m in bribes to local doctors.

He points out that the marketing process begins before new drugs are approved by regulators. There has been growing concern in recent years that articles in influential medical journals describing experimental products, assessed by reviewers and editors, are excessively favourable to new drugs. On occasion there has been selective design and presentation of the evidence and publication of ‘flattering’ safety data.

Building relationships with prescribers

• Sales representatives make presentations to doctors; a study last summer showed that, on average, US doctors who received payments from companies were twice as likely as their peers to prescribe their products.

• Money is spent on bringing doctors to conferences for “continuing medical education”, often in luxury international hotels. GSK last year settled a record $3bn fine in the US for paying prescribers to attend conferences in luxury resorts in Hawaii.

• “Key opinion leaders” among physicians are paid as consultants to give speeches and presentations to their peers. They often sit on professional bodies that draft treatment guidelines. They may also be paid to advise on and recruit patients into lightly regulated “post-marketing” trials for drugs that are already approved.

• Companies have also offered doctors discounts or donations of their medicines to wean them off rival products.

Examples of improved practice

US and European regulators are pushing for greater publication of clinical trial data, opening the possibility of third-party analysis of drug safety and efficacy.

Doctors and healthcare systems are being advised to pay for continuing medical education, reducing the influence of industry funding.

Some universities and hospitals already ban visits by sales representatives or consulting payments to doctors.

AstraZeneca no longer pays for physicians to attend international medical conferences. GSK last week announced similar moves, as well as plans to sever any bonuses to its marketing staff linked to individual sales targets. It wants them to be judged by the quality of medical advice they provide doctors rather than the crude volume of prescriptions.

“Health technology assessment”, the use of third-party review of the evidence of the value of treatments to guide doctors’ prescribing habits is being undertaken by the National Institute for Health and Care Excellence (NICE) in the UK; the transparency commission in France and Amnog in Germany already conduct such assessments of new medicines.

Legal advice: “Over 12 months after the UK Bribery Act was introduced, and with increasing enforcement in the pharmaceutical and medical business sectors, pharmaceutical companies should ensure that their compliance programmes are in place and updated to reflect developments over the last 12 months”.

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Whistleblowers in the Orphan Medical/Jazz Pharmaceuticals settlement and cases that were part of the settlements by Amgen, Glaxo and Pfizer: http://www.forbes.com/sites/erikakelton/2013/01/04/off-label-pharma-prosecutions-wont-be-silenced-by-first-amendment-decision/

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Antibiotic resistance – a wake-up call

More than 20,000 people a year are dying from drug-resistant bacteria in Europe and a similar number in America.

This is not a sudden development – it has been reported year after year. As long ago as 2002,  the World Health Organisation warned that the widespread use of antimicrobials outside human medicine is of serious concern given the alarming emergence in humans of bacteria, which have acquired, through this use, resistance to antimicrobials.

Most of this is due to the overuse and misuse of antimicrobials by doctors, other health personnel and patients. However, some of the newly-emerging resistant bacteria in farm animals are transmitted to humans; mainly via meat and other food of animal origin or through direct contact.

(Note: the Heads of Medicines Agencies objection to the conflation of the terms antimicrobial & antibiotic may be read by following the link and searching on ‘definitions’)

European Antibiotic Awareness Day

Professor John Watson, Deputy Chief Medical Officer for England wrote on European Antibiotic Awareness Day, 18 November 2013, about preserving antibiotics for ourselves and for future generations.

“ Without tough action we will quickly approach a time when antibiotic resistance will be so widespread that patients with serious conditions will be extremely vulnerable to infection and further complications. The drugs simply won’t work”.

The Chief Medical Officer for England, Professor Dame Sally Davies, has made this her priority and has persuaded government to put the problem on a national risk register, alongside flu pandemics. In her recent book The Drugs Don’t Work, she explains that antimicrobials such as penicillin are so widely used to combat infections that the bacteria they fight are now mutating and becoming resistant.

Around 35 million prescriptions for antibiotics are dispensed every year by GPs in England. Many people do not complete their course and this can lead to antibiotic resistance. antibiotics should only be prescribed when they are really needed – not for ordinary coughs and colds.

No large profits, no research

In an FT article Davies is quoted:“No new class of anti-bacterial has been developed since 1987 . . . partly because companies can no longer make enough money out of antimicrobials to justify investing in the research needed.” Centers for Disease Control and Prevention
Atlanta http://www.cdc.gov/features/antibioticresistance/charts.html

There have also been some initiatives to change behaviour. British hospitals have recently cut reported incidences of MRSA – one drug-resistant bug – by 80% after improving hygiene on wards (for example, by insisting staff wash their hands).

• Countries such as France have reduced antibiotic usage through a public health campaign.
• The use of antibiotics in agriculture is being curbed in Denmark and Norway where fish-farmers have recently stopped tipping antibiotics into their tanks and are immunising the fish individually instead.
• Last week the BBC reported that the US FDA is to curb antibiotic use in livestock.
• A host of bureaucrats and ministers will be holding international meetings to discuss the problem in places such as Doha and Rome.

Professor Watson warns: “We could all be facing a future where it is no longer possible to have an organ transplant or help our bodies through cancer treatment as the risk of fatal infection is too great.  Everyone has a role to play in preserving the antibiotics that we have now, both for ourselves and to protect future generations”.

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STOP PRESS: ‘Superbugs’ found breeding in sewage plants

HOUSTON – (Dec. 16, 2013) – Tests at two wastewater treatment plants in northern China revealed antibiotic-resistant bacteria were not only escaping purification but also breeding.

Joint research by scientists from Rice, Nankai and Tianjin universities found “superbugs” carrying New Delhi Metallo-beta-lactamase (NDM-1), a multidrug-resistant gene first identified in India in 2010, in wastewater disinfected by chlorination. They found significant levels of NDM-1 in the effluent released to the environment and even higher levels in dewatered sludge applied to soils.

The study, led by Rice University environmental engineer Pedro Alvarez, appeared this month in the American Chemical Society journal Environmental Science and Technology Letters.-

See more at: http://news.rice.edu/2013/12/16/superbugs-found-breeding-in-sewage-plants/#sthash.DGucq6aA.dpuf

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“Data clearly shows that GMOs do not increase yields and do not decrease the use of agrichemicals”

 

Vandana Shiva draws our attention to her article in the Deccan Chronicle. On one side of the debate over genetically modified organisms is scientific evidence that GMOs are not delivering on their promise, and on the other side is ideological propaganda by the genetically modified seed industry and scientists whose careers are locked into the GMO trajectory.

Extracts

After two decades of commercial applications, data clearly shows that GMOs do not increase yields and do not decrease the use of agrichemicals, but have instead created super-pests and super-weeds.

It is because of these failures and the fact that GMOs are linked to patents, which translates into royalty extraction and high prices, that GMOs worsen the economic status of farmers. India has witnessed more than 2,84,694 far­mer suicides in a span of 17 years, between 1995 and 2012. The worst off is Maharashtra, which has the maximum area under cultivation of genetically modified Bt cotton . . .

Farmers chose Bt cotton not because it was the best alternative but because all other alternatives were destroyed. The seed varieties were replaced. India’s Central Ins­titute for Cotton Res­earch has not released any public varieties after Monsanto entered the market, and most Indian seed companies are locked into licensing arrangements with Monsanto.

Nor is it true that yields have incre­ased. Yields of cotton in the pre-GMO period reached 1,200 kg in good years. After Bt cotton was introduced the yield has stagnated at 500 kg.

As the University of Ca­n­terbury research team led by Prof. Jack He­i­nemann has shown, North American crop production has fallen behind that of Western Europe, despite farmers in the United States using genetically modified seeds and more pesticide. According to the team, the main point of difference between the regions is the adoption of GM seeds in North America and the use of non-GM seed in Europe. The failure to control pests has led to an increase in pesticide use.

A study published in India’s Review of Agrarian Studies also showed a higher expenditure on chemical pesticides for Bt cotton than for other varieties by small farmers. Non-target pest populations in Bt cotton fields have exploded; it is expected that this will likely counteract any decrease in pesticide use.

In China, where Bt cotton is widely planted, populations of mirid bugs — pests that previously posed only a minor problem — have increased 12-fold since 1997.

A 2008 study in the International Journal of Biotechnology (see abstract) found that any financial benefits of planting Bt cotton had been eroded by the increasing use of pesticides needed to combat non-target pests.

In the US, due mainly to the widespread use of Roundup Ready seeds, the use of 4 herbicide (a group of herbicides) increased 15% from 1994 to 2005 — an average increase of one-fourth pound per each acre planted with GM seed — according to a 2009 report published by the Organic Centre. Moreover, the rise of gly­phosate (the herbici­de in Roundup) resistant weeds has made it necessary to combat these weeds by employing other, often more toxic, herbicides . . . This trend is confirmed by 2010 USDA pesticide data, which shows skyrocketing gly­phosate use accompanied by constant or increasing rates of use for other, more toxic, herbicides . . .

. . . Bt cotton has not given higher yields. It is not disease resistant. Disea­ses that never affected cotton, like aphids and jassids, have exploded. In India the bollworm, which Bt cotton was supposed to control, has become resistant and Monsanto has had to introduce Bollgard II, a higher variety of insect-resistant genetically modified cotton. All this has created debt not profits for farmers. If seed costs jump 8,000 per cent and pesticide use increases 1,300 per cent, farmers’ incomes do not increase.

Good science looks at evidence and takes feedback from the real word. Bad science that shuts its mind to evidence and be­comes propaganda. Sa­­dly, in the GMO deb­a­te, those defending GMOs have only power and propaganda on their side.

The writer is the executive director of the Navdanya (nine seeds)Trust

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 A direct link to 2010 USDA pesticide data was not found but there was a similar passage in the 2010 Californian report below (AI, active ingredient?).

Yet again, Bt63 GM contaminated rice imported from China to Europe

In November this year [2011] the EU Business website reported that the European Union had tightened controls on imports of Chinese rice products after a growing number of shipments were contaminated by unauthorised genetically-modified rice, requiring Chinese authorities to provide a report on all rice consignments before export, instead of the current random checks.

The European Commission said in a statement that this move was in response “to an increasing detection of products contaminated with unauthorised genetically-modified (GM) rice.”

Chinese rice products contaminated with the unauthorised GM rice Bt63 have been notified through the EU’s alert system since September 2006 and a control system was set up in April 2008 to prevent the introduction of such rice in Europe but despite this, further quantities of Bt63 rice were detected.

Today, Gordon Davidson, in the Scottish Farmer newspaper, reports that the European Commission has confirmed the presence of unapproved GM traits in further consignments of Chinese rice arriving at European ports.

A draft EC regulation, due to come into force in January 2012, contains several new measures to prevent illegal GM rice shipments reaching European outlets – the main one being that all consignments of rice and rice products from China must be accompanied by a certificate of analysis showing no GM presence – but the products should still be re-analysed before being allowed to enter the EU market.