Drug industry can profit from clinical-trial data openness, say leading regulators

The drug industry’s opposition to greater access to clinical trial data is misplaced, four senior figures in the European Medicines Agency (EMA) said today.

The agency is preparing to vastly expand the amount of information it makes available to researchers, and is close to finalizing a policy on making public data submitted to it by drug companies applying for licences for new medicines. Some elements of the pharmaceutical industry have fought back, complaining that this will release confidential data crucial to its interests and harm investment in the development of new drugs (see ‘Secrets of trial data revealed‘).

But writing today in the New England Journal of Medicine, an EMA team says that putting clinical trial data in the public domain will make it more cost-effective to develop new medicines — for example by making sure one company does not run down a blind alley already mapped by another and by providing more information that companies can use to prove the superiority of their treatments over rivals’ drugs.

“It is ironic that the organisations that most resist wider access to data are the ones that stand to benefit so much from greater transparency,” write the EMA experts, who include senior medical officer Hans-Georg Eichler and executive director Guido Rasi. Despite their roles in EMA, the authors wrote in a personal capacity.

They add: “Contrary to industry fears, we argue that access to full — though appropriate deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.”

In another article published alongside the piece by Eichler and his colleagues, Michelle Mello, a health-policy researcher at the Harvard School of Public Health in Boston, Massachusetts, and her colleagues set out a set of principles by which data can be safely and usefully shared, down to the level of information from individual patients.

“As in other areas of health care, the push for greater transparency in the area of clinical trial data appears inexorable,” they write. “The question is not whether, but how, these data should be broadly shared.”

http://blogs.nature.com/news/2013/10/drug-industry-can-profit-from-clinical-trial-data-openness-say-leading-regulators.html

Drug Swapping: Omnicare Pays $120M To Settle Kickback Charges

http://www.pharmalive.com/drug-swapping-omnicare-pays-120m-to-settle-kickback-charges?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot%29

It is clear that the federal government is getting a tremendous “bang for the buck” in its anti-fraud activities in health care.

There is no doubt that the federal government’s initiatives to fight health care fraud have returned large
sums of money to US taxpayers. These initiatives also improve the integrity of federal health care
programs and make a substantial contribution to their solvency. In times of constrained government
budgets, we can ill afford to have federal money wasted or stolen. It is clear that the federal government is getting a tremendous “bang for the buck” in its anti-fraud activities in health care. There
are various ways of calculating that bang for the buck, but this report makes clear that accounting for
only federal civil returns associated with FCA cases still shows a better than 16:1 return on investment,
while a more robust calculation of the federal return that factors in both civil and criminal fines and
recoveries show a far greater return. It is our estimate that a total taxpayer benefit-to-cost return from
False Claims Act law enforcement exceeds 20:1.

http://www.taf.org/TAF-ROI-report-October-2013.pdf

GlaxoChinaGate contd. - so how's business?

GlaxoSmithKline Plc (GSK) said third-quarter sales of pharmaceuticals and vaccines in China fell 61 percent after an anti-corruption probe began there in July.

Sales of consumer health-care products in China fell 29 percent, the London-based company said today in a statement. Total revenue rose 1 percent to 6.51 billion pounds ($10.5 billion), compared with 6.64 billion pounds expected by analysts.
In China, a “dramatic decline” in Glaxo’s Seretide lung drug and Flixonase nasal spray has led to a rapid acceleration in sales of AstraZeneca Plc (AZN)’s Symbicort inhaler, Barclays Plc analysts said last week. China accounts for slightly less than 3.5 percent of Glaxo’s global pharmaceutical revenue and is less profitable than its Western businesses, though the world’s most populous nation presents significant growth opportunities, the analysts said.
“It is still too early for us to quantify the longer-term impact of the investigation on our performance in China,” Glaxo said in the statement.
Allegations by China’s government that Glaxo bribed hospitals, doctors and officials prompted Witty to dispatch his head of emerging markets to China to oversee the company’s response. Some senior executives appear to have acted outside Glaxo’s processes and controls to both defraud the company and the Chinese health-care system, Chief Executive Officer Andrew Witty said on July 24.
Third-quarter earnings excluding some items were 28.9 pence a share. That compared with the average estimate of 27.2 pence from 17 analysts surveyed by Bloomberg.
The company maintained its forecast for the year as revenue from other regions offset the declining sales in China.
Glaxo shares fell 0.7 percent to 1,590 pence at 12:08 p.m. in London. Before today, the shares had returned 24 percent this year, compared with a 21 percent return in the Bloomberg Europe Pharmaceutical Index.
To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

http://www.bloomberg.com/news/2013-10-23/glaxo-s-china-sales-plunge-61-after-corruption-probe.html?

Remember

Antibiotic resistance documentary tonight in the US.

Tonight at 10:00 Eastern/9:00 Central, PBS Frontline will air a documentary about the growing threat of antibiotic-resistant bacteria. 

http://boingboing.net/2013/10/22/antibiotic-resistance-watch-a.html

Reckitt Benckiser reviews all options for drugs unit

Reckitt Benckiser, the consumer goods giant, is reviewing all options for its pharmaceuticals unit, it said on Tuesday, effectively hoisting a for sale sign on its prescription medicine business.

Shares in the maker of Strepsils and Gaviscon rose more than 6pc in morning trading after the Bank of America Merrill Lynch has valued the pharmaceuticals unit at about $3.2 billion (£2 billion)

The business centres around the drug Suboxone, which Reckitt sells as a film that dissolves in the mouth. It is used to treat heroin addiction, but now faces increased competition from cheaper copies, or generics. In the third quarter, its revenue fell 14pc to £191m.

"Critically, the decision to conduct a ‘strategic review’ of the pharmaceuticals business signals an intent to exit, in our view, and a move to resolve a troublesome valuation hangover, once and for all," said Martin Deboo analyst at Investec.

The company, which also sells cleaning products such as Varnish and Cillit Bang had said before that the right time to consider options for the pharmaceutical business would be following the launch of cheap, generic Suboxone tablets.

In February, U.S. regulators approved two generic versions of the drug.

"We expect the review to take some time and will update shareholders during the course of 2014," said chief executive Rakesh Kapoor.

http://www.telegraph.co.uk/finance/10395967/Reckitt-Benckiser-reviews-all-options-for-drugs-unit.html

Antibiotics for people, not animals - LA Times

So far this year, more than 300 people have gotten sick from bacteria called Salmonellaheidelberg. Almost three-quarters of them live in California.

The Centers for Disease Control and Prevention reported that chicken produced in three Central California processing facilities is the "likely source of this outbreak" and that the bacteria are "resistant to several commonly prescribed antibiotics."

The CDC estimates that for every reported salmonella infection, there are about 29 more unreported cases, bringing the potential toll to more than 9,000 victims. About 42% of the patients who reported their illness have been hospitalized, an uncommonly high rate that indicates this bug is more virulent than usual. According to the CDC, drug resistance "may be associated with an increased risk of hospitalization or possible treatment failure in infected individuals."

Yet on a food industry website, an associate professor of food policy at Iowa State University downplayed the risks. "The occurrence of some resistance is not concerning," he said, "as virtually every bacteria is resistant to some type of antibiotic."

Resistance may be ubiquitous, but it hasn't always been this way. It's a new normal that industrial farming practices helped create. In fact, the CDC, the Food and Drug Administrationand the World Health Organization, among others, consider widespread antibiotic resistance a cause for grave concern.

Forty years of scientific investigation demonstrate that using antibiotics to make food animals grow faster, and to compensate for the overcrowded conditions in which they are raised, breeds drug-resistant bacteria that can infect and hospitalize people.

In fact, some of the outbreak strains of this salmonella resist treatment with several antibiotics used both in poultry production and human medicine. According to the FDA, drug makers sold about 30 million pounds of antibiotics in 2011 for use in chickens and other food animals. This was a record high and nearly four times the amount sold to treat sick people.

Fortunately, we have it in our power to slow the emergence of drug-resistant bacteria.

President Obama committed during the 2012 presidential campaign to "limit antibiotic use for livestock [to] … help ensure that antibiotics are used only [to] … address diseases and health problems, and not for enhancing growth and other production purposes." The FDA is planning to ask drug companies to stop marketing antibiotics for growth promotion. The policy is now at the Office of Management and Budget, one step from being finalized. It is a good start, but it ultimately falls short of Obama's promise.

Congress can fulfill it by passing the Preservation of Antibiotics for Medical Treatment Act and its Senate counterpart, the Preventing Antibiotic Resistance Act. These landmark bills would eliminate the use of antibiotics for all production practices, not only to promote growth but also to compensate for conditions that foster disease. Importantly, the legislation would still allow sick animals to be treated with antibiotics.

Meanwhile, many consumers are taking matters into their own hands and buying meat raised without antibiotics. Parents are urging their children's school systems to do the same; Chicago and Jefferson County, Colo., are early leaders. A growing number of hospitals, including UC San Francisco's Medical Center and Burlington, Vt.'s Fletcher Allen Health Care are serving meat from animals given antibiotics only to treat illness.

Antibiotics are modern medical miracles that rendered lethal infections minor nuisances. But that 20th century success story is turning into a 21st century parable about shortsightedness and denial. The president and Congress have more than enough scientific justification to curb antibiotic overuse in food animal production. It is time for them to act.

Gail Hansen is a doctor of veterinary medicine and senior officer with the Pew Charitable Trusts' campaign to reduce antibiotic overuse on industrial farms.

Nervous?

AllTrials Update - write a letter

Dear Friends

If you live in an EU member state we need your help this week. Will you write to your country's health minister to ask your Government to support the good progress towards clinical trial transparency in the draft Clinical Trial Regulation in debates in Europe next month.

Thanks to the letters you sent to MEPs last May some very good additions were made to the draft Regulation. These new parts of the law would mean that all clinical trials taking place in Europe would have to be registered and summary results published within a year of its ending. We need to make sure that these good additions make it into the final law, and we don't have much time as the next stage of the process starts in the first week of November.

The next stage is a series of 'trilogue' discussions between the European Parliament, Commission and Council. We understand that the European Council hasn't decided its position yet. The Council is made up of representatives of all of the individual Governments of European countries so your Government's position is very important. There's no time to lose - please write to your health minister this week and urge them to support the good additions to the Clinical Trials Regulation.

What you need to do now

You'll find a sample letter here including details of the specific parts of the Regulation that we need Governments to support, and details of how to contact your health minister on this page.

If you can translate the letter into more European languages, please get in touch.

AllTrials fundraising appeal

We have launched a fundraising appeal for a video to spread the AllTrials campaign around the world. Please donate to help us produce that.

Best wishes

Ben

http://www.alltrials.net

Please donate at https://www.justgiving.com/alltrialsappeal

University of Minnesota must investigate suicide in psychiatric research study

The University of Minnesota must set up independent inquiry to examine what happened in clinical trial that led to the 2004 death of Dan Markingson, say scholars

Over one hundred seventy leading scholars in health law, bioethics and medical research have called on the University of Minnesota to investigate the 2004 death of a psychiatric research subject, charging that university administrators have ”refused to publicly engage in a transparent, open, and critical assessment of what went wrong in this study.”   The letter, led by Trudo Lemmens, the Scholl Chair of Health Law and Policy at the University of Toronto, and five colleagues from leading U.S. institutions, urges the Faculty Senate of the University of Minnesota to request an immediate, public inquiry into the troubled study.

Dan Markingson was acutely psychotic when University of Minnesota psychiatrists enrolled him into an AstraZeneca-sponsored study of antipsychotic drugs. He had been repeatedly judged incompetent to make his own medical decisions and was also under an involuntary commitment order that legally required him to obey the recommendations of the psychiatrists. His mother, Mary Weiss, attempted to get her son out of the study for months, warning that he was in danger of killing himself, but her warnings were ignored.  On May 8, 2004, Markingson committed a violent suicide.

A 2009 investigation of Markingson’s death by the St. Paul Pioneer Press found that the university psychiatrists had received large payments from antipsychotic drug manufacturers, including the study sponsor. “There was an overt conflict of interest, and there is reason to believe that the boy's death was an indirect consequence of the financial inducements of the study,” says Dr. Jerome Kassirer, a former editor of The England Journal of Medicine and a signatory of the letter.  In 2012, an investigation by the Minnesota Board of Social Work found that the study coordinator overseeing Markingson’s care, who was working under the supervision of senior faculty members of the University of Minnesota, had committed an alarming number of professional violations, including fraudulently initialing for physicians on study charts and dispensing drugs without a license.

An inquiry is crucial, the scholars argue, because the Markingson study raises serious and ongoing concerns about the enrollment of vulnerable patients in research, the impact of conflicts of interest on the behavior of clinical investigators and university administrators, the qualifications of research personnel, and the integrity of medical research at major medical schools.

In addition to Lemmens, the letter was organized by Alice Dreger of Northwestern University, Raymond De Vries of the University of Michigan, Lois Shepherd of the University of Virginia, Susan Reverby of Wellesley College, and Jerome Kassirer of Tufts University.  Reverby, a historian, uncovered the notorious Guatemala syphilis studies that led to a formal apology by President Obama in 2010.  Other notable signatories include Marcia Angell of Harvard University, also a former editor of the New England Journal of Medicine; Richard Smith, a former editor of the British Medical Journal; Virginia Barbour, a former editor of PLoS Medicine; George Annas, a leading Health Law and Human Rights Professor from Boston University; and Daniel Callahan, the co-founder of The Hastings Center.

###

To schedule an interview contact Trudo Lemmens, by phone at 416 978 4201 or 647-878 6752; or e-mail: trudo.lemmens@utoronto.ca; or Lois Shepherd, by phone at 434-249-4489 or by e-mail at LLS4B@hscmail.mcc.virginia.edu

The China Conundrum

China: An Increasingly Risky Bet for Drug Makers

For the world’s largest pharmaceutical companies, China is an increasingly critical, yet risky bet.

Multinational drug companies expect sales from China to continue to grow quickly, as they did last year, accounting for 3.8% of total sales, up from 3% in 2011, according to a new report from consultancy McKinsey & Co.

Agence France-Presse/Getty Images

GlaxoSmithKline has said it expects its performance in China to take a hit from Beijing’s probe into alleged bribery by senior staff.

Meanwhile, nearly half of the 50 senior pharmaceutical industry executives surveyed said that they expect China to account for over 10% of their global sales by 2020, when China is projected to become the world’s second-largest pharmaceutical market. Sales of 85 brands exceeded $50 million in China last year, with 11 surpassing $200 million, according to the study.

For years, drug companies have seen big potential in China, where the government began overhauling its healthcare industry in 2009, developing a national insurance system. Easier access to medicine for the country’s 1.34 billion citizens has propelled growth for the sector.

But the good news stops here: China’s becoming a bigger headache, McKinsey said. The business models that presented drug makers with solid growth in China are now under pressure. Regulatory risks are rising, with China clamping down on drug prices and protectionism on the rise.

Multinational drug companies report obstacles to getting new products to market and a fragmented system of getting drugs into pharmacies, the McKinsey report said.

In recent months, pharmaceutical companies have been under a microscope in China and officials have launched crackdowns largely focusing on foreign companies. Authorities in late June opened an investigation of U.K. drug maker GlaxoSmithKline PLC, alleging the company bribed doctors and hospitals across China to boost drug sales in pharmacies. GlaxoSmithKline said it is cooperating with authorities in the investigation.

The Administration for Industry and Commerce this summer visited the offices of Denmark’s Novo Nordisk A/S and France’s Sanofi SA. Novo Nordisk said it hasn’t been accused of wrongdoing. Authorities have announced a formal investigation of Sanofi, which said it is cooperating with investigators.

Pharmaceutical companies also face an underfunded system that is aiming to contain costs and squeeze out profit, the report said, noting that while the government plans to increase spending on healthcare to 7%-7.5% of GDP by 2020, up from its current 5.6%, spending is still far lower than the 12% of GDP in France or 18% of the U.S.

Hospitals, many of which have costs that far outweigh their revenue, have buffered their revenue by over-prescribing drugs in recent years, but the government is looking to reform payment systems and cost structures to prevent such reliance on the drug industry. That will no doubt affect pharmaceutical sales, McKinsey said.

There’s no easy solution for pharmaceutical players, McKinsey said. Companies will need to boost compliance structures, form more partnerships with local research and development companies, target diseases prevalent to China and cater to government initiatives.

– Laurie Burkitt

http://blogs.wsj.com/chinarealtime/2013/10/21/china-an-increasingly-risky-bet-for-drug-makers/?

It will never replace an espresso

Australasian college of physicians sacks its ethics committee

The Royal Australasian College of Physicians has sacked its own ethics committee just days after the committee produced strict new guidelines on doctors’ ties to industry.

The college has also provoked an outcry by refusing to release its guidelines for public consultation, opting for an internal process instead.

The draft Guidelines for Ethical Relationships Between Health Professionals and Industry had strengthened the already tough, pro-transparency stance of previous editions. Among its recommendations it labelled doctors’ use of drug samples and starter packs as “inappropriate,” it said, given that these were “primarily a marketing exercise.”

The draft guidance also explicitly called on the college to establish processes for publicly declaring its relations with the drug industry and the competing interests of members and office holders—something the college does not currently do.

Three years in the making, the 105 page document briefly appeared on the college’s website in early September before being quickly taken down.

Paul Komesaroff, who chaired the guideline working party and also the now defunct ethics expert advisory group, warned that valid public consultation was “critical” to ensuring the legitimacy and integrity of the final document.

In an open letter to the college’s president, Leslie Bolitho, which was also signed by 12 working party members, Komesaroff said that the draft reflected “the large volume of data now available concerning the nature and impact of relationships between health professionals and components of industry.” Previous editions of the guidance had been influential and “widely quoted around the world,” he said.

Disbanding the ethics committee could “cause serious damage to the College and its national and international standing,” Komesaroff wrote in a second letter, made public by the online newspaper the Global Mail.1

“As far as can be determined, every college in Australia has an ethics process. The abolition of the group representing ethics in the RACP [Royal Australasian College of Physicians] would make it unique,” he wrote. Komesaroff has declined to comment further.

The college did not meet the BMJ’s request for an interview with Bolitho.

In a statement a spokesman said that the college had more than 200 committees and that it was cutting these back to streamline the organisation’s outdated and “overly bureaucratic structure,” after feedback from members.

The spokesman said, “None of this is linked to the release of the draft guidelines for ethical relationships between health professionals and industry.” He added that the draft had been circulated to almost 100 parties for feedback, consistent with standard college practice.

Peter Brooks, a Melbourne rheumatologist and former honorary secretary of the college, said that it was “unfortunate” that the guidelines would not be open to the same public scrutiny as previous editions.

“We’re not being quite as open as we have been perhaps in the past,” he said.

Brooks said that the decision to disband the ethics committee was “fascinating.” He said, “How can an organisation like the college not have an ethics committee? The [implications] are pretty serious in terms of how one does one’s business.”

Notes

Cite this as: BMJ 2013;347:f6242

http://www.bmj.com/content/347/bmj.f6242?etoc=

The Global Mail Drug Money Series

http://www.theglobalmail.org/features/in/drug-money/?utm_source=Custom+sidebar&utm_medium=Homepage&utm_campaign=Custom+sidebar

Medical Ethics Under The Knife. By Clare Blumer

It took three years to complete. Professors, physicians and philosophers collaborated with Australian and New Zealand transparency and ethics compadres, labouring on the latest edition of Guidelines for ethical relationships between health professionals and industry.

This document serves predominantly as the ethical guidebook for fellows of the Royal Australasian College of Physicians (RACP), and in its 20-year history has been adopted as the benchmark template by comparable medical professional bodies in Australia and around the world. The 4th edition is stricter in its recommendations than that produced in 2006 and targets a kaleidoscope of new tactics that medical industries, including drug companies, use to influence doctors.

However, the guidelines themselves now pose an ethical dilemma for the college. The executive has intervened to prevent a draft of the latest edition from undergoing public scrutiny that is a time-honoured — and according to advocates — essential part of the process.

The draft guidelines were posted on the RACP website on September 4, with a request for public comment, but within three days college administration removed all trace of the document. For a group of ethicists and transparency advocates, undermining the public-consultation process was akin to a hog-tying — a hostile takeover.

Henry Zwartz/The Global Mail

At the same time, it emerged that the ethics committee responsible for the guidelines had been quietly disbanded, as part of a variety of measures aimed at replacing the painstakingly democratic process of old, following a corporate restructure in 2008 which made the board and executive the hub of power.

In the past month, three open letters have been sent to the board, which question its actions, specifically the board’s removal of the consultation draft from the RACP website, and the simultaneous disbanding of the ethics committee of the college, without notifying its members.

Insiders suggest that college president, Dr Les Bolitho, himself shut down the public-consultation process. Bolitho could not be reached for comment as he is on leave. However, a statement from the college says: “It is inappropriate to comment prematurely on the draft document until it is considered by the College Board and finalised. When this occurs, the document will be released to the public”. It also says that the draft had been sent to “college bodies” and to “external individuals” for consultation. It does not say whose decision it was to remove the guidelines from the college website and change the review process without consulting with the ethics committee.

A spokesman for the RACP told The Global Mail that the college no longer intends to have a public-consultation process, but will instead release the guidelines after an internal consultation. “The College will always adopt and advocate for an ethical approach and has robust structures and processes to ensure it lives up to this commitment,” says the college executive spokesman.

As a continuation of our series Drug Money, which shines a light on the relationship between medical professionals and industry, The Global Mail is publishing the draft guidelines, in the belief that the agency of the final guidelines relies on transparent exchange and community debate.

Keep in mind, the guidelines are not rules or laws; rather, they’re like the Jiminy Cricket on a doctor’s shoulder, guiding the complex interactions that doctors have with medical industry.

College members are specialist physicians — the extremely influential doctors who inform health policy and prescribing from the top down. As such, pharmaceutical companies want these opinion leaders on their advisory boards, supporting new medicines; and medical-equipment manufacturers want their latest half-million dollar inventions in these physicians’ surgeries.

The guidelines not only inform the RACP fellows’ relationship with industry, but previous editions have served as a gold-standard template for other medical professional colleges in Australasia and around the world.

Read the guidelines below and leave a comment on this story. Or send your feedback to the college.

One of the major changes evident in the updated guidelines, is that they label doctors’ use of free drug samples as “inappropriate”, and declare that by accepting the samples they’re taking part in what is “primarily a marketing exercise — intended to create a relationship of reciprocity between the clinician and industry representative, or to establish a cohort of patients on long-term treatment with a particular drug”.

The guidelines also expand their definition of the medical industry to include complementary medicines companies (vitamins and supplements), not-for-profit sectors of the industry (community groups and charities) and sectors not previously captured.

It offers a new section addressing “E-health and the use of medical software containing advertising”, and warns that companies are inserting covert advertising into such programs. (Direct-to-consumer advertising of prescription medicine is banned in Australia.)

One organisation that has been consulted about the guidelines is the The Royal Australasian College of Surgeons (RACS), which has given the new edition its nod of approval. President of the RACS, Associate Professor Michael Hollands, pledged his college’s support of the guidelines in a letter to Dr Bolitho. “Should you wish,” he writes, “we would be happy to co-badge your document if you consider that helpful”.

Dr Ken Harvey, a transparency advocate who contributed to the guidelines says: “It’s clearly much stronger than the last one. It's really saying you shouldn't accept hospitality, you shouldn’t accept free samples ... but it’s nothing that’s not in the mainstream of public debate.”

However, Dr Ian Kerridge, a bioethicist, who had been on the RACP’s Ethics Expert Advisory Group, and is author of one of the open letters to the college board, worries that the way in which the RACP went about changing the process of updating the guidelines has damaged the reputation of the college itself.

Kerridge heard that the ethics committee was to be disbanded "on the grapevine...I hadn't heard anything from the college at all telling me that my services were no longer required."

In his letter to Dr Bolitho, on September 18, Kerridge wrote: “This came as an enormous shock, given that there has been no correspondence from the college to me or, as far as I am aware, to any other members of the Ethics Expert Advisory Group.”

Kerridge’s rather poetically expressed letter addresses the fundamental necessity of self-scrutiny by medical professionals, medical industries and everyone involved in health care. He writes, “Health care is ultimately a moral exercise and not simply a scientific or political one – and reflection upon the ethics of medicine is as old as medicine itself.”

Henry Zwartz/The Global Mail

All of the college’s Expert Advisory Groups were abruptly disbanded in August and, as yet, few members have been informed. In fact, as far as The Global Mail can ascertain, the larger community of 14,300 physicians has not been notified of any such changes.

Professor Paul Komesaroff is one interested party who did receive such notification. Komesaroff, an endocrinologist, had had an unbroken association with the different manifestations of ethics committees of the college since 1991, and had run them for 20 years until he received a letter from Dr Bolitho telling him that the ethics group was to be disbanded and that an “ethics working party” was instead being created to finish the 4th edition of the guidelines.

In a personal open letter to the college board, Komesaroff asks the board to reconsider the decision, “on the basis that it has the capacity to cause serious damage to the college and its national and international standing”.

Another letter, written by Komesaroff and signed by 11 other members of the ethics group and guidelines working party, despairs at the sudden change in the public-consultation process: “Public consultation is now regarded as critical in the development of important policy documents, but certain conditions are required to ensure that the consultation process is valid,” writes Komesaroff. “We seek your assurances that the integrity of the public-onsultation process will be protected.”

He has had no response to either letter but could not speak about the issue, having been told by the college that all media interaction about the guidelines should go through Dr Bolitho.

Dr Peter Brooks, rheumatologist and professor at the University of Melbourne, is a signatory to Komesaroff’s second letter and former secretary of the college.

He says the guidelines are, “something that medical groups need to get right because the relationship we have with the pharmaceutical industry is a very important one, but it’s one that has enormous potential for possible harm to patients”.

http://www.theglobalmail.org/feature/medical-ethics-under-the-knife/707/

An Australian Affair - can anyone help with more information?

 http://extras.theglobalmail.org/uploads/MedicalEthics/Reply-to-President-re-Ethics-EAG.pdf

GlaxoSmithKline faces quiz over China bribes probe

By Ben Griffiths

PUBLISHED: 22:35, 20 October 2013 | UPDATED: 22:35, 20 October 2013

Investors are poised to quiz drugs giant GlaxoSmithKline on Wednesday over a damaging bribery probe in China that is set to have an impact on its financial performance.

The FTSE 100 company has admitted that four of its local executives may have broken Chinese corruption and bribery laws.

It is accused of using more than 700 travel agents to funnel cash to doctors and other medical staff to boost sales.

Scandal: China is seen as key growth market for GlaxoSmithKline

The British former head of GSK in China, Mark Reilly, recently returned to the country to assist authorities with their investigation, having left before police arrested the four senior workers.

Reilly is understood to have been asked to remain in China, although he has not been detained and it is unclear whether he is banned from leaving.

Before the scandal hit, GSK was making up to 4 per cent of annual sales in China, which is regarded as a key growth market. Despite the crisis, GSK is forecast to report growth in pre-tax profits to £1.8billion during the third quarter, up from £1.7billion a year earlier.

http://www.thisismoney.co.uk/money/markets/article-2469492/GlaxoSmithKline-faces-quiz-China-bribes-probe.html?

Margaret McCartney writes

Bribing patients is bad medicine

A pen, some Post-it notes, a delicate box of chocolates. As a junior doctor, I am ashamed to admit that I liked the freebies that drug reps offered me, a token of their appreciation for my time while they delivered the latest in their company’s developments. It was only when I read the evidence and realised that these small treats could produce big swings in my prescribing — to more expensive but not better drugs — that I stopped seeing the reps.

Last week, the British Medical Journal published a paper showing that when people with schizophrenia or bipolar disorder are offered £15 to turn up and receive an injection of their antipsychotic treatment, more will do so. The medicines were given every one to four weeks, and the cash immediately afterwards.

Some 71 per cent in the “usual care” group came for their injections, compared with 85 per cent in the intervention group. The researchers pointed out that the costs of the incentives would be offset by the reduction in the need for emergency care for people with untreated mental illness.

Even so, this rings alarm bells. Giving payments to comply with treatment strikes at the heart of medical ethics: as the General Medical Council says, doctors must “maintain effective relationships with patients” and “respect patients’ autonomy”. People have the right to self-determination.

When clinicians try to swing patient choice using cash incentives — £15 may not sound much but to someone living on benefits it is substantial — we decrease the autonomy of the patient and contaminate our relationship with them.

Patients may end up taking the drugs — and enduring the side effects — because they will lose money if they don’t, rather than making a decision based on whether it works for them. In effect, doctors become the new “drug reps”.

Nor is this the only use of financial incentives in the NHS. In Glasgow, a trial is running that offers pregnant women £400 in high-street gift vouchers to stop smoking. Supporters say that we don’t have much help to offer female smokers, and that cutting smoking rates will reduce pre-term births and cot deaths. All this is true. But the patient must have her breath, saliva and urine tested to prove she has not inhaled before she gets the money, a process that assumes the patient may lie, and is potentially degrading.

The relationship between physician and patient is one of trust; the awkward interposition of money places conflicted interests between the two, damaging the assumption that we are each telling the truth.

The issue of inducements is among the most contentious questions in modern medicine, and it’s not just a matter of sweeteners for patients. Under the GP contract, we get “quality points” for showing our skill at prescribing drugs to lower cholesterol and blood pressure, and for demonstrating how often we have asked whether you smoke, and for inviting you to dementia screening. Patients are reduced to sets of tick boxes on the computer; every day I apologise to patients when I feel I have looked longer at the flashing screen than at them.

I am conflicted because I am paid by how well I comply with the contract; not for how clearly I explain the lack of evidence and the problems that may arise from dementia screening, say, or whether I tell you that your statin tablets may bring you more trouble than they prevent.

This causes me enormous professional pain. When people come in to see their doctor, they often have several issues to discuss, often something worrying, and many questions. Patients need time to be listened to. This is what I trained for. Yet the personal consultation has been usurped by the demands of the tick-boxing GP contract. My computer flashes up my failings — the requirements I haven’t satisfied — regardless of whether this is helpful for my patient.

If doctors and patients are to trust each other, we must not only remove those financial incentives that encourage patients to “comply”, but abolish doctors’ inducements, too. Medics ought to be liberated from the shackles of the modern GP’s surgery, so that they practise medicine for patients, not to satisfy targets, not to increase medicine-taking, not to bribe people to do what “doctor thinks best”. In the 21st century, doctors and patients need to be on the same side.

‘The Patient Paradox: Why Sexed-up Medicine is Bad for your Health’, by Margaret McCartney (Pinter & Martin), is available from Telegraph Books at £9.99 + £1.10 p&p. See books.telegraph.co.uk

http://www.telegraph.co.uk/health/10389401/Bribing-patients-is-bad-medicine.html

Mmmm Danone!

Danone Dumex vows ‘disciplinary action’ in wake of infant formula bribery probe

In a statement sent to DairyReporter.com earlier today, Dumex China accepted “full responsibility” for the illegal payments made by its employees, and promised that “disciplinary actions will be taken according to the relevant company regulations including appointing new management personnel to deal with relevant issues.”

Dumex issued the statement following the conclusion of a probe, conducted by police and local health officials in Tianjin, into allegations that hospital staff across the city were paid by Dumex employees to promote the company's products.

The investigation discovered that since 2011 bribes had been paid to 116 doctors and nurses acorss 85 medical institutions in the Tianjin Municipality “distribute promotional materials, and promote the use of Dumex milk powder."

This was done in exchange for “illegally accepted Dumex company fees in varying amounts,” said an extract of a statement issued by the local government in Tianjin.

Thirteen hospital workers have been dismissed or suspended from their jobs following the investigation, the statement added.

“Immediate suspension” of health education program

In response to initial allegations, which were detailed a September China Central Television (CCTV) news report, Dumex China launched its own internal investigation, which has since“been substantially completed.”

“The reports were found to be related to a company-sponsored program supporting mother-and-child health education,” said Dumex China in its statement.

“Dumex policies include support for maternal breast feeding, as well as compliance with all local and nation regulations in China. However, even though the program is in good condition it has been found that the educational program was not appropriately managed in some cases. This resulted in some practices that contradicted the purpose of the program, which violated company-wide policies. The company has expressed it deep regret for these shortcomings.”

In response, Dumex China has ordered the “immediate suspension of the mother-and-child health education program, in all regions.”

Mandatory marketing training

Alongside the temporary shutdown of its mother-and-child health education program, Dumex China announced plans to introduce a policy of “mandatory training programs in marketing responsibility for all employees, to ensure full compliance with Dumex policies, and local and national regulations.”

“This specific training will be completed in a three month period. At the same time, Dumex China will further strengthen its internal management and governance systems.”

“Dumex will continue to strictly follow all regulations set by the Chinese government and local authorities, as well as the guidance of the World Health Organisation. We welcome the supervision from the government, media and public," the statement added.

http://mobile.dairyreporter.com/Manufacturers/Danone-Dumex-vows-disciplinary-action-in-wake-of-infant-formula-bribery-probe#.UmHxIue9KK1