Kickback allegations against its former editor prompted the Journal of Patient Safety to review his writings and adopt new standards for disclosing commercial conflicts of interest
This story was co-published with NPR's Shots blog.
The aftershocks of what's been called "patient safety's first scandal" continue to reverberate in the medical community, most recently in the current issue of the Journal of Patient Safety.
The Journal's editorial team reviewed 10 articles by Dr. Chuck Denham, the publication's previous editor, and said nine had potential conflicts of interest, five of them undisclosed. Though it's unlikely the articles resulted in patient harm, the editorial said, they may have hurt the journal's credibility.
The review is the latest turn in a rapid fall from grace for Denham, whose business dealings and patient advocacy came under scrutiny this year after a Justice Department kickback settlement.
A year ago, Denham was a golden figure in the burgeoning patient safety movement, a smooth-talking advocate who brought Hollywood pizzazz to the cause with his connection to actor Dennis Quaid and commitment to filmmaking.
As ProPublica reported, Denham also served in other prominent patient safety posts – most notably as co-chairman of a committee that set guidelines for the National Quality Forum, a nonprofit group that endorses best practices that are widely adopted throughout the healthcare community.
He ran a nonprofit patient safety organization and a for-profit consulting business, but Denham wasn't a practicing physician and didn't have strong academic credentials.
The scandal started when the Justice Department accused Denham of taking $11.6 million in kickbacks from CareFusion, a pharmaceutical company that makes the surgical antiseptic ChloraPrep. Denham was not a defendant in the civil case, which the company settled for $40 million. But prosecutors claimed he was paid to influence recommendations of the Quality Forum in favor of the drug.
Denham has denied the allegations. He did not return a call for comment about this story.
On Jan. 28, ProPublica reported that Denham had not disclosed that his for-profit company had been paid by CareFusion while he led the Quality Forum's Safe Practices committee and advocated for ChloraPrep's formulation. The Quality Forum ended up endorsing the formulation, excluding other antiseptics, in its guidelines. Other experts on the panel told ProPublica that had not been their intent.
The Quality Forum cut its ties with Denham, as did the Journal of Patient Safety.
A new editorial board was appointed in Denham's wake. The editors wrote in their review that they were surprised when Denham was named editor in February 2011. They hadn't been consulted, there was no formal search process and Denham had previously published only 17 academic articles.
A spokeswoman for Wolters Kluwer Health, the company that publishes the Journal of Patient Safety, told ProPublica that Denham was appointed because he was a prominent member of the editorial board who had been recommended by the previous editor.
The Denham articles that editors reviewed included no direct references to ChloraPrep.
But the articles contained numerous references to the Quality Forum's Safe Practices guidelines. That was a potential conflict-of-interest given that the company that could have benefitted from Denham's control of the guidelines, the editors concluded.
"This is a clear violation of the standards of the Journal," the editors wrote.
Dr. Albert Wu, an associate editor with the journal and a professor in the Johns Hopkins Bloomberg School of Public Health, said it was clear when Denham's ties to CareFusion became public that a review of his published work would be necessary.
Wu said the Denham controversy has helped the patient safety movement grow up by showing that the world of quality improvement presents opportunities for industry to corrupt medical practice.
People are becoming as wary and aware of the influence of money on patient safety as they have been in the world of medical devices and pharmaceuticals, he said.
"We're now much more aware that we need to be more vigilant," Wu said.
The Journal of Patient Safety launched in 2005 and hadn't adopted some of the conflict-of-interest standards of the International Council of Medical Journal Editors. Now conflict-of-interest forms will be published with articles, and editors will publish disclosure statements and recuse themselves from decisions where they have conflicts.
The new editors should be commended for airing their dirty laundry because the openness will build trust, said Eric Campbell, a professor of medicine at Harvard Medical School.
"The reputation of a journal is all it has," said Campbell, who studies conflicts of interest.
Campbell said the controversy opened the eyes of many in the patient safety field to the notion that money could corrupt, "even something as awesome and great for society as patient safety."
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By unanimously boycotting the CIC hearing, RTI experts say, political leaders across party lines do not want betterment and transparency for the country
Ruling Bharatiya Janata Party (BJP) which professed transparency and good governance if it came to power, showed its true colours, by defying summons issued by Central Information Commission (CIC). The Commission had asked the party to attend the hearing to bring political parties under the Right to Information (RTI) Act by declaring them ‘public authorities’. All other five major political parties – Indian National Congress (Congress), Communist Party of India (Marxist)-CPI(M), Communist Party of India (CPI), Nationalist Congress Party (NCP) and Bahujan Samaj Party (BSP) too boycotted the hearing of 21st November, reflecting their united stand to keep their funds, 75% of which comes from unknown donors, a deep secret.
Former Central Information Commissioner and RTI activist, Shailesh Gandhi, terms this as ‘arrogance’ with the intention of protecting their ‘family turf’ instead of betterment of the country. When contacted by Moneylife, he stated, “This is very unfortunate and reflects the arrogance of those who can exercise power. If the political parties are willing to think of the future of India, they would have agreed to become transparent.
Transparency will act as a curb on arbitrary and family controlled political parties. Do they want this for a better India, or are they concerned only with protecting their feudal and arbitrary turf?”
According to a senior bureaucrat, united boycott on CIC hearing by six political parties is an extreme case but the stark reality is that they do not have respect for transparency, accountability and to the highest adjudicatory body in RTI. "CIC decision has attained finality for not being invalidated by High Court or Supreme Court. As such, boycott amounts to absolute disrespect and disobedience for higher appellate authority. As the CIC does not have contempt powers, this disrespect and disobedience is blatant, rampant and dangerous for it can be treated as exemplary and followed by others to weaken the RTI regime," he said.
It may be recalled that, Association of Democratic Reforms (ADR) had procured documents of income tax (I-T) returns and statements from Election Commission of the six major political parties through RTI. Its analysis showed that between the years 2004 and 2012, these parties together had received Rs3,675 crore as donations through unknown sources.
However, during the course of their campaign, the ADR and RTI activist Subhash Agrawal, who was also pursuing this issue, did not get some crucial replies from the relevant public authorities. This include, details of 10 maximum voluntary
contributions received by the party from fiscal 2004-05 to fiscal 2009-10 and; details pertaining to voluntary contributors along with their addresses who have made single contribution of more than Rs1 lakh to the party from fiscal 2004-05 to fiscal 2009-10.
Hence, they filed a complaint with the CIC under the RTI Act.
ADR, through its analysis proved to the CIC that political parties receive substantial beneficiaries in terms of land, use of government buildings at throwaway rates and free airtime, besides the fact they are answerable to the public. On 3 June 2013, the CIC declared political parties as ‘public authorities’ under the RTI Act.
Ever since, all the major political parties have skipped CIC hearings, which wants to thrash out the issue of political parties as public authorities, thrice earlier, and except for CPM, all other parties replied that they do not come under the RTI Act. On 21st November too, they stood united. The CIC has reserved the judgment although the petitioners – ADR and Agrawal, requested the Commission for penalties to be
imposed on these parties (under section 20 of the RTI Act).
The press release of ADR says, “All six political parties were conspicuously absent from the hearing. This defiance was very much in-line as how three earlier notices from the CIC that had already been sent to these parties in relation to the implementation of the 3 June 2013 order, were treated by these parties.”
When contacted by Moneylife, Subhash Agrawal rued, “Attitude of political parties is an insult to an institution formed through legislation passed by the Parliament of which they themselves were the parties for passing such a wonderful legislation. If political parties and Union government were not agreeable to CIC-verdict, they should have challenged CIC-verdict in court. Even legislation to amend RTI Act for the purpose was deferred despite Parliamentary Committee’s recommendations perhaps because the then Attorney General opined against such legislation.”
He also demands that CIC should make strong recommendations to the government regarding this defiance. “Apart from imposing maximum penalty under RTI Act and providing exemplary compensation under provisions of RTI Act, the CIC should make some strong recommendations to Union government, Election Commission, Union Ministry of Urban Development (MoUD), Central Board of direct Taxes (CBDT), Prasar Bharti and others concerned because of political parties not complying with CIC-verdict”.
Agrawal lists out the recommendations:
1. Further land-allotment at subsidized cost, free voters’ list, free Doordarshan & All India Radio (AIR), and all other government-provided free facilities to political parties may be instantly abolished. All other direct/ indirect financing by Union and state governments to political may be immediately stopped.
2. No further government-accommodations may be allotted to any political party. Existing ones may be got vacated say within three years.
3. Buildings built by political parties on subsidized land provided by governments may be taken over by governments in case of division in the party. Divisions-after divisions in Congress-party left its one time headquarters at 7 Jantar-Mantar Road (New Delhi) in very bad condition. No more land at subsidized price may be provided in future.
4. Union government may abolish all Income Tax exemptions on contribution made to and received by political parties. This will abolish indirect government-financing to political parties through tax-exemptions. Extra revenue so generated for national-development/public-welfare-schemes is much more important than exemptions so enjoyed by political parties and to those contributing to them.
5. Political parties may be made to submit their complete fiscal details including incoming and outgoing funds to Election Commission for making these public through website.
6. Election Commission may de-recognize all about 1,600 non-serious political parties which might not have contested any election in last say three years.
7. Election Commission may intervene for making political parties complying with CIC-verdict by giving them time-bound ultimatum for their de-recognition in case of their not complying with the said CIC-verdict dated 3 June 2013.
8. Any other such recommendations as deemed fit by Central Information Commission for making political parties accountable to public through RTI Act may be made.
You may also want to read:
Congress brags about bringing in the RTI Act but was the only party to skip the CIC hearing
Indian political parties fear RTI consequences; skip CIC hearing
A secret cabinet note reveals desperation of Netas to hide from RTI Act
Political parties receive 75% of funding from 'unknown' sources
Why I-T returns of Pawar, Jindal and Gandhi are exempted from RTI?
Congress, BJP, CPI, CPI (M), NCP and BSP yet to appoint PIOs under RTI Act
Another mid-cap and small-cap oriented close-ended scheme
Joining the race to launch close-ended equity schemes, Canara Robeco recently launched Canara Robeco India Opportunities a mid-and small-cap oriented close ended equity scheme. The scheme will have tenure of three years from the date of allotment. While this scheme offers a specific allocation range of its portfolio to stocks of different market-capitalisation, will an average saver know how much to invest in such a scheme and would they be aware of the risks?
The scheme would invest 65%-90% of its assets in small-and mid-cap stocks. Between 10%-35% of the portfolio will be invested in large-cap stocks and up to 5% will be invested in micro-cap stocks. The balance part of the portfolio will be invested in debt and money market instruments. In the last six months of the tenure of the scheme, “the exposure to large-cap stocks may go up to 100%, if considered in the best interest of investors, in order to facilitate smooth completion of maturity of the scheme,” mentions the scheme information document.
The scheme defines large-cap companies as those that are among the top 150 Companies appearing in BSE 200 index or those companies whose market capitalisation is within the range of market capitalisation of top company and the 150th company of BSE 200. Stocks that appear in the CNX Midcap index or those with a similar market-cap, will be considered mid-cap stocks. The stocks appearing in the CNX Small Cap index or will a similar market-cap will be considered as small-cap companies.
Ravi Gopalakrishnan, who has 10 years experience in the capital markets will be the fund manager of the scheme.