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By Andrew Newton on 11 Sep, 2009 - 12:28 UTC

Having spent a few years as a compliance professional in the financial sector, I was intrigued to read about the detail of the Pfizer settlement.

 

The drug company Pfizer, you'll recall, has just settled with the US Department of Justice for a total financial penalty of $2.3 billion - the largest ever. The allegations against Pfizer concerned illegal marketing of painkiller Bextra and several other drugs.

 

What did not come through in the original reports was that in one part of the settlement, the inspector general  of the US Department of Health and Human Services  (HHS) required Pfizer to change the reporting line of the company's compliance department from the General Counsel to the Chief Executive. 

 

In-house compliance professionals are often in a bit of a bind. They are supposed to advise the business on how it needs to conduct itself if it is to remain within the letter of the regulations. Their reporting line, however, is often to someone with a strong personal interest in the short-term financial success of the business development to which the advice relates. Although compliance departments inevitably attract the label of "business prevention", their reporting lines (and remuneration and retention prospects) in fact incentivise them to bend over backward to accommodate the concerns of their superior. So much for independence.

 

In Pfizer's case compliance reported to the general counsel. As Lewis Morris, general counsel for the inspector-general's office put it:

 

"The lawyers tell you whether you can do something, and compliance tells you whether you should ... We think upper management should hear both arguments."

 

If that is what the lawyers are there to do, then they will be rewarded on the basis of their overall contribution to business development. Compliance reporting into that setup risk ending up singing the same tune, or leaving.

 

I predict regulators will become more prescriptive about the precise reporting lines of compliance professionals. I am not sure, though, that instituting a reporting line to the chief executive is the most effective course though. Although the CEO has a group-wide interest and won't want the actions of a particular division to threaten the overall reputation of the group, the CEO is still guided by short-term financial incentives. A better solution might be a reporting line into the audit committee of the board, which should be majority comprised of independent non-executives.

I was intrigued to see this news article on the BBC website this morning: WHO warns against homeopathy use.

 

Quickly, throw open the door of your medicine cabinet and eject all those little white homeopathic tabs; the World Health Organization after careful consideration reflecting its singular position of authority has clearly at last come down firmly on the side of homeopath sceptics.

 

Except that is not really what the article says.

 

Firstly the article is not talking about homeopathy in general but is instead focused on the problem of homeopathic remedies being promoted as primary medication for developing world sufferers of TB, infant diarrhoea, influenza, malaria and HIV. Not even the Royal Homeopathic Hospital in London agrees with reliance on homeopathic remedies for such conditions, according to a comment by Dr Robert Hagan - a St Andrews University researcher quoted in the BBC article.


I am not particularly convinced that homeopathy works, and so I agree with the assertion that people with HIV, TB and the like should not RELY on homeopathy at the expense of readily available conventional medicine.

Even so, I detect more than the passing hand of the pharmaceutical industry behind this article.


The letter to the WHO by the young doctors concerned reliance on homeopathy at the expense of conventional medicine, but the headline suggests that the WHO has come out completely against the use of homeopathic treatments, full stop. The headline is sensationalist and incorrect in the breadth of its assertion.

 

Secondly, the article ignores the problem of access to conventional medicine even though it is focused on the developing world where the problem of the prohibitive cost of drugs is well documented. Homeopathy may be little more than a placebo for all I know, but better that in desperate situations where the patient has little hope of being able to get something that actually works.


The primary source for the story is Sense About Science which, a small amount of googling reveals, is a pharmaceutical industry-funded astroturfing unit whose main aim would indeed have been to get a headline suggesting incorrectly that the WHO has come down firmly against treatments competing with pharmaceutical drugs.

US Healthcare reform, by Paul Simon
By Andrew Newton on 13 Aug, 2009 - 13:04 UTC

Paranoia strikes deep in the heartland
But I think it's all overdone
Exaggerating this and exaggerating that
They don't have no fun

 

Paul Simon, "Have a good time"

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Health insurers "tone deaf" on the Hill
By A P Newton on 18 Jun, 2009 - 12:31 UTC

In a "tone-deaf" session before Congress, executives from major health insurance companies testified yesterday that they have no plans to stop their practice of rescinding the policies of sick people on the basis of whatever technicalities they can dig up.  For example, a woman with breast cancer found her policy was cancelled because she had failed to disclose a visit to a dermatologist for acne treatment when she took out her policy.  While rescision is a legitimate tool to fight fraud, insurers regularly seek out innocently omitted information in order to justify cancelling the policy of a patient whose care will be expensive.  When Congressmen asked the executives whether they would consider revamping their policies and limit their rescisions to clear cases of fraud, the executives answered that they would not. 

 

This development could be useful for those advocating a public health option, as it makes the position of the insurers unpalatable at best, if not downright dastardly.

 

From the LA Times: "Rep. John Dingell (D-Mich.) said that a public insurance plan should be a part of any overhaul because it would force private companies to treat consumers fairly or risk losing them.

"This is precisely why we need a public option," Dingell said.

Proponents of a public plan seized upon the hearing, saying it showed why access to healthcare cannot be left to private insurance companies.

"This could reshape the debate," said Jerry Flanagan, a patient advocate with Santa Monica-based Consumer Watchdog.

"When insurance companies go under oath and admit they are canceling innocent patients when they get sick, it makes it very difficult for lawmakers to pass a law that requires every American to buy a policy or face a tax fine. It opens the way for a public option to hold the companies in check.""

Alliance Boots ends ethical pledge
By Andrew Newton on 14 Jun, 2009 - 11:27 UTC

In a bizarre move, British pharmaceuticals and beauty products group Alliance Boots has withdrawn from the Ethical Trading Initiative.

 

The ETI is a retail industry-recognized commitment to ethical trading standards designed to ban suppliers from using child or forced labour.

 

There is no press release on the Boots website explaining the move. The company's 2007 corporate social responsibility report made it clear that the company was working to expand its supplier reviews in accordance with ETI standards. The report that came out a year later did not mention the ETI at all.

 

Boots, previously a FTSE 100 company, was bought by private equity firm Kohlberg Kravis Roberts in April 2007. Union groups and campaigners are suggesting that the withdrawal from the ETI commitment has been driven by its new owners, a suggestion that Boots has apparently denied. Earlier this month KKR posted a $1.19bn (£722m) loss for 2008.

Not sure how I missed this, but David Leonhardt's most recent column addresses work/life balance--or the total lack thereof--in the financial services and consulting fields.  Leonhardt talks about this Harvard study, among others, that compares the family-friendliness of various elite fields and finds, surprisingly, that medicine is actually one of the most flexible professions, often allowing established practicioners to carve out an enjoyable family life while also having a satisfying career.  Finance and consulting, by contrast, allow for little to no flexibility in working hours or conditions, thus forcing people who want to spend more time with their children to drop out of the field entirely, or to take time off for which they are later penalized: taking time out from a financial services career means an average 41% pay disparity with former colleagues upon returning to work.

 

Nice to see this issue taken up in the Economy section of the Times; after all, the issue of whether workers have lives worth living, complete with thriving families, should be a central question in the cultural conversation.  And while the studies that Leonhardt references deal with elite, highly educated workers, they could be the beginning of a broader public discussion needs to address these issues and their implications for the average Janes and Joes of the workforce. 

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The New Yorker has a great piece on healthcare in McAllen, Texas, home to the highest medical costs in the US.  The McAllen case may hold the keys to a viable public healthcare plan, and seems to also have all the key ingredients for a soap-opera miniseries: corruption, greed, sick people and lots and lots of money.


 


This is my favorite paragraph: "About fifteen years ago, it seems, something began to change in McAllen. A few leaders of local institutions took profit growth to be a legitimate ethic in the practice of medicine. Not all the doctors accepted this. But they failed to discourage those who did. So here, along the banks of the Rio Grande, in the Square Dance Capital of the World, a medical community came to treat patients the way subprime-mortgage lenders treated home buyers: as profit centers."

Drugmaker AstraZeneca faces a class-action lawsuit in the UK from 16,000 patients who were prescribed the drug Seroquel for "off-label" indications and claim to have experienced significant side effects, like weight gain and diabetes.

 

Internal documents show that the company had aggressively promoted the drug for off-label, unapproved uses to doctors.  Seroquel was originally created and approved to treat schizophrenia, but AstraZeneca has promoted its use for other psychiatric disorders such as bipolar disorder.  The internal documents also show that the company was aware of the dicey legal territory they were navigating:

 

"Other documents show AstraZeneca keeping a close eye on the legal line between promoting clinical studies of Seroquel in disorders for which it is not yet approved and outright marketing of the drug for off-label use by the commercial department. One 2004 email said that slides prepared in connection with a study involving off-label use of Seroquel were "financed outside of Commercial for obvious legal reasons". On another document, the minutes of a meeting about doctors' attitudes to anti-psychotic drugs, a brand manager had scrawled that the sales force could "grease the skids" for Seroquel's use as a treatment for dementia."

A nice, long piece from Alternet details the likely plans of the healthcare industry lobby to try and sabotage any attempt by Congress to implement a public health insurance option as part of overall healthcare reform in the US.

The US National Institutes of Health (NIH) is consulting on whether to tighten rules relating to conflicts of interest in medical research it finances.

The move comes following growing concern about the objectivity of research that has been financed or materially supported by drug companies or medical device manuafacturers.

An update from The Scientist (free reg'n req'd) on the Merck/Elsevier story: there were six other fake journals issued on behalf of unnamed sponsors.

 

We previously covered Elsevier's publication of an apparently peer-reviewed serious journal for Merck, that was in fact a Merck-sponsored promotional tool.

 

Now The Scientist has found that there were seven such journals published between 2000 and 2005 by Elsevier's Australian operation.

 

"a "series of sponsored article publications" were put out by their Australia office and bore the Excerpta Medica imprint from 2000 to 2005. These titles were: the Australasian Journal of General Practice, the Australasian Journal of Neurology, the Australasian Journal of Cardiology, the Australasian Journal of Clinical Pharmacy, the Australasian Journal of Cardiovascular Medicine, and the Australasian Journal of Bone & Joint. Elsevier declined to provide the names of the sponsors of these titles, according to the company spokesperson."

 

If they can, would Merck and the other major drug companies please start denying their involvement in these others so we can see who the unnamed drug companies are?

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Corporate-Driven Healthcare Reform

Posted by christinearena to the Case in Point blog

As Washington fights an uphill battle, corporate players McKesson and GE deliver the health care reform the Nation desperately needs. >>

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  • on 22 Jul 2009

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