Pfizer to disclose US clinical trial payments
Tuesday , February 10, 2009

Pfizer has announced plans to disclose payments to healthcare professionals involved in clinical trials.  The company will publicly declare all payments made in the US for work on its phase I-IV clinical trials.

Pfizer is the first pharma company to commit to this kind of disclosure, which builds on its recent policy of declaring payments made to opinion leaders for consulting and speaking engagements.

From July this year Pfizer's payments will be recorded, and the figures will be published online in early 2010, in the company's first annual update.

This will include payments to practising US physicians and other healthcare providers, as well as principal investigators, major academic institutions and clinical research sites.

The company is still working out the finer detail of the policy, but is considering reporting payments to individuals of more than $500 a year, and detailing non-monetary items, such as meals, that exceed $25 in value.  The company said the move demonstrates its commitment to "increased transparency and public candor".

"These collaborations are an essential part of medical progress," said Pfizer's chief executive Jeffrey Kindler. "Simply put, without these collaborations, Pfizer would not be able to continue delivering the medical innovations that the global health community has come to expect."

In 2008, Pfizer worked with almost 8,000 clinical investigators to conduct more than 280 studies of medicines. In common with industry practice the company makes payments to investigators and research institutions to compensate them for work done on the company's behalf.

Examples of payments include clinical development and commercial consulting, promotional speaking, phase I-IV clinical trials, investigator-initiated research as well as meals and other non-monetary items.

Pfizer's plans come ahead of proposed legislation in the US that would make the reporting of payments to physicians mandatory. Pfizer and a number of other companies have already announced their intentions to reveal payments to physicians for opinion leader work, but Pfizer is the first to include clinical development work in its plans. "We are committed to taking the steps necessary to achieve greater transparency in our interactions with US healthcare professionals," Kindler said.

"By disclosing payments to physicians, we are breaking down a major barrier and increasing the trust healthcare providers must have when prescribing our medicines. To be viewed as an open, candid and transparent company, we must address the concerns of our customers and take action. This new initiative does just that."

Pfizer UK hints at disclosure of payments to doctors
Monday , January 19, 2009

The UK might soon follow US companies by publicly declaring payments made to opinion leaders.

David Gillen, Pfizer UK's medical director, has said industry leaders in the UK and Europe now at least have to consider making public the payments in order to disprove impropriety or undue influence.

Speaking in an exclusive Pharmafocus interview, Gillen admits the UK pharma industry has made errors around transparency over the years, and that it must find a way to restore its image. He hints that this is incompatible with the current model of funding for medical education.  "It seems to me that we put money in [to medical education] and we get criticised for it. So something there has got to change," said Gillen.

The US operations of Pfizer and rivals GSK, Lilly and Merck have announced plans to declare such payments, ahead of new legislation that will oblige companies to do so, and it seems companies in the UK and Europe may follow suit.  Pressure for change has grown considerably in recent years. Suspicions that pharma-doctor relationships are tainted by large payments have damaged pharma's reputation, despite protestations that the relations are ethical. Gillen is a member of a working party made up of Royal College of Physicians members and representatives from UK pharma.

The group has met regularly over the past 12 months to examine the challenges involved in creating the ideal relationship between doctors and industry. A report written by Lancet editor and the working party's chairman Richard Horton due in February will reveal their conclusions.

"It's about trying to reconstruct this relationship, which has got to a place where it shouldn't be," said Gillen.

He believes the findings of the project will have an impact on a global level. "If you look at where this reputational change can start, it can start here, and we can maybe change the industry's reputation around the world." Gillen also believes the industry needs to improve transparency around clinical studies.

GSK transparency moves

Pfizer's rival GSK is among companies that have announced clinical trial data will be published online when a product is approved.  The news marks part of a bigger effort from GSK to improve its transparency, which was called into question in 2004 following accusations it withheld negative data on the antidepressant Seroxat/Paxil.

In a further move the company has also announced it will no longer make corporate political donations, to avoid accusations of lobbying. Like other pharma firms, GSK has made political contributions in the past, and in 2007 these amounted to £249,000.  In the US, the company will continue to facilitate political contributions by eligible GSK employees through its independent Political Action Committee.

Declaring doctor payments

What do stateside changes mean for UK pharma?

A number of pharmaceutical companies in the US have recently announced they will declare all the payments to healthcare professionals. It sounds like an inspiring leap towards transparency, but is it really such an innovative or admirable step?  Cynics would say the companies involved are simply more media savvy than their industry competitors - that rather than breaking new ground, they are simply grabbing the chance of headlines to boost their corporate social responsibility.

It's would be a harsh assessment, and yet in the UK the practice is virtually enshrined in the ABPI's Code of Practice. The industry body led the pharma world in 2006 by insisting that companies operating in the UK had to declare which patient groups they were supporting. This year the ABPI's lead was followed by its EFPIA, its European counterpart, which required similar declarations to be written into all national codes, prompting peals of anguish across the region. However, the European requirement went further and, instead of just publishing a list of supported patient groups, companies were required to provide brief details of the support provided. Not the amounts, just the 'nature' of the support.

Elsewhere in the EFPIA Code, later adopted by the ABPI as a member of EFPIA, were 'encouragements' to consider regarding both payments made for services provided by healthcare professionals and also grants made to healthcare organizations. Where grants to organizations are concerned, companies are 'encouraged' to 'make available publicly' information about the support they provide. And of course, it has long been a requirement of the EFPIA and ABPI Codes that all activities, materials and meetings arising from industry support should bear declarations of pharma's involvement.

What may not be so widely realized is that some NHS trusts now publish lists of donations they receive. In fact the NHS was the source of information used in the latest round of concerns raised by Consumers International when they issued a report about pharma sponsorship for certain hospital departments and NHS employees in the autumn of last year. And, of course, the Freedom of Information Act means that anyone can ask for a list of donors to hospitals and the NHS has to respond because it is a government institution.

However, the aspirations to transparency are being driven at the highest international level, with the International Federation of Pharmaceutical Manufacturers (IFPMA) introducing the requirement for written agreements for consultants back in 2006. EFPIA built on this requirement and introduced a new twist. Within the written agreement (that's a contract to me and you) was a requirement that the consultant declare they are being paid when speaking at events, writing articles, etc. Most of pharma's consultant contracts already include a relevant clause.

Educational sponsorship for individuals, however is not currently subject to the requirements for transparency declarations of any kind. Indeed it is a bizarre anomaly that the payment that most closely resembles a 'gift' of money (albeit for a worthy purpose) is not subject to any documentary controls at all. That said the majority of companies are already implementing the need for written agreements when providing travel grants, etc. This is not really a surprise. Every time that money changes hands, companies must be wary of anti-bribery legislation. In particular the impact and reach of the US Foreign and Corrupt Practices Act - which has so far not fully flexed its considerable muscles.

It would be a brave firm that had a sister-company in the US and failed to maintain basic standards of documentation regarding financial transactions with government officials (which in the UK includes just about every healthcare professional!).

Prediction time

The next revisions to the ABPI Code are perhaps 12 months away. When they arrive, expect those areas that 'encourage' or 'strongly encourage' transparency to become mandatory. In other words, companies will probably be expected to publish lists of the healthcare organisations to which they give support and financial grants. The Code of Practice watchdog the PMCPA currently says that only support to the value of £500 or more needs to be declared where patient groups are concerned, so expect a similar level to apply here - which basically means all institutional grants. It will almost certainly apply to GP practices, including single-handed GPs.

Will we have to publish the nature of the support and the amounts involved? Well, that seems to be a reasonable assumption. And if we don't need to publish the amounts this time round, then I would bet my house on it being in the 2011 ABPI Code. But back to next year, and companies should expect to have to announce the amounts of money they give to patient groups. Some already do this - GSK's policy is probably 'best practice' in this area. A good amount of information is given on the patient group section of their website, even though the page itself is a little hard to locate.

What about payments made for services received? There may be a number of issues for the lawyers to consider here, regarding the fact that these are commercial arrangements and therefore some aspects of competition law could conceivably prevent pharma companies from declaring the amounts they pay. Certainly, the service providers will not want their charges to be published to their competitors (other speakers). And if one regards the payment as personal income, then there may be data privacy issues to consider too. Even the NHS only publishes the bandings of salary scales - not the amounts paid to individual employees.

And so we return to the anomaly that is travel grants. It would be astonishing if, in 2009, some controls were not introduced in this area. So expect a requirement for written agreements and probably 'encouragement' to publish list of recipients of support.  Finally - a question: if a company ignores 'strong encouragement' would it have to defend their rationale if a complaint arose? Answers by email please.