BLOGSCAN - The WHO, NGOs, and the Pharmaceutical and Biotechnology Industries

On PharmaLot, Ed Silverman wrote about claims that most of the non-governmental organizations (NGOs) offering comments at a World Health Organization meeting designed to boost innovation in treatment of neglected diseases like tuberculosis and malaria were from organizations with financial ties to pharmaceutical manufacturers and biotechnology companies.

Post Title → BLOGSCAN - The WHO, NGOs, and the Pharmaceutical and Biotechnology Industries

From the British Medical Journal: Financial Links Among the World Health Organization, Patient Organizations, and Pharmaceutical Companies

We have posted frequently about questionable financial links between commercial firms that produce health care goods and services (for example, pharmaceutical, biotechnology, and medical device companies) and not-for-profit organizations and government agencies that provide or regulate health care (for example, hospitals, academic medical centers, and government agencies). The latest example of such links, and one with global implications, comes from one of my now favorite outlets for investigative journalism, the British Medical Journal. [Day M. Who's funding WHO? Brit Med J 2007; 334: 338-340).

Serious questions have been raised about whether the World Health Organization is using patient groups as a conduit for receiving proscribed donations from the pharmaceutical industry. Email correspondence passed to the BMJ seems to show that in June 2006 Benedetto Saraceno, the director of WHO's department of mental health and substance abuse, suggested that a patient organisation accept $10 000 (£5000; {euro}7000) from GlaxoSmithKline (GSK) on WHO's behalf. The sum was then to be passed on to WHO—ostensibly with the intention of obscuring the origins of the donation. GSK withdrew its offer of funding when it learnt that acceptance was conditional on obscuring its origin. However, the email exchange indicates that other sums of money originating from drug companies may have already been channelled to WHO through patient groups.

When asked about this correspondence, Dr Saraceno told the BMJ that his email to the patient organisation was 'clumsily worded' and that he had 'never intended to solicit donations from the pharmaceutical industry through' the patient organisation. In the email dated 16 June 2006, Dr Saraceno thanks Mary Baker of the European Parkinson's Disease Association (EPDA), for raising the $10 000 'requested by the WHO.' The money was to have funded a report on neurological diseases, including Parkinson's disease, for which GSK produces treatments.

Dr Saraceno then seems to advise Mary Baker on how to get round the WHO's rules forbidding drug industry funding. 'Unfortunately,' he says, 'WHO cannot receive funds from pharmaceutical industry. Our legal Office will reject the donation. WHO can only receive funds from Government agencies, NGOs, foundations and scientific institutions or professional organisations. Therefore, I suggest that this money should be given to EPDA and eventually EPDA can send the funds to WHO which will give an invoice (and acknowledge contribution) to EPDA, but not to GSK.'

According to paragraph 13 of the WHO's guidelines on interactions with commercial enterprises, which deals with cash donations, WHO should avoid indirect collaboration (particularly if arranged by a third party acting as an intermediary between WHO and a commercial enterprise).' Paragraphs 15 and 16 of the guidelines state that funds may not be sought or accepted from commercial enterprises that have a direct commercial interest in the outcome of the project and that caution should be exercised even when the business has an indirect interest. And paragraph 27 says that for reasons of transparency, contributions from commercial enterprises must be acknowledged.

Richard Nicholson, editor of the Bulletin of Medical Ethics, said: 'It would be very bad indeed if the WHO were trying to obtain money surreptitiously from drugs companies. Unfortunately it's also under-funded, and sadly there's always going to be the temptation of senior officials who ought to know better than to accept such money. But they should remember that there's always a price attached to such funding.'

He adds: 'This is in line with what we have done so far with other contributions to the report which all are coming from other professional organisations,' — suggesting that less than transparent transactions were the norm for this fundraising operation.

It turns out this has not been the first time that WHO was accused of being caught up in commercial entanglements.

Ralph Edwards, the director of the WHO's drug monitoring centre in Uppsala, Sweden, warns .... 'These days it's so hard to find anyone completely free of the pharmaceutical industry. A couple of years ago we wanted to publish a safety report on Lapdap [chlorproguanil-dapsone], the combination malaria treatment. The WHO's tropical disease research group had developed the treatment jointly with Glaxo, but Glaxo weren't happy with what we wanted to publish.'

'This was a bad situation and it was very, very difficult. We raised the issue with WHO because we thought that there had not been enough safety studies done. We managed to get the report published eventually, after a lot of lobbying and pressure—but it was delayed for more than a year,' said Dr Edwards.

'It's an example of how tortuous it is working with pharmaceutical industry money.'

This story is yet another reminder of how globally pervasive are financial ties amongst various health care organizations that naively physicians and the public may think are supposed to work at arms' length. However, if we want health care that puts the needs of patients first, we have to align the incentives with the mission, and eliminate opportunities for well-heeled vested interests to pay for increased influence.

Post Title → From the British Medical Journal: Financial Links Among the World Health Organization, Patient Organizations, and Pharmaceutical Companies

WHO Calls for Transparency in Clinical Research

The Lancet this week contains a commentary from the WHO [Sim I, Chan AW, Gulmezoglu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet 2006; 367: 1631-33.] calling for the creation of an international clinical trials registry. It is worth quoting from its introduction:

Recent scandals in the UK and elsewhere have diminished public trust in the clinical research industry. [References were to trials of TGN 1412 ; Vioxx; and Trovan in Africa.]
Transparency is the best antidote to such free-floating distrust. Clinical trial registration will allow the necessary tracking of trials to ensure full and unbiased reporting of the results for public benefit.
Individuals voluntarily participate in trials expecting that the results will be used to improve medical knowledge in general, and not only to serve proprietary or commercial interests. These ethical oblibations to the public good are in addition to the obligations to protect individual research participants during a trial (e.g., informed consent), and they extend to all trials regardless of study design or trial population.

Their emphasis on trial subjects' expectations that they are contributing to science, not just to a commercial project, is a welcome reminder. The authors underline this point later, asserting that their registry proposals

are consistent with the Declaration of Helsinki requirement that 'the design of all studies should be publicly available', as well as with the recognition by the Declaration of Helsinki and the Nuremburg Code that the rights of trial participants hold primacy over commercial and career interests.

The proposed WHO registry will include early trials (called Phase I and II in the US) as well larger, late-phase trials is important. Their argument was that early-phase trials "are often terminated for economic reasons." But that registration of them will "ensure that information about the risks of new interventions will be publicly available."

The WHO authors found that "arguments for delayed disclosure were neither convincing nor compelling. First, there is a large variation in disclosure practices - some companies disclose all outcomes, some none - raising the question of what disclosure is truly threatening. Second, information that is claimed to be sensitive is often available for a fee through intelligence services readily found on the internet or through trial participants and consumer websites. Finally, there is no convincing evidence that disclosure threatens competition and hence innovation."

This sort of clarity about the integrity of clinical research is welcome. Hopefully, it will get some attention.

Post Title → WHO Calls for Transparency in Clinical Research