The US database disclosing transfers of value from pharma and medical technology companies to doctors went live at the end of September with details of 4.4 million transactions. But there are complaints it has not delivered transparency

After a number of delays the Open Payments database, set up under the US Sunshine Act, has launched with its first set of records showing 546,000 doctors and 1,360 teaching hospitals received payments totalling $2.5 billion between July – December 2013.

Open Payments has been set up by the Centers for Medicaid and MedicareServices (CMS) to make exact information about financial relationships between companies and healthcare professionals available to the public.

The database did not get a good reception, with complaints that it is hard to search, that different types of payments are listed in separate parts of the database, and that payments are listed under different subsidiaries, making it hard to find out how much any company has paid out overall.

For now, a big cloud over the transparency that was promised is that much of the data is de-identified. While names of the recipients of 2.7 million payments worth $1.3 billion are given, the recipients of a further 1.7 million payments, valued at $2.2 billion are not named.

That’s not the end of the teething troubles. A further 199,000 records of payments worth $1.1 billion that were submitted to the CMS were not published in the first release of the database.

Robert Wah, President of the American Medical Association (AMA) said he is “very concerned” about the accuracy of the data. “Only 26,000 physicians out of the nearly 550,000 physicians affected by the Sunshine Act were able to register to review their data and seek correction of any inaccuracies,” Wah said.

While the CMS provided a short period of time to review and correct any inaccurate data that were submitted by industry, several factors unfortunately hindered participation by many of the physicians. These include a complex, non-user friendly and cumbersome registration process to review data and request corrections of any inaccuracies.

Meanwhile, the website was plagued by repeated shut downs and other issues. “Notably, CMS has indicated problems with one-third of the data, which raises significant questions about the accuracy of the data content,” said Wah.

Publishing inaccurate data leads to misinterpretations, harms reputations and undermines the trust that patients have in their physicians. It can also discourage research and care, the AMA said.

The AMA strongly opposes inappropriate, unethical interactions between physicians and industry, but said Wah, “There are relationships that can help drive innovation in patient care and provide significant resources for professional medical education that ultimately benefits patients.”

Clouding a critical distinction

There was a more specific complaint by researchers at the Johns Hopkins Institute of Bioethics, about the disclosure of the value of medicines donated by companies for testing in clinical studies. Investigators are not only required to disclose funding for research per se, but also the value of any pharmaceuticals used in trials.

Writing in the American College of Physicians journal, Annals of Internal Medicine, the researchers say this could be interpreted by the general public as investigators personally receiving payments valued at hundreds of thousands of dollars.

As the researchers say, “Attributing such large payments to individual physician-investigators seems inconsistent with the [Sunshine Act’s] intent. Donated drugs are intended for use by patients and do not provide direct monetary value to physicians-investigators. The [Sunshine Act] rules cloud this critical distinction.”

The potentially misleading nature of this information could deter some physicians from participating in research, to avoid giving the impression they are receiving large payments from industrial sponsors, the researchers conclude.