Guest Post: More Transparency Is Needed to Fight Grand Corruption in the Pharmaceutical Sector

Today’s guest post is from Till Bruckner, the founder of TranspariMED:

In the pharmaceutical sector, public agencies are routinely handing over billions in public money to private companies for products whose value they cannot accurately assess, because the vendors control the flow of information generated by clinical trials. (Even the purchasing price is often kept secret, but that is another story.) If we observed this sort of opacity in the public procurement sector, it would immediately raise red flags. If public contractors were taking billions from governments in exchange for products of dubious quality that the governments cannot assess, the anticorruption community would be–rightly–up in arms. But for the pharmaceutical industry, this is business as usual.

Consider, as one particularly egregious example, what can only be described as an $18 billion heist of public money by a pharma company. In 2006, governments around the world began stockpiling Tamiflu, an anti-retroviral drug, due to fears that outbreaks of bird flu (and later swine flu) could turn into a lethal global pandemic. The evidence available at the time suggested that the drug was safe and effective at reducing the symptoms of influenza. In total, 96 counties accumulated enough Tamiflu to treat 350 million people. Then, in 2009, a doctor noticed that the results of eight clinical trials of Tamiflu were missing from the public record. (Worldwide, around half of all clinical trials have never reported their results.) After a struggle lasting four years, independent scientists finally got the company to turn over the relevant data from these trials—and concluded that the drug did little, if anything, to help patients.

This example is especially egregious, but it is not otherwise exceptional. Amazingly, comprehensive information on the safety and effectiveness of drugs is not only inaccessible to independent scientists, but also to government agencies. When a drug company applies for a marketing license, it has to submit detailed documentation from every relevant trial to regulatory agencies such as the U.S. Food and Drug Administration (FDA). Regulators review these submissions, called Clinical Study Reports (CSRs) – and then promptly lock them away in their confidential archives. This is especially frustrating for scientists working for health technology agencies, who are tasked with assessing the cost-effectiveness of different drugs but are often unable to access CSRs. To date, only the European Medicines Agency systematically releases (some) CSRs.

Politicians have tried to bring transparency into the sector, but the laws they pass often remain unenforced. In the United States, the 2007 FDA Amendment Act made it compulsory for companies and universities to publish the summary results of some clinical trials on public registries. (Summary results are a kind of “executive summary” of a clinical trial; they are far shorter and less detailed than CSRs, but still better than nothing). In 2015, an investigation by STAT News found that pharmaceutical companies routinely violated the law. The law stipulates a fine of up to $10,000 for every day a result is overdue. In theory, Big Pharma has already racked up over $25 billion in fines. In practice, the FDA has yet to collect a single cent. In the European Union, a similar regulation exists, but there too it remains unenforced by national agencies. In Britain, a 2013 parliamentary inquiry called for greater transparency, but its recommendations were largely ignored.

Last December, a coalition of four health integrity organisations issuing a wake-up call for governments to finally get serious about clinical trial transparency. Transparency International Pharmaceuticals & Healthcare (PHP), TranspariMED, Cochrane, and the Collaboration for Research Integrity and Transparency (CRIT) released a study that documents in detail how opacity in the sector harms patients, prevents public health agencies from making informed decisions, wastes public health funds, slows down medical progress, and exposes shareholders to substantial risks. The study also shows that clinical trials can be made significantly more transparent without introducing new legislation. Public research funders could demand that grantees report the results of publicly funded trials. Regulators could make continued market access conditional on companies agreeing to make CSRs publicly available. And in many cases, simply enforcing the rules already on the book could make a huge difference – and the costs of enforcement could easily be covered by imposing fines for noncompliance.

The medical research community has long called for greater transparency in medical research. The AllTrials campaign, which calls for all clinical trials to be registered and fully reported, has attracted the support of over 700 groups, including the American Medical Association and dozens of patient groups, and TranspariMED is currently building a broader coalition to push for greater transparency in the sector. It’s high time for the wider anticorruption community to join the fray.

Guest Post: The Long, Long Road from Talking Transparency to Curbing Corruption in Mauritania

GAB is delighted to welcome back Till Bruckner, an international development expert who recently spent six months living Mauritania, and contributes the following guest post based on his experience there:

What do fish and iron have in common? Answer: Mauritania, a largely desert country of less than four million people in north-western Africa, is immensely rich in both. At the same time, most Mauritanians are poor. And one of the biggest reasons is corruption and misgovernance.

Consider first fishing. Although Mauritania has some of the world’s richest fishing grounds, its marine wealth is carried away by foreign ships whose owners often bribe senior government figures to obtain fishing permits and take their catch straight to Europe or Asia. As a result, the country has failed to develop a significant fishing industry, or domestic fish processing industry, of its own, and a fishing industry that boasts an annual catch of half a million tons generates a mere 40,000 jobs inside Mauritania. Yet to the south, Senegal translates a catch of similar size into at least 130,000 jobs, while to the north, Morocco has turned its million-ton-a-year catch into a massive export industry whose turnover is projected to reach two billion dollars by the end of this decade.

Inland, deep in the Sahara, some mountains contain more metal than rock, consisting of up to 75% iron, one of the highest concentrations in the world. Mauritania nationalized its iron mines in 1974, creating the state-owned monopoly company SNIM. Its workers blast the slopes to rubble, and conveyor belts transport the rubble into waiting railway waggons. The longest train in the world then chugs its way across 700 kilometres of desert, loads its cargo onto giant foreign freighters—and neither the ore nor most of the money paid for it are ever seen again. The looting dynamics in Mauritania’s mining sector are illustrated by the stark contrast between Zouerate, the town in the Sahara where the iron is mined—which looks like a dystopian hellhole straight out of a Mad Max film—and the rich suburbs of the capital city of Nouakchott (which produces virtually nothing), where giant villas rise out of the sand, and oversized SUVs cruise the streets. And in Nouakchott itself, in the poor suburbs, families living five to a windowless room have to pay for their drinking water by the barrel.

The preferred prescription in a situation like this (from the usual suspects: development professionals, anticorruption activists, etc.) is a combination of transparency, accountability, and civil society monitoring. But Mauritania is actually doing well on those dimensions. Continue reading

Guest Post: Pro-Transparency Organizations Fail To Practice What They Preach

Till Bruckner, freelance journalist and Advocacy Manager for Transparify (an initiative that rates the financial transparency of think tanks and advocacy groups), contributes the following guest post in a private capacity:

“Transparency” is the watchword of the international anticorruption movement, a fact perhaps best illustrated by Transparency International’s choice of name. And partly due to the efforts of TI and many other groups, the world has changed for the better: transparency has become the new norm. Yet many of the anticorruption groups themselves need to wake up to this reality, and become more transparent themselves. Indeed, those of us in the anticorruption community would do a lot better if we started to walk our transparency talk.

This fact was driven home to me in a recent exchange I had with Professor Peter Eigen, the living legend who helped found Transparency International, about his newest venture, the Fisheries Transparency Initiative (FiTI). FiTI aims to curb corruption in international fisheries, and if it works as planned, it could have a positive impact on many issues, including overfishing, food security, and public revenue in developing countries. Somewhat unconventionally, FiTI is financed by the government of Mauritania, whose controversial president, Mohamed Ould Abdel Aziz, first announced the initiative. (see my recent article in Foreign Policy for more background.) I asked Professor Eigen about Mauritania’s financial support for the FiTI; he explained that Mauritania was only sponsoring the initial conceptual phase of FiTI, and he persuasively argued that its government would have no undue influence, let alone control, over outcomes. I then asked Professor Eigen how much Mauritania was paying his organization (the Humboldt-Viadrina Governance Platform) in connection with its work on the FiTI project, but he told me he didn’t want to disclose the figure. He explained:

“This is a normal consulting arrangement of our not-for-profit organization with the [Mauritanian] government. We do not feel it would be proper for us to disclose details of contracts. If media or taxpayers want to find out how [the] Government spends its budget, they can ask the Government. This is for FiTI an unimportant side issue.”

Professor Eigen added two more points. First, his organization would at some later point account for the money on its website. Second, he himself would be working “pro bono.”

Summary: There’s no influence peddling; the use of taxpayer funds is a domestic issue; all money will be accounted for; and nobody is lining their pockets. So, everything is okay, right?

No, it’s not okay at all. Here’s why: Continue reading