Editorial Note: This is not a RxISK Story – it’s about preventing RxISK Stories.
Those who read RxISK Stories are well aware of the economic might of the pharmaceutical industry (and the medical device industry) and their growing political clout with the government agencies that are supposed to regulate them. Their capture of the U.S. FDA, which operates within a largely private, for-profit healthcare sector, is perhaps the most infamous example. Yet Health Canada, the British MHRA and the European Union’s EMA have faced the same pressures, and have largely knuckled under too.
Many have thought for quite awhile that things could not get worse – but they just did.
On September 10, the newly-appointed head of the European Commission, Jean-Claude Juncker, announced he was taking the EMA (European Medicines Agency) and other health agencies out of the supervision of the Directorate of Health and Consumer Affairs – and putting them under the Directorate of Enterprise and Industry. The mission of that agency (known as DG-ENTR for short) is to work with European companies to promote their products, both within the EU and worldwide. DG-SANKO, the health directorate, is at least required to give patients, consumers and healthcare experts a token seat at the table – even though they increasingly feel their voices are trumped by those of industry.
At DG-ENTR, the voice of industry is the only one at the table. This transfer amounts to an open public declaration of what many have long suspected: Corporate profits now come before public health. Patients, doctors and the public at large had better just learn to live with that.
We urge our friends in the EU to protest this move, and contact their MEP’s (delegates to the European Parliament). They have the final vote on the appointments of Mr. Juncker and his colleagues, and can demand the rollback of this policy.
You might want to draw their attention to this letter from the editors of the British Medical Journal and the French medical journal Prescrire, titled “Mr. Juncker, medicines are not just a commodity.”
Already the health ministers of France, Belgium, Greece, Austria, Portugal, Romania, Bulgaria, Slovakia, Lithuania and Cyprus have declared their opposition. So has a coalition of twenty-eight patient, consumer and public-health watchdog groups across the European Union, whose statement is posted here. They include Health Action International, the European Public Health Association, the European Patients’ Forum, and others. (They offer some good resources for making your own protests.)
As the editors of BMJ and Prescrire pointed out, the EMA justified its recent backsliding on the issue of public access to clinical trial data (see here and here) by saying it “had to take into account the Commission’s position in ongoing negotiations on transatlantic trade.” This refers to the proposed Transatlantic Trade and Investment Partnership (TTIP) along with its cousins, the EU-India and USA-Pacific trade treaties. Healthcare corporations may have more to gain than any other sector from these highly secretive treaties, from enhanced patent protection to the power to reverse safety, equal-access and public health measures taken by individual states.
The British healthcare workers union Unison recently demanded that health care be taken off the table in these talks, warning that U.S. for-profit healthcare providers could sue to block any attempt to slow down or reverse the privatisation of the National Health Service. “Quality” minister Earl Howe, dismissing the union’s concerns, argued that British pharma needed these treaties to advance their competitive interests in the U.S. market.
If Unison and the journal editors are right, the TTIP could gut even the few EMA actions that have protected public health. In the past year EMA has refused to license two very dicey diet drugs approved for use in the U.S., despite heavy pressure from Pharma. Belviq (lorcaserin) and Qsymia (phentermine + topimirate), which combined only marginal weight-loss properties with significant risks. They are still studying a third problematic diet drug, Contrave (naloxone + bupropion), recently green-lighted by the FDA. As the BMJ-Prescrire letter points out, Europe already has too many high-priced drugs that “offer no tangible therapeutic advantages for patients,” and may even be inferior to older medicines.
If this transfer to DG-ENTR goes through – and the TTIP is concluded as planned – there may be no dubious pill in the world that we are not obliged to swallow. Lots more RxISK Stories – but ones that we and you could do without.