FDA approves first drug that prevents migraines. Is the price tag worth it?
The FDA has approved the first drug designed to prevent migraines, a move that could help the four million Americans who suffer from at least 15 migraine days per month.
The Food and Drug Administration has approved a drug designed to prevent migraines, marking a first for the pharmaceutical industry and the millions of Americans who suffer from the chronic, debilitating disorder.
The new drug, Aimovig, is a once-monthly self-injection, and biopharmaceutical company Amgen will sell it for $6,900 a year.
“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.”
Over the course of several studies, migraine sufferers who took Aimovig experienced an average of 1 to 2.5 fewer migraine days per month. It’s not quite a cure-all, but the drug will likely be welcomed by the 4 million Americans who have migraines at least 15 days a month.
Never experienced a migraine? Here’s a description of what one feels like:
“Put your finger on your temple and imagine drilling it inside your head,” said a 29-year-old woman named Heather to Prevention. “My migraines feel like a screwdriver in there, in that one spot, always on my left side and in my left eye. I get a burning sensation throughout my body and in my jaw. Everything becomes sensitive to the touch, like my muscles are on fire.”
Image: aka Tman via Flickr
Migraines are also often accompanied by nausea, vomiting, and hypersensitivity to light and sound, and they can be triggered by stress, hormonal changes, flashing lights, changes in sleep or diet. Women are three times as likely to experience chronic migraines, and the disorder affects about 10 percent of people worldwide.
In the 1980s, researchers observed that people who suffer from migraines produced too much of a protein fragment called CGRP. The new drug is an antibody that effectively blocks some of that CGRP but allows the rest to perform its normal functions in the body. Still, not much is known about what exactly CGRP does, as is evidenced by a rather vague description on the Amgen website:
“There may be a connection between CGRP, CGRP receptors, and migraine.”
In any case, the annual price tag of $6,900 might seem steep, but it comes as a surprise to some analysts who expected it to be $10,000 or more. It’s predicted that insurers will reimburse patients for much of the costs.
“The payers recognize that there is a clear and longstanding unmet need in migraine,” said Tony Hooper, executive vice president of global commercial operations at Amgen, who added that pharmacy-benefit managers and insurers are mostly “supportive of our price.”
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Best case: redrawing borders leads to peace, prosperity and EU membership. But there's also a worst case
- The Yugoslav Wars started in 1991, but never really ended
- Kosovo and Serbia are still enemies, and they're getting worse
- A proposed land swap could create peace - or reignite the conflict
The death of Old Yugoslavia
Image: public domain
United Yugoslavia on a CIA map from 1990.
Wars are harder to finish than to start. Take for instance the Yugoslav Wars, which raged through most of the 1990s.
The first shot was fired at 2.30 pm on June 27th, 1991, when an officer in the Yugoslav People's Army took aim at Slovenian separatists. When the YPA retreated on July 7th, Slovenia was the first of Yugoslavia's republics to have won its independence.
After the wars
Image: Ijanderson977, CC BY-SA 3.0 / Wikimedia Commons
Map of former Yugoslavia in 2008, when Kosovo declared its independence. The geopolitical situation remains the same today.
The Ten-Day War cost less than 100 casualties. The other wars – in Croatia, Bosnia and Kosovo (1) – lasted much longer and were a lot bloodier. By early 1999, when NATO had forced Serbia to concede defeat in Kosovo, close to 140,000 people had been killed and four million civilians displaced.
So when was the last shot fired? Perhaps it wasn't: it's debatable whether the Yugoslav Wars are actually over. That's because Kosovo is a special case. Although inhabited by an overwhelming ethnic-Albanian majority, Serbians are historically very attached to it. More importantly, from a legalistic point of view: Kosovo was never a separate republic within Yugoslavia but rather a (nominally) autonomous province within Serbia.
Kosovo divides the world
Image: public domain
In red: states that recognise the independence of Kosovo (most EU member states – with the notable exceptions of Spain, Greece, Romania and Slovakia; and the U.S., Japan, Turkey and Egypt, among many others). In blue: states that recognise Serbia's sovereignty over Kosovo (most notably Russia and China, but also other major countries such as India, Brazil, Mexico, South Africa and Iran).
The government of Serbia has made its peace and established diplomatic relations with all other former Yugoslav countries, but not with Kosovo. In Serbian eyes, Kosovo's declaration of independence in 2008 was a unilateral and therefore legally invalid change of state borders. Belgrade officially still considers Kosovo a 'renegade province', and it actually has a lot of international support for that position (2).
The irony is that on the longer term, both Kosovo and Serbia want the same thing: EU membership. Ironically, that wish could lead to Yugoslav reunification some years down the road – within the EU. Slovenia and Croatia have already joined, and all other ex-Yugoslav states would like to follow their example. Macedonia, Montenegro and Serbia have already submitted an official application. The EU considers Bosnia and Kosovo 'potential candidates'.
Kosovo is the main stumbling block on Serbia's road to EU membership. Even after the end of hostilities, skirmishes continued, between the ethnically Albanian majority and the ethnically Serbian minority within Kosovo, and vice versa in Serbian territories directly adjacent. Tensions are dormant at best. A renewed outbreak of armed conflict is not unthinkable.
Land for peace?
Mitrovica isn't the only area majority-Serb area in Kosovo, but the others are enclaved and fear being abandoned in a land swap.
In fact, relations between Kosovo and Serbia have deteriorated spectacularly in the past few months. At the end of November, Kosovo was refused membership of Interpol, mainly on the insistence of Serbia. In retaliation, Kosovo imposed a 100% tariff on all imports from Serbia. After which Serbia's prime minister Ana Brnabic refused to exclude her country's "option" to intervene militarily in Kosovo. Upon which Kosovo's government decided to start setting up its own army – despite its prohibition to do so as one of the conditions of its continued NATO-protected independence.
The protracted death of Yugoslavia will be over only when this conflict is finally resolved. The best way to do that, politicians on both sides have suggested, is for the borders reflect the ethnic makeup of the frontier between Kosovo and Serbia.
The biggest and most obvious pieces of the puzzle are the Serbian-majority district of Mitrovica in northern Kosovo, and the Albanian-majority Presevo Valley, in southwestern Serbia. That land swap was suggested previous summer by Hashim Thaci and Aleksandar Vucic, presidents of Kosovo and Serbia respectively. Best-case scenario: that would eliminate the main obstacle to mutual recognition, joint EU membership and future prosperity.
If others can do it...
Image: Ruland Kolen
Belgium and the Netherlands recently adjusted out their common border to conform to the straightened Meuse River.
Sceptics and not a few locals warn that there also is a worst-case scenario: the swap could rekindle animosities and restart the war. A deal along those lines would almost certainly exclude six Serbian-majority municipalities enclaved deep within Kosovo. While Serbian Mitrovica, which borders Serbia proper, is home to some 40,000 inhabitants, those enclaves represent a further 80,000 ethnic Serbs – who fear being totally abandoned in a land swap, and eventually forced out of their homes.
Western powers, which sponsored Kosovar independence, are divided over the plan. U.S. officials back the idea, as do some within the EU. But the Germans are against – they are concerned about the plan's potential to fire up regional tensions rather than eliminate them.
In principle, countries consider their borders inviolate and unchanging, but land swaps are not unheard of. Quite recently, Belgium and the Netherlands exchanged territories so their joint border would again match up with the straightened course of the Meuse river (3). But those bits of land were tiny, and uninhabited. And as the past has amply shown, borders carry a lot more weight in the Balkans.
The controversy around the Torah codes gets a new life.
- Mathematicians claim to see a predictive pattern in the ancient Torah texts.
- The code is revealed by a method found with special computer software.
- Some events described by reading the code took place after the code was written.
- Facebook and Google began as companies with supposedly noble purposes.
- Creating a more connected world and indexing the world's information: what could be better than that?
- But pressure to return value to shareholders came at the expense of their own users.
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