藥價過高讓美國處於破產的邊緣

America is the land of breakthrough science -- and health care scams. The two seem to go hand in hand in the case of the new hepatitis C virus (HCV) cure named sofosbuvir, sold under the brand name Sovaldi by the drug company Gilead Sciences. There is no question that Solvadi is a godsend -- a lifesaver for millions of Americans, and perhaps someday for hundreds of millions of people around the world infected by Hepatitis C. Yet Sovaldi is also the poster child of a U.S. health care system that is being bankrupted by greed, lobbying and indefensible policies on drug pricing.

美國不僅僅擁有突破性技術發展，還有各種醫療保健騙局。在一款叫做Sofobuvir治療丙肝病毒的藥品中，我們看到了這兩種事物似乎結合到了一起，Sofobuvir由藥品公司Gilead冠以品牌名Sovaldi進行銷售。毫無疑問，這款藥是天賜之物，是數以百萬計美國人的救命之物，或許某一天也會是全世界丙肝患者的救命之物。但是Sovaldi如今卻成了美國醫療保險體系中的典型案例，美國的醫療保險體系正在被貪婪、遊睡和本身卻站不腳的藥價政策所腐蝕。

The basic facts are these. In December 2013, the Food and Drug Administration approved Sovaldi, and another formulation, Harvoni, which is sofosbuvir used in combination with another drug. Gilead set the price for a 12-week treatment course of Sovaldi at $84,000, amounting to $1,000 per pill. Gilead set the price of Harvoni at $94,000.

基本事實是這樣的，早在2013年，美國食品藥品管理局批准通行了Sovaldi以及Harvoni，Harvoni其實是使用Sofobuvir和其他一些藥物結合使用。Gilead將Sovaldi的12周藥程定價爲84000美元，大概相當於1000美元一片藥，而Harvoni的價格則爲94000美元。

According to researchers at Liverpool University, the actual production costs of Sovaldi for the 12-week course is in the range $68-$136. Indeed, generic sofosbuvir is currently being marketed in India at $300 per treatment course, after India refused to grant Gilead a patent for the Indian market. In other words, the U.S. price-cost markup is roughly 1,000-to-1!

根據利物浦大學的研究，Sovaldi的12周實際藥程成本不過68到136美元。在印度拒絕給予Gilead專利權之後，印度市場上銷售Sofobuvir的仿製品每療程只有300美元。也就是說美國市場上利潤和成本比幾乎高達1000比1.

How can Gilead Science charge $84,000 for a drug that costs less than $300 to produce? First, Gilead's patent on sofosbuvir runs until 2028, giving it a monopoly in the U.S. market. Second, a range of Federal and state government programs will cover the $84,000 for a sizeable number of patients. For those not covered by government programs, some will be covered by private insurance, a few will pay out of pocket, and still others will likely die because they lack coverage and can't afford the treatment.

Gilead把不到300美元的藥定價爲84000美元，爲何如此膽大妄爲。第一，Gilead的在美國的特許經營權要到2028到期，第二，相當一部分病人所支付的84000美元費用會由聯邦政府和州政府的醫保項目支付，即使沒有政府的醫保項目，也有一部分人有私人保險，其餘少部分人會傾家蕩產，肯定還會有人既沒有保險也沒錢，會面臨死亡。

In the first year of marketing, Sovaldi and Harvoni are already blockbusters, reaping a remarkable $12.4 billion of market sales in 2014, more in just one year than the $11.2 billion price that Gilead paid in January 2012 to buy sofosbuvir from a biotech start-up named Pharmasett.

在進入市場的第一年Sovaldi和Harvoni就已經名聲大噪，在2014年狂掠124億美元銷售額，而2012年1月Gilead從一家叫做Pharmasett的創業生物科技公司買到Sofobuvir的價格也不過112億美元。

The standard defense by the drug companies of these astronomical prices is that drug discovery is costly and their high profits reimburse the R&D costs. Here is where the story of Sovaldi gets even more interesting. The total private-sector outlays on R&D were perhaps $300 million, and almost surely under $500 million, meaning that the decade-long R&D outlays were likely recouped in a few weeks of drug sales.

藥品公司對於要價過高通用的說法都是藥品研發高，賺錢利潤是爲了償還研發費用。這就是Sovaldi最讓人注意的地方，私人部分對於Sovaldi的研發支出可能只有3億美元，至多不超過5億美元，就是說長達10年的研發費用，其實在藥品出售幾個星期後，就已經收回了成本。

Here is the background. Sofosbuvir was developed under the leadership of Prof. Raymond Schinazi, a brilliant professor of biochemistry at Emory University. The U.S. Government heavily funded Prof. Schinazi's research, with major grants from the National Institutes of Health (NIH) and support from the Veterans Administration. Like many academic researchers, Schinazi has frequently parlayed his government grants into private companies to market his discoveries. He set up Pharmasset Inc. as a Delaware corporation in 2004 as his business to develop sofosbuvir and hold the patents on the new prospective drug.

Sofobuvir由埃默裏大學生化教授Raymond Schinazi領導開發，美國政府投入重金資助Schinazi的研究，還有美國國立衛生研究院和和退伍軍人管理局的幫助。但是和很多研究者一樣，Raymond Schinazi拋棄了美國政府而是轉向私人企業以便於將其研究成果市場化，他在2004年特拉華建立了Pharmasett公司，專門研發Sofobuvir，並且取得了這一大有前景的藥品的專利權。

Pharmasset raised around $45 million in a 2007 IPO and used those funds and others to supplement the R&D. According to the company's SEC filings, the total Pharmasset R&D on sofosbuvir up through 2011 totaled around $62.4 million. In January 2012, with an eye on sofosbuvir, Gilead paid $11.2 billion to purchase Pharmasett. Schinazi pocketed an estimated $440 million for his shares in Pharmasett.

Pharmasett在2007年首次公開募股4500萬美元，用這筆錢進行研發，根據的公司的季度財報，Pharmasett在2011年研發Sofobuvir的投入總共約6200萬美元，在2012年1月，虎視眈眈的Gilead出資112億美元收購了Pharmasett，Schinazi在Pharmasett的股票約價值4.4億美元。

By the fall of 2011, sofosbuvir was ready for Phase 2 clinical trials, which were carried out between October 2011 and April 2012 by the NIH, which published the results in the Journal of the American Medical Association in 2013. Phase 3 trials were then carried out in mid-2013 and were paid by Gilead, at a cost of perhaps $50-$100 million for a two-month trial that covered around one thousand patients. (Gilead has not disclosed the exact costs of the Phase 3 trials).

在2011年秋天，Sofobuvir準備進入第二階段的臨牀試驗，2011年10月到12年4月由美國國立衛生研究院執行，試驗結果發佈在2013年美國醫學會的期刊上，第三階段的臨牀試驗在2013年中期進行，由Gilead出資，2個月的試驗有大約1000名病人，花費大約在5千萬美元到1億美元。（Gilead沒有公佈第三階段試驗的支出）。

We can therefore estimate that private investors spent perhaps $300 million in R&D outlays for sofosbuvir over the course of a decade, and perhaps well below that sum. Those R&D outlays were likely recouped in a few weeks of sales in 2014.

我們可以估算私人投資者在Sofobuvir過去十年的研發花費了3億美元，甚至可能會更低，這些研發在2014年藥品開始銷售後幾個星期就已經收回。

With a rational drug pricing system, Gilead might have paid $1 billion rather than $11.2 billion for the drug, and Prof. Schinazi might have pocketed $40 million rather than $440 million. Sovaldi would most likely still have been developed and brought to market on the same timeline, but with taxpayers spared of perhaps $10 billion a year in outlays.

在藥品價格合理的體系中，Gilead本應該是花費10億美元而不是112億美元得到Sofobuvir，而Schinazi教授應該得到4千萬美元而不是4.4億美元，納稅者也會每年省下100億美元，Sovaldi也不會因爲這些變動而不被開發或者推遲上市。

Gilead has worked the political system to protect its windfall by ramping up its lobbying activities. That soared to $2.2 million in 2013, the year of FDA approval, and $2.9 million in 2014, the first year of sales. The lobbying helped to smooth the way to the massive uptake of the drug and the substantial financing by the U.S. Government of Gilead's inflated prices.

Gilead爲了保護這筆飛來之財，在政治體系上用心不小，增加其遊說行動，2013年，也就是食品藥品管理局批准通過的那一年，花費了220萬美元。在2014年，上市的第一年，花費了290萬美元，遊說行爲讓大藥劑量的服藥不在受阻撓，讓美國政府持續財政支持Gilead的天價藥。

Sovaldi therefore represents the best and the worst of the U.S. health system. It represents the best of U.S. produced science, and the government's support for it. Sofosbuvir is a remarkable, life-saving medicine at the cutting edge of science.

Sovaldi成了美國醫療體系最好的和最壞的代表縮影，美國不有最好的科學，並且有政府的強力支持，Sofobuvir是尖端領域中非凡的救人良藥。

Yet Sovaldi also shows how publicly financed science easily turns into arbitrarily large private profits paid for by taxpayers. The challenge facing the U.S. is to adopt a rational drug pricing system that continues to spur excellent scientific breakthroughs while keeping greed in check. Big Pharma and the U.S. public are on a collision course when they should be partners for the advancement of health.

Sovaldi上面，同樣可以看到資助科學發展如何轉變爲醫藥公司專橫的從納稅人身上掠奪財富，美國如今面臨的挑戰是要採取什麼樣的藥品價格體系，不僅能刺激科學創新發展還能讓監管其中的貪婪。大醫藥公司和美國公衆本應該爲醫療進步成爲合作者，但是他們卻站在了獨木橋的兩端。