Daraprim (pyrimethamine) 大漲50倍的奧秘!!!

1顆「藥價」2萬5 希拉蕊籲降 2015-09-23 〔編譯李信漢／綜合報導〕美國圖靈藥廠（Turing Pharmaceuticals ）今年8月才取得弓蟲病用藥達拉匹林（Daraprim）的製藥權，本月就宣布將該藥售價從單顆13.5美元（約台幣442元），調漲到每顆750美元（約台幣2萬5000元），足足調漲逾50倍。此舉引起醫藥界強烈抗議，連民主黨總統參選人希拉蕊也宣示將採取行動，打擊調漲特定用藥的藥商。 飆漲50倍 醫界抗議 達拉匹林是於1940年代研發，用以治療弓蟲病（toxoplasmosis）感染的用藥。弓蟲病為一種寄生蟲疾病，現已不常見，然而，如果是經由母親垂直感染給嬰兒，或是因感染愛滋或其他癌症導致免疫系統受損的成人染患弓蟲病，就有可能喪命。 對於圖靈藥廠大幅調漲藥價，「美國傳染病學會」（Infectious Diseases Society of America，IDSA）等多個醫學團體9月初發表公開信，要求圖靈藥廠重新考慮。公開信中指陳，達拉匹林不合理的藥價會對真正有用藥需求的弱勢族群造成傷害，並讓醫療保險體系難以維持。 在龐大批評聲浪下，曾任避險基金經理人的圖靈藥廠執行長史克瑞里（Martin Shkreli）本週終於出面辯解，宣稱藥廠必須要讓達拉匹林能夠獲利，因為之前的公司幾乎都放棄了達拉匹林；他強調，調漲的藥價將用來研發新版本的達拉匹林，「我們是數十年來第一家真正專注在這種藥物的藥廠，而這種研究是十分花錢的。」他還說，如果你買不起達拉匹林，他們可以免費贈送。 根據英國廣播公司（BBC）報導，達拉匹林每顆製藥成本才1美元，但史克瑞里稱，這個成本未包含像是行銷和配送等成本。稍早史克瑞里還曾在社群網站「推特」（Twitter）上嘲笑那些質疑圖靈藥廠決策的人，指稱一名記者為「傻蛋」。 民主黨總統參選人希拉蕊在紐約時報報導該項藥價調整新聞後，即透過推特發文說，如此拉高特定藥物售價，「令人憤怒」。她之後在阿肯色州的競選場合上承諾，未來將以鼓勵研發、採用學名藥與利用政府購買力當作談判籌碼的方式，來打擊不合理暴漲的藥價。希拉蕊的談話讓21日華爾街生物科技公司的股價大幅下跌。Drug Company Reverses Course on Controversial Price HikeThe price of Daraprim had gone from $13.50 a tablet to $750 A pharmaceuticals company that raised the price of a drug 5,500% practically overnight says it will now lower its price following intense backlash. Turing Pharmaceuticals founder Martin Shkreli confirmed the price cut to NBC News on Tuesday but did not say how much the company would reduce the cost of Daraprim. Early this week, Turing's decision to raise the price of Daraprim from $13.50 a tablet to $750 was the subject of a New York Times story. The drug, which is generically known as pyrimethamine and was acquired by the company acquired in August, is used to treat a serious parasitic infection called toxoplasmosis, which can be life-threatening for those with compromised immune systems. It's also been used to treat malaria. Shkreli said the new price will allow the company to break even or make a "small profit" on the drug.

Drug Goes From $13.50 a Tablet to $750, Overnight  By ANDREW POLLACKSEPT. 20, 2015 Specialists in infectious disease are protesting a gigantic overnight increase in the price of a 62-year-old drug that is the standard of care for treating a life-threatening parasitic infection. The drug, called Daraprim, was acquired in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager. Turing immediately raised the price to $750 a tablet from $13.50, bringing the annual cost of treatment for some patients to hundreds of thousands of dollars."What is it that they are doing differently that has led to this dramatic increase?" said Dr. Judith Aberg, the chief of the division of infectious diseases at the Icahn School of Medicine at Mount Sinai. She said the price increase could force hospitals to use "alternative therapies that may not have the same efficacy." Turing's price increase is not an isolated example. While most of the attention on pharmaceutical prices has been on new drugs for diseases like cancer, hepatitis C and high cholesterol, there is also growing concern about huge price increases on older drugs, some of them generic, that have long been mainstays of treatment. Martin Shkreli is the founder and chief executive of Turing Pharmaceuticals, which raised the price of the drug Daraprim to $750 a tablet from $13.50.  Although some price increases have been caused by shortages, others have resulted from a business strategy of buying old neglected drugs and turning them into high-priced "specialty drugs."Cycloserine, a drug used to treat dangerous multidrug-resistant tuberculosis, was just increased in price to $10,800 for 30 pills from $500 after its acquisition by Rodelis Therapeutics. Scott Spencer, general manager of Rodelis, said the company needed to invest to make sure the supply of the drug remained reliable. He said the company provided the drug free to certain needy patients. In August, two members of Congress investigating generic drug price increases wrote to Valeant Pharmaceuticals after that company acquired two heart drugs, Isuprel and Nitropress, from Marathon Pharmaceuticals and promptly raised their prices by 525 percent and 212 percent respectively. Marathon had acquired the drugs from another company in 2013 and had quintupled their prices, according to the lawmakers, Senator Bernie Sanders, the Vermont independent who is seeking the Democratic nomination for president, and Representative Elijah E. Cummings, Democrat of Maryland.Doxycycline, an antibiotic, went from $20 a bottle in October 2013 to $1,849 by April 2014, according to the two lawmakers.The Infectious Diseases Society of America and the HIV Medicine Association sent a joint letter to Turing earlier this month calling the price increase for Daraprim "unjustifiable for the medically vulnerable patient population" and "unsustainable for the health care system." An organization representing the directors of state AIDS programs has also been looking into the price increase, according to doctors and patient advocates.Daraprim, known generically as pyrimethamine, is used mainly to treat toxoplasmosis, a parasite infection that can cause serious or even life-threatening problems for babies born to women who become infected during pregnancy, and also for people with compromised immune systems, like AIDS patients and certain cancer patients. Martin Shkreli, the founder and chief executive of Turing, said that the drug is so rarely used that the impact on the health system would be minuscule and that Turing would use the money it earns to develop better treatments for toxoplasmosis, with fewer side effects."This isn't the greedy drug company trying to gouge patients, it is us trying to stay in business," Mr. Shkreli said. He said that many patients use the drug for far less than a year and that the price was now more in line with those of other drugs for rare diseases."This is still one of the smallest pharmaceutical products in the world," he said. "It really doesn't make sense to get any criticism for this."This is not the first time the 32-year-old Mr. Shkreli, who has a reputation for both brilliance and brashness, has been the center of controversy. He started MSMB Capital, a hedge fund company, in his 20s and drew attention for urging the Food and Drug Administration not to approve certain drugs made by companies whose stock he was shorting.In 2011, Mr. Shkreli started Retrophin, which also acquired old neglected drugs and sharply raised their prices. Retrophin's board fired Mr. Shkreli a year ago. Last month, it filed a complaint in Federal District Court in Manhattan, accusing him of using Retrophin as a personal piggy bank to pay back angry investors in his hedge fund.Mr. Shkreli has denied the accusations. He has filed for arbitration against his old company, which he says owes him at least $25 million in severance. "They are sort of concocting this wild and crazy and unlikely story to swindle me out of the money," he said. Martin Shkreli, the chief executive of Turing Pharmaceuticals, explains the increase in drug prices in a CNBC interview. By CNBC on Publish Date September 21, 2015. Photo by CNBC. Daraprim, which is also used to treat malaria, was approved by the F.D.A. in 1953 and has long been made by GlaxoSmithKline. Glaxo sold United States marketing rights to CorePharma in 2010. Last year, Impax Laboratories agreed to buy Core and affiliated companies for $700 million. In August, Impax sold Daraprim to Turing for $55 million, a deal announced the same day Turing said it had raised $90 million from Mr. Shkreli and other investors in its first round of financing. Daraprim cost only about $1 a tablet several years ago, but the drug's price rose sharply after CorePharma acquired it. According to IMS Health, which tracks prescriptions, sales of the drug jumped to $6.3 million in 2011 from $667,000 in 2010, even as prescriptions held steady at about 12,700. In 2014, after further price increases, sales were $9.9 million, as the number of prescriptions shrank to 8,821. The figures do not include inpatient use in hospitals. Turing's price increase could bring sales to tens or even hundreds of millions of dollars a year if use remains constant. Medicaid and certain hospitals will be able to get the drug inexpensively under federal rules for discounts and rebates. But private insurers, Medicare and hospitalized patients would have to pay an amount closer to the list price. Some doctors questioned Turing's claim that there was a need for better drugs, saying the side effects, while potentially serious, could be managed. "I certainly don't think this is one of those diseases where we have been clamoring for better therapies," said Dr. Wendy Armstrong, professor of infectious diseases at Emory University in Atlanta. With the price now high, other companies could conceivably make generic copies, since patents have long expired. One factor that could discourage that option is that Daraprim's distribution is now tightly controlled, making it harder for generic companies to get the samples they need for the required testing. The switch from drugstores to controlled distribution was made in June by Impax, not by Turing. Still, controlled distribution was a strategy Mr. Shkreli talked about at his previous company as a way to thwart generics. Some hospitals say they now have trouble getting the drug. "We've not had access to the drug for a few months," said Dr. Armstrong, who also works at Grady Memorial Hospital, a huge public treatment center in Atlanta that serves many low-income patients.But Dr. Rima McLeod, medical director of the toxoplasmosis center at the University of Chicago, said that Turing had been good about delivering drugs quickly to patients, sometimes without charge."They have jumped every time I've called," she said. The situation, she added, "seems workable" despite the price increase.Daraprim is the standard first treatment for toxoplasmosis, in combination with an antibiotic called sulfadiazine. There are alternative treatments, but there is less data supporting their efficacy.Dr. Aberg of Mount Sinai said some hospitals will now find Daraprim too expensive to keep in stock, possibly resulting in treatment delays. She said that Mount Sinai was continuing to use the drug, but each use now required a special review."This seems to be all profit-driven for somebody," Dr. Aberg said, "and I just think it's a very dangerous process."