Lawsuit challenges anti-ageing claims Former executive sues manufacturer of pill meant to rejuvenate cells. Brendan Borrell 31 July 2012 The drug TA-65 is claimed to be able to remodel ageing immune systems by lengthening the telomere caps on chromosomes."You're going to be hearing from my attorney," Brian Egan told his boss on his last day of work, nearly a year ago. Last week, Egan filed a class-action lawsuit that accuses Telomerase Activation Sciences (TA Sciences) in New York of engaging in deceptive business practices in promoting a proprietary herbal extract intended to reverse the effects of ageing. The lawsuit threatens to put the science of telomeres — repetitive nucleotide sequences that protect the ends of chromosomes during DNA replication — on trial. But Noel Patton, president of TA Sciences, denies all of the allegations. "We stand by what we say," he adds. The connection between cellular ageing and telomere length is rooted in solid research. Telomeres become shorter every time a cell divides, and when they are lost cells can no longer reproduce. The enzyme telomerase can lengthen telomeres, possibly slowing or reversing degenerative diseases. In one study1, mice genetically engineered to lack functional telomerase showed brain degeneration and shrunken testes, but those effects were reversed when the enzyme was reactivated. Such findings have sparked a lot of hype and encouraged a cottage industry of companies that assess a person's 'biological age' on the basis of their telomere length. But TA Sciences has taken the buzz further: it sells a pill called TA-65, which it says can lengthen short telomeres. The pill brings in an annual revenue of US$6 million in the United States alone. "A compound that can lengthen telomeres would be excellent," says Carol Greider, a molecular biologist at Johns Hopkins University in Baltimore, Maryland, who shared a Nobel prize for her work on how telomerase protects chromosomes. But, she adds, "we would need to test it rigorously". The active ingredient of TA-65 was isolated from the herb Astragalus membranaceus and patented by Geron, a biopharmaceutical firm in Menlo Park, California. Research sponsored by TA Sciences and other companies has shown that the compound can lengthen telomeres in mice2 and humans3, but Greider and others are sceptical of the assay used. Calvin Harley, president of Telome Health in Menlo Park, spearheaded the studies as chief scientific officer at Geron. He stands by the conclusion that TA-65 is a "weak telomerase activator". However, TA Sciences sells the pill as a nutritional supplement, or 'nutraceutical', rather than a drug, so the firm's health claims have not been evaluated by the US Food and Drug Administration (FDA).
Difficult relationship In May 2011, Patton hired Egan to help to expand TA Sciences' reach in foreign markets. Egan was required to take TA-65 twice a day, he later wrote in a discrimination complaint, so "that I could tell customers that I was also taking the product, and that it was safe and effective". Patton denies that it was obligatory. On 14 September, Egan says, he told Patton that he had been diagnosed with prostate cancer. The next day, according to Egan, Patton fired him and said that his prostate cancer could ruin the company. Egan says that when he was fired, he was offered a cash settlement to keep quiet about his cancer, but turned it down."A compound that can lengthen telomeres would be excellent. But we would need to test it rigorously. "Patton denies Egan's version of events. According to an affidavit that Patton filed in the discrimination suit, Egan was fired for meagre sales. On being told of his dismissal, Patton alleges in the affidavit, Egan threw his keys at his boss and demanded to settle things "man to man". An employee broke up the confrontation, and Egan stormed out, says Patton. Egan denies Patton's version of events. On 19 September, Egan told a potential TA Sciences partner in Spain that he had developed cancer while taking TA-65. Patton and TA Sciences sued Egan for defamation in March, saying that he had lost the company $2 million in sales. Patton says that TA Sciences believes that if Egan had cancer, he had it before he started taking TA-65. Egan stands by his allegations, and has now launched a broader attack on the company's science with his class-action suit, which he filed on 23 July, in the New York State supreme court, along with another man who took TA-65. The suit challenges statements on TA Sciences' website, including the assertion that TA-65 can lengthen short telomeres. Greider doubts that TA-65 caused Egan's cancer, but agrees that the science behind it is murky. A telomere-lengthening compound would be a boon to patients dying of bone-marrow failure and pulmonary fibrosis, she says, and firms could be expected to explore its pharmaceutical potential. "I don't think a company would be selling it on the side as a nutraceutical," she says.
Nature 488, 18 (02 August 2012) doi:10.1038/488018a
首个抗衰老药被控商业欺诈 发布时间：2012-8-2 来源：药品资讯网信息中心 "你将会收到我的律师信，"近一年前Brian Egan在他工作日的最后一天告诉他的老板说。上周Egan提起了集体诉讼，指控制药商Telomerase Activation Sciences (TA Sciences)在宣传一种预期可以逆转衰老效应的专利药本草提取物时涉及了商业欺诈行为。对此，TASciences总裁NoelPatton否认了所有的指控，"我们坚持我们所说的，"他补充道。端粒是位于染色体末端的DNA脱氧核糖核酸重复序列，有了端粒的保护，染色体末端就不会被细胞修复机制误认为是DNA碎片而自动加以修复。2009年的诺贝尔生理学或医学奖就授予了3位美国科学家，以表彰他们"发现端粒和端粒酶是如何保护染色体的"。端粒会随着细胞的不断分裂而逐渐变短，当它短到不能再短时，细胞也就停止了分裂，并最终步向老化和死亡。端粒的长度靠端粒酶的活性来维持，但端粒酶通常只在人体干细胞、生殖细胞、免疫细胞和恶性癌细胞内激活，其他成人细胞中的端粒酶则处于"关闭"状态。生物学家一直试图通过阻断端粒变短的机制来控制人体衰老进程。过去科学家们在研究中证实遗传工程操作丧失功能性端粒酶的小鼠现实脑退化和睾丸缩小，但当端粒酶得到重新激活时这些效应可以被逆转。这样的研究结果引发了大量的炒作，并鼓励了一些山寨公司基于端粒的长度来评估个体的"生物学寿命"。2001年，生物科技巨头美国杰龙生物医药公司从中草药黄芪中分离出一种名为TA-65的分子，并声称其能够增强端粒酶的活性。随后杰龙生物医药公司将其产品授权给了纽约的制药商TASciences公司，后者将从黄芪中提取的TA-65分子提纯浓缩，开发成为一种营养补充剂，宣传称其能够延长缩短的端粒。这种药丸仅在美国就可以带来600万美元的年收入。"一种化合物能够延长端粒是极好的，但我们还需要严格地测试它，"诺贝尔奖获得者、约翰霍普金斯大学分子生物学家Carol Greider说。过去在TA Sciences和其他公司发起的研究中均证实TA-65可以延长小鼠和人类的端粒长度。但是Greider和其他人对于所采用的分析持怀疑态度。在杰龙作为首席科技官带头开展这些研究、现为Telome Health公司总裁的Calvin Harley坚持TA-65是一种"弱端粒激活剂"的结论。然而TA Sciences是以营养补充剂或称"保健品"形式而非作为药物来销售这些药丸，该公司的健康声明并没有经过美国食品和药品管理局(FDA)的评估。困难的关系2011年5月，Patton聘请了Egan来帮助扩展TASciences进入海外市场。Egan被要求每日服用两次TA-65，后来他在一份差别诉讼中写道；"我可以告诉顾客我也服用该产品，并且它是安全有效的。"Patton否认这是强制性的。去年9月14日，Egan说他告诉Patton他被确诊患上了前列腺癌。第二天，根据Egan所说，Patton解雇了他并说他的前列腺癌会毁掉公司。Egan说当被解雇之时，他被提供了一份现金结算让其对患癌之事守口如瓶，但是他拒绝了。Patton否认了Egan所说事件版本。根据Patton在差别诉讼中提交的口供，Egan是因为不良销售业绩而被解雇。Patton在口供中说当被告知解聘，Egan将他的钥匙扔向了老板，并称将以"一对一"的方式解决此事。一名雇员解开了对抗，Egan冲了出去。Egan同样否认了Patton关于事件的说辞。9月19日，Egan告诉TA Sciences在西班牙的一个潜在合作伙伴他在服用TA-65时患上了癌症。Patton和TA Sciences在今年三月起诉Egan诽谤，并称其导致公司销售上损失了200万美元。Patton说TA Sciences相信如果Egan罹患了癌症，也应该是在开始服用TA-65之前就有了。Egan坚持他的指控，并与另一位TA-65的服用者于7月23日向纽约州高等法院提交了集体诉讼对该公司进行了更广泛的攻击。诉讼反驳了TASciences网站上的一些声明，包括断言TA-65能够延长端粒。Greider怀疑TA-65c引起了Egan的癌症，但也同意背后的科学是模糊不清的。一种端粒延长化合物对于因骨髓衰竭和肺纤维化而濒死的患者而言是一种恩赐，她说公司预期会探索它的药用潜力。"我不相信一个公司会只将其作为保健品销售，"她说。
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