Wednesday, November 03, 2010

book review of 'good calories bad calories' by gary taubes

Confirmed what I always suspected through observationby Anonymous
Reader Rating: See Detailed Ratings
07/22/2008: Though I'm not a nutritionist, this book makes a lot of sense in terms of what I have observed throughout my life. At age 47, I have been thin my entire life and with good cholesterol numbers, despite the fact that I rarely pay attention to the amount of cholesterol or saturated fat that I consume (especially eggs which I love and consume--yolks and all--with almost total abandon). I'm sure that this book will infuriate a lot of people who will be unable to counter its claims factually, but who will have to resort to reiterating--but not supporting--the current quasi-religious nutritional high carb/low fat dogma. The premise of this book also supports the politically incorrect notion that eating red meat is O.K. nutritionally and perhaps even downright healthy. The Diet for A Small Planet folks sure won't like that idea being accepted. One aspect that I wish Mr. Taub had covered or at least mentioned is the effectiveness of the low-carbohydrate Ketogenic diet in treating epilepsy. The super high fat/extremely low carbohydrate Ketogenic diet was created and implemented at Johns Hopkins University during the 1920's to treat epilepsy. This diet has successfully treated many epileptics for over eighty years. It is less in favor today not because it is less effective than most anti-epileptic drugs, but because it is less convenient. I have always wondered how a high fat/low carb diet which is supposedly so 'unhealthy' for the heart can be so beneficial to at least some particular brains. This book touches on why this may be so, but it would be nice to have more details.
A reviewerby Anonymous
Reader Rating: See Detailed Ratings
05/24/2008: If what he implies is true, many people will respond with hostility to what he says, however, I would point out that this author really seems to have done his homework. The 11 Critical Conclusions of Good Calories, Bad Calories: 1. Dietary fat, whether saturated or not, does not cause heart disease. 2. Carbohydrates do, because of their effect on the hormone insulin. The more easily-digestible and refined the carbohydrates and the more fructose they contain, the greater the effect on our health, weight, and well-being. 3. Sugars--sucrose (table sugar) and high fructose corn syrup specifically--are particularly harmful. The glucose in these sugars raises insulin levels the fructose they contain overloads the liver. 4. Refined carbohydrates, starches, and sugars are also the most likely dietary causes of cancer, Alzheimer's Disease, and the other common chronic diseases of modern times. 5. Obesity is a disorder of excess fat accumulation, not overeating and not sedentary behavior. 6. Consuming excess calories does not cause us to grow fatter any more than it causes a child to grow taller. 7. Exercise does not make us lose excess fat it makes us hungry. 8. We get fat because of an imbalance--a disequilibrium--in the hormonal regulation of fat tissue and fat metabolism. More fat is stored in the fat tissue than is mobilized and used for fuel. We become leaner when the hormonal regulation of the fat tissue reverses this imbalance. 9. Insulin is the primary regulator of fat storage. When insulin levels are elevated, we stockpile calories as fat. When insulin levels fall, we release fat from our fat tissue and burn it for fuel. 10. By stimulating insulin secretion, carbohydrates make us fat and ultimately cause obesity. By driving fat accumulation, carbohydrates also increase hunger and decrease the amount of energy we expend in metabolism and physical activity. 11. The fewer carbohydrates we eat, the leaner we will be. This book is backed with solid research by a respected scientist-reporter on concrete, tangible things we can do to improve our health. The background and politics of how the publicly 'acceptable' diet to lower heart disease came to be is both fascinating and a great read for anyone...especially if you question governmental political spins. I recommend this book to everyone who wants some solid information on how to take control of their own health.

Wednesday, February 24, 2010

郎世宁

康熙末年,意大利传教士郎世宁来到中国,以其绘画技能任职于宫廷,担任待诏画师。喜爱西洋技艺的康熙皇帝对西洋画的写实技能深为赞许。他要求郎世宁学习中国画的意蕴,以便更好地为宫廷服务。


  在学习中国画的同时,郎世宁还奉旨在宫内为中国画师开设了西洋写真课。为保证讲课的效果,他坚持要画人体模特。此事惊世骇俗,大度的康熙批示"不许画男,亦不许画女"。让他带学生在秘室画了裸体的太监。

  来华之前,郎世宁曾在葡萄牙王室专为王后和公主画像。而在清宫他却不能为女性作画。他对此迷惑不解。康熙的幼女、年轻美丽的七格格偶尔从他面前走过, 七格格活泼的身影吸引了郎世宁的注目,他偷偷地给七格格画起了速写。七格格发现了他的举动,很想看他是如何画自己的。有一天康熙终于下诏让郎世宁给七格格 画像,原来康熙要将七格格远嫁西疆去和亲。七格格泪眼相视,郎世宁无法下笔……

  而宫里一场激烈且微妙的夺嫡斗争就在郎世宁身边展开。他在奉诏为皇室画像时,往往深陷于这场斗争之中而自己却浑然不觉。

  十四阿哥出征西疆,康熙授予他金甲以状声色。而十四阿哥迫不及待地穿上它,偷偷让郎世宁画像,俨然要君临天下。

  康熙去热河狩猎,他带着最喜爱的孙子弘历(后为乾隆)一起射杀了一只大熊。而四阿哥(后为雍正)刺死了一只老虎。康熙让郎世宁将两件事画在一幅图上。实际上,这是一幅隔代传位图。康熙不仅是想传位给四阿哥,也希望四阿哥将来传位给弘历。

  该画不该画的,郎世宁都画了。他的画像所传达的康熙或其皇子的意图,以及皇子们的荣辱兴衰,比画像本身更令朝野关注。

  雍正即位,郎世宁因给十四阿哥画穿金甲的"僭越"像,身陷囹圄。雍正并以此画为谋反证据,制服了与他作对的八阿哥和十四阿哥。然后,雍正又因郎世宁画"传位图"有功,赦免了他,并封他为宫廷供奉画师。

  此时郎世宁才幡然猛醒,原来他的绘画应更切合宫廷政治的需要,而不仅仅是体现一种艺术的追求。雍正即位引起非议,他曲意迎合雍正所好,主动进献他融贯中西的新作如"聚瑞图"等,表明雍正登基天降祥瑞,以搏雍正的欢心。

  但在内心深处,郎世宁却倍感压抑。与康熙的宽容与大度相比,雍正显得严厉而苛刻。郎世宁因替同事收藏八大山人讥讽满清的画作而惹祸上身,他装糊涂逃过了处罚。但他对中国画的写意从此有了恐惧。中国画的意境是他无法把握的,他不能看着好就学。

  雍正的三个儿子,弘时、弘历和弘昼又再延续上一代夺嫡的悲剧。弘历是既定的太子,老大弘时不服,竟派人暗杀弘历。事情败露后,雍正赐死了弘时。而雍正也从此一蹶不振。

  弘昼为避开残酷的宫廷斗争,整天装疯卖傻。他装乞丐、装女人、甚至装死人升天,并让郎世宁给他画这些污七八糟的像,说是可以避邪。他实际上是要表明,他不想跟弘历争权。心灰意冷的雍正听任弘昼瞎胡闹。毕竟,他只有两个儿子了,他不想再让他们争斗。

  铁血君主雍正后来被八阿哥收养的吕四娘刺杀,弘历即位,是为乾隆。

  乾隆当政,盛世来临。这位年轻的皇帝比他的祖父和父亲似乎有更多的闲情逸致,他也更喜爱郎世宁的绘画。风流倜傥的乾隆常与郎世宁一道吟诗作画,甚至还让郎世宁进入后宫,为他的爱妃们一一画像。他赏赐给郎世宁三品高官的地位,郎世宁成了御前画师。

  在为乾隆效力的时候,有一点让郎世宁特别困惑。即乾隆一方面对西方大国表示鄙夷,一方面又对西方文明兴趣盎然。乾隆对英吉利、俄罗斯等西方大国的扩张 野心十分警惕,并坚决与之斗争,最终导致闭关锁国。但西方好的东西他都想拥有:音乐、绘画、机械甚至建筑工程。他让郎世宁设计建造了圆明园西洋园,供他享 乐。

  乾隆派兵平定了西疆部族叛乱。军队班师,带回了该部落首领之女。乾隆见其美貌,将她收至后宫,封为香妃。他深深地爱上了这位宁死不屈的女性。但香妃对乾隆始终不理不睬,还在衣内藏刀,随时要与乾隆同归于尽。

  乾隆让郎世宁与香妃接近,弄清了香妃的思乡情结。又让郎世宁在圆明园中设计建造了有伊斯兰风味的方外观,供香妃居住。香妃终于被乾隆一片真心所感动,丢掉了她防身的刀。但关键时刻,皇后搬出太后懿旨,以香妃带刀为由,赐死了香妃。

  乾隆悲痛欲绝,郎世宁也伤感不已。君臣泪眼相视,一个美丽的梦破灭了……

  郎世宁在来华效力的几十年里,目睹了中华帝国盛极而衰的历史进程。

  在这几十年里,他逐渐模糊了对上帝的信仰。他收养了一对子女,有了家庭的幸福与烦恼。

  他逐渐失去了对艺术的追求。作为宫廷画师他地位高高在上却毫无创作自由。

  如同此时的中国逐渐迷失了前进的方向,郎世宁在这一进程中逐渐迷失了自我……

中国十大传世名画欣赏

中国十大传世名画欣赏

2009-9-6 15:36:29 来源: 字体:【 】 点击数:160 我要投稿

一、东晋——顾恺之《洛神赋图》
这 幅画根据曹植著名的《洛神赋》而作,为顾恺之传世精品。这卷宋摹本在一定程度上保留了顾恺之艺术的若干特点,千载之下,亦可遥窥其笔墨神情。全卷分为三个 部分,曲折细致而又层次分明地描绘着曹植与洛神真挚纯洁的爱情故事。人物安排疏密得宜,在不同的时空中自然地交替、重叠、交换,而在山川景物描绘上,无不 展现一种空间美。














二、唐——阎立本《步辇图》
《步辇图》是以贞观十五年(641年)吐蕃首领松赞干布与文成公主联姻的历史事件为题材,描绘唐太宗接见来迎娶文成公主的吐蕃使臣禄东赞的情景。




三、唐——张萱 周昉《唐宫仕女图》
《唐 宫仕女图》,唐代作为封建社会最为辉煌的时代,也是仕女画的繁荣兴盛阶段。中国古代仕女众生像,“倾国倾城貌,多愁多病身”,唐代仕女画以其端庄华丽,雍 容典雅著称,《唐宫仕女图》展示着“回眸一笑百媚生”的唐代美女众生像。 其中最杰出的代表莫过于张萱的《虢国夫人游春图》、《捣练图》和周昉的《簪花仕女图》、《挥扇仕女图》以及晚唐的《宫乐图》。它们所表现的贵族妇女生活情 调,成为唐代仕女画的主要艺术特征。





四、唐——韩滉《五牛图》
这 幅《五牛图》,是韩最为传神的一幅。5头健硕的老黄牛,在这位当朝宰相笔下被“人格化”了,传达出注重实际、任劳任怨的精神信息。它问世后,收藏者包括赵 构、赵伯昂、赵孟兆页、乾隆等著名人物。在明代,它几易其主。清兵入关后一度下落不明,直到乾隆年间,才从民间收集到宫中珍藏。1900年,八国联军洗劫 紫禁城,《五牛图》被劫出国外,从此杳无音讯。上个世纪50年代,它被一位寓居香港的爱国人士发现。





五、五代——顾闳中《韩熙载夜宴图》
《韩 熙载夜宴图》全长三米,共分五段,每一段画面以屏风相隔。第一段描绘韩熙载在宴会进行中与宾客们听歌女弹琵琶的情景,生动地表现了韩熙载和他的宾客们全神 贯注侧耳倾听的神态。第二段描绘韩熙载亲自为舞女击鼓,所有的宾客都以赞赏的神色注视着韩熙载击鼓的动作,似乎都陶醉在美妙的鼓声中。第三段描绘宴会进行 中间的休息场面,韩熙载坐在床边,一面洗手,一面和几个女子谈话。第四段是描绘韩熙载坐听管乐的场面。韩熙载盘膝坐在椅子上,好像在跟一个女子说话,另有 五个女子做吹奏的准备,她们虽然坐在一排,但各有各的动作,毫不呆板。第五段是描绘韩熙载的众宾客与歌女们谈话的情景。





六、北宋——王希孟《千里江山图》
《千 里江山图》,北京故宫博物院馆藏珍品。绢本,设色,纵51.5厘米,横1191.5厘米, 为中国北宋青绿山水画作品。作者王希孟。王希孟18岁为北宋画院学生,後召入禁中文书库,曾得到宋徽宗赵佶的亲自传授,半年後即创作了《千里江山图》。惜 年寿不永,20馀岁即去世,是一位天才而又不幸早亡的优秀青年画家。




七、北宋——张择端《清明上河图》
《清明上河图》画卷,北宋风俗画作品。传世名作、一级国宝。《清明上河图》是中国绘画史上最著名的作品之一,不但艺术水平高超,而且围绕着它还流传下来许 多有趣的故事。 这幅画描绘的是汴京清明时节的繁荣景象,是汴京当年繁荣的见证,也是北宋城市经济情况的写照。通过这幅画,我们了解了北宋的城市面貌和当时各阶层人民的生 活。《清明上河图》具有极高的史料价值。



















八、元——黄公望《富春山居图》
元 至正七年(公元1348年),黄公望开始创作这卷山水画名作,历时多年方始告竣。它以长卷的形式,描绘了富春江两岸初秋的秀丽景色,峰峦叠翠,松石挺秀, 云山烟树,沙汀村舍,布局疏密有致,变幻无穷,以清润的笔墨、简远的意境,把浩渺连绵的江南山水表现得淋漓尽致,达到了“山川浑厚,草木华滋”的境界。



九、明——仇英《汉宫春晓图》
《汉宫春晓图》是仇英重彩仕女画的杰出代表。此图勾勒秀劲而设色妍雅,画家借皇家园林殿宇之盛,以极其华丽的笔墨表现出宫中嫔妃的日常生活,极勾描渲敷之能事。不仅是仇英平生得意之作,在中国重彩仕女画中也独树一帜,独领风骚。



十、清——郎世宁《百骏图》
《百骏图》,该稿本为纸质,纵102厘米、横813厘米。目前保留在美国纽约大都会博物馆。意大利人郎世宁1715年他以传教士的身份远涉重洋来到中国, 就被重视西洋技艺的康熙皇帝召入宫中,从此开始了长达五十多年的宫廷画家生涯。在绘画创作中,郎世宁融中西技法于一体,形成精细逼真的效果,创造出了新的 画风,因而深受康熙、雍正、乾隆器重。《百骏图》是他的代表作之一。









《中 国十大传世名画》是中国美术史上十座不朽的丰碑,是华夏文明史上十部伟大的巨著。她们承载着这个古老的东方民族独特的艺术气质;她们用色彩记录了中华绵延 五千年的悠久历史和横亘万里的锦绣河山;她们流传的历史就是中华民族荣辱兴衰的历史;《中国十大传世名画》是一部流动的历史、无声的乐章,是华夏文明的永 久标鉴。

《中国十大传世名画》皆为历代不二至宝,高头巨帙,历经磨难流传有序。至清乾嘉时 期,陆续收入内府,遂与世隔绝。随后历经战火纷繁,流散四海,如今皆为各大博物馆镇馆之宝被束之高阁。《中国十大传世名画》都具有引首、题跋、历代名家题 记、收藏玺印等浓厚文化痕迹,向世人展示中国艺术瑰宝的真正魅力。

Tuesday, February 23, 2010

actos

Pioglitazone

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1 : 1 mixture (racemate)
Systematic (IUPAC) name
(RS)-5-(4-[2-(5-ethylpyridin-2-yl)ethoxy]benzyl)thiazolidine-2,4-dione
Identifiers
CAS number 111025-46-8
ATC code A10BG03
PubChem 4829
DrugBank APRD00653
Chemical data
Formula C19H20N2O3S
Mol. mass 356.44 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Protein binding >99%
Metabolism liver (CYP2C8)
Half life 3–7 hours
Excretion in bile
Therapeutic considerations
Licence data

EU EMEA:link, US FDA:link

Pregnancy cat. C
Legal status POM (UK) -only (US)
Routes oral
Yes check.svgY(what is this?) (verify)

Pioglitazone is a prescription drug of the class thiazolidinedione (TZD) with hypoglycemic (antihyperglycemic, antidiabetic) action. Pioglitazone is marketed as trademarks Actos in the USA and UK, Glustin in Europe, Zactos in Mexico by Takeda Pharmaceuticals. Actos was the tenth-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion.[1]

Contents

[hide]

[edit] Pharmacology

Pioglitazone selectively stimulates the nuclear receptor peroxisome proliferator-activated receptor gamma (PPAR-γ) and to a lesser extent PPAR-α.[2][3] It modulates the transcription of the insulin-sensitive genes involved in the control of glucose and lipid metabolism in the lipidic, muscular tissues and in the liver. As a result, pioglitazone reduces insulin resistance in the liver and peripheral tissues; increases the expense of insulin-dependent glucose; decreases withdrawal of glucose from the liver; reduces quantity of glucose, insulin and glycated haemoglobin in the bloodstream. Although not clinically significant, pioglitazone decreases the level of triglycerides and increases that of high-density lipoproteins (HDL) without changing low-density lipoproteins (LDL) and total cholesterol in patients with disorders of the lipid metabolism, although statins are the drug of choice for this.

More recently, pioglitazone and other active TZDs have been shown to bind to the outer mitochondrial membrane protein mitoNEET with affinity comparable to that of pioglitazone for PPARγ.[4][5]

[edit] Indications and usage

Pioglitazone is used for the treatment of diabetes mellitus type 2 (previously known as non-insulin-dependent diabetes mellitus, NIDDM) in monotherapy and in combination with sulfonylurea, metformin, or insulin. Pioglitazone has also been used to treat non-alcoholic steatohepatitis (fatty liver), but this use is presently considered experimental.[6]

[edit] Contraindications

Pioglitazone cannot be used in patients with a known hypersensitivity to pioglitazone, other thiazolidinediones or any of components of its pharmaceutical forms. It is ineffective and possibly harmful in diabetes mellitus type 1 and diabetic ketoacidosis. Its safety in pregnancy, lactation (breastfeeding) and people under 18 is not established.

Given previous experiences with the related drug troglitazone, acute diseases of the liver are regarded as a contraindication for pioglitazone.

[edit] Side effects

A press release by GlaxoSmithKline in February 2007 noted that there is a greater incidence of fractures of the upper arms, hands and feet in female diabetics given rosiglitazone compared with those given metformin or glyburide. The information was based on data from the ADOPT trial. Following release of this statement, Takeda also admitted that pioglitazone has similar implications for female patients.[citation needed]

The risk of hypoglycemia is low in the absence of other drugs that lower blood glucose.

Like other thiazolidinediones, pioglitazone can cause fluid retention and peripheral edema. As a result, it may precipitate congestive heart failure (which worsens with fluid overload in those at risk). It may cause anemia. Mild weight gain is common due to increase in subcutaneous adipose tissue. In studies, patients on pioglitazone had a slightly increased proportion of upper respiratory tract infection, sinusitis, headache, myalgia and tooth problems.

On July 30, 2007 an Advisory Committee of the Food and Drug Administration concluded that the use of rosiglitazone for the treatment of type 2 diabetes was associated with a greater risk of "myocardial ischemic events" when compared to placebo, but when compared to other active comparators, there was no increased risk. Pioglitazone is currently being reviewed. A meta-analysis released subsequently showed that pioglitazone reduced the number of ischemic cardiac events rather than increase the risk, but increases CHF, a common class effect of the TZD's..[7] The PERISCOPE study compared pioglitazone with glimepiride in diabetics; atherosclerotic plaque volume was measured and followed over time. Glimepiride therapy had highly significant progression of plaque volume over time of 0.73 percent. In comparison, pioglitazone had a -0.16 percent regression in plaque volume. This is the first study to show that diabetic therapy slowed progression of atherosclerosis. Therapy with pioglitazone raised HDL, and lowered triglyceride and hsCRP; these are all beneficial effects on risk factors for coronary artery disease, however to date, no oral anti-diabetic drug has been shown to reduce the risk of cardiovascular complications.[8] Chronic administration of the drug has led to occasional instances of cholestatic hepatitis, reversible upon drug discontinuation.[9]

[edit] Drug interactions

Sulfonamides, metformin, and insulin reciprocally exponentiate hypoglycemia. Therapy with pioglitazone increased risk for pregnancy in those taking oral contraception.

[edit] How supplied

Pioglitazone as Actos is supplied in oral tablets containing 15, 30 or 45 mg of pioglitazone base. It is also available in combination with metformin as ActoplusMet (tablets containing 15 mg pioglitazone and either 500 or 850 mg of metformin) or in combination with Amaryl as Duetact (tablets containing 30 mg pioglitazone and either 2 or 4 mg of Amaryl).

[edit] References

Monday, February 22, 2010

Dangerous Drugs


Archive for the 'Dangerous Drugs' Category

Three Things You Don’t Know About Drug Trials

Friday, April 18th, 2008

1. It pays to be a middle-aged white male.
When it comes to new drug trials, white men under 65 seem to be in high demand. That’s despite the fact that other people develop deadly diseases – and more often than this population. One study found that ony about 10% of cancer-study participants were African American or Hispanic, despite the fact that these groups make up more than 25% of the general population. Or how about this: nearly 60% of cancer diagnoses are in people over 65…but cancer trials typically include no more than 25% people in that age range.

This information comes to us from Baylor College of Medicine, where researchers were concerned that older people are rarely included in trials, even though most of the drugs being tested will be used primarily by them. Older people can be more prone to side effects and drug toxicities, so even FDA-approved drugs are coming to with unknown consequences. Same for women, who generally weigh less than men, and who absolutely have different hormonal makeup – drugs may not impact them the same way, yet they are less likely to be included in trial groups.

But since drug companies are allowed to design their own trials and choose participants, this problem may not be solved in the foreseeable future. After all, if you were a Big Pharma executive, would you want to test your billion-dollar profitmaker on old sick people or younger stronger people?

2. Cutting them short may short-change us.
It sounds (on the surface at least) like a good thing – stopping promising trials for innovative cancer therapies early so they can get to patients sooner. But the ugly truth is that the practice definitely benefits the drug companies more than cancer patients. Especially with cancer drugs, cutting trials short means there is no data about long-term survival outcomes – and isn’t that what patients are really looking for?

Italian researcher Giovanni Apolone looked into prematurely-stopped trials conducted between 1997 and 2007. According to Apolone, “If a trial is evaluating the long-term efficacy of a treatment, short-term benefits, no matter how significant statistically, may not justify early stopping.” More disturbing, Apolone discovered an alarming trend: the results of trials are being increasingly used in marketing applications, suggesting “a commercial component in stopping trials prematurely.”

3. Drug companies “edit” their findings, then hide the original data.
Case in point, the new, improved Merck-Vioxx scandal. New evidence suggests that Big Pharma giant Merck knew as early as 2001 that Vioxx was deadly, but chose not to present that information to the FDA when they were trying to get their prescription painkiller approved. They skated a very thin ethical line when they decided to remove certain patients from the trial pool, including patients who died after they stopped taking Vioxx, even though their deaths may have been attributable to the drug.

The raw trial data showed deaths in the Vioxx group were nearly 3 times higher than in the placebo group. When Merck presented trial information in their FDA approval packet, they edited those findings. By excluding patients who died after their course of Vioxx treatment, the drug appeared much less dangerous.

The kicker: According to New Scientist (a British scientific magazine), public health researcher David Egilman uncovered another hushed-up study called Protocol 906. That experiment found that Vioxx caused nearly double the side effects of Celebrex (made by Pfizer), another drug in the same family. In that paper work, he actually came across an email from one Merck employee to another saying…

“…this is a very serious result and you will hardly be surprised by the idea of keeping this VERY TIGHT for the moment.”

Court-Sponsored Fraud…or Murder?

Tuesday, April 8th, 2008

Let me get this straight: A drug harms us, and we can’t sue the drug company because the drug was FDA-approved. Or, as I like to put it, the government has decided it’s ok for the drug companies to hurt us as long as they make plenty of money at it.

It was bad enough when this ridiculous “preemption” law (preempting us from suing) had the spirit of protecting genuine unforeseen errors – unforeseen due to insufficient testing, of course. But now there’s a case of actual intentional fraud going on. FRAUD! Intentional FRAUD! And it’s possible that the preemption law may still apply.

Here’s the case. According to the New York Times, my old Big Pharma buddy Johnson & Johnson seems to have purposely lied and covered up damaging information in order to sell a drug they KNEW was mislabled and potentially deadly. In fact, this drug was literally deadly for at least 50 women. Other consequences were slightly less dire, like strokes and heart attacks. And ALL of these dangerous drug side effects could have been prevented if the company hadn’t lied because they wanted to sell more. To me, that sounds like they should be charged with murder, or negligent homicide, or some other punishable felony.

The drug in question was a birth control patch, called Ortho-Evra, which was supposed to deliver an even lower dose of estrogen than low-dose birth control pills. But the company (again, according to the Times) KNEW that the patch, in fact, delivered a much higher estrogen dose. And they KNEW that the dose actually delivered was known to cause complications like strokes and heart attacks. And they lied about how much estrogen the patches contained, telling the public they contained 40% less estrogen than they actually delivered. Their own studies, one from 1999 and one from 2003, clearly showed that the estrogen dose of the patch was higher than that of the pill…but they told no one about it at the time.

Finally, in November 2005, the FDA realized something was amiss and issued a warning: “exposes women to higher levels of estrogen than most birth control pills.” The patch’s labeling was changed…and prescriptions for it plummeted. See, virtually no women would knowingly subject herself to that kind of danger to wear a patch instead of taking a pill. And virtually no reputable doctor would prescribe that dangerous dosage to his patients. But no one knew about the danger before November 2005…except the caring folks at Johnson & Johnson.

So, now, a group of more than 3,000 is trying to sue the corporation. And in true Big Pharma fashion, the corporation is trying to make sure the case dies a quick death – under the “our drug was FDA-approved” exemption.

I say the courts should absolutely let this FRAUD case in. I say the judges should find in favor of the hurt, sick and dead women, and declare J&J guilty of fraud, negligence, and homicide…and sentence them all to a year on the Ortho-Evra patch.

How to Murder Your Husband (or Wife)

Thursday, April 3rd, 2008

These days, you don’t need to hire a hitman to knock off an annoying spouse with a hefty life insurance policy. Nope, you can get rid of your spouse – permanently – without doing anything illegal at all. All you have to do is encourage him (or her) to try a drug that’s been approved by the FDA in the past few years. Because these days, “FDA-approved” often means “may have deadly consequences.”

Think I’m kidding? Bextra. Vioxx. Avandia. Ketek. Singulair. Vytorin.

Any one of these drugs might do the trick. Well, not any one…you can’t get Bextra or Vioxx anymore. The FDA finally cottoned to the dangers - after the number of patient deaths grew too high to ignore - of these COX-2 inhibitors and they were taken off the market.

Now Avandia and Ketek have black-box warnings, but you can still get them. Singulair and Vytorin are under investigation, but you can still get them. And there are dozens of new drugs in the approval pipeline, all just waiting to be prescribed before someone notices they’re potentially deadly.

The days of the hitman are over. There’s a new danger in town – and this one is probably covered by Medicare.

A Singulair-ly Bad Drug?

Friday, March 28th, 2008

It’s all over the news: The FDA is looking into the possiblity that asthma/allergy drug Singulair causes suicidal thoughts and actions. For a change, they’re telling us at the front-end of the investigation (which they expect will take at least 9 months to conduct), giving people a chance to stop taking the drug NOW instead of waiting almost a year to find out they should have stopped taking it NOW.

My guess is that the FDA will find this drug can cause extreme mental disturbances. And that’s because I’ve seen it in action. About four years ago, our pedicatrician prescribed Singulair for my then four-year-old son. A couple of days later, he started hearing a dog-man’s voice in his head telling him to do things. The pediatrician took him off Singulair right away – she told me it had probably caused his “auditory hallucinations.”

And hallucinations is just one of the possible known side effects of Singulair. More already-admitted side effects (as per Merck’s own labeling) include anxiousness, depression and – yes, you read it on their own label first – suicidal behavior. That’s right…this comes directly from their own patient information circular, just a small sample of a very long list of possible side effects:

behavior and mood related changes [agitation including aggressive behavior, bad/vivid dreams, depression, feeling anxious, hallucinations (seeing things that are not there), irritability, restlessness, suicidal thoughts and actions (including suicide), tremor, trouble sleeping]

Imagine how bad it really is if Merck has – on its own, without being forced – updated it’s labeling to cover these horrific side effects. Don’t wait for the FDA to discover what Merck is already admitting.

If you take Singulair, talk to your doctor today about other treatment possiblities. And if you’re interested in a safe, natural approach to keeping allergy and asthma symptoms under control, check out the HSI archives.

UK KOs Big Pharma

Wednesday, March 26th, 2008

If that was only a small subset, experts wonder what other data might be out there.

That was the line in this AP article that most drew my attention. It’s referring to the fact independent researchers looked through the data provided to the FDA by GlaxoSmithKline for drug approvals…and found that antidepressants are largely ineffective. GSK responded by saying that the researchers conclusions didn’t mean much as they were only at “a small subset of the data available.”

If that doesn’t show that the drug company carefully chose the data they presented to the FDA to get their drugs approved, I don’t know what will. And, apparently, the UK government agrees with me – even if the US government remains firmly on the side of Big Pharma. The UK government feels so strongly, in fact, that they’re planning to force drug companies to share more complete data when they conduct clinical trials.

The lynchpin case here is about a drug called Seroxat, produced by GSK. It turns out that this antidepressant can raise the suicide risk in teens by 600%. And that the drug company appears to have purposely withheld the information from the government and the public.

Of course, the company denies doing anything wrong. Their spokesman said, “We firmly believe we acted properly and responsibly.”

Well, sure. They skated within the fine line of the law. Legally, they only have to report problems found in a drug when that drug has been used as officially recommended. And since the Seroxat was only officially recommended for use in adults, the company bears no responsibility for reporting data when the drug was prescribed for teens.

GSK has made their position quite clear – they will follow the strict letter of the law, when it comes to product disclosures. Obviously, we can’t count on Big Pharma to do the real right thing, just the officially proper action. So, clearly, the law needs to change.

U.S. Congress – are you paying attention?

Fosamax & Femur Fractures

Monday, March 24th, 2008

This just in, folks. According to a newly published study, Fosamax – the drug millions of women take to strengthen their bones – may cause “unusual femur fractures.”

What’s so unusual about these femur (a.k.a. thigh bone) fractures, you ask? Well, they were all caused by falls of standing height or less – meaning these people didn’t fall off ladders or down a flight of stairs. In fact, according to the senior study author, the women were “basically doing nothing” when their legs broke. The breaks also formed atypical horizontal patterns. And it turns out that 37% of the women who experienced these fractures had been taking Fosamax for years, most for at least seven years. Talk about a product not working as expected!

Here’s what else the brilliant (sarcasm alert) study author, Dr. Joseph Lane, had to say, according to the Medline report. He believes that women taking this medication should keep taking it, and these findings shouldn’t cause them alarm. And he’s quoted as saying “This is a great drug that does wonderful things. Bisphosphonates have dropped the rate of hip fractures.”

So, unusual femur fractures are less important than hip fractures? Not to me! I like all of my bones to be unbroken and in good working order. Which is why I would never take a drug like Fosamax. Especially when this news comes on the heels of an FDA warning back in January that the drug also seems to cause severe bone pain. Oh, and a severe pain in the wallet, as a one-month supply runs $83.99 on Drugstore.com.

I prefer to strengthen my bones the Spreen way, courtesy of HSI Panelist Dr. Allan Spreen. His natural solution for building and maintaining bone is the right mix of nutrients. Most people load up on calcium and stop there – but, as Dr. Spreen tells us, calcium can’t do the job alone.For proper absorption of calcium, your body also needs plenty of magnesium as well as manganese, boron, silica, strontium, usually digestive enzymes, often additional betaine hydrochloride, and ALWAYS vitamin D. For more safe, natural – and relatively inexpensive – ways to strengthen your bones, check out the HSI e-Alert archives at http://www.hsibaltimore.com/

Protecting Profits, Killing Patients

Sunday, March 16th, 2008

Remind me, please? Who is the FDA working for? And who is protecting us from dangerous drugs that may be killing us?

We all need protection against greedy drug companies pushing unnecessary and dangerous drugs on us – but endstage cancer patients need even more protection. Those patients are the most willing to try anything, just to gain a little time or feel a little better. And the fact that they may be treated with a drug that we know can make them worse, and actually steal time from them – that’s unconscionable, disgusting, infuriating, and some words that I’m not allowed to post on this website.

I’m talking about anemia drugs that we now know are horrific choices for cancer patients: Procrit, Aranesp and Epogen. The FDA has already cost Big Pharma a few hundred bucks (they made them relabel the products with stronger warnings), and it looks to me like they don’t want to cut more deeply into their buddies’ profits – because they’re NOT taking these sometimes deadly drugs off the market. In fact, the AP article I just read lead with this line:

“Federal advisers said anemia drugs sold by Amgen Inc. and Johnson & Johnson should be sharply restricted to a segment of cancer patients - a recommendation that could cost the companies millions.”

How about the fact that it could cost the cancer patients what’s left of their lives? But, hey, no worries. The FDA advisory panel wants to restrict the use to a particular segment of patients – limiting use to only those “with uncurable forms of cancer.”

The article is full of infuriating information:

The limits, proposed Thursday by a Food and Drug Administration panel, were the latest blow to three blockbuster medications already plagued by concerns over increased risks of death and tumor growth.

The recommendation was not as restrictive as some on Wall Street had feared, and shares of Amgen climbed by nearly 5 percent in afternoon trading. Many analysts said the panel could have recommended halting the drugs’ use in all chemotherapy patients, endangering as much as $1 billion in Amgen sales.

Earlier on Thursday, FDA staff told panelists there is no definitive evidence that the blockbuster anemia drugs are safe when used as recommended.

Amgen and J&J representatives argued Thursday that the problems cited by FDA have been inconsistently reported across dozens of studies. And they pointed out that only studies involving higher-than-recommended dosing levels showed significant safety risks. The companies outlined a large-scale study Thursday to try and answer whether anemia drugs hasten death and tumor growth when used according to the current label, but results won’t be available for at least five years.

On top of all this, the FDA doesn’t even have to follow the recommendations of the advisory panel. They could choose not to limit the use of these drugs at all. And, based on their Big Pharma-loving track record, I think they’ll do just that – nothing.

What I think they should do: Make the Big Pharma execs test the drugs on themselves. They’re already rats, why not make them lab rats?

Think You’re Drug-Free? You’re NOT!

Monday, March 10th, 2008

Did you know that every time you take a drink of tap water, you’re taking drugs? And I’m not just talking about flouride here. Anticonvulsants, antidepressants, antiobiotics…and that’s just a few of the As!!

The AP just published an article about pharmaceuticals found in municipal water supplies. Not just floating around in the reservoirs, but in the actual water you’re drinking, cooking with, and bathing in. And every time you connect with that water, you’re taking in low levels of drugs. Which drugs and how many – well, no one is being directly forthcoming about that. But count on this: It’s a lot of different drugs, and more than you should be getting.

This is some seriously scary stuff – alarming, really. And it’s worse than it sounds, because not every municipality tested their water for drugs. And the ones that did, well only the drugs they’ve specifically tested for will be reported. Some water supplies contained dozens of different trace pharmaceuticals – Philadelphia, for example, turned up 56 different drugs in their drinking water. 56!

Yes, this is scary, and overwhelming. But it does have its funny moments, as reported in the AP article. Here are a few of my favorite lines:

Arlington, Texas, acknowledged that traces of a pharmaceutical were detected in its drinking water but cited post-9/11 security concerns in refusing to identify the drug. [O]fficials in Emporia, Kan. refused to answer AP’s questions, also citing post-9/11 issues.
(Right…because Arlington, TX and Emporia, KS are known terrorist target cities, and not disclosing drug findings protects their citizens from…what exactly? )

Water sampled downstream of a Nebraska feedlot had steroid levels four times as high as the water taken upstream. Male fathead minnows living in that downstream area had low testosterone levels and small heads.

Ask the pharmaceutical industry whether the contamination of water supplies is a problem, and officials will tell you no. “Based on what we now know, I would say we find there’s little or no risk from pharmaceuticals in the environment to human health,” said microbiologist Thomas White, a consultant for the Pharmaceutical Research and Manufacturers of America.

“It could be that the fish are just exquisitely sensitive because of their physiology or something. ”

Confidence about human safety is based largely on studies that poison lab animals with much higher amounts.

“I think it’s a shame that so much money is going into monitoring to figure out if these things are out there, and so little is being spent on human health,” said Snyder.

Excuse me, but how is this issue not related to human health? We’re prescribed too many drugs. Those drugs end up hitting us a second time through the water supply – along with dozens of other drugs. Antibiotic-resistant bacteria are breeding like never before. And the paltry amount of money governments are spending to find out if our most basic need is safe – that’s not critical human health spending? Now I’m really afraid.

Creating Generation Rx

Sunday, March 2nd, 2008

Contrary to what you’ve been led to believe, Nexium is NOT a wonder drug…except maybe in the sense of “I wonder why anyone would take it.” That includes babies, for whom this destructive drug has now been approved by the FDA, an agency that seems to do more horrible and stupid things every day.

The latest travesty is the approval of Nexium for kids aged one to eleven who have “acid reflux disease.” Nexium is a proton-pump inhibitor (PPI), a drug that decreases stomach acid production. Sounds like a great plan - treat acid reflux with a drug that reduces acid. But doing that is a BIG mistake.

Here’s what they’re not telling you: Putting kids on Nexium (or any PPI for that matter) practically ensures that they’ll be drug users for life. This drug actually suppresses their bodies’ natural stomach-acid producing mechanisms – and no one can digest food properly without stomach acid. If you can’t digest your food, you can’t properly absorb the nutrients…and who needs nutrients more than growing children?

Another thing they’re not telling you: Acid reflux is not caused by too much stomach acid. Rather, it’s caused by a weak LES (lower esophagus sphincter), the flap that’s supposed to close after food has passed down so that nothing can pass back up. When the LES is working right, nothing is going to come back up, no matter how much acid you have in your stomach. When it’s not working well, though, even a tiny amount of acid could cause great discomfort. So suppressing much-needed stomach acid is not the solution…in fact, it can make the LES even lazier, causing more acid to flow up. That, in turn, makes people seek out even stronger acid suppressants – and the real problem is never addressed.

Finally, Nexium comes with some very lovely side effects. (You didn’t think this drug was side-effect free, did you?)
· headache
· diarrhea
· dizziness
· abdominal pain
· nausea
· gas
· constipation
· dry mouth
· sleepiness
And, of course, even the side effects usually lead to additional drug use. Kid’s got a headache? Give him some Motrin. Can’t sleep? Try a Benadryl. More drugs, more side effects, more drugs. Luckily, there’s a much better way to deal with this problem.

Believe it or not, there’s a ridiculously simple, cheap, side-effect free way to help a child who appears to be suffering from acid reflux: Acidophilus. That’s right, acidophilus supplements (use the powder form – the liquid tastes awful) protect the esophagus without killing off any acid, and kill the pain of reflux almost immediately. The trick with acidophilus capsules is that for treating reflux, it’s best to open the capsule and let saliva carry the powder down your throat to your stomach. (If your child won’t do that, try mixing it up in some apple sauce.) And you don’t have to worry about dosage, since acidophilus supplements represent a sample of the billions of ‘good guy’ bacteria that you want in the GI tract.

You can find acidophilus easily at most health food stores. The best ones to get are those in the refrigerated section. Look for labels that say billions of CFU (colony-forming units). Give your child about 1/4 teaspoonful right before meals and bedtime, plus anytime he experiences the burning feeling.

Drug Approval Reaches Ridiculous Low

Monday, February 25th, 2008

Cancer patients often suffer horribly, clinging to the hope that a treatment will give them more time. So when a new drug gets approved, or an old drug learns new tricks, cancer patients gather hope. And when that hope is betrayed because of money or politics, it’s just disgusting. Congratulations, FDA – you’ve just given breast cancer patients false hope, and the chance to suffer through a newly-approved treatment for absolutely no reason.

That’s right. Despite a thumbs down from their advisory committee, the FDA has just given existing lung and colon cancer drug Avastin a new lease on life – Genentech’s (the manufacturer) financial life that is, not the lives of the patients the drug is approved to help. The drug does not prolong the lives of breast cancer patients. The drug does not cure breast cancer. It does not appear to improve quality of life for breast cancer patients. And when the advisory panel voted down the approval of this drug for breast cancer, they indicated (according to the AP) that “the drug’s benefits did not outweigh toxic side effects.” Which, by the way, include high blood pressure and death.

So how did the FDA get around all this negativity and approve the drug anyway? Well, there’s evidence that Avastin does slow down tumor growth…for the lovely low price of $100,000 a year. Slower tumor growth could theoretically give breast cancer patients a little more time, time in which a better treatment could be discovered…though that doesn’t help the six patients (from the Avastin group) who died during the trial. (Did I mention that death is a possible side effect of this drug?)

Some people (like the idiots at the FDA) consider this to be good news for breast cancer patients. With news like this, who needs enemies?

med-drug scandal

Former Pfizer Exec Sues Over Lipitor Marketing

17 Comments

lipitorA former Pfizer exec has filed a whistleblower lawsuit that accuses the drugmaker of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines; using misleading educational programs for doctors, and unlawful sampling kickback schemes, among other things, that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare (this is the lawsuit).

Jesse Polansky, who was director of outcomes management from April 2001 until July 2003, claims “thousands of physicians have prescribed Lipitor to millions of patients for whom drug therapy is not recommended, and for whom the medication could be dangerous. Millions of those improper prescriptions were ultimately paid for by various government healthcare plans,” according to the lawsuit, which was filed in federal court in New York. Six years ago, Polansky first filed such a suit, but the government decided not to intervene, and he has now updated some of his claims (background).

In painting the broader picture, Polansky charges Pfizer allegedly disregarded distinctions in the National Cholesterol Education Program (NCEP) guidelines, which approved drug therapy for about 36.5 million Americans. However, the largest subset are ‘moderate risk’ patients, those with two or more risk factors and less than 10 percent risk of heart attack. Of those, 14.6 million need only therapeutic lifestyle changes, while drugs are recommended only for the remaining 2.8 million. By off-label marketing to the rest, the suit charges, Pfizer realized “it could increase revenues by billions of dollars.”

Pfizer accomplished this, according to the suit, by repeatedly and deliberately blurring distinctions between patient groups established in the NCEP guidelines in slide presentations and other materials used for continuing medical education programs; information distributed at health fair and screening programs; material provided by sales reps; on its Lipitor web site; and with inaccurate cardiac risk calculators used by physicians. In doing so, Pfzier was able to “classify falsely many moderate risk patients as moderately high risk, making them eligible” for Lipitor prescriptions.

The suit also claims Pfizer tried to widen the Lipitor market by targeting patients with hypertension and “misrepresented the design and findings” of a company-funded trial called ASCOT, in which drugmaker “falsely claimed” that all hypertensive patients benefit from taking Lipitor. “Not only did the Ascot trial not result in such a finding but the ASCOT trial was only designed to address the role of Lipitor in hypertensive patients who had at least three additional cardiac risk factors,” the suit charges.

Another charge: Pfizer used reps and CME to misrepresent guidelines and limit distribution of unfavorable studies to promote off-label Lipitor use for patients with chronic kidney disease, including those with end-stage renal disease, which represents a substantial potential market. Pfizer promoted the idea that CKD is the same equivalent risk as coronary heart disease, according to NCEP guidelines, but “this is false,” the suit states. “Lipitor does not have an FDA-approved indication for more aggressive treatment to slow the deterioration of kidney function in patients with CKD.

The lawsuit goes on to reiterate how Pfizer attempted to educate physicians about Lipitor through the National Lipid Education Council, which included many members with ties to the drugmakers. And Pfizer allegedly limited distribution of samples of entry level doses - 10mg or 20 mg - so docs would write more prescriptions for higher doses, which are more expensive and don’t face generic competition.

Pfizer has previously denied the charges and we await comment.

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  1. A previous version of the complaint was dismissed with leave to amend.

    http://www.kslaw.com/library/publication/HH060809_Opinion.pdf (memorandum and order granting Pfizer’s motion to dismiss, 5/22/09)

    http://www.bloomberg.com/apps/news?pid=20601124&sid=aTeZesJxLJlg

  2. Everything alleged for Lipitor should also be examined for a lot of other chronic diseases such as hypertension, especially those where a “pre” condition was invented or diagnostic criteria were revised (ie, expanded) or cut off levels for normal were lowered.

  3. First, this disclosure. I use Lipitor. And I am definitely within appropriate guidelines.

    Still, every time I hear of a new study suggesting some additional benefit of any of the statins (beyond cardio issues), I wonder if there is not another study buried somewhere which shows precisely the opposite–that the manufacturer is aware of a potential risk directly related to the condition about which we hear the potential benefit.

    It is obviously sad to be so cynical. But I believe there are enough instances where this turned out to be the case that it is not irrational to be so.

  4. Whatever Jesse says in his claim is true. Not only for Lipitor but for most mega drugs.Bigpharma has learned long time ago, that by relentless pushing of their drugs they can increase the use way beyond what is really needed based on number of really sick people.This relentless pushing is more than pushing it for approved indication. If they did only that kind of pushing/selling they would never sell what they sell, for instance in case of Lipitor, in billions of $$. They need to go beyond approved indications and they do it all the time. Offlabel promotion is the most common, briberies of all kinds are also common (you Rx we pay you). The “education” of doctors mentioned is also an ingenious way to push their drugs beyond indications. They use so called key opinion leaders (top specialists who sold their services to big pharma, hired guns in other words) who under the “science” of it push company’s agenda and promote the drug beyond indications. This they can, for any specialist can make a claim of drug being effective in non-approved indication. He is a specialist after all. The drug Co can not by law, so they pay these mouthpieces to do it for them. The ways they push their drugs beyond the law, are limitless. Whenever they get caught and fined they invent new ones and the relentless promo goes on.We know most top bigpharma cos have been fined for different misconduct, offlabel being the most common. Recently Novartis got fined 185M with more to come. Lilly paid 1.6B for offlable promo of some drug. The list goes on and on. Would these fined cos stop as they promise and sign a pledge (while paying the fines)? Not a chance, they will just invent new and harder to prove ways. Bigpaharma or bigpharmafia, that is the question, Jimmy?

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  5. Let me first say this, drug companies like many of companies do, at times, try and strech the truth or present things in a missleading way. This complaint appears to be a rehash of the earlier dismissed one. The problem here is that in medicine there are no clear cut off points and variables that may lead to problems are just that, variables, that are difficult to quantify for an individual, but may be easier to do for a group. Thus the problem in this case, saying that maybe it is better to start Lipitor now because your lipids are so so or because your kidney disease appears to be worsening and Lipitor MAY help is very difficult to get a handle on for an individual. This is why the gov’t didn’t pursue the complaint the first time and probably won’t this time. The complaint does not outline clear cut abuse it brings forth the grey areas doctors face when treating. No doubt Pfizer exploited this, but it’s difficult to say this is criminal.

  6. I just want clarify something, I am not defending bigpharma, I only commenting on this whistle blower case. (Don’r forget they stand a chance of hitting a huge payday as well and may exagerate their claims as well.) Also please read Codes R Not Us’ discussion above, it is right on the money! Bigpharma’s use of opinion leaders to promote a drug through the opinion leaders’ social networks is legendary. This stuff (doctors, drugs, and social networking) was first studied in the Midwest in the 1940s. As a matter of fact this study is legendary. Today, we see an acceleration of this as bigpharma themselves utilize social networks and encourage their opinion leaders to use them as well. What are these networks? — Facebook, Myspace, Twiter, websites, etc. Another big thing bigpharma does is invent new diseases to drive prescription volume. Examples are, impotence becoming erectile dysfunction, heartburn becoming GERD, moodiness become premenstrual dysphoric disorder, and check out psych’s bible Diagnostic and Statistical Manual of Mental Disorders 4 (DSM-IV) it is full if disorders that “in the day” used to be treated with a few beers with the boys or a glass of Chardinay with the girls plus a little bitching!

  7. Yobo, I would comment on the “invention of new diseases” that chronic GERD was not invented by the pharmaceutical industry. A quick Pubmed search shows that publications describing the condition and using the term go back to the 1950’s, well before H-2 antagonists and proton pump inhibitors were conceived. In my own case, antacids provided no relief at all for pain that frequently brought tears to my eyes for hours. Did I mention that its a risk factor for esophageal cancer?

    Whether impotence / erectile function is a disease or not, if renaming it reduces the stigma so more guys talk to their doctor, I don’t think its a bad thing. For the price of dinner at Denny’s, a lot of guys can make love to their wives again? Would you prefer that the R&D money have been spent on better displays for cell phones or maybe a 500 GB iPod?

    As for disorders that “can be treated with a few beers with the boys +or a glass of chardonnay with the girls with a little bitching”, I really don’t know how to respond to that.

  8. Just as an observation, I note that it has been nearly 8 hours since Yobo’s post.

    The cries of outrage that we would see on this blog if a pharma employee had posted comments trivializing drug-induced sexual dysfunction, psychiatric disorders, pain, or increased cancer risk are notably absent.

    Just something to think about….

  9. John, that your post coincides with Valentine’s Day weekend is not lost. And if dinner at Denny’s does it for some wives, well, fantastic. I suspect that an iPhone or a 500 gig iPod would be appreciated too.

    Maybe one of Ed’s surveys is in order.

  10. I have a lot of patients taking Lipitor or some other statin to keep them within “guidelines”. But therein lies the problem. The lipid theory of atherogenesis is a foundation that is starting to show cracks. Statins beneficial effects may be due some mechanism other than their lipid lowering property. e.g. an anti-inflammatory mechanism. Another theory, the hemorheologic-hemodynamic theory of atherogenesis may play are much bigger role.

    http://en.wikipedia.org/wiki/Atherosclerosis

    Medical practice guidelines are, in effect, ghostwritten by pharma. They cannot be trusted. This places both patients and their physicians in a serious bind. The net effect of ghostwritten medical practice guidelines is direct injury to the public’s health and the federal healthcare fisc.

    Perhaps a greater concern should be the myriad pleiotropic effects of the statins, e.g. their effect on Vitamin D3 and CoQ10 levels.

  11. Patrons99,

    Obviously (in pediatrics) I don’t have any patients on a statin. However, through my managed care work (and prior PhRMA time) the statins and beta blockers which prove to be most interesting and beneficial are also those with antioxidant and other apparent effects at the tissue level. I wonder if it is a case of serendipity that these antioxidant compounds just happen to lower levels of things we can measure (LDL or BP - assumed to be “bad” by association). I wonder the same about the effects of ACE Inhibitors which almost certainly offer very interesting and helpful effects for blood vessels and cardiac tissue. Most things which ultimately prove to be good and useful in medicine are “happy accidents,” and not all turn out to work the way we think they do.

    What I wonder, and what hasn’t been adequately answered in my mind is this: If you treated a patient consistently with an antioxidant statin at a dose which would not necessarily get them to “goal,” and they actually took the med at least 75-80% of the time, would they gain the same survival benefit/CV event avoidance as if they “got to goal?” If the answer is “yes” why not treated everyone with risk factors at a 20 to 40mg dose of simsvastatin. I’ll bet that if someone studied CRP(or other non-specific inflammatory marker) levels prior to and after simvastatin (or atorvastatin) treatment there would be comparable reductions as seen with rosuvastatin. With an answer to that question, would it really matter what Pfizer’s marketing campaigns did? Of course they sought off-label use. However, any CV med is not used (or promoted) off-label to the extent that mental health medications are.

    I still think Linus Pauling had the right idea - It is oxidation which kills us. And we also already know “Rust Never Sleeps.”

    Thanks for reminding me that I forgot my Vit D last week.

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  12. M Helm, M.D., I’ll bet that we could design some interesting prospective studies to undertake, if we didn’t have our daytime jobs. With an independent source of funding and no COIs to bias us, there would be no “sacred cow” dogma that should be considered untouchable.

  13. Patrons99,

    I’d like to collaborate on that venture! But isn’t this what we should expect from NIH (not to mention all the public money funding academic research)?

    Prospective studies are definitely preferred, but I there may be some retrospective (health claims administration) data which would be useful to validate certain hypotheses. Some countries with universal coverage and robust claims data (or the US VA system which has the advantage of including clinical outcomes measures/lab results) might be able to answer some of these questions tomorrow. Maybe some folks already know these answers, they just haven’t gotten around to telling us.

    We probably need to find a way to pay for “scientific liaisons” to bring our findings to practicing clinicians also…

  14. There _was_ a recent study (I think I recall seeing summary on Cardiobrief) which suggested that consistent statin dose for pt.’s situation (primary or seconday) was as beneficial as getting to a particular LDL goal.

  15. Does this news surprise anybody? Anyone who has ever worked in Big Pharma knows that having a sense of right and wrong is frowned upon. You must leave your ethics behind because ethics and Big Pharma are like oil and water. the Big pharma mafia will do anything it can to make more money, driven by greed rather than caring for patients. However, until the CEOs and other top execs are prosecuted, convicted, fined and pay jail time, the status quo will continue. There is nothing to hold them back from their evil ways. If the companies are caught, they admit no wrongdoing, pay a minimal fine and laugh all the way to the bank.

  16. Vytorin marketing accusations can’t be far behind. One can only hope that Schering-Plough and Merck get dragged into court soon. Now that would be the old downer on the merger!

  17. BP watch, has obviously watched the BIGPHARMAFIA (my name for it and I also call NOVAMAFIA AG, the company I worked for).Yes, anyone who worked for this biz in the last 25 years, has seen it all.It started in earnest some 25 years ago, when the BF wiseguys dacided to turn it into business as any other, where max+++ bottom line is the only measure of success. To acheive that they figured out what they must do.It called for them to go beyond the number of really sick and beyond the laws of the countries they operate in.That way they decided to sell their drugs to anyone who is willing to take them (by convincing doctors their drugs are useful in real and invented sicknesses) and to be successful in this they had to go beyond approved indications for their drugs, thus braking the laws of the host countries.The fact that this was planned, deliberate and approved by their top managements, tells you they do behave like mafia. In fact they are new mafia of the Organized Corporate Crime (OCC) that is real and doing well in our