LyrArc Article Gist
Interview with Levinson of Genentech and answers to a wide range of questions about ther drug discovery process at Genentech, the cost of Avastin to treat cancer, the long years taken to develop the drug, the development and pricing of Lucentis for macular degeneration from the basic process of blocking the VEGF protein that helps the macular degeneration develop. The reasons for the pricing of Avastin- $55,000 for one year. And of Lucentis $2000 for one shot and the possible equivalence of Avastin and Lucentis so that doctors can take a small fractional dose of Avastin and use it in a tiny opthalmic syringe for cost of $50. The research budget of $1.86 billion. And the philosophy of Levinson about attracting the best scientists to Genentech by giving them opportunities as he puts it for "doing great science." And his emphasis on making Genentech a great place to work. Genentech was on Fortune's top twenty list 4 years in a row and No 1 in 2007 and No 2 in 2008 behind Google. Can Roche keep this up without Levinson and his team and the culture they have fostered, and the way they have created a great place to work ? ...

LyrArc Article Gist
Achieving a right balance between the needs for public health in developing countries- and the need for cost reduction in developed countries- with the need to keep innovation, is the challenge facing the Indian Supreme Court as it hears the Novartis case on its leukemia drug Gleevec. The efforts by Novartis and other western pharmaceutical companies to restrict the flow of low cost generic drugs from India. India stopped granting patents on drugs in 1970. It only resumed giving patents under a WTO agreement on patents. The Indian government denied the patent on Gleevec and the case is now coming up before the Supreme Court.

LyrArc Article Gist
Reinvented drugs, by combining drugs that have lost patent protection with some other ingredient to make product extensions, accounts for 27% of Glaxo's sales growth over the last 7 years. Critics point to this as a lack of innovation in its labs. Example of this is Treximet for migraines that combines older drug Imitrex with a painkiller ingredient. Glaxo has lost 28% of its share value on the London Stock Exchange.

LyrArc Article Gist
A Vermont musician could not practice her livelihood after her arm was amputated because of gangrene. The gangrene developed as a result of a physician's assistant at a clinic using a a wrong technique for adminstering Phergan for nausea. The PA used IV Push instead of an IV drip or intravenous which is the right method. He missed the vein and and hit an artery causing the gangrene to develop. A Vermont state court awarded Ms Levine $6 million from Wyeth Pharmaceutical. Now the Supreme Court upheld the Vermont Court, with Justices Kennedy, Souter, Ginsberg, and Breyer joining Justice Stevens. Justice Thomas concurred. Scalia, Roberts and Alito were in dissent. Wyeth had a FDA approved label that warned against "inadvertent intra-arterial injection," but it did not say do not use IV Push. Justice Stevens writing the majority opinion said Wyeth's reading of the regulation was "cramped" and based on a "fundamental misundrstanding." He said "the manufacturer bears responsibility for the label at all times," and affirmed the Vermont Court's opinion that Federal law provides afloor not a ceiling for state regulation." ...

LyrArc Article Gist
Controversy about the American Heart Association's support for Vytorin use, saying the Enhance study was too limited and patients not discontinue use of Vytorin. House Commerce committee to investigate lack of disclosure of ties of AHA to Vytorin makers. AHA receives $2 million from Merck and the joint venture that makes Vytorin. In the absence of Vytorin patients, can get Zocor in generic form for $6 for 30 days supply. Is Vytorin, if its not any better, a clever way of marketing a combination of Zocor and Zetia and touting its effectiveness over Zocor alone with a much higher price?

LyrArc Article Gist
Are high prices for pharmaceutical products and healthcare services putting a severe burden on U.S. finances and defunding education, infrastructure, R&D in new technologies, which provide the underpinnings for future U.S. competitiveness? Yes say experts. In 2009 Americans per person cost of healthcare was $7,960. By comparison Canada was $4,808, Germany $4,218, and France $3,978. And without necessary efforts for educating people about caring for health and preventive care, the health conditions of Americans are no better than these countries, and poorer in some dimensions. Klein says deficits would not be a problem for the U.S. if prices for pharmaceutical products and healthcare services in the U.S. were similiar to that of the largest developing countries. Experts say the Obama healthcare law simply postponed the addressing of this problem.

LyrArc Article Gist
Abbott Laboratories agreement to pay $1.6 billion in civil and criminal fines for promoting unapproved off label uses of the neurologic drug Depakote, to sedate older patients in nursing homes. The acting associate attorney general, Tony West, said: "Not only did Abbott engage in off-label promotion, it targeted elderly dementia patients and down played the risks apparent from its own clinical studies." Abbott aggressively promoted its use in nursing homes. It also aggressively promoted the use of the drug for schizophrenia between 2001 and 2006. In 1999 Abbott had to discontinue a clinical trial testing Depakote's effectiveness against dementia after results showed increased incidence of anorexia, drowsiness and dehydration.

LyrArc Article Gist
Elizabeth Rosenthal looks at Obamacare's contribution to cost containment in 2013-2014. Rosenthal says its is a kind of delicate maneuvring at the edges, because serious work needs to be done. The fee-for-service and many of the drivers for increases in medical costs, the old system of pricing, are still in place. In 20 years at the current rate and after Obamacare health care will still take 25% of the U.S. budget if nothing is done. Healthcare costs are about half that of the U.S. in some of the advanced European countries. She calls Obamacare a trickle down theory of cost containment becaue it leaves most of the drivers for cost increase in place and works at the margins. Princeton economist Uwe Reinhardt calls it an ugly patch on a somewhat ugly system. Rosenthal cites the armies of consultants anticipating every move to reduce prices, and working on "strategic billing'' to increase revenues for hospitals and doctors. For those who say the prices are now up more slowly than in the past, Michael Chernew of the Harvard Medical School, has this to say- its like a diet, reminding us that that we haven't even lost weight, just gaining weight slower than before. ...

LyrArc Article Gist
Glaxo's Dr Garnier talks with Jeane Whalen of the WSJ about his work, a lot about his committment to running a company not just for rich countries, that access is a very important word for him and his efforts to make drugs affordable or even free or close to free depending on the country's standard of living, his 24-7 day handling the Avandia issues, and the innovative drug pipeline he has put together over the years.

LyrArc Article Gist
Global sales growth will be from developing countries as US sales slow down to the rate of a 4-5% growth, losing 1 percentage point and be at the level growth is in Europe. This growth will mean U.S. sales of 305 billion dollars in 2009 for pharmaceuticals. Next year two thirds of prescriptions will be generics, increasing from 50% in 2003. Forecasts from IMS. Also FDA is taking a tougher line in regulation. Top seven emerging markets will grow at 12 to 13% a year in contrast- from improving economies and greater demands for spending on health care.

LyrArc Article Gist
Estimates show the 50 million Americans enrolled in Medicare today will increase to 80 million by 2030, according to the program's actuaries. Simple demographics as the baby boom generation ages is making controlling the deficit without controlling increase in health care costs as both sides in the fiscal cliff negotiations are attempting to do can only lead to defunding critical areas such as education, R&D and infrastructure, and breaching the safety net for lower income Americans. Health care spending took up 7% of GDP in 1960, increasing to 17.9% of GDP in 2010. Federal spending on healthcare has grown to about 25% in 2012 from 10% in 1960, and is projected to increase to about 33% in ten years by the Congressional Budget Office.

LyrArc Article Gist
This article details the manner in which pharmaceutical companies like Sanofi, Novartis and other western pharma companies are using EU patent laws to have customs offices in the Netherlands and other European transit points to detain pharma shipments by Indian companies to developing countries. Cipla and Ind-Swift shipments are mentioned. India's pharma exports of generics and other medicines is $4.9 billion in 2009 according to Global Trade Information Services. Indian pharma companies are having to divert these shipments through Singapore and other transit poits to avoid this detaining of shipments and this costs more. India plans to file a complaint with the World Trade Organization according to India's commerce secretary, which one expert says it has agood chance of winning.

LyrArc Article Gist
The 10 year distribution contract between Walgreen Co., Alliance Boots, and AmericsourceBergen Corp., for distribution of generic and other drugs worldwide. The higher volumes as a result of the distribution contract gives it leverage in negotiating better prices from generic manufacturers.