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Sanofi-Aventis and liver risks of its drug Ketek. And the questionable practices of Sanofi in the study assessing the liver risk that the FDA draws attention to in its letter to Sanofi-Aventis.

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Information on Glaxo's own website about the results of test for Avandia a popular diabetes drug that led to findings of cardiac risk by independent doctors.

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Slowdown in drug sales growth in USA and Europe. Top seven emerging markets will account for 34% of global sales growth upfrom 7% in 2000. And the USA accounted for 40 to50% of growth in global pharmaceutical sales each year early in this decade, in 2009 the sales in the USA will account for just 9%. Forecasts and figures are from IMS consulting firm. USA sales will rise only 1-2% if at all, while emerging markets will grow by 4.5% to 5.5%. With the economic troubles American consumers are less likely to fill prescriptions and insurers are not covering new drugs and favoring generics. Intense competition among generics drug makers is reducing prices. IMS predicts that the global generic market will grow by 5 to 7% in 2009 to $68 billion, slowing from double digit growth. This is from total sales forecast for pharmaceuticals globally of $830 billion.

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Avandia may lose additional sales to Actos a competing drug from Takeda Pharmaceutical if the warning label further discourages users of the drug because of heart risks. There is considerable debate within the FDA itself.

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The response of a new government to gang violence in Ecuador is the subject of this report and the accompanying editorial that follows that points to its transnational roots and the effect of changes in its neighbors. It shows how the demand for drugs in Europe affects small Latin American countries leaving the institutional structures at risk.

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Marty Makary, John Hopkins surgeon, is the DJT nomnee for head of the US Food and Drug Administration, FDA. Here a colleague of his at John Hopkins offers her experience working with Makary.  Leanna Wen says Makary is concerned about plastics, dyes, preservatives and chemicals that are entering our bodies and causing disease. Diseases that were not so prevalent one or two generations back are widespread today, says Makary. Makary wants to know why. Why has obesity quadrupled among young people in the US?Makary is also asking questions about why rates of childhood obesity are 5 times lower in Japan. Makary tell this Post reporter that ultra processed foods that are loaded with chemicals such as preservatives, artificial dyes and thickeners , take up 60% of calories Americans consume. This and poor food habits of today can cause diabetes, cancer, heart attacks and dementia. Pesticides and microplastics can cause early onset Alzheimer's and autoimmune diseases, attention-deficit/hyperactivity disorders. Makary wants medicine practiced in the US to direct resources to prevention, not simply hand out medicines with increasingly risky side effects. ...

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Drug companies spent $168 million on lobbying in 2007, up 32% from 2006, according to the Center for Public Integrity. The biggest spender is the Pharmaceutical Research and Manufacturer's Association of America which paid $23 million, a 26% rise from ayear earlier. Amgen was first among drug firms at $16.2 million, Pfizer at $13.8 million, Roche at $9 million, Sanofi-Aventis at $8.4 million, GlaxoSmithKline at $8.2 million, and Johnson & Johnson at $7.7 million. In 2006 Democrats received 31% of the industry lobbying funds, now with Democrats controlling Congress the shift is to more money given to Democrats.

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The WSJ responds to president Biden ramping up renewable energy plans and linking Republicans with Senator Rick Scott's plan for sunset provisions on federal legislation every 5 years that Biden says would include Medicare and Social Security. WSJ is critical of Biden's renewable energy plans and calls for increasing production of oil and gas to meet energy shortages and price increases. It is also against a wealth tax, Biden's $2 trillion Workers and Families Plan, and Biden's plan for Medicare to negotiate drug prices. WSJ says real disposable personal income increased $4205 under the Trump presidency 2017-2020, and has since declined by $374 with high inflation depressing purchasing power. The impact of climate change requiring brave choices and strong action is missing in the Republican plan as Republicans focus on attacking Democrats controlling the presidency and Congress on the issue of inflation. The issue of remaking supply chains are on both the Republican and Democratic agendas with president Trump giving more rhetoric against China's role in dominance of supply chains and Mr. Biden taking stronger action in Theodore Roosevelt's style of carrying a big stick and quiet posture in restoring America as a manufacturing powerhouse. The impact of climate change is short term rather than long term as seen by the heat wave in South Asia today, the fires in North America and Europe. Republicans are losing sight of the importance of making the shift on renewable energy quickly with some short term pain, as they push for oil and gas solutions and a less effective program for renewable energy. Mr. Biden is taking on bigger risks in the short term in the midterms and beyond but following a sound policy of aggressively pushing renewable energy. This can also be seen in the importance renewable energy is being given even in countries with a need for coal and natural gas such as India. Modi's plans in India are to buildup renewable energy capacity with aggressive targets for 2030. ...

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How competition from generics and shortfall in new drugs and more consumer awareness of risks is affecting the sales of bigger drug companies

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Bayer CEO, Marijn Dekkers, plans to divest its plastics business, called Material Science. The plastics division requires large investments with lower returns than can be made in health care or the agricultural crop science business. Crop Science generated earnings before interest and taxes of 1.81 billion euros in 2014, and Health Care helped by 5 new prescription drugs reported EBIT of 3.58 billion euros, compared to poor returns of 555 million euros on the polyurethane and polymers used for laptops to soccer balls in the Materials Science division. CEO Dekkers is a Dutch born executive who worked for 25 years in the U.S. Since taking over in 2010 he has brought a significant culture change to Bayer, by insisting on speed and agility from executives. Division heads with marketing backgrounds are preferred to science degrees, and the planning orientation of the company is being changed to one where the company executives are not afraid to take risks based on incomplete information. Dekkers prefers an IPO for the $10 billion plastics business to generate more cash and reduce the debt of 20 billion euros. He acquired the over the counter drug business of Merck for $14.2 billion, and has boosted drug sales with the introduction of Xarelto in partnership with J&J, eye treatment Eylea, cancer drugs Stivarga and Xofigo, pulmonary hypertension drug Adempas. Sales of these 5 drugs are expected to go up from 2.9 billion euros in 2014 to 4 billion euros in 2015, contributing significantly to Bayer's profits. Dekker's venture capitalist type focus on profit margins is showing results in share price performance- Bayer's share price has advanced 60% in 2015 mid-March price of 145.85 euros compared to the prior year month. In the small town of Leverkusen, Germany, where Bayer is located, there were initially fears that Dekkers was "too American" and too focussed on shareholder value to understand the need to respect tradition. Since then Germans have realized that Dekkers understands tradition and is only bringing necessary change- the transition to being a life sciences company makes sense to shareholders in Germany, for employee representatives on the supervisory board the guarantee of current level of 17,000 jobs in the plastics division for a few years shows his concern for job protection during the transition period. For Dekkers who left Holland in 1985, and has a U.S. passport with an American wife and kids who speak no Dutch or German, the important thing is to get the right balance- he says the system of 99-1 where 99% of the information had to be in before a decision could be made is making the change to 90-10 where only 90% of the information is now necessary to go ahead, even if he would like to see it at 80-20. Bayer still sponsors the local soccer team known as Bayer Leverkausen, and 26 other clubs. Dekkers steps down at the end of 2016....

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Among the reasons given for Roche's bid are the need to bring the creative energies of Genentech inside Roche's own pharmaceutical division. This at a time when pharmaceutical companies are having a difficult time coming up with new drugs, without as Bill Burns the head of Roche pharmaceutical put it, a "Chinese wall" between Genentech scientists and Roche scientists. Other reasons are the opportunity for the Basel based company to capture all the profits from Genentech and achieve cost savings of $850 million annually by combining the 2 companies' clinical research teams and sales, manufacturing and administrative departments in the USA. Another reason is that the agreement with Genentech for Roche to market its drugs outside the USA expires in 2015. With Genentech's share price at a low Roche's bid at a 9% premium also appears as an attempt to get the remaining 44% of the company that Roche does not own for a low bid. It risks however the 18 year relationship betweeen Roche and Genentech, in which Genentech operated within its own scientific culture in the San Francisco area, almost like a separate company. Roche CEO Schwan, still wants to keep some of this arrangement and have Genentech drug researchers operate as a separate group, but its not clear how the cost savings and the interaction with Roche scientists would occur under the new arrangement. Genentech was founded in 1976 after a meeting between venture capitalist Robert Swan and bichemist Herbert Boyer at a bar near the University of California, San Francisco campus. It has come up with a number of successful cancer drugs such as Avastin, Herceptin, and Tarceva, and total sales are $11.7 billion, a significant part of Roche's overall sales....

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FDA's approach to Eli Lilly's drug Prasgrel which is more effective than Plavix for preventing heart attacks but can lead to fatal bleeding in some patients. The other side of the picture is that 30% of patients are not suited for Plavix, and these patients could have an alternative. In weighing the risks and the benefits, and of letting some patients who may be suited to Prasugrel have access to the drug, the FDA has to find the right approach. An FDA panel was set to recommend whether to approve the drug and under what conditions.

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Glaxo spent $279 million in the first half of 2008, second only to Pfizer's 462 million. Much of this is televison advertising, which has come under criticism for exaggerating the benefits of drugs and minimizing the risks. Television advertising for prescription drugs is banned in most countries, except for the USA and New Zealand. Now Glaxo CEO, Witty says, Glaxo will do less television advertising than in the past.

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The corporate governance reforms settlement agreement for Merck requires hiring a chief medical officer to serve as a sort of independent ombudsman to monitor product marketing and safety. Board members are required to take on tasks of research ethics and drug safety. Two new committees are to be formed- one on product safety and the other to address risks to the company. Michael Santoro, an associate professor of business ethics at Rutgers Business School helped draft the settlement.

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Warning labels for the diabetes drug Avandia and a great deal of agreement that Avandia does pose some higher risks for the heart is how the FDA concluded its vote and discussion on what to do about Avandia for the safety of users.