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Treatment costs with Praluent for cholesterol control are extremely high at $14,600 a year.

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While communities with high unemployment and depressed areas like Rocky Mount in N. Carolina, with 14% unemployment -and many customers skipping prescriptions because they can't afford them- are the worst off, the national picture shows many similiarities. Even with Medicare drug benefit, lowcost generics, and Walmart type low cost drugs, many Americans cannot afford prescription medications for life threatening illnesses. Nationally a third of respondents say they are not complying with prescriptions as they cannot afford them, compared to a fourth three years ago.

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This editorial in the Wall Street Journal says faster approvals at the Food and Drug Administration have helped bring more generic drugs to market lowering prices for the public. In 20 months the Trump administration approved 1617 generic drugs, 81 a month on average or a 17% increase over the preceding 20 months. Council of Economic Advisers in October said this was a saving of $26 billion for the public.

President Trump is looking at price controls as a way to bring down drug prices. With increasing outcry about high drug prices in the U.S. the Trump administration and Democrats in Congress are looking for new approaches to bring down prices.

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According to the General Accountability Office inquiry, 28 drug products had price increases over 100% in 2000, in 2008 71 drug products had such large increases. Medicines like Adderall for attention deficit disorder, Inderal for chest pain, Sumycin for infections were in the list of 416 brand name drug products where makers or distributors raised prices at least once by 100% or more for period 2000-2008. As large pharmaceutical companies sold their marginally profitable drug products or small selling products to smaller companies, these smaller companies would immediately increase prices to recover the money they paid to the large pharmaceutical companies. 26 of the brand name products saw prices raised 10 fold. A third of the drugs with large price increases treat depression and disorders of the central nervous system.

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Bayer AG CEO Marijn Dekkers talks to the Journal's Geoffrey Rogow about the company's pharmaceuticals business and job retention. Dekkers says profits are reduced by the tight budgets of European governments and the pressure on pricing. He cites the 16% mandatory rebate in Germany on prescriptions. For Bayer diversification through the chemicals business offers a way to handle the ups and downs in the pharmaceuical business with patent expiration. He is not interested in acquisitions because of the high premium involved and the difficulty of recovering this for investors. Bayer like other drug companies has extensive operations in China. Bayer is training salespersons in top and second tier Chinese cities. It has a program to train 10,000 physicians in rural areas of China working with the local government. Dekkers makes an interesting point about jobs and job retention in the U.S. He says a lot of jobs were outsourced in the 1990's and its difficult to bring them back. Germany has done a better job with job retention with "kurzarbeit" and other programs working in partnership with industry. In his view this could have been managed better in the U.S. with active programs such as this in the last two decades....

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A study by AARP of 514 brand name and generic drugs between 2005 and 2009, shows that generic drug prices went down an average of 31% during this period, and brand name drug prices went up by 41%. One of the authors of the report says that it is important to look at individual drug prices and not studies showing total spending on drugs, because this is a significant cost for people paying out-of-pocket, It drives up insurance premiums, and pushes retirees into coverage gaps in Medicare Part D drug program. Analysts indicate pharmaceutical companies are increasing prices on drugs before patent expiration to get as much profit before the patents expire.

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The shift to finding new drugs for cancer. Pfizer has a development team of 10000 researchers in one location near San Diego, California, to develop new drugs for cancer even though some experts say the search for cancer drugs is devilishly complicated. The causes of cancer at the molecular level are complicated and vary even from person to person for the same cancer. Says one expert this also raises questions about the benefit to people as a large amount of resources are shifted to areas like cancer that affect fewer people than other diseases, and where the existing drugs have only prolonged life marginally, in some cases even as low as a few months at a huge cost of thousands of dollars. Tarceva for pancreatic cancer for example only prolongs life by 12 days at a cost of $3500 per month. 860 cancer drugs are being tested in clinical trials according to the trade group of the pharmaceutical industry. This is more than twice the number for heart disease and stroke, and nearly twice the number for AIDS and all other infdectious diseases combined, and nearly twice the number for Alzheimier's and all neurological dieases combined....

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Thre drug companies are placing bets on the vaccine business. Johnson and Johnson paid 302 million euros for 18% of Dutch biotech company Crucell NV, to jointly develop vaccines. Abbott Labs says it will acquire a unit of Belgian conglomerate Solvay SA for 4.5 billion euros in adeal that includes a vaccine business. And Merck obtained the marketing rights for a seasonal flu vaccine from Australia's CSL Ltd. This follows Pfizer's Wyeth acquisition. Low prices, high costs and fear of lawsuits made most drug makers to exit the business in the 1980's and 1990's. Now vaccine sales are growing faster than other prescription drugs and are largely protected from generic competition. And government agencies here in the USA and around the world are reliable buyers of vaccines as they seek to stockpile medicines that could be needed in aflu outbreak. Merck never exit the vaccine business and now makes 8 of 10 vaccines recommended for adults. Flu and other vaccines are especially attractive for entering drug markets in Brazil and China and developing countries. Governments lke the idea of lowcost prevention at $10 adose, and with this new relationships are developed in these countries. And even at price of $10 or $20 a dose they provide asteady stream of revenue.Vaccines are estimated to generate $21.5 billion in revenues by 2012 according to Sanofi-Aventis SA, which is a leading vaccine maker....

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Abbott is placed on a five year probationary period by the U.S. Justice Department. This comes after the $1.6 billion legal settlement for aggressive marketing practices to sell the drug Depakote in nursing homes.

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The use of Zyprexa in nursing homes, and Lilly's marketing of the drug as "requiring fewer skilled nursing staff hours", and "reduced caregiver stress." The lawsuit alleged that this meant it was " an effective chemical restraint for demanding, vulnerable and needy patients." Zyprexa has the risk of life-threatening infections like pneumonia and of heart failure in elderly patients. Lilly also marketed the use of Zyprexa to treat disruptive children, even though there are side effects of severe weight gain and metabolic disorders. The case is being prosecuted by the US Attorney's Office of the Eastern District of Pennsylvania. In the negotiations Lilly agreed to pay $1.2 billion to 31,000 Zyorexa plaintiffs. This is the biggest case and settlement of its kind.

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Under a new program to increased spending on healthcare from 1.3% of GDP to 2.5% the Indian government plans to provide free pharmaceuticals at state run hospitals. This is expected to cost $5 billion over 5 years. Initially 350 drugs would be on a list of essential medicines and would be purchased from generics manufacturers in India. Dr. K. Srinath Reddy, heads the committee advising the Indian government on healthcare. He says this will help improve access to medicines for the vast majority of the people. Estimates show 70% of out of pocket medical costs for Indians come from spending on drugs. About 40 million people are pushed into poverty each year because of the high cost of medicines, says Dr. Reddy. He said that in 1984 31% of the medicines at government run hospitals were provided free to admitted patients, dropping to 9% in 2004. For outpatients this dropped from 18% to 5%. The free medicine program would be part of a larger universal health care program to be introduced over the next decade. India's large generics pharmaceutical industry makes the provision of free medicines on a large scale a feasible option in India because of the lower prices, with additional pricing advantages when purchased in larger volumes by the government. This would also have a major impact on the quality of healthcare in the country of 1.2 billion people for a relatively small investment. It also promotes a sense of fairness and equal access because the benefits of decades of modernization have been unevenly distributed and because of widespread poverty....

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Questions raised about Dr Pazdur's decisions at FDA for anemia drugs made by Amgen and Johnson and Johnson. Dr Pazdur is head of the FDA office that regulates oncology drugs, all cancer drugs. Dr Pazdur's review process and decision shows how reviewers are human and their own experience helps determine what they see prominently. His experience with his father who suffered severely from the side effects of steroid drugs would make him aware of the the other effects of drugs. He is an oncologist, his wife is an oncology nurse, and some relatives have died of cancer, so he has lived with cancer patients. It appears from close associates that he like open communication and hears all sides but makes the final decision himself. He had an experience with a drug for lung cancer Iressa made by Astra -Zeneca, which the FDA approved based on testimonials, but not enough statistical evidence, which later failed and approval had to be withdrawn. This may have made him more inclined to look for strong results and statistical evidence before concluding on the safety and effectivenes of a drug. An approach evident with Amgen's anemia drug. It also appears that the FDA is not clear on whether the drug's effectiveness is to be judged by what result, is it whether it prolongs life only that counts, or whether the effectiveness in relieving significantly the symptoms of a patient even if life is not prolonged. There is the controversy surrounding the FDA's rejection of a drug by Genta Inc Genasense that relieved patient symptoms for leukemia but did not prolong their life. These and other questions continue to give sleepless nights to people at the FDA and outside as the drug review process faces difficult balancing act between what to give importance and what direction to take with a drug in patient's interests. In Dr Pazdur's case this is made more difficult as he thinks every day of his father who died in 1979 and suffered from the side effects of steroid drugs, went blind when Dr Pazdur was only a teen, and had pulmonary fibrosis and diabetes. He is described by doctors who trained under him as gentle but did meet a patient's eyes and tell him that he had to come to terms with his disease. ...

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A report by pharmacy benefits managing company Express Scripts shows a 13% increase in the price of branded drugs in the U.S. from Sept 2011 to Sept 2012. Generic drug prices declined by 22% in this period. The report also shows that growing spending on specialty drugs for cancer, MS and other diseases is a big reason for the increase in prices of branded drugs. This report is from a random sample of six millon Express Scripts members using prescription drug coverage. Prof. Schondelmeyer of the University of Minnesota, who manages the drug benefits program at the university and conducts a similiar price report for AARP, says the potential benefits for these specialty drugs are not that good to justify the high prices.

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Stricter warnings on Amgen's Epogen and Aranesp, and J&J's Procrit, Anemia drugs.

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Two of Amgen's drugs that treat anemia in cancer and kidney-failure patients have questions raised about their safety and marketing. The two anemia drugs Epogen and Aranesp generate about half of Amgen's sales. THey now have ablack box warning placed on them by FDA requirements.

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Just as the drug industry is more getting more dependent on the government with the medicare drug benefit raising the retail drug purchases paid by government to 34% in 2006 from 28% in 2005, the industry is facing more governmental scrutiny, from the FDA, from Congress from the public, and during this election campaign. Rep .Rosa DeLauro, who heads the House appropriations subcommittee that has oversight over FDA funding compares the drug industry to the tobacco industry saying that it requires the same amount of scrutiny. At the same time the drug industry is aware of the changes in the public mood and the recent controversies over drug studies, such as the one on Vytorin and other controversy. It is initiating some voluntary changes, registering clinical trial results, submitting commercials to the FDA before they air, and under pressure from medical journals registering trials before they are performed. A new law will requires and its not clear whether the drug industry is dragging its feet and then making changes when there is increasing public pressure. This is the feeling of the medical journals like the Journal of the Medical Association and the New England Journal of Medicine. JAMA's editors will be keeping up this pressure as they have more articles showing how the drug industry manipulates data and the need for public skepticism of information that comes out of the drug industry. The New England Journal editors expressed the need to publish information that helps doctors get all the available information, and not just the information from the drug industry that makes the drug look better than it really is, such as the information and analysis it provided on antidepressant medications. The chairman of the energy and commerce investigations subcommittee Rep. Stupak, finds the advertising for drugs contains information that cannot be backed up and not true ethically, medically, or legally. As this reflects the public mood look for more investigations in Congress and investigative research by the journals. On the issue of importation of drugs from Canada there is bipartisan support as both Senator McCain and Senator Clinton support importation. Clinton supports legislation that allows the FDA to approve new generic versions of biotech drugs which would lower prices of biotech drugs. And with the US consumer budget facing strains in a recession there will be increasing pressure and demands for relief in the area of drug prices, especially for the elderly and uninsured and from corporate payors. ...

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Glaxo, like other pharmaceutical companies facing severe competition from generics, aggressively marketed the treatment for Restless Legs Syndrome (RLS) with its drug Requip. Glaxo made a strong marketing push for Requip with advertising in medical journals even before approval of Requip by the FDA, sending specialists to discuss treatment with general practitioners, and advertising strongly to consumers. Half of Requip's sales come from treatment of Parkinson's disease for which it was originally designed, the other half comes from RLS. Are their pressures to treat an expanding array of diseases merely to increase sales.