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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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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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India's National Pharmaceutical Pricing Authority placed pricing controls on frequently used antibiotics including Ciprofloxacin, diabetic drugs including Metformin, and heart medications. It also said it would audit manufacturers to ensure that normal production continues. The pricing authority acts under a 1955 law that requires pricing to be affordable for essential drugs needed by the vast majority of poor people in the country. Some mass consumption drugs are now imported where it is unprofitable to make them in India. In the case of other drugs the volume increases from lower prices increases access to medicines, and the volume makes up for the price cuts. An example cited by the pricing authority is essental antibiotic (especially for children), Augmentin, where the prices dropped by 40% but the volume increases as it became more affordable have more than made up for the price reductions, with overall sales higher than before the price cuts.

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Cuba needs 100,000 gallons of fuel a day. It produces 40,000 gallons a day on the island. The shortfall is leading to a humanitarian crisis with the dererioration faster than expected. Reports from Le Monde, El Pais, and other media show adire situation unfolding. To provide about 10,000 private companies with enough fuel to operate as they import $1 billion of food and goods each year the US government is allowing the flow of some oil to Cuba. This is about 100,000 gallons in small containers as a step to avoid a economic catastrophe. For Cuba, as in Venezuela, and Colombia, and also in Mexico, central America, thirty years of experimenting with ideological movements has led to unmitigated disaster with drug trafficking, drug cartels, migrant trafficking, economic mismanagement on a massive scale. The result is repercussions across the continent and disturbing the social, political and economic fabric of the United States.

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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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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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The restructuring underway at Pfizer. Experts view the cut in R&D budgets, when more new drugs are needed, with skepticism. Pfizer and other drug manufacturers believe they can make up for this by working closer with universities. Pfizer is reducing the size of its Groton, Connecticut R&D facility and is moving research operations closer to universities in Boston and Cambridge, England. R&D budgets will be cut 30%, from $9.4 billon to $6.5- $7 billion. The emphasis now is to develop a new model for drug development by focussing on a few promising areas, collaborate closely with universities, and fill gaps with acquisitions, as a more efficient way to develop new drugs. In this new approach the infant nutrition business, even with its high growth rates, did not fit in. Cash from the operations sold to Nestle will be used to make share buybacks and be returned to shareholders. Other drug companies from Novartis to Bristol Myers are trying this approach.

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The pharmaceutical companies are reducing the size of their sales forces, but increasing the number of MSL's or Medical Science Liaisons. The drug companies are using the MSL's to discus the science behind a particular drug, and how the drug can have increased applications. Pharmaceutical companies are barred by the FDA from promoting unapproved drug uses, or "off-label" use.

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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.

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How the Drug Industry and Drug Companies will go through a complete change and look nowhere near what it looks like today. Huge changes are overtaking the Drug industry and old ways of doing things will go out the window. Patent expirations for blockbuster drugs, safety issues, increased regulation, rise of generics drugs, cost issues, outsourcing of manufacture and testing and some R&D, changes in marketing practices, slimming down of marketing and sales force personnel, new approaches to R&D- Novartis emphasizing science, Glaxo breaking up into smaller teams, and the growth of emerging markets. All this happens as the public in the USA looks at healthcare in anew way and the demand for healthcare expands quickly in growing developing countries of Asia, Africa and Latin America and Eastern Europe.

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The Trump administration is taking aim at drug costs under Medicare inflated by deals pharmaceutical companies make with industry go-betweens.  These are the secret deals of pharmaceutical companies with pharmacy benefit managers who negotiate the price of drugs for insurers and employers.

Under the proposal pharmacy benefit managers lose the legal protections that let them take rebates from drug companies.

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Chris Klomp, 45 years, takes over at 65,000 person $2.6 trillion government agency, Department of Health and Human Services, as Counselor, as Robert Kennedy Jr. heads for the campaign trail in addition to HHS duties March 12 2026. He impressed DJT with his negotiating ability against the drug companies in the government's efforts on Affordability of medicines. DJT calls him "my favorite Mormon." Susie Wiles was looking for a stabilizing force at HHS after vaccine controversies and wants the message to focus on improving health and cutting costs. Robert Kennedy Jr says about Klomp- "He is moving quickly to impose operational discipline, sharpen our strategic direction, and fortify a renewed sense of mission and accountability.” Klomp is pulling together all the agencies under HHS including FDA and others. Klomp takes his role seriously to cut costs and improve Health- .“In health care in particular, I do believe that I’m my brother’s keeper, and our job is to do the very best that we can for the people that we serve — the American people.” ...

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Changes Novartis CEO Daniel Vasella is making in the pharmaceutical business. He has hired Joe Jimenez, who is running Novartis's consumer health care business to be the new pharmaceutical division chief. Jimenez previously worked at packaged goods companies including H.J. Heinz Company. Jimenez is cutting 25% of the jobs at pharmaceutical division's headquarters in Basel to reduce bureaucracy and costs. In March he promoted Trevor Mundel and Andrin Oswald, 2 young executives, to head the drug developmet group which puts drugs through human testing and submits them for regulatory approval. This group had become too bureaucratic and slow to move and take initiative. To improve its functioning Jimenez is organizing it into small teams with each team assigned an experimental drug in Novartis's pipeline. Each team of 8 people including physicians, experts in regulatory affairs and marketing and toxicologists work together to spot potential safety issues early and discuss them with regulators to determine whether to put the drug through expensive clinical trials. Each team takes the responsibility to take its drug to the market. The pharmaceutical unit is also being organized to be more nimble. It solicits health systems early on whether its willing to pay for drugs. And Jimenez has startd 4 pilot projects in tough markets to improve relationships with payers, including the Pacific Northwest where Novartis has offered to train an HMO's nurses in aspects of heart disease. Vasella supports the generics division of Sandoz because the growth is in generics, with generics commanding 60% of the prescription volume in Germany and USA, and sales for generics up 25% this year in the generics division. And Novartis paid $39 billion for Alcon, a eye care company. Its also working aggressively in the vaccines business, which like generics enjoys double digit growth. ...

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Pfizer's aggressive promotion of Chantix an antismoking drug. Article by Steinberg and Foulds in the Annals of Internal Medicine, suggesting treating smoking not like alcoholism but like diabetes with lifelong taking of medication like Chantix to curb craving for nicotine after cessation of smoking. The article may have been intended to promote Chantix to insurance companies to cover its use as a drug for treatment of diabetes type lifelong disease. It costs $100 a month for Chantix. The drug can cause depression and psychological disorders so the FDA is considering putting a black box warning on the drug for patients to take due care in using it. Chantix had USA sales of $680 million in 2007.

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German drug company Boehringer has applied for FDA approval for a drug that treats low female sexual drive for premenopausal women. A staff report by the FDA recommends not approving the drug. An FDA advisory panel meets this week to vote on whether the FDA should approve it. Meanwhile Boehringer is setting up a marketing campaign for the drug, including a website, Twitter feed, Discovery Channel documentary and a publicity tour by Lis Rinna, a soap opera actress. Boehringer's R&D designed the drug to treat depression but it did not work. Along the way Boehringer discovered that this drug, flibanserin, taken for weeks restores female sexual drive. It works by reducing the brain chemical serotonin and increasing dopamine. Results for this drug in a medical conference report show that the increased self-reported "sexually satisfing events" to 4.5 a month on average, and this compares to 3.7 a month on a placebo, and 2.7 for women not taking any pill. Critics at Georgetown University say this shows how drug companies are medicalizing normal conditions, and working on the insecurities and psychology of people. ...

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Areas for growth for the Indian drug Industry include the large growing domestic market, the outsourcing by US drug manufacturers, and sales in other developing countries of Asia, Middle East, Latin America and Africa. Analyst estimates are that India will spend $30 billion a year on drugs to improve care for its people in the next 10 years up from $8 billion today. And the distribution network is being developed by drug companies insdie India to reach more people. Also companies like Pfizer plan to double outsourcing of manufacturing drugs from 10% today to 20%.

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UK will spend $3 billion more through NHS payment to pharma companies in UK to get the US to cut its pharma tariffs on UK to zero for 3 years. This agreement with UK helps to protect $11 billion in UK pharma exports to the US. For the US it addresses it's complaint that Americans pay more for the same drugs because in Europe the pharma customers pay less, and has called for a correction.

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President Biden removes one of the costly boondoggles thrust on the American people with Bush's Drug Improvement and Modernization Act of 2003, which was anything but an improvement. .The following are the 10 pharmaceutical drugs that will be negotiated for Medicare prices under the Inflation Reduction Act- Eliquis and Jardiance (strokes), Jardiance, Xarelto (diabetes), Entresto (heart failure), Enbrel (arthritis). Laws passed under Republican president younger Bush incomprehensibly took away the right of the government to negotiate drug prices with pharmaceutical companies in one of the most egregious and costly decisions in postwar history by the government of the United States. It has only aggravated the problems and cots of healthcare for the American people. President Biden reversed this with the passage of the Inflation Reduction Act during the pandemic. Strangely it is part of the real culture war in America in which about 80% of both Republicans and Democrats support this but the media allowed the Bush legislation to be passed without saying it made no sense to say this negotiation was a form of price controls by the US government. This is how low the US policymaking had fallen by 2003 with legislators and press unable to make a simple point. Bush's legislation was called even more incomprehensibly the Medicare Drug Improvement and Modernization Act, when it was one of the biggest financial disasters for the American people costing them hundreds of billions of dollars in their savings and incomes to pay inflated prices of pharmaceuticals that people in Europe and Asia (India and China) were not paying.  ...

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How the new marketing approach for drug companies and Pfizer in particular is affecting how Pfizer is marketing an anti smoking drug. the approach is measure and careful and mindful of all the difficulties in making it work for patients including the psychological aspects of smoking addiction.

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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.

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The EU's competition commissioner to crackdown on pharmaceutical companies that are delaying the entry of generics drugs with various tactics that are anticompetitive. EU has raided the offices of several marge drug companies and retrieved documents that show this activity was going on. About 5% of medical bills or 3 billion euros coud have been saved from 2000 to 2007, if companies had allowed generics to enter the market earlier and not resorted to these antitcompeitive strategies. Like paying off generics companies or having so many patents on the ingredients of the drug, in one case 1300 patents on one single drug, and then suing the generics companies to tie up the case in the courts.

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Copies with slight changes to extend drug life with new brand names- Clarinex for Claritin, Nexium for Prilosec, Paliperidone for Risperdal being the latest in this new marketing strategy of drug companies to extend the life and sales of a successful drug. The drug companies try to market the copy drug as a significant improvement, which is what J&J is doing with Paliperidone. Experts are skeptical. Pricing of the generic versions of Risperdal or its copy will be much less expensive. Cost is a sensitive issue. About 15% of Risperdal's $1.35 billion sales were from Medicaid, generic substitutions offer potentially large savings. Meantime J&J did not do clinical tests between Risperdal and Paliperidone, the tests with 1600 patients compared Risperdal with a sugar pill. A psychiatry Professor at Duke and another professor at NYU are skeptical of J&J claims for Paliperidone. United Health shows savings of $150 million by using generics instead of Nexium, so managed care payors will tread carefully....