Posts Tagged ‘ Pharmaceutical Industry ’

The Institute of Medicine stands outside the government, offering independent advice to both the decision-makers in government and the public. As a nonprofit, its mission is to improve the quality of the healthcare services by providing detailed policy suggestions based on the best available evidence. This July, it published a highly critical report on the continuing refusal of the medical profession to accept comparative effectiveness research. This is work to discover which treatments are the most effective. At present, we are left to guess which treatments offer the best outcomes for each illness or disorder with little effort made to collect evidence on safety and quality. Hence, at one end of the scale, we can go years without knowing a particular drug or surgical procedure is ineffective. Or we can find ourselves participating in unofficial trials where doctors talk patients into off-label experiments with drugs.

Unfortunately, this is all part of the general lack of accountability within the healthcare services. The present culture allows the pharmaceutical industry and the doctors to dictate the treatment standards based on what generates the most profit for them. The idea such people would actively seek evidence to show whether their cherished treatments were medically effective is a nonstarter. There’s no willingness to engineer a learning environment where everyone tries to improve. Rather everyone wants to avoid any liability for errors of judgement and mistakes. Imagine the litigation if it emerged that doctors had for years been advising we agree to ineffective treatments.

Until there’s a major change in the culture, we will have to look with envy at the approach of the Europeans in the pain management field. As a symptom of our problems, the words “pain management clinic” in Florida and certain other states usually indicates a borderline illegal operation to sell pills. We should modify all aspects of the current service. The first reforms should affect the health insurance industry and the public bodies like Medicaid and Medicare. At present, these administrators and business people simply pay out on the bills submitted by the hospitals, clinics and doctors. Since the taxpayers fund the entitlement systems and the rest of us with money pay ever higher premiums, there’s no pressure on insurers to demand value for money. They are not there to guarantee good quality care for their insured. All they do is pay out on the bills and pocket the rest as profit.

At present, it suits everyone concerned with pain management to do as little as possible. That means the shortest possible consultations followed by the prescription of one of the standard drugs, the most effective being Tramadol. This gives everyone in the healthcare services industry the maximum possible profit with the least possible effort. If they were to adopt the European model of one-to-one treatment by physical therapists, cognitive behavioral therapists, and so on, the labor costs would rocket and profit would decline. So there’s no chance of a team-based, patient-centric approach in our great nation. Further, any evidence that might show the European approach to be more effective in medical terms must be suppressed. Everything possible must be done to reinforce the current practice standards. That means you take another Tramadol and accept second best.

You have probably noticed Washing almost produced a default on “foreign” debt. The Republican party held the government hostage to force action on the deficit. Now don’t be misled here. There are real problems in owing too much money and, truth be told, we do owe too much as a nation. But there are a number of real problems if the only strategy government is allowed to discuss is where to make cuts because there comes a point when you stop cutting the waste and the redundant programs, and start cutting the socially useful programs. At some point, we need more revenue. That said, there’s a big issue to talk about here: the Affordable Care Act or Obamacare. In theory, this is a good idea. If you force everyone to pay for their care, the premiums for everyone will fall and we all benefit. But forcing everyone to pay may not be constitutional and it does nothing to control costs.

The government is the biggest buyer of drugs through Medicare and Medicaid. It has the power to negotiate with the pharmaceutical industry on the price for each drug. If it used this power, it could save the country billions of dollars and, as individuals within health plans, we would all see our premiums drop. All it takes is for the government to show a little concern for taxpayers. Except that would mean cutting the profits of the drug manufacturers and the President backed away from that during the first stages of trying to get the bill into law. He thought it was more important to get the votes for the law and worry about the costs later. Put another way he realized too many Democrats take lobby money from Big Pharma and would not vote for his law.

In other countries, governments direct the medical profession on what they are allowed to prescribe. So where there’s a choice, doctors are only allowed to prescribe generic drugs and not the brands. Even where branded drugs are still under patent protection, doctors in the public sector may not be allowed to prescribe the drugs if the regulators consider the prices too high. This leaves patients with the option of paying for the drugs out of their own pocket or, if they have private insurance, negotiating with the insurer to pay. Yes, this cuts into the profits of the drug companies, but which is more important? That a country should have an affordable healthcare service? Or that the profits of a few drug companies should be allowed to grow without limit?

A recent report on healthcare policy called for a revolution in the culture of American healthcare. It argued there should be a radical change in the attitude of both government and the insurers, forcing the pharmaceutical manufacturers and doctors to reduce their profits. Note the force of this article. It’s on a site encouraging you to use Tramadol as your drug of choice if you are in pain. This is the generic version of Ultram which is sold at significantly higher prices. This site is trying to be responsible in encouraging you to use the cheaper Tramadol. As an approved generic, it’s exactly the same as the more expensive brand. There’s no need to pay more.

The webinar, entitled ‘Building Green Pharmaceutical Manufacturing on a Foundation of PAT and QbD’ will be held on Wednesday, November 3, 2010, and METTLER TOLEDO invites participation from interested parties.

In the webinar Paul Thomas, Senior Editor of Pharmaceutical Manufacturing, will present an overview of how the Process Analytical Technology (PAT) framework and Green Manufacturing initiatives complement and reinforce each other in the pursuit of research and manufacturing efficiency in the pharmaceutical industry.

Paul Thomas, Principle Scientist METTLER TOLEDO said, “Although the Quality by Design (QbD) and PAT efforts extend beyond the goal of safe and sustainable manufacturing, many of their objectives are in complete agreement with principles of Green Engineering, which emphasize maximizing efficiency; preventing waste and reducing energy consumption.
“Efficiency, quality and sustainability are key focuses for METTLER TOLEDO and our customers, and we are sure that this webinar will stimulate interesting discussion and ideas.”

The webinar will incorporate case studies illustrating how the application of PAT and Green concepts are mutually beneficial in the development and operation of sustainable manufacturing processes.

An interactive Q&A session at the conclusion of the seminar will allow participants to ask questions relevant to their individual applications.

In this webinar, Paul Thomas, Senior Editor of Pharmaceutical Manufacturing, will present an overview of how the Process Analytical Technology (PAT) Framework and Green Manufacturing initiatives complement and reinforce each other in the pursuit of research and manufacturing efficiency in the pharmaceutical industry. Case studies will also be presented to illustrate how the application of Process Analytical Technology (PAT) and Green concepts are mutually beneficial in the development and operation of sustainable manufacturing processes.

Although they began on different paths, the Principles of Green Chemistry and Engineering share plenty of common ground with the Quality by Design (QbD) and Process Analytical Technology (PAT) initiatives. Full process optimization must take a holistic view of health, safety, environment and economic concerns; and applying the principles of Quality by Design (QbD) and Process Analytical Technology (PAT) to the design of a robust pharmaceutical manufacturing process should result in improvements in process efficiency, process consistency, and product quality. The application of QbD builds a higher level of 
process understanding to facilitate the robust design and scale-up of optimized processes. The application of PAT enables the monitoring and control of manufacturing processes to minimize wasted time, energy and raw materials – assuring product quality while improving overall production throughput and profitability. Although the QbD and PAT efforts extend beyond a goal of safe and sustainable manufacturing, many of their objectives are in complete agreement with select principles of Green Engineering which emphasize maximizing efficiency, preventing waste (rather than treating it), and reduction of energy 
consumption.

Registration for the webinar is free and can be completed online at http://us.mt.com/us/en/home/events/webinar/live/qbd-pat.html

Looking around the journals published so far in 2010, it’s clear the research community is finally beginning to challenge the assumption that America should be medicated. If you listen to the pharmaceutical industry and the doctors who are paid to stand up and promote drugs as the best treatment for any disorder, you will hear a consistent pattern of propaganda. All our products have the FDA seal of approval. The clinical trials show our products are safe and effective. The health insurance industry pays most of the price for our products (only a small co-payment element for you). Take our pills and get better. Indeed, when it comes to the top-selling sleeping pills, there are record numbers of prescriptions being written by doctors. The reason? Well, its not hard to suspect stress levels are increasing thanks to the recession. Unemployment is high. Credit levels have been reduced, There are foreclosures in every neighborhood. That’s bound to make sleep more difficult. What’s curious about the new records being set in the number of prescriptions is the additional financial burden this places on families when they can least afford it, and the implied assumption that sleeping pills can cure the underlying social and economic problems causing the stress.

The Journal of the American Medical Association reports talk therapy is more effective than sleeping pills. The research team gave the participants sleeping pills alongside therapy sessions and measured which had the better outcome. Because the talk asked why people were finding it difficult to sleep and discussed ways of resolving problems, people with the therapy sessions had better sleep than those on pills. This follows on research testing the effectiveness of cognitive behavioral therapy (CBT) which teaches people how to change their habit patterns to restore sleep. Therapists encourage people to avoid naps during the day, adopt a set routine for going to bed, and physically change the bedroom to minimize light and noise that might disturb sleep. When combined with techniques to address the cause of stress and relax, CBT has consistently been found to outperform sleeping pills.

When you look at the statistics, there can be little doubt we use too many sleeping pills. Add in the increasing use of online pharmacies which supply drugs without the need for a prescription, and the scale of reliance on sleeping pills is almost certainly worse than we imagine. Why should we care? Because all the sleeping pills on the market can cause dependence. As people continue to take them, tolerance builds and the pills actually become less effective. Increasing the dose confirms the dependence and can lead to unwanted side effects. Yes, ambien is one of the better pills and there are fewer problems with its use, but if your insomnia has been disrupting your life for six months or more, you should consider undergoing therapy first. CBT is clearly the best. To help you focus during this learning period, your doctor may offer the use of a sleeping pill. If you decide to accept, ambien is the best but you should only take it for a few weeks at low dose. The long-term restoration of sleep is going to come from the therapy. Although this is a short-term cost to meet, your life will improve with natural sleep and your finances will be better of without having to buy sleeping pills for the rest of your life.

In different cultures at different times, there have been radically different views of female “beauty”. Some cultures have seen women as most desirable when they are voluptuous. The reason is not hard to find. When a family is rich, it can afford to buy all the best food. This shows most clearly in the children, particularly the girls and women who are less active than the boys. So when food is generally in short supply and what you can afford is not very nutritious, you almost certainly grow up thin. When you are looking to marry money, you therefore look for a well-padded son or daughter of marriageable age. At other times when even the rich cannot find good food, everyone makes a virtue of being thin, even accentuating the figure by using corsets to pinch in the waist to the disappearing point. In modern times, the one question of body size has been hijacked by big business. Magazines are full of pictures showing young women of painful thinness. This makes the ordinary person dissatisfied. The food industry therefore sells weight loss meals. The pharmaceutical industry sells pills and diet supplements. The publishing industry sells walls of books on weight loss, healthy eating, nutrition, cooking for weight loss, and so on. The world grows rich on the backs of those in search of weight loss.

So, cutting through all the hype and marketing double-speak, is there any one diet or strategy to make weight loss easier? Surely one of the books that sell in their millions, must have some value? Well, if weight loss was easy, no-one would be overweight. No matter who you are, where you live or what your lifestyle, shedding unwanted pounds is a challenge. The most interesting piece of research came out in February, 2009. It allocated a large group of people to four diets with different levels of fat, proteins and carbohydrates. Each of the four diets was nutritionally sound and offered healthy outcomes to the cardiovascular system. People were followed over two years and encouraged to keep the diet going for as long as possible. There were no significance differences in the results. Everyone lost an average of 7% of their body weight regardless of the diet followed. So here is a message from someone without a book to sell. People who follow a calorie-reduced diet lose weight regardless whether that diet is high- or low-carb, high- or low-fat, high- or low-protein.

The biology could not be easier to describe. We store fat in our bodies against the need for energy when there is no food to eat. At that time, we burn the fat to give us the energy we need. An effective diet tricks the body into burning the fat. It’s the equivalent of a famine. The lower the calorie intake, the faster you burn the fat, but the more hunger you will feel. This is where a drug like meridia becomes so important. This is one of the leading appetite suppressants, sending a message to your brain that your stomach is full. If you stop feeling hungry, it’s easier to keep to the diet. Over time, your stomach will naturally contract and you genuinely will be full when you eat smaller portions. Meridia helps you lose weight safely.