August 29, 2013

Pharmaceutical Dilemma: New Antibiotics Needed to Fight Superbugs

CECON posted an article for titled: "Should there be a TARP for Public Health Superbug Issues?"

Read the full text of the article below:
 TARP Approach for Public Health Superbug Issues?

In March 2013, both the U.S. Centers for Disease Control and Prevention (CDC) and the chief medical officer in England, Sally Davies, sounded the alarm about the current infection dangers that are rapidly growing in severity, stemming from the “nightmare bacteria” such as the E.coli and CRE superbug strands.  At the moment, there are only seven new treatment drugs currently in development and that are being tested on people with infections that are drug resistant and gram-negative.

The CDC made their statement based on the most recent data that has been released by the Infectious Diseases Society of America (IDSA) which showed the results of having monitored the number of bacteria that are capable of remaining resistant to even the strongest antibiotics available in today’s treatment arsenal.

At the very heart of these announcements is the suggestion that the world may be on a rapid path back in time to the days before antibiotics could come to the rescue and keep patients safer from infection following premature birth, surgery, or chemotherapy.  In the words of Dr. David Relman, the president of the IDSA, in a statement he released following the report “Simply put, the antibiotic pipeline is on life support and novel solutions are required to resuscitate it – now”.

According to the author of the IDSA report, Dr. Helen Boucher, a Tufts Medical Center infectious diseases expert and IDSA board member, “We’re all at risk.”.  Boucher explained that she feels this way because health officials are not only failing to move forward, but they are actually losing ground because the drugs simply are not being developed fast enough to keep up with the evolution of these superbugs in building resistance. There is an “alarmingly low” number of antibacterial compounds in the phase 2 or 3 of development trials right now.

Drug resistance isn’t anything new.  Bacteria has been growing resistant to available drugs since shortly after penicillin first made its way into pharmaceutical use in 1940.  This has also been the story with each new generation of antibiotics that has been developed since that time.  The blame for this has been aimed directly at the misuse and overuse of each of these different forms of drug.

It is already known that not all of the antibiotics currently being tested will make it all the way through the development process.  Among the seven that were identified as being in phase 2 or 3 of development, the company behind one of the drugs, Polymedix, has already filed for Chapter 7 bankruptcy.  Another company, AstraZeneca, which is the manufacturer of two of those drugs, has announced that it will be moving forward with a smaller investment into the development of antibiotics. The remaining companies include GlaxoSmithKline, Cubist Pharmaceuticals, Merck, and Achaogen Inc.

The IDSA is now seeking new and innovative economic incentives to help to encourage pharmaceutical companies to turn their attention back to the development of antibiotics.  Could a TARP-like approach (used to strengthen the financial sector) for the pharmaceutical industry be a solution to this public health crisis?
The author of this article. Mike Fisher, is the President of The CECON Group, Inc..

August 15, 2013

A Better Silica Gel – By Accident?

Researchers in Uppsala, Sweden accidentally left a reaction running over the weekend and ended up resolving a century-old chemistry problem. According to Science Alert: “Their work has led to the development of a new material, dubbed Upsalite, with remarkable water-binding properties.  Upsalite promises to find applications in everything from humidity control at home to chemical manufacturing in industry.”

Currently, silica gel is the most common desiccant (or drying agent) on the market. Silica gel packets can be found in almost everything you purchase including shoes, foods, medicines, and electronics. Silica gel absorbs and holds water and is easily contained in fiber packets due to its large particle size. It does not react chemically with most substances and is safe in proximity to food.

However, the newly formulated Upsalite, or dry Magnesium Carbonite (MgCO3), may be an even more efficient desiccant than silica gel due to its larger surface area. The obstacle to overcome: Upsalite  may not be easily contained in porous packages due to its small particle size.

It will be interesting to see how this discovery is integrated into commercial products and chemical processes.

This article was authored by an employee of The CECON Group, Inc., which has been providing chemists, chemical engineers, pharmaceutical consultants, and other scientific and technical experts to businesses and law firms for over 25 years.

August 1, 2013

Why Hire a Consultant to Point out the Obvious? A Business 101 Reminder

As the person who knows the most about your business, aren’t you the obvious choice to uncover your issues and find the best solutions?

In the article below, a CECON business expert outlines how a consultant can offer a fresh perspective and  see things that you may be overlooking. While the examples are basic, they show how a few hours of a consultant’s time can often  pay for themselves in increased profitability.

Case 1.  A restaurant owner couldn’t figure out why his business wasn’t doing nearly as well as  his market predictions. He had quality food prepared very well, slightly high yet not unreasonable prices, and had just refurbished the restaurant. The business just wasn’t there. He told me about this and said that it must be “the economy.” I told him it wasn’t the economy and then asked him where he was located during the restaurant hours. He said, “In the back office with the accounting books.” I suggested that he get out at the hostess’s desk. He did that and saw that she wasn’t there half the time. He also saw that the employees - servers and busboys - that walked by the front area didn’t look at the customers waiting at the hostess’s area. He also saw that two out of three waiting customers walked out in less than 5 minutes.

I told him that I thought he had his employees take a graduate level course in “how to avoid eye contact or any communication with the customers” since they were very good at it. That avoidance was the reason people left the restaurant. He actually had the customers in his restaurant and then - by ignoring them - invited them to leave.

I said “All your predictions about how many persons will come to your restaurant are true. The fact is, they come to your restaurant and then leave after being ignored. You measure how many meals you serve; you don’t measure how many meals you lost due to people leaving. People who enter your establishment like to be acknowledged, and don’t like to be kept waiting. When you are there greeting the customers, they stay. Instruct all your employees to smile and say “Hello” to the customers.

The problem was in front of him but he wasn’t looking. Also, the solution was in front of him, a solution which he implemented promptly.

Case 2.  Let’s call the product “Widgets.” A company was very successful in producing the highest quality widgets. Then suddenly, customers began returning their orders because the company’s quality had decreased significantly. This puzzled management since they had always been committed to high standards. When I asked the President what may have changed just about the time the quality dropped he said, “Nothing changed. I don’t understand this.”

Of course he said that nothing changed. If he knew what changed he would have fixed things himself. After I convinced him that something changed, otherwise the orders wouldn’t be returned, and that he simply hasn’t yet identified it, he emphasized that he even installed a bonus program for the plant manager.

When I said, “Isn’t that a change?” he said that he didn’t think about that.  I asked what the bonus was for. The reply was “For the amount of product shipped, of course.”

Now, jumping to the end of the story, the problem was that the bonus for the plant manager was for the number of items shipped and not for the quality of the items. Nothing was deducted from his bonus for the number of items returned. Essentially, the plant manager was directing all his thoughts to his bonus and was shortcutting quality in production by shipping everything that the plant made. He did this to get a nice bonus. That was his motivation. As a result, the quality was slipping and the customers were leaving.

The answer to the problems of loss of customers and decreased quality was not hidden. It was just overlooked. The two cases presented above have the common feature that the problems - and the solutions - were immediately in front of the persons.

Sometimes you need to engage the services of a consultant to see what’s in front of you because you’re too busy with other things to see such problems and solutions. The consultant provides concentrated effort on identifying and solving problems, with no distractions caused by other things. The consultant is also looking at the problem as an outsider, with a fresh, unbiased perspective.

There is an adage with consultants that if you want to know what the problems are, just ask the persons on the line. They will tell you. If you want to know what the solutions to those problems are, just ask the same persons on the line. They will tell you.

Why doesn’t management do that? They are too busy with other things. Maybe a consultant could help.

The author is a Former FDA Employee, Regulatory Consultant, Expert Witness and Pharmaceutical Chemist. He has written management textbooks, works of fiction, and short stories, and is a consultant with  The CECON Group, Inc.