QDIS Blog

This article concerning changes in over-the-counter (OTC)cold medications is interesting.

Phenylephrine reformulation a flop?

The basic story is that in order to prevent pseudoephedrine from being extracted from OTC products and made in methamphetamine (aka crystal meth). The main product being used instead is phenylephrine. Below are the structures.

While these two compounds are similar in structure, they have very different effects in the body. I have heard personally from several folks who say the phenylephrine formulation is either totally ineffective compared to pseudoephedrine or not nearly as effective.

Here in Oregon, all pseudoephedrine products are behind the pharmacy counter and require filling out form and only a limited amount can be purchased.

This is another case of hurrying a “solution” without it being investigated. To my knowledge, no studies have been done comparing these and the article points this out. All medications must be both safe and efficacious. But again a lot of money would have to be spent for a small benefit in terms of the pharmaceutical company. That is there return in investment would not be large enough to justify studying it without some sort of incentive. Now, I think incentives can be abused but that this is an areas (along with orphan drug status) where it is worth it in the long run. This is an areas that I think the government should get into. Testing of drugs in some limited context when there is a overwhelming interest to consumers is where the government should get involved.

i personally think that a better effort would be to reformulate pseduoephedrine in such a way as to make it almost impossible to extract the active ingredient for making meth. However, again, the pharma companies are not going to invest a large amount of money into doing this since the pay off would be low compared to other possible activities they could invest their time and effort into. This is where a small company could make some money in collaboration with the government.

It remains to be seen what will be the outcome. My best guess is that phenylephrine will be withdraw as a cold medication due to lack of efficacy and that pseduoephedrine will continue to be available only directly from the pharmacist and in limited amounts.

Technorati Tags: col medicines, phenylephrine, pseduoephedrine, reformulation

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I found this recent article about the changes occurring within the biotech industry interesting.

SignOnSanDiego.com > News > Business > Biotechnology — Good old days gone for biotech:

Basically it talks about outsourcing and how it is impossible for US discovery businesses to compete on the basis of price with India or China. It is telling that large pharmaceutical companies such as Pfizer, are trying to get US companies to compete head to head, based on price with companies overseas. While I understand their need to get the lowest price, I also believe there is more to such contracts than just price. I think companies need to think about more than just price and to think loner term rather than the bottom line of the next quarter. If these higher paying jobs such as chemistry and biology are outsourced, what is left for those in the US even with an advanced degree?

Previously outsourcing use to be primarily in the manufacturing industries such as automobile parts or refrigerators. Now, it is increasingly moving to higher value industries and the pharmaceutical industry is a prime example. I personally have been caught up in this, not so much from an outsourcing perspective but from a merger of which cost cutting was a major factor. It was cheaper in a foreign country to hirer someone to do my job than to pay me the going wage in the US. I do not oppose outsourcing directly, but do ask what is to become of US citizens who no longer have a job. The common refrain is that there will be other jobs for the next “big thing” here in the US. But I argue that this has not happened and when I ask, no one can point to what the next “big thing” is.

I think too much focus on price has occurred and there needs to be a lot of thought given to whether or not outsourcing of almost everything is in the best interest of the US as a whole. This applies not only to large companies but also to individual. Our obsession with the cheapest price drives jobs overseas in order to meet those low price demands. By purchasing the cheapest items, we are indeed encouraging outsourcing. Instead of focus on bringing prices down, we should focus on increasing wages and better jobs here at home.

Technorati Tags: outsourcing, biotech

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Outsourcing is a hot topic and is really coming to the fore in the fine chemicals and pharmaceutical industries. A new twist on that is now the outsourcing of animal testing. The Boston Globe had a recent article.

Outsourcing animal testing - The Boston Globe

I’ve also seen some of this. At the last Informex meeting in Jan 2006 in Orlando, there was at least one company that was focusing on animal testing and other pre-clinical services located in China. They claimed to have a great facility and the ability to do whatever testing was needed. Most of the principles were also educated in the US. It is interesting that almost all aspects of e drug develo-pment process are now being outsourced.

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Much has been written recently about the issue of the government being able to negotiate with drug companies for prescription drugs covered under Medicare. Here are just a few of the recent articles.

Drug Industry Is on Defensive as Power Shifts - New York Times
On drug prices, are Democrats in a fix? - Los Angeles Times
Why Medicare Drugs May Be Sticking Point - WSJ.com (free content)

Some argue that by allowing the government to negotiate you limit the number of drugs that will be covered. I don’t know that I agree with that. In cases where there are many drugs, which is the case for the most prescribed drugs such as statins there will be competition. In cases where it is the only drug to treat a given disease, the prices will be higher but that is understandable., When you have something unique in the market you should be able to demand a higher price.

However, healthcare just like energy are not the same as other products in the free market and I don’t necessarily believe those rules apply. That’s because regulations are already in place and the fact that for drugs, the rest of the world has price controls, means that it isn’t a free market. I also think the chances of the US convincing the rest of the world to come over to our market of drugs is impossible. Therefore, we have to come to some sort of decision on where we go from here and the status quo is not the answer. I don’t claim to have an answer myself and it will be interesting to see how this issue develops in the next year or so.

Technorati Tags: drug cost, drug price

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I am working on the next full episode of my podcast Searching the Internet and came across a new (at least new to me) site called Become.com. This allows you to find information on a great variety of product and where they are available online. It has a nice interface that allows you to refine your initial search by color or brand or store or price. I’ve found it useful and easy to use. They claim to cover 3.2 billion pages of products and information on a wide range of items.

You can get an overview of all the services they offer. I’ve found it very useful and wanted to let others know about it now that were are in the middle of the holiday shopping season.

Technorati Tags: Become.com, shopping

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I finally got around to watching the latest episode (Nov 21, 2006) and found segment on the 1918 flu pandemic and the bird flu to be very informative for the average person. It does a great job of describing many of the issues in a way that everyone can comprehend. You can watch the segment at the link below. THe file is in Quicktime, Real Video and Microsoft Media formats.

NOVA | scienceNOW | 1918 Flu | PBS:

I highly recommend it and think just about everyone in the general public will find it informative.

Technorati Tags: avian flu, bird flu, sciencenow

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In another recent deal, Biota, an Australian company has entered into a deal with Boehringer Ingelheim to develop and commercialize Biota’s nucleoside analogues for treatment of Hepatitis C.

PharmaLive: Biota and Boehringer Ingelheim Complete US$102 Million Licence for HCV Program :

The deals is worth $102 million to Biota based on meeting certain milestones. Biota would be responsible for discovery research and Boehring Ingelheim would be responsible for development and commercialization.

Hepatitis C virus(HCV) is a long standing target for many companies and one that hasn’t paid off yet. Although there are a couple of treatments for it, they are biotech products that require weekly injections. The hunt for a oral drug has not yet been successful. I remember work being done on this at Bristol-Myers Squibb way back in 1994. It would indeed be a major step forward since HCV infects approx. 170 million people and an additional 3-4 million are newly infected each year. Of these, approx. 4.1 million are in the US and of these 3.2 million are chronic.

Other Sources

WHO | Hepatitis C

Hepatitis C: Fact Sheet | CDC Viral Hepatitis

Technorati Tags: Biota, Boehringer Ingelheim, Hepatitis C

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Actelion is going to acquire Cotherix for $425 million in another recent pharmaceutical deal.

PharmaLive: Actelion Announces Definitive Agreement to Acquire US-Based CoTherix, Inc.:

Again this deal is at a large premium; 72% over the closing price approx. a month ago. The main product from CoTherix is Ventavis (iloprost) an inhaled treatment of Pulmonary Arterial Hypertension (PAH).

This is another case where companies with a long-standing relationship eventually ends up in an acquisitions. Again the deal makes sense from a strategic point of view since both have a focus on PAH but I tend to think that again the price may have been too high.

Technorati Tags: Actelion, Cotherix, pharma M&A, pharmaceutical deals, iloprost, Ventivis

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I should have posted this earlier but I decided to take some time off and relax over the Thanksgiving holiday and not post. I needed some down time and besides, the college basketball season got off to e flying start with several tournaments and it was great to just relax and watch some good college basketball.

I’m working on several posts and will be back on a more regular posting schedule now.

Hope everyone in the US had a Happy Thanksgiving.

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There has been lots of press recently about how the new Democratically controlled congress could impact the drug and biotech industry. Many of those I’ve read have a negative outlook and appear to me to focus on the negative without talking about what the possibility of these coming fruition. Here’s just one example:

newsobserver.com | Drug companies going on defense

Although the Democrats have a narrow majority, they do not have enough votes to override a presidential veto. I think we will see many more vetoes in the next two year and many of these will likely be concerned with the prescription drug and biotech industries.

Here are just a few of the issues I think Congress will attempt to deal with.

• Biogenerics
• Vaccine manufacturers protection from liability
• Add the ability for the government to negotiate pricing for medicare drugs
• Importing of Canadian drugs
• Drug safety in general including
• Food safety

All of these are complicated issues and SHOULD involve folks on both sides talking about what they can do to make it better for the majority of Americans. However, I am fearful that it will turn into the usual finger pointing and trying to protect turf and profits without regard for what is best for the majority.

For a decent article on the biogenerics issues check out this article in the LA Times.

Generic biotech drugs backed - Los Angeles Times

Technorati Tags: congress, drug cost, drug price, drug safety, food safety

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