A blog about chemistry, drug development, science, and technology
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The Washington Post had an article earlier this week where experts questioned whether or not allowing imported drugs would result in significant saving for US customers.
Expert Questions Import Drug Savings - washingtonpost.com
Stephen Schondelmeyer, a University of Minnesota pharmaceutical economist testified that imports would cut U.S. prices by only 12 percent to 20 percent (emphasis mine). I’m not sure what this economist think is significant but for many people on fixed incomes who are paying hundreds or dollars (or more) each month for prescription drugs this is indeed significant! I think it may again be a case of someone in an ivory tower not being in touch with some of the concerns of normal everyday people.
As regular readers know though, this doesn’t mean I favor drug imports. I also don’t think the safety issue usually raised is insurmountable, but it would be costly and I doubt congress would increase the FDA budget enough to allow it to do this job thoroughly and safely. My disfavor of this approach is simply based on populations of the listed countries. Usually this list includes Canada, New Zealand, Australia and some European countries (but never specifically identified).
Excluding Europe for now (I’ll comment on that below) these other countries are so small in population that the US, if even a small percentage of people imported drugs, it would easily strip them of their supplies. Also, some drug companies have already stated that if this occurs, they will only sell certain amounts of drugs to these countries and they would have to decide whether to sell them to their own people or export them to the US but that the drug companies would not allow the purchase of huge amounts of drugs just so those countries could export them to the US.
It should also be noted that in Europe, drug companies must negotiate prices directly with the government since in most cases they are the sole healthcare provider (this could be looked at as another reason why the US should seriously consider universal healthcare, but that’s another subject for another time). If you ask people on the street here in the US if they favor price controls on drugs, most will say no. However, this is basically what would occur. Importing drugs from Europe would essentially be saying we agree with the price controls of foreign governments. If we truly believe that, then why not just pass legislation with price controls tied to those in Europe?
My larger concern is that Congress has a history of giving the FDA additional responsibility but has not given them an increase in funding to achieve those responsibilities. They are already underfunded by most experts estimates and setting up a new system to deal with drug imports would be costly at least at first. Then there are other issues Congress wants the FDA to deal with such as biogenerics and a drug safety database. This is one of the reasons I favor giving the FDA powers similar to the EPA of fining drug companies for infractions of the rules.
The bill being discussed is S424 (S. 242–110th Congress (2007): Pharmaceutical Market Access and Drug Safety Act of 2007
Technorati Tags: drug cost, drug imports, drug price
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Here is a recent article in the Boston Globe. They report that European regulators testified to a congressional panel that some biological products can fairly easily be produced such as insulin and human growth hormone. Others are too complicated to be safely duplicated.
Caution urged on biologic drugs - The Boston Globe
Europe has had biogenerics for the last four years but European regulators have required human clinical trials for these products. I think there is need for talking about what process may be in the best interest of patients and is safe. I’d like to see criteria developed for biologics that would allow it to be determined which can be safely approved in a fashion similar to the current generics model based on bioequivalence, and which would have to undergo human trials. I don’t fall into the trap that some do of insisting it is either one or the other. However I think it may be difficult to draw up guidelines for determining which track a given product should follow that a majority will agree with. That doesn’t mean it can’t happen, but it will be contentious.
Technorati Tags: biogenerics, FDA
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Seems the FDA started podcasting in Feb 06 on drug safety. Only two have been made so far and they are very short (two minutes and seven minutes)
While I find it refreshing that they would do these (and they also provide transcript by the way) it seems that only a few minutes is too short to convey any really useful information. Also, they have a lot to learn about how to do podcasting and making it successful.
It sounds unnatural and stilted. I’m sure they are just reading a script as there in no intonation or dynamics at all. They also need to learn proper mic technique to get rid of popping p’s and hissing s’s. I could barely get through the seven minutes without nodding off due to the monotone nature of the podcast.
While I find it promising they are taking advantage of a new technology, I certainly wish they would have done more to learn about it before putting together such as poorly produced product.
Technorati Tags: drug safety, FDA, podcast
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Here are some article regarding flu pandemics in general and some on the bird flu that have come across my desk recently.
H5N1 bird flu outbreak confirmed on English farm - health - 03 February 2007
About a month ago there was an outbreak of Bird flu on a turkey farm in England. The interesting thing in this article is the timing of the outbreak. It occurred when birds are not migrating and so it was not immediately obvious how this started.
New ScientistPandemic flu may be only two mutations away - health - 01 February 2007 - New Scientist
Interesting article concerning work on how much change needs to occur for H5N1 to have the potential for creating a pandemic. The researchers compared the 1918 flu with the H5N1 bird flu and determined it may only take changes at two amino acids. Unfortunately, they don’t comment on the probabilities of each of these happening and I would note that you have to multiply the percentages to arrive at an overall probability. If one has a probability of 10% and the second also is 10% then the overall probability (assuming both are necessary) is 1%.
World moves closer to having bird flu vaccine: WHO | Top News | Reuters.com
Article about developing a vaccine for bird flu. Mentions CSL Ltd in Australia has developed a vaccine that brins about a strong immune response. Also mentions the GlaxoSmithKline is working on this as well as
The above article concerns Baxter having an agreement with Indonesia and that the Indonesia is no longer sharing samples. They are interested in the IP rights surrounding the H5N1 strain.
An article further clarifying the situation with regard to sharing samples of bird flu from humans.
Flu Preparedness Still Lags Globally - Forbes.com
Report about the World Health Organization report that the world as a whole is poorly prepared for dealing with any sort of word-wide flu pandemic.
Technorati Tags: bird flu, flu, flu pandemic, flu vaccine
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A recent report from the Government Accounting Office (GAO) was released a couple of months ago and I’d not yet commented on it.
New Drugs Declining, Research Costs Increasing, GAO Says - washingtonpost.com:
This Washington Post article gives a good overview of the situation but what is interesting ot me is the wide range of opinions on what the underlying data means. Some in congress use this data to prove this the system need to change. I don’t think that is necessarily the case. There could be many reasons why costs increase and why productivity hasn’t increased. I tend to be of the opinion that the low lying fruit has been picked over and that more research is needed to find better ways to get the fruit higher up on the tree. Adding additional regulation that does not directly effect safety would be counter-productive.
Heres the actual report.
GAO Report on New Drug Development
Technorati Tags: drug cost, drug development
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Eli Lilly is acquiring a small company in Mass. called Hypnion that focuses on sleeping disorders. No financial details were released.
Lilly Announces Acquisition of Hypnion
Hypnion lead candidate is HY10275 and has completed phase I and II trials earlier this year. It would likely be a non-schedule sleeping pill and is suppose to be better than those on the market.
More importantly though is the technology Lilly acquires, the SCORE-2004™ platform which is predictive software for a sleep-wake bioassay system. This could be used to make predictions of what compounds would have the best overall profile. Here is the companies quote:
Using SCORE- 2004™, the world’s only predictive sleep-wake bioassay system, we have profiled and evaluated the universe of sleep-wake pathways, screened known marketed CNS drugs which act on those targets, and optimized the sleep or wake-inducing effects of those compounds in order to produce novel, patentable New Chemical Entities (NCE’s) ready for preclinical development.
We are moving ahead with a robust program which includes multiple scaffolds and clinical candidates that have proven themselves to have distinct advantages in efficacy and safety over the market leaders in insomnia and fatigue including Lunesta™, Ambien™ and Provigil™ as well as soon to be marketed drugs including indiplon.
Interesting to note they don’t mention Rozarem (ramelteon).
If it is indeed predictive, it could be a major step forward in terms of being able to test compounds “in silico” without having to make numerous drugs and test them. It remains to be seen and I personally think these “in silico” system are overhyped and still do not take into account side effects or toxicology problems. However, it is a step forward just not as large a ne as many in the industry make it out to be, at least in my opinion.
As an aside, DTC Marketing Blog has an interesting article from back in November about Rozarem, Ambien, and Lunesta in terms of website traffic. They also have an article of Lilly acquiring Hypnion.
Technorati Tags: Eli Lilly, pharma M&A, pharmaceutical deals, Hypnion
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There have been many reports today, most saying basically the same thing, Here are two that cover the issue.
Report: FDA Eyes Kids’ Cold Drugs - Forbes.com
Warnings sought on kids’ cold medicine - Yahoo! News
The cause of this was a filing by Baltimore health authorities and others yesterday (Mar 1, 2007). A recent report from the Center for Disease Control that noted 1,500 toddlers and babies had been taken to the emergency room because of over the counter cough and cold remedies over a two year period. And the medical examiner in Baltimore noted that at least four children under the age of four have had their deaths linked to these products over a five year period.
None of these products are recommended for children younger than two and all state that it should not be used except under the advice of your doctor. But the report says that many products contain the name “infant” or “baby” such as “baby aspirin”. These along with pictures of mothers holding infants and other children much younger than two are shown in the packaging.
I personally think the warnings are adequate but that some of the pictures and wordings in the packaging should be changed so as to not be misleading. I’d like to see the OTC industry do this voluntarily but I don’t think that will happen. And I don’t think the FDA is likely to step in and require that. It is much more likely in my opinion for the FDA to issue a statement saying that these products should not be used in children younger than two without instruction from their doctor.
This does bring up the bigger issue of how do you determining the proper dosing of these OTC products in children? Most data is from extrapolation of adult data and may not be appropriate to children. THis is really the bigger question and one for which there is no answer currently.
Technorati Tags: drug safety, pediatric drugs
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More pharm lay-offs. This time it is Bayer Healthcare who will layoff 6,100 people world-wide including 1,500 in Germany. This seems to be mainly due to overlap resulting from the acquisition of Schering AG and the down-sizing is set to be complete by 2009.
PharmaLive: Bayer HealthCare Announces Concrete Plans for the Global Synergy Goals and Job Cuts :
Here is a further breakdown of where the layoffs will occur:
3,150 in Europe
1,000 in the US
750 in Asia and Japan
1,200 in Latin America and Canada.
Here is the breakdown by function:
1,400 in R&D
1,850 in production
2,850 in admin
Technorati Tags: down-sizing, layoffs, Bayer
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Seems the external panel of experts has recommended approval of Sanofi’s H5N1 bird flu vaccine. While the FDA doesn’t have to follow the panels advice, they typically do. This despite the fact that the vaccine only showed antibodies in approximately 50% of the people vaccinated.
Sanofi Gets Nod From FDA Panel:
Sanofi Bird-Flu Shot’s Benefit Isn’t Clear, FDA Says
I would comment that vaccination are not 100% effective in all cases. I know from painful experience that this is the case. When I was young I was given a attenuated live vaccine for measles along with gamma globulin. Then as an adolescent, I developed full blown measles.
However to help prevent a pandemic, 100% effectiveness is not necessary. It is only necessary to vaccine a critical number of folks that will help prevent the spread of the disease. Right now, I think that this particular vaccine is not worth the risk unless you happen to be a chicken farmer. No one in the US has ever developed bird flu and right now it is difficult to spread from human to human. There have only been 270 cases in 10 countries world-wide. An interesting comment in the article is that this vaccine will NOT be commercially available and that governments will likely stockpile it to protect first responders and healthcare workers if needed.
Technorati Tags: bird flu, vaccine
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Several additional lay-offs have come across my desk recently for the pharmaceutical industry and I thought I would list them.
Pfizer to cut 10,000 jobs in Japan
Dated 1st March it reallt deals with the issues Pfizer announced these back on Jan. 23.
Abbott cuts 200 scientists, hundreds of drug reps | Chicago Tribune
From a Feb 26th article that Abbott will be getting rid of 200 scientists mainly in drug discovery and an unspecified number of sales reps. Tje drug discovery units effected are early discovery, and metabolic research in areas such as obesity and diabetes.
delawareonline ¦ The News Journal ¦ 50 jobs to be cut at plant in Bear (near Newark, Delaware): AstraZeneca to shed 3,000 jobs by 2010.
Let’s hope that these trends don’t translate into much higher employment in the coming year.
Technorati Tags: Abbott Labs, AstraZeneca, down-sizing, layoffs, Pfizer
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