QDIS Blog

The 16th International AIDS conference is underway in Toronto and this article talks about the big picture and how the disease spreads from a world-wide perspective.

AIDS researchers : single strategy won’t work - Yahoo! News:

Basically, there are different causes for different areas and one of the major causes is the increase in heroin production in Afghanistan in central Asia, eastern Europe, and the former Soviet Union! There the disease is predominate among drug users particularly heroin. I find it interesting that the US invades Afghanistan and then the heroin production dramatically increases?!

The basic idea is to understand what human actions or ideas may contribute to the spread of the disease. In different areas and cultures, there will almost certainly be different issues that need to be addressed in fighting the disease. We can have drugs to control the disease, but preventing its spread must involve an understanding of the local culture and issues that must be addressed with education.

Technorati Tags: aids drugs, HIV drugs

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Occasionally I come across articles that truly pull on your heart strings and this is certainly one of them.

Costly drugs force life, death decisions - Yahoo! News:

The article covers patients who forego treatment due to costs. I should point out though that these are primarily patients deciding that the highest cost of the drug is not worth a few months of possible extended life. It isn’t necessarily that they can’t afford it but more that the cost isn’t worth the benefit.

One of the downsides of biologics is the high costs. These materials are much more expensive and difficult to produce. One of the major roadblocks to generic version is the lack of agreement on what testing is necessary for such approvals. While Europe is well on its way to having a process in place, the FDA still seems to be waiting around for something to occur rather than taking the lead and setting up a process to use to approve these sorts of drugs regardless of what they are called. Whether you call them follow on protein products or you call them generic biologics, the bottom line is there needs to be a process for this to happen and sooner rather than later.

Technorati Tags: biogenerics, drug cost, generic

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Since I try and spend a week each year in Hawaii for a vacation and I have some friends and fellow podcasters there, I always keep my eyes open to what may be happening there in terms of biotech companies.

Ruling hailed by opponents of genetically altered crops

In a nut shell, a federal judge ruled that the US agriculture officials cut corners and violated some environmental laws by allowing permits for genetically modified crops meant for producing drugs. The islands involved are Kauai, Maui, and Molokai and the laws involved are the Endangered Species Act and National Environmental Policy Act . The primary problem was that no preliminary environmental review occurred before the permits were issued. This has been in the courts for more than two years now and potentially has impact beyond Hawaii to all GM permits issued throughout the US.

Now, I am one of the first to state that I support the use of GM crops to make drugs but I also believe that all the processes and procedures need to be followed and that concerns for locals needs to be clearly and straight forwardly addressed. I also agree that we need to be cautious as there is always the law of unintended consequences. I also know Hawaii is a fragile environment and can be easily disrupted by introducing non-native animals and plants. Feral pigs on Kauai are an example; they root out endangered plants and destroy habitat for other animals found only in Hawaii.

I see again the polarization of this issue by the both sides and it seems no one is willing to be reasonable and look at the facts and concerns. Each side only wants what best for themselves and chooses to ignore arguments from the other side. I have also seen in the past exaggerations on both sides that do not fit scientific facts.

The companies involved are:

1. ProdiGene (web page no longer available; here is the last home page from the Internet Archives)
2. Monsanto
3. Hawaii Agriculture Research Center
4. Garst Seed

It should be pointed out that no one is currently biopharming or growing crops to produce drugs in Hawaii and that all of the above companies currently have any crops planted.

Also, all parties are order to appear in court next week (Aug 22) to discuss remedies. This will be an interesting case to keep an eye on to see what remedies are agreed to.

Other resources

• Officials cut corners on biotech permits

• First Ever Federal Court Ruling on Controversial Drug-Producing GE Crops Manufactured by Monsanto and Others - Yahoo! News
• Copy of the court ruling (pdf)

• USDA Inspector General’s report (pdf)

• Yahoo! News Search Results for Hawaii biotech permits

• USDA - APHIS (US Department of Agriculture: Animal and Plant Health Inspection Service)

Technorati Tags: biopharming, biotech crops, genetically modified crops, GM crops, hawaii

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Gilead and Merck will be distributing the new AIDS drug Atripla, a drug drug combination in a once-a-day pill, to developing countries.

Gilead, Merck to distribute combination AIDS pill | Reuters.com

One interesting fact is that the pills for developing countries are white whereas those for US and Europe are salmon colored. While this article doesn’t state why, it is most likely to prevent cheaper version from developing countries from make their way into the US and Europe.

The major take home fact here is that there is now a single, once-a-day pill which replaces a regime of taking dozens of pills and tablets at specified times through out the day. This is especially important in developing countries where obtaining drinking water is difficult. Also, not having to take the drugs on a schedule makes compliance much easier. It should be kept in mind that one of the most serious issues confronting AIDS is the virus developing resistance to known drugs.

Technorati Tags: aids drugs, HIV drugs

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Occasionally my reading material stacks up and I have to set aside some time to go over it and read through all the various trade journals and magazines I get. In the course of that exercise, I came across a good article on HIV/AIDS in Drug Discovery and Development.

A Quarter Century of Battling HIV/AIDS

Since the XVI International AIDS Conference is occurring in Toronto, Canada this week, I though it was a good time to alert folks to this.

Basically 21 drugs have been approved since 1987 or about one per year. And this doesn’t include the recent approval of Atripla, the three drug combo for once a day dosing. I’ll post more about some developments on Atripla later this week.

Technorati Tags: aids drugs, HIV drugs

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Healthworld IT is reporting that Steven Paul, executive vice president at Eli Lilly is stating that the cost to develop drugs could top $2 BILLION by 2010 if changes are not made.

Drug Costs Nearing $2 Billion, Warns Lilly Executive

Other than mentioning the FDA’s Critical Path Initiative there isn’t much else new here. The one point that always seems to get mention is the need to reduce the attrition rate in phase II. Currently only 20% make it to phase III studies (one on five). Biomarkers may help with this but I still think that your are always going to have phase II as the place to make go-no go decisions. This makes sense if you stop and think about it. This is the first place where it is tested in humans for the disease indication and the first time it is tested in more than a few people. It should be expected that this is where potential drugs are going to fail. Until we develop much better animal models, this will continue to be the case.

I do think the talk of allowing the use of biomarkers and possibly allowing drugs to go onto market for those identified with certain biomarkers after a successful phase II study could help. However, I don’t see this happening anytime soon as a lot of processes and procedures would need to be put into place before it could be eliminated.

I do find the following quote from the article to be interesting:

The effective patent life of blockbuster drugs is approaching 10 years, said Paul, who contrasted that short lifespan with the 50 years of copyright protection enjoyed by Mickey Mouse! “We should start the clock when the drug reaches market,” Paul suggested.

I think pharmaceutical executives tend to forget or overlook the current attitudes of consumers. There is already much talk about how expensive drugs are and this seems to play right into the view of some consumers of pharmaceutical companies being greedy. While increasing potential income is one approach, I think there is much more room for improvement with the lead discovery to phase II stages.

Technorati Tags: drug development, drug cost

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I mentioned in a previous post that R&D directions magazine had a cover story entitled “From Pipeline to Market” about the state of drug development and I gave a few numbers from that in terms of the number of drugs being developed for various indications.

Now, the trade magazine Contract Pharma has their cover stories “Top 20 Pharmaceutical Companies” and “Top 10 Biotech Companies“. Both of these are gold mines if you want to know who is doing what and how well is each drug is doing. Kudos to Contract Pharma for putting this together. The companies are ranked on the basis of revenues.

Here is a sampling of what is included for each pharmaceutical company; headcount, total revenue (and the change from the previous year), net income, and R&D Budget. For each company it also lists drugs approved/launched, those pending approval, those in phase II and beyond, and drugs coming off patent. They also list the sales and percent change for each companies top selling drugs.

Just for the record, here’s the lists:

Top 20 Pharmaceutical Companies

1. Pfizer
2. Sanofi-Aventis
3. GlaxoSmithKline
4. AstraZeneca
5. Johnson & Johnson
6. Merck
7. Novartis
8. Roche
9. Bristol-Myers Squibb
10. Wyeth
11. Eli lilly
12. Abbott
13. Boehringer-Ingelheim
14. Takeda
15. Schering-Plough
16. Astellas Pharma
17. Daiichi-Sankyo
18. Novo Nodisk
19. Eisai
20. Bayer AG

Top 10 Biotech Companies

1. Amgen
2. Genentech
3. Serono
4. Biogen Idec
5. Gilead Sciences
6. Genzyme
7. MedImmune
8. Chiron (now part of Novartis)
9. Millennium Pharma
10. ImClone

Technorati Tags: biotech companies, pharmaceutical companies, pharma stats

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In the June issue of R&D Directions magazine they list drugs being developed by indication and I thought it was interesting enough to give some of the numbers.

1. 566 drugs for cancer
2. 242 for CNS disorders
3. 229 for infections
4. 198 for pain/inflamation
5. 195 for cardiovascular disease
6. 122 for respiratory disorders
7. 97 for diabetes
8. 88 for blood disorders
9. 83 for gastrointestinal disorders
10. 62 for dermatology disorders

I’m not surprised that cancer drugs are by far and away the bulk of all the drugs being developed; more than twice as many as the next highest category. The one surprise to me was that there were 229 compounds being investigated for infections. I find this promising and hopeful considering the need for new antibiotics.

The magazine requires a subscript but if you can get a copy, I highly recommend it for a high level overview of what is going on in drug development. They also have a list of drugs approved in 2006 from Jan 1 to May 16, those approved from May to Dec of 2005, those awaiting approval as of May 16, and those in development by stage.

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Just wanted to let anyone concerned know that I am fine here in Salem OR where four pipes bombs were found yesterday. They were exploded without injury and no one was hurt. None were anywhere near where I live.

• Police Busy With Pipe Bombs In Salem Area
• Bomb Squad Called To Third Location In Salem
• Four pipe bombs found, destroyed in Mid-Valley: Three incidents occur in the Salem area; one in Dallas

• Timeline of events for Aug. 10

This on the same day as the airline bombing plots from Britain made the news. This means that this situation was not widely reported but it was indeed unnerving to have four pipe bombs found all in the same day spread across the city.

Luckily, the hospital called and cancelled my wife’s outpatient treatment or she would have gotten caught in all the confusion.

There are no reported leads at his point so it will be unnerving not knowing if another pipe bomb will turn up.

Here is a list of all the news stories from Google News

salem oregon pipe bomb - Google News

Technorati Tags: pipe bomb, Salem

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I find it very different and quite interesting that several AIDS drug manufacturers have said they are actually going to help generic manufacturers in India to make generic versions of some AIDS drugs.

Gilead offers secrets to AIDS drug - Marketplace by Bloomberg - International Herald Tribune:

I’d be interested to hear what the details are as I’m sure they aren’t doing this without some sort of compensation (upfront payment or royalties?).

Hear is a quote from Bristol-Myers Squibb.

Bristol-Myers says it will assist two manufacturers, the India-based Emcure Pharmaceuticals and Aspen Pharmacare in South Africa, in making copies of its AIDS pills. “We didn’t just send them the owner’s manual, but we also sent them our technicians to work in their labs,” said Donne Newbury, director of global HIV access programs at Bristol-Myers.

I think this sort of cooperation should be encouraged for just these sorts of situations. Making affordable medications for the rest of the world is going to be a major challenge in the 21st century.

Technorati Tags: aids drugs, BMS, Bristol-Myers Squibb, drug development, Gilead

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