QDIS Blog

A newly announced technology related to stems cells has been in the news recently and some of those articles are listed below.

• The Stem-Cell War Heats Up - Newsweek Health - MSNBC.com
• TIME.com: Why the Stem Cell Advance May Not Be a Breakthrough
• Firm makes “ethical” embryo stem cells | Top News | Reuters.com
• Critic Alleges Deceit in Study On Stem Cells

The technique describes a method to remove embryonic stem cells without destroying the embryo. While many think this gets around some of the ethical objections, I’m not as hopeful. It will be interesting to see how this develops and I think there will still be objections to this. It will b interesting to se what objections are now raised. My best guess is those opposed to stem cell research will suggest that after removing the stem cells the embryos may no longer be able to be implanted into a womb and therefore it is the same as killing them. There will be many questions raised and the goal for everyone should be to see if these are legitimate scientific questions or are they objections raised to prevent or slow further stem cell research. Look for phrases such as “we don’t know what will happen after a cell is removed from these embryos” or “we don’t know that the embryo is indeed viable” and further no effort made on their part to support such claims.

Technorati Tags: stem cells

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

Just saw an article in USAToday about the CDC and the University of Colorado developing a microchip capable of detecting bird flu and identifying where the virus originated. The new test takes longer (about 12 hours) vs the lab test of 4 hours but the lab test only says it is positive or negative.

USATODAY.com - CDC announces test distinguishing bird flu

Technorati Tags: avian flu, bird flu, biological microchip

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

I’ve posted about Gardasil several times here and was even a guest on the Bicyclemark Audio Communique to discuss it before it was approved. I am very excited about it as it is the first cancer vaccine to be approved and works very well for several varieties of human papillomavirus (HPV) that cause the majority of cervical cancer cases. I would point out that getting this vaccine does not guarantee the female will not get cervical cancer but the odds are dramatically reduced.

New Cervical Cancer Shot Hard to Find - Newsday.com

However, Newsday is reporting that the vaccine is hard to find. Many doctors offices and clinics don’t yet have the shots on hand. It is interesting that a lot of students retuning to college or high school get physical checkups now and it is important to have the vaccine available. Otherwise, it is likely a year or more before they see a doctor again. I would note that I checked the FDA webpage on drug shortages and Gardasil is not one of them. So it would appear to not be a case of a shortage but more a case of it not being on hand where it is needed in doctors offices and clinics. A Merck spokesperson said it was available in all 50 states but would not comment on the amount shipped.

Another major concern is that health insurance may not cover the cost. The vaccine is a series of three shots and the cost is estimated to be several hundred dollars ($300-500). While I think it is well worth this to eliminate the chance of contracting HPV which could lead to cervical cancer, I do realize that paying for this can be a problem for some people. Hopefully, this is just the usual issues you run into with a new medication and it just takes a while to get all the forms and reimbursements figured out. I hope it is not due to fear of political fall out if a company does decide to cover the vaccine.

• Gardasil Vaccine Information from Merck

Technorati Tags: cervical cancer, Gardasil, Merck, cancer vaccine

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

Merck has released some preliminary data for a large clinical trial regarding Arcoxia (etoricoxib), Merck’s second generation Cox-2 inhibitor. It has generated quite a bit of news recently and here are some of the articles.

• Merck’s Vioxx Heir - Forbes.com
• Merck Sees Successor to Vioxx - New York Times
• Merck Provides Preliminary Analyses of the Completed MEDAL Program for ARCOXIA(TM) (Etoricoxib): • Financial News - Yahoo! Finance

Since it will likely be at least three years before any other studies related to COX-2 inhibitors are released, these results will be examined in great detail. Many people want to understand what it is that may be behind the increased risk of hear attack. There are already some people pointing out that they are comparing Arcoxia to Voltaran (diclofenac) from Novartis. Not everyone thinks Voltaran is the best comparator.

I would say that I think coming up with a new pain relief that is safe and effect is needed. I have talked to several people who would almost rather take the risk of cardiovascular problems than continue to put up with the daily chronic pain. Although the FDA now recommends Aleve (naproxen) as the pain relieveer with the lowest risk of the pain medications for arthritis. Arcoxia is approved in about 62 other countries and it is interesting that now, without releasing all the study details, Merck has decided to push the FDA for approval in the US. It was interesting that one side effect seems to be an increase in blood pressure. Merck has stated they will release the full details before the end of this year including articles in peer reviewed journals.

Technorati Tags: Arcoxia, etoricoxib

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

A recent article came across my desk and I thought it misrepresented the facts and wanted to make some comments on it. The article was in the Signs on San Diego site.

SignOnSanDiego.com > News > Health — Study: FDA advisers typically recommend approval for drugs and devices

The article implies that something improper may be occurring with the process of having external experts make recommendations on drugs and devices I would point out that the whole drug development process involves weeding out those candidates that do not preform well at early stages. It is in the best interest of the company developing the drug that they be able to make a go-no go decision as soon as possible. Therefore, only the drug candidates that have a very high potential to be approved make it to the point of filing an new drug application (NDA). It is not surprising to me that the majority of those get approved. It should also be noted that just because an expert panel recommends approval, does NOT necessarily mean it will be approved.

While I do acknowledge that there have been some conflicts of interest that were not made transparent in the past, I think there has been some progress made in this regard. I just hope that reason prevails and this isn’t used as another bullet against the FDA.

Technorati Tags: drug development, FDA

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

I heard on the Democracy Now podcast that it was reported that Evolutionary Biology is not on a list of approved majors to receive federal study grants for low income students. It is the second story from the end of that page.

This appears to be another attempt to politicize science again and attack accepted science that may not agree with the current administrations beliefs. While I tend to believe more in incompetence than in conspiracy, there has been a long trend of attacks on accepted science; global climate change is probably the most well known example.

Democracy Now mentions this was reported in the NY Times and so I tracked down the original article. The claim is that the omission was just an oversight and that it would be added back to the list, however as of this writing it still has not been added.

If you want to help me keep an eye on this and make sure it does get added back to the list, the list can be found online.

Technorati Tags: Democracy Now, evolutionary biology, NY Times

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

News out of China shows that a bird flu vaccine in initial test shows it appears to be safe and effective.

Initial tests show China’s bird flu vaccine safe for humans - Yahoo! News:

This is good news but very preliminary. It was only 120 subjects and there were no serious adverse reactions and the vaccine did stimulate the production of antibodies. It is interesting to note the antibodies were produced in 78.3% of the people above the standard of 70% accepted for the regular flu vaccine .

It will be several more years before there is enough information to really tell if this works. at least for now, it seems possible as several companies are working in this area and are reporting positive results.

Technorati Tags: bird flu, avian flu, vaccine

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

I am convinced that most major companies don’t understand podcasting. It’s a new hip term and some groups are trying to capitalize on. As an example, take the website for the new prescription sleep aid Rozerem made by Takeda.

If you look at the home page for Rozerem they list a “listen to podcast” on the main page.

However, you can’t even click on this. That itself is pretty poor but even worse, once you do get to their so called podcast page, it is just a link to a TV commercial!?

Podcasts are regularly updated audio and/or video enclosures within an RSS feed. You can subscribe to that field in a podcatcher such as iTunes. There is no feed anywhere on this site as far as I can tell. You have to go to the website and watch the mp3 or m4v files or download them. This is NOT a podcast. This is merely making your commercials and some music available on a website which has been going on for years now.

I think it is possible to make podcasting work commercially. However, too many large companies just look at it as another method to force their advertising on consumers. This will not work. If it had some advice about sleeping problems and what to do about them or maybe had some easy listening music each week to help you fall asleep, then it might be worthwhile.

As another example, Disney had a podcast about Walt Disney World called “Walt Disney World® Resort: Plugged In“. The feed still exists but it hasn’t had any new content since April; over four months ago! I did listen to a couple of these and they ended up being hour long commercials for the Disney resort. Now, I understand the desire to use this new content distribution as a means for advertising, but I think that misses the point of offering something worthwhile to the listener. If they had information on using the fastpass system, or maybe tips and hints on dealing with crowds at the parks, etc. then it might be worth it. There are many very popular podcasts regarding Disney and I regularly listen to several of those, but the Disney company itself isn’t one of them. On of my favorites is Ricky Brigante’s “Inside the Magic” podcast.

Bottom-line, if your company looks at podcasts as a means to distribute your advertising without offering anything worthwhile to your listeners, I think you will be sorely disappointed. However, if you offer something interesting and exciting, you can fit in your ads without turning off your listeners.

Technorati Tags: Disney, podcast, Walt Disney World, rameltreon, Rozerem, sleeping pill, Takeda

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

A recent eMarketer report states that spending on pharmaceuticals online will increase to over 1.3 billion by 2008, just over two years from now.

eMarketer.com - Pharmaceutical Spending Expected to Reach $1.3 Billion:

This is interesting since overall Internet advertising actually dropped in 2005. This is supposedly a move from direct to consumers television and radio ads to a so called “direct to patient” ads. Now, I’ve not come across this terms before and I’m not sure I agree with it. It really doesn’t differentiate from direct-to-consumer advertising.

I really wonder if this is a true trend and if so, what does it mean. I also wonder what this will mean for trying to enforce pharmaceutical advertising rules in the FDA. How do you track down these ads online to make sure they are not misleading. Is this really a way to try to make an end run around the scrutiny that comes with print, radio or TV ads? It will be interesting to keep an eye out for future developments and to see if these predictions come true.

Technorati Tags: pharma stats, pharma ads

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

Lately, it seems that more and more drugs are coming under scrutiny for possibly increasing the risk of heart problems. The latest is Evista (raloxifene), an osteoporosis drug.

Breast cancer drug’s ties to heart ailments explored

The title itself is confusing. First, Evista has been shown in the study quoted to reduce the likely hood of developing breast cancer. The article also mentions Nolvadex (tamoxifen) which I’ve posted on before which has been shown to be less effective than Evista.

Here’s the quote from the article:

After about six years, women who had taken the drug were 44 percent more likely to have had a blood clot than were those in the placebo group and 49 percent more likely to have died from a stroke — each translating to about one more instance per 1,000 women treated each year. Overall, the two groups had heart problems at the same rate (533 events such as heart attacks and heart failure).

As I always state, all drugs, even over-the-counter drugs, have risks associated with them. The key is does the benefit outweigh the risk. This is always the case but it rarely gets thought out. Patients may not know the risks and doctors don’t often talk about the side-effects and risks.

I always recommend that patients read the full prescribing information (aka patient package insert) for any medication you are taking. While this may take some effort on some folks part, it is definitely worth it.

The first place to look for the prescribing information (if it doesn’t come with your prescription) is on the website for the medication or the company that produces it. As an example, I would try the following:

www.evista.com

This does indeed bring up the correct website for Evista.

You can also look at the Eli Lilly company website (they are the makers of Evista).

Also, the FDA website has a lot of information for approved drugs. You can find them at Drugs@FDA, and then give at least three letters for the drug and it will give you information on it although the prescribing information isn’t always included.

Technorati Tags: Evista, raloxifene, Tamoxifen

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |