Looking behind the FDA curtain

Thank you for all the comments to my blog postings about the FDA and its process for reviewing Genasense. It’s still up to the FDA to approve it or not. It is an uphill battle as the advisory committee voted 7-3 against approval. The earlier blog posting and the very expert comments from so many CLL’ers will provide you with a all the background if you are new to the discussion.As you know, the FDA has told me they had CLL specialists who consulted with them. I asked who and was told it was confidential and that the sponsor of the drug up for approval, Genta, would have to request the FDA take me behind the scenes. Genta has done that, and I have been told from the FDA that I will be hearing from Dr. Pazdur’s office. He’s their head man in the analysis of new oncology drugs. I will let you know what I find out. My goal is to probe whether or not this drug is getting a fair shake both from what we saw publicly at the Oncologic Drug Advisory Committee Hearing in Washington, D.C. and what the FDA does back at the office down the street? Beyond that, I am trying to understand if the process is well set up (particularly the picking of advisory committee members), for future drug applications across all diseases.For our HealthTalk readers with other serious conditions beyond CLL, this does have significance for you. As we look increasingly at “personalized” medicines, might the FDA deny your doctor the chance to use a new drug because the effectiveness data was marginal across the whole population, even though it could be significant in a slice of the disease group? The problem, of course, is knowing which people might get the benefit. That is the problem today as diagnostics and typing lag. But when we are talking about cancer (where such a drug could be lifesaving or life-extending), if the proposed drug has relatively low side effects, shouldn’t it be given a chance for doctors to learn how to use it best - and in addition encourage the diagnostics to catch up? In CLL, that is certainly happening with Campath (alemtuzumab) and Rituxan (rituximab), neither of which have a low toxicity.As I have written before, I am worried smaller biotechs and Wall Street backers will be very discouraged, and that will mean fewer innovative drugs in the pipeline for you, me and our loved ones.Obviously, I cannot fight this battle alone. My plan is to have further dialogue with the FDA and, with you, to lobby our U.S. senators to look into this issue. I recognize they are already looking at protecting the public safety and not approving drugs that could threaten lives once they get on the market. But where should the bar be set and how does it apply to already life threatening conditions?This comes at an interesting time when some senators are threatening a “hold” on the approval of Dr. von Eschenbach, a cancer physician from M. D. Anderson as FDA Commissioner. Maybe this can become part of the discussion?If you’d like to write to the FDA, e-mail:ombuds@oc.fda.gov or visit their Web site.Again, for our friends with autoimmune conditions and other cancers, this is your fight too. I hope you will join me.Because of my business endeavors, there are a few things you should know. HealthTalk has, in the past, produced programs on CLL treatment that were sponsored by unrestricted grants from Genta, the developer of Genasense. While there are no current or planned programs, you should know that the possibility of future programs exists. In addition, I now run a company called Patient Power that received an unrestricted grant from Genta to facilitate the travel of three people (myself, a CLL patient’s family member, and another CLL patient) to the public hearing. Both at HealthTalk and at Patient Power, Genta has neither prompted nor had any control or influence over what we say or write.

The 2 Ways to Get Satellite TV and One Way is Free

Satellite TV has been around for quite sometime now. The problem about it though is that not too many people have it. The reason for this is because it costs a lot just to have it set up and then you have high monthly payments on top of that. Today, I would like to go over a new type of satellite TV that has come out that costs 80% less then the regular type and does not require any monthly payments.Now, let’s take a quick look at what regular satellite TV can get for you. You have the capability to watch over 2000 channels. These channels can be viewed in any type of language you prefer and you can even watch your favorite shows from around the world. Let’s say that you are a huge sports fan. Well, you could have on every single game on that you please because there are over 20 different sports broadcast channels that come with satellite TV. Satellite TV is an amazing feature to have especially if you enjoy late night movies on your big screen TV. You will have to ability to watch all the movie channels that you couldn’t even imagine. Watching satellite on your big screen will lead me onto my next subject and that pertains to the cheaper version of this type of television.This type is known as satellite TV software. You might be thinking off the bat that this isn’t for you because you would prefer it on a screen as large as your own television. Well, hear me out first when I say you can buy connector cords to hookup your computer screen to your TV screen. Now, let me go on with some benefits that you can have with this software.Just like regular satellite TV you get 2000 channels, but the difference is you could upgrade to get 4000 channels max. With this amount of channels you would have pretty much every single channel from around the world and more. With satellite TV software you can also watch your shows on demand. Let’s say that you missed your favorite show because you were late coming home from work. Well, you could look it up in the software and play it from the beginning. If you are familiar with demand, then you should know that you can also fast forward through commercials as well. I don’t know about you but, when I am really intense into one of my shows, I hate commercials because they always come on right when the show is getting good. The best thing about this software is that there are no monthly fees, just the cost to purchase the software.So, I have explained to you the two choices you should be aware about when looking into satellite TV. Hopefully now you can make your decision a lot better now.

Got a New Product or Invention, Now What?

Got a new product or new invention and don't know where to begin? Here are 3 Must-know things about marketing your new invention. Being the First and Fastest to the MarketplaceIf you have a truly innovative product and launch your product on television, exposure is almost guaranteed. Further, a successful product on television usually attracts retail outlets. Exposure of this kind can also drive business to your website, creating marketing synergy. Television offers one of the fastest ways to bring your product to market and the options for bringing your product to market in this manner are countless. Some of the most popular ways include getting your product on the home shopping channels like QVC and HSN. Nick Romer, best selling author of "Make Millions Selling on QVC: Insider Secrets to Launching Your Product on Television and Transforming Your Business (and Life) Forever" says, "Being first and fastest to the marketplace with your product can give you a competitive edge over other similar products." (For a full description of Romer's book, visit: www.sellonq.com/ambook ).Romer ought to know, he's made millions tapping into the shopping channel phemomenon. "If you're looking for a way to gain massive exposure for your product, QVC should be a top priority in your marketing efforts," he says. "One hit on QVC can not only get you immediate sales, but it can also open doors to chain store buyers that might otherwise not have noticed your product." The Internet as a Product Launch ToolThe top video sharing site, Youtube.com, can get your exposure for your product with potentially millions of impressions (views) if you think through the creation of your video and offer an informative, funny, or otherwise creative video. But it doesn't stop at Youtube. Video sharing site Metacafe.com is also another popular destination for videos and there are countless others. A simple Google search for "online video sharing sites" should produce a list of other candidates for your marketing efforts. Trade ShowsGenerally speaking, there are two types of trade shows. Those that are geared towards the wholesale industry and those that cater to individual consumers. With thousands of buyers in attendance for either style venue, the right trade show can provide tremendous concentrated exposure for your new product or invention. Marketing at a trade show includes travel expenses, lodging, and the cost of the trade show booth at a minimum. Booth costs range from hundreds to thousands of dollars. The larger the show, the higher the cost. A simple internet search can provide information on tradeshows for your industry. Contrasting tradeshow opportunities to television, according to Romer's blog on www.sellonq.com, "In my experience, it takes about four consumer trade shows to do what we can do in ten minutes on QVC." He says, "But that should never deter you from doing trade shows because they reach a different crowd and can broaden exposure for your product."ConclusionWhile television can be the skyrocket you need for gaining exposure to your product, the key to success in marketing your new product or invention is in being consistent in your efforts. The more time you spend planting the seeds of marketing the greater the potential will be for you to see measurable results, especially if you do a little a day for a great length of time.

Dean Martin: Cool as Ice

Rat Pack's fifth member Dean Martin is the exact person you will think of the moment you hear the word cool. He is not only potent at the record sales but also in the box-office and television. As an actor, he is a Golden Globe recipient for his performance in The Dean Martin Show apart from other awards from various award-giving bodies. He is the culprit of such songs that used as movie or tv themes such as "Memories Are Made Of This", "That's Amore", "Everybody Loves Somebody", "Mambo Italiano" and "Sway" To notice that he got the same voice timber as Frank Sinatra, it is because they are the best of friends.He teamed up with comedian Jerry Lewis and formed a dynamic duo that was called Martin and Lewis which stand for about 11 years and made about 16 movies. He gained international fame when he did The Young Lions but his most remembered performance is in the film Ocean's Eleven. He entertain household viewers via The Dean Martin Show. The show was renamed from The Dean Martin Comedy Hour to The Dean Martin Celebrity Roasts. It created tv history as it features notable actors such as Bob Hope, Frank Sinatra, Lucille Ball, James Stewart, George Burns and Milton Berle. He spent his final years with grief for his son's death in a plane crash. That made his health to crumble until he was defeated by lung cancer on Christmas Day of 1995.