QDIS Blog

Google Trends is an interesting tools to see trends in what people are searching for on Google. I decided to do a little investigation on some items of interest to the drug industry.

1. Vioxx: I looked at the trends for “Vioxx”and the results spike at the end of Sept 2004 when Merck announced they were withdrawing the drug from the market. It’s been relatively flat since.

2. If you limit the results to just the US, it is interesting that the number one city searching for Vioxx was Barnwell, SC (population 24,000), So I was curious as to why such a small town in SC would be by far and away the largest searcher for the term Vioxx. A quick search for “vioxx” and Barnwell yields the answer; one of the law firms involved in the Vioxx case in NJ was Weitz & Luxenberg and they have offices in Barnwell, SC. They also have offices in Mannford, OH.

3. Search for “Plan B” has also seen a trend up. Unfortunately, Google trends doesn’t list any news items for this term.

4. A Search for “FDA” shows that there are more than twice as many searches for this term in India than in the US. This isn’t surprising since India is a growing market for pharmaceutical products, active pharmaceutical ingredients (API) and other related services.

If we limit it to the US, then Rockville, MD is the number one city, not surprising since that’s where the FDA headquarters are located.

I’m sure there may be even more interesting results after I’ve had time to play with it more. Also, keep in mind that uncommon search terms don’t give good results.

Technorati Tags: Google, Google Trends

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After posting my entry on Biogenerics and the FDA, I came across another excellent article in PharmaManufacturing entitled A Wave, Suspended: Follow-on Biologics. I can highly recommend this article. It gives a very good insight and does a better job of explaining the situation than I did.
Technorati Tags: biogenerics

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Cubicin is the first in a new class of antibiotics approved in Sept 2003 by the FDA. This is the first new antibiotic in many years and with the rise in resistant bacteria, there will be even more need to new antibiotics in the future. However, currently most pharmaceutical companies have gotten out of the antibiotic business. One reason for this is because more money can be made in other therapeutic areas especially in those that treat chronic disorders. This has created a great opportunity for the growing biotech industry to step in and fill that gap. This is what Cubist Pharmaceutical did with Cubicin which they licensed from Eli Lilly.

Also, antibiotic over-prescription and incorrect use add to the problem resulting in excellent conditions to develop bacterial resistance. I know people who, once they get to feeling better, stop taking their antibiotics. This results in conditions under which the few bacteria that do survive have resistance to those drugs. Also, some doctors seem to bow to the demands of their patients for antibiotics even in cases where the cause is most likely viral and not bacterial. They follow the path of least resistance but this leads to unintended consequences.

Quite a few years ago I was involve in developing a manufacturing route for a new beta-lactam and the group spent a lot of time and effort into creating a viable chemical synthesis for the first few kilograms so that clinical studies could get underway. However, after about 8 months of work by a team of about 8 folks and just when the route had been completed and was ready, the marketing department admitted they made a decimal point error in the calculations and the project was cancelled because not enough money could be made from the product. I’ve had a lot of projects fail along the development pathway but this was the first time I was involved with a project that was cancelled due to a marketing mistake.

Technorati Tags: antibiotics

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The pharmaceutical industry has really kind of taken it on the chin recently. There have been quite a few problems and other issues recently none of which have been positive. Here’s a list of ones I’m aware of.

• Baycol: Philadelphia Court OKs Baycol Settlement: Financial News - Yahoo! Finance
• Vioxx: Anti-Inflammatory Drugs Full Coverage on Yahoo! News
• FDA commissioner indicted: Ex-FDA chief faces criminal inquiry - Crime & Punishment - MSNBC.com
• Plan B Fiasco: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual
• Lack of Biogeneric guidance: PharmaGossip: FDA - federal judge orders action on Omnitrope
• Institute of Medicine to report on the FDA: http://www.windhover.com/ezine/pdf/DrugSafety0604.pdf
• Problems with the sleeping pill Ambien: ScienceDaily: Doctors wake up to sleeping pill risks
• Ketek antibiotic problems for Sanofi-aventis: ScienceDaily: Validity of key clinical trial questioned and US lawmakers question FDA OK of Sanofi antibiotic - Yahoo! News
• BMS antibiotic Tequin: Drug Company Taking Tequin Off Market
• FTC to subpeona drug companies for paying to keep generics off the market: Generic Drug Payoff Draws Gov’t. Interest and Drug pacts keep some generics off market - FTC - Yahoo! News
• Pfizer class action lawsuit regarding Lipitor: Class-Action Lawsuit Challenges Pfizer’s DTC Ad Claim of Lipitor’s Effectiveness in Reducing Cholesterol Levels
• DTC Drug Ads Under Fire
• UK fraud charges for price fixing: Drug chiefs on price-fixing charges - Health - Times Online
• Public Citizen | Congress Watch | Legislation Closing Loopholes in Drug Patent Law Will Help Assure Consumers Access to Lower-Priced Generic Drugs

Drug Safety in General

• FDA Is Criticized Over Drugs’ Safety Problems
• USATODAY.com - We’re curing ourselves:
• USATODAY.com - FDA ill on tracking pills:

Then there are several lawsuits of one company suing another such as Ariad vs Eli Lilly and now Ariad vs Amgen (and I’m sure there are others I’m overlooking). While I know the importance of protecting intellectual property rights to Joe Citizen on the street it just look like greedy companies suing each other to try and get rich.

There have been a couple of positive things recently. The voluntary holding off of direct-to-consumer advertising may be increasing consumer. Opinion: It’s All Relative - PhRMA’s new voluntary guidelines are about much more than DTC advertising—and they’re not really voluntary. - PharmExec

Another positive has been making public clinical trials results. Clinicaltrials2005.pdf

Now neither of these were done without some arm twisting so they don’t do much to improve consumer confidence, but they are steps in the right direction. I always believe in doing the right thing, for the right reason, in the right way (this includes at the right time), and if any of those three are missing, there will be problems.

Technorati Tags: biogenerics, FDA

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One of the major upcoming hurdles for the FDA will be approval of biogenerics (aka generic biodrugs). These are biologics that will soon be coming off patent such as human growth hormone Omnitrope (somatropin) from Sandoz (generics division of Novartis) and Valtropin (somatropin) from BioPartners GmbH. Currently, there is no process for approval of these by the FDA. Unlike small molecule drugs, these compounds are complex proteins with a complex manufacturing process. I personally think (at least initially) this needs to be handled on a case-by-case basis but with a well-thought out process for doing so. Small changes in a proteins structure can have a major impact on the biological activity. Also the process by which the biologic is produced has a major impact on the overall quality. Use of yeast is different from the use of e.coli to produce a given compound.

There are 11 biologics who’s patents have either expired or will expire before the end of 2006. I good article in C&EN listed these back in Sept 2002.

The market size for biopharmaceuticals is approximately $20 billion and continues to have strong growth. Estimates for biogenerics is less well known but is estimated to be $2 billion in 2010 and will grow to $12-15 billion in 6-8 years after that. The US is already behind other countries such as Australia and the EU with regard to approving biogenerics. This issue is particularly important for the US healthcare system since the generic market was developed as a way to control costs and these are some of the most costly pharmaceuticals. The average daily cost for a small molecule drug is $1.66 whereas for biologics at is $45 per day. (ref: Kathleen Jaeger, president and chief executive officer of Generic Pharmaceutical Association in Generics in 2006 in Pharma & Bio Ingredients Jan/Feb 2006, p44).

According to Crystal Rice, spokeswoman for the FDA’s Center for Drug Evaluation & Research the FDA expects to release guidance documents soon. “We can’t say exactly when it will be ready, but we certainly plan for this calendar year.” This was from an article in Drug Topics in 2004! It’s been over two years now and still no guidance documents on this have been released.

A federal judge in the District of Columbia has recently ordered the FDA to act on Sandoz’s application. Judge Ricardo Urbina called the delay “egregious” and said the FDA must give some kind of response. Sandoz is already marketing Omnitrope in Germany and Austria as well as Australia.

Here is a list of some good recent articles covering this area:

Biogenerics: US to finally follow EUs lead? - Pharmaceutical Business Review
Sandoz Wins EU Approval, US Progress for Biogeneric Product - PharmTech
Regulators struggle with generic biodrugs - The Boston Globe:

TAKING BIOLOGICS FOR GRANTED? TAKINGS, TRADE SECRETS, AND OFF-PATENT BIOLOGICAL PRODUCTS
Moving Towards Biogenerics in the U.S. - Pharma & Bio IngredientsSSRN-The Generic Biologics Debate: Industry’s Unintended Admission that Biotech Patents Fail Enablement by Gregory Mandel

Technorati Tags: biogenerics, FDA, somatropin

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Roche has issued a guide on how to avoid fake Tamiflu (oseltamivir phosphate). As the press continues to report on bird flu (coverage of which has not been very helpful in my opinion) the potential for further fake Tamilfu increases.

Here is how to tell true Tamiflu:

• white cardboard box
• single blister package of 10 pills
• pills are yellow and light grey
• printed on pill is “Roche 75mg”

Here is a picture of the packaging and pill from the Tamiflu site.

Back in December custom agents seized 50 shipments of Tamiflu so it is a really a concern and will likely only become more important if an epidemic does occur.

Here are some sites for more information on Tamiflu:

• Official Tamiflu site
• Tamiflu on Drugs.com
• Tamiflu on PDR Health
• WebMD on Tamiflu

Technorati Tags: bird flu, H5N1, Tamiflu

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I just wanted to let folks know that a few days ago, I posted episode 2 of “Searching the Internet” podcast. This episode covers how to use some of the advanced search features on Google and Yahoo. You can read the show notes on the site or subscribe via iTunes by clicking here (mp3 version).

If you want to subscribe to the enhanced version in iTunes or to listen to on your iPod the link is below:

http://www.qdinformation.com/searching/?feed=rss2&category_name=enhanced-podcast-aac

Copy the above link and go to iTunes. Under the menu item “Advanced” select “Subscribe to Podcast” and in the resulting dialog box, paste in the above URL. This will subscribe you to the enhanced version of “Searching the Internet” and allows you to automatically get all future episodes when they are posted. The enhanced version offers the advantage of placing a picture in the lower left corner of itunes to let you know what that section of the podcast is all about as well as a URL link to the page I’m talking about. You can also skip to certain parts within the podcast by clicking on the icon just to the left of the the search bar. It looks like this:

If you use iTunes and an iPod, I highly recommend the enhanced version. Episode 3 should be out later this week and will cover some non-search engine sites to find addresses, phone numbers, and more.

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The European Medicines Agency (EMEA) has recommended approval of Sanofi-aventis’ Accomplia (rimonabant) weight loss drug. While not binding, the EU usually follows the recommendation within three months. This means it may be approved by the end of July. It should be noted that the EMEA did not recommend approval of Accomplia for smoking cessation.

Also, the FDA sent an approvable letter in Feb to Sanofi-aventis for weight loss but also did not think the drug worked for quitting smoking. It is unclear when it may be approved in the US. The NDA was filed in June 2005 so it may happen by the end of 2006.

The interesting thing about rimonabant is that it works by a new mechanism different from most other drugs by blocking a pleasure center in the brain.

Wikipedia has a nice article on rimonabant. Two article are available for those seeking more information; one from the New England Journal of Medicine (free) and the other from the Lancet (registration required). Drug Development Technology also had a nice article on rimonabant.

Technorati Tags: rimonabant

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Just a quick update; after blogging about TagClouds on Friday, it seems they are undergoing major changes. Until now, it had been run on a single server as a weekend project. It has now grown beyond that and they have a sponsor and are moving the service to new servers. I’ve temporarily taken down the TagClouds until the service is back up and running. Sorry for that. Hopefully they’ll be back soon.

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The Boston globe has an article on a recent ruling that will likely limit how low the price of generic versions of Zocor (simvastatin). This is one of the leading statin drugs and the patent is set to expire on June 23rd. There is expected to be almost a dozen generic companies via for this market. The District Judge Richard Roberts declared invalid an FDA decision to NOT allow Ivax (a division of Teva Pharmaceuticals) and Ranbaxy Laboratories to sell generic versions of Zocor. This means it is sent back to the FDA to reconsider. Ivax and Ranbaxy will both most likely have 6 months exclusivity to the generic market with others allowed to enter the market after the six month time period is over. Merck is also working with a third company to make an “authorized” version so there will likely be three companies making a generic version.

The price will likely be about 65% less than the brand name Zocor initially. This also means that patients who are on Lipitor may also be switched to generic simvastatin since the price will be much lower. However, the assumption is that when the market becomes more crowded, the price will likely drop even more as the 10 or so companies compete for this market (maybe by as much as 95%!). Zocor was a $4.5 billion in 2005 so the market is huge.

For a more detailed analysis see the article from the Patent Barista.

Here is a collection of news articles from Yahoo on this issue and here is the Google news on Zocor (simvastatin).

Technorati Tags: FDA, simvastatin

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