QDIS Blog

Well yesterday the FDA released a report containing a lot of proposals for improving drug safety. It includes more than a dozen initiatives of various sorts but all related to drug safety.

FDA Reinforces Commitment to Drug Safety (from FDA website; just a press release)
The Future of Drug Safety — Promoting and Protecting the Health of the Public (actual report)

This report outlines the FDA’s response to the Institute of Medicine Report a few months ago and include making “report cards” on unusual side effects. Mark over at Eye on FDA has a great post about this.

This has brought up concerns about patients seeing these “report cards” and stopping taking their medications. I agree this is likely and think it has more to do with helping the general public understand risk and probability. We humans seem to have difficulty with understanding probabilities. I have taught classes on statistics and probability and know that it is difficult to help people gain an understanding.

I think the FDA is trying to head off the changes Congress is likely to make in the Kennedy-Enzi bill (not yet introduced), but that it is likely too little too late to avoid sweeping changes coming from Congress. While I applaud the initiative, I think it is being done with limited enthusiasm and later than many would like. Also, I do think that any Democratic back billed giving increased authority to the FDA will likely lead to a presidential veto if it gets through both houses of Congress.

Until the FDA has the ability to fine drug companies for not following through on their promises of post-marketing studies, I don’t think much will change. They need an ability similar to the EPA to allow the FDA to fine companies for not complying. Right now, the only alternative the FDA has is to remove a product from the market, something I think everyone agree should be a last resort. And it should be meaningful amounts that really make the drug company want to avoid fines. I would purpose that the drug company be fined the equivalent of whatever they earn on a daily basis. As an example, if a drug earns $1 billion in revenue annually, then the fine would be $2.8 million per day for every day late they are in starting a required study. Obviously there should be the ability for the company to present to the FDA why they can’t start a study and if the FDA concurs, then a new date would be set. Otherwise, the FDA starts the fines.

The other obvious need is for more money to be able to adequately do their job. If you look at the amount of the gross domestic product the FDA overseas, and then look at their percentage of the overall budget, it is vastly out of whack.

Here are some other articles on this news.

FDA proposes drug safety “report cards” (from BusinessWeek)
FDA to Monitor Post-Market Drug Safety (from HealthCentral)
PharmaLive: FDA Reinforces Commitment to Drug Safety

Other Resources

Yahoo! News Search Results for FDA drug safety
FDA drug safety - Google News

Other Blog Posting

Google Blog Search: FDA drug safety
FDA: See what people are saying right now on Technorati

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I did want to relate an email exchange I had recently with a reader who was having problems finding a pharmacy carrying Gardasil. She had seen a doctor and they did not have the vaccine so he wrote her a prescription. The vaccine comes is in a pref-illed syringe according to the prescribing information. Her normal pharmacy, CVS said it was “backordered” and they would not get it for some time. She was asking me for recommendations, I gave her some suggestion such as calling the Merck number for information about the vaccine but she finally tracked it down on her own at her local Walmart.

This sort of situation isn’t uncommon for newly approved drugs or vaccines. It takes a wile for the supply chain to fill and for the drugs to make it to your local pharmacy. If you are looking for a new drug, call you local pharmacy and ask about the availability and when they think they will have it in stock. Also larger corporations such as Walgreens or Walart are likely to have it sooner since they buy in large quantities. Hopefully, this will help someone else who may be in a similar situation.

Technorati Tags: Gardasil

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One of the big topics recently has been the deals that some large pharmaceutical companies have struck with smaller generic firms to keep the generics off the market.

Senate bill aims to end deals that slow generics - Yahoo! News:

The article talks about the Senate plans to ban the deals made between brand name pharmaceutical companies and potential generic makers. This allows the brand name to continue making large profits and sometimes the generic maker makes more money in the short run than they would have made otherwise.

Here is a quote from Partick Leahy (D-VT)

“Congress never intended brand-name drug companies to be able to pay off generic companies not to produce generic medicines,” Leahy said at a Judiciary Committee hearing. “That would be a shame, harmful to consumers, and a crime.”

What is interesting is the increase in the number of such deals. In 2005 there were seven such deals; in 2006 that doubled to 14. Also recent court rulings such as an appeals court in Atlanta brought by the FTC about Schering-Plough illegally keeping a generic version of its K-Dur off the market were ruled against the FTC and for the pharmaceutical company. The US Supreme Court declined to take up the case. Another lower court also threw out a similar case involving Tamoxifen from AstaZeneca.

What is interesting is that some companies in the generics industry have come out against it also. The chairman of Barr Labs, Bruce Downey said the proposed bill;

will discourage vigorous challenges of patents because generic companies will lack the flexibility to settle some cases once they are filed.”

“The proposed bill therefore would undermine the incentives Congress has carefully created to promote generic competition,” Downey said.

I don’t know that I agree with that statement. His statement, to me, implies that sometimes the generic drug companies may really not have a case but it is a way to make the big pharma company pay them even if the generic company might not have a solid case. I think the purpose of the government incentives was to manufacture cheaper generic drugs, not to make money off of big pharma from stifling of competition.

PharmaLive: FTC Provides Senate Testimony on Anticompetitive Patent Settlements in the U.S. Pharmaceutical Industry :

The Pharmalive article covers the recent testomony of Federal Trade Commissioner Federal Trade Commissioner Jon Leibowitz . He said that the recent court rulings I mentioned above have made it more difficult for the FTC to proceed with antitrust cases in order to stop exclusion payments.

The Pharmagossip blog also recently had a posting on this topic.

PharmaGossip: Big Pharma payoffs to Generics companies - “somewhere between bribery and extortion”:

This posting is actually part of an editorial recently in the Star Ledger and can be found here. Given the number of really big drugs coming of patent in the next 4-5 years this practice is sure to get more lucrative for the generic drug makers and occur more frequently. It will be interesting to see if this gets through Congress and even then it will almost certainly face a presidential veto. This will be a interesting topic to cover in the coming months.

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Since I reported previously about the merger between Genetech and Tanox I thought I’d follow up about the FTC requesting more information.

SignOnSanDiego.com > News > Business — FTC asks for more info on Genentech, Tanox merger:

Not much new here and no specifics but it will push the finalization of the deal off by a few months.

Disclosure: I own a few shares of Genetech stock.

Technorati Tags: Genentech, pharma M&A, pharmaceutical deals, Tanox

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I have a certain fondness for Hawai’i and keep track of issues related to science and biotech there. I try to vacation there once a year since it is easily reached from the west coast. I have become friends with several folks there and listen to several podcasts about Hawaii and try to read the online news about the islands.

Seems that biotech crops are big there and second only to pineapple in terms of dollars generated. The genetically modified seed business is valued at over $70 million. I also know that the industry employes about 2,000 jobs many of which are well paid and they contribute over $7 million in taxes to the local government.

Biotech now second only to pineapple - Pacific Business News (Honolulu)
I have mixed feelings about GM crops in Hawaii. I have posted about this before. While I am a supporter of GMO and think it can greatly benefit person-kind, I also know how fragile small isolated environments such as the Hawaiian Islands can be. I also understand and respect those who have concerns and think those need to be adequately addressed.
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The New York times is reporting that Bristol-Myers Squibb and Sanofi-Aventis may be in merger talks!! If this happened, it would make the new company the second largest pharmaceutical company behind Pfizer

Rumors Fly About Bristol, Lifting Stock - New York Times:

My take is that if both companies are vehemently denying it then there are good chances it is true. Then again, it could be rumors started by folks taking advantage of the market to make money in the stock. Both companies have had a lot of activity and BMS is actually up on the possibility. Also news that some top management at BMS have announced agreements that would allow them to walk away with significant compensation if certain triggers happen including demotions, transfers or cuts in pay. While these are sometimes put in place to keep managers who would otherwise leave during times of turmoil, they are also often put into place just before major mergers.

The market has been anticipating some sort of merger or take-over of BMS since they have failed to name a new CEO and only have an interim one. I don’t like to speculate but it does seem likely given all the indications. Also, remember that Sanofi and BMS have a partnership on Plavix which may be seeing generic competition soon. All of these point towards a merger in my opinion. I don’t believe it will necessarily be for the best in the long run but it is hard to convince those involved that that may be the case. They have too much to gain by pushing such mergers to completion.

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The recent Contract Pharma article about the Outlook 2007 from Tufts for contract manufacturers paints a fairly rosy view.

Contract Services: Outlook 2007

According to the article, companies are figuring out what they are best at and outsourcing the rest. A lot of this is due to the very lean human resources at many companies these days. It is an interesting read and I recommend anyone interested in outsourcing in the pharmaceutical industry.

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I recently read the C&EN article reviewing chemistry highlights from 2006. It covers a lot of interesting stuff that happened last year but two items caught my attention. One of happenings they cover is Tamaflu which I’ve posted about many times before and the other is about a new organic catalyzed asymmetric reaction. Each by themselves is fairly impressive but I find it interesting that the author did not tie the two together!!

For those of you not familiar with Tamiflu, here is the structure.

And then here is the reaction that forms four sterocenters and three carbon-carbon bonds. It is asymmetric and catalyzed by a proline derivative. [Control of four stereocentres in a triple cascade organocatalytic reaction, Dieter Enders, et. al., Nature 441, 861 - 863 (15 Jun 2006)].

What is amazing to me is that the author of the C&EN review didn’t comment on how related these two items are. I did not read the Nature article and maybe it does mention the possibility of using this reaction for this specific compound. I’ve not sat down to analyze what would be needed and am not familiar enough with this reaction to know what groups it might tolerate without affecting the overall reaction, but it certainly is a fascinating idea.

Technorati Tags: Chemical & Engineering News, Tamiflu

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This recent article from Economist.com is a good read about the current state of the pharmaceutical industry from a financial point of view.

Pharmaceuticals | Billion dollar pills | Economist.com

The article talks about many points I’ve made here before and even talks about bringing together scientists in one center and focusing on just a few therapeutic areas. It is an interesting read although think it still falls short of outlining what needs to be changed in the pharmaceutical industry.

One of the premises of the article is that the pharmaceutical industry tries to do it all and does many things in-house. The authors suggest more out-sourcing (although that terms is not used) and to concentrate on just a few strengths. The author uses the term “disaggreagted”. While this may work to some extent, I don’t think it will ever be as prevalent as say the automobile industry. While I do believe there are things the pharmaceutical industry can learn from other industries about how to become more efficient, I think you need to be careful and closely scrutinize the ideas before trying to apply them to pharmaceuticals. All ideas that work in other industry may not be applicable to pharmaceuticals.

One of the major problems from my perspective is still the blockbuster drug mentality. All of the things outlined in the article are still geared towards finding the billion dollar a year drug. This mentality is what has brought on the current situation for big pharma and will continue to be a major issue in the next 4-5 years. By this, I mean anytime the bulk of a company’s revenues are from one or two products, they are in a precarious situation. It would be much better in my view to have three or four $500 million products rather than a single $1 billion. They have basically put all the eggs into one basket. Too many times, projects that have good possibility are not pursued because they don’t meet this arbitrary mark of a billion dollar a year in sales. I would much rather have a company with four or five products generating hundreds of millions of dollars in sales that expire intermittently over many years than one product with a billion dollar a year in sales that expires in a few years.

Here are the top 20 pharmaceuticals companies and the percentage of pharmaceutical revenues generated by their top two selling drugs according to 2005 data. This data is generated from the Top 20 Pharmaceutical Companies article published last year in Contract Pharma.

Pfizer 38% from Lipitor and Norvasc
Sanofi-Aventis 18% from Plavix and Lovenox (increases to 25% if you include Taxotere, its third best selling drug)
GlaxoSmithKline 23% from Advair and Avendia
AstraZeneca 31% from Nexium and Seroquel
Merck 35% from Zocor and Fosamax
Novarits 29% from Diovan and Gleevec
Hoffman-La Roche 31% from Rituxan and Epogin
Bristol-Myers Squibb 40% from Plavix and Pravachol
Wyeth 36% from Effexor and Protonix
Eli Lilly 40% from Zyprexa and Gemzar
Abbott Labs 20% from Humira and Mobic
Boehringer-Ingelheim 25% from Spiriva and Mobic
Takeda Pharmaceuticals 40% from Actos and Prevacid
Scheringer-Plough 24% from Vytorin and Remicade
Astellas Pharma 28% from Prograf and Harnal (increases to 39% if you include Lipitor its third best selling drug)
Daiichi-Sankyo figures not available
Novo Nordisk 66% from insulin and insulin related analogs
Eisai 51% from Aricept and Aciphex
Bayer 27% from Ascensia and Kogenate

As you can see it ranges from a low of 18% for Sanofi-Aventis to a high of 66% for Novo Nordisk. The Novo Nordisk may be an unfair number since they lump insulin products and insulin analogs as their top two drugs and these are really aggreagates. However, the point is that for all the top pharmaceuticals, a large portion of their revenues are generated from only a few products.

Many of these either have patents expiring or have had bad press recently which combined with the decreasing number of potential products will likely lead to a desperate situation for the foreseeable future..

Technorati Tags: pharma pipelines, pharma stats, pharma worldwide markets

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Just wanted to let you know that I am going to be at the Informex conference at the Moscone Convention Center in San Francisco Feb 13-16. If anyone else is going to be there and would like to meet up, send me an email and we’ll see about getting together.

For those of you not familiar with Informex it is a big meeting of pharmaceutical contract manufacturers and fine chemicals producers. The big attraction is the networking and ability to meet with a lot of companies in a few days. I go every year to meet with contract manufacturers and see what has changed and who has added new capabilities. it also gives me a chance to catch up with many of my friends in the industry.

Hope to see some folks there!

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