QDIS Blog

This past week thee were two interesting hearings on the safety of both food and drugs.

PharmaLive: Sen. Enzi Holds Hearings on Food and Drug Safety

Given the number of instances lately that have received media attention (Vioxx and the e coli 0157 problems with spinach) I think this is timely. What follows are my thoughts, comments and interesting points on the drug safety hearing made while watching it.

Ms Burke of Institute of Medicine
• General feeling of the need giving the FDA more authority to ensure safety
• Need for new tools to predict safety.
• Central clearing house for clinical trials information
• S 3807 closely parallels many of the suggestions in the Institute of Medicine Report released in Sept.
• FDA scientists may have been pressured to change recommendation based on politcal views according to Senator Ted Kennedy
• $6 per year for every American is what the FDA budget comes to even though they oversee about 25% of the GNP
• A life-cycle approach to drugs should be taken including post-marketing studies
• The CEDR organizational structure is sometimes dysfunctional.
• A major need for leadership and stability.
• Recommendation to make the FDA Commissioner a fixed 6 year appointment.
• Recommend entirely funding from congressional budget and curtailing use of PUDFA.

This is interesting since this model is being proposed for reviewing ads for approved drugs.

• IOM committee did not think breaking up CEDR into one for approval and one for safety made sense. Did want to get post marketing folks involved earlier in the process.
• Legislation will NOT force cultural change. This is why leadership is critical.
• IOM had many recommendations especially with regard to ways to possibly integration various divisions and to change the culture.
• FDA ability to unilaterally change labeling was discussed.
• Appropriations should be primarily but PUDFA funds are needed these should also be made available for post-marketing
• IOM did not want to comment on biogenerics. Senator Hatch pursued this quite extensively.
• Senator Patty Murray brought up concern of politicalization of scientific information within the FDA.
• Statues need to be given to the FDA to unilaterally make changes to labeling. This came up several times.
• DTC ads were discussed and are needed but need to be informative to the consumer. They should be easily understood.
• Senator Clinton asked about comparative effectiveness studies. Nothing was really offered in this regard.

2nd segment; five people testified
• Clinical trial registries were discussed by several people giving testimony.
• Better funding was mentioned by almost all.
• In this part, sometimes questions asked and answered led to more questions in my mind but the Senators never seemed to follow up on what the people testifying really meant. There should be more follow-up questions in my opinion. Sometimes it seemed the clock was more important than the content of the meeting.
• No one was in favor of separating safety from approval within the FDA.

One last comment. I truly believe all government hearing should be easily available online in video as well as pdf version of the statements.

Other Resources

• Full Committee Hearing Hearing - Hearing on Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation (includes links to pdf files of witness testimony)

• Video of hearing (Real Player: begins at 35:04: ~1 h 54 min in length)

• Full Committee Hearing on Food Safety: Current Challenges and New Ideas to Safeguard Consumers (includes links to pdf files of witness testimony)

• Video of hearing (Real Player: begins at 17:47: ~x h y min)

• Ted Kennedy | S. 3807, The Enhancing Drug Safety and Innovation Act of 2006

Technorati Tags: drug safety, FDA, food safety

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Well, now this is interesting. It seems Pfizer is now cutting 2,200 jobs in its sales and marketing and that this only a first step.

Pfizer Cuts Could Change Drug Business - Forbes.com:

It will be interesting to see if other large pharmaceutical companies follow suit.

I personally think it is about time. The number of “detail men” has increased dramatically in the last decade and there is now 1 drug sales rep for every nine doctors. I think this will become a trend with other large pharma companies cutting back also. I’m not sure how this plays out with the ideas of cutting direct to consumer advertising for the first two years of a drugs launch. I also have envision large pharma becoming more of a marketing entity than a research and development company but if there is dramatic down-sizing in the marketing area then this may not happen.

Still, the most interesting aspect to me will be if other large pharmaceutical companies follow suit.

Technorati Tags: drug marketing

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Kyphon who makes medical devices will purchase St. Francis Medical Technologies who make a spinal device for $525 million.

UPDATE 2-Kyphon to buy spine product maker for $525 mln | Reuters.com:

Since I don’t keep up as actively in the medical devices as I do in the pharma/bitech areas I’m not sure what the impact of this will be. This appears from what I’ve read to be a good merger and may be driven by the need for diversification.

Technorati Tags: pharma M&A, pharmaceutical deals

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This stem cell article appeared in the Washington Post about a week ago and I am just now getting around to commenting on it.

Democrats Plan to Revive Stem Cell Bill - washingtonpost.com:

I really think there are other things I’d like to see at the top of congresses agenda. While I think this is important, I doubt there would be enough votes in congress to override a certain presidential veto. The president has already veto it once and there is no reason whatsoever to expect it not to happen again. However, there could be consideration beyond just getting the bill passed as is common in politics. This may be a way for Democrats to benefit from the debate and ensuing media attention after a second veto and would certainly bring the issue to the forefront for the presidential elections in 2008.

My impression is that the majority of people think there should be funding for such research. It brings to my mind the times when the church and other groups felt that cutting up human bodies to understand the various system such the the respiratory system or the circulatory system was unconscionable and an abomination. I don’t know of anyone today who would say that was wrong given the enormous impact of such knowledge on medicine today.

I truly hope stem cell research can be funded and continued in order to keep the US at the forefront for such research.

Technorati Tags: stem cells

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A recent UPI report focused on the number of FDA approvals.

United Press International - Health Business - Analysis: FDA approving more drugs:

The report states that September and October were strong and there have been 83 approvals putting it in line with 2004 results. However, this may be temporary and not a long term trend. I think the lack of a lead and the possibility of even more legislation regarding drug safety will likely slow down the process.

I personally think the low-lying fruit has been picked over throughly and now there needs to be more validation of potential drug targets in order to facilitate research and allow for more potential drugs to be developed. Until more valid targets are discovered, I think the rate of drug development will continue to be sluggish.

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Commonwealth Biotechnolgies (CBI)of Richmond, VA will buy Mimotopes, an Australian company for $5.8 million.

TimesDispatch.com | Biotech firm sets major merger:

The details are interesting in that CBI will issue 2.15 million shares of its stock to PharmAust Chemistry Ltd. who will then own 40% of CBI. According to the article, CBI wants to get into the drug discovery aspect which is valued at ~%7 billion by 2009. It is interesting since several drug discovery based companies have been acquired or gone out of business in recent years. While I think drug discovery will continue to be important, I think it will see major price pressures and that this means more centers in China and India. I see a certain decline in drug discovery houses in the US. I’m not sure where Australia comes out in this discussion but the labor costs are almost certainly higher than in China or India.

CBI is a biotech drug and diagnostic contract services company and Mimotopes supplies lab quantities of research-grade peptides.

I’m not really familiar with either of these companies so it is hard to judge the value here. However, since I’ve been focusing on the number and size of mergers in this area, I at least wanted to mention this one.

Technorati Tags: Commonwealth Biotechnolgies, pharma M&A, pharmaceutical deals, Mimotopes

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I always get concerned when I see drug imports touted as a way to achieve lower drug prices.

Congress seen pushing for imported drugs:

The main point brought up by the pharmaceutical industry and the FDA is safety. While I think safety is a concern, it is something that could be overcome and the proper procedures put into place to ensure safety. The safety concerns are important especially with regard to companies that set up websites that appear to be Canadian based but are really getting the “drugs” from questionable sources.

The more important point from my perspective is that if even if a low percentage of Americans start this, there simply are not enough drugs in Canada to supply even a small percentage of the US. Also, the Canadian government has considered and are still considering a ban on sales into the US. Also, it is interesting as to how you word the question. If you ask simply about importing cheaper drugs then the majority are for it. If you change the question to be should we have price controls on drugs similar to Canada’s then the majority are not in favor. They are basically the same thing just worded differently.

Also, not all drugs from Canada are cheaper. Primarily it is the brand name drugs that are cheaper. Generic drugs in general tend to be more expensive when purchased form Canada. The US has chosen a different approach than the rest of the world with regard to generics ever since the Generic Drug Act.

The main problem is that prescription drugs are like energy, it is something you basically can not do without. With other products, the consumer can decide whether or not to purchase say a car or even how much they want to spend on a car. With energy and medicines, this isn’t the case. The choice of a generic can save money but it is not always the case that generics are available.

It is a trouble-some issue and the main point to be kept in mind is that on an international scale, the drug and biotech industry are not a free market. In most of the rest of the world, the government is the sole purchaser and the companies must negotiate with the governments. This basically means that the US subsidizes drug costs for the rest of the world.

Technorati Tags: drug cost, drug imports, FDA

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If you are a regular reader you know I’ve posted several times about the antibiotic Ketek (telithromycin). It seems that Senator Charles Grassley (D) Iowa has asked for information from the FDA on this and that the FDA has not responded appropriately.

PharmaLive: Grassley Makes Available Responses from FDA Nominee :

Here are the three aspects that are pertinent .

1. Written answers from von Eschenbach to confirmation hearing questions from Grassley (pdf)
2. Letter from Grassley to the Senate Majority Leader placing a hold on the von Eschenbach nomination
3. Letters from Grassley to the Secretary of Health and Human Services regarding agency responses to congressional inquiries.

The third point is the one I want to more fully discuss.

I fully agree with the need for any agency including the FDA to respond to congressional inquiry. The third letter is interesting in that it states in no uncertain terms that Grassley feels the FDA has not been forthcoming with information and may be withholding information. Here is a portion:

In recent weeks, my Committee staff interviewed a number of FDA officials who
referred to extremely relevant documents, which have been withheld from the Committee
to date. Further, the Committee is aware that at least three FDA officials, who played
integral roles in the FDA’s review of Ketek, were never asked to review their files and
turn over relevant documents in their possession to the Office of Legislation. For
example, most recently, my Committee staff was to interview the Regulatory Project
Manager (RPM) for Ketek, pursuant to my request letter, dated October 5, 2006. Last
Wednesday, more than six months since the Committee subpoenaed Ketek documents,
FDA notified my Committee staff that during interview preparation it was discovered that
the RPM was never directed to produce documents responsive to the Committee’s
subpoenas. It is simply dumbfounding that someone as centrally involved as the RPM in
the review of a drug was not directed to produce documents pursuant to the Committee’s
subpoenas. This latest “oversight” is but one of many that shows the inability of
HHS/FDA to comply with the Committee’s subpoenas in good faith.

While it may not be deliberate, it certainly is disturbing that there my be this sort of lack of communication.

The original subpoenas were issued May 19, 2006 and as of Nov. 21, 2006 the response still had problems according to Grassley especially with regard to redacted information where no notation was made as to why the information was redacted.

I know that Grassley has a reputation of being tough on the FDA and some have come out against this hold. See (Eye on FDA: Hold It). I think that if the FDA indeed has not appropriately replied to the subpoena then it might be justified. I personally don’t think it help the situation in the long run but I do know that congressional oversight has been lacking and that that situation may be changing starting next year now that the Democrats control Congress.

This has also been covered in the following article from the Washington post.

FDA, Lawmaker Clash Over Antibiotic - washingtonpost.com:

What is interesting is this reply to Grassley from Dr. von Eschenbach

Von Eschenbach wrote that “the disclosure of information that might relate to any open investigation in response to congressional inquiries poses an inherent threat to the integrity of the executive branch’s enforcement and litigation functions.”

This sounds like what I’m sure we will here a lot of in the coming year; executive powers.

I personally think there are ways to handle this where the enforcement and litigation can be handled without causing problems and feel this sort of reply from Dr. von Eschbach certainly doe not bode well with regard to working with Congress. If I were up for a position of any sort, this certainly would not be the tone of my rply to an important group I knew I would have to work with closely in the future.

Here was Senator Grasley’s response.

“The actions and words of this nominee display a misunderstanding of congressional oversight of the executive branch of government,” Grassley said.

I think we are going to hear much more of this sort of exchange between the executive branch and the legislative branch for the next two years. I think it could lead to some ugly confrontations and eventually the judicial branch may be involved. It will be interesting to see how this develops.

This appears to me to be setting up a showdown and it looks like it could go on for sometime. In the meantime, consumers lose because again, the FDA has no permanent leadership.

Technorati Tags: drug safety, FDA, Grassley, Ketek, telithromycin

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I wanted to post about some pharmaceutical deals including the following.

PharmaLive: Johnson & Johnson Announces Definitive Agreement to Acquire Conor Medsystems, Inc.:

Conor Medsystems has a drug delivery system that is used in paclitaxel eluting stents. The acquisition is all cash and valued at $1.3 billion.

It should be noticed that the stents made by Conor Medsystems are NOT yet approved for use in the US but are approved in other countries.

J&J definitely wants to continue compete with Boston Scientific in the eluting stent area and this gives them several potential product that are fairly far along in development. This is likely a good deal for J&J but again, I question the high price.

Technorati Tags: Conor Medsystems, Johnson & Johnson, pharmaceutical deals

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I found this article interesting regarding drug companies paying the FDA to review TV ads for drugs to make sure they do not contain any violations. This is voluntary; drug companies do not have to do this but many do. This is somewhat akin to the PUDFA (Prescription Drug Users Fee Act) where the drug manufacturers pay to get their applications reviewed and the money goes to hiring more staff to ensure timely approvals.

Drugmakers to pay FDA to OK ads: WSJ | Entertainment | Industry | Reuters.com:

What is interesting about this is one of the recommendation from the Institute of Medicine concerning reforms within the FDA was the elimination of just such funding. They believed that it is better for congress to fun the agency at an appropriate level for the amount of work they are required to do.

I should point out that this is not yet finalized since FDA’s parent depart the the Department of Health and Human Services has not yet approved this and it would also require Congressional approval.. It is estimated that the FDA would get ~$300 million in 2007 and $400 million in 2008.

I tend to agree with the IOM report that Congress should really be the ones responsible for funding. Congress gets to avoid dealing with the agencies funding by allowing this to happen and it could be abused. There is currently no evidence of this but the generic scandal in the past should be kept in mind. I personally think there needs to be more oversight and more budget for the FDA but also think that more attention needs to be paid to how those funds are acquired.

Technorati Tags: drug ads, FDA

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