QDIS Blog

I’ve posted about Ketek several times now and today it is announced that Sanofi has agreed to change the labeling of the drug.

Technology News: Health: Antibiotic Label Will Carry Liver Warning

The warning is in regard to the liver problems and now includes that the drug should not be taken along with any of the statins, which are very common drug for reducing cholesterol. I’ve posted several times about Ketek and have been somewhat pessimistic about it. I guess time will tell. I should note that the side effect is pretty rare; 23 in 10 miilion prescriptions on par with other antibiotics. However, it least adding the warning alerts doctors (and patients who bother to read the package insert or prescribing information) to the potential problems. Also it is approved for use in sinusitis, bronchitis and pneumonia including cases where the bacteria may be resistant.

Here’s quote from the following article: Sanofi adds new liver warning to antibiotic label | Reuters.com

The new, bold-faced warning on Ketek’s label advises doctors and patients to watch for signs of liver problems and stop taking Ketek if they appear. Symptoms can include fatigue, malaise, loss of appetite, nausea, yellow skin and dark urine.

I should also mention that this is a new class of antibiotics called ketolides that certainly hold promise as bacteria become more resistant to the commonly used antibiotics.

Here is the warning on the front page of the Ketek.com website.

KETEK® is contraindicated in patients taking cisapride or pimozide and in patients with a history of hypersensitivity to telithromycin or any macrolide antibiotic.
Exacerbations of myasthenia gravis have been reported in patients with myasthenia gravis treated with KETEK®. KETEK® is not recommended in patients with myasthenia gravis.
KETEK® has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias, including torsades de pointes. Thus, KETEK® should be avoided in patients with congenital prolongation of the QTc interval, and in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents.
KETEK® may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation. Visual disturbances included blurred vision, difficulty focusing, and diplopia.
There have been post marketing adverse event reports of syncope. Patients should be cautioned about the potential effects of visual disturbance and syncope on driving or engaging in potentially hazardous activities.
Hepatic dysfunction, including increased liver enzymes and hepatitis, with or without jaundice, has been reported with the use of KETEK®. Caution should be used in patients with a previous history of hepatitis/ jaundice associated with the use of KETEK®.
Use of simvastatin, lovastatin, or atorvastatin concomitantly with KETEK® should be avoided. If KETEK® is prescribed, therapy with simvastatin, lovastatin, or atorvastatin should be suspended during the course of treatment. Concomitant treatment of KETEK® with rifampin, a CYP 3A4 inducer, should be avoided.
Most adverse events were mild to moderate and included diarrhea, nausea, headache, dizziness, and vomiting.
*KETEK® is indicated for 5-day treatment in:
Acute bacterial exacerbation of chronic bronchitis (AECB) due to Streptococcus pneumoniae, Haemophilus influenzae,
or Moraxella catarrhalis

Acute bacterial sinusitis due to S pneumoniae, H influenzae, M catarrhalis, and Staphylococcus aureus

7- to 10-day treatment in:
Mild to moderate community-acquired pneumonia due to S pneumoniae, multi-drug resistant S pneumoniae, H influenzae, M catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae

Other sources:

KETEK® - Treatment for the Following Respiratory Tract Infections…
Yahoo! News Search Results for ketek label warn
ketek warn label - Google News

Blog Sources:

Google Blog Search: ketek sanofi label
ketek sanofi label - Ask.com Search
IceRocket Blog Search: ketek warn label

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

Email Ed Vawter

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

I’ve posted before about Merck’s cancer vaccine Gardasil. You can see my other posts for further details. The final step after the FDA approval was whether or not the CDC would recommend it be used generally for young girls.

Merck Gets Vaccine-Panel Backing for Gardasil Shot Bloomberg.com

Today, the CDC did recommend the vaccine for all girls age 11-12 and as young as 9 at their doctors discretion. Since the vaccine is 100% effective in the clinical trials it should go a long way towards reducing or eliminating cervical cancer in women.

Merck is also looking at the vaccine in young boys and those clinical trials should be conclude by 2008. Human Papilloma Virus (HPV) can also cause cancers and other problems in men.

It will be interesting to see what price Merck charges and whether or not insurance companies will cover it. Hopefully the relatively low cost of the vaccine will convince insurance companies that it is better than trying to catch the disease and treat it later.

Technorati Tags: Gardasil, Merck, vaccine

Email Ed Vawter

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

Biotech crops seem to be getting a lot of bad press in last few years. One company, Ventria has developed a GM rice that produces two proteins found in breast milk and which could then be extracted and eventually sold as a drug. An application has been filed is not yet approved. The proteins would be used to treat diarrheal illnesses in children in developing countries which kills about 2 million children each year. Here’s an article from the Sacramento Bee on this.

Kansas opens arms to Ventria’s biotech rice - sacbee.com:

The company only has 18 employees and has had resistance in both California and Missouri due to concerns about GMO from other rice farmers in that state. They currently grow the rice in North Carolina and in greenhouses in California. This would allow them to expand their fields into Kansas and so far there hasn’t been local opposition. Also, Kansas has no existing rice crop so the fears of cross contamination are not there.

It should be made clear that this rice is not for human consumption. It will be collected and further processed to extract the proteins.

Further resources:

Web Search:

• Ventria - Yahoo! Search Results
• Ventria - Google Search

News Search

• Yahoo! News Search Results for Ventria
• Ventria - Google News

Blog Search:

• Yahoo! Search Results for Ventria
• Google Blog Search: Ventria

Technorati Tags: biotech crops, Ventria

Email Ed Vawter

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

Recently, Rep. Henry Waxman (D-Ca) posted some interesting information on his website.

Committee on Government Reform Minority Office

Here is a link to the original pdf report:

“Prescription for Harm: The Decline in FDA Enforcement Activity”

While I find it interesting I am always cautious when looking at other peoples results of data. For one thing I want to make sure and see what kind of agenda (either hidden or open) they may have. Waxman is well known for the Hatch-Waxman act passed in 1984 which allowed basically created the generic drug industry.

Let’s take a look at the first of their figures shown below:

I’m always skeptical of a graphs with only two points. One could easily pick two years to prove a point but not necessarily a trend. So I went back and counted all the warning letters from the FDA (both CDER and CBER) listed on the FDA website and came up with my own chart shown below. Note I’ve excluded the Cyber warning letter that deal with web sites offering drugs.

I came up with different numbers since I did not include food safety, devices and radiological health, or vet medicines. Also, even for the years listed my numbers are slightly different. For 2000 I counted 124 for drugs and biologics and the report lists 130; for 2005 they list 79 whereas I counted 65.

While there are some differences, I think the trend stands. If anything it is even clearer since I went back to 1997 (as far back as possible with data on the FDA website). There definitely seems to be a drop off starting in 2002. I personally think this is a disturbing trend and will definitely be keeping an eye open to see if this continues or changes.

Here are the three key findings quoted from the report.

1. FDA enforcement actions have declined under the Bush Administration. The number of warning letters issued by the agency for violations of federal requirements has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low. During the same period, the number of seizures of mislabeled, defective, and dangerous products has declined by 44%.

3. FDA’s recordkeeping and case tracking practices are inadequate. Although the Federal Records Act and internal agency procedures require FDA to keep records that document agency enforcement decisions, FDA does not appear to comply with these requirements. FDA’s response to Committee requests for relevant enforcement documents was haphazard, incomplete, and untimely. FDA officials explained that FDA could not provide prompt and complete responses because the agency lacks a system that enables it to track enforcement recommendations from field offices.

I especially find item 3 disturbing; while the FDA insists that pharmaceutical companies keep accurate records of all their data, it seems they themselves don’t keep track of enforcement recommendation from their field offices! It is really disturbing that they have no system of any kind for this according to my reading of this.

Other resources:

Press Release
Rep. Waxman’s Statement on the Anniversary of the FDA (pdf)
Letter from Professor Jerry Avorn, M.D. (pdf)
Letter from Professor Michael Wilkes, M.D., Ph.D. (pdf)
Letter from Sammie Young, former senior FDA enforcement official (pdf)

Technorati Tags: drug safety, FDA enforcement

Email Ed Vawter

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

Yesterday, the FDA approved Exelon (rivastigmine tartrate) made by Norvartis for the additional indication of mild to moderate dementia associated with Parkinson’s disease.

FDA OKs drug to treat Parkinson’s dementia - Yahoo! News

Exelon was originally approved in 2000 for mild to moderate dementia associated with Alzheimer’s dementia. It is the first drug to be approved to treat dementia associated with Parkinson’s disease.

It is not without side effects such as nausea and weight loss. Some also had a worsening of tremors associated with the drug.

I personally have been lucky and not had to deal with a family member or friend having either Parkinson’s or Alzheimer’s so I can’t say if I think the side effects are worth the potential risk. I do hope that this is a first step towards improving the condition of people with these diseases and that more advanced better treatments will be coming in future years.

Further resources:

• Alzheimer’s Disease Treatment - Exelon (rivastigmine tartrate)
• Exelon prescribing information (pdf)
• Exelon Online, Description, Chemistry, Ingredients - Rivastigmine Tartrate - RxList Monographs
• Yahoo! News Search Results for exelon drug
• exelon drug - Google News

Here is what the blogsphere is saying about Exelon:

• Google Blog Search: exelon
• Yahoo! Search Results for exelon
• exelon - Sphere
• exelon - Sphere

Technorati Tags: dementia, Exelon, FDA, Novartis, Parkinson’s disease, rivastigmine

Email Ed Vawter

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

A report earlier this month in the Medical News Today expressed concern over the recommendations from “The American National Cholesterol Education Program” that people at “high risk” should be treated more aggressively. By more aggressively, they mean a reduction in LDL (so called bad cholesterol) from the current level of 2.56 mmol/L down to 1.81 mmol/L a reduction of 30%. The study was reported in the British Medical Journal vol. 332, p. 1330.

Here’s the commentary from Medical News Today.

Concern Over ‘aggressive’ Cholesterol Recommendations

It’s interesting they note that to achieve these levels most adult in the western world would require higher doses of statins higher than currently used. Here’s the paragraph:

To achieve this new goal, most of the Western world’s adult population would be on statins, and doses would have to be more than eight times higher than currently used, say the authors. This would increase both the number and seriousness of side effects.

The authors conclude that any reduction in non-fatal events may be outweighed by more numerous and more severe adverse effects.

As I have stated before, I believe that for any drug and a given patient you need to weigh the risk vs. the reward. No drug is totally safe and if you recommend increasing the dose and the number of people using them you are going to see an increase in the number of side effects. Since the study states that overall mortality is not reduced and that side effects are generally under reported is this a good recommendation? I firmly believe that well thought out guidelines are useful but this seems to me to be overboard. I also think that these sorts of decisions need to be made on a personal level of a patient and their doctor based on their medical situation. While drugs are certainly helpful, the reward should be evaluated against the potential risks.

My overall opinion, while cholesterol should be kept down, I don’t think this specific recommendation is warranted.

Technorati Tags: cholesterol

Email Ed Vawter

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

Here’s more on what I posted yesterday regarding Merck’s pricing of Zocor and Senator Schumer’s (D-NY) reaction to that. Here’s more details.

Schumer Reveals Merck Offering Payoffs To Discourage Health Plans From Using Generic Version Of Zocor

It seems that Merck if offering major rebates to health insurers if they will give Zocor it’s lowest co-pay and then ensure that the generic version (simvastatin) is given the highest co-pay. Schumer thinks this is illegal and violates anti-competitve laws. I’m no lawyer and won’t comment on whether or not it is illegal. However, I would say that it is questionable from a moral point of view (at least in my opinion). It does NOTHING but reinforce in the mind of the general consumer that pharma companies are greedy and will do anything to try and keep their prices high. With the current state of the pharmaceutical industry, this is the last thing needed now. Also, Merck is already taking it on the chin for the Vioxx situation which will hang around their neck for the next several years.

If they want to keep market share then it might be better to just lower their price to either the same or slightly lower than generic version once it comes out. Making your price low only if the insurer makes the price of the generic drug higher is certainly questionable.

I think most people miss the point (I did too at first) that it isn’t just the pricing but that the pricing is only available if the generic has a higher co-pay.

The following are some good references to this matter:

• Generics and Pricing, Part II - A Drug, A Price and a Senator - Eye on FDA
• newsobserver.com | Cheaper Zocor? Critics smell a rat
• Schumer to Merck: Raise Your Prices Now - DrugWonks
• Mises Economics Blog: Because drug price competition is bad, mmmkay???
• Senator Raps Drug Giant Over Zocor Price - New York Times
• SCHUMER: MERCK MADE PAYOFFS TO INSURERS TO UNDERCUT GENERIC ZOCOR - FDA News

Technorati Tags: Merck, simvastatin, Zocor

Email Ed Vawter

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

Seems the drug industry is coming under fire for having prices too low?! Senator Schumer (D-NY) is upset because Merck has chosen to price Zocor very low.

Senator Raps Drug Giant Over Zocor Price: Financial News - Yahoo!
Finance:

Typically when a drug goes generic (Teva is about to launch a generic version of Zocor) price drops but the brand name drug is still usually sold at a higher price than the generic equivalent. Merck has chosen to try and maintain it’s market share by offering the drug at a very attractive price (probably lower than what Teva may be planning on selling simvastatin for). I’ve always wondered why drug companies didn’t do this with their brand name drug once a generic comes on the market.

It seems if drug prices are too high, drug companies are excused of price gouging (as example see a recent AARP report). Now when they lower the price more than normal, they are accused of being anti-competitve. I’ve always said that in the mind of the “man (or woman) on the street” medications are viewed as essentials and are thought of differently from other products such as an automobile. I think having strong competition such as this will ultimately help make medicines more affordable. All of this is provided brand name companies are not selling at a lose in order to drive the competition from the market.

More news results:

• Yahoo! News Search Results for zocor merck price
• zocor merck price - Google News

Technorati Tags: generic, Merck, simvastatin, Teva, Zocor

Email Ed Vawter

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

I posted previously on Neurocrine and the insomnia drug Indiplon. There seems to be much more to the story than what I first thought. I concentrated on the information that the FDA hadn’t fully reviewed all the data and that the lower doses (in capsules) were given an approvable letter and the higher dose tablets were not. Now it seems Pfizer is ending their agreement with Neurocrine. Here’s the press release.

Neurocrine and Pfizer Terminate Collaboration Agreement for Indiplon

The Street.com has another article.

Pfizer Drops Neurocrine Deal

It should be noted that the FDA sending an approvable letter does not mean it is approved. It means that, provided the questions that the FDA may have are satisfied, they would then approve the drug. It seems they rejected the long lasting version (the tablets) and asked for more data on the lower dose fast acting version (the capsules).

Neurocrine had a webcast yesterday and they have a link on their website. I’ve not had a chance to listen to it (and probably won’t for reasons I’m not going into). My guess is without Pfizers support, that Neurocrine will discontinue their work on this drug. Also the area of sleeping pills is becoming competitive and I’m not sure how well they would be able to penetrate the market. I do want to disclose that I have been an occasional user of Ambien for a couple of years now.

It’s also interesting to note Forbes has been hinting that Pfizer may buy Sepracor who makes Lunesta. I’m not sure how much weight to put on this. If Pfizer is truly interested in getting into the insomnia market this may be a better route to get into this area.

More news results:

• Yahoo! News Search Results for neurocrine

• neurocrine - Google News

Technorati Tags: Indiplon, insomnia, Neurocrine, Pfizer, Sepracor

Email Ed Vawter

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

Just wanted to let folks know that I haven’t been posting as much as I would like recently. Not only has the news been kind of slow, but I also recently badly sprained an ankle playing softball. I’ve been on crutches for a couple of weeks and am just now literally, back on my feet (although I do have to wear a brace on the ankle and things are still tender). The posts continued for a while since I usually try to work several days ahead and then automatically post one or two articles each day. Hopefully I’m now back to a normal schedule.

Email Ed Vawter

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