QDIS Blog

The US government Center for Disease Control (CDC) has added Gardasil to the list of government subsidized vaccines for children.

U.S. gov’t adds Merck’s Gardasil to subsidized health program - iht,business,US Merck Vaccine - Business - International Herald Tribune

I think it is good that this is deemed important enough that the government will provide subsidized vaccines for those who may not otherwise be able to afford it.

Technorati Tags: Center for Disease Control, Gardasil, Merck, vaccine

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Well, I think it was just a matter for time but it seems to have occurred much sooner than I thought it might. A new strain of bird flu called H5N1 Fujian-like has been discovered at the University of Hong Kong. This new strain is resistant to the vaccines that are currently in development for bird flu.

Scientists Uncover New Bird Flu Strain - Los Angeles Times

It will be interesting to see how this plays out. Unfortunately it looks like the virus is drifting but there is no way to know if the drift will make the virus more easily spread.

Other Resources

Emergence and predominance of an H5N1 influenza variant in China — Smith et al., 10.1073/pnas.0608157103 — Proceedings of the National Academy of Sciences (abstract)

Technorati Tags: avian flu, bird flu, vaccine

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Last week there was an article about a study in the New England Journal of Medicine that basically came to the conclusion that common antipsychotic medications do not particularly help Alzheimer’s patients.

No sign antipsychotics a great help to Alzheimer’s patients: study - Yahoo! News

The drugs they looked at were olanzapine (Zyprexa), quetiapine (Seroquel) and risperidone (Risperdal). While they did have some beneficial effects, the side effects were not worth the small benefit. This is common for central nervous system (CNS) drugs and points to the fact that more targeted molecules are needed. This may stem from our rather poor understanding of the biological systems and mechanisms involved in how these drugs have there affect.

Side effects are the primary reason for not taking CNS drugs. Anyone who has had a loved one or a friend who has been on one of these or other CNS drugs can testify to that. Another problem, once a drug has been found that works and has few or no side effects, is that once they are feeling better, the patient thinks they can do it on their own and don’t need to continue taking their medications. I personally have seen this happen and it results in a roller coaster ride for both the patient and those who care for them. I found this to be particularly true for adolescents and young adults.

All of these are reasons I personally think more work needs to be done in understanding how these rugs work in the body and what can be done to improve the effectiveness of CNS drug by eliminating or reducing these side effects.

Other Resources

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Genentech has one of the most expensive drugs for cancer in Avastatin which can cost $50,000 per year. for colon cancer. Avastin was recently approved for lung cancer but since twice as much is needed to treat lung cancer, it would cost $100,00 per year. So it was interesting to see that Genentech is capping the cost.

Genentech Caps Cost of Cancer Drug for Some Patients - New York Times:

The drug was to be capped at $55,000 for families of certain income levels. This isn’t too big of a deal though because many patients never live long enough to reach this cap (median survival is 12.3 months). As it is apporved for more indications based on future trials, this could change especially if

Their other choice would have been to reduce the price of the drug across the board but it is likely this wold have reduced the income from Avastin more than just capping the cost. From the terms of maximizing their profits, this may be a good deal. Also, as Avastin is approved for additional indications, the potential for Avastin is enormous; some consider it to be able to reach$ 4 to $10 billion in sales per year.

Technorati Tags: Avastin, cancer drug, drug cost, Genentech, lung cancer

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Some recent reports claim that newer more expensive anti-psychotic medications may be no better than older cheaper ones.

• ScienceDaily: Second-generation Antipsychotic Medications Appear To Offer Little Advantage Over Older Drugs
• Newer Schizophrenia Drugs May Be No Better - Yahoo! News

Both these news stories refer to a recent article in the October issue of the Archives of General Psychiatry which showed that after a year, there was no significant difference between those on older medications (118 patients) from those on newer medications (109 patients). iI was based on a quality of life score and after a year the group on the older medications were 53.2 and with the newer medications was 51.3.

Now granted, the number of patients is small but the results seem to indicate that older cheaper medications could be used in some cases. The thing I think that always needs to be kept in mind is that the results vary with individual patients and this is the reason I have reservations about health plans that try to “encourage” patients to use older medications when studies such as this come out. I understand the need to have access to affordable drugs, but i also firmly believe the decision on what to prescribe should be between the patient and their doctor. I understand the need for a preferred formulary, but think that the hurdles put in place up to prevent the use of newer mediations in some cases is detrimental to the patients health. If a patient tries the first generation drug and it either does not work effectively for them or has side effects, then there should be an easy way for them to get access to the second generation drugs. I some cases, the health insurer may refuse to pay for any costs of these newer drugs. While I think paying a larger co-pay is reasonable, not covering the drug at all is not.

Technorati Tags: antipsychotic drugs, schizophrenia

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The FDA has recently approved additional flu vaccines for the upcoming season. This is good news in light of past problems in this area.

FDA Approves Additional Vaccine for Upcoming Influenza Season

The new vaccine is called FluLaval made by ID Biomedical (a subsidiary of GlaxoSmithKline biologics) and distributed by GlaxoSmithKline and was approved under the accelerated approval pathway. I fin it encouraging that the FDA recognizes problems with the supply in the past and is taking steps to make sure it doesn’t happen in the future.

This brings the total number of flu vaccines averrable in the US to five. Another vaccine, Fluarix was approved last year and is also made by GlaxoSmithKline.

Other Resources

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

Technorati Tags: flu, FluLaval, GlaxoSmithKline, Fluarix, vaccine

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Today seems to be genetic testing day on this blog. Reuters had a report recently on a new genetic test that will likely find great use in oncology.

Test to predict response to chemotherapy drug | Top News | Reuters.com

This is exciting news. Basically, people with lung cancer that express a gene called ERCC1 will likely not respond to cisplatin. For these patients, other chemotherapy should be considered. While not proven yet in large studies, this is interesting and might in the future allow oncologists to select the proper treatment based on genetic testing. Since chemotherapy can have devastating side effects, it is important to get a treatment that has the highest probability of success for a given patient. If you are one of those who would not respond to a given drug, regardless of how effective it is in the given population, you would want to know that before going through a treatment with nasty side effects that won’t work for you. The fact that 75% of people respond doesn’t do you any good if you are in the 25% group. I also think that until recently there seemed to be much more emphasis on finding genes that indicated a person would respond to treatment rather than identifying those who would not respond. I think both are important and in the case of oncology identifying those who would not respond is very important to avoid going through a treatment that causes serious side effects but with no really benefit.

Another example is the HER2 and Herceptin. Women with early breast cancer who have higher levels of HER2 are at significant increase risk of the disease recurring and worst prognosis. However, these very patients respond quite well to treatment with Herceptin. This test is routinely used now for women with breast cancer.

I see this as the future of personalized medicine and not the process of making a specific compound for an individual. Finding out who will and who will not respond to a given treatment will be of tremendous importance to medicine in the 21st century.

Other Sources

• HER2/neu - Wikipedia, the free encyclopedia
• NEJM — HER2 and Responsiveness of Breast Cancer to Adjuvant Chemotherapy
• Adjuvant Trastuzumab: A Milestone in the Treatment of HER-2-Positive Early Breast Cancer — Baselga et al. 11 (Supplement 1): 4 — The Oncologist
• Low ERCC1 Expression Correlates with Prolonged Survival after Cisplatin plus Gemcitabine
• Chemotherapy in Non-Small Cell Lung Cancer — Lord et al. 8 (7): 2286 — Clinical Cancer Research

Search Results

• her2 - Yahoo! Search Results
• her2 - Google Search
• ERCC1 - Google Search
• ERCC1 - Yahoo! Search Results

Technorati Tags: chemotherapy, cisplatin, genetic testing, Herceptin, personalized medicine, trastuzumab

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Lately I’ve been thinking about genetic testing and its proliferation recently, especially those available by mail. A lot of those advertising are paternity related but others cover a wide variety of diseases.

CBS News recently had a good article about this.

Home Genetic Tests For Disease - CBS News

One of the problems with these mail-in testing is that, in the vast majority of cases, there is no counseling involved. What about the situation where a woman has sent in a DNA testing for breast cancer and the results come back that she has the gene in question. What does this mean to her? Does that mean she will definitely develop breast cancer? All of these are sure to be though about and without any access to genetic counseling how are they to get answers. Hopefully, most would turn to their primary care physician but some studies indicate they aren’t informed on what these various genetic testing results mean.

Seems that in some cases, these are like the old snake oil salesmen. They claim to test for all sorts of things but don’t disclose the limitations. There is also the worry of counseling if the results are potentially devastating. THen there is the fact that this industry is largely unregulated.

I think this area will be one that sees a dramatic increase in use in the next few years but like any tool, it needs to be used correctly. I can’t say, based on what I know now, that I think the mail order genetic testing is worth the cost, both monetary and psychological. This is another case where science is far ahead of public policy.

Other Resources

Genetic testing - Wikipedia, the free encyclopedia
DNAPolicy
Talk to Your Doctor or Healthcare Practitioner About Home Genetic Tests

Technorati Tags: genetic testing

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In what I consider to be a very good development the FDA has now issued guidance to industry on developing cell-based viral vaccines. Right now, chicken egss are used and the process hasn’t changed in many years. Development of cell-based methods for manufacturing vaccines could increase the ability to produce vaccines.

FDA Issues Guidance to Industry for Development of Cell-Based Viral Vaccines

The New York Times also reported on this.

FDA Rules May Speed Flu - Shot Modernizing - New York Times

One of the important reasons for this is if the bird flu should happen to wipe out the chicken pollution, it would make producing vaccines using chicken eggs impossible and another method would need to be developed. It is good to see thought is going into this before something catastrophic happens.

Other Resources

• Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
• FDA Rules May Speed Flu - Yahoo! Search Results
• FDA Rules May Speed Flu - Google Search

Technorati Tags: FDA, flu, vaccine

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I continue to be concerned about the number of bacteria that are developing more and more resistance to most known antibiotics. Recently, tuberculosis (TB) has seen a rise world-wide but even more concerning is that he number of multi-drug resistance strains have been turning up in the US.

More drug-resistant TB seen in U.S. - Yahoo! News:

There are about 2 million cases of TB world-wide each year and most are in Africa and southeast Asia. Recently in Africa 50 people died from a strain which is said to be extensively drug resistant.

In the US, about 74 cases of TB have been reported since 1993. But in the modern area of jet travel, it seems inevitable that it will spread. Already there has been an increase in the US in these multi-driug resistant strains: in 2004 there were 18 cases but in 2005 that increased to 24.

Unfortunately, until this becomes profitable for the pharmaceutical companies, I don’t see many of them investing significant amounts of money. I hold hope that some smaller nibbler biotech or pharmaceutical company will be able to make progress in this area.

Other Resources

• Division of Tuberculosis Elimination (DTBE) - Home Page (Center for Disease Control)
• WHO | Tuberculosis
• MedlinePlus: Tuberculosis
• Tuberculosis - Wikipedia, the free encyclopedia
• Institute for Tuberculosis Research
• Stop TB Partnership - Home Page
• Tuberculosis News

Technorati Tags: antibiotics, drug resistance, tuberculosis

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