Antibody Issues

There are questions about the reproducibility of antibodies. There are potential major problems because of the change in the the way the antibodies are being produced and the way they are being used.

History of Antibody Research

Antibodies were used over 50 years ago in immunoassays in immunohistochemistry and Western blots. The technology today, ELISA/aPCR, nanoscopy, ChIP sequencing, and nanoimmunoassays are stretching the limits of antibody capabilities.

Mergers

In the 1950s, scientists created their own polyclonal antibodies. In the 70s and 80s different small companies were formed that sold antibodies to researchers. Then pathologists began using the antibodies and the light bulb went off in larger companies that antibodies had market potential. By the 1990s many of the startup companies were being bought out by larger companies.

Quality

The original companies often had the names of the founders and they took great pride in the quality of the product. The merged companies are putting out product but there are questions about the validity and the reproducibility of data generated using the new antibody tools.

Researchers are not blameless. Due to pressures to publish, many just buy something from a catalog instead of taking the time to check and make sure that it is the best product for their intended purpose. Some by on the reputation of the company alone, others buy on price figuring that high priced products must be good.

Expertise?

There is another problem. If the company, because of mergers just sells what it has acquired and has never developed any of these products, they may not have the expertise to give advice to researchers as to what would be best for their intended purpose.

Some of the problems can be overcome by researchers stopping inappropriate short cuts. One of these short cuts is the not used controls. And Western blots have limited use if there aren’t positive and negative controls. If it is done correctly though, it can be very helpful and revealing.

Another problem is that research reagents aren’t adequately scrutinized and tested. Some antibodies are sold by OEMS. Some are bad and some are good. The good ones have excellent quality control. Bad ones look to sell as much as possible and have little or no technical support.

One thing that would improve the situation would be to slow down the rush to market and also to have well defined acceptance criteria.

 

Vaccines

It is kind of ironic that the last post talked about malaria. This post will talk about the vaccines for malaria and ebola. The new ebola vaccine is apparently quite effective which is a relief with such a scary disease. The malaria vaccine is effective but not as much as had been hoped for.

Malaria vaccine

Interestingly, this vaccine won’t be given to travelers. It was designed for children of affected regions. This would be Africa, Pakistan and India, the primary places where 80-100% of the people are at risk of contracting malaria. Almost 600,000 people die a year from malaria, mostly kids under 5 from sub Saharan Africa.

Efficacy

The problem is that four shots are needed. Without the final booster shot administered 20 months after the first three shots, you might just as well not bother. There is no significant difference. With the booster shot, severe malaria cases decreased by about a third. Not ideal, but far better than nothing.

Timing

The other problem is the timing. It was found that it was more effective done a bit later and not at the same time that the children got their other vaccine shots. This will create a logistical nightmare for giving the shots. It also means that the youngest children who are very susceptible will not be protected.

Economic Impact

Anthropologists have found that in areas with high malaria, the population was more spread out, there were fewer beasts of burden and the people were never able to organize into a more advanced civilization. Rather amazing that one parasite can have such an effect. Modern technology is helping some and even something as simple as bed netting can be as effective or more so than the vaccine. Will the two of them combined help to bring sub Saharan Africa into the 21st century?

The malaria vaccine has been worked on for 30 years and is the first human vaccine against a parasite. The Ebola vaccine was essentially developed 10 years ago and then just sat.

Ebola Vaccine

The problem is that vaccines are just as expensive to take through the regulatory process but little or no money is made on them. The only reason that the Ebola vaccine that was developed 10 years ago is getting out now is because of the recent Ebola outbreak. If the vaccine had come out when it was developed, it would have saved the lives of thousands of people in this recent outbreak. Recent tests have shown it to be extremely effective.

A proposal has been made to create an international fund to support vaccine research and to pay for the regulatory approval process. Countries and drug companies would contribute. The amount of money sought is around $2 billion dollars which may seem like a lot, but considering the cost of clinical trials isn’t that much. Also when you consider that fighting the recent Ebola outbreak cost over $10 billion, it would be an investment that was well worth it.