#1: Passage of FDA Legislation on Drug Regulation and Safety

The Food and Drug Administration Amendments Act of 2007 was signed into law by President Bush in September. The result of the bill is to increase the FDA’s authority to regulate drugs. This legislation renews two programs for five years that collect fees from drug and medical device manufacturers to defray the FDA’s expense in reviewing products. The FDA’s traditionally focuses on approval of new drugs, however, Congress also used the bill expand the FDA’s powers to police drug safety.

The bill gives the FDA the power both to require drug companies to conduct additional studies to further assess the safety of medicines and to mandate new label warnings when problems become apparent. It also requires companies to publicly release results of all clinical trials that show how well their drugs performed. The FDA also gains the ability to fine drug companies for not completing follow-up studies on their drugs after they’ve received government approval. Direct-to-consumer advertisements, such as television commercials, will now be more strictly regulated by the FDA. The agency can review drug ads and fine companies for false or misleading claims, but it cannot ban them.

Two pediatric drug programs also were reauthorized for five more years as part of this legislation. The Pediatric Research Equity Act of 2007 requires a drug or biologic manufacturer that submits an application to the FDA to also submit a pediatric assessment. The Best Pharmaceuticals for Children Act of 2007 grants an additional six-months of marketing exclusivity to a manufacturer of a drug in return for pediatric use studies and reports.

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#2: Quantification of Work Limitation and Earnings Losses

If you are afflicted with a form of arthritis you may be well aware of the limitations it can cause in your life. This includes your ability to hold a job and make a living.

In 2007 the U.S. Centers for Disease Control and Prevention released results from 2 surveys taken to evaluate the cost of arthritis.

The first study indicates that 1 in 3 working-age adults in the U.S. are affected by arthritis-attributable work limitation (AAWL). The CDC estimates that AAWL among working-age adults with doctor-diagnosed arthritis ranged from 25.1% in Nevada to 51.3% in Kentucky. The median among all of the states was 33.0%.

The second study demonstrated that earnings losses attributed to arthritis and other rheumatic conditions range from $79 in Washington D.C. to almost $4.3 billion in California.

The CDC also estimated the total cost (medical expenses and lost earnings) that can be attributed to arthritis and other rheumatic conditions in the U.S. was approximately $128 billion in 2003. That is equivalent to 1.2% of the gross domestic product. Of the $128 billion, $80.8 billion were from direct costs, such as medical expenses, and $47 billion for indirect costs, such as earnings loss. This calculates to a $1,752 annual per person average for direct costs and $1,590 a year lost earnings per working-age adult.

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#3: Projections of Increases in Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation

It is estimated that 46 million adults in the U.S are afflicted with rheumatoid arthritis or other rheumatic conditions (e.g. gout, lupus, fybromyalgia). It is further estimated that nearly 67 million adults will have doctor-diagnosed arthritis by the year 2030. This includes 25 million that are expected to have limitations in their activity as a result of the arthritis.

In 2007 the U.S. Centers for Disease Control and Prevention developed state-by-state projected increases based on state arthritis prevalence estimates. This analysis indicates an average projected increase in doctor-diagnosed arthritis of 34% from 2005 to 2030. In addition, 10 states are projected to have increases between 50% and 99% while 3 states are projected to have increases of over 100%.

Florida, with an estimated increase of 3.7 million people, is projected to have the largest increase in the absolute number of people with doctor-diagnosed arthritis. Likewise, Florida is predicted to have an increase of 1.3 million people with arthritis-attributable activity limitation. Primarily because of an expected population decline, the District of Columbia is projected to have the only decrease in the country in the numbers of adults with doctor-diagnosed arthritis and arthritis-attributable activity limitations.

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#4: Identification of RA Susceptibility Genes STAT4 and TRAF1-C5

Genetic researchers have been able to perform evaluations of variations in DNA. One of the areas of research that has advanced is the study of single nucleotide polymorphisms, or SNP (pronounced “snip”). These advances have allowed evaluations to be performed in a fraction of the time it used to take.

As a result of this researchers have exploded their ability to link genetic variants with disease susceptibility. Relationships between a variant and a disease used to take years to identify, but now can be accomplished in just days.

In 2007, Dr. Peter K Gregersen of the Feinstein Institute for Medical Research in Manhasset, N.Y., along with a substantial international tem, announced that they discovered 2 genes that are linked to an increased risk for development of rheumatoid arthritis (RA). This brings to 5 the total number of genes with links to RA.

These 2 genes, important in both RA and lupus, are known as STAT4 and TRAF1-C5. Having 2 copies of STAT4 was associated with a doubling of the risk for lupus and a 60% increase in risk for rheumatoid arthritis. TRAF1-C5 are actually 2 genes that are very close to each other on chromosome 9 but it is not yet know which of these genes is linked to the increased risk. However, it is know that having a variant at this location on chromosome 9 was linked to a 35% increase in risk for RA.

Read more in our post on Another Genetic Link to Rheumatoid Arthritis

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#10: Uncovering the importance of cadherin-11

Synovial tissue is found between surfaces of joints and provides lubrication and nutrients for the cartilage. When a person has inflammatory arthritis, such as rheumatoid arthritis, the synovial tissue experiences unregulated growth and forms a pannus, which attaches to and invades bone and cartilage surfaces, destroying them.

Cadherins are a transmembrane protein that provides adhesion between cells, ensuring that cells within the tissues are bound together.

Researchers from Brigham and Women’s Hospital, Harvard Medical School in Boston, along with an international team of scientists, have discovered that blocking the action on cadherin-11 prevents the destruction of the bone and cartilage that typically occurs in inflammatory arthritis. Their study involved specially bred mice that developed autoimmune arthritis, some of which could produce cadherin-11 and some of which could not. Then they examined whether chemically interfering with cadherin-11 would act as a therapy against autoimmune arthritis in these mice.

The team discovered that when the inflamed joint tissue has no cadherin-11 present, the structural changes associated with the formation of pannus on the cartilage did not occur. Additionally, they found that chemically that interfering with the function of cadherin-11, inflammatory arthritis could be prevented in mice that had not yet developed the disease and could be alleviated in mice with established arthritis.

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