Physician Spotlight - Dr. Jetty

Preetham Jetty, M.D., F.R.C.P.

As a young boy, Dr. Jetty witnessed first-hand the difference a doctor can make in a community. Growing up in a factory town in India where his father worked as a general practitioner, Jetty often saw patients being treated for accident wounds. He recalls watching his father sit for hours, stitching up wounds by hand, sometimes doing nearly a hundred stitches for one wound. It was this influence that attracted Dr. Jetty to helping others.

Dr. Jetty completed his initial medical education in India. However, seeing the U.S. as the country with the greatest opportunity for anyone who wants to work hard and be the best they can be, he came to the U.S. for the remainder of his education and training. Dr. Jetty began his work in Anderson in 1998 as a cardiologist for Indiana Heart Associates before working with Heart Partners of Indiana, LLC. He started the Jetty Heart Clinic in 2008, which he currently runs in addition to being the Chief of the Department of Cardiology at Community Hospital Anderson.

In 2005, Dr. Jetty partnered with CCRC as a principal investigator for trials studying cardiac conditions such as ACS and atrial fibrillation. Dr. Jetty sees his involvement in clinical research as a way to stay in contact with patients while still staying ahead of the ever-evolving field of medicine. By taking part in clinical research, Jetty gets to see new medicines come to fruition, eventually bringing them into practice. In addition, access to the research community allows for a flow of ideas and information between the country’s leading physicians.

According to Dr. Jetty, the rewards of clinical research do not stop with the physicians involved. The people who take part in clinical trials allow for the great life-saving medicines and treatments that we have today. Dr. Jetty believes that if we had the perfect medicine for you, we would not need research, but physicians and others in the medical field are always looking for better treatments. Participants in clinical trials receive first-rate medical care. Trials follow highly regulated practices and are done with the knowledge that current treatments are inadequate and can be improved upon. Patient safety is the number one priority in all clinical research. Monitoring of patients is held to a much higher standard than in typical treatment situations and patients are always free to choose whether or not they want to participate in a study.

Despite his position as one of the area’s leading and busiest cardiologists, Dr. Jetty is an avid concertgoer, attending shows all over the country. A fan of alternative music, the last show he attended was a Modest Mouse concert in St. Louis. An escape from his busy life, Dr. Jetty finds music to be calming to his sense.

CCRC would like to thank Dr. Jetty for his hard work and dedication to medicine and clinical research.

Evolution of U.S. Drug Laws - Food and Drug Act of 1906/ Nuremberg Code

Food and Drug Act of 1906

• First comprehensive U.S. drug law
• Followed the 1905 release of a book by Upton Sinclair called "The Jungle", which exposed the unsanitary conditions of Chicago's meat-packing industry and led to legislation requiring processing inspections and forbidding interstate and foreign commerce in both impure and mislabeled food and drugs
• Did not require drugs to be effective, but it did require "that drugs meet standards of strength and purity.  The burden of proof was on FDA to show that a drug's labeling was false and fraudulent before it could be taken off the market." - quoted from www.fda.gov.
• Prior to 1907, medications were bought and sold like any other good.  There was no requirement to reveal the ingredients of a drug.
• In 1938, as a result of 107 deaths from "Elixir Sulfanilmade", the FDA was able to require drug manufacturers to prove the safety of a drug before it could be sold to the public.

Nuremberg Code

• Formed in 1947 in response to Nazi abuses of prisoners during World War II
• First international ethical guidelines for clinical research
• Required that volunteers provide informed consent prior to participating in experiments and that the benefits of the research be weighed against the risks and discomforts of the patients 

Evolution of U.S. Drug Laws - Vaccine Act of 1813/ Import Drug Acts of 1848

 

Vaccine Act of 1813

• First federal law concerning consumer protection and medicinal substances.
• Smallpox epidemics were a common occurrence throughout the 1700s and 1800s.
• Efforts were made to develop a vaccine for smallpox from cowpox scabs imported from England.
• The cowpox virus could not live very long in dried scabs.  
• As a result, the virus was transmitted by arm-to-arm contact in successive person-to person inoculations.  
• This means that an infected vaccination lesion on one person was scraped and used as material to inoculate the next person.
• This method is no longer used, as other infectious diseases were often transmitted along with the cowpox vaccine.
• The Vaccine Act mandated that a purer supply of the cowpox be sustained and be given to any citizen.
• Dr. James Smith was named as the first vaccine agent. 
• He had 20 years of experience in the transmission of the cowpox vaccine through arm-to-arm contact every 8 days.  
• However, in 1821 he accidentally sent smallpox crusts instead of the cowpox vaccine to North Carolina.  
• The inoculation of patients with live smallpox led to a smallpox epidemic as well as the repeal of the Vaccine Act of 1813.
  
  
  
                                           
  Import Drug Act of 1848

• Established customs laboratories
• Responded to counterfeit, contaminated or adulterated drugs being transported into the U.S.
• Prior to the passing of the act, American troops in Mexico had received counterfeit and ineffective medicines for malaria.

Clinical Trial Time and Cost Statistics

Time 

• It typically takes from 12-15 years for a new drug to be brought to market.
• There is a "fast-tracking" approval path for AIDS and cancer drugs, but the process still takes several years in these cases.
• Of all the drugs that start out in the early development stage of clinical research, only 1 out of 1,000 drugs makes it beyond the animal-testing phase to testing in humans.  From there, only 1 in 5 to 1 in 10 drugs is eventually approved.
• Only 3 out of 10 approved drugs bring in more money in profits than the cost it took to get the drug through the testing phases.  Drug manufacturers depend on these few profitable drugs to make up for the financial losses they suffer from the other 7 out of 10 drugs.

Cost

• The major annual costs for a large sponsor or drug manufacturer include the following:
• $150-$200 million for investigators
• $50-$100 million for CROs
• $10-$15 million for central laboratories (special studies)
• $8-$12 million for monitoring
• A typical New Drug Application that must be filed for a new drug to receive approval from the FDA tobe placed on the market requires nearly 70 studies that consist of around 90,650 pages and an overall investment of $359 million, according to "Internet-Based Tools to Facilitate Clinical Trials" by Hassan Movahhed for Genetic Engineering News.
• Delays in the approval process of a drug can cost from $684,931 to $1 million per day.
• In 2000, pharmaceutical companies invested more than $26 billion for new drug development.
• According to Tufts Center for Drug Development, the average cost of bringing a new drug to market is $802 million.

Information taken from "Conducting Clinical Research" by Judy Stone, M.D. Copyright 2006.