The Essential Importance of STD Testing

Sexually transmitted diseases (STD) or sexually transmitted infections (STI)  are reportedly on the rise nationwide, with an increasing number of incidents reported each year. Unsafe sexual practices are spreading infection and illness through people from all backgrounds, requiring medical intervention in many cases to prevent septicemia, infertility and even death. STDs are no laughing matter, and those who engage with multiple partners or without adequate protection are at most risk. Because many of these conditions can be symptom-less in the early stages, those who suspect they may be infected need to arrange to be tested for a range of the most common conditions.

Image source: http://thumbs.dreamstime.com/thumblarge_131/1174289173yDSOph.jpg

The first thing to do if you suspect you may have an STD is to arrange an appointment with your physician. For some, this may be an embarrassing experience, and one they may be initially reluctant to pursue. This is understandable, and most doctors and healthcare professionals are sympathetic to these feelings. There is a rise in companies offering the ability to order tests from the privacy of your own home (such as STDCheck.com) so that is a new option. However, from a health perspective, it is essential that you are seen by a doctor at an early stage in the process, so you can confirm diagnosis and receive the right prescription treatments for your condition. The effects of STDs can vary, depending on the nature of the infection, but it is always wise to seek medical attention to prevent these conditions from worsening.

FDA approves 2 new drugs at the end of 2012

On the last day of 2012, the FDA approved 2 new drugs:

Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Fulyzaq is distributed by Salix Pharmaceuticals, based in Raleigh, N.C. under license from Napo Pharmaceuticals, Inc.

Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. Sirturo is manufactured by Janssen Therapeutics, a division of Janssen Products LP, based in Titusville, N.J.

FDA approves new combination pill for HIV treatment

The FDA has approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.

Here's the information from the FDA:

Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat.

Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply.

Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir.

The combination of emtricitabine and tenofovir disoproxil fumarate, approved in 2004 and marketed as Truvada, blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection.

Read more about this approval here.

FDA approves the first drug for HIV prevention (pre-exposure prophylaxis or PrEP)

Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.

Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.

Learn more here.

FDA approves first over-the-counter home use HIV test kit

The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

You can read more about this here.

FDA approves Edurant (rilpivirine) for HIV

FDA approves new HIV treatment

The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).

Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.

Technology Continues to Fight AIDS

Author: Jack Lundee

In 2008, Sub-Saharan Africa was populated with over 22 million HIV+ inhabitants, and currently there are over 5 million South Africans infected with the virus. Worldwide, there are upwards of 40 million people infected with HIV, a very frightening number. But with the coming of the 22nd annual World AIDS Day, it’s important to take note the progress that has been made in the fight against HIV/AIDS. At the same time, it’s very vital we familiarize ourselves with a couple great HIV research and technology investors.

Granted, there have already been major advances concerning affordable microbicides and vaccines as preventative measures against the virus. Similarly, the introduction of low-cost antiretroviral drugs has allowed people already infected to lead longer, healthier and happy lives.

This can most certainly be attributed to tremendous associations like the CGI (Clinton Global Initiative). The Clinton Global Initiative has put a tremendous amount of money into AIDS research. Known for his work in raising money for Hurricane/Tsnuami victims, former President Clinton and his close personal aide Doug Band also have great interest in tackling one of the deadliest STDs in the world, HIV/AIDS. Back in 2006, Clinton helped open people’s eyes to the severity of the disease in foreign states by traveling deep into Burma with the crew of 60 Minutes.

FDA approves Egrifta to treat Lipodystrophy in HIV patients

The FDA announced this yesterday: "FDA approves Egrifta to treat Lipodystrophy in HIV patients"

The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.

Read more here.

Dr. J. Joseph Kim CEO of the Year

CEO of the Year is J. Joseph Kim | president, co-founder and CEO | Inovio Pharmaceuticals

Here are several snippets from Philadelphia Business Journal:

In just 10 years, Dr. J. Joseph Kim has built his business from a startup vaccine development business in the University City Science Center incubator into a publicly traded company with 40 employees in Blue Bell.

While the young company, originally known as Viral Genomix, was in the incubator, Kim and his co-founder Dr. David Weiner began pre-clinical development of a class of drugs for treatment of HIV, cancer and inflammatory diseases using intellectual property they licensed from the University of Pennsylvania. Their progress enabled them to successfully raise $40 million and bring the company out of incubation within four years.

Zolinza (Vorinostat) to fight HIV/AIDS?

David M. Margolis, MD at University of North Carolina is approaching the fight against HIV/AIDS using a novel approach. He's testing the Merck cancer drug Zolinza (Vorinostat). Given that Zolinza blocks HDAC, it could push out latent HIV hiding in infected cells. Sounds interesting, doesn't it? Let's wait to see what ends up happening.

Thanks to BusinessWeek for the interesting story.

International #mHealth Perspectives

Today was the first day of the 2nd International mHealth Networking Conference. It's been a full day of presentations and discussions about mobile health. As a physician champion for the HCPLive Network, I'm excited to blog about some of the highlights from this meeting. You can also follow updates about the mHealth Networking Conference on HCPLive.com.

This afternoon, there was a presentation focusing on international perspectives on mHealth. The presentation was titled, "The Most Advanced Hospital in the World? Report from Severance Cardiovascular Hospital in Korea" by Byung-Chul Chang, MD. This hospital is part of the Yonsei University Health System (YUHS).  Dr. Chang spoke about the digital infrastructure that's found in their hospital. He showed a marketing video that demonstrates how doctors in their hospital are using mobile PCs, smartphones, RFID, and other technologies. I love the idea of an automatic payment system that leverages a card (similar to a credit card) and an ATM-like machine in the hospital lobby.

World AIDS Day

Today is December 1 and is World AIDS Day. Here are some staggering statistics:

• More than two million AIDS related deaths reported globally in 2008 - two million children under the age of 15 now live with HIV.
• New figures released by the World Health Organization and UNAIDS estimate the number of new HIV infections have declined each year by about 17% from 2001 to 2008, but for every five people infected, only two start treatment.

The World AIDS Campaign is a global coalition of national, regional and international civil society groups united by the call for governments to honor their AIDS commitments under the slogan “Stop AIDS. Keep the Promise.” The campaign is governed by a steering committee of global constituency-based networks and supported by a team of support staff based primarily in Cape Town, South Africa and partially in Amsterdam, The Netherlands.

To learn more about World AIDS Day and the World AIDS Campaign, visit: http://www.worldaidscampaign.org

Should CME be mandatory for physicians?

In the world of rapidly changing medicine, how often should physicians participate in continuing medical education (CME)? Did you know that some states actually don't require physicians to complete any CME activities? Most states require a certain number of CME credits for relicensure, but most state medical boards are not actually checking to ensure that physicians are up-to-date on their CME requirements. They simply have a box that you check that indicates that you have met the CME requirements for relicensure. In the event that you were audited, you would need to show proof of your CME participation.

What's especially interesting is that certain states require CME in specific topic areas such as:

• medical ethics
• HIV/AIDS
• risk management
• pain management
• cultural competency
• domestic violence
• end-of-life care
• medical error prevention
• bioterrorism
• geriatrics
  
• prescribing controlled substances
• and more

You'll notice that the only topic that relates to a specific diseases is HIV/AIDS. Does it really make sense for every physician to take CME courses in these specific areas? For instance, if I'm a pathologist, do I really need to learn about domestic violence? What if I'm a radiologist?

Well, in my opinion, these CME requirements are reasonable, so as long as physicians don't complain too much, I don't think that state medical boards will be making any significant revisions in the near future. 

Progress on an HIV vaccine

Are we making progress on a viable HIV vaccine?

According to the AIDS Vaccine Advocacy Coalition (AVAC), results from a recent clinical study show promising results. We won't have a vaccine ready anytime soon, but we may now have evidence to show that there is a way to reduce the risk of HIV infection. Consider it a "test of concept" more than anything at this point.

AVAC executive director Mitchell Warren says, “It will take time and resources to fully analyze, understand and validate the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field as all of us begin the hard work to translate this landmark result into true public health benefit.”

This study involved more than 16,000 men and women living in Thailand. They found that HIV infection were roughly 30 percent lower among volunteers who received the vaccine versus those who received the placebo. Volunteers were injected with vaccines that contained synthetic fragments of common HIV strains known to circulate in Thailand and Southeast Asia. So, as long as you're not a world traveler engaging in high-risk behavior, maybe a local vaccine strategy can be protective.

To read the press release (AVAC Praises Thai AIDS Vaccine Trial Collaborators and Volunteers for Historic Study) on the AVAC site, click here.

John School: educating men about paid sex

Men who are caught trying to buy prostitute services are being sent to the John School so they can learn about the morals, ethics, and public health issues concerning paid sex. They are learning about STDs, about the life of a prostitute, and about the risks associated with hiring a prostitute. Here's a quote from a recent CNN story:

"It will make them [offenders] see that this is not a victimless crime, and they are contributing to the exploitation of women," said Stephanie Davis, policy adviser on women's issues at the mayor's office in Atlanta. "It's hurting them, the man, and it's hurting their families and its hurting the community."

In the early 1990s, Nashville's mayor helped launch the John School with the help of the Magdalene House, public defenders, prosecutors and police officers. Nashville became one of the first major cities in the U.S. to focus on the customers, predominantly men.

So many men (and women) have no idea what types of risks are involved when they hire a prostitute. In many Asian countries, prostitutes (also called "commercial sex workers") can be found everywhere. Along with that, you'll also find HIV, Hepatitis B, herpes, syphilis, gonorrhea, and a host of other STDs. You don't have to be an infectious disease specialist to know that you want to avoid these like the plague. Are these "John Schools" making a difference in this country? Perhaps the government needs to step up and create more public health campaigns aimed at educating and influencing men.

FDA: "Expanded Access to Investigational Drugs for Treatment Use"

FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs

The U.S. Food and Drug Administration published two rules today that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.

To support the effort to help these patients, the agency also is launching a new Web site where patients and their health care professionals can learn about options for investigational drugs. In general, these options include being treated with a drug that has been approved by FDA, being given an investigational drug as part of a clinical trial, or obtaining access to an investigational drug outside of a clinical trial.

The new rule, “Expanded Access to Investigational Drugs for Treatment Use,” makes investigational drugs more widely available to patients by clarifying procedures and standards. The other rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies the specific circumstances and the types of costs for which a manufacturer can charge patients for an investigational drug when used as part of a clinical trial or when used outside the scope of a clinical trial.

“With these initiatives, patients will have the information they need to help them decide whether to seek investigational products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.”

Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational therapy works, and how safe it is for patients. Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials.

The FDA has allowed expanded access to experimental drugs and biologics since the 1970s. That access has allowed tens of thousands of patients with HIV/AIDS, cancer, and other conditions to receive promising therapies when no approved alternative is available.

“The final rules balance access to promising new therapies against the need to protect patient safety and seek to ensure that expanded access does not discourage participation in clinical trials or otherwise interfere with the drug development process,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Clinical trials are the most important part of the drug development process in determining whether new drugs are safe and effective, and how to best use them.”

Web site that explains the options for investigational drugs

Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs

So, how many of your patients should be on an investigational drug? If you're an oncologist or an HIV specialist, then you may be referring your patients to all sorts of clinical studies. There are so many new biologic agents and novel antiviral combinations that are emerging for cancer and HIV/AIDS patients.

Advances in HIV/AIDS treatment

It's quite amazing when we look back at advances in HIV and AIDS treatment. CNN has a story titled, "A generation born with HIV/AIDS defies the odds." I hope this title or story doesn't give people the wrong idea. Some people out there may think that HIV and AIDS are not serious conditions. They may think that the majority of patients with HIV and AIDS live for a very long time when they read something like, "With advances in medicine, the babies born with what was once thought of as a sure-fatal virus have danced at their high school proms, walked on stage to receive their diplomas and even experienced the birth of their children."

The reality is that HIV and AIDS are still killing many people each day. In this picture, teenagers born with HIV/AIDS are paying respect to their deceased friends at the memorial tree. Perhaps the important message is that HIV patients need support and community. The CNN story talks about a group of HIV-positive teens called the Kool Kids. Patients with HIV can support each other as they take their antiviral medications and endure various side effects. They can encourage each other when their HIV friends pass away from AIDS-related complications. It's great to see that advances in HIV/AIDS treatment have resulted in fewer pills and better ways of measuring and evaluating drug resistance. I still wonder if we'll ever develop an effective HIV vaccine. Because the virus mutates so frequently, it may never happen. Perhaps advances in medical technology will prove me wrong.

To read the story on CNN, click here. Image source: CNN

Kids at summer camp getting swine flu

Three kids at a summer camp in Georgia got the swine flu. Thankfully, it sounds like the infection is mild and the kids are recovering quickly (according to a report on CNN). It seems like the virulence of swine flu might be diminishing, but we probably don't know how it will impact individuals who have chronic lung conditions or immunodeficiencies such as HIV/AIDS. Most kids have robust immune systems and they're able to bounce back from infections pretty quickly. Let's hope that we don't hear any stories about immunodeficient kids at summer camps getting H1N1.

VGX Pharmaceuticals: PENNVAX and CELLECTRA

Dr. J. Joseph Kim (no, not me) is president and CEO of VGX Pharmaceuticals. We're both MIT alumni, so we share one similar connection. There have been some exciting news from VGX recently.

Here's the headline from a recent press release: "VGX Pharmaceuticals Proprietary DNA Vaccines Delivered with Electroporation Achieve Immune Responses Superior to Recombinant Adenovirus Serotype 5 (Ad5) Vectors"

That sounds very exciting to me because there is such a need for better vaccines. Plus, we really need an HIV vaccine. This press release deals with some results on the PENNVAX HIV Vaccine Program. Researchers have been working on delivering the PENNVAX™ DNA vaccines using a novel electroporation device called CELLECTRA®.

Collaborators include the University of Pennsylvania, VGX, and Merck. These results are truly exciting and they reflect what can happen when you apply novel technologies in healthcare. Perhaps we will see a safe and effective HIV vaccine someday.