Commentary

Mark Mulligan

HIV Vaccine Awareness Day occurs every May 18 to raise awareness of, and encourage participation in, HIV vaccine clinical trials in humans.

We need an HIV vaccine. Every year for 15 years, about 56,000 Americans have become newly HIV-infected. This number has not fallen despite behavioral education efforts.

Over the same period, HIV treatment has improved tremendously, and AIDS deaths are down dramatically, from 55,000 to 16,000 annually.

In a disturbing calculus, treatment success paired with prevention failure means the United States is adding 40,000 more people living with HIV each year. The global trend is similar: 900,000 more people are living with HIV each year. So a vaccine for HIV is a key missing prevention tool.

Earlier, candidate vaccines in four large clinical trials failed to prevent HIV infection or lower virus levels after infection. Then, in 2009, an HIV vaccine study of 16,000 heterosexual men and women in Thailand demonstrated — for the first time ever — a modest reduction (31 percent) in HIV infections in vaccinated people over a three-year follow-up period.

When the analysis was limited to the first year after vaccination, a 60 percent protection rate was observed, suggesting that a booster was needed.

However encouraging these findings are, the hard truth is that we are still several years away from a widely available vaccine. Sadly, that means millions more women and men will become HIV-infected before we have the vaccine we need.

Last week, a panel of experts recommended that the FDA approve preventive use of the HIV medication Truvada, a combination of tenofovir and emtricitabine, in people who are HIV-negative but at high risk of infection. Emory scientists were the inventors of emtricitabine, which has helped transform treatment for infected individuals over the past decade. The FDA, which usually accepts such expert panel recommendations, will decide by mid-June on Truvada for prevention.

The prevention pill could be a supplement to — but not a replacement for — condoms, counseling, and safer sex. If it is not taken daily, its effectiveness goes down. One barrier to broad uptake is the cost, $14,000 per year, and there’s more we need to learn about its long-term side effects and the development of resistance.

Still, it is good to know that we may soon have a new FDA-approved HIV prevention tool for some truly high-risk people who can afford the drug and take it faithfully. Ultimately, however, we still need a vaccine!

The Emory Vaccine Center at Emory University, along with the Yerkes National Primate Research Center, is a global leader in laboratory-based HIV/AIDS vaccine research. The Hope Clinic at Emory conducts cutting-edge AIDS vaccine clinical trials in volunteers who are not HIV-infected.

On Friday, HIV Vaccine Awareness Day, consider becoming a local participant in these trials at the Hope Clinic. If you are not infected with HIV, this is a powerful way to — literally — roll up your sleeves, take a shot, and help fight HIV.

To learn more, visit www.hopetakesaction.org or call 877-424-HOPE.

Or, you can support HIV vaccine research through advocacy. One community organization that for 10 years has been a model of support and tireless fundraising for HIV vaccine research is Action Cycling Atlanta, which puts on the AIDS Vaccine 200 Bike Ride this weekend. Learn more at http://actioncycling.kintera.org

It’s inspiring that more than 200 people are choosing to bike 200 miles this weekend to fight AIDS.

Dr. Mark J. Mulligan is a professor of medicine within the Division of Infectious Diseases at Emory University. Dr. Mulligan serves as co-director of the Clinical Core for the Emory Center for AIDS Research. He is also executive director of the Hope Clinic of the Emory Vaccine Center, a human research clinic focused on clinical trials of vaccines and other prevention technologies, translational immunology studies, education and training the next generation of vaccine researchers.

Ralph Hudgens

On March 23, 2010, President Obama signed the Affordable Care Act into law.

The Act itself is a 2,700-page behemoth that was hastily cobbled together in secrecy and through backroom deals by Speaker of the House Nancy Pelosi, Senate Majority Leader Harry Reid and a bunch of health insurance lobbyists.

The Act was the culmination of a tumultuous year for health care “reform” that witnessed several false starts and a near mutiny in the Congress. Pelosi and Reid, along with Obama, embraced the Act despite its obvious flaws. In doing so, they ignored the American people.

The Act has been in place for more than two years now and it has already earned a dubious track record. For starters, the Act had to undergo a major amendment because one of its provisions threated to wipe out countless small businesses. The Act has also led to the near extinction of child-only health plans.

The Act has not brought down health care costs or the cost of insurance, as was promised by the promoters of it. Moreover, the Act would have caused an exodus of health insurers from Georgia had I not intervened and requested a waiver of one of the requirements of the Act.

Tellingly, my waiver request was granted by the U.S. Department of Health and Human Services, the executive agency that is charged with implementing the Act and is led by President Obama’s appointees — presumably supporters of the Act.

Even they agreed with me, at least in part, that the Act was harmful.

Not only does the Act not work as promised, I believe it is unconstitutional. Though I am not a lawyer, I understand, as all Americans understand, that our Constitution is a document that limits the power of the federal government.

If the federal government can force you to enter into an unwanted contract of insurance under the Commerce Clause, then, as was observed by an Obama appointee, Justice Sonia Sotomayor, “there is no limit to that power.’’

I can put it no better than did Justice Anthony Kennedy when he said that the Act “changes the relationship of the federal government to the individual in a very fundamental way.”

I, along with millions of my fellow citizens, oppose the Act, not because we oppose reform of health care, but because we oppose a government takeover of health care and we oppose the destruction of individual freedom that the Act portends.

The Act does not reform health care because on balance it does not improve health care. Quite the opposite. It changes health care into a commodity that will be more expensive and less effective, and will render a free people less free.

The real solution and the real reform is to be found using free-market principles, not in an overbearing government program.  I hope that Georgia gets that opportunity.

Ralph Hudgens  was elected Georgia’s insurance commissioner in 2010. A Republican, Hudgens is a businessman and served in the Georgia General Assembly for 14 years.

Dr. Harry Heiman

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA) — historic legislation designed to transform our health care system.

Unfortunately, the health care reform debate, both before and after the legislation’s passage, has been hostage to a highly partisan political process that has had little to do with health and health care. Now two years later, most Americans remain uninformed about the legislation. Lack of knowledge, however, has not precluded strong and passionate feelings on both sides of the political and ideological divide.

It is time to repeal and replace — time to repeal and replace the rhetoric. It’s time to take an honest look at why we embarked on health reform in the first place and how the ACA addresses the underlying problems in our health care system.

Our current health care system, by any measure, is broken and unsustainable. The U.S. has the most expensive health care system in the world, yet our outcomes are no better. We pay much more, but don’t get more in return.

We are the only developed country in the world that doesn’t provide universal access to care. We have the greatest disparities in health and health care of any developed country in the world. Quality of care and life expectancy vary based on your income, where you live, the color of your skin, and whether you have health insurance.

Otis Brawley, chief medical officer at the American Cancer Society, in his recent book “How We Do Harm,” describes our health care system as one that combines famine and gluttony, depending on your ability to pay. Famine for those who are uninsured or underinsured and suffer for lack of access to basic medical care, and gluttony, for those who are well off and insured, but who, in fact, may suffer as a result of overtreatment and unnecessary treatment.

Almost 50 million Americans are uninsured. The rate in Georgia is even higher, with more than 20 percent, or one in five Georgians, not having health insurance.

A recent CDC study reported that those without health insurance are seven times more likely to go without needed health care because of cost.

Physicians see these patients every day — suffering complications from what are often preventable problems. These are the patients we see putting off refills of their essential medications for high blood pressure and diabetes, delaying important cancer screening tests like mammograms and colonoscopies, and often ending up in the emergency department or being admitted to the hospital for preventable illnesses and complications. They suffer and we collectively pay the costs. We share the costs in dollars, while uninsured people pay with their lives.

The ACA is designed to achieve goals most Americans agree are necessary. It expands access to health care for an estimated 32 million Americans who are currently uninsured. It eliminates pre-existing exclusions for those with chronic medical problems or a history of a serious illness. It eliminates rescissions of insurance policies and annual or lifetime caps on coverage and extends dependent coverage to age 26.

Already, as a result of the ACA, children with diseases like diabetes, autism, or asthma cannot be denied coverage. More than 50,000 adults previously denied coverage have obtained health insurance. Almost 2 million young adults are now covered through their family’s insurance plan. For the first time, co-pays and deductibles for preventive services are eliminated, removing barriers to lifesaving tests like mammograms and colonoscopy, PAP smears and immunizations.

Some have argued that this is an unnecessary expansion of government.  I challenge them to show me how the free market has created opportunities for those who are poor — especially the working poor, and those with chronic medical problems, who need access to care the most, but are unable to purchase health insurance.

Health care providers understand how the current system is failing the most vulnerable in our communities. This is why the ACA has been supported by the American Medical Association, with more than 200,000 members, the American Academy of Family Physicians, with more than 100,000 members, the American Academy of Pediatrics, with more than 60,000 members, and the American College of Physicians, with almost 130,000 members. The ACA is about the government providing a framework and support for many of the most vulnerable in our society when market systems have failed.

The “mandate” being challenged in the Supreme Court requires that each person take responsibility for their health care by having health insurance. To suggest that we all won’t require health care services at some point in our lives is ludicrous.

From birth to death, we are all subject to the unpredictability of life. Who hasn’t had a friend or family member with a sudden, unanticipated injury or illness requiring medical treatment?  If personal and community responsibility is a value we support, then shouldn’t everyone be held accountable?

The Affordable Care Act is not perfect. Legislation rarely is. But it goes a long way toward improving our current system by expanding access, improving quality, controlling costs, and creating value; goals that most Americans agree will move us in the right direction.

Physicians are professionally bound by the Hippocratic Oath of “do no harm.” To perpetuate a health system that denies basic access to care for 50 million Americans is both harmful and unconscionable. It is time to repeal and replace the rhetoric of division and distraction. The ACA takes a major step forward in assuring that all Americans have access to affordable, high-quality health care.

Harry J. Heiman, MD, MPH, is director of health policy for the Satcher Health Leadership Institute at the Morehouse School of Medicine. He is active in Georgians for a Healthy Future and the Georgia Academy of Family Physicians.

Robert McNally

According to numbers circulated by UNAIDS and the World Health Organization in November, the worldwide population of individuals living with HIV/AIDS in 2010 stood at 34 million.

Yet despite the continuing importance of developing HIV vaccines, a range of research groups and small biopharma companies are finding challenges in obtaining the amount of funding that is required to conduct effective research and clinical trials.

As an example, HIV researchers in India recently asked that nation’s government to raise funding levels for their programs, and researchers at an international symposium on HIV and infectious diseases in Chennai pronounced funding levels “largely insufficient and disappointing” in light of the number of individuals with the virus. Elsewhere, the National Research Council of Canada recently awarded Sumagen Canada Inc. $728,000 for a Phase 1 human clinical trial for its HIV vaccine candidate; yet the lead researcher, Chil-Yong Kang, remarked that the entire trial is “going to take almost ten times that amount.”

The challenges being experienced by scientists and small biopharma companies working on HIV vaccine research can be ascribed to a variety of sources, but three stand out: First, the idea that the epidemic has improved since it initially came to the public’s attention in the early 1980s; second, the opinion that the absence of a viable vaccine up to the present time means that none is forthcoming; and third, the nature of financial support from the National Institutes of Health and potential investors.

Let us analyze each of these views.

First, why has the HIV/AIDS crisis diminished in the public consciousness, domestically and elsewhere, despite the continued high cost of present treatment regimens?

Consider sentiments within the United States. There are portions of the American populace that think HIV is a non-issue, rooted in the fact that antiretroviral therapy drugs can be effective and provide an extended life to those with HIV. What they seem not to realize is that the expense and considerable side effects of these treatments are still problematic — not a long-term solution, and definitely not a solution for developing regions worldwide.

The populations of developed nations in 2012, and their governments, may be tempted to believe the HIV/AIDS crisis is an issue for other regions of the globe. Yet this is contradicted by facts. Note, for example, that in the U.S. there are 55,000 new HIV infections annually, a number that has stayed the same since the mid-1990s in spite of the use of counseling, medications and protective measures.

In this sense, government sentiment may be echoing media coverage of HIV/AIDS, which, according to a recent study, fell more than 70 percent in developed nations during the last two decades. This study — the Trends in Sustainability Project — tracked coverage of a range of sustainability issues in 115 leading broadsheet newspapers in 41 countries from 1990 until May 2010.

Although newspaper readership has been steadily eroding over the past decade due to the rise of online news, this study is still a powerful indicator of the priority that traditional news organizations assign to various subjects. In the early 1990s, an average of 1.5 articles about HIV/AIDS was found in every issue of these newspapers; since 2008, that average has fallen to less than 0.5.

Now consider the second principal factor possibly driving government reluctance to provide long-term HIV/AIDS research funding: the spotty record of vaccine efforts to date. Over the last couple of decades, there have been several false hopes, and plenty of failures, on the road toward a vaccine. Consequently, it is tempting to doubt that a cure or treatment lies in our future.  But those in government with this belief are disregarding good news from clinical studies that shed a very real ray of hope on finding a safe, inexpensive, universal treatment.

Substantial advances are being made toward the creation of a viable vaccine. In autumn 2009, a collaboration between the Ministry of Health in Thailand, the U.S. military, and the U.S. National Institute of Allergy and Infectious Disease (NIAID) announced the first encouraging results from an efficacy trial — 31 percent prevention of infection in a 16,402 person community-based trial in Thailand. This result achieved significance in an analysis that excluded seven subjects who were determined to have been infected at the time of the initial vaccination, showing for the first time that an HIV vaccine could prevent infection.

Meanwhile, an Emory University research group may be one step closer to finding a vaccine that will provide long-lasting protection against HIV/AIDS. Dr. Harriet L. Robinson, senior vice president for research and development at GeoVax Inc., our biotech company specializing in the development of HIV/AIDS vaccines, along with her team at Emory University, showed that a novel class of vaccines against HIV has demonstrated significant protection against the most potent strains of HIV infections in animal models.

The novel class of vaccines is a combination vaccine. Using a vaccine candidate in monkeys, Dr. Robinson’s team has been able to demonstrate that this combination is capable of achieving a highly encouraging prevention of infection. Most notably, the GeoVax candidate has shown effectiveness against SIV251, the most difficult simian version of HIV in humans. Such an encouraging result demands attention by funding decision makers.

Finally, consider the nature of National Institutes of Health (NIH) funding for biopharma companies, as well as the tendencies of investors.

The NIH is very supportive of new protocols and the running of clinical trials.  However, during the long clinical trial period, the company must separately fund general overhead and vaccine production.  Once a vaccine candidate exhibits human efficacy in later stage trials, equity investors and partnering opportunities are more prevalent.  Meanwhile, finding equity investors is a challenge due to the long time scales involved in developing a viable vaccine; investors are more likely to seek out opportunities that pay off in a relatively shorter term.

As argued above, there are certain factors behind the roadblocks currently faced by small biopharma companies engaged in HIV/AIDS vaccine research.  An enhanced recognition of these and other factors could lead to a more suitable level of funding for a disease that still threatens millions worldwide.

Robert McNally is president and CEO of GeoVax, an Atlanta-based biotech company that is developing vaccines that prevent and fight HIV infections.

Dr. Patrice A. Harris

Congress’ pattern of procrastination has led to a series of fiscally irresponsible compromises that threaten Medicare’s physician foundation and endanger access to care for more than 40 million seniors, veterans and military families.

Unless Congress acts, Medicare payments are scheduled to be slashed by 27 percent on March 1, and physicians will be forced to make unwelcome choices, including limiting the number of Medicare patients they take on. In Georgia, the cut threatens access to care for the 1.2 million seniors who rely on Medicare. Almost half a million veterans and military families in Georgia will also be affected, since TRICARE – the military’s health program – ties its payment rates to Medicare.

Congress has intervened 13 times in the past decade with temporary patches, postponing drastic Medicare payment cuts mandated by a broken government formula. Failing to take decisive action to eliminate the broken formula has made the problem worse by compounding the cost of a solution for taxpayers and mandating steeper cuts in physician payments year after year.

As recently as 2005, the cost of eliminating the broken payment formula would have been $48 billion. Today, the cost stands at $300 billion. If Congress continues its temporary interventions instead of fixing the problem once and for all, that eventual cost will escalate to $600 billion in only five years.

Another temporary patch is fiscally irresponsible. The price of a long-overdue solution will never be less than it is right now. It is irrational to spend increasing amounts of taxpayer money to support a payment policy that is a proven failure.

Since Medicare was founded in 1965, advances in medical research, education and training have helped increase the average senior’s life expectancy to age 78 – an eight-year increase. While the practice of medicine has evolved, Medicare’s payment formula created in 1997 remains stuck in the last century. Now is the time for a prudent, permanent solution that will preserve the security and stability of health care for seniors and military families.

As a practicing physician in Atlanta, I know Medicare patients are already having trouble finding physicians in Georgia and around the nation. The government’s own Medicare advisory committee has said 22 percent of seniors have had trouble finding a new primary care physician. The president of the Military Officers Association of America has called the scheduled cut the No. 1 threat to military beneficiaries’ health care access.

There is a unique opportunity right now to use projected spending for the wars in Afghanistan and Iraq to eliminate the flawed formula and protect access to care for seniors and military families. As these wars wind down, projected spending that won’t be spent on them becomes available to pay for eliminating the fatally flawed Medicare physician payment formula to ensure access to care for seniors and military — without adding to the nation’s deficit. Using this funding to help military members and their families maintain access to care makes sense and is simply the right thing to do.

A recent poll found that 94 percent of Americans believe the impending cut is a serious problem for seniors who rely on Medicare. Doctors have already given Congress their opinion. Patients now need to give their representatives in Washington a second opinion. By using the AMA’s Patients’ Action Network at www.patientsactionnetwork.com or calling 888-434-6200, you can learn more about this important issue and identify and contact your members of Congress.

Decisive congressional action is needed now to stop spending billions on patches and eliminate the flawed Medicare payment formula that threatens Medicare’s promise for current and future generations.

Dr. Patrice A. Harris is an Atlanta psychiatrist and a board member of the American Medical Association.