Herpes Cure Needs Free To Choose Medicine

Until recent weeks, I knew almost nothing about herpes. The few people I’ve known who admitted they had it didn’t want to talk any more about it. Because of a longstanding and unfortunate stigma attached to the disease, far more people have it than most of us would ever suspect. Many around the world with severe cases suffer an agonizing ordeal in hopeless silence.

This is not a story, however, without hope. Quite the contrary. Thanks to a remarkable man who passed away on June 22, 2017 at the untimely age of 48, relief from the scourge of herpes may soon be a reality.

Hope for a Herpes Cure

For the sake of the many who suffer from the disease of herpes, it’s now up to the rest of us. This is a story about a genius who challenged conventional wisdom, blazed new trails in scientific research, dedicated his life to helping others, developed promising new tools against a terrible affliction, and lighted a path for the policy changes needed to end the suffering of millions. His name was Dr. William P. Halford. 

Now that I’ve come to know the Halford story, regrettably too late to have met the man himself, I feel compelled to share it with as many people as possible. I hope you will find it as motivational as it has become for me. More on Dr. Halford in a moment, but first a few words about the chronic and unrelenting contagion he did so much in his short life to defeat.

Infections by the two strains of the herpes simplex virus (HSV) are epidemic, generating every single week more than a million new cases worldwide. It’s commonly thought that HSV-1, or oral herpes, manifests itself in blisters on the face or mouth, whereas HSV-2 attacks the genital region. In fact, both strains can cause the painful lesions anywhere on the body. In one form or the other, the disease has been recognized for at least two millennia. Ancient Rome’s Emperor Tiberius reportedly forbade the act of kissing to combat a severe outbreak of herpes in the First Century A.D.

Herpes symptoms vary widely in afflicted individuals. For some, those symptoms may never present more than an occasional and minor inconvenience. Others find the disease excruciating. Aside from the visual sores, the most unfortunate victims experience almost intolerable pain as the virus establishes itself in the sensory and autonomic ganglia of the nervous system. When the virus is contracted by a pregnant woman, both she and her unborn fetus are at serious risk of life-long complications. Evidence also exists showing that the more common HSV-1 can even lead to Alzheimer’s Disease, meningitis and blindness.

He ultimately developed four vaccines—a preventive one and a therapeutic one for both HSV-1 and HSV-2.

Among the many desperate sufferers who communicated with Dr. Halford is one who wrote this: “Some of us can no longer wait, for the pain in the head, in the anus, in the ears, and in the whole body is too much. I cannot stand it anymore.”

The standard treatment for herpes involves the use of anti-viral drugs that don’t kill the virus but can inhibit its development and reduce some symptoms. In spite of decades of their usage, though, the epidemic remains largely unchecked.

To Bill Halford, that meant the conventional approach had reached a dead-end. He believed a new direction was needed, namely, the development of a live and “appropriately attenuated” (or weakened) version of the virus in vaccine form. He was determined to develop it, motivated in part by the fact that, in his words, “Never once, in the history of medicine, has a live-and-appropriately-attenuated viral vaccine failed to stop the spread of its corresponding disease in the human population.” Nonetheless, Halford’s theory was an unconventional one that ran counter to what science had heretofore believed, what drug companies were offering, what the medical establishment was prescribing, and what the Food and Drug Administration (FDA) seemed willing to allow.

The Good Doctor

William P. “Bill” Halford was born in 1968 in New Orleans, Louisiana. He received his B.A. from the University of California, Santa Barbara, in Marine Biology in 1991, and his Ph.D. in Immunology and Microbiology from Louisiana State University Health Sciences Center in 1996. He completed his postdoctoral Fellowship at the University of Pennsylvania, then assumed faculty positions at Tulane University School of Medicine and Montana State University. He spent the last decade of his life at Southern Illinois University School of Medicine, where he achieved the rank of Associate Professor in the Department of Medical Microbiology, Immunology and Cell Biology. 

Tragically, Halford was diagnosed with cancer six years ago and given one year to live. He outlasted the prognosis by five years before finally losing his long battle with the illness on June 22, 2017. Reflecting on his life, the obituary in The State Journal-Register in Springfield, Illinois, noted that he “was a gifted scientist who attained international recognition following his twenty-five years of research on herpes simplex viruses. His studies were always guided by the premise that the fundamental purpose of medical research is to help people.”

Before reading further, take a moment to look at this preview of a documentary on Dr. Halford that will appear in the fall of 2018. It has been provided to FEE exclusively by the team that is producing the film.

Halford worked feverishly to realize his passion, the formulation of vaccines that would treat and/or eradicate herpes altogether. His cancer diagnosis and the plight of desperate herpes patients who sought his help only spurred him on. He ultimately developed four vaccines—a preventive one and a therapeutic one for both HSV-1 and HSV-2.

Before new drugs and vaccines can be tried, they face a gantlet of barriers in the approval process at the Food and Drug Administration (FDA). Some are defensible, but the FDA makes it far more expensive and time-consuming to get approval here in the U.S. than even in most European countries. Writing in The Hill last March, Bartley J. Madden and Susan E. Dudley explained,

FDA’s primary goal appears to be to avoid risks of adverse side effects from approved drugs. This is the classic reaction to the lopsided incentives FDA faces; if it approves a drug that later shows undesirable side effects, the victims are visible and its officials get dragged before Congress and pilloried in the press.

On the other hand, when it delays approval of a promising drug that could improve patients’ lives, the victims of delay are invisible; patients who die before the drug is available were unaware of its promise. As a result, FDA is rewarded for erring on the side of risk aversion, rather than for making better affordable drugs available to patients as soon as possible.

Before manufacturers can market and patients can benefit from a new drug, FDA requires three phases of clinical trials. These trials can easily take 12 years or longer and cost the sponsoring company $2 billion or more.

Reading through Dr. Halford’s blog entries in the last year of his life, I found his frustration with the Washington bureaucracy a recurring theme, powerfully expressed. For example, on July 24, 2016, he wrote:

…[I]f Albert Einstein were alive today, I don’t think the FDA would be his first choice for a place of employment. This is not saying that everyone who works for the government is an idiot, but I don’t exactly see it as a think-tank of the most highly motivated innovators… [T]he federal government (and likely most large corporations) is pervaded by a CYA [Cover Your Ass] culture in which there are 100 times more incentives to say “No” rather than “Yes.” Bureaucrats who do not approve a clinical trial of a live HSV vaccine are not liable for what might go wrong in the trial and that is what drives the process. The fact that 1 million people worldwide will, this week, contract new HSV-1 or HSV-2 infections has no bearing on their standing within the machine that is the FDA…We can bitch, we can moan, or we can just say “Let’s go to the other 95% of the world not under the FDA’s thumb and get a functional HSV vaccine out there and start helping people.”

Impatient with Washington, Halford injected himself, his family and a group of ten herpes patients. None of his family exhibited any ill effects, evidence that the vaccines were safe. All the sufferers enjoyed dramatic pain relief, suggesting effectiveness. The early success of his research led him to co-found, along with film-maker and entrepreneur Agustin Fernandez, a company known as Rational Vaccines, Inc. (RVx)). Its mission is to fight the herpes epidemic worldwide, using the live, attenuated strains that Halford created.

“Why does an American company founded by Americans and based around a technology created in the USA,” asks Fernandez, “have to go outside of the US to advance its science and help those in need?” Good question, right?

Free to Choose Medicine

Here’s where a promising, innovative proposal enters the picture. It’s called “Free to Choose Medicine” or FTCM. It was succinctly explained on FEE.org in this article by Bartley J. Madden a year ago. If Congress won’t reform the FDA or if the FDA won’t reform itself, why not allow a separate track—a competitive alternative that would run alongside the conventional FDA clinical testing track?

Madden suggests that “after a new drug has successfully passed safety trials and shows initial effectiveness in early clinical trials, a drug developer could request that the drug be available for sale. Such an arrangement would allow for new drugs to be available up to seven years earlier than waiting for a final FDA approval decision.” Surely patients for whom conventional drugs and therapies haven’t worked ought to have the freedom to choose a promising alternative. Whose body is it, anyway?

The result could be millions of lives saved.

Something close to the FTCM approach is already in place in the European community. An EU statute actually affirms a doctor’s “right to administer” an unapproved therapy so long as he or she files information on any negative effects. In fact, the Halford/Fernandez company, Rational Vaccines plans to soon make the Halford vaccines available in Europe, likely years before the FDA gets around to allowing their use in the U.S. It will, in effect, be able to offer people outside the U.S. the freedom to choose that we Americans presently don’t have here.

The Halford story and the persistent herpes epidemic are adding new urgency to the need for freedom of choice in medicine. If Congress endorses it, or if the new FDA head should embrace it, the result could be millions of lives helped, saved or both. It would be a well-deserved tribute to the perseverance and compassion of Dr. Halford and other frustrated medical innovators.

On August 24, 2016, Dr. Halford wrote, “I am confident that I can put the ball across the goal line before my time is up, and show my scientific colleagues and medical professionals that we have the power to (1) stop the spread of herpes with effective HSV vaccines and (2) reduce the amount of suffering herpes causes in those already infected with effective therapeutic HSV vaccines.”

Halford died ten months later, having carried the ball to within inches of the goal line. For the sake of the many who suffer from the disease of herpes, it’s now up to the rest of us. Where Halford left off, Free to Choose Medicine can pick up the ball and score a big one for humanity.

What are we waiting for?

For further information, see:

“FDA, Get Out of the Way: Free to Choose Medicine” by Ronald Bailey 
“In Health Care, Freedom is the Only Way Forward” by Bartley J. Madden
“The Pathway to Faster Cures” by Bartley J. Madden 
“Why Drug Companies Oppose ‘Free to Choose’ Medicine" by Max Kennerly 
“Free to Choose Medicine: Better Drugs Sooner at Lower Cost” by Bartley J. Madden