A Passionate Plea to Parents of Preteens

Adults can make informed decisions about their own medical care. However, young children are not able to make complex decisions for themselves, so the authority to make medical decisions on behalf of a child usually falls to the child’s parents. Some of these choices have long-lasting repercussions that cannot be undone later in life.

Whether or not to vaccinate against preventable diseases is one such decision parents will face. Supported by high-quality medical and scientific evidence, vaccines are one of the most significant achievements of medical science and public health. Deaths due to vaccine-preventable diseases, including smallpox, polio, measles, diphtheria, pertussis, and others, have declined dramatically.

Debunking popular misconceptions about every vaccine is beyond the scope of this article. Instead, my focus is on the human papillomavirus (HPV) vaccine, one of the most heavily-scrutinized vaccines of all time, and one of the safest. It is also an essential vaccine that can help prevent six different cancers which may develop much later in life.

For the nearly 80 million people—about one in four—currently infected in the United States, HPV often goes away on its own. But a small group of people will experience health problems—sometimes even 20 or 30 years after the initial contact. In these individuals, HPV can cause changes in the body that can lead to the development of:

  • Cervicalvaginal and vulvar cancer in women;
  • Penile cancer in men; and
  • Oropharyngeal (the tongue, tonsils, and back of the throat) and anal/rectal cancer in both women and men.

Unlike HIV and other sexually transmitted diseases (STDs) spread via bodily fluids, human papillomaviruses reside in certain skin cells found in the moist surfaces (called mucosal surfaces) of areas such as the vagina, anus, cervix, vulva, inner foreskin and urethra of the penis, inner nose, mouth, throat, and the inner eyelids.

HPV is transmitted by direct contact with an infected person, usually sexual, but can occur following nonpenetrative sexual activitywhich even includes kissing. While condoms are highly effective in preventing HIV and other STDs transmitted through bodily fluids, they provide less protection against STDs spread through skin-to-skin contact like HPV.

Celebrities, charlatans, homeopaths and other people who are entirely unqualified to advise on medical issues promote genuinely heartbreaking images and stories of teenagers suffering paralysis, bodily pain, convulsions, and even death, which they attribute to autoimmune disorders directly caused by HPV vaccination. It’s a natural claim to make. After all, a vaccine, by its nature, is designed to provoke an immune response.

Sadly, autoimmune disorders are pervasive and affect ∼8% of the population, the vast majority (78%) of whom are women. These occur when the immune system goes awry and mistakenly attacks healthy parts of the body rather than infectious invaders such as bacteria and viruses.

Scientists believe that sex hormones may play a role, as many autoimmune disorders occur in women soon after puberty. Some examples include systemic lupus erythematosus (lupus), postural orthostatic tachycardia syndrome (POTS), Guillain-Barré syndrome, and complex regional pain syndrome (CRPS). My heart breaks for anyone affected by these terrible diseases, especially children.

The Centers for Disease Control and Prevention (CDC) recommends that BOTH girls and boys begin getting the HPV vaccine series at age 11 or 12. This is because the vaccine produces a better immune response at this age than during the teenage years. For the HPV vaccine to work best, it is also essential to administer prior to coming into contact with the virus. That’s why the vaccine is recommended for children before they grow up and start kissing or become sexually active.

Because autoimmune disorders are more common in women and begin to appear around the age that they receive the HPV vaccine, the potential to use autoimmune disorders to discredit the vaccine is high. In statistics, when two variables are found to be correlated, it is tempting to assume that one variable causes the other. However, this is a perfect example that correlation does not imply causation.

According to the World Health Organization (WHO), since licensure in 2006, over 270 million doses of the HPV vaccine have been distributed worldwide, with many countries monitoring vaccine safety post-licensure. A 2017 report by the Global Advisory Committee on Vaccine Safety (GACVS) concluded that HPV vaccines are extremely safe and found no evidence to suggest a causal association between HPV vaccine and CRPS, POTS or the diverse symptoms that include pain and motor dysfunction.

Why am I so passionate about HPV vaccination? Because I was diagnosed with Stage IV oropharyngeal (head and neck) cancer caused by HPV in December 2015 at the age of 47. After undergoing aggressive chemoradiation treatment, I was cancer-free for six months. Then, in December 2016, doctors discovered distant metastasis (spread) in both of my lungs. Recurrence of this disease is often lethal—no effective treatment exists.

Had the HPV vaccine been available when I was a preteen, I could have been spared a terminal disease and the numerous toxicities of cancer treatment. Parents, I beg you—please vaccinate your children against HPV. Believe in high-quality medical and scientific evidence, not social media anecdotes. Instead of speaking to well-meaning relatives and friends, talk to a knowledgeable pediatrician about the HPV vaccine and make an informed decision. Follow Australia’s example, where the HPV vaccination program is so successful that within 10 years, it is expected that no women will develop cervical cancer there. In doing so, we can eliminate high-risk HPV and the resulting six cancers.

‘Right to Try’ Legislation is a Trojan Horse

The House will vote tonight (March 13th) on a revised Right to Try Act that was unveiled over the weekend. On a positive note, the new House version appears to reflect some changes FDA Commissioner Scott Gottlieb recommended in October testimony before the House Energy and Commerce Subcommittee on Health regarding a previous version of the bill that passed the Senate by unanimous consent last summer. But the new bill is still nothing more than a Trojan horse positioned as the “first step on a longer path to push the Food and Drug Administration (FDA) to loosen up on its oversight.”

Proponents of Right to Try know precisely how to wage an effective public relations war by tugging at people’s heartstrings. They tout grim statistics, such as the fact that over 600,000 Americans with cancer are projected to die in 2018 – supposedly because they are waiting for access to experimental therapies that haven’t yet been approved. Pitchforks and torches in hand, libertarians use the FDA as a scapegoat for blocking patient access to a mystical treasure trove of investigational treatments.

Politicians and other opponents of Right to Try have been quiet or slow to act. This is because a lack of support for Right to Try can be perceived (albeit incorrectly…) as not being sympathetic to the needs of terminally ill patients. Encouragingly, nearly 40 patient advocacy groups argued that Right to Try would “likely do more harm than good” in a letter sent to House leaders of both parties last month.

The fact remains that under existing regulations, patients can already seek expanded access, sometimes called compassionate use, to experimental therapies that are currently being studied for safety and effectiveness but that have not yet been approved by the FDA. For the past decade, the FDA has received approximately 1,000 such requests for expanded access each year. But with more than 600,000 Americans dying each year from cancer alone, Right to Try supporters argue that red tape and government regulations must be restricting access to promising new treatments for the other 599,000 patients. Hence their desire for an alternative parallel pathway that eliminates these barriers.

However, two key steps are required before the FDA even receives a request for expanded access, which demonstrates that the FDA isn’t the logjam. First, a physician must certify that the patient seeking expanded access has exhausted available treatment options and is unable to participate in a clinical trial involving the desired experimental drug. Second, the physician contacts the drug company developing the investigational drug to ask permission to test the treatment. Assuming that the drug company agrees, the physician then completes and submits paperwork to the FDA. At this point, more than 99 percent of such requests are approved within days (24-hour turnaround for emergency cases), and the FDA even suggests important changes approximately 10 percent of the time to help improve patient safety. Nonetheless, the Right to Try Act being considered by the House eliminates this critical FDA oversight.

Beginning in 2014, Right to Try has now been signed into law in at least 38 states. FDA regulations cannot preempt state laws that preserve constitutionally protected rights, such as the fundamental right to life and medical self-preservation (e.g., the legalization of marijuana in individual states while still illegal under federal law). And yet, there is scant evidence that patients have successfully accessed investigational drugs through state Right to Try programs who wouldn’t otherwise be eligible under the existing expanded access program. This provides further support that the FDA isn’t the bottleneck.

Since the FDA clearly isn’t the problem, why are Right to Try supporters so intent on creating a ‘parallel pathway’ that excludes them? Why not collect more data to understand exactly why there are only 1,000 requests for expanded access each year? More importantly, if Right to Try is the solution – why hasn’t it been successful in state programs over the past several years?

The simple truth is that physicians and drug developers understand better than most the concept of “first, do no harm” that is attributed to the ancient Greek physician Hippocrates. In the case of cancer drug development, the probability of progressing from Phase I to FDA approval is only 5 percent. Accordingly, if all 600,000 terminally ill cancer patients received access to experimental treatments under Right to Try this year, only 30,000 would likely benefit. The other 570,000 patients could suffer toxicities that hasten their death, severely diminish their quality of life, and lead to uninsured medical expenses.

While Right to Try is being positioned as pro-patient, in reality, it’s nothing more than a libertarian Trojan horse designed to weaken the FDA. And once this dangerous precedent is set, I fear it could easily be expanded to include patients with less severe diseases.

No one, especially myself as a terminal cancer patient, wants to deny patients the right to receive potentially beneficial drugs. We already have that right today. Our current expanded access framework is meant to protect patients, and the FDA has a program that approves nearly 100 percent of all expanded access requests it receives. My sincere hope is that the House votes today to put the safety and best interests of patients before politics.

No Such Thing as “Risk-Free”

In a recent guest editorial that I penned for BioCentury, I referenced that a parent’s choice whether or not to vaccinate their child against the human papillomavirus (HPV) isn’t a “risk-free” choice. Every drug has risks – consider the following statement by the U.S. Food and Drug Administration (FDA): “although medicines can make you feel better and help you get well, it’s important to know that all medicines, both prescription and over-the-counter, have risks as well as benefits.” I would also point out that there are risks in forgoing a medication.

Let’s take a look at the HPV vaccine’s side-effects according to the prescribing information for Gardasil® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant). The most common side effects include pain, swelling, redness, itching, bruising, bleeding, and a lump where your child got the shot, headache, fever, nausea, dizziness, tiredness, diarrhea, abdominal pain, and sore throat. These are adverse events disclosed by the sponsor (Merck & Co., Inc.) to the FDA from completed clinical trials of Gardasil 9. Since licensure in 2006, over 270 million doses of HPV vaccines have been distributed and the sponsors are obligated to report any new side effects to the FDA.

What’s that you say? You don’t trust the pharmaceutical industry? The Global Advisory Committee on Vaccine Safety (GACVS), an independent expert clinical and scientific advisory body that provides the World Health Organization (WHO) with scientifically rigorous advice on vaccine safety issues of potential global importance, first reviewed the safety data for HPV vaccines in 2007 and subsequently in 2008, 2009, 2013, 2014, 2015, and 2017. In each period, the GACVS examined various vaccine specific safety issues, such as links to Guillain-Barré syndrome (GBS) and other autoimmune safety issues. No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe. According to the WHO, there are now accumulated safety studies that include several million persons and which compare the risks for a wide range of health outcomes in vaccinated and unvaccinated subjects.

Early on, the GACVS was presented with signals related to anaphylaxis and syncope related to the HPV vaccines. According to the GACVS, the risk of anaphylaxis from HPV vaccines has been characterized as less than 2 cases per 1,000,000 doses, and syncope was established as a common anxiety or stress- related reaction to the injection. Anaphylaxis is a severe allergic reaction that needs to be treated right away with an epinephrine (adrenaline) shot. Anaphylaxis is rare, and most people recover from it. Syncope, also known as fainting, is a loss of consciousness and muscle strength characterized by a fast onset, short duration, and spontaneous recovery. It is caused by a decrease in blood flow to the brain, usually from low blood pressure. For these reasons, the prescribing information for Gardasil 9 recommends observation of the individual for 15 minutes after administration.

Next, let’s consider the risks of not getting vaccinated against HPV. Again, according to the prescribing information for Gardasil 9, the vaccine helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV. Gardasil 9 also helps protect boys and men ages 9 to 26 against anal cancer and genital warts caused by those same HPV types. Accordingly, individuals who do not get vaccinated against HPV are at risk for the aforementioned cancers and genital warts.

In addition, the 9 types of HPV that infect the genital areas can also infect the mouth and throat (called oropharyngeal cancers). HPV is thought to cause 70% of oropharyngeal cancers in the United States, with HPV type 16 causing 60% of all oropharyngeal cancers. The HPV vaccine was originally developed to prevent cervical and other less-common genital cancers and has been shown in clinical studies to prevent cervical and other precancers. However, HPV vaccines could also prevent oropharyngeal cancers because the vaccines prevent infection with HPV types that can cause oropharyngeal cancers.

HPV vaccines were not available until I was age 38, which is well-beyond the upper age limit of 26 when the vaccines are considered effective. In late 2015, I was diagnosed with poorly differentiated, oropharyngeal squamous cell carcinoma, HPV type 16 related. My three treatment regimens thus far have included: chemoradiation, immunotherapy and currently chemotherapy.

Side-effects that Michael Becker has experienced from cancer and its treatment (click image to enlarge)

My diagnosis is terminal, so “death” would be the primary side effect from the disease that I would gladly forgo in favor of any of the aforementioned HPV vaccine side effects. Setting my grim humor aside for the moment, there are more than a dozen other side-effects that I have personally experienced to date from either cancer or its treatment (see accompanying image for details). And these side-effects don’t include others that I haven’t personally experienced, such as kidney damage.

I’m an advocate of HPV vaccination and strongly encourage parents to speak with a physician when it comes to deciding whether or not to vaccinate a child. The purpose of this blog post is to underscore that deciding not to vaccinate against HPV isn’t a risk-free decision. In my experience, the diagnosis of any one of the six cancers resulting from HPV infection is associated with plenty of important risks for parents to also consider.

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