By MIKE MAGEE

“We the People of the United States, in Order to form a more perfect Union, establish Justice, insure domestic Tranquility, provide for the common defence, promote the general Welfare, and secure the Blessings of Liberty to ourselves and our Posterity, do ordain and establish this Constitution for the United States of America.”

This striking and sweeping statement of values, the Preamble to our Constitution, was anything but reassuring to the wives, mothers, sisters and daughters of the Founding Fathers. Abigail Adams well represented many of them in her letter to John Adams in March, 1776, when she wrote:

“Remember the Ladies, and be more generous and favorable to them than your ancestors. Do not put such unlimited power into the hands of the Husbands. Remember all Men would be tyrants if they could. If particular care and attention is not paid to the Ladies we are determined to foment a Rebellion and will not hold ourselves bound by any Laws in which we have no voice or Representation.”

Her concern and advocacy for “particular care and attention” reflected a sense of urgency and vulnerability that women faced, and in many respects continue to face until today, as a result of financial dependency, physical and mental abuse, and the complex health needs that accompany pregnancy, birth, and care of small infants.

The U.S. Constitution is anything but static. In some cases, the establishment of justice, or the unraveling of injustice may take more than a century. And as we learned in the recent Dobbs case, if the Supreme Court chooses, it may reverse long-standing precedents, and dial the legal clock back a century overnight.

Roe v. Wade was a judicious and medically sound solution to a complex problem. Perfection was not the goal. But in the end, most agreed that allowing women and their physicians to negotiate these highly personalized and individualized decisions by adjusting the state’s role to the reality of the 1st, 2nd, and 3rd trimester made good sense. But getting physicians to step forward and engage the issue was neither simple nor swift.

In July, 1933, McCall’s magazine published one of hundreds of ads that year for contraceptive products. This one was paid for by Lysol feminine hygiene. It pulled punches, using coded messages, and suggesting that the very next pregnancy might finally push a women over the edge, and that would indeed be a “travesty.”

The ad read:

The most frequent eternal triangle:
A HUSBAND…A WIFE…and her FEARS

Few marriages would flounder around in a maze of misunderstanding and unhappiness if more wives knew and practiced regular marriage hygiene. Without it, some minor physical irregularity plants in a women’s mind the fear of a major crisis. Let so devastating a fear recur again and again, and the most gracious wife turns into a nerve-ridden, irritable travesty of herself.

Birth control had by then become a huge and unregulated business. As one report noted, “Capitalizing on American’s desire to limit family size in an era of economic hardship, pharmaceutical firms, rubber manufacturers, mail-order houses, and fly-by-night peddlers launched a successful campaign to persuade women and men to eschew natural methods for commercial devices whose efficacy could be ‘scientifically proven’. . . with the industry’s annual sales exceeding $250 million, Fortune pronounced birth control one of the most prosperous new businesses of the decade.”

This was a decided shift from the Roaring 20’s when coded messaging was the rule rather than the exception, and the AMA maintained a respectful, self-protective distance from the controversy.

As one report described, this was “…an era when the American Medical Association did not consider contraception part of medicine . . .The goal of the birth control movement in the 1920s and 1930s was to take power away from the commercial advertiser and place it in the hands of the physician.”

For Margaret Sanger, medicalizing women’s autonomy over birth decisions was essential. Having highly respected and politically powerful physicians as allies in the struggle provided much needed shielding nationwide. Sanger’s efforts to expand women’s health services, especially to immigrants fleeing the war clouds settling over Europe, demanded partnerships with physicians. But physicians were leery when it came to going public in support of birth control. Even noted academic supporters feared being accused of advertising birth control for profit which was distinctly outlawed under the AMA code of ethics.

By 1937, however, the AMA felt the winds of change blowing. FDR already knew a war was coming and that availability of contraception would be a critical factor in avoiding outbreaks of venereal disease among the troops as the nation had experienced in WW I. On the morning of June 9, 1937, the nation awoke to front page headlines in the top two columns of the New York Times that read “Birth Control Is Accepted By American Medical Body: Association Backs Doctors in Use of ‘Legal Rights’ on Contraceptive Advice.”

The body of the article explained that the association’s house of delegates – defined as “the supreme court of American medicine” – adopted two recommendations dealing with the issue. First, “that the American Medical Association investigate the various forms of contraception with a view to disseminating authoritative information on the subject to the medical profession”, and second, “that the association promote the teaching of proper methods of birth control in the medical schools.”

Labeling the action as “another landmark in the annals of American medicine,” they offered perspective noting that “For many years all efforts to gain official status for birth control, as a legitimate part of medical practice, have been bitterly fought and successfully blocked by powerful groups, religious and otherwise, within the ranks of American medicine.”

In the very next paragraph, the Times article asserted that, with this issue now out of the way, the delegates were focused on “the most important problem facing American medicine today” – whether to give official recognition to the principle that  “the health of the people is the direct concern of the government, and that a national health policy directed to all groups of the population be formulated…Whatever the outcome, every one here realizes that organized medicine in America now stands at the crossroads and that it can no longer champion the status quo as it has done in the past.”

Roughly three decades later, on June 7, 1965, in a 7 to 2 decision titled Griswold v. Connecticut, authored by Justice William O. Douglas, the Supreme Court issued a 7–2 decision and struck down Connecticut’s last state law banning the sale and advertising of  contraceptives.

In the Majority Opinion, Douglas wrote: “Would we allow the police to search the sacred precincts of marital bedrooms for telltale signs of the use of contraceptives? The very idea is repulsive to the notions of privacy surrounding the marriage relationship.”

Griswold v. Connecticut  became one of the most referenced landmark cases in history. All Americans now had their “sexual privacy” protected from government intrusion. As a result, a series of cases were successfully built on top of this precedent setting ruling. These included:

Eisenstadt v. Baird (1972) – Contraceptives for Single Adults.
Roe v. Wade(1973) – Abortion Legal in Non-viable Fetus.
Lawrence v. Texas (2003) – Texas Anti-Sodomy Law Unconstitutional.
Obergefell v. Hodges (2015) – Same Sex Marriage Legal.

When the Dobbs decision that effectively reversed Roe v. Wade was handed down, Justice Clarence Thomas in a concurrence statement wrote, “…in future cases, we should reconsider all of this Court’s substantive due process precedents, including Griswold, Lawrence, and Obergefell.”

In a Clarence Thomas world, historic precedent and scientific progress be damned. Bodily autonomy is a product of the state. Health is a luxury, doled out in small measure only to those who toe the religious party line.

Mike Magee MD is a Medical Historian and author of “CODE BLUE: Inside the Medical Industrial Complex.”

Forget being pigeon-holed as a “femtech” company! VERY early-stage women’s health startup, Pollie, is taking an integrated care approach to complex chronic conditions that either just affect women, OR impact women differently or disproportionally than men. Think not only about conditions caused by hormone imbalances like PCOS (polycystic ovarian syndrome) or endometriosis, but also auto-immune disorders and digestive disorders that present differently or more frequently in women.

Co-Founder and CEO, Jane Sagui, drops by to talk us through the platform Pollie is building (and I mean, building-as-we-speak) which will ultimately teach women how to manage their chronic conditions via a highly-personalized program that includes all possible treatment management solutions, from pharmaceuticals to lifestyle-based treatments like diet and exercise. The company is currently piloting a version of their solution with a cohort of PCOS patients, but, has grand plans to expand their multi-modality pill-plus approach into other categories of women’s health that are NOT reproductive system related. Their biz has already caught the eye – and some investment dollars – from Bayer, as the company is one of four that’s been selected for this year’s Growth Track within G4A’s Digital Health Partnerships Program.

Jane gives us the details behind Pollie: their business, the pilot, the round they’re currently raising, and the types of partners they’re seeking as they evolve their offering. What’s also exciting? An early-stage bet from a big pharma co like Bayer that signals a future for women’s health care that may (finally) be about MORE than just reproductive health.

By ZOYA KHAN

A couple weeks back, Matthew met with MIRA Fertility Tracker at TechCrunch Disrupt 2018. Sylvia Kang, CEO & Co-founder of MIRA, spoke to Matthew about her new fertility tester for women trying to track their cycles. It also has an AI component built into its system, in order to inform women the days they are most likely to get pregnant. MIRA also took center stage at #Health2con’s Venture Connect, placing 1st among a series of talented health tech startups. 

Zoya Khan is the Editor-in-Chief of THCB as well as an Associate at SMACK.health, a health-tech advisory services for early-stage startups.

A preventive breast cancer vaccine developed by Professor Vincent Tuohy of the Cleveland Clinic will be brought forward to the FDA for permission to begin clinical trials to see if it is safe and effective for use in women.

The vaccine was shown to be completely safe and 100% effective in preventing breast cancer in three animal models, (see study in Nature Medicine), and was also found to slow the growth of tumors that had already formed. The vaccine is especially powerful in inhibiting the growth of triple-negative breast cancer, the most aggressive form of the disease with the lowest survival rate.

Triple-negative breast cancer lacks estrogen, progesterone and Her2 receptors. It occurs in approximately 15% of cases is the kind of breast cancer most common in women who carry a BRCA mutation.

The initial clinical trials, called Phase I studies, will be conducted in two groups of volunteers, women with triple-negative breast cancer who have completed their treatment and are free of disease, and women who will be vaccinated shortly before undergoing bilateral prophylactic mastectomy (typically these are women like Angelina Jolie with BRCA mutations who elect to remove their breasts to lower their risk for cancer.)

The first group of women will be studied to determine the dose and effectiveness of the vaccine; the second will be studied to make sure the vaccine does not trigger an untoward immune response in breast tissue.

The vaccine targets an unique protein normally made only by women who are breastfeeding, alpha lactalbumin (ALA). In the 12 years Tuohy spent developing and researching his vaccine, he discovered that the majority of breast tumors express, or make, ALA. Priming the immune system with a vaccine so that it attacks any cell that makes ALA is the method by which Tuohy’s vaccine works.

Because the vaccine targets ALA, a protein necessary for successful lactation in healthy women, the vaccine would not be appropriate for use in women who are still in their childbearing years.

However, the majority of women diagnosed with breast cancer in the United States and other western countries are post-menopausal: at least 60% of the cases in the United States occur in women over 55; thus, Tuohy’s vaccine holds great potential as a preventive vaccine for the majority of women.

Because the vaccine has also demonstrated therapeutic potential (in slowing the growth of tumors that have already formed), it may also prove useful in treating women who already have the disease, particularly women with triple-negative breast cancer for which there are presently no available targeted therapies.

Other scientists have joined the movement toward creating preventive as well as therapeutic vaccines. Dr. Brian Czerniecki of the University of Pennsylvania has a very effective vaccine to treat women with ductal carcinoma in-situ whose tumors express the growth receptor, Her2. And just recently, Dr. Susan Love and the National Breast Cancer Coalition began working with a panel of scientists on the Artemis Project, whose goal is to end all breast cancer in seven years, hopefully by way of a vaccine.

However, only Tuohy’s preventive breast cancer vaccine and Dr. Czerniecki therapeutic breast cancer vaccine have reached bench-to-bedside potential to begin clinical trials in human subjects.

While it’s true that not everything that works in mice works in women, everything that currently works in women first worked in mice. Since so much is at stake – millions of lives, millions of breasts, billions of dollars – the possibility of developing an effective preventive breast cancer vaccine has captured the imagination of scientists, the financial commitment of institutions like the Cleveland Clinic, and broad support from a groundswell of women who would prefer prevention to the rigors of a cure. The Pure Cure for breast cancer, prevention, is now the mission.

Fast-tracking Tuohy’s vaccine through the FDA so that clinical trials can begin as soon as possible is the present objective – to see if it’s safe and, if safe, to see if it works. Opinions may vary about its potential – they always do – but, fortunately, clinical trials are the arena in which final scientific arbitration takes place, and they are now on the road with regard to this vaccine.

The gruesome data on the global burden of breast cancer remains vivid: In 2013 alone, 1.5 million new cases – one every 20 seconds – and 500,000 deaths – one every minute. And provide the most compelling arithmetic for moving forward, reasonably but quickly. Let the vaccine speak for itself. Put it to the test and “let slip the dogs of war” to prevent breast cancer if we can, as soon as we can.

Kathleen T. Ruddy, MD is a breast cancer surgeon and Founder and President of the Breast Health and Healing Foundation.