Medical futility .... or failure to hope?

By James J. Gormley

Some years ago there developed a movement of people who wanted to convince society that doctors could decide whether to withhold, or withdraw, treatment for very sick, or "terminal," patients, "even over the objections of a competent patient."

The movement peaked in 1995 when 134 articles on the topic were published. Between June 1st 2006 and June 1st 2007, there were 75.

In 1992, in an article in the journal, Healthcare Ethics, the authors argued that "complete respect for patients' autonomy reduces the physician from a moral agent to an extension' of the patient's wishes."

God forbid!

Physicians are not moral agents. They are support staff in the job called "health." Mentally competent patients, and their immediate families, are the "moral agents. "

What bothers me is the presumption that care should be rationed for those of us who are the sickest, and moreso, that there's an outrageous assumption that because toxic drugs and invasive surgery (heroic measures) aren't working, then that means that "medicine" can do nothing else for this person.

Clearly, so-called "alternative" healing systems, such as Ayurvedic, Tibetan and Traditional Chinese Medicines, have been providing hope to people for over 4,500 years.

It would seem that mainstream medicine, then, is the "alternative," or new kid on the block. Since "medicine" encompasses so many valid healing systems, we cannot say that medicine has failed.

What has failed is hope. What has failed are the drugs and surgery. What has failed is our capacity to imagine. To imagine a totally different approach.

To imagine vibrant health. To pray. To go outside the bounds of an illness care system that has admitted defeat: medical futility.

An author on the topic wrote, "Talking to patients and their families should remain the focus of our efforts."

How true that is.

Ribbonless Presents, Unwrapped Gifts

By James J. Gormley

Now that the holidays are over, it’s worth remembering that gifts don’t always come in shiny red paper with bright golden ribbons. One of the first gifts I received from my parents had no holiday packaging at all.

On cold winter nights, when I was two, my father, whom I would call Papa, and later “Pa,” would lie awake on the floor next to my crib to comfort me when I would awaken with a bad dream. That’s what a father is; that’s who my father is.

I remember so many special times with my father and mother from my childhood. Me inside the shopping cart Pa pushed up the hill to the A and P. My father telling me the stories about how he and his father, the Old Man, would drive the horse-and-carriage along the Boston Post Road, in Mamaroneck, N.Y., before there were cars. Pa gently singing “All the Kings Horses and All the Kings Men” to me as a bedtime lullaby. Playing catch at Bowne Park in Flushing, N.Y., where I grew up. Walking Rexie, my dog, along the tracks of the Long Island Railroad.

My father and mother gave me so many things, ribbon-less presents that I can never reciprocate. Priceless gifts of love, time, caring, wisdom and so much more. I hope Pa knows and Ma knew how special they have always been to me, even if I haven’t always shown it.

Now that the holiday season is over, remember that exchanging presents isn’t the only way to show appreciation to the people who have made a difference in your life. Your gifts to them don’t have to be fancy or trendy or expensive or wrapped in shiny red paper with bright golden ribbons.

Offer them your gratitude to honor, in a small way, all of the many unwrapped gifts they have given you.

New Year, New You!

By James J. Gormley

New Year’s means change. It also means tradition, or that which doesn’t change.


Guy Lombardo

When I was little, the night of December 31st was not New Year’s Eve until I sat down with my parents to watch Guy Lombardo and His Montreal Canadians. It wasn’t New Year’s until my grandmother reminded me to put a shiny quarter out on the windowsill so that the new year would be prosperous, or until the ball dropped in Times Square.

There was no “Rockin’ New Year’s Eve,” and definitely no televised California New Year’s with fake snow and people jumping up and down for the cameras, screaming at 9:00 p.m. Pacific Standard Time.

New Year’s Eve was not always celebrated with drunken revelry and blasts from toy horns, however. In ancient times, and even in some mainstream religions today, the New Year is a time for reflection on the past and hope for the future.

New Year’s, today, can be a curious mixture of the old and the new, the completed and the yet to be. As we usher in this new year, let’s not feel like powerless beings swept along by the unrelenting forces of time.

Let’s embrace the New Year and its challenges. Whatever changes we are faced with, we can be the rulers over our lives. We can transform tragedy into positive energy. We can go forward, then, with a new perspective or a new appreciation for life, itself, and all that which makes it worth living.

Each of us has within ourselves the capacity for change, the capacity for (and right to) happiness and the power to take charge of our lives.

Let’s tap into these energies now, as we enter this new year.

‘Supplements Are Safe, Healthful and Well-Regulated’!

By James J. Gormley

On March 25th, 1999, I was part of a live television debate on FOX-TV’s “Good Day New York” with a drug industry attorney on the topic: “Are dietary supplements regulated?”(1)

Needless to say, with all of the facts showing how well regulated dietary supplements were then, winning the debate was not a difficult accomplishment; I even had the host, Jim Ryan, on the side of supplement consumers about midway through the segment.

In fact, the regulations and laws governing nutritional supplements in 2011 are even more stringent than they were in 1999, when I did that show.

According to attorney Peter Barton Hutt, the “bedrock food safety requirement that has been the foundation of the American food supply since 1906 — the prohibition of poisonous or deleterious substances in food—applies equally to dietary supplements and conventional food” (2).

Supplements: A Super-Regulated Category
Today, dietary supplements have the following requirements and controls over them:

• Pre-market notification to the U.S. Food and Drug Administration (FDA)—not required for drugs or medical devices.
• Labeling.
• Mandatory adverse event (side effect or reaction) reporting to the FDA (not required for foods).
• FDA Good Manufacturing Practices (GMPs).
• Facility registration (for the FDA).
• Advertising (by the U.S. Federal Trade Commission).

In fact, broadly speaking, the laws governing supplements under the umbrella of the Food Drug and Cosmetic Act (FD and C) are: the Nutrition Labeling and Education Act of 1990 (NLEA); the Dietary Supplement Health and Education Act of 1994 (DSHEA); the Bioterrorism Act of 2002; the Food Allergen Labeling an Consumer Protection Act of 2004; the Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006 (AER Law); and Federal GMPs.

Regarding dietary supplements, the FDA has significant powers, including (but not limited to) the authority to:

• Stop a company from selling any dietary supplement that is unsanitary or unsafe.
• Stop the sale of any dietary supplement that makes false or non-substantiated claims on its labeling.
• Stop the sale of any nutritional supplement that poses “a significant or unreasonable risk of illness or injury.”
• Block a new dietary ingredient (NDI) from being marketed if the agency does not receive enough safety information in advance.

Likewise, the FTC has a great deal of surveillance and enforcement powers that it uses for dietary supplements, including the ability to: challenge and stop advertising that is not sufficiently substantiated; negotiate a consent order for a company to change or fix its promotional, marketing or advertising practices; and to seek substantial civil penalties for violations of trade regulation rules or violations of cease and desist orders. 

So Why Do We Keep Hearing About Supplements Being Unregulated?
Part of the problem is the media.
As I noted way back in 1999 (1), despite powerful and authoritative research underpinning many of the most popular supplements today, the mainstream media appear to be on a planet where this research is unavailable or incomprehensible.

The FDA itself has also been stoking the misinformation fires about the supplement regulations that it is mandated to implement and enforce. As I noted in July 2009, “The FDA should cooperate with the responsible core of the natural products industry rather than criticizing the very laws that the American people saw fit to pass and which the FDA is sworn to uphold and enforce” (3).

Dietary supplements have “always been regulated as a category of food in this country, and DSHEA did not change that,” according to the Council for Responsible Nutrition (CRN) (4).

“Dietary supplements are not regulated as drugs because they are not drugs,” added Jeffrey Blumberg, PhD, FACN, director of the Antioxidants Research Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging, at Tufts University (3).

According to Hutt, it is “apparent that FDA has adequate statutory authority to assure the safety of both dietary ingredients and conventional food ingredients” (2).

In fact, Hutt adds that the “safety provisions under the FD and C Act applicable to dietary supplements would appear to be stronger than those applicable to conventional food.”

‘Supplements Are Safe, Healthful and Well-Regulated’ may not be a very “sexy” story title as they go, but it is one that really should be front-page news.

Gormley Take-Away: Given all of the recent drug recalls and food contamination outbreaks, I would be much more concerned about the safety of pharmaceuticals and conventional foods than about dietary supplements if I were the average consumer advocate, legislator or reporter. Looking at the powerful safety record of dietary supplements, now officially demonstrated via the AER Law, I would consider beating a different drum than the one associated with unwarranted and uninformed attacks on supplements.

REFERENCES
1. Gormley J. Mass media is unregulated [Editor’s Desk]. Better Nutrition. August 1999.
2. Hutt PB. FDA Statutory Authority to Regulate The Safety of Dietary Supplements [White Paper]. Covington and Burling, June 6, 2003.
3. Gormley J. Making the ‘cut’: What the latest recall tells us … and doesn’t. The Gormley Files. July 21, 2009.
4. Council for Responsible Nutrition. Dietary supplements: Safe, beneficial and regulated. Revised December 2009. Accessible at: http://www.crnusa.org/CRNRegQandA.html

Which is the real bioterrorism?

By James J. Gormley

Recently, I was thinking about the many ways in which nature's balance and our bodies are thrown off kilter by toxins,allergens and disease.

Many of the imbalances are the result of a complex web of disastrously irrational environmental and industrial policies. In most cases, however, the poisoning of our world is not generally considered wantonly malicious, in the strictest sense of that term.

In general, we try to deal with these assaults on our bodily systems' living order (homeostasis) by attempting to purify the body — by identifying toxins and allergens and reducing our exposure to them, supporting the liver and cleaning up the diet.

However, in a post 9/11 world threatened, or haunted, by the specter of biological and chemical warfare, it was not without a degree of trepidation that I happened upon an old article in the New England Journal of Medicine, entitled "Mass Psychogenic Illness Attributed to Toxic Exposure at a High School."

Although the word "psychogenic" is a tip-off that the authors concluded that people were imagining things, I was very curious as to what went on.

Apparently, in November 1998, a teacher at a high school in Tennessee smelled a gasoline-like odor in her classroom. Then she, and others, began to experience such symptoms as headache, nausea, shortness of breath and dizziness.

The school was evacuated, and 80 students and 19 staff members went to a local emergency room; 38 people were hospitalized overnight. Five days later, after the school had reopened, 71 people went to the emergency room.

Although "extensive investigations" were carried out by several government agencies, the authors said: "We were unable to find a medical or environmental explanation for the reported illnesses," and that the illness — although similar to symptoms reported by victims of "bioterrorism" — "bore the "major features of psychogenic shock."

In other words, although over 170 people went to the hospital over the course of five days, they were all, presumably, suffering from some kind of mass hysteria; they were all just imagining things.

Were the Operation Desert Storm veterans all just imagining things, too?

And what about the biological warfare the United States allegedly conducted in Korea in 1952 and 1953, which was said to include plague and anthrax bacilii. Was our entire biological warfare effort just something we imagined, as well?

I wish it were.

Whenever there is something that doesn't offer up immediate scientific validation in neon lights, then, clearly, mainstream medicine's easiest solution is to dismiss it as a figment of an overactive imagination or "mass hysteria."

I truly would like to believe that people in McMinnville, Tennessee, just freaked out for 5 days. I'd also like to believe that a whole host of serious autoimmune disorders, such as chronic fatigue syndrome, are all just products of "psychogenic shock."

But, unfortunately, they're not. And the sooner mainstream medicine, and, our "guardians of public health," come to terms with the fact that our inability to immediately put a "pre-printed label" on a given symptom picture is not, in any way, a determination that a patient is imagining things, the sooner mainstream medicine will come closer to where holistic medicine has always been.

Until then, we have to ask ourselves: where is the real bioterrorism?

Is it a missile carrying plague, or is it when medicine sabotages health, and truth, in a quest for easy answers?

Good Intentions Do Not A Good Bill Make; President Obama Must Veto This Bill

By James J. Gormley

President Obama is waiting to hear from you, your neighbors, your brothers, your sisters, your parents — and all of America — as to whether to sign the "food safety bill" into law.

If you agree with all of the problems we have identified with this bill — or even with most of them — I ask you to please go to the White House comment page and ask the President to veto this bill.

It’s not that the bill is meant to disrupt the American Way of Life or forever change the fabric of our great nation. It is not badly intentioned. It even has some decent provisions in it. On top of that, dietary supplements were ostensibly excluded, as were farms and small food-service operations.

The problem is not what was intended, or what FDA Commissioner Hamburg believes is in this bill. The problem is that the bill’s advocates and many of its supporters were all sold a bill of goods.

The fact is that FSMA will do very little to improve food safety; and, in truth, by obscuring the real core of our nation’s food safety problems with layer upon layer of HACCP requirements, and food allergenicity protections and food safety recordkeeping plans — and all of the $1.4 billion worth of stuff (red tape and feel good busywork) in this bill — this bill would actually make things worse.

Why? Because while Dr. Hamburg and the bill’s cheerleaders are busy shaking hands, and slapping each other on the back as to what an amazing bill this is (which it is not), the disgusting factory farms and filthy slaughterhouses in this country — which are the real problems with our food supply, let’s face it — will not be made any less filthy by this $1.4 billion boondoggle.

What are the remaining problems with this bill that make it un-signable?

If the FDA (Secretary of the HHS) has a “reasonable belief” or feels there is a “reasonable probability” that a food is unsafe, records inspections must be carried out and foods can be quarantined. The FDA has a long and sordid history of abusing this power by making assumptions that hurt food producers, and ultimately consumers.

The FDA already believes (without a shred of evidence) that raw milk and raw milk cheeses are unsafe — wouldn’t this be the perfect opportunity for the FDA to close down a cottage industry towards which it has always held such animus?

Now while it is potentially good that the bill includes a proviso (in Section 113) calling for dietary supplement products (that’s why I said ostensibly excludes, above) that may contain (or may be) anabolic steroids to be referred to the DEA, the problem is that that it is way too vague: "may contain" is not definitive enough by a long stretch, which opens the doors for the FDA to believe that many supplements “may contain” anabolic steroids, and hurt legitimate manufacturers in the process.

Section 423 offers manufactuers an opportunity to voluntarily take a product off the market and recall it if the FDA feels that there is a “reasonable probability” that an article of food is misbranded. Well, here we go again; the FDA has time and again greatly overarched in its authority in these areas, often calling products “misbranded” for the smallest mistake in a nutrition facts or product label.

Section 404 insists that nothing in the bill shall in any way be inconsistent with the World Trade Organization or any other international treaty or agreement to which the U.S. is a party! Okay, again, can anyone explain why (I ask why) domestic, sovereign, internal U.S. laws and regulations need to be consistent with international treaties and agreements (such as Codex)?

Section 420 calls for limited distribution of the guidance documents that food producers would need in order to comply with this law in the interests of “national security.” This says that although food facilties will be required to comply with this new law, if the U.S. government does not feel like releasing instructions and guidance on how to properly comply with the requirements, it does not have to, if blanketed under the usual sacred cow of “national security.” Outrageous!

FDA Commissioner Margaret A. Hamburg MD truly believes that the Food Safety Modernization Act (FSMA) is the greatest thing ever. Sadly, it is not worthy of the President’s signature and was railroaded through Congress under suspended rules and other legislative sleight of hand.

I ask you to tell President Obama to please veto this bill; we will work together on coming up with an alternative bill in 2011 that will be signature-worthy.

Escape from the Emergency Room

By James J. Gormley

I realized one day that I had a medical "situation," a male concern I had wondered about for a couple of months, yet had dealt with via the time-honored male tradition of "avoidance"-- if I pretend everything's okay, the problem will go away -- not exactly the best approach.

Scared about cancer, I sat down with my wife. We resolved to speak with a physician friend the next day, which I did. I was told: "Get thee to an emergency room," in no uncertain terms.

Wracked with fear, I stepped into an emergency room in the Bronx, where I live, and I was shocked. Before me were hundreds of people waiting to be called -- victims of a world without a family doctor, statistics at the periphery of an HMO universe.

There was no hope in this room. Only desperation. Only sickness. Only pain. The room was dark and filthy, the staff looked shell-shocked, and the triage "window" was a l-inch-thick bulletproof barrier.

My heart sank. I felt a ball of worry in the pit of my stomach. I telephoned my car-service friend, Marvin, and asked him to pick me up and drive me to a hospital in Manhattan, one regarded as one of the finest medical institutions in the world.

When the cab drove in along the graceful, flower-lined driveway, I thought that I was pulling up to a Hamptons dinner party, not to a place of X-rays and blood. There were only a couple of people waiting in the immaculate, "elegant" waiting room. I thought, "Now I'll be safe. Now I'm in good hands. "

Or not? The triage nurse ignored most of my questions, and I wound up in a room within the bowels of the E.R. Freezing in a hospital gown, I was examined by a surgeon who was compassionate yet overworked. He informed me that I would need ultrasound testing, and that a urologist would have to see me.

After he left, a nurse ordered me to vacate the room, since they needed it for an "eye injury." I painfully climbed down (without a step-stool) and found myself, ignominiously, having to climb up onto a stretcher in the hallway.

About 2 hours went by before transporters came to bring me to ultrasound. When I was brought back to the E.R., I was deposited in a wheelchair and forgotten.

When my meal arrived (for which I had to practically beg), the urologist intern showed up: 7 hours after I arrived, 4 hours after the ultrasound. He was very vague, and just didn't seem to care. He promised to give me the names of three urological surgeons, and sent me back to the nurse's station, where I waited another hour for my discharge instructions, which I could barely read.

When asked by one of the night-shift nurses, "Who was your nurse?," I told her that I had no idea -- that no one (except for the surgeon) had bothered to give me a name, or ask me if I was okay, or if I needed a sip of water ... anything at all.

When I sit back, and try to process what this experience taught me, I'm left with this thought: It represents the very worst and the very best of what's horribly wrong and allegedly right about mainstream medicine today. It's high-tech but "low-heart," the apex of empirical skill yet the nadir of compassionate medicine.

In 1975, Ashley Montagu said, "One goes through [...] medical school and one's internship learning little, or nothing, about goodness, but a good deal about success."

Pity that goodness needs to be taught, and sad that this is a definition of success.

Is it any wonder that holistic medicine holds the key?