Townsend’s New York Observer

by Marcus A. Cohen

Field Notes From the Cancer Wars: The War Against Nutrients and Natural Products

Part 2

Big Pharma’s Role in the Scarcity of Clinical Trials on Nutrients and Natural Products

In an ideal world, pharmaceutical companies would devote their vast research resources to searching for long-shot cures for major scourges such as Alzheimer’s disease. They would sponsor trials to help doctors figure out what treatments work best and are most cost-effective. They would develop drugs and vaccines against malaria, schistosomiasis, and other Third World diseases, even though there’s little chance of making money off them. And they wouldn’t threaten cuts in research and development for breakthrough medicines whenever politicians challenged their ability to charge high prices.

What a world it would be. But the pharmaceutical industry is no paragon of selfless public service. …

John Carey, reviewing a book scalding the drug industry in Business Week in 2004, wrote the sentences I just quoted.¹¹ Carey said more that rates quoting about the goals and values of Big Pharma:

Of course, drugmakers charge the highest prices the market will bear for their products, just as other manufacturers do. Anything less, and they’re not doing their duty to shareholders. And is it really a shock that companies spend a big chunk of their R&D budgets on drugs that sometimes show no clear medical advantage but that bring surefire profits, or on trials aimed solely at boosting sales?… If consumers are paying high prices for drugs discovered with taxpayer money, how is that different from the computer and Internet world, where tech businesses profit on research that was originally funded by the government?… In fact, there often is an inherent conflict between doing well financially and doing what’s best for medicine.

In the column introducing my “Field Notes” series (Townsend Letter, October 2010), and in Part 1 of this column, I’ve stressed that the columns in “Field Notes” will be very personal. By personal, I mean visceral rather than cerebral.

By the time I’d read through John Carey’s review to his blunt observation that with drug companies, corporate profits frequently conflict with serving medical needs, an urge possessed me to grab the biggest cudgel I could lay my hands on and whale the bejabbers out of Big Pharma.

Blame “the system” for the lack of clinical trials of natural substances in cancer patients – if that’s your explanation for the lack. Lots of “culprits” besides the drug companies in “the system”: doctors, insurers, the FDA, the NIH, Congress, whichever administration is hanging out in the White House.

I scan that pack, and higher than all looms Big Pharma. I want to beat up on the drug-makers (or drug-pushers, since both hats fit the same head). They’re aware that their chemo kills patients with advanced cancer. In his JAMA editorial back in 1991, Dr. Moertel confirmed this: “There is prima facie evidence that toxic effects of such therapy may shorten life and impair quality of life.” I’m beyond being lectured on how “the system” is mainly responsible for the corpses strewn over the deadliest cancer battleground. System, hell! I want the poison-producers! Where’s that cudgel?

H.R. 745

In January 2009, Congresswoman Anna G. Eshoo (D-CA-14) sponsored the Pancreatic Cancer Research and Education Act – H.R. 745 – a bill that would require the Secretary of the Department of Health and Human Services to establish and implement a Pancreatic Cancer Initiative (PCI).

Essential purpose of the PCI

: Assist in coordination of activities addressing the high mortality rate associated with pancreatic cancer.

Rationale

: Pancreatic cancer will strike nearly 38,000 Americans this year, over 34,000 of whom will die. (The incidence among African Americans is 40% to 50% higher than any other ethnic group.) In 2003, pancreatic cancer leapfrogged over prostate cancer to become the fourth leading cause of cancer-related death in the US.

Less than 2% of federal funding for the National Cancer Institute (NCI) goes into research on pancreatic cancer. The NCI awarded 5000 research grants in 2006. According to the NCI, just 134 (approximately 3%) were at least 50% relevant to pancreatic cancer.

H.R. 745 cites other reasons (“findings,” in congressional language). I’ve touched on the most arresting ones.

Appropriations

: H.R. 745 would authorize a total of $169 million in fiscal 2010 for pancreatic cancer, with $140 million for the PCI. For fiscal years 2011 through 2014, Congress would authorize such sums as may be necessary.

By midsummer 2010, cosponsors in the House of Representatives neared 240, Republicans as well as Democrats. A related bill has been introduced in the Senate, S. 3320, but the public info release that I have, from the Pancreatic Cancer Action Network, concentrates on the House bill, supplying only the number of the Senate bill.

H.R. 745 has been referred to the Committee on Energy and Commerce. My impression, from the release: the bill may still be in committee. If it doesn’t pass during the present session of Congress, it must be reintroduced in January 2011, and all the cosponsors rounded up anew.

Guess what H.R. 745 provides for research on nutrients and natural products?

Under Sec. 320B. Pancreatic Cancer Initiative, subsection 5. Prioritization and Award of NIH Grants, it states that in evaluating grant applications, emphasis should be placed on applications whose primary focus is on at least one of three areas. The third area:

“Advanced innovative clinical trials testing targeted therapeutics and novel agents that will extend the survival of pancreatic cancer patients and improve their quality of life.”

In specific language? Nada! Zero! Zilch!

The Man with the Greed in His Eyes

Andy Irvine’s song “Never Tire of the Road,” quoted in Part 1 of this column, paid tribute to the American folksinger Woody Guthrie (1912–1967). Guthrie bequeathed to Americans hundreds of traditional and improvised songs. His political songs are a “hallmark.” (He often performed with the sign “This Machine Kills Fascists” on his guitar.) Irvine’s tribute included the following stanza:

Don’t ever let them fool you

Or take you by surprise,

The dirty smell of the politician

And the man with the greed in his eyes.

Folksingers, troubadours: they’re given to wandering, but the best rarely stray from truth – sometimes in the plainest, stomach-searing form. As a columnist dealing with medical politics, I’m prone to spoon out harsh facts in a form that slides down the esophagus like gruel and neutralizes stomach acid.

I usually don’t write with the kind of breathtaking directness that characterizes Adam Smith (1723–1790). “People of the same trade seldom meet together, even for merriment and diversion,” he said in Wealth of Nations, “but the conversation ends in a conspiracy against the public, or in some contrivance to raise prices.”

Here’s my read on the complete absence of language in H.R. 745 authorizing appropriations for the full range of studies on nutrients and natural products.

A recent credible estimate on how long and costly it is to pass one new drug though the FDA runs a billion dollars and 10 years. (H.R. 745, by contrast, will pump a mere $169 federal million into all pancreatic cancer studies in fiscal 2010, with more promised.)

Only Big Pharma can ante up the billion and afford that length of time. And Big Pharma won’t gamble a penny and spend a minute on natural substances, which aren’t patentable. They’ll shower money and time on research and development of synthesized analogues, which can be patent-protected to maximize profits.

The undermanned FDA plays along because the synthesized analogs, which are alien to our bodies, will inevitably produce toxic effects. Covering their rear ends, the FDA insist on extensive safety data (in addition to data on efficacy and comparative efficacy). The FDA director and allies in Congress and nongovernmental organizations (NGOs) then push for more staff and operating money to upgrade and rev up the whole drug approval process.

You can liken Big Pharma to “the man with the greed in his eyes” in Irvine’s song.

For politicians, I don’t speak of their “dirty smell,” as Irvine does. The odor that penetrates my nostrils when I’m around politicians is a whiff of mold.

The source? In my direct experience with members of Congress, they rely on their staffs to brief them on legislation and to assist them in making public their positions on related issues. In matters of medical research and health care, the positions taken too often suggest feeds from drug company lobbyists and gleanings from behind-the-times news reports about nutrition and disease.

I’d be surprised if most member of Congress know more than a smidgen about the pile of rock-solid mainstream preclinical evaluations of nutrients and natural substances in cancer. The few in the know may wonder why only a smattering of promising preclinical evaluations have been followed up by clinical trials in humans.

Should they actually ask the drug company lobbyists why clinical trials on naturally-occurring preventive and therapeutic agents are slightly more common than hen’s teeth, the lobbyists simply keep mum on the fundamental reason: no profit for Big Pharma in conducting clinical trials on molecules straight from Mother Nature’s medicine cabinet – so hardly any have been conducted, or will be conducted, by the commercial sector.

On the validity of the mass of scientific evidence for the superior effectiveness and safety of nutrients and natural products in prevention or treatment of a host of maladies, Congress isn’t the only body fogged in. Many establishment medical societies, certain prominent consumer-protection “watchdogs,” and plenty of patient organizations are fogged in too. But Congress has a lock on power to legislate a change in the foggy overcast. If …

If Congress finally saw that scaling down health-care spending ain’t gonna happen while our entrenched drug approval system keeps drug multi-nats competition-free. I’ve published several columns in Townsend Letter since 2008 that proposed a rational overhaul of the approval system. The latest, most comprehensive proposal appeared in the July 2010 issue. Two sentences here are enough for the gist:

Set up a National Institute of Nutrition in the NIH to coordinate, sponsor, or fund human trials of nutritional and natural compounds shown through lab and animal studies to have strong therapeutic potential.

Establish a quick, low-cost approval system for nutritional and natural compounds, one which would make approved products primarily available for over-the-counter (OTC) sale, not through prescription.

A separate NIH institute devoted to nutritional research could touch off an explosion of studies (1) demonstrating the mechanisms of action of natural substances at a technologically sophisticated level; (2) indicating their optimal intake requirements; (3) offering the public and the medical profession guidelines for safe consumption.

A National Institute of Nutrition could phase out the piecemeal approach to research on nutrition that now appears the practice at the various specialty institutes at the NIH. Crucially, it could undertake clinical trials of natural substances shunned by Big Pharma because they can’t patent and reap huge profits from them.

An inexpensive, fast-track approval process for nutrients and natural products would signal that Congress and the FDA have reconciled themselves to the fact that the majority of these biochemical compounds have been eaten or otherwise absorbed by humans for thousands of years, with far fewer known adverse effects than the synthetic analogs and molecules developed as treatments by drug companies, which are foreign to our body systems and apt to induce serious side effects.

A separate approval process for treatments derived from naturally occurring substances could also redirect the focus of researchers and the FDA away from monopharmacology (how a solitary therapeutic agent acts in the body) to polypharmacology (how multiple therapeutic agents combine or act synergistically in the body). The shift in pharmacological focus, along with more frequent therapeutic use of nutrients and natural compounds, could change the treatment paradigm for numerous illnesses to a less invasive, less costly one.

But a rational overhaul of our drug approval system hasn’t made headway in Congress. Congress hasn’t grasped the sensibleness of a National Institute of Nutrition and a separate approval system for nutritional- and natural compound-based therapy. Congress may never “get it.”

I Call It War

If Congress passes the Pancreatic Cancer Initiative without a substantial requirement for clinical trials in humans of nutrients and natural products, and without an authorization of considerable appropriations for the trials, drug companies – not patients – will benefit primarily.

They will cherry-pick studies from the initiative’s research likeliest to lead to patentable analogs and develop chemotherapeutic agents a hair less toxic and dismal in outcome than the currently available chemotherapy described in the first part of this column.

Since 1971, the NCI has dribbled away $105 billion in its frustrated pursuit of a cancer cure. Much of the money that the Pancreatic Cancer Initiative would funnel through the NCI would drip down the same hole. Still, “the number of new drug treatments is accelerating, along with their prices,” reports a recent article in Managed Care. “Most of the 400 new therapies in the pipeline are expected to cost at least $50,000 a year.”¹²

The Managed Care article doesn’t break the 400 into kind. The article is about cancer. In that context, I’d bet that chemotherapeutic agents make up the majority, and that many of these tweak existing treatments (in many cases of pancreatic cancer, painfully postponing death a few weeks).

The patients? Thanks in part to the well-intentioned but misguided Pancreatic Cancer Initiative, they’ll get more of Big Pharma’s toxic, futile chemotherapy – an ugly shafting!

What do you call the drug industry’s aversion to clinic trials of natural substances that might dramatically extend survival for pancreatic cancer patients? Business as usual?

Per year, pancreatic cancer now kills nearly eight times more Americans than the number of US troops slain in the Iraq war (4417), and roughly 1000 shy of the total number of military casualties (35,2600). The pharmaceutical industry’s neglect of naturally occurring remedies has contributed big time to the carnage from pancreatic cancer. This, I insist, is tantamount to waging war!

Notes

11. Carey J. Drugs: is something rotten? Business Week. April 19, 2004.

12. Butcher L. Insurers and oncologists forge a better cancer drug policy. Manag Care. April 2008.

Marcus A. Cohen’s “baptism” in the whirlpools of medical politics dates to 1984, when he served as government and media liaison for patients under alternative cancer therapy. Subsequently, he has advocated broadening plausible treatment options for patients unresponsive to conventional care. A Townsend Letter columnist since 2004, he has reported and commented on a wide range of health-care topics; he is also the author of a paperback, Lyme Disease Update, published by the Lyme Disease Association in 2004.