Reading between the lines:

[Guest guest]

http://www.naturalhealthvillage.com/newsletter/1nov02/cancer.htm

 

 

 

Reading between the lines:

The FDA and nutritional supplement regulation,

And the latest cancer statistics

 

 

Reporting and Commentary © By Peter Barry Chowka

 

(November 1, 2002) - Two decades ago, I wrote a regular column titled " Between

the Lines " for a national magazine. Each month I examined and deconstructed an

issue relating to health, alternative medicine, politics, the environment, the

media, and so on. The theme was to select an issue that was being covered - or

glossed over - by the mainstream media and to reexamine it by carefully reading

between the lines.

 

During the past month, among the numerous stories that deserve a closer look,

two stand out as between the lines-type material: potential changes in how the

Food and Drug Administration (FDA) regulates products including nutritional

supplements and conflicting reports about how we are doing in the war against

cancer.

 

 

The FDA and the First Amendment

 

Proponents and consumers of alternative therapies have long identified the FDA

as an impediment to medical freedom of choice. The agency regulates products and

services that represent twenty percent of every dollar spent in the U.S.

including almost everything relating to health care. Its staff of 10,000

oversees new drug approval, nutritional supplements, and medical therapies -

both conventional and alternative - and wields draconian powers that have been

granted to it by the Congress or that over time the agency just assumed for

itself.

 

In a decision handed down on April 29, 2002, Thompson v. Western States Medical

Center, the U.S. Supreme Court ruled against the FDA for prohibiting compounding

pharmacies from advertising or promoting their products. The decision included a

strong rebuke. " We have previously rejected the notion, " the Court wrote, " that

the government has an interest in preventing the dissemination of truthful

commercial information in order to prevent members of the public from making bad

decisions with the information. "

 

Two earlier federal appellate court decisions, in 1998 and 1999, ruled against

the FDA on similar grounds. The 1999 case, [Durk] Pearson v. Shalala, involved

the FDA's refusal to allow dietary supplement makers to place four health claims

on product labels. The FDA had maintained that the claims failed its test of

" significant scientific agreement. " But the United States Court of Appeals for

the District of Columbia Circuit ruled that the First Amendment requires a

" preference for disclosure over outright suppression. "

 

Faced with these kinds of significant court rulings challenging its policies on

fundamental constitutional grounds, the FDA announced on May 16 that it was

giving " interested parties " four months to comment on " First Amendment Issues. "

The comment period ended on September 13, and on October 28 the period for the

FDA accepting responses to the comments ended.

 

The outside input was the first step in the FDA's process of deciding in the

months ahead what changes if any to make in its regulations vis-à-vis First

Amendment issues involving things like claims of health benefits for foods and

nutritional supplements. In the meantime, Mark B. McClellan, MD, PhD, 39, was

nominated by President George W. Bush to head the agency after two years of its

being without a commissioner. McLellan is Professor, Department of Economics,

and Director, Program on Medical Outcomes Research, at Stanford University. The

U.S Senate voted to confirm McClellan on October 18.

 

 

The Critics Respond

 

On October 28, Cybercast News Service wrote that Bruce Silverglade, of the

Center for Science in the Public Interest, " is 'very concerned' that the FDA's

decision to re-think its regulatory zeal is politically motivated. . .It's a

'license to practice quackery,' Silverglade warned. " (The FDA currently has no

comment on any possible changes.)

 

CSPI is a not-for-profit, public advocacy group often referred to as the " food

police " for its media savvy targeting of things like fat in fast food meals. The

organization frequently criticizes nutritional supplements, as well, and is in

favor of strong government regulations. There are signs that critics, like CSPI,

are succeeding in a positioning strategy to get the media to look askance at any

potential FDA First Amendment reform. (CSPI wrote the book at getting the media

to highlight things like " the dangers of nutritional supplements " and its other

pet themes from its own point of view.)

 

An example occurred on October 29 in a heavily promoted feature segment on the

CBS Evening News, its nightly " Eye on America " report. That evening, the report

was titled " The Dangers of Health Supplements. "

 

" From energy builders to mood escalators to libido enhancers -- up to half of

Americans take some form of dietary supplement, " according to the introduction.

" And as CBS News Correspondent Sharyl Attkisson reports, many believe that 'all

natural' means 'always safe.' "

 

Atkisson's report was a classic hit piece that included mention of a deceased

victim who, according to Atkisson, had " just gotten a clean bill of health from

doctors. But hoping to ward off winter colds, she tried a natural supplement

touted as an amazing immune booster -- Yew Tree Tea. She drank a cup every day

for two weeks and then had a seizure. Four weeks later, she was dead. "

 

In the three minute-long piece, no definitive link between the woman's death and

the Yew Tree Tea was established - other than a passing mention that the woman's

" family and doctors suspected the Yew Tree, which is long known in the medical

community, as it turns out, for its poisonous potential. "

 

What were the underlying problems, according to CBS? The fact that " warnings

aren't required for any dietary supplements. They don't have to be proven safe

or effective. And there are no purity standards. "

 

The only expert interviewed was Raymond L. Woosley, MD, PhD, a pharmacologist

and academician who was recently appointed Vice President for the University of

Arizona Health Sciences Center (AHSC) and Dean of the UA College of Medicine.

According to the CBS transcript of the report, " it's nearly impossible to yank

bad supplements off the market, says pharmacologist and FDA consultant Dr.

Raymond Woosle [sic]. "

 

An alert observer of this issue - possible FDA reform of its own policies -

should be vigilant in the weeks and months ahead as we can likely expect an

increase in reporting of this kind.

 

 

The War on Cancer: Are We Winning or Losing?

 

This coming December, it will be 31 years since the War on Cancer, the result of

bipartisan legislation that overwhelmingly passed the U.S. Congress, was signed

into law by President Richard Nixon. Since then, approximately $2 trillion has

been spent on conventional cancer treatment and research. One would think that,

after almost a third of a century and such an astronomical investment, it would

be easy to determine if significant progress has been made in combating the

nation's number two cause of death.

 

Cancer statistics, however, are a highly specialized, arcane, obscure, and

surprisingly politicized area where clear answers are impossible to come by.

 

Over the decades, the government and the private sector - which together

comprise an enormous cancer Establishment that includes federal agencies,

private charities, academia, and the for-profit research sector - have worked

closely to put a positive face on cancer survival rates. It is in the interest

of all of the players to do so. From time to time, a small number of

professional observers have challenged the party line. One of the most

noteworthy is John Bailar, author of several critical articles in the New

England Journal of Medicine, including one (May 8, 1986) titled " Progress

Against Cancer? " Other critics include Manu Kothari, MD and Lopa Mehta, MD,

authors of Cancer: Myths and Realities of Cause and Cure (Marion Boyars, London,

1979) and The Other Face of Cancer.

 

In October, two studies were published which suggest that the ongoing

contradictions continue. One study appeared in the British medical journal, The

Lancet Volume 360, Number 9340 12 October 2002 ( " Long-term survival rates of

cancer patients achieved by the end of the 20th century: a period analysis " ). As

the New York Times reported about it on October 11, " A study of 24 million

Americans in whom cancer was diagnosed from 1978 through 1998. . .argues that

the traditional cohort method used to estimate survival rates does not consider

the leaps made in cancer diagnosis and treatment in recent years. Using a

different method called period analysis, the epidemiology study concluded that

all cancer patients whose tumors are diagnosed today have a 51 percent chance of

living 20 years. The cohort method would give them only a 40 percent chance. "

 

Changing definitions is a strategy that has been used previously, as some

critics contend, to massage cancer statistics in order to make them appear more

positive. As an old adage holds, " figures don't lie, but liars can figure. "

 

Another study, however, " Impact of Reporting Delay and Reporting Error on Cancer

Incidence Rates and Trends, " published the following week in the Journal of the

National Cancer Institute (JNCI) (Clegg et al., pp. 1537-1545 JNCI Vol. 94, No.

20, 1537-1545, October 16, 2002), comes to very different conclusions than the

one in The Lancet. As the Wall Street Journal reported about the JNCI study on

October 15, " America isn't winning the war on cancer after all. Contrary to

optimistic reports from the National Cancer Institute showing the incidence of

several devastating cancers has leveled off or even declined in recent years,

rates for at least some of those cancers has been rising, according to a new

analysis by NCI scientists. Previous indications of a decline reflected

significant delays in reporting cancer cases, the researchers report Wednesday

in the Journal of the National Cancer Institute. More accurate information about

cancer rates presents a grimmer picture.

 

" 'Maybe we were a little too eager to declare the effectiveness of our

intervention and prevention programs,' " says Brenda Edwards, who is associate

director for the surveillance research program at NCI, of Bethesda, Md., but

wasn't among the authors of the new study.

 

" The revised estimates present a dispiriting picture of the nation's progress in

preventing cancer. "

 

The study itself concludes: " Reporting-adjusted cancer incidence rates are

valuable in precisely determining current cancer incidence rates and trends and

in monitoring the timeliness of data collection. Ignoring reporting delay and

reporting error may produce downwardly biased cancer incidence trends,

particularly in the most recent diagnosis years. "

 

An obvious question that might be asked - but rarely is - is, If there is

progress and success in treating cancer, why do more and more people with cancer

opt for alternative treatments?

 

The most recent study to confirm the popularity of alternative cancer treatments

was published on September 4. According to a news release issued by the Fred

Hutchinson Cancer Center in Seattle, " More than 70 percent of adult cancer

patients in western Washington use alternative therapies and almost all report

substantial improvements in well-being as a result of using alternative

medicine, according to a Fred Hutchinson Cancer Research Center survey. The

results of this survey - the first population-based study of its kind to look at

predictors, motivators and costs of different types of alternative-medicine use

in adults with cancer - appear today in The Journal of Alternative and

Complementary Medicine: Research on Paradigm, Practice and Policy. "

 

On September 5, the Seattle Post-Intelligencer quoted Ruth Patterson, PhD, RD,

an epidemiologist at the Hutchinson Center and lead author of the study: " 'The

conclusion is the use [of alternative therapies] is very high and that anybody

treating cancer should assume their patients are also using alternative

medicine. "

 

 

 

 

 

 

 

 

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