FDA Fails to Protect Americans from Dangerous Drugs & Unsafe Food,

[Guest guest]

FDA Fails to Protect Americans from Dangerous Drugs & Unsafe Food,

Watchdog Groups Say

Agency Captured by Industries It Should Be Regulating, According to

Rep. Waxman, Public Citizen, and CSPI

by Public Citizen

www.citizen.org

June 27, 2006

 

http://www.thenhf.com/fda_54.htm

 

 

While the Food and Drug Administration (FDA) is in the self-

congratulatory throes of its 100th anniversary, leading independent

experts on nutrition, food safety, and drug safety say the agency is

failing to protect Americans. While the beleaguered agency

obediently rushes expensive new drug therapies on the market, it

does virtually nothing to help reduce the toll of diet-related and

drug-induced disease in America, according to Public Citizen's

Health Research Group and the Center for Science in the Public

Interest (CSPI).

 

The FDA is scheduled to mark the 100th anniversary of the passage of

the 1906 Pure Food and Drug Act at a June 30 ceremony at the Harvey

Wiley Federal Building in College Park, MD. That building is named

for the reform-minded U.S. Department of Agriculture chemist who

became the first director of the Bureau of Chemistry, which later

became the FDA.

 

" FDA was our country's first consumer protection agency and

Americans have relied on FDA to ensure the safety of their food and

drugs for 100 years, " said Representative Henry A. Waxman. " Under

the Bush Administration, FDA has undermined enforcement and betrayed

its consumer-first legacy. FDA must start enforcing the law and

return to a culture that places public health concerns ahead of

industry profits. "

 

" The FDA's centennial is not so much a time to celebrate, but to

mourn the FDA's gradual descent into irrelevancy, " said CSPI

executive director Michael F. Jacobson. " The great Republican

president Theodore Roosevelt would be sick to his stomach if he

could see how Harvey Wiley's hard-charging tiger of an agency became

such a pliant pussycat. "

 

According to Public Citizen's Health Research Group, some of the

problems and failures at the FDA include:

 

User fees.The FDA's increasing reliance on so-called user fees from

drug and medical device companies encourages the agency to treat

those companies more like fee-paying customers.Instead of being

fully funded by the government, FDA took in $380 million in user

fees in the 2006 fiscal year.Former FDA official Janet Woodcock

stated that the law authorizing such fees creates a " sweatshop

mentality " at the agency's Centers for Drug Evaluation and Research.

 

No Learning from Drug Mistakes.In testimony before the Institute of

Medicine, Public Citizen Health Research Group director Sidney M.

Wolfe, MD, cited 13 instances of drug approvals which either should

not have been approved (including Crestor, Rezulin, and others), or

should have been restricted (Accutane and others) or withdrawn

(Baycol, Seldane, and others) earlier than they were.

 

Tobacco Failures.Five companies illegally market and promote laser

treatment for smoking cessation.Public Citizen last week petitioned

the FDA to crack down on those companies, since the FDA hasn't

approved the device and there's no evidence the treatment

works.Consumers who are convinced to pay up to $399 for laser

treatment may be diverted from real programs that work, such as

nicotine gum or patches—thus fewer smokers will be helped to

quit.And, though it had essentially removed nicotine-containing

beverages from the market in 2002, those drinks have reappeared.Just

this month, NICLite, which the company breathlessly says is

the " World's only Nicotine Replacement Drink!, " and that it

is " classified as a Dietary Supplement by the FDA, " began a

marketing campaign.According to Wolfe, either the company is lying

about the status of these products or the FDA inexplicably reversed

itself and declared that they can legally be sold as dietary

supplements.Either way, it represents a failure of the FDA to

enforce the law of the land.

 

" The FDA's 100th anniversary propaganda campaign hides and denies

the many ways the agency is engaging in an unprecedented assault on

the American public on behalf of its drug, device, food, and other

industry `clients,' " said Wolfe.

 

CSPI says failures on the food side of the FDA include:

 

Obesity. Over the past three decades, rates of obesity have

doubled in young children and adults, and tripled in teenagers. In

2003, then-Commissioner Mark B. McClellan declared FDA's intention

to " confront the obesity epidemic ... to help consumers lead

healthier lives through better nutrition. " Three years later,

according to CSPI, the agency has done essentially nothing. Even

with a food that's a major contributor to obesity—soda—FDA has

declined to place health notices on cans and bottles, require added

sugars to be listed separately on labels, or to require multi-

serving containers to list the number of calories for the whole

container.

 

Heart Disease. One of the most potent promoters of heart disease

is the trans fat in partially hydrogenated oil. Though after a 10-

year slog the FDA finally required trans fat to be listed on

nutrition labels—spurring some manufacturers to abandon the oil—the

FDA has done nothing to get restaurants to disclose or eliminate

it. In 2004 CSPI petitioned the agency to ban partially

hydrogenated oil and, until such a ban, to require disclosure in

restaurants, but the FDA has not acted. The result: thousands of

unnecessary premature deaths every year.

 

High Blood Pressure. Perhaps the single most harmful substance in

the food supply gets zero attention from the FDA—sodium chloride, or

salt. CSPI and the American Medical Association want FDA to revoke

the " Generally Regarded as Safe " status of salt and to treat it as a

food additive, subject to reasonable upper limits in packaged

foods. In 2004, the head of the National Heart, Lung, and Blood

Institute estimated that cutting the sodium content of the food

supply in half would save 150,000 lives per year.

 

Fraudulent Labels. Of 11,000 employees, the FDA tasks a grand

total of four people at headquarters to police food labels. Thus,

supermarket shelves are graced with carrot cake virtually without

carrots, fruitless " fruit snacks " made with high fructose corn

syrup, " whole wheat " products with a lot of white flour, and so on.

CSPI says the most significant FDA labeling initiative in recent

years was an industry-written initiative to let manufacturers place

misleading " qualified health claims " on food labels. FDA's own

research found that the program confused consumers, but the program,

championed by food companies, continues.

 

Food Safety. Faced with the emergence of dangerous chemicals (such

as mercury or acrylamide) in food, the FDA takes years before acting—

and even then, its response is typically tepid. Faced with

outbreaks of bacterial pathogens in food, FDA is similarly

nonresponsive: Salmonella in eggs could be all but eliminated with

finalized on-farm regulations to control the hazard, but those have

been delayed for years. Shellfish contaminated with deadly Vibrio

vulnificus kill 20 or so people every summer, but FDA relies on an

industry-funded partnership with state governments to ensure

shellfish safety.

 

" A scrappy nonprofit like CSPI, with one litigator on staff, forced

labeling changes from major companies like Tropicana, Frito-Lay, and

Pinnacle Foods, " said Jacobson. " Yet when we hand the FDA neatly

wrapped complaints on a silver platter, it just ignores them. "

 

Industry Capture. The FDA often relies on advisory committees made

up of outside experts to offer science-based advice, particularly on

approvals of drugs and medical devices. But those panels often

include—and are sometimes dominated by—scientists or researchers who

have direct financial relationships with the companies whose

products are under scrutiny. In recent years, FDA advisory

committees evaluating antihypertensives, various diabetes drugs, and

the pediatric use of anti-depressants, have all included industry-

funded scientists. On one committee, 10 of 32 panelists

investigating the controversial painkillers known as COX-2

inhibitors, including Vioxx, had ties to the makers of those drugs.

 

CSPI and Public Citizen acknowledge that the FDA has many hard-

working, diligent civil servants who need more resources to do their

jobs effectively. But both the Administration and Congress have

hampered the agency: the Administration, by leaving the agency

rudderless and without a permanent commissioner for roughly 70

percent of the Bush presidency; and Congress, by abdicating much of

its oversight responsibility, and by slashing the headquarters

staffing of the food side of the agency by 11 percent since 1978.

 

Much of the attention the Administration does pay to the agency

comes in the form of unwelcome political interference, the groups

say. The FDA's failure to approve the over-the-counter use of the

contraceptive Plan B is one case where the agency has been accused

of letting politics, rather than science, rule the day. (Susan

Wood, the assistant FDA commissioner for women's health, resigned

over the matter, citing political interference from then-

Commissioner Lester Crawford). In April, an out-of-the-blue FDA

declaration that marijuana has no medical benefit seemed politically

motivated, since it contradicted the findings of a 1999 science

panel that said it did.

 

" As we celebrate the 100th anniversary of this important agency,

there are too many instances in which it appears to be moving back

to the 19th century, when industry did whatever it wanted, " said

Wolfe. " All too often, the FDA seems to forget that it is a

regulatory agency with legally mandated responsibilities to protect

the public. "