paywalled: Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms

Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms

• Accepted March 12, 2012.

Abstract

Nutritional supplementation is now a multibillion-dollar industry, and about half of all US adults take supplements. Supplement use is fueled in part by the belief that nutritional supplements can ward off chronic disease, including cancer, although several expert committees and organizations have concluded that there is little to no scientific evidence that supplements reduce cancer risk. To the contrary, there is now evidence that high doses of some supplements increase cancer risk. Despite this evidence, marketing claims by the supplement industry continue to imply anticancer benefits. Insufficient government regulation of the marketing of dietary supplement products may continue to result in unsound advice to consumers. Both the scientific community and government regulators need to provide clear guidance to the public about the use of dietary supplements to lower cancer risk.

blog: Supplements: Not mystical anticancer magic [Respectful Insolence]

Supplements: Not mystical anticancer magic [Respectful Insolence]:

It's no secret that over the years I've been very critical of a law passed nearly 20 years ago, commonly referred to as the DSHEA of 1994. The abbreviation DSHEA stands for about as Orwellian a name for a law as I can imagine: the Dietary Supplement Health and Education Act. Of course, as we've pointed out time and time again, the DSHEA is not about health, and it's certainly not about education. Indeed, perhaps my favorite description of this law comes from blog bud and all around awesome internist Dr. Peter Lipson, who refers to it as a "travesty of a mockery of a sham." Rather, it's about allowing supplement manufacturers and promoters of so-called "complementary and alternative medicine" (CAM, with or without a preceding "s," depending on your taste) who do not want pesky things like government laws and regulations to interfere with their selling of pseudoscience to market various compounds as "dietary supplements" with near-impunity. As Harriet Hall once put it so accurately, the DSHEA is "a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines."
The DSHEA accomplishes this by making a seemingly reasonable distinction between food and medicine and twisting it in such a way that allows manufacturers to label all sorts of botanicals and various other compounds, many of which have substances in them with pharmacological activity, and sell them as "supplements" without prior approval by the FDA before marketing.

FDA (U.S.) Press Announcements > U.S. Marshals seize ultrasound gel product at a New Jersey company

Press Announcements > U.S. Marshals seize ultrasound gel product at a New Jersey company

 FDA NEWS RELEASE
For Immediate Release: April 18, 2012
Media Inquires: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
U.S. Marshals seize ultrasound gel product at a New Jersey companyProduct samples revealed bacterial contamination

FDA commissioner talks counterfeit drugs (and drug shortages) - CNN.com

FDA commissioner talks counterfeit drugs - CNN.com

FDA: The Quality Problems Causing The Drug Shortage Were Not News To Those Making The Medicines - blog

Dr Len's Cancer Blog:

"Sometimes you have the opportunity to be educated, or to learn a bit more about a topic of importance. Yesterday was one of those opportunities.

Attending a meeting (as an observer) of the National Cancer Institute Director's Consumer Liaison Group on the issue of cancer drug shortages, there were some messages delivered that provided a bit more clarity surrounding a very complex problem. And there were messages delivered that had even me sit up and take notice, and frame the seriousness and depth of the problems that confront patients, their families and those who treat them. The observations were--to say the least--very unsettling.

Try this one, for example:......

open access: Perspective: Assessing Supplement Safety — The FDA's Controversial Proposal — NEJM

"Each year, Americans spend more than $28 billion on supplements assuming that they are both safe and effective. More than 100 million Americans consume vitamins, minerals, herbal ingredients, amino acids, and other naturally occurring products in the form of dietary supplements....."

FDA fines Red Cross $9.6 million - Healthcare business news and research | Modern Healthcare (includes copies of letters FDA and Red Cross)

"....The Red Cross said in a written statement that the fine focuses on one inspection conducted at a donor and client support center in Philadelphia more than a year ago. The not-for-profit also said it is addressing other issues cited by the FDA in the letter.

“We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago and it is important to know we have already taken corrective steps to address those matters and that improvements in operations have been made,” the Red Cross said. “We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report.”

FDA plans survey on direct-to-consumer drug ads -Modern Healthcare

By Melanie Evans

Posted: January 15, 2012 - 1:00 pm ET

The Food and Drug Administration announced plans to survey doctors, nurse practitioners and physician assistants on their awareness and perception of direct-to-consumer prescription drug advertising. The agency is seeking comment on a proposed survey of 2,000 healthcare professionals, according to a notice scheduled to appear in the Federal Register (PDF).

Consumer Updates > FDA Warns About Stem Cell Claims

On this page 

• Regulation of Stem Cells
• Advice for Consumers
• Thwarting a Stem Cell Scheme

Study Calls Approval Process for Medical Devices Flawed - NYTimes.com

FDA Should Not Mandate Comparative-Effectiveness Trials

"Consumer groups are pushing for a new drug approval mandate that would require drug companies to conduct "comparative effectiveness" trials to win Food and Drug Administration (FDA) approval for new medicines.  Proponents of this policy argue that new drugs should have to prove superior to older medicines to gain marketing approval.  These requirements would add a major hurdle to the development and approval of new medicines, adding significant time and cost, says Scott Gottlieb, M.D. and a resident fellow at American Enterprise Institute.

• Consumer groups are pushing to add a step to the FDA drug approval process: "comparator" trials, which test a new drug against the current standard treatment.
• But these trials are already being conducted in important cases; a new FDA approval requirement would slow down the drug approval process elsewhere.
• If such an FDA mandate were adopted, the resulting studies would likely be "noninferiority trials," which are unlikely to conclusively show whether a new medicine is indeed more effective than an existing alternative.
• Achieving the goal consumer groups want -- safer and more cost-effective drugs -- requires innovation in clinical trial design, not a congressional mandate.

The market already demands that a new drug show that it is superior to an older, often cheaper alternative..."

NCI Cancer Bulletin: (U.S.) FDA Approves Test to Identify Candidates for Breast Cancer Drug - Trastuzumab (Herceptin) - HER2 gene

FDA Approves Test to Identify Candidates for Breast Cancer Drug

The Food and Drug Administration (FDA) has approved a genetic test that doctors can use to help identify women with breast cancer who have extra copies of the HER2 gene and therefore may benefit from the drug trastuzumab (Herceptin).
Trastuzumab targets the protein made by the HER2 gene, which is located on chromosome 17. Approximately 25 percent of breast cancers have extra copies of the HER2 gene and produce higher levels of the HER2 protein. These tumors tend to grow faster and are more likely to recur than tumors that don’t overexpress HER2........cont'd

(U.S.) FDA Considers New Rules to Speed Up Confirmatory Trials of Cancer Drugs Granted Accelerated Approval

U.S. FDA Warning Letters > Meditherm Inc. 4/4/11 thermal imaging system

Genetic Tests Sold Direct To Consumers Should Be Supervised By Doctors Says FDA Panel (and the debating issues)

Avastin: Key cancer-fighting (breast) drug on verge of being delisted by FDA - media

(full access $$$) FDA Increases Focus on Postmarketing Studies — J. Natl. Cancer Inst.

Note: reference to Avastin/breast cancer

How the Politics of Breast Cancer Drives Up Costs - blog discussion on breast cancer/Avastin/FDA (U.S.)

Think tank calls for FDA to forgo approval of drugs cleared by European regulator - media article

U.S. FDA Panel Nixes Bevacizumab (Avastin) for Breast Cancer