WIDESPREAD criticism of the Therapeutic Goods Administration has forced the Gillard government to consider overhauling Australia’s drugs regulator because it is failing to adequately police the $2 billion industry in ”miracle” cures and other quasi-health devices.

Claims that therapeutic products can cure everything from AIDS to cancer, guarantee weight loss or improve strength, balance and flexibility are misleading and deceptive and can sometimes lead to lethal results, health experts say.

The Federal Department of Health and Ageing released a consultation paper on the advertising of therapeutic goods in June, saying it was important the public received accurate information about the risks as well as the purported benefits of goods.

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”Concerns have been raised by some opponents of the current advertising framework that the system is not working to protect consumers as well as it might,” the paper said. ”There is a perception that the complaints-handling process is not as transparent as it could be, and that the sanctions available to the [TGA's] complaints resolution panel … do not provide sufficient deterrence.”

Unlike registered pharmaceutical drugs, most herbal and complementary medicines are ”listed” by the TGA, which means their makers pay a fee and are expected to have evidence to back their claims. Listed products are not reviewed by the TGA but are subject to random audits.

Public Health Association of Australia chief executive Michael Moore said there was a perception the TGA did not take consumer protection seriously and its ”light touch” approach was no longer appropriate in an industry in which Australians spent more than $2 billion a year.

Mr Moore said product names such as Fat Magnet, Weight-Loss Accelerate and Slim Me were misleading and deceptive, and provided minimal or no information about known side effects.

Under the Therapeutic Goods Act, there is no provision for the TGA to impose civil penalties for breaches of the advertising code. It can only remove products from the register and refer repeated breaches of the advertising code to the Commonwealth Director of Public Prosecutions.

TGA spokeswoman Kay McNiece said most companies supplying therapeutic goods to the Australian market complied with advertising requirements, ”but it is acknowledged that the complaint-handling arrangements for those companies that do not comply could be improved”.

Ms McNiece said the TGA supported reforms that provided an effective complaint process.

One long-standing critic of the TGA, La Trobe University public health expert Dr Ken Harvey, who complained to the administration’s complaints resolution panel in June about Power Balance wristbands, said the company continued to make millions of dollars from wristband sales while the TGA was yet to finalise its investigation into the product.

Power Balance claims to improve strength, balance and flexibility.

via theage

This report covers the nutritional supplement market, including vitamins, heart health supplements, joint supplements, Omega 3s, eye care supplements, sleep supplements, omega 3s, and other ingredients.

Rockville, MD, September 02, 2010 –(PR.com)– MarketResearch.com has announced the addition of Packaged Facts’ new report “Nutritional Supplements in the U.S., 4th Edition” to their collection of reports. For more information, visit:

Via: pr.com

An ancient herbal remedy that constitutes the active ingredient in a modern diabetes drug may soon play a new role in combating cancer, two studies show. The findings, published in the September Cancer Prevention Research, support earlier population studies suggesting that diabetes patients receiving the drug, called metformin, are less prone to develop cancer.

Metformin helps to stabilize blood sugar by decreasing the liver’s glucose output and increasing the sugar’s use by muscle tissue. Scott Lippman, an oncologist at the University of Texas M.D. Anderson Cancer Center in Houston, estimates that more than 40 million metformin prescriptions have been filled in the United States. “It’s been around for a while,” he says.

In one of the new studies, Atsushi Nakajima of Yokohama City University School of Medicine in Japan and colleagues measured how metformin affected the development of tiny lesions in the colon. These lesions, called aberrant crypt foci, are precursors of polyps, which themselves can be the forerunners of colon cancer. Using colonoscopy data, the scientists identified 26 patients who had had polyps removed during a colonoscopy. The scientists randomly assigned some to get metformin and others to get a placebo.

After a month, the nine patients getting metformin who returned for a follow-up colonoscopy had substantially fewer lesions in the bowel than they had when they started on the drug, whereas 14 patients receiving a placebo had no change.

In the other study, a U.S. team induced lung cancer in mice with injections of a tobacco-based carcinogen. One week after the last shot, some mice were given either a low or a medium dose of metformin in their drinking water for 13 weeks. The tumor burden in these mice declined by 39 percent and 53 percent over that time, depending on the dose they received.

When the researchers delivered an even higher dose of metformin, this time by injection, the tumor burden shrank by 72 percent, says study coauthor Phillip Dennis of the National Cancer Institute in Bethesda, Md.

Metformin is a drug in the biguanide class. The drug is derived from the French lilac plant (Galega officinalis), also known as goat’s rue or Italian fitch. In medieval Europe the plant was used to treat frequent urination, says Michael Pollak, an oncologist at McGill University in Montreal. Modern-era scientists took an interest in the biguanides in the 1920s, and found they could use the compounds to lower blood sugar in rabbits.

Metformin was derived from the plant in the 1950s in France and was approved by the U.S. Food and Drug Administration in 1994 as Glucophage (literally “glucose eater”). The drug has since become generically available under the name metformin.

A history of use with few side effects may help metformin as it faces regulatory hurdles to become a cancer fighter, Lippman says. “A lot is known about the safety of this,” he says. “From a research perspective, this is extremely exciting. The next step will be to take it to a clinical trial.”

Less clear is the mechanism by which metformin seems to inhibit cancer, and which cancers would be most susceptible if it succeeds. Earlier, Pollak’s team had shown that metformin could inhibit growth of breast cancer cells in a lab dish by awakening an enzyme called AMPK. The group further found that revved-up AMPK inhibits the activity of mTOR — a protein involved in cell growth and proliferation. That could explain part of metformin’s apparent anticancer effect, Pollak says. But, he adds, “We are not yet in a position where we understand perfectly how it works.”

The cancer connection didn’t come out of the blue. In recent years, several population studies have noted that type 2 diabetes patients on metformin seem less likely than others to develop cancer.

Via: U.S.News

The decision by scientists from the Food and Drug Administration (FDA) paves the way for the first GM animal to be sold as food.

The fish, called AquAdvantage salmon, could be on American plates within two to three years, raising fears among environmental and food-safety campaigners.

However, shares in Aqua Bounty Technologies Inc, the company which created the fish, leapt by 26 per cent on the London Stock Exchange on Friday, indicating that analysts see GM as the future of fish production.

The FDA is to hold a public meeting later this month on the DNA-altered fish, which could also open the door to producing genetically engineered trout and tilapia.

In a report prior to the talks, FDA experts said the altered salmon were “as safe to eat as food from other Atlantic salmon” and that they saw “no biologically relevant differences” in vitamins, minerals or fatty acids.

The fish are “highly unlikely” to cause significant harm to the environment, the report added.

However, critics of the technology have voiced concerns that it could lead to the creation of mutant misshapen fish and could harm wild fish populations if they escape.

Research on GM trout in Canada found that while they grew faster and were much bigger, a number developed misshapen heads and bloated bodies.

A coalition of 31 US consumer, animal welfare, environmental and fisheries groups is opposing approval of the salmon for food production.

They claim tests used to show the safety of the GM salmon were based on very small samples and point out that some of the fish had higher levels of growth hormone in their bloodstream, which is claimed to create a cancer risk.

While the GM fish are supposed to be sterile, critics said up to 5 per cent might be able to conceive and breed if they got into the wild.

“The FDA is basically just assuming these fish are OK to eat,” said Jaydee Hanson, a policy analyst for food campaigners the Center for Food Safety.

Pete Riley, director of campaign group GM Freeze, added: “We are extremely concerned about the potential for these fish to escape.”

However, the FDA said the chances of the salmon escaping from production or growing facilities and reproducing are “extremely small” due to the Aqua Bounty’s containment measures.

Aqua Bounty claims the technology could boost the US fish sector and reduce pressure on the environment from overfishing.

The firm’s chief executive Ronald Stotish added that the salmon taste “great”.

The salmon reach a market weight of around 6.6lbs in 16-18 months instead of the three years for farmed fish.

The growth is speeded up by the insertion of two genes, one linked to the production of growth hormone and a second to ensure growth continues even in very cold temperatures.

The technology allows fish farmers to produce many more salmon at much lower cost, so boosting output and profits.

At the three-day meeting starting on September 19, the FDA will seek input from a panel of outside advisers before making a final decision on whether to allow production of the salmon.

The FDA will also listen to views from the public on whether the bio-engineered salmon should be labelled differently to natural fish.

Via: Telegraph

Transcript

TONY JONES, PRESENTER: The panel that handles complaints against misleading advertisements for medical products and services is being criticized tonight for failing consumers.

Lateline can reveal that last year a third of the companies were found to have breached the Therapeutic Goods Administration’s rules on advertising and they failed to publish retractions and withdraw misleading information.

Steve Cannane has this report.

STEVE CANNANE, REPORTER: Fran Sheffield runs a homeopathic practice on the Central Coast of NSW and she has a controversial position on vaccination.

FRAN SHEFFIELD, HOMEOPATH: The research we have, and it is limited research, shows that the rate of protection that a homeopathic immunising agent provides seems to be similar and in some instances better than what the orthodox vaccines offer. In terms of safety they are way, way better than vaccines.

STEVE CANNANE: On her website Homeopathy Plus! Fran Sheffield claims homeopathic immunisation is effective against polio, meningococcal, cholera, whooping cough and other serious diseases.

DR KEN HARVEY, LA TROBE UNIVERSITY: There is no good scientific evidence to my knowledge that homeopathic immunisation works. There is references in obscure journals that you cannot find and there is anecdotal reports by homeopaths that it works, but it’s not in the mainstream scientific literature.

STEVE CANNANE: Dr Ken Harvey made a complaint against Homeopathy Plus! to the Complaints Resolution Panel. They review potential breaches of the advertising code in relation to therapeutic goods.

DR KEN HARVEY: The complaint resolution panel agreed there was a breach of at least nine sections of the Code and one sections of the Therapeutic Goods Act, including very serious sections such as promoting to the general public the treatment of serious diseases for which there was no evidence of efficacy.

STEVE CANNANE: The Complaints Resolution Panel asked Fran Sheffield to remove the claims about immunisation, and to publish a retraction which included the statement:

(Excerpt from Complaints Resolution Panel request)
VOICEOVER: We did not provide adequate evidence to support the claims made in the advertisement, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code.

STEVE CANNANE: But Fran Sheffield has refused to publish the retraction. She says she wasn’t advertising – merely providing information, and sufficient evidence to back up claims about homeopathic immunisation.

FRAN SHEFFIELD: I’m providing the evidence on the website. I think you’ve had a chance to go and read the historic usage and our recent trials on it.

STEVE CANNANE: But they say that evidence doesn’t stack up, it’s not good enough, it’s not strong enough.

FRAN SHEFFIELD: Well, obviously I’m disagreeing with them, and that’s why the retraction hasn’t gone up.

STEVE CANNANE: Fran Sheffield is not alone. In 2009 a third of those found to breach the code failed to comply with the panel’s recommendations.

If a failure to comply is reported to the panel, it goes back to the Therapeutic Goods Administration or TGA. But what happens next is a mystery. The TGA does not publicise what action it takes.

DR KEN HARVEY: It’s unclear why the Therapeutic Goods Administration is not transparent at all. And certainly it’s annoying to people who put in complaints. You feel that it’s hardly worthwhile and it certainly encourages the sponsors to keep on doing bad things.

STEVE CANNANE: No-one from the TGA was available to talk to Lateline, but in a statement said.

(Excerpt from TGA statement)
VOICEOVER: The TGA is actively working to improve the transparency of its regulatory processes, and will be publishing its actions relating to handling of complaints referred from the CRP.”

STEVE CANNANE: The TGA also confirmed that no legal action has been taken over non-compliance.

But reform could come soon.

MARK BUTLER, PARLIAMENTARY SECRETARY FOR HEALTH: The Australian community is entitled to expect that an advertising complaints system will be timely, transparent and have teeth and I’m not sure we have that at the moment.

We’re now in a position I hope in the near future – as I have indicated to those players – of publishing options for reform that we think will address all of those issues in one fell swoop.

STEVE CANNANE: But in the meantime, practitioners are able to continue to make questionable claims about various remedies without fear of sanctions.

A recent Homeopathy Plus! email alert was headed “Homeopathy as Good as Chemotherapy for breast cancer.”

Steve Cannane, Lateline.

Via abc

THE Food and Drug Administration (FDA) is set to screen the advertisements of food or dietary supplements to prevent product manufacturers from making false claims about their purported health benefits or efficacy in curing diseases before they hit the press or go on air.

In a news conference during the Philippine Heart Association’s (PHA) 2nd Summit on Supplements at the Bayview Park Hotel in Manila on Friday, Director Nazarita Tacurong said the agency is now in the process of creating a technical working group (TWG) representing the various stakeholders in the health sector for the purpose of setting up guidelines for the screening of materials that regularly bear product labels that are often confused with the disclaimer “No approved therapeutic claims.”

The move was in response to clamor by the PHA, an organization of cardiovascular specialists and lay members, which recently made a stand against the proliferation of questionable food and dietary supplements and their false advertising in the media.

Supplements, the PHA said, are not drugs that are scientifically proven and tested to prevent, if not cure, disease.

Members of the organization expressed concern over the proliferation of various food or dietary supplements, which commercial advertisements pass on to consumers as replacements to medicines. Most of such commercial advertisements often have prominent personalities, including physicians, actors and actresses, beauty queens and singers as endorsers.

Catchy slogans, such as “helps lower blood cholesterol” or “fights diabetes” are just a few of the misleading or false claims used in print. On radio, as well as on television, such advertisements using those slogans are also being aired.

During the news conference, Tacurong extended an invitation to the PHA to sit as a member of the TWG that will conduct the screening.

Health Secretary Esperanza Cabral said the use of these health claims is “patently illegal” as the manufacturers misrepresent their products.

“Supplements are not drugs. They are only meant to supplement inadequacy in the diet,” she said.

Tacurong said screening the commercial advertisements of food or dietary supplement will prevent the malpractice of some manufacturers of making false claims about their products, such as its health benefits that help cure certain conditions, like drugs.

The FDA has vowed to be stricter in the registration and labeling of food supplements and has decided to replace the disclaimer “No approved therapeutic claims” with a Tagalog phrase, reminding the public that the product is not a drug and neither can it cure diseases.

Via Businessmirror

Dietary supplements will now be regulated at a higher level.

The New Zealand Food Safety Authority will still have an administrative role but will now sit under the Ministry of Health.

Natural Products New Zealand executive director Michelle Palmer says supplemented food will no longer fall in no man’s land.

She says most of the products on the market are already being manufactured to high global standards, so once a different New Zealand system comes into place it’ll put us on an even playing field.

The change means dietary supplements with low levels of Folic acid may be coming off the shelves.

Palmer says changes already announced will see the maximum level of Folic Acid increase.

She says companies will be taking products with 300 micrograms off the shelves and replacing them with ones with 500 micrograms.

Proposed new measures that aim to make a distinction between drugs and food products that look like drugs still leave a “grey area”, according to makers and retailers of complementary medicines.

The Therapeutic Goods Administration (TGA), together with Food Standards Australia and New Zealand, is currently undertaking a legislative review which aims to stamp out confusion caused by certain food products being sold in tablet, pill or capsule form while not having any therapeutic value.

The so-called Section 7 Declaration to the Therapeutic Goods Act will only allow goods sold in this form to be medicinal in nature.

However, in a submission to the TGA on the proposed measure released last week, the Complementary Healthcare Council of Australia (CHC) claimed the amendment would not address the problem.

“Under the proposal, products could still be sold on the market in a powder or liquid form therefore any concerns around consumer public health and safety would not necessarily be addressed,” the CHC submission stated.

The council claimed basing the restrictions around “dosing” criteria was “inappropriate” and should also take in labelling and advertising, calling for more enhanced regulation of the food industry.

“The CHC also points out that this proposal will have a significant impact financially on many companies within the complementary health care industry, which will potentially reduce consumer.

Via pharmacynews

The Therapeutic Goods Administration (TGA) has released a statement saying there have been no restrictions placed on a popular weight loss drug in Australia.

The statement follows media reports which incorrectly said the TGA had warned doctors not to prescribe the drug because of safety concerns.

The TGA says there are no restrictions on prescribing the drug and instead it had sent letters to doctors advising them of additional information available about the drug.

Jennifer Stevenson from Abbott, the company that manufactures Reductil, has reinforced TGA’s statement.

In 2009 a clinical trial found some patients using Reductil showed higher rates of heart attack and stroke.

Following the trial, Ms Stevenson says Abbott, in consultation with the TGA, distributed information to doctors.

“The letter sent to GPs made them aware of added information on the SCOUT study and reinforced already-existing information in the product information stating that Reductil was not intended or recommended for use in patients with cardiovascular disease and inadequately controlled hypertension,” she said.

“As stated in the TGA statement online, prescribing of Reductil has not been restricted and it has not been withdrawn from the market.”

Via ABC

The Office of Complementary Medicines (OCM) has announced that an additional condition of listing will be imposed on any medicines containing Ginkgo biloba leaf extract as an active ingredient.

Manufacturers will be given a three month transitional period, whereby any batches of existing medicines manufactured on or after 18 January 2010 are required to comply. Medicines listed after 19 October 2009 will be subject to this condition from the date of listing

The TGA has recently conducted testing on twenty-two (22) batches of medicines, covering twenty (20) products, and a number of associated Ginkgo extract raw materials. The testing focused on determining the quality of the Ginkgo extract used in the formulation of the medicines.