Mexico enacts rules against 'miracle cure' ads

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MEXICO CITY (AP) — Mexico enacted tough new rules Thursday to ban advertising of "miracle cures" for weight loss, sagging body parts and more serious illnesses like prostate ailments, chronic fatigue and even cancer.

Mexico has a long history of faith healers and home remedies, but the problem has come to a head in the last few years with a constant stream of ads on television for more "scientific" sounding creams that supposedly lift or enlarge breast and buttocks, magnets that help users lose weight, or pills and powders that cure gastric problems or diabetes.

In a country with levels of diabetes and obesity among the highest in the world, the combination of a sick population and fake cures can be deadly.

"This is a fraud," said regulator Mikel Arriola, whose Federal Commission for Protection against Health Risks is the agency in charge of regulating pharmaceuticals in Mexico. "It is a very serious public health problem, because people take these things instead of going to the doctor ... they lose time in getting treatment or getting cured."

Under the new rules, which take effect in 30 days, authorities can order media outlets to remove such advertising within 24 hours, and it steeply raises fines that can be levied on manufacturers and distributors that advertise the products.

The rules require that any product making a therapeutic claim will first have to prove it is listed in Mexico's pharmaceutical register. The register requires scientific proof of effectiveness and a scientific description of how the medicine or medical apparatus achieves its claimed effects.

That is probably not going to be possible for products like "Acu-Mag." Its advertising purports that when the tiny pad with eight bumps is placed in the outer ear and massaged a few minutes each day, it helps customers lose weight through what ads call "auricular therapy" — an alternative medicine supposedly derived from acupuncture.

According to the manufacturer's published claims, the pad "helps you lose weight ten times faster than any other (method) ... eliminates anxiety, burns the fat on your body, improves digestion."

Arriola said the ad should no longer be able to air because it makes claims of medical treatment.

Nor should ads for an herbal supplement called Prostaliv, which promises to reduce prostate enlargement and urinary problems in two to four weeks. Similar claims are made for Mulunggay, another herbal extract that is touted as being able to "combat 300 diseases" and control diabetes.

Anyone with real health issues who relies on such non-working treatments could wind up getting worse, "and that represents a cost for the government," Arriola said, because public hospitals have to treat sicker people.

But he added that supposed "miracle cures" are seldom outright dangerous. "Mainly what these companies are doing is selling a placebo, and spending a lot of money on advertising to promote it."

Executives at two of Mexico's largest vendors of such cure-alls could not be reached for comment. An employee at one of the companies appeared not to have heard of the new rules, and the other firm had an incorrect phone number listed with the Mexican stock exchange.

Companies do appear to have been taking note of the government's plan.

Some already run small-print slogans with their ads stating that "this is not a medicine." Arriola called that "an evasive maneuver" and said such ads won't be exempt from the new rules if they still make medical claims.

And the marketing companies also appear to be moving into less-regulated areas, such as corsets in various forms that are "guaranteed" to give wearers a perfect figure instantly. Those ads could continue to run, in theory, as long as they don't make claims that the product is doing anything but hiding fat.

President Felipe Calderon announced the new rules as a sort of crusade against the power of deceitful advertising.

"Every day, at every hour, on radio, television and the Internet, in print media, the public is literally being bombarded with a huge quantity of ads for all sorts of products that supposedly have curative powers," Calderon said. "They put the health and economic well-being of the population at risk."

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Texas delays action on stem cell therapy rules

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AUSTIN, Texas (AP) — The Texas State Medical Board voted Friday to delay until next year final approval of new stem cell therapy rules that could restrict — or even block — procedures such as the one Gov. Rick Perry recently underwent on his aching back.

Its 19 members, including a dozen physicians, voiced support for greater oversight but opted to tweak the proposed rules and take them up again at their next meeting in February. If the reworked rules are satisfactory, formal approval could come as early as April.

The Food and Drug Administration hasn't approved using adult stem cells to help people heal from surgery, but experimentation is common. Some scientists tout the possible benefits, including treatment for heart disease, diabetes, and some cancers. Others argue adult stem cell experimentation actually increases the risk of cancer and can cause blood clots.

Perry, 61, a Republican presidential candidate, had stem cells taken from fat in his own body that were then grown in a lab. They were injected into his back and his bloodstream during an operation in July to fuse part of his spine.

The proposed rules would require an independent panel to conduct a comprehensive safety review of any procedure involving stem cells before it is carried out. Without that review, procedures such as the one Perry underwent would not be allowed.

Some noted that new stem cell regulations could have unintended consequences, however, such as limiting the ability of tissue banks to collect genetic material for transplants. As a result, the board asked its staff to modify the rules.

"My sense is, this 80, 85 percent ready for primetime and they're just adding some material," said Leigh Hopper, a board spokeswoman.

Perry, who appoints the board, sent it a letter in July saying he appreciated the responsibility to protect patients. But he also urged members to "recognize the sound science and good work that is already being done, and will continue to be done in the future, in this field."

"We need to ensure that physicians in this state can continue to pursue new technologies and treatments that will benefit all Texans," Perry wrote. "Texas is a leader in innovation in many fields. It is critical that we continue to foster an environment that encourages technological advancement in the health care arena."

Following his surgery, Perry has worn a back brace but maintained his hectic campaign schedule — though he has begun wearing orthopedic shoes, foregoing his trademark cowboy boots. Adult stem cell therapy is different from using embryonic cells, a controversial technology that the governor opposes.

Lucy Nashed, a spokeswoman for the governor, said Friday that he "expects the Texas Medical Board to review all the facts and make the appropriate decision regarding the use of this promising technology in Texas."

At least 10 states — including California, Illinois and New York — have enacted rules governing stem cell research, according to the Interstate Alliance on Stem Cell Research.

The impetus for Texas' proposed rules did not grow out of Perry's procedure but did involve the physician who performed it, Dr. Stanley Jones. The Houston-based orthopedist, who is Perry's doctor and friend, touted the benefits of stem cell therapies at the medical board's June meeting. He said many Americans pay thousands of dollars to undergo treatment abroad and that it is a shame that Texans can't access the treatment in their home state.

Perry also helped push an amendment to a larger health care bill through the Texas Legislature in June creating a state bank to store and cultivate adult stem cells for treatment purposes.

NBC reported in September that the first bank approved by the state — Celltex Therapeutics Corp. of Houston — is co-owned by Jones and David G. Eller, the former chairman of the board of Texas A&M University, and a top Perry donor.

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EU rules 'put patients at risk'

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19 October 2011 Last updated at 00:12 GMT By Nick Triggle Health correspondent, BBC News The European Commission is already reviewing the regulations Patients are being put at "unacceptable risk" because of EU rules governing the movement of health workers, peers say.

A House of Lords committee said the current balance between free movement of labour and safety had been skewed.

It said regulatory bodies should be able to test the language skills of all doctors, nurses, midwives, dentists and pharmacists wanting to work in the UK.

They also called for better sharing of data about the disciplinary history of staff seeking to work abroad.

The ability of health professionals - and in particular doctors - to work across the European Economic Area (EEA) has been a controversial issue in the UK in recent years.

It hit the headlines after the case of Daniel Ubani, a German locum doctor, who gave 70-year-old David Gray a fatal painkiller overdose on his first and only shift in Britain in February 2008.

Investigations found Dr Ubani had been rejected for work in Leeds because of his poor English skills, but had been allowed on an approved list by another trust.

A UK coroner recorded a verdict of unlawful killing and accused Dr Ubani of gross negligence.

Frustration

The GP was given a suspended sentence in Germany for death by negligence but has still been able to work there.

Since the case, ministers and the General Medical Council, which regulates doctors in the UK, have expressed frustration at the current situation.

The European Commission has already announced a review of the rules with firm proposals expected by the end of the year.

It is likely they will recommend a tightening of the rules, although it could take another year for the changes to be made.

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The committee is right - the safety of patients should always come first. Like us, they believe that current EU rules are putting patients at risk and urgent changes are needed”

End Quote Niall Dickson General Medical Council In the meantime ministers in England have placed a duty on local trusts to vet the language skills of doctors - they have had the power to do this but it was inconsistently carried out - as well as giving the GMC powers to investigate language competency where concerns are raised.

But the conclusions reached by the House of Lords social policies and consumer protection committee call for a much more radical overhaul.

The peers have suggested that an alert system be set up to ensure that information about disciplinary procedures are shared between regulators from different countries.

They also want regulators to be given the power to vet language skills - as they have for doctors from outside the EEA - while the qualifications and skills recognised as being appropriate need to be updated to ensure staff are trained to the appropriate standards.

Committee chairwoman Baroness Young said: "It is absolutely unacceptable that current EU rules put patients at risk. The EU is failing our patients.

"We recognise that mobility can bring significant benefits, but we have to make sure that this is not at the expense of patients' health, care and confidence."

The report has been warmly welcomed by regulators, ministers and campaigners in the UK.

Niall Dickson, chief executive of the General Medical Council, said: 'The committee is right - the safety of patients should always come first. Like us, they believe that current EU rules are putting patients at risk and urgent changes are needed."

Health Secretary Andrew Lansley: 'We are able to apply language tests to European doctors for employment purposes on the NHS'

And Peter Walsh, chief executive of Action Against Medical Accidents, described the current arrangements as "crazy".

"Patient safety must be put before political correctness."

Health Secretary Andrew Lansley added: "It's completely unacceptable for doctors to work in the NHS if they can't speak English properly."

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EPA Postpones Power Plant Emissions Rules

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The Environmental Protection Agency has decided to delay new rules that would limit emissions of climate-warming gases from power plants. It's the second time this month the EPA has either withdrawn or postponed new pollution rules that industry didn't like.

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STEVE INSKEEP, host: News about the Arctic ice coincides with this news from the United States: The Environmental Protection Agency has decided to postpone new rules that would limit emissions of climate-warming gases from power plants. This is the second time this month the EPA has either withdrawn or postponed new pollution rules that industry did not like. Here's NPR's Christopher Joyce.

CHRISTOPHER JOYCE: The EPA got itself into hot water with environmental groups early this month when it scrapped new rules to limit industrial emissions of ozone. Ozone can cause health problems. Now, the agency says it cannot make a September 30th deadline for new rules that would limit greenhouse gases that warm the climate. The U.S. Supreme Court says EPA has the authority to do that, but industry and many members of Congress have fought the plan. Some environmental groups say both decisions look as if President Obama has caved in to opponents who say the rules would hurt the economy. Another view, however, is that controlling greenhouse gases is very complex. John Coequyt is with the Sierra Club.

JOHN COEQUYT: The EPA is in the process of setting the first-ever real regulations for global warming and pollutions from power plants. And the fact that that's taking longer than expected isn't that surprising.

JOYCE: Groups that suing EPA to get on with the rule making will meet with the agency to set a new deadline. Christopher Joyce, NPR News.

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