The Age (Australia), August 8, 2006

Bayer´s Levitra: Impotence drug push falls flat

IMPOTENCE pill manufacturer Bayer Healthcare has been reprimanded for a money-back guarantee program offered for its drug Levitra.
The program, which returned money to men if the erectile dysfunction drug failed, will be ditched after a committee found it breached the drug industry's code of conduct. Money-back guarantees were inappropriate for prescription medicines, said the committee, which is set up by industry body Medicines Australia but is designed to be independent.
But Bayer Healthcare, a repeat offender under the Medicines Australia ethics code, escaped a fine (which can be as high as $200,000). Instead, the committee ordered the company to stop the guarantee, issue a letter to GPs and publish a corrective advertisement in journals where the promotion was offered. The Australian Consumers Association said Bayer should have been fined and the committee was too slow to act.
"This proves the code of conduct is ineffective in monitoring pharmaceutical advertising," said Viola Korczak, the association's health spokeswoman.
The money-back deal, which started this year, was set to run until next month. A spokesman for Medicines Australia said the committee's decision was a sign the code worked.

June 30, 2006, Sydney Morning Herald

Stand up and be counted - love drug that comes with a money-back guarantee

YOU might call it a hard bargain. Men who take the impotence pill Levitra but still fail to rise to the challenge will be given their money back.
But a leading specialist says this marketing thrust is unethical because it creates unrealistic expectations about the effectiveness of drugs.

In advertising to the medical profession, which uses pictures of bananas to represent the men's before and after state, the manufacturer, Bayer HealthCare, urges doctors to hand out the "Levitra guarantee" with prescriptions for the drug, which costs about $70 for a four pack and is one of two competitors to Viagra.

Meanwhile, a campaign using the same suggestive imagery is running in the consumer press, encouraging men to register online at, where they can request a "performance pack" to be sent to their doctor, with whom they then make an appointment.

But nowhere in the consumer advertisements or on the website is Levitra mentioned by name - this sidesteps a ban on promoting prescription drugs to patients.

The deal, which runs until September and is limited to one prescription per patient, was an attempt to win market share from competitors Viagra and Cialis, said Bayer's medical director, Dr Jeff Hassall.

No corroborative evidence would be required of men's failure to achieve satisfaction, he said. "It's just on the word of the patient."

Studies suggested the drug, which is designed to increase blood flow to the penis, was effective for 80 per cent of men prescribed it, Dr Hassall said.
But in similar schemes the company has run in Scandinavia, only about 2 per cent of patients applied for a refund.

Bayer was fined $100,000 last year by the industry self-regulator, Medicines Australia, for promoting Levitra directly to men in an earlier version of its website. However, Dr Hassall said the refund scheme met industry standards.
"We consider this a totally appropriate and ethical initiative that helps both the doctor and the patient," he said. The objective was "to remove one of the barriers to patients obtaining treatment".

A professor of clinical pharmacology at the University of Newcastle, David Henry, said offering patients their money back set a dangerous precedent because it set up the expectation that medicines were "purely a commodity" like any other consumer purchase.

"It does cross the line because something that changes a doctor's decision about what's the best treatment for a patient has got to be undesirable," Professor Henry said. (Julie Robotham Medical Editor)

July 13, 2006

Online sexual enhancement products risky: FDA

Some sexual enhancement products sold on the Internet contain the same ingredients as prescription drugs such as Viagra and are not only illegal but dangerous, the US Food and Drug Administration cautioned on Wednesday. Erectile dysfunction products can cause a deadly interaction with many heart drugs, notably those containing nitrates."The US Food and Drug Administration is warning consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON," the agency said in a statement. "These products threaten the public health because they contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products," added Dr Steven Galson, Director of the FDA's Center for Drug Evaluation and Research."This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure."Zimaxx contains sildenafil, the active pharmaceutical ingredient in Viagra, Pfizer's prescription erectile dysfunction product. The other products contain chemical ingredients that are similar either to sildenafil or to vardenafil, the active ingredient in Levitra. Levitra is a prescription erectile dysfunction drug developed and sold jointly by Bayer AG, GlaxoSmithKline Plc and Schering-Plough Corp.."Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates," the FDA said. "ED (erectile dysfunction) is a common problem in men with these conditions, and they may seek products like the ones noted above because these products claim that they are 'all natural' or that they do not contain the active ingredients used in FDA-approved ED drugs." The agency said it had stopped a shipment of 4 EVERON from entry to the United States and warned the companies selling the drugs.

February 17, 2007; THE AUSTRALIAN

Fines fail to curb bad advertising

The latest round of penalties for excessive drug promotion has rekindled criticisms that self-regulation is not working. Health editor Adam Cresswell reports

LOVE or your money back: who wouldn't jump at that? Presumably that's exactly what the marketing gurus at drug giant Bayer HealthCare thought too when they dreamed up their money-back guarantee for the firm's erection drug Levitra.
It doubtless looked like a sure-fire way to claw back some ground from the market leader, Pfizer's Viagra: either men got a smile from their "banana" - as the campaign's advertising imagery rather cutely had it - or they got a full refund, no questions asked.
Neither Levitra, nor its competitors Viagra and Cialis, are subsidised by the Pharmaceutical Benefits Scheme, meaning that although patients still need a prescription, they must pay the full cost of the drugs themselves. With Levitra costing between $66 and $80 for four 20mg tablets, the money-back deal was certainly not to be sniffed at.
The campaign ran from June to August last year, and featured a blitz in the general media urging men to seek a "performance pack" from their GP if they suffered from erectile dysfunction. At the same time, advertising direct to the medical profession - which unlike those aimed at the public, could mention Levitra by name - made clear which drug GPs should consider prescribing for patients coming in asking for the pack.
The whole thing probably worked like a dream, possibly a wet one. We will never know for sure, because Bayer has declined to say either whether sales went up or how many refunds were given, citing commercial confidentiality.
But it's all history now, because within months the campaign fell foul of the voluntary code of conduct on drug marketing and promotion that is policed under the umbrella of the drug industry umbrella group, Medicines Australia.
As revealed in the latest six-monthly report of the committee that considers alleged breaches of the code, Bayer was ordered to pull the campaign after complaints were made by the Choice (formerly the Australian Consumers' Association), the federal Government's ultimate regulatory body the Therapeutic Goods Administration, and an unnamed pharmacist and health care professional.
Bayer was also ordered to write corrective letters to health professionals who had received earlier letters plugging the money-back offer, and place corrective advertisements in publications where earlier ads offending the code had appeared.
But that's it. By a majority decision, no fine was imposed.
Should one have been? The committee found the very concept of a money-back guarantee likely to "decrease the value of prescription medicines" and bring "discredit to the industry" - even though one committee member thought a refund scheme a good thing if it meant patients "were to stop taking Levitra if it had been ineffective".
Certainly Bayer was defending its withdrawn offer this week. Medical director Dr Jeffrey Hassall accepted the committee's adverse decision, but defended the promotion.
"In this area of erectile dysfunction, there are barriers to men seeking therapy, and one of those barriers is price," Hassall says. "Bayer's view is that we consider this campaign to be an ethical and necessary activity, to encourage patients with ED to seek and to continue to comply with therapies and to overcome the hurdle of price. Our perspective is that this was an ethical, warranted campaign."
Others aren't so sure.
Ken Harvey is adjunct senior research fellow in the School of Public Health at Victoria's La Trobe University, and a well-known critic of drug company marketing efforts. He condemns the Levitra money-back promotion as a "gimmick" to encourage greater use.
"This is putting commercial marketing concerns over what should be a medical decision," he says. "There can be no 100 per cent guarantee that any medical treatment works; none of them are without side-effects and downsides. A lot of erectile dysfunction is psychological - this is just encouraging people to rely on drug solutions."
But to Harvey's mind the episode merely illustrates a wider question over the effectiveness of the code generally.
Even when fines are imposed - and large fines are rare - he says they are flea bites by comparison to drug giants' marketing spending, and akin to shutting the stable door after the horse has bolted.
In the latest report, 12 drug companies were the subjects of 20 complaints, most of them by rival companies forever nervous of their competitors stealing a march on them. Thirteen of these complaints were upheld by the committee.
The two biggest fines resulted from complaints over one product - the drug Betaferon, a trade name for interferon beta-1b. Its maker, Schering, was ordered to pay $150,000 for distributing materials at a conference on multiple sclerosis which was open to the public. The committee found the materials made false or misleading claims, by suggesting the drug was the best treatment for multiple sclerosis, and by promoting a use of the drug that was not approved by the TGA. Schering was also found to have promoted the drug direct to the public, which is unlawful.
Schering was separately fined a further $100,000 by the committee for the second complaint over Betaferon, again over claims made at an MS conference open to the public.
Roche was fined $75,000 for breaking the rules on wining and dining of doctors at a series of slap-up meals, including one at the Sydney Opera House for over 200 cancer specialists costing over $200 a head.
However, as reported in The Australian this week, Roche had spent $65,000 on the meals that prompted the complaint in the first place - raising the question of whether the fine was enough to be a realistic deterrent.
Another firm, AstraZeneca, was fined $75,000 for false and misleading claims about its cholesterol-lowering drug Crestor.
Remaining fines in the other complaints were much smaller, ranging from $25,000 to $10,000.
The maximum fine that can be imposed by the committee is $200,000. Harvey says even this is "a minuscule amount compared to the profit that can be generated from 'creative' promotional campaigns", and their ineffectiveness is shown by the fact that companies are prepared to risk them over and over.
"Finalised Code complaint reports show that some companies have been associated with repeated code breaches over many years, despite the sanctions applied by Medicines Australia," he says, pointing out that equivalent penalties imposed by the US Federal Trade Commission can run into millions.
"In addition, by the time complaints and appeals have been heard by Medicines Australia the offending promotional campaign has usually run its course," Harvey says. "While corrective letters and advertising orders are useful, they do not undo the damage done before they were invoked.
"Finally, the motivation of drug companies which complain is more likely to be an attempt to stymie advertising campaigns by their competitors rather than any concern over what misleading ads might do to health professionals or the public. It takes time and effort to complain, which is why few complaints come from health professionals or consumers."
Medicines Australia tends to distance itself from the code committee, stressing the latter's independence - it is chaired by an independent lawyer and draws members from four medical colleges or other organisations, the Consumers Health Forum, drug experts and the TGA as well as Medicines Australia itself.
But MA also defends the robustness of the process and rejects claims it is too lenient, claiming the code is "the most rigorous of any business sector in Australia".
"We set high standards for the conduct of our industry," says Medicines Australia's chief executive, Ian Chalmers. "On rare occasions those standards are not met. There are significant consequences for those found in breach of the code."
Harvey says the job of policing the code should be "taken out of the hands of an industry association" and a different independent committee established under the aegis of the TGA. Fines should also be increased, and the money given to the National Prescribing Service to educate doctors and patients about drugs and best practice.
Finally, he says "prospective monitoring of promotional campaigns" should be contracted out to appropriate bodies, so campaigns in breach of the code can be stopped quickly rather than considered months later, often after they have run their course. And the current crazy paving of responsibilities - at least four different agencies, from the TGA to the Australian Self Medication Industry, have oversight for different areas currently - should be consolidated into one body.
"There is a fundamental conflict of interest between having an ethical code of conduct, which does advocate reasonable conduct, and the rewards that come from marketing," he says.

more information:
FDA Orders Levitra Ad Off the Air
Australia: Plug pulled on Bayer Levitra campaign
Kadair Advertising sues Bayer over Levitra 'robot' pen idea