Eli Lilly fined $60,000 over Cialis spin

THE makers of an anti-impotence treatment have been fined $60,000 for a publicity initiative that the industry’s self-regulating complaints body found breached the ban on promoting drugs direct to the public.

Eli Lilly, the maker of the erectile dysfunction drug Cialis, was also found by Medicines Australia’s Code of Conduct Committee to have issued a product-specific media statement in April this year.

However, the company escaped censure on a third charge, that of bringing discredit to the industry and reducing public confidence in it.

Despite the fine, Eli Lilly will not have to lodge corrective advertisements in trade or other media — as sometimes required after proven code breaches — as members of the committee decided such an order “would provide Eli Lilly with another opportunity to discuss the product with the general public”.

Cialis competes directly with Pfizer’s better-known drug Viagra, which is also used for erectile dysfunction.

The complaint was lodged over a press release issued by Eli Lilly in April, which was timed to coincide with the release of a new version of the drug called Cialis Once-a-Day.

The press release, headlined “New research reveals scheduled sex a turn-off”, reported the results of a national Galaxy poll — commissioned by Eli Lilly — which purported to show that 74 per cent of Australian men said “spontaneity … is an important part of sex”. The poll also claimed that more than half of men aged 45 to 54 “admit … that their ability to have sex on impulse has declined drastically or noticeably” since they turned 30.

The release linked the results to the launch of Cialis Once-a-Day, which it said would “(restore) their ability to respond to spontaneous opportunities for sex”.

The press release and its claims, which were widely reported in the media, became the subject of a complaint to Medicines Australia’s code of conduct committee by consumer group Choice and LaTrobe University academic Ken Harvey. It was also featured on ABC TV’s Media Watch in May.

In his complaint, Harvey said the press release in his view was “not bona fide news but rather thinly disguised promotion of the prescription drug tadalafil (Cialis) to the general public. Eli Lilly have now provided the latest example of how a drug company can undermine quality use of medicines activities.”

Choice’s complaint said the release did not educate the public about the use of the medicine, but rather was intended to promote the medicine to the general public.

Eli Lilly had advised GPs, pharmacists and specialists about the availability of its new product before the media release was distributed. Under Medicines Australia’s code of conduct, companies are allowed to issue a media release to announce a new product, or new circumstances under which an existing product can be prescribed. But any releases must be “educational” and must not promote particular products.

Body: In the minutes of its decision, the MA committee said Lilly’s press release “included overly positive statements about the benefits of once-a-day treatment such as ‘exciting news’, ‘important new option for men with ED’ and ‘a new option with 24/7 coverage will be most welcome as it will make them feel more like they did before they got the condition’.”

The committee also found some statements in the press release that were not justified by Cialis’s official product information, such as the claim that the drug is “most appropriate for men who anticipate sexual activity at least twice a week and who have responded to the on-demand treatment regime”.

The minutes also reveal that some members of the code of conduct committee had argued for Eli Lilly to be fined more than $60,000. The maximum fine the committee can impose is $200,000. Eli Lilly, which claimed all along that the media release was within the code’s guidelines, has the right to lodge an appeal.

A spokeswoman for the company said it was disappointed with the decision and was considering its response. “Eli Lilly is disappointed with the decision of the Code of Conduct Committee as we take our responsibilities as a member of Medicines Australia, including adherence with the Code, most seriously,” she said. “Lilly is currently reviewing the Committee’s decision and will determine next steps shortly.”

Harvey said the decision was a “useful shot across the bows” and he was “reasonably happy” with the verdict and the fine. “Hopefully this will make other companies think twice before doing it again — and if another company went down the same path, I hope the fine would be bigger.”

He praised Medicines Australia for its relatively fast action, which he said was dramatically quicker and more effective than a parallel complaints process for complementary and alternative medicines, run under the auspices of the Complementary Healthcare Council. “The (Medicines Australia) system is reasonably fast and the sanctions have some bite — and that’s very different to the Complaints Resolution Panel,” Harvey said.

Online Pharmacies: Dangerous Prescription?

Dr. Mallika Marshall Waves Caution Flag Over Buying Discounted Drugs Via The Web.

(CBS) Many of us get them every day: e-mails offering popular prescription drugs online at discount prices.

You may toss them into the spam file, but millions of Americans buy what they’re selling - and could be putting themselves in danger, says Early Show medical contributor Dr. Mallika Marshall.

Why are so many people turning to the Internet for prescription drugs? More and more people are finding themselves without health insurance coverage, unable to afford the expensive drugs they need, and the Web appears to offer a cheaper alternative, Marshall explains.

But keep in mind, the Food and Drug Administration says, if you ask for generics, chances are you’ll pay less at the drug store than you will if you order brand names online.

Then there are people who say they’re too embarrassed or too busy to get to the doctor, and that buying online is easier and more private. But that creates another serious problem: People are looking to the Internet to diagnose their own illnesses, then searching for the recommended drugs online, leaving doctors completely out of the equation - a very dangerous practice.

There’ve been some truly terrible stories about the consequences of buying drugs from Web sites, Marshall points out. One man who was suffering from severe back pain received an e-mail offering Xanax and Ultam, two pain-killers. He took one of each tablet, suffered a heart attack and went into a coma. The tablets contained four times the usual starting dosage. A woman who decided she suffered from chronic fatigue syndrome bought steroids online, and ended up with severe cataracts, so severe they couldn’t be removed. We’re hearing more and more stories like this.

In some cases, the problem is the pills are either placebos, made of sugar with only a minimal amount of the drug in them. But some have been found to contain other substances that are dangerous, even potentially deadly. One offshore drugmaker was manufacturing Viagra tablets that were 85-percent cement. There are reports of Viagra that is actually made of vodka. Allergy medications were found to contain steroids, to suppress the symptoms. You just don’t know what these counterfeit pills may be made of.

How can you tell the difference between a legit site and an unregulated, rogue one?

ADVICE FROM MARSHALL FOR PEOPLE SHOPPING ONLINE FOR DRUGS

CONSULT YOUR DOCTOR

We can’t say it strongly enough. Don’t diagnose your own illness and prescribe your own care. See a doctor, and get a prescription.

AVOID SITES THAT DON’T INSIST ON A PRESCRIPTION

Many of those sites will ask for a doctor’s name and nothing else. A recent study showed that only 11 percent of online pharmacy sites ask for a prescription. Most will send you the prescription drugs with no prescription. The site should ask for a prescription, should post its name and address, and have a licensed pharmacist you can speak to. If it doesn’t, stay away.

ONLY USE LICENSED ONLINE PHARMACIES

To be sure it’s licensed, you can check with the National Association of Boards of Pharmacy in your state. They license online pharmacies, and can tell you if the site you’re looking at is safe.

AVOID SITES BASED IN FOREIGN COUNTRIES

There are sites based in places such as Belize, Thailand or China, and you don’t know where the drugs are coming from, or whether they’re counterfeit. That’s where the danger lies, so you must be careful.

Makers of Cialis say daily dose keeps men ready for sex any time

Cialis was originally designed to be taken on an “as needed” basis, with one dose lasting 24 to 36 hours, earning it the moniker “Le Weekend” when first approved in Europe in 2002.

Now it’s being repackaged and sold in a once-a-day, lower-dose version. Taken daily, the drug builds in a man’s body until it reaches a circulating level in the bloodstream that would allow a man to be sexually active “whenever the moment is right,” according to a news release issued by drug giant, Eli Lilly.

Dr. Gerald Brock says the once-a-day pill will appeal to men who find timing an issue.

“Taking the drug on a daily basis and having complete spontaneity is going to be a real, genuine advance,” says Brock, a urologist at St. Joseph’s Health Care in London, Ont. Brock has received speakers’ fees and research grants in the past from Eli Lilly.

Last year, more than 1.6 million prescriptions for erectile dysfunction drugs were dispensed by Canadian drugstores, according to prescription drug tracking firm IMS Health Canada. About 593,000 of those prescriptions were for tadalafil, the chemical name for Cialis.

Cialis belongs to a class of drugs known as PDE-5 inhibitors that includes Viagra and Levitra. The pills act on the chemical signals that open up the blood vessels in the penis.

“Is it safe to take a PDE-5 inhibitor every day? It probably is. These drugs are probably much safer than Aspirin,” says Dr. J. Paul Whelan, Braley-Gordon Chair of Urology at McMaster University in Hamilton.

The drugs aren’t thought to benefit men with normal sexual function. And there can be rare side-effects that can include headache, facial flushing and indigestion. The drug should not be used by men who are taking nitrates or those with cardiac disease “for whom sexual activity is not advisable,” Eli Lilly says.

Whelan says once-a-day erectile dysfunction drugs can help with what is known as “penile rehabilitation” after prostate cancer surgery.

In addition, men who experience side effects with the “on demand” Cialis may better tolerate the once-a-day version, which comes in 2.5 and 5 mg capsules, says Brock.

“And finally, we as urologists have people who are very sexually active — they may be having sex two or three or more times per week. By taking a very small dose of Cialis every day they can actually take less medication, have greater spontaneity, have lower side effects and, I think, at the end of the day have greater patient and partner satisfaction.”