Fiddling with Drugs Takes Clay Deputy Headon

Jason Gambill, 32, was charged with the sale and delivery of a controlled substance and sale and delivery of a legend drug after an investigation that initiated last month found he was distributing Cialis and Lortab for recreational use.

Cialis is a prescription drug for males suffering from erectile dysfunction. Lortab is in a class of drugs called narcotic analgesics, which serve as pain relievers.

“Today is a sad day for me personally and for the agency as we must arrest one of our own,” said Sheriff Rick Beseler. “While I have known the Gambill family for many years, the citizens must know that our officers will be held to a higher standard.”

Per the authorities, Gambill was recorded delivering the medication to a cooperating witness. The source of the drugs and the recipient inside the agency is still under police investigation, and more arrests could come after it is over.

Gambill was a probationary employee who earlier worked for the CCSO from 1992-2002 and again from May-September 2003. After resigning to work in construction, he returned to the agency in January 2005 as a deputy assigned to patrol. He was suspended without pay April 5 while the investigation continued, and was promptly terminated upon his arrest.

According to Clay County Sheriff’s Office Public Information Coordinator Mary Justino, ” His employment history is a mix of both good and bad.”

Mixed Report for Cialis

First-quarter sales grow, but cooling wholesale demand drops stock

BOTHELL – First-quarter sales of Cialis improved by 39 percent compared to the same time last year, but recent dips in wholesalers’ demand for the erectile dysfunction drug muted investors’ enthusiasm Monday.

In fact, after the joint venture of Lilly ICOS LLC announced its first-quarter results, the stock price of Bothell-based ICOS Corp. fell markedly. It ended the day at $22.20 a share, down by $2.42, or 9.8 percent.

Worldwide sales of Cialis totaled $150 million during the first quarter, compared to $108 million in early 2004, according to the joint venture formed by ICOS and Eli Lilly & Co. Sales in the U.S. alone totaled $42.7 million.

Those results were all well above the first quarter of last year. However, they declined – for the second quarter in a row – in comparison to the third quarter of 2004.

Paul Latta, an analyst with McAdams Wright Ragen in Seattle informed, “The U.S. sales numbers were a little light. The Europe, Mexico and Canada numbers were right in line, and the rest of the world was above expectations. But the net was the numbers were a little light.”

Lilly ICOS blamed the lower sales on new supply agreements made with drug wholesalers. As a result, wholesalers have been reducing their existing stockpiles of Cialis, to the tune of $27 million in the first quarter alone.

Because of this, the first-quarter results fell short of forecasts put out by Latta, Morgan Stanley and other analysts.

On the positive side, Lilly ICOS noted the cut in its quarterly expenses by nearly $60 million from the first quarter of 2004. That, added to the higher sales revenue, shrank the joint venture’s loss for the first quarter to less than $42 million, compared to $139 million last year, when the U.S. advertising blitz for Cialis was just getting into full swing.

The joint venture still is in line to become profitable by the middle of this year, said Paul Clark, ICOS’ chief executive officer.

Lilly ICOS also announced that Cialis has grabbed 49 percent of the erectile dysfunction drug market in France, compared to 40 percent for Viagra, during February.

According to IMS Health, France is the world’s fourth-largest market for prescription drugs. Since shortly after its introduction there, Cialis earned the nickname “le weekend” because of its effectiveness for up to 36 hours after ingestion.

In most other countries, Cialis also is moving ahead, Latta noted.

“The trend has been Cialis friendly,” he said. “The market-share numbers have continued to creep up in Europe and the U.S.”

ICOS spokeswoman Lacy Fitzpatrick said there are other markets, notably Germany and Australia, where Cialis has 30 percent or more of the market.

In the U.S., the latest prescription-tracking figures have shown Cialis with about 22 percent of the market for erectile dysfunction drugs, compared to about 67 percent for Viagra and 11 percent for Levitra.

If worldwide sales of Cialis live up to forecasts in the coming quarters, the drug is expected to generate between $700 million and $800 million this year.

Eli Lilly Profit Jumps

Eli Lilly (LLY :NYSE – news – research) Wednesday posted solidly higher fourth-quarter net income, edging past analysts’ EPS estimates thanks to its latest generation of drugs.

The Indianapolis-based drugmaker had a net loss of $2.4 million, equivalent to zero cents a share, primarily due to a $465.0 million tax expense on the expected repatriation to the U.S. of $8.0 billion of eligible overseas earnings in 2005 under the American Jobs Creation Act of 2004, as well as the charges for the previously announced restructuring initiatives. That compares with a profit of $747.2 million, or 69 cents a share, in the year-ago period.

Lilly is the latest drugmaker to take advantage of a one-year tax break for overseas profits. Under a law signed by President George W. Bush in October, the tax rate will be 5.25% instead of the customary corporate tax rate of 35%. Schering-Plough (SGP :NYSE – news – research) and Johnson & Johnson (JNJ :NYSE – news – research) also outlined their tax plans in fourth-quarter results.

Pfizer (PFE :NYSE – news – research) said it is looking into the option.

Excluding items, net income rose 13% to $814.3 million, or 75 cents a share, vs. $723.3 million, or 67 cents a share, a year ago. Economists were expecting 74 cents a share, according to Thomson First Call.

Operating income decreased 48% to $450.9 million, due largely to $494.1 million in asset impairments, restructuring and other special charges.

Revenue increased 5% to $3.64 billion. The company said sales of what it called “new products” — such as Alimta, Cialis and Cymbalta — contributed $498.7 million to fourth-quarter sales and accounted for 14% of total sales, twice the rate of a year ago.

For the first quarter of 2005, the company expects EPS of 65 cents to 67 cents a share. Excluding items, EPS is seen at 71 to 73 cents. The consensus estimate is 73 cents a share.

Cialis sales end year No. 2 to the better-known Viagra

Cialis ended the year with one weak quarter, but in the first full year of the global battle among erectile-dysfunction drugs, it still finished where many expected — a popular but distant No. 2 to Viagra.

The joint venture between Bothell-based Icos and Eli Lilly, the makers of Cialis, said yesterday the drug reached all its financial goals for the year. Cialis had $552 million in worldwide sales for 2004, within its $500 million to $600 million forecast. The joint venture spent $606 million on marketing and administrative costs, and ended up losing $262 million, within the expected range.

The drug now has 20 percent of the U.S. market share, compared with Viagra’s 69 percent.

Based on the current trends, with marketing spending expected to decline, Icos and Eli Lilly repeated they expect their joint venture to become profitable in mid-2005.

Still, the drug finished the year with a thud. Fourth-quarter Cialis sales were flat worldwide, and down in the U.S. from $70 million to $53 million. The reason: Wholesalers stocked up on the drug in the third quarter, just before the price went up 6 percent to $9.02 per pill. The wholesalers then began selling the extra inventory after the higher price kicked in on Sept. 30, without needing to make more short-term orders.

Icos spokeswoman Lacy Fitzpatrick said the company discovered the stockpiling in December through an audit, and has put a stop to it by reaching agreements with all its wholesalers. She said the company may still feel the effects through the first quarter of this year.

Icos stock fell 66 cents to $25 per share yesterday after the report. Charles Hill, a business professor at the University of Washington and an Icos shareholder, said the fourth-quarter sales were “a disappointment” but the overall year was solid. He said he’s still concerned about how much Icos and Lilly will have to spend on the marketing competition with Viagra. There will be intense interest among shareholders next week, he said, when Icos releases its financial forecasts for the coming year.

Dr. Fred Govier, the head of urology at Virginia Mason Medical Center in Seattle, said there was a surge in patients’ interest in Cialis and rival Levitra after their introduction, which lasted about six weeks for both. After a period of experimentation, he said, many patients have settled on their “favorite,” which he said surprised him. Cialis is a longer-acting drug, which can allow for more sexual spontaneity, but in other respects, all three are very similar.

Govier, who consults for all the erectile-dysfunction drug makers and owns stock in Pfizer and Icos, said he believes the overall market for the drugs hasn’t exploded because there really aren’t 70 million men in North America and Europe who are candidates for the drugs, as the companies claim. Many of those men, and their partners, aren’t interested in sex, he said.

Still, he said there is opportunity because many men remain reticent about seeking treatment. He said the companies need to get their message across to primary-care physicians, who are less familiar with the drugs than specialists. He expects Pfizer’s Viagra, which had $469 million in worldwide sales in the fourth quarter, to have an edge for a long time.

“They were the first, they have great name recognition, they have a great drug,” Govier said. “I don’t think anybody expected the new drugs to come in and knock them off their pedestal.”

Erectile Drugs Coverage Stirs Controversy:

U.S. drug firms are fighting efforts in Congress to bar Medicare from paying for Viagra and other erectile dysfunction drugs, the New York Times said Monday.

The issue relates to Medicare’s new prescription drug benefit and whether the program should cover treatment to heighten sexual performance.

“We cannot pay for everything, but, unlike many advanced industrial countries, the United States has no explicit process to analyze the cost and value of medical goods and services,” Jonathan Weiner, a health policy professor at Johns Hopkins University, told the newspaper.

Supporters say erectile dysfunction often has a physical cause and treatment can significantly improve the quality of a man’s life. Opponents say financially-troubled Medicare cannot afford to pay for “lifestyle drugs” and should concentrate on other drugs for senior citizens.

In support of providing the coverage, Kindra Strupp of Eli Lilly & Co., which sells Cialis, says 17 percent of that drug was dispensed to men over the age of 65.

Cialis Plans to Invigorate Super Bowl

With growing concerns of people towards the subject of male impotence, Cialis has surely been able to come up as a savior.

Marketed jointly by Eli Lilly and Co. & ICOS Corp., Cialis plans to sweep off the customer base towards it with its advertisement on this year’s Super Bowl. The 60-sec commercial is said to show flirtatious moments between middle-aged and elderly couple to the tune of the 1960s song “Be My Baby.”

Super Bowl, the most-watched US television event, has been the marketing debut facilitator for Cialis – last year, and the rival impotence pill Levitra – in the year 2004, as Pfizer Inc.’s Viagra prepared up for the new competitors.

More than three and a half million men worldwide have tried Cialis and the sale of this vital drug has witnessed an exponential growth.

Come Super Bowl and the vitality of Eli Lilly would surely be felt.

Men shy away from sexual knowledge

Men hesitate to get involved in issues concerning sexual reproductive health because of their poor knowledge in matters relating to sex. Alah Moya of the Community Health Service Department, Botswana expressed his concern while addressing men on issues relating to ‘Male involvement and HIV/AIDS’ at the Prevention of Mother to Child workshop

The main objective of the workshop was to share the PMTC update, to motivate people to adopt to change, provide accurate information and help group processes to obtain self- realization.

An active member of UNICEF, Mercy Puso gave a lecture on ‘Community mobilization’. Puso supported men willing to take roles as mobilisers and facilitators in order to work on generating a list of problem issues and their ranking.

The workshop focused on sexual knowledge for men, as they are the decision makers at home when it comes to sexual issues.

Cialis market sales picking up: Lilly Icos

The Erectile Dysfunction drug Cialis, created by Icos Corp. surpassed $1 billion in worldwide market sales this year. Lilly Icos, the joint venture set up to market Cialis certified the growing US market share and said that the rising venture is touching close to profitability.

Cialis was launched two years ago and in January 2005, it became France’s leading erectile dysfunction treatment drug. More men are opening up to their health care provider about ED. Rich Pilnik, President of Lilly’s EMEA region expressed happiness over the patients’ willingness to seek treatment options.

Cialis is the second PDE5 inhibitor drug after Viagra to become available in Europe and it is marketed in nearly hundred countries.

Canadian Pharmacies Trying To Curb Meth Production

Canadian pharmacies are doing their part to curb the production of methamphetamine. Methamphetamine is extremely harmful for men’s health as it’s a potentially-deadly drug that can cause respiratory problems, irregular heartbeat and can lead to anorexia. Due to this, the National Drug Scheduling Advisory Committee (NSDAC) recently recommended certain cold medications to be rescheduled in pharmacies.

Products containing single-entity pseudo ephedrine, which are used to manufacture methamphetamine, should be moved behind the counter, according to the committee. These products include most of the decongestant and cold and sinus medication. This recommendation of NDSAC was publicly supported by the Canadian Association of Chain Drug Stores last week.

Counterfeit drug counterpunch

BOTHELL – Amid the e-mails promoting racy Web sites, new credit cards and dubious financial schemes, spammers are peddling drugs.

While most computer users block out or repeatedly delete the electronic inducements, Bothell’s ICOS Corp. can’t just ignore them.

Many of those spam messages tout “generic” – and even chewable – versions of Cialis, the company’s high-profile erectile dysfunction drug.

But there is no legitimate generic version of Cialis. Instead, these are counterfeits or illegally traded versions of prescription drug.

Hunting down spammers and drug counterfeiters isn’t easy, but ICOS and other companies are trying. This month, Pfizer Inc., the maker of Viagra, and Microsoft Corp. jointly filed lawsuits against 17 online pharmacies.

ICOS hasn’t made similar headlines for its efforts, but it’s also fighting the problem, said spokeswoman Lacy Fitzpatrick.

“We continue to have operations that work with law enforcement and regulatory agencies throughout the world,” she said. “It’s a very quiet operation, very effective, and they’ve had some successes, but they don’t talk about them.”

Leonard Blum, senior vice president for sales and marketing at ICOS, said his company and its pharmaceutical partner for Cialis, Eli Lilly & Co., have focused most of their efforts on countries in Asia, India and Eastern Europe. That’s where the majority of online peddlers and illegal producers seem to be.

The number of people arrested for drug counterfeiting is rising. A Korean newspaper reported several weeks ago that prosecutors charged six people for trying to smuggle in 160,000 counterfeit Cialis and Viagra tablets from China. In San Diego a month ago, three people pleaded guilty to federal charges of making up to $2.5 million by selling fake erectile dysfunction drugs.

ICOS and other drug companies obviously have a financial interest in fighting fakes. But the industry also sees it as a safety issue. Blum pointed out that analyses of fake Cialis show the tablets can contain almost anything.

“Some of it has the active ingredient, some advertising as Cialis has the active ingredient in Viagra, and some of it has both ingredients,” Blum said. “It’s really a crapshoot.”

In addition to not working, the fake versions could have potentially dangerous side effects, he added.

The same is true for fake Viagra, which may be the world’s most counterfeited drug, Pfizer spokesman Bryant Haskins said. His company estimates that one out of every four spam messages sent is trying to sell fake versions of an erectile dysfunction drug.

The more counterfeit drugs are produced, the more likely they are to get into the mainstream distribution system. In August, Britain’s regulatory authorities issued their first recall for a fake drug in a decade after counterfeit Cialis and a fake anti-obesity drug were sold by pharmacies.

Counterfeit drugs of all kinds also have caught the attention of the U.S. Food and Drug Administration and the World Health Organization. The WHO estimates that 10 percent of the world’s overall pharmaceutical supply is counterfeit.

It’s an attractive crime because knockoffs of most prescription drugs can command high prices while being cheap to produce, according to WHO.

“They can be produced in small cottage industries or in back yards or under the shade of a tree,” the organization wrote in a report on the problem.

The FDA said it conducted 20 counterfeit drug investigations nationwide in 2000, compared to just five per year in the late 1990s. The agency also is working closer with Immigration and Customs Enforcement and the Federal Bureau of Investigation.

Pfizer hopes its new tactic of suing spammers and Web sites continues to be effective.

“Our goal is to shut these Web sites down,” Haskins said. “Oftentimes, just the filing of a lawsuit or other type of legal action is enough to shut a site down.”

While spammers and online drug outlets are among those peddling counterfeit, gray market or otherwise questionable versions of prescription drugs, there are a few legitimate online pharmacies. The National Association of Boards of Pharmacy has created the Verified Internet Pharmacy Practice Sites program, which has compiled a list of pharmacies that meet its licensing, inspection and other quality assurance requirements. To view the list, go to www.nabp.net/vipps. When the company filed suit against 30 online sites in 2004, he said, 29 shut down quickly. That doesn’t always stop spammers and online operations, however.

“They change their addresses as quickly as we can get to them,” Blum said.

In the meantime, he offers simple advice: If a drug doesn’t seem to be the real thing, don’t use it.

“We will continue to invest in trying to prevent this,” Blum said. “But the more important thing people should know is if they need the real thing, visit a doctor, get a prescription and shop around with legitimate pharmacies.”