Coinciding with the annual conference of the British Cardiovascular Society taking place in London this week a UK-based biotechnology company, Cambridge Theranostics, introduced today a new pill aimed at lowering cholesterol and reducing atherosclerosis.

The pill, called Ateronon, is made from lycopene, a carotenoid antioxidant found in fruits and vegetables, especially tomatoes (it’s responsible for the tomato’s bright and colorful skin color). Cambridge Theranostics spent a decade developing a way to manufacture lycopene in a more absorbable form.

No large-scale clinical trials have yet been performed to determine the safety and efficacy of the pill. Ateronon is not currently approved by the FDA for use in the United States.

In the last six months of 2008, doctors at Broward’s pain clinics handed out more than 6.5 million pills of the potent painkiller oxycodone — almost four pills for every Broward resident, according to federal data compiled by the Broward Sheriff’s Office.

Pills flow by the thousands every day through an ever growing number of clinics offering drugs and prescriptions to walk-in patients at strip malls and nondescript office parks — some with armed guards stationed by the clinic doors. One Fort Lauderdale clinic has taken over a defunct drive-through fast-food restaurant.

Many clinics lure patients with the promise of drugs sold on site, and with coupons and discounts advertised in the back pages of alternative weekly newspapers, or on bus benches and billboards.

“Out of State Patients Welcome,” blares a recent ad for A1 Pain in Fort Lauderdale. “No Wait for Walk-Ins,” another clinic’s ad says. One doctor offers a $25 gasoline coupon to the weary, pain-afflicted traveler.

And the travelers come — by the thousands, narcotics investigators say, from Kentucky, Ohio, West Virginia, Massachusetts and other states. Prospective pill buyers sometimes camp outside clinics overnight, waiting for the doors to open, said Hollywood police Capt. Allen Siegel, director of a South Broward narcotics task force.

“Broward County has become the Colombia for pharmaceutically diverted drugs,” Siegel said. “We’re supplying everywhere.”

The number of pain clinics in South Florida has ballooned from 60 to 150 in just the past year, the U.S. Drug Enforcement Administration estimates. Broward alone has 89 clinics, Siegel said.

Pain management with narcotics is recognized as a legitimate medical practice to quell chronic pain for those with injuries or conditions like arthritis. But investigators and health advocates say many of these clinics are merely pill mills where doctors feed narcotics to 65 patients a day or more.

“This medicine is about profit-making,” said Mark Trouville, special agent in charge of the DEA’s Miami office. “I hate to call them doctors. These people are just out to make money.”

A single physician can dispense hundreds of thousands of pills. In the last six months of 2008, Trouville said, just 45 South Florida doctors dispensed nearly nine million pills of oxycodone — a favorite among drug addicts and traffickers.

Experts blame these clinics for a startling rise in prescription-drug overdose deaths in Florida, including a 107 percent jump in oxycodone deaths in two years.

“The rate [of overdoses] is just incredible,” said George Hime, assistant director of toxicology for the Miami-Dade County Medical Examiner’s Office. “It is the new epidemic of drug abuse.”

Yet, regulators and police can’t control the problem — handcuffed, they say, by tepid Florida laws that allow these clinics to open in-house pharmacies and sell drugs directly to clients walking in off the street, even from far-away states.

“We are source-supplying many other states. This is literally embarrassing,” Sgt. Lisa McElhaney of the Broward Sheriff’s Office told a recent meeting of a county drug task force. “The system has enabled this.”

The Swiss Competition Commission has charged the three companies and their distributors with price fixing. Olivier Schaller, a commission spokesman said the companies engaged in am unlawful agreement to maintain a “recommended public selling price” for the medications Viagra, Cialis and Levitra.

According to Mr. Schaller, the selling price was followed by the pharmaceutical companies, drug stores and doctors. The commission gave the three firms 20 days to answer before it decides whether it will follow the panel’s recommendation to impose penalties on the three drug firms or ban them from suggesting prices for erection dysfunction medication.

The Eli Lilly spokeswoman said the company is confident it obeyed Swiss regulations, while the spokesmen of Pfizer and Bayer declined to comment on the findings of the commission because it had no time yet to study the panel’s claims.

Thinking of buying prescription drugs online to save time and money? Consumers have lots of choices for buying prescription drugs these days.

One indisputable benefit of shopping online: It’s more convenient to compare prices among Internet pharmacies than among the brick-and-mortar drug stores. Because of the centralized warehousing for fulfilling orders and the efficiencies of scale, some online drugstores can save their customers 20% to 30% on most prescriptions. A 1999 Consumer Reports study found that buying prescription drugs online typically saves shoppers 10% compared with the prices at national drugstore chains and neighborhood supermarkets.

For those whose biggest concern is privacy, there’s a clear advantage to buying prescription drugs online instead of having to deal with a pharmacist face to face. “The benefit of getting their medications over the Internet is simply that sometimes there are certain things you don’t want people to know you have,” says Bob Forsythe, a spokesman for Discount Prescriptions. “Some people don’t even want their own doctor to know.”

Even with the advantages afforded by online pharmacies, consumers should beware – counterfeit drugs are on the rise. You might throw your money away on ineffective drugs, or even worse, you could be harmed by taking drugs that aren’t what they pretend to be.

Phony Generics - A Deal Too Good to be True

According to the World Health Organization, “Since January 2006, customs officials around the world have seized more than 3 million counterfeit or suspected counterfeit tablets, in more than 1,000 separate actions.” In 2004 a woman with mild anemia was fatally poisoned after taking a highly toxic counterfeit. Another woman died after taking fake drugs she bought online that were contaminated with deadly metals.

Also in 2004, an overseas pharmacy based in India was caught selling counterfeit contraceptive patches containing no active ingredients. Women using these products, which were promoted as being the Ortho Evra transdermal patch manufactured by Ortho-McNeill, actually had no protection against becoming pregnant.

In May 2007, the FDA uncovered a ring of 24 online pharmacies selling fake Viagra, the erectile dysfunction treatment manufactured by Pfizer Inc. According an analysis conducted by Pfizer and submitted to the FDA, none of the capsules ordered off the web sites contained sildenafil citrate, the active ingredient in authentic Viagra. An FDA analysis showed that other “prescription drugs” from the bogus pharmacy sites contained only talc and starch.

An online pharmacy can look very sophisticated and legitimate, but actually be an illegal operation. Consumers should be especially wary if:

• the online pharmacy doesn’t list an address or toll-free phone number to contact in case of a problem
• prices are dramatically lower than the competition
• the pharmacy offers generic versions of popular drugs such as Cialis or Viagra
• the pharmacy claims to be FDA approved

A Word of Caution Before You Buy Prescriptions Online

• Purchasing a medication from an illegal website puts you at risk for receiving a contaminated or counterfeit product, an incorrect dose, or no product at all.
• Taking the wrong medication could put you at risk for serious drug interactions or other health consequences.
• Don’t buy from online pharmacies which sell drugs that are not FDA approved.
• Don’t use online pharmacies which do not offer access to a registered pharmacist to answer your questions.
• Don’t purchase drugs from foreign websites.
• Beware of websites that make outrageous claims or offering quick cure-alls.
• Always consult your healthcare professional prior to taking a drug for the first time.

Buying prescription drugs online saves you a trip to the pharmacy, could save you money, and affords you better privacy than placing an order at a retail pharmacy. If you choose to buy prescription drugs online, do so from a reputable online pharmacy, and recognize the risks involved in purchasing medication from questionable “rogue” sites.

The move is an example of the increasingly aggressive nature of generic companies in trying to push their products to the market. An application for generic drug certification may be filed as early as four years after FDA approval of the brand product. Cialis was approved on Nov. 21, 2003.

Although Cialis is protected by five patents which are not due to expire until between 2016 to 2020, its exclusivity expires in November 2008. A generic company could seek approval to market its version as long as Lilly’s patents are not infringed or made invalid.

Being the first to file for a generic Cialis could be significant because of market exclusivity for the first generic to be approved. The agency will review the application for up to 60 days. If it accepts the application, the generic firm must notify Lilly of its challenge.

Under the law, Lilly could sue the applicant for infringement within 45 days of that notice, putting an automatic 30-month stay on the approval of the generic drug. The drug manufacturer would then be protected from any harm that might result from the FDA granting marketing approval to a potentially infringing product.

The FDA doesn’t identify the filing company, or possibly multiple companies, and the legal process dictates that it could be months before it is revealed who made the filing.

Officials from Lilly weren’t immediately available to comment. Lilly recently reported 2007 sales of the Cialis of $1.14 billion, making it its fifth largest drug by sales.

The Food and Drug Administration has approved once-daily formulations of Cialis, in dosages of 2.5 milligrams and 5 milligrams, that will allow men to be more spontaneous and enjoy sex any time between doses.

Lilly officials say the new tablets, which are also available in parts of Europe, provide “a new option for men… that can be taken without regard to timing of sexual activity.” Shawn Heffern, Lilly’s U.S. marketing director, says that with the daily dose, men will not need to take Cialis in anticipation of sex because it is already in their system.

“They’ve got a lot of pressure to perform, and the worst thing we can do is then put some limited amount of time … where they need to have sex or otherwise it’s out of their system and doesn’t work,” he said.

The low dose daily treatment option is designed for men who anticipate more frequent sexual activity, for example, having sex twice a week or more. Lilly’s wholesale pricing for Cialis for once daily use will be comparable to Cialis for use as needed, so that patients who currently use two or more pills per week of as-needed Cialis should not experience higher costs with once-daily Cialis.

Cialis 5 mg, 10 mg and 20 mg have been approved in the United States for as-needed treatment of ED since November 2003. At these higher doses, the drug has proven to provide sustained efficacy for up to 36 hours.

Viagra and another erectile dysfunction drug, Levitra, also can be taken daily, but Cialis is the only drug specifically approved for a daily treatment regimen.

Pfizer’s prescription drug Chantix has been used by more than 5 million patients as a smoking cessation aid, according to the manufacturer. After the FDA received nearly 500 reports of suicidal thoughts, behaviors, and completed suicides, 420 of which were in U.S. patients, the drug will now carry new labels warning doctors and consumers.

Thirty-four cases of completed suicide were recorded in the U.S., along with five cases overseas.

The reports don’t prove that Chantix was the cause of the suicide. But FDA officials say their investigation showed several suicide cases in patients with no history of psychiatric problems.

“We’ve become increasingly concerned as we’ve seen that there are a number of compelling cases that truly look as though they are the result of exposure to the drug,” said Bob Rappaport, MD, director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products.

“Clearly these are very concerning findings for this product, which is being very widely used,” he told reporters on a telephone conference call.

The agency asked Pfizer to increase the prominence of warnings on the Chantix label. The company made similar changes to the label two weeks ago.

The drug was approved in May 2006 as a smoking cessation agent. It is different from the variety of nicotine gums, patches, and lozenges on the market. While those products help replace nicotine when patients quit, Chantix acts directly on brain centers affected by nicotine.

In a statement issued two weeks ago, Pfizer said any risks associated with Chantix should be balanced with the known risks of smoking.

“Chantix is a real breakthrough medicine that has helped many smokers who want to quit. We hope that today’s labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication,” a release from the company stated.

The FDA considers Chantix “extremely important and extremely effective” in helping people quit smoking, but patients taking the drug and their doctors should be on the lookout for any behavior or mood changes.

“They should discuss with their health care provider as soon as possible whether they should continue with the drug or not” if mood changes occur, he said.

The FDA’s public health advisory emphasizes the following safety information on Chantix:

• Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.
• Health care professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors, and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix.
• Patients taking Chantix should immediately report changes in mood and behavior to their doctor.
• Patients taking Chantix may experience vivid, unusual, or strange dreams.
• Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

The FDA is working with Pfizer to finalize a medication guide for patients.

Generic drug manufacturers to predict further gains in 2008, as brand name prescription drugs with over $20 billion in annual sales lose their patent protection. Capitalizing on efforts by health insurers, state governments, and consumers to control prescription drug costs, generic drug companies are becoming increasingly aggressive in applying to bring generic versions of popular brand name medications to the market.

Since 1984, generic drug makers have been permitted to apply for FDA approval to copy popular brand name drugs once their original patents expire or are ruled invalid. Being the first to apply can give a generic drug maker the advantage of market exclusivity, a significant edge in a competitive, low-margin industry. The FDA reports that between 2002 and 2006, the number of applications for generic drug certification have more than doubled.

More expensive brand name prescription drugs account for about 80 percent of all dollars spent on medication in the U.S. each year. Since generic drugs cost anywhere from 30% to 80% less than brands, the GPhA estimates that a 1% increase in generic use saves approximately $4 billion a year.

According to a new clinical study completed in January 2008, users of the transdermal contraceptive patch have a higher risk of developing serious blood clots than women who use birth control pills such as Ortho Tricyclen, Yaz, or Lybrel.

Also known as venous thromboembolism (VTE), these blood clots can lead to pulmonary embolism (a blockage in an artery in the lung).

The Ortho Evra Contraceptive Patch is manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson. The label changes are based on a clinical study conducted at the drug maker’s request. The study included women aged 15-44, and the conclusions support a 2005 research study which also found that women in this group were at higher risk for venous thromboembolism.

Ortho Evra was the first transdermal patch approved for birth control. Applied to the skin once a week, Ortho Evra is a prescription patch that releases an estrogen hormone and a progestin hormone into the blood stream. Because these two hormones are processed by the body differently than hormones from oral contraceptives, women who use Ortho Evra are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. These increased levels of estrogen may increase the risk of side effects, including VTE. Women who are considering the birth control patch are advised to discuss this possible increased risk of blood clots with their doctor.

The FDA is plans to continue to monitoring safety reports for the Ortho Evra patch. In a statement released today, the FDA says, “Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.”

The yellow pill, which allows men to achieve an erection up to 36 hours after ingestion, is the third anti-impotence drug to win approval from the U.S. Food and Drug Administration in the past five years. Competitors are Viagra, the blockbuster pill from Pfizer Inc., and Levitra, a medication from Bayer AG and GlaxoSmithKline that was approved in August.

Cialis is the first marketable drug for Icos, a 13-year-old Bothell biotechnology company whose largest investor is Microsoft co-founder Bill Gates. With yesterday’s approval, Icos becomes one of a handful of Seattle-area biotechnology companies to successfully bring a drug to market.

Balloons and Champagne corks were popping at the company’s Bothell headquarters yesterday in celebration of the milestone.

“After 13 years and a lot of work, it sure feels good to have our first U.S. approval,” said Icos Chief Executive Paul Clark. “It is a momentous occasion for a biotech company to have their first product on the market and especially one that has blockbuster potential.”

Cialis, which is manufactured at Eli Lilly’s plant in Puerto Rico, will be on the shelves of more than 40,000 pharmacies in early December, Clark said. It will sell for about $10 per pill.

“Locked and loaded,” said Clark, when asked if the drug is ready to ship.

Cialis is already available in 50 countries, including France, where its long-lasting effects have won it the nickname “Le weekend” pill. Sexual therapists, urologists and patients cite the 36-hour time frame as a potential advantage over competing products.

“That is the differentiating thing as far as I know,” said Robert Weissman, a urologist at Overlake Hospital Medical Center in Bellevue. “I am glad we have something like this.”

Unlike Viagra, it takes about 30 minutes to kick in and can quickly take effect on a full stomach. Of the 40,000 records of sexual attempts chronicled during Icos’ research, only a handful of men had sex more than once during the 36-hour period on one dose.

Elizabeth Rae Larson, co-founder and director of the Seattle Institute for Sex Therapy, Education and Research, believes there is a niche for a pill that allows men some flexibility in choosing when they want to have sex. In the past five years, Larson has dealt with some Viagra users who become obsessed with performing sex during its four-hour window.

“I have heard from women who say when their men take Viagra there is this sort of rush to sex,” said Larson, who counsels couples on sexual issues, including erectile dysfunction. “The other partner starts feeling harassed or rushed, and the big crisis becomes ‘I have this pill and I am anxious about it wearing off.’ ”

With Cialis lasting up to 36 hours, Larson said, that stressful situation could be alleviated. She also said the drug could help couples who are courting but have a relationship in which sexual activity is not predetermined.

That appeals to a 63-year-old Seattle man who has not been in a committed relationship for 10 years. A frequent dater and former Viagra user, the man said he would like more spontaneity in sex.

“I can’t wait to try (Cialis),” said the man, who has suffered from erectile dysfunction for 30 years and experienced side effects with Viagra. “One of the things I have discovered with Viagra is that you take the stuff and you have your hour to wait before it is going to work and then the bait doesn’t work? Then your system has the stuff in it, you have the side effects” even when you don’t have sex. “It is frustrating.”

While Cialis has been used by more than 1 million men in Europe, South America and Australia, it is still relatively new. And as with any new medication there remains some uncertainty. To take a bite out of the Viagra franchise, Cialis must prove that it is just as safe as its rival.

“The thing you can always say about Viagra is that it must be safe, because everybody and their brother was taking it when it first came out,” said Larson, the Seattle sexual therapist. “Any medicine that comes after it has to compete for safety to make it worth it.”

Introduced in 1998, Viagra now accounts for $1.7 billion in annual sales. About 23 million men have popped the $10 pill, including former U.S. Sen. Bob Dole and baseball player Rafael Palmeiro. The drug, approved in 120 countries, is one of Pfizer Inc.’s best-selling medications. While Pfizer spokesman Daniel Watts admits that some men will be curious about Cialis, he thinks they will eventually come back to Viagra.

“Viagra is true blue,” said Watts. “It has been out for five years. Men can count on it and they know what side effects they are going to get, which is not much.”

He also discounted the importance of the 36-hour effect of Cialis.

“It is not like there is a marathon session that is requiring a drug for 36 hours,” Watts said. He added that there are no plans at Pfizer to try to increase the time that Viagra stays in the bloodstream.

Research indicates that Viagra may be tough to dethrone. According to a study presented at the Society for Sexual Medicine this week, only 21 percent of men preferred Cialis and Levitra to Viagra.

“Most long-term users of Viagra find the medicine works for them and are content to stay with the treatment,” said Hubert Claes, author of the study and a doctor with the University Clinic in Gatuisberg, Belgium. Research by Pfizer shows that 96 percent of men are satisfied with the drug.

But Cialis already has won more than 20 percent of the market in Europe and Australia, where it has been sold for less than 10 months. And further research by Lilly and Icos indicates that up to 50 percent of men chose to wait 12 hours or more before engaging in sex after taking the medication.

“Patients really want the freedom to choose the moment for their intimacy,” said Clark, a former vice president at Abbott Laboratories. “They don’t want to have their sexual actions controlled by the clock. Market research study after market research study has told us this.”

Cialis works by relaxing blood vessels in the penis, allowing increased blood flow that causes an erection. Like Viagra and Levitra, it does have several side effects and restrictions. The drug should not be used in combination with nitroglycerin tablets or medicines used to treat high blood pressure. It is also not recommended for men who have suffered a stroke or heart attack in the past six months. Side effects include headache, indigestion, back pain, muscle aches, flushing and stuffy nose. A small number of patients also have experienced blurred vision, according to the FDA.

Now that Cialis has won approval in the largest market for erectile dysfunction, Clark said, the company is ready to begin its next phase. A marketing blitz will begin in the coming months, with television advertisements and sponsorship of the PGA Tour. Icos also has hired a 165-person sales staff to start calling on doctors.

Clark said he is ready to compete against Viagra — the drug that put erectile dysfunction on the map.

“We have already taken them on in Europe … and literally in only a few months we have achieved those impressive market share (numbers),” said Clark. “And we are quite excited about getting going in the U.S. It is a tremendous opportunity for us.”