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May 1, 2000 (Washington, D.C.) — Pietr Hitzig, MD, never listened to Alvin Chernov’s heart. In fact, he never even met him, let alone checked his blood pressure or pulse. Yet in March 1997, via his Internet web site, the Maryland physician diagnosed the 25-year-old Arizona man with stress-related depression and prescribed two powerful muscle relaxants for him, as well as the diet drug widely known as fen-phen.

Chernov received none of the careful monitoring routinely advised for patients on these drugs and, over the ensuing months, developed a pattern of behavior so bizarre that family members complained to both Hitzig and the Arizona Board of Medical Examiners. Six months later, Chernov committed suicide with a handgun. Family members attribute his death to the wild mood swings brought on by the drugs.

Last July, Hitzig, 56, was indicted on 34 federal charges of prescribing medicine illegally between 1996 and 1998. His indictment was just one skirmish in what many law officials say could become an all-out war on drug-peddling web sites. While some sites distribute drugs both ethically and legally, the vast majority of the estimated 400 online pharmacies are mailing prescription drugs, like Viagra (for impotence) and Propecia (for hair loss), to anyone with a credit card who is willing to fill out a simple questionnaire.

Medical experts complain that such practices expose patients to doses of drugs that, depending on their personal medical histories, could be lethal or cause them to become extremely ill.

Regulators point to the case of Robert McCutcheon, a 52-year-old Illinois man who had a family history of heart problems. Without seeking the counsel of his doctor, he ordered Viagra over the Internet. In March of last year, after drinking a few beers on the way home from work, he went to his girlfriend’s house, popped a Viagra, and died of a heart attack while having sex.

Merck vigorously warns expectant mothers not to even handle its Propecia pills for fear of birth defects. But Lisa Meiners, an assistant attorney general in Missouri, was able to order the drug — in a sting operation — from a Texas online pharmacy despite being 26 weeks pregnant at the time. Missouri later barred the pharmacy from doing business within its borders.

Online buyers might also find themselves obtaining defective, potentially dangerous drugs. “Americans can, unwittingly, order prescription drugs from rogue web sites that appear to be companies, but are actually overseas sites offering drugs that are unapproved, counterfeit, contaminated, expired, mislabeled, in unapproved facilities, or not stored or handled in a proper manner,” says Sen. James Jeffords (R-Vt.), the chairman of the U.S. Senate Committee on Health, Education, and Labor.

Jan. 2, 2001 — There’s no doubt about it: Viagra is one of the most popular and best-selling drugs ever to hit the pharmacy. Since it first appeared on the market in 1998, more than 20 million have been written for it. But while countless men have bade farewell to impotence or erectile dysfunction, others have found that Viagra does not work well for them. For these men, good news may be on the way, as researchers have discovered yet another promising treatment for sexual dysfunction.

“Many different types of treatments exist for men with erectile ,” says Craig , MD, FACS, who explains that much of Viagra’s popularity is credited to the fact that it can be taken as a pill.

Other treatments, he adds, are less convenient and may involve injection of medication directly into the penis. Niederberger, who was not involved in the recent research, is chief of the division of andrology at the University of Illinois, in Chicago.

“Traditionally, treatments for erectile dysfunction have focused on the processes that turn on smooth muscle relaxation and produce erection, rather than by blocking the contraction of smooth muscle,” says study author Christopher J. Wingard, MS, PhD. In their study, which appears in the January issue of Nature Medicine, Wingard and his colleagues looked at the latter process.

When men are sexually aroused, blood flow into the penis increases, filling up spongy cylinders called corpora cavernosa. When the cylinders fill with blood, the penis hardens and becomes erect. Acting like flood gates, muscular blood vessels called arterioles control the flow of blood into the penis. A chemical called nitric oxide is a signal for the gates to open, and Viagra works by increasing the amount of nitric oxide, signaling the gates to open and increasing the blood flow.

Researchers from the Medical College of Georgia, in Augusta decided to explore a different approach. They found that an enzyme called Rho-kinase is present in the spongy cylinders. Elsewhere, this enzyme enhances the activity of muscle, like the muscle in those flood gate muscular vessels. The researchers reasoned that if they inhibited the activity of this enzyme, the muscle would relax, opening the flood gates.

Sure enough, it worked. They injected a drug called Y-27632, a known inhibitor of Rho-kinase, into the spongy cylinders of rats, causing penile erections. In further testing, they showed that the Rho-kinase inhibition worked completely independently of the way Viagra works.

It’s estimated that about half of all American men between the ages of 40 and 70 are affected with impotence to some degree, and the underlying causes vary. Sometimes, psychological reasons or lifestyle factors, such as excessive alcohol consumption, can lead to impotence. However, a persistent problem is usually due to a chronic illness or a side effect of certain drugs.

“Viagra has proven effective in 60-70% of the general population and only about 40% effective in specific groups like diabetics who have some form of erectile dysfunction,” says Wingard. “Thus, it appears that we have a new angle on developing a therapeutic treatment of erectile dysfunction that does not rely on the action of the nitric oxide pathway.”

“The type of drug studied in this article uses an entirely new pathway to cause erections in animals, and opens the door to many new possible drugs,” says Niederberger. “If the studied drug is used in the future, it may add to the list of drugs used in direct injection.”

So, while the need exists for a wider range of therapies, and the news of this research is encouraging, it is still too early to tell whether Y-27632 will sit beside Viagra on the shelves of the local pharmacy.

While this work examined an injectable form of Y-27632, says Wingard, current research efforts have been focusing on using it in a topical form. If this method proves a viable means of the compound, he says, “It could lead the way for the development of a new drug treatment of erectile dysfunction.”

The study was supported by grants from the National Institutes of Health, the American Heart , and the American Health Assistance Foundation.

Aug. 1, 2000 — Daily doses of Viagra may ease the pain of diabetes — but not the way you might think. Animal studies hint that the male impotence drug reverses one of the worst miseries of diabetes: The stomach’s refusal to empty after meals.

The problem affects as many as half of all diabetics and some three-fourths of those who have had diabetes for more than five years. Called gastroparesis, the occasional illness causes bloating, pain, appetite loss, and sometimes fits of vomiting. Currently, there is no effective long-term treatment in the U.S. — especially since Propulsid, the most commonly used drug, has been withdrawn from the market due to safety concerns.

The new findings turn current thinking about gastroparesis inside out. “Maybe we have been thinking about it wrong,” lead researcher D. Ferris, MD, PhD, tells WebMD. “They called it gastroparesis, which means ’stomach paralysis,’ because they thought the stomach failed to squeeze stuff out. But now we know it is failure to relax — we’ve kind of turned it around.”

Ferris and co-workers at Johns Hopkins in Baltimore discovered something unusual in the muscle that opens and closes the bottom of the stomach. Using laboratory mice with diseases that mimic human diabetes, they found that emptying food from the stomach depends on the ability of nerve cells in this muscle to process an important chemical. This same problem — in a different muscle, of course — afflicts men whose impotence can be relieved by Viagra.

When Ferris’ team gave Viagra to the mice, it prevented the animals from developing stomach problems. Because gastroparesis in the mice was strikingly similar to gastroparesis in diabetic patients — and because Viagra already is an approved drug — Ferris says he will begin human studies in September or October of this year. Should these trials prove the treatment is safe — a major question, as diabetics are prone to heart disease and Viagra can be dangerous in heart patients — larger human studies will follow quickly. Such studies will be centered at Vanderbilt University in Nashville, Tenn., with which Ferris now is affiliated.

Should Viagra prove safe and effective, its cost will be a major issue. Insurance companies already are about supplying more than six of the popular blue pills each month. Diabetics would need at least one pill per day — and those with severe cases would need three pills each day.

Ferris warns patients not to try this treatment at home until the studies can be completed. “I would caution consumers that any drug treatment is not without potential side effects,” he says. “With Viagra, there is a particular concern for patients with heart disease, which is very common in diabetics. People need to be cautious that these studies have been done only in mice, not in humans. History is littered with things that work great in mice and then never pan out. Also, Viagra is expensive. To spend a lot of money on a drug that may not help is not wise.”

The new studies also will have to prove that accepted theories about why stomachs fail to empty are wrong. William W. Webb, MD, who disagrees with the Ferris study, tells WebMD that the muscle at the base of the stomach — known as the pylorus — is supposed to work perfectly well in diabetic patients.

“Relaxing the pylorus is not usually the problem,” says Webb, a gastroenterologist at Henry Ford Hospital in Detroit. “The pylorus usually works fine … It’s not an open drain problem, but failure to push stuff out of the stomach.”

Feb. 8, 2002 — Viagra, the drug best known for reviving men’s sex lives, may also the brain, according to new research. An animal study suggests that the anti-impotence drug can reduce the effects of stroke by helping the brain heal itself.

“What we found is that we can use certain drugs like Viagra to create new brain cells,” said study author Michael Chopp, PhD, scientific director of the Neuroscience Institute at Henry Ford Hospital, in a news release. “And these cells are created in both elderly as well as young subjects.”

Chopp presented his research today at the 27th International Stroke Conference in San Antonio, Texas. He says Viagra was selected for testing in stroke treatment because it is chemically similar to other compounds that have been shown to improve brain function in animals after stroke.

In the study, gave rats Viagra for six days after inducing an ischemic stroke (the most common type of stroke caused by a blockage of an artery that supplies blood to the brain). After 28 days, they found the rats that received the drug grew more new brain cells. The Viagra-treated rats also performed better on agility, sensory, and muscle function tests.

“When animals are treated with Viagra, the drug provides very significant … benefit to the brain. These animals do better on many different outcome measures,” said Chopp.

say additional studies have also shown that Viagra given one day after stroke reduced function problems in animals.

However, human clinical trials to test Viagra as a treatment after stroke are still a long way off. testing is needed to determine the best time for treatment and screen for adverse effects in rats.

March 14, 2000 (Anaheim, Calif.) — New research shows that 522 patients have died while taking Viagra (sildenafil) in the first year the drug was on the market. Since its introduction in March of 1998, more than 12 million prescriptions of the blockbuster treatment for erectile dysfunction (ED) have been written. There are continued concerns that the drug could trigger heart problems in some users; already it is not recommended for patients taking nitrates for this reason.

“Our data appear to suggest that there’s a relatively high number of deaths and adverse cardiovascular events associated with the use of Viagra. I want to emphasize that in no way are we trying to imply a cause-and-effect relationship,” lead researcher Sanjay Kaul, MD, a critical care at Cedars-Sinai Medical Center in Los Angeles, tells WebMD. Kaul presented his findings here Tuesday at the 49th Annual Scientific Session of the American College of Cardiology.

Kaul got his numbers by lodging a Freedom of Information Act request with the FDA. Overall, he found 1,473 major adverse events in the agency’s database related to Viagra. For instance, in addition to the 522 deaths, Kaul noted 517 patients who experienced heart attack or anginal chest pain when using the drug.

However, it’s difficult to interpret the data without comparing them to a similar population not taking the drug, and that’s why Kaul says that additional research is necessary. In the meantime, he says there’s no reason to panic.

“The most important message is that in most patients at low risk, Viagra is generally safe. However, you need to evaluate the patient’s cardiac risk before you prescribe Viagra,” says Kaul.

Meanwhile, another Viagra study presented here Tuesday came to a very different conclusion. This research, done in collaboration with Pfizer, Viagra’s , compared some 4,500 patients taking the drug to about 3,100 on placebo. The bottom line is that the rates of heart attack and death in men with ED treated with Viagra were low, and there wasn’t any real difference between the groups.

“It’s reassuring that … in general, for most patients, even those with existing coronary heart disease … resuming sexual activity is very unlikely to trigger a coronary event,” says lead researcher Murray A. Mittleman, MD, an internist and preventive cardiologist at Beth Israel Deaconess Medical Center in Boston.

Mittleman says that the FDA database is better at spotting unusual events than seeing aberrations in common conditions like heart attacks. However, the agency concedes that drug problems are drastically underreported, with perhaps only one in 10 eventually getting the FDA’s attention.