Pfizer Drug Settlement Fails

Settlement talks between Pfizer and Nigerian officials broke down last weekend after members of the families of children left injured or dead following a Pfizer drug trial in the West African country more than a decade ago turned down a $10 million compensation offer from the pharmaceutical company.

About 200 Nigerian families who contend their children were harmed rebuked an offer of $10,000 to each victim with “minor deformities” and $100,000 to each victim with “major deformities” or death arising from the Trovan drug test of 1996, the Nigerian Daily Trust reported.

Officials called the offer “demeaning” and “amazing,” based on the company’s offer to pay $21 million for the settlement of all legal fees incurred by both parties in the case, the newspaper reported.

Pfizer contends that the company actually saved lives during the drug trial, and there is no evidence showing that Trovan actually caused deformity or death.

The clinical drug trial was the subject of a 2000 Post investigation by The Post’s Joe Stephens titled “The Body Hunters,” which examined drug trials conducted by American corporations in the poorly regulated developing world.

Six years later, a panel of Nigerian medical experts concluded that Pfizer violated international law by testing an unapproved drug on children with brain infections at a field hospital, a lengthy government report given to The Post showed.

Authorities in Kano, the country’s largest state, last year filed eight criminal charges related to the 1996 clinical trial, including counts of criminal conspiracy and voluntarily causing grievous harm. They also filed a civil lawsuit seeking more than $2 billion in damages and restitution from Pfizer.

Taking Viagra for sports risky

For those young jocks or even middle-aged weekend warriors thinking about taking Viagra to help their performance on the field, be careful.

In the wake of a report in the New York Daily News that claimed Roger Clemens, Barry Bonds and other star athletes took Viagra to help them athletically — and not just in the bedroom — experts cautioned men from going overboard popping the “male enhancement” pills.

Experts said the drug should be used only after consultation with a doctor. Even then, the potential side effects of the drug if used regularly during strenuous athletic activity are largely unknown. And the long-term effects aren’t well understood, which would make it risky for budding athletes — preteens or teenagers — to try it.

“It’s unwise and potentially incredibly dangerous to be taking it without consulting a doctor,” said Scott Eggener, an assistant professor of surgery and urology at the University of Chicago.

Among the hazards, Eggener said, is that the drug, which increases blood flow by dilating blood vessels, can reduce blood pressure. Someone who is not properly hydrated, or taking nitrates for a heart condition, could be at risk.

“When mixed with other drugs, medicines like Viagra could kill you,” said Michael Terry, an assistant professor of medicine at the U. of C. Other side effects include headaches, dizziness and light-headedness.

Other situations could cause problems as well.

“It can cause dangerous drops in blood pressure if you drink a lot of wine, take Viagra and sit in a hot tub,” said Najah Musacchio, an assistant professor of pediatrics at Northwestern, who studied recreational Viagra use.

But for someone who only uses it occasionally and has no other health condition, “it seems to be a pretty safe drug,” Musacchio said.

Currently, no professional sports body bans the use of Viagra or its active ingredient, sildenafil citrate. Neither the Illinois High School Association nor the National Collegiate Athletic Association restrict its use.

But the World Anti-Doping Agency is funding a study at the University of Miami to determine whether taking the drug helps cyclists pedaling at high altitudes.

An earlier study out of Stanford found that the drug can boost athletes’ performance in higher altitudes, because it increases the delivery of oxygen to muscles in the body. However, the small study did not find a benefit under normal conditions.

Eggener said the lack of data on the drug’s impact on preteens or teenagers make it impossible to know what impact taking it would have on physical development.

Terry, who is the team physician for the Chicago Blackhawks and also a doctor for the U.S. Olympic Men’s Volleyball team, said while the drug has only recently become a topic of discussion among mainstream athletes, “people who are riding that edge or on the wrong side of the line have been talking about it for a while.”

Whether that has trickled down to student athletes remains to be seen. Vince Carter, coach of the Von Steuben High School boys basketball team, said he’s still more concerned with athletes drinking alcohol or smoking marijuana.

But “there is always something new,” he said. “You have to keep up with the kids because they’ll start doing it.”

Steroid accused says he’s ahead of his time

A man charged after a massive seizure of steroids in Waterloo Region was refused bail yesterday.

In ordering Fernando Reis held in custody, Justice of the Peace Andrew Marquette said the trafficking of steroids is a public safety issue.

“There are problems with steroids in society,” he said. “Young people have a tendency to try steroids to enhance their looks.” This is a problem because of the lack of quality control over the drugs Reis allegedly had with him and because of the potential abuse of the drug, Marquette said.

Reis, 46, faces 35 charges, including possessing steroids for the purpose of trafficking and trafficking steroids. Waterloo Regional Police and the RCMP arrested him in April after raiding a Kitchener home, where they seized a huge quantity of steroids packaged in cardboard boxes.

Police also found drugs at a U-Haul storage unit on Fairway Road and at 707 Black Cherry St. in Waterloo. Steroids speed muscle growth and are linked to performance enhancement in bodybuilding and other sports.

Along with the steroids, police seized counterfeit Viagra and other drugs used for erectile dysfunction. Reis is also charged with possessing ephedrine for the purpose of trafficking. It’s a chemical derivative of the herb ephedra, often used by bodybuilders to lose weight and increase energy.

Reis was more recently charged with four counts of importing steroids and possessing the proceeds of crime.

In arguing Reis should be released on bail, lawyer Devin Bains said his client isn’t charged with trafficking heroin or cocaine.

“Even though these things are bad, they sit on the lower range of things when it comes to trafficking,” he said. “Nobody is suggesting people walking around with muscles or erections are dangerous . . . .”

But the justice of the peace noted that when the RCMP got a warrant to search the storage unit, they allegedly found Reis and two other men who seemed to be there “to clean out the unit.” Marquette also noted Reis was convicted in 1997 of 31 counts of trafficking, “similar to what we’re dealing with right now.”

He was concerned Reis has said he wants to go to the Bahamas and continue his “hobby” of selling steroids and other products as a business there. Federal prosecutor Catrina Braid argued Reis is a flight risk.

Yesterday, Reis defended the substances he sold in 1997, painting himself as a man before his time who was really acting for the public good.

He was charged under the Food and Drug Act after being accused of manufacturing illegal drug products and distributing them through a mail-order business. He got an 18-month jail sentence after pleading guilty to more than 30 counts of violating the Food and Drug Act.

Among other things, Reis sold diet aids, cancer remedies, a cure for hypothermia, cures for impotency, anti-aging products and vitamins.

“The products I was wrongfully convicted of have now been legitimized,” he claimed. “I spent 21 months in jail for selling things that are now legal that the public is benefitting from.”

He cited glutamine and creatine as two examples of the “food supplements” he sold.

“You felt you were doing something to help the community,” Braid suggested. “So you’re a pioneer in the health field?”

“I may have been,” Reis said.

The little pill that launched a second sexual revolution: Viagra turns 10

Ten years ago this month, erectile dysfunction — a once-whispered-about disorder — did more than just come out of the closet. ED, as it’s now known, began strutting across America’s television screens.Bob Dole started talking. Then the grandfatherly former senator stepped aside and NASCAR drivers took over. Then a middle-aged garage band soon crooned, “Viva Viagra!”

The U.S. Food and Drug Administration approved the Pfizer-made drug Viagra in March 1998 to treat erectile dysfunction, a disorder gussied up with a new name (impotence was out) and a sophisticated advertising campaign. An extremely private matter suddenly seemed everywhere.

Since then, more than 35 million men worldwide have taken the drug. Viagra has spawned a new class of drugs, greater insight into men’s health, an effort to find similar drugs for women — and, yes, a rash of Jay Leno jokes.

To some, Viagra has started nothing less than a second sexual revolution. The massive effort to sell the drug knocked down barriers to talking about a once-taboo subject: sex and aging.

“These drugs have been the gateway to allow patients to have open communication with doctors and their partners about sexuality,” said Terrie Ginsberg, a physician at the New Jersey Institute for Successful Aging. “Doctors have opened up, too. These drugs have helped us explore the myth that people over 50 are not sexual.”

Physicians say the value for patients cannot be overestimated. Many men with prostate cancer discovered they could enjoy sex again. So did many, but not all, men with diabetes or cardiovascular disease.

“Before these drugs, all we had was a vacuum pump, surgery or herbal things that didn’t work,” said Stuart Shoengold, chairman of the urology department at Newark (N.J.) Beth Israel Medical Center. “So most men lived with the situation. It was hard for primary-care physicians even to talk about erectile dysfunction because they had nothing to offer.”

(On the negative side, some older women began to complain that, with Viagra, their husbands had become much more interested in sex than they were.)

How it was developed

The blockbuster drug — $1.7 billion in sales last year — was not one that Pfizer ever set out to create. In the 1980s, Pfizer scientists in Sandwich, a small town on England’s southeastern coast, theorized that blocking an enzyme called PDE5 could expand blood vessels and treat angina caused by reduced blood flow to the heart.

They began testing the drug on volunteers in the 1990s. But the drug had a short life and volunteers needed to take the medication three times each day, causing side effects such as muscle aches. Yet men also began reporting another side effect: unexpected erections.

Pfizer switched tracks. The company began testing the drug specifically on men with erectile dysfunction.

“The results were quite amazing,” said Peter Ellis, a Pfizer scientist who worked on the drug’s development. At the end of the study, many volunteers did not want to return unused pills. Ellis recalls a letter from a 44-year-old man with Parkinson’s disease who said he could once again make love to his wife.

“It was like throwing a drowning man a life preserver and then pulling it back,” Ellis recalled. “But feedback like this made us think we needed to provide this drug to people who needed it.”

More than 10 years after the PDE5 inhibitor project began, Pfizer asked the U.S. Food and Drug Administration and other regulatory agencies around the globe to let the company sell the drug, marketed as Viagra.

New view of dysfunction

Viagra and two similar drugs that followed, Cialis by Eli Lilly & Co. and Levitra by Schering-Plough, have changed the way physicians and psychologists treat, and even view, sexual dysfunction.

“The drugs have ushered in an era of looking at sexual problems from a medical perspective instead of from a psychological perspective,” said Margaret Nichols, a sex therapist and founder of the Institute for Personal Growth, a mental health organization.
Nichols said she still treats men with erectile dysfunction, which can be complicated by psychological issues. “We see the more complicated cases … But for a lot of men, whatever psychological issues they have can be overridden with Viagra,” Nichols said.

Pfizer scientists said their research showed that erectile dysfunction — like the canary in the coal mine — is often an early indication of other health problems, such as diabetes, hypertension, high cholesterol or cardiovascular disease.

“ED can be a warning sign. This was not really known but is now established and accepted,” said Teresa Griesing, senior medical director of Pfizer’s Global Viagra team. For instance, Pfizer cited one study that found 64 percent of men hospitalized for heart attack experienced prior erectile dysfunction.

Changes for women

The changes sparked by Viagra have spilled into women’s health. Nichols, the sex therapist, said psychologists now are more likely to look at women’s sexual dysfunction, such as painful intercourse or low sex drive, from a medical viewpoint and not simply assume the women are experiencing psychological distress.

Pharmaceutical companies are searching for the female equivalent of Viagra to treat female sexual dysfunction, or FSD, but treating women appears far more complex. Pfizer tested Viagra on women and abandoned the effort. Hormonal patches, some containing testosterone, have failed to gain FDA approval for treatment of female sexual dysfunction.

Yet drug companies continue research, spurred on by estimates that the market for treating female sexual dysfunction could reach $5 billion in the United States alone.

Women’s sexual disorders get medical attention in new Stanford program

Medicine is finally opening the bedroom door to women. When the male erectile dysfunction drug Viagra was approved by the U.S. Food and Drug Administration in 1998, many middle-aged men experienced a new lease on life, or at least on life in the bedroom.

The women who were their partners, however, were not included in this revolution, even though many were old enough to be starting their own sexual decline.

Although many groups began calling for a “female Viagra,” they met skepticism. Long after the term “female sexual dysfunction” was coined in 1997, some doubted its existence; a 2006 article in PLoS-Medicine flagged the dysfunction as an example of disease mongering by pharmaceutical companies.

Now the new Female Sexual Medicine Program at Stanford Hospital & Clinics has put that attitude aside.

“Five years ago, when I suggested we start this program, people said ‘Why? There are so many other important things in medicine,’” said Leah Millheiser, MD, an instructor in obstetrics and gynecology at the Stanford School of Medicine, and founder and director of the program. “My response was that if this is such a common problem, and it’s relatively easy to treat, why are we keeping it in the closet?”

Female sexual dysfunction affects 43 percent of women, yet it continues to be one of the most underdiagnosed medical problems in the United States. It is classified by four disorders: lack of sexual desire, the inability to become aroused, lack of orgasm (or sexual climax) and painful intercourse.

“These problems are underdiagnosed, underreported and undertreated. They deserve a lot of attention,” said Jonathan Berek, MD, professor and chair of Stanford’s Department of Obstetrics and Gynecology.

Millheiser said she started the Female Sexual Medicine Program after recognizing there were no other programs or fellowships available to medical students in the Bay Area on how to manage women’s sexual dysfunction. This multidisciplinary program integrates gynecology, urology, primary care, mental health, pelvic-floor physical therapy and sex therapy. It also includes clinical research-to understand how sexual well-being is affected after a woman is diagnosed with cancer or undergoes chemotherapy.

“We have an opportunity at Stanford to develop a program in an area that is frequently overlooked by practitioners in California and throughout the country,” said Berek. “We can and will be a leader in this very important area.”

Millheiser said there is often a strong disconnect between how a woman feels about sexual function and what she tells her physician in a typical 15-minute, once-yearly gynecological visit. The purpose of the program is to provide women with the education and therapy they need to take back control of their sexuality and sexual function.

“There is a ‘don’t ask, don’t tell’ policy about sexual dysfunction in managed care, as many physicians simply do not receive the training for discussing sexual dysfunction,” said Millheiser. “If a patient doesn’t feel her doctor is open to the topic of sexual dysfunction, she may not relay that information. A sexual complaint can be a marker of serious underlying disease, which is why it’s so important for a patient to tell her doctor so it can be further explored.”

According to the National Institutes of Health, sexual dysfunction in women can result from a variety of medical conditions such as diabetes, heart disease, nerve disorders or hormone problems. Medication, work-related stress and anxiety may also affect desire and function.

Cultural or religious beliefs may also impact sexual behavior, Millheiser said. For example, being told sex is bad or evil may imprint messages in a woman’s mind that won’t allow her to experience sexual pleasure, even while in healthy relationships. “The brain simply won’t allow you to relax,” she said. “We want to remove these barriers and have these women view sex as a normal part of a healthy relationship.”

Millheiser said the program, which is housed in the gynecology practice at the Blake Wilbur Building, has drawn patients of all ages who are seeking basic answers about sexuality. In addition to her work at Stanford, she also lectures around the nation and is a regular contributor on radio and television programs such as “The View from the Bay” on ABC-7 News.

Viagra works for man and animal

Anti-impotence drug Viagra has given a ‘new lease of life’ to a dog suffering from a heart condition.

Talisker, a three-year-old border collie, developed heart problems after contracting a lung infection.

This meant that whenever he got a little too excited, he would lose consciousness as his heart was not pumping blood fast enough.

Owner Lesley Strong admits that though she had been ’shocked’ when the vet told her to give her pooch Viagra, it certainly worked wonders for her beloved pet.

“I was shocked when the vet recommended Viagra and it raised a few eyebrows when I first collected the prescription. But it’s given Talisker a new lease of life,” the Telegraph quoted her.

Ignition Locks Prevent Repeat DWI Offenses

 Breath-testing devices thatprevent a vehicle from starting if the driver’s blood alcohol levelexceeds a preset limit can dramatically reduce more DWI offenses amongfirst-time offenders, a new study shows.First offenders with “interlock” devices installed on their cars were60 percent less likely to have a repeat offense than those who did not usethe devices, according to findings published in the current issue ofTraffic Injury Prevention.”This study on first-time offenders reinforces prior studies on thisissue that show a 65 percent reduction in drunk driving while interlocksare installed,” Paul Marques, of the Pacific Institute for Research andEvaluation, said in a prepared statement.The findings may help resolve questions about whether interlocks workas well with first-time offenders as with repeat offenders. Two earlierstudies had questioned their effect, but the researchers noted that inthose studies, only a small proportion of those required to install theinterlocks actually did.In the new study, researchers examined the records of 1,461 first-timeDWI offenders in New Mexico who had interlocks installed in their vehiclesand compared them with 17,562 first-time offenders in the state whodidn’t use the devices. The two groups were matched by age, gender andblood alcohol concentration at the time of arrest.”The average first offender has driven drunk many times before he orshe was arrested. The big risk difference is between non-offenders andfirst offenders. The risk difference between first offenders and repeatoffenders is small by comparison,” Marques said.This research — funded in part by the Substance Abuse Policy ResearchProgram of the Robert Wood Johnson Foundation, a philanthropicorganization that focuses on health and health-care issues — also citedpossible economic benefits to vehicle interlocks.One device cost the offender $2.25 per day, leading the authors toestimate that for every dollar spent on interlocks for first offenders,the public saves $3 in damage and destruction caused by DWI crashes.”Interlocks present an opportunity to help change behavior rather thansimply punishing or incarcerating the offender,” Marques said. “It’s notenough to revoke a license — 75 percent of all people with revokedlicenses drive anyway — but you don’t want to sentence an entire familyto poverty if they’re dependent on that driver getting to and from his orher job. By installing an interlock, the risk that the DWI offender posesis controlled, and interlocks become a public benefit.” Only about 10 percent of arrested DWIs nationally are ordered a periodof interlock-controlled driving, Marques said. Four states mandateinterlocks for first DWI offenses: New Mexico, Louisiana, Arizona andIllinois (effective in 2009).The National Institute on Alcohol Abuse and Alcoholism offers has moreabout preventing alcohol abuse.

HEPA Filters May Improve Cardiovascular Health

 A breath of filtered indoor air mayhelp your health, according to researchers in Denmark.Using high efficiency particle air (HEPA) filters for just two dayssignificantly improved a key measure of cardiovascular health in healthy,nonsmoking elderly individuals, according to a study published in thesecond February issue of the American Journal of Respiratory andCritical Care Medicine.”Our main finding was a significant improvement in the function ofsmall finger blood vessels after reduction of indoor air particles. Thiseffect most likely indicates a general improvement in the function of theinner lining of small vessels, including those supplying the heart,” Dr.Steffen Loft, of the Institute of Public Health in Copenhagen, said in aprepared statement.Abnormal function of the inner lining of small vessels is known to be apredictor of dangerous or possibly fatal cardiovascular events.HEPA filtration removed about 60 percent of the ultrafine, fine andcoarse air particles in homes, according to researchers, and wasassociated with an 8.1 percent improvement in individual microvascularfunction (MVF).”This suggests that indoor air filtration represents a feasible meansof reducing cardiovascular risk,” he said.The researchers measured ambient airborne particles in the homes of 21nonsmoking couples, aged 60 to 75, who lived close to heavily traffickedroads. Each couple used air purifiers for two 48-hour periods. During oneperiod, the purifier was equipped with a HEPA filter, and during theother, it ran without it. The size distribution and number concentrationof indoor air particles in each home were continuously monitored.Each couple’s individual MVF was assessed using a noninvasive fingersensor.”We expected that removing air particles with the HEPA filters wouldresult in improvement of MVF, but we were heartened and surprised by theextent it did, considering the modest levels of particles in the indoorair of the homes of the elderly,” Loft said.The U.S. Environmental Protection Agency has more about improving indoorair quality.

Unlike Fine Wine, Crabby People Don't Age Well

There’s new evidence thatgetting along with others is more than a key to pleasant humaninteraction. It also appears

to be good for your health. Researchers who studied a survey of almost 700 older adults found thatthose who got along with their relatives, friends and neighbors were lesslikely to report health problems and physical limitations.The findings don’t prove a cause-and-effect relationship between sociallife and health. Still, “the take-home message is that conflict in yourlife may have important impacts on your physical health,” said study leadauthor Jason T. Newsom, associate professor at the Portland StateUniversity School of Community Health in Oregon.There’s nothing really new about a supposed link between attitude andhealth, but Newsom said his study was unique, because it lookedspecifically at interactions between people. Newsom and his colleagues looked at the results of a multi-yearnational survey of people aged 65 to 90. A total of 666 people completedthe survey, in which researchers asked them questions about their livesand their health.Many of the questions were designed to reveal whether the studyparticipants were prone to have “negative social interactions” with otherpeople, Newsom said. The questions asked whether “people have interferedor meddled in your personal matters, have they acted unsympathetically orbeen critical of you. We asked them in a very general way,” he said.The survey didn’t ask whether the participants were the instigators ofnegative encounters — by being crabby or cranky, for instance — or thevictims of others who made their lives difficult.The researchers found that those who reported more negative socialencounters suffered greater declines in health. “What we suspect is that there’s some impact on the immune system, butthere are other kinds of things that might be happening as well,” Newsomsaid. “It may be that when there’s a great deal of interpersonal conflictgoing on in someone’s life, they’re not able to take care of medicalconditions as well.”The findings were published in the journal HealthPsychology.The study authors noted that their research had limitations. It onlylooked at senior citizens and relied on their own estimates of theirhealth status instead of physical examinations, for one, and only examinedchanges over two years. Janice Kiecolt-Glaser, director of the Ohio State University College ofMedicine’s Division of Health Psychology, said the new study came from “agroup of excellent investigators.” But, she added, she would like to haveseen more analysis of whether the study participants were depressed. “When people are blue, they tend to be overly sensitive to negativeinteractions, to feel that others are often unsympathetic — and then theybehave in ways that tend to elicit even more negative behaviors fromothers,” Kiecolt-Glaser said. “They’re cranky and critical andcantankerous. If you’re seeing the world through dark-colored glasses,you’re more likely to focus on how unsympathetic or insensitive otherpeople act toward you, and there’s a big element of self-fulfillingprophecy.”Newsom acknowledged that it’s no easy task to make people get alongbetter. But, he said, studies have shown that one approach –conflict-resolution training — actually works. To learn more about conflict-resolution training, visit the University of Wisconsin.

Blacks Awaiting Lung Transplants Face Poorer Outcomes

Blacks awaiting a lungtransplant during a recent 10-year period were less likely to receive anew lung and more likelyto die or be removed from the transplant listthan whites, according to researchers.The findings, published in the second February issue of the AmericanJournal of Respiratory and Critical Care Medicine, also showed thatblacks on the transplant list between 1995 and 2004 were more likely tolack private insurance, live in poorer neighborhoods, and have greatercardiovascular risk factors, such as diabetes and pulmonary hypertension.However, these factors did not account for the findings.These disparities are consistent with those observed among patientsawaiting kidney and liver transplantation and among patients with otheradvanced lung diseases such as pulmonary arterial hypertension andpulmonary fibrosis, lead researcher Dr. David Lederer, of ColumbiaUniversity Medical Center, said in a prepared statement. This finding wasindependent of age, lung function, cardiovascular risk factors, transplantcenter volume, type of health insurance coverage, and neighborhood povertylevel.The researchers assessed the 280 non-Hispanic black adults and 5,272non-Hispanic white adults diagnosed with chronic obstructive pulmonarydisease (COPD) or emphysema who were on the United Network for OrganSharing lung transplantation list between 1995 and 2004. The investigatorstracked the outcomes (death, transplantation, removal from the list orstill living) of those on the list and analyzed the results with respectto age, sex, disease severity, community poverty level and transplantcenter volume.While the organ allocation system in place during the study period hasbeen replaced with one that prioritizes patients based on the survivalbenefit of transplantation, Lederer said the effects of poor insurance andpoverty will likely still place blacks at increased risk for removal fromthe list or death.Also, researchers were surprised at the low number of blacks that evenmade the list. “Based on what we know about COPD, we expected that twiceas many black patients would have been put on the lung transplant waitinglist. Our findings point to significant barriers to accessing lungtransplantation for minorities,” Lederer said. “These findings shouldalert primary-care physicians and pulmonologists to consider referral ofblack patients with COPD for transplantation at the earliest signs ofadvanced disease.”The National Heart, Lung, and Blood has more about chronicobstructive pulmonary disease.