EVERYBODY GETS garden-variety tension headaches, but certain types of brain pain affect men more than women. Experts don't fully understand why, but stereotypical theories abound. Everything from business stress, tobacco and alcohol use and heavy lifting to overexertion at the gym have been blamed for male headaches. Whatever their origins, male headaches can range from mild to severe--and sometimes even debilitating. However, relief is at hand: There are several traditional and natural ways to mitigate these male-centric maladies.
Cluster busters
Of the 1 million Americans who suffer from cluster headaches, about 75 percent are men. Pain typically strikes several times during a 24-hour period, frequently between one and three hours after falling asleep, and lasts from 30 to 90 minutes at a time. Episodes can continue anywhere from 2 to 12 weeks. The attacks occur when the trigeminal nerve pathway at the base of the brain is activated by the hypothalamus, the brain's internal clock, for as yet undetermined reasons. Cluster headaches, which tend to peak in the spring and autumn, are rarely caused by an underlying serious brain condition like a tumor or aneurysm, but may be the result of a vascular disorder.
The intense pain--sometimes described as a red-hot poker in one eye--is usually accompanied by swelling, tearing, flushing, and nasal congestion on the affected side. (If you ever experience sudden, severe head pain with vomiting, weakness, or sensory impairment, seek medical attention immediately.) An injection of the migraine drug sumatriptan (Imitrex) is the most successful prescription response, according to the Cleveland Clinic Neuroscience Center in Ohio.
However, alternative approaches have plenty of scientific support. Irregular levels of melatonin, which frequently drop during episodes, could be a factor. In a study published in the journal Cephalalgia in 1996, patients reduced the frequency of cluster headaches by taking 10 milligrams of this natural hormone each evening for at least 14 days.
Because the worst symptoms of these headaches can come and go quickly, some treatments are applied through the nostrils for faster uptake. Anesthetic use of lidocaine spray is often prescribed, while another study in Cephalalgia in 1993 found that subjects who received nasal applications of capsaicin--the active ingredient in cayenne pepper--twice daily for seven days during episodes had a significant reduction in pain for the following 15 days. (Before trying intranasal capsaicin, get an OK from your doctor.)
Ayurveda offers an alternative solution. According to this ancient science, cluster headaches may be a result of a vata-dosha imbalance, says Vasant Lad, B.A.M.S., M.A.Sc., director of the Ayurvedic Institute in Albuquerque, N.M. His remedy to calm the agitating energy of vata: Spread warm ghee (clarified butter) around the inside of each nostril, or rub nutmeg oil on the temples.
Since part of headache pain is caused by the swelling of arteries that surround the brain and oxygen may reduce that swelling, oxygen therapy can be another effective strategem to employ at the beginning of an attack. "Inhaling 7 to 10 liters per minute of 100 percent oxygen via a face mask for 15 to 20 minutes has been shown to relieve pain in about 70 percent of cluster headache sufferers, say Marc S. Husid, M.D., a physician with the Walton Headache Center in Augusta, Ga.
In addition, people with low ionized-magnesium levels eased symptoms after receiving injections of magnesium sulfate, according to a 1995 report in Headache; however, oral magnesium supplementation was not evaluated.
Barbells and bedrooms
Exertion headaches kick in shortly after vigorous physical activity, such as heavy weight lifting or aerobics. To avoid sudden fluctuations in the blood vessels, cool down after intense training instead of stopping abruptly, and mix low-impact options like swimming or walking into your routine. Dehydration and low blood sugar could be triggers as well.
To prevent them, drink plenty of water--6 to 12 ounces every 15 to 20 minutes--during exercise, suggests Jeff Kotterman, L.M.S.N., director of the National Association of Sports Nutrition in San Diego. Within 30 minutes after a workout, eat a 1-to-3 ratio of protein (whey, turkey, or cottage cheese) to simple carbs (fruits like bananas, apples, and strawberries). If the pain returns, breathe slowly and deeply, ice the source of the pain, and rest in a dark room--or take a walk, preferably in fresh air.
Men are also more prone to sexual headaches, caused either by muscle contractions in the head and neck or by dilation of blood vessels just before orgasm. The vascular version, called orgasmic cephalalgia, involves a sharp pain around or behind the eyes that generally lasts for minutes but can linger for hours; it often occurs in men who also suffer from migraines. To take the pain out of your pleasure, slow down the pace and gradually increase sexual intensity. Beta-blockers used to treat migraines can be helpful; another option is to take aspirin or ibuprofen before intercourse. You could also take a break from the triggering activity--though most men would rather grimace and bear it.
COPYRIGHT 2006 Weider Publications
COPYRIGHT 2006 Gale Group
Monday, June 4, 2007
Teva Announces Tentative Approval for Generic Cozaar® Tablets
JERUSALEM -- Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's antihypertensive agent Cozaar(R) (Losartan Potassium) Tablets, 25 mg, 50 mg and 100 mg. Final approval of this ANDA is expected in April 2010 when patent protection for the brand product expires.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80% of Teva's sales are in North America and Europe.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra(R), Neurontin(R), Oxycontin(R) and Zithromax(R), the effects of competition on Copaxone(R) sales, including as a result of the expected reintroduction of Tysabri(R) into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
COPYRIGHT 2006 Business Wire
COPYRIGHT 2006 Gale Group
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80% of Teva's sales are in North America and Europe.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra(R), Neurontin(R), Oxycontin(R) and Zithromax(R), the effects of competition on Copaxone(R) sales, including as a result of the expected reintroduction of Tysabri(R) into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
COPYRIGHT 2006 Business Wire
COPYRIGHT 2006 Gale Group
Inflammatory lesions on every finger
A 25-year-old man presented with aching, swollen, scarlet lesions on the tips of all 10 fingers (Figure 1) following a three-day prodrome of worsening sharp pain in his thumbs, little fingers, and lips. His temperature was 38.2[degrees]C (100.8[degrees]F), and he was unable to fully extend his fingers because of throbbing pain. Small, round, crusted lesions resembling recently ruptured blisters lined his lips. Tense, pustular lesions surrounded by a bright border of erythema and some superficial desquamation encircled the fingertips (Figure 2). The patient denied any recent trauma or other lesions. No adenopathy was appreciated. His white blood cell count, blood chemistries, and transaminase levels were within normal limits.
[FIGURES 1-2 OMITTED]
Question
Based on the patient's history, physical examination, and laboratory tests, which one of the following is the correct diagnosis?
[] A. Pompholyx.
[] B. Herpes zoster.
[] C. Herpetic whitlow.
[] D. Endocarditis with Osler's nodes.
[] E. Paronychia.
Discussion
The answer is C: herpetic whitlow. Herpetic whitlow is in the differential diagnosis of any patient with a fingertip infection. Positive results from direct fluorescent antibody tests and viral cultures from the patient's oral and digital lesions confirmed type 1 herpes simplex virus (HSV) infection. Further history revealed that the patient regularly bit his nails.
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Herpetic whitlow is an HSV infection of the fingers and toes and may represent a primary infection or a secondary recurrence of type 1 or 2 HSV infection. It occurs primarily in medical personnel and in patients with herpetic stomatitis. Before the advent of universal precautions, herpetic whitlow occurred predominantly in health care professionals inoculated by infected patients. (1) The virus is transmitted via saliva, semen, cervical fluid, and active lesions, and often is introduced through direct contact. (2) Following a short incubation period, painful, coalescing vesicles with surrounding erythema develop. The vesicle fluid usually is serous but may appear purulent in patients with secondary infection. Low-grade fever, malaise, and regional lymphadenopathy also may occur. (3) Treatment involves inhibition of viral replication with acyclovir (Zovirax), valacyclovir (Valtrex), or famciclovir (Famvir); symptomatic pain relief; and treatment of bacterial superinfection. The course typically lasts a few weeks, and healing usually is complete.
Pompholyx, or dyshidrotic eczema, is a nonspecific reaction pattern of unknown etiology that preferentially affects the palms and sides of the fingers. (4) Painful pruritus precedes the appearance of bilateral, symmetrical, clear vesicles that progress to bullae. Desquamation, inflammation, and secondary infection often follow. Attacks normally subside spontaneously within two to three weeks.
Herpes zoster infection results from reactivation of the varicella zoster virus, which lies dormant in the sensory ganglia after primary infection. While its vesicular lesions resemble those of HSV infections, their key distinguishing feature is their distribution. (5) Herpes zoster vesicles typically form a dermatomal distribution throughout the affected nerve, while HSV vesicles form at the distal ends of affected nerves.
Osler's nodes are painful, swollen, violaceous subcutaneous nodules occurring mainly in the pulp of the fingers and toes. They are one of several cutaneous manifestations of bacterial endocarditis, and are caused by septic emboli from acute bacterial endocarditis or small-vessel perivasculitis in subacute bacterial endocarditis. (6)
Paronychia, a localized infection of the perionychium, may be acute or chronic and is characterized by pain, erythema, and swelling of the posterior or lateral nail folds, and subsequent superficial abscess. Acute paronychia commonly results from nail biting or trauma and is typically a mixed infection, with Staphylococcus aureus predominating, whereas chronic paronychia likely represents a multifactorial eczematous condition or fungal infection. (7)
REFERENCES
(1.) Jones JG. Herpetic whitlow: an infectious occupational hazard. J Occup Med 1985;27:725-8.
(2.) Yeung-Yue KA, Brentjens MH, Lee PC, Tyring SK. Herpes simplex viruses 1 and 2. Dermatol Clin 2002;20:249-66.
(3.) Spruance SL, Overall JC Jr, Kern ER, Krueger GG, Pliam V, Miller W. The natural history of recurrent herpes simplex labialis: implications for antiviral therapy. N Engl J Med 1977;297:69-75.
(4.) Crosti C, Lodi A. Pompholyx: a still unresolved kind of eczema. Dermatology 1993;186:241-2.
(5.) Chen TM, George S, Woodruff CA, Hsu S. Clinical manifestations of varicella-zoster virus infection. Dermatol Clin 2002;20:267-82.
(6.) Fitzpatrick TB, Johnson RA, Wolff K, Polano MK, Suurmond D, eds. Color atlas and synopsis of clinical dermatology: common and serious diseases. 3d ed. New York: McGraw-Hill, 1997:623.
(7.) Rockwell PG. Acute and chronic paronychia. Am Fam Physician 2001;63:1113-6.
Selected Differential Diagnosis
of Inflammatory Finger Lesions
Condition Characteristics
Pompholyx Painful pruritus with vesicles on palms
and sides of fingers
Herpes zoster Vesicles along a dermatomal
distribution
Herpetic whitlow Painful, coalescing vesicles with
surrounding erythema on fingers
Endocarditis with Painful, swollen, violaceous nodules in
Osler's the pulp of fingers and toes
Paronychia Pain, erythema, and swelling of the
posterior or lateral nail folds
RAMEY WILSON, M.D.
ALEX G. TRUESDELL, M.D.
TODD C. VILLINES, M.D.
Walter Reed Army Medical Center
Washington, D.C.
COPYRIGHT 2005 American Academy of Family Physicians
COPYRIGHT 2005 Gale Group
[FIGURES 1-2 OMITTED]
Question
Based on the patient's history, physical examination, and laboratory tests, which one of the following is the correct diagnosis?
[] A. Pompholyx.
[] B. Herpes zoster.
[] C. Herpetic whitlow.
[] D. Endocarditis with Osler's nodes.
[] E. Paronychia.
Discussion
The answer is C: herpetic whitlow. Herpetic whitlow is in the differential diagnosis of any patient with a fingertip infection. Positive results from direct fluorescent antibody tests and viral cultures from the patient's oral and digital lesions confirmed type 1 herpes simplex virus (HSV) infection. Further history revealed that the patient regularly bit his nails.
Advertisement
Herpetic whitlow is an HSV infection of the fingers and toes and may represent a primary infection or a secondary recurrence of type 1 or 2 HSV infection. It occurs primarily in medical personnel and in patients with herpetic stomatitis. Before the advent of universal precautions, herpetic whitlow occurred predominantly in health care professionals inoculated by infected patients. (1) The virus is transmitted via saliva, semen, cervical fluid, and active lesions, and often is introduced through direct contact. (2) Following a short incubation period, painful, coalescing vesicles with surrounding erythema develop. The vesicle fluid usually is serous but may appear purulent in patients with secondary infection. Low-grade fever, malaise, and regional lymphadenopathy also may occur. (3) Treatment involves inhibition of viral replication with acyclovir (Zovirax), valacyclovir (Valtrex), or famciclovir (Famvir); symptomatic pain relief; and treatment of bacterial superinfection. The course typically lasts a few weeks, and healing usually is complete.
Pompholyx, or dyshidrotic eczema, is a nonspecific reaction pattern of unknown etiology that preferentially affects the palms and sides of the fingers. (4) Painful pruritus precedes the appearance of bilateral, symmetrical, clear vesicles that progress to bullae. Desquamation, inflammation, and secondary infection often follow. Attacks normally subside spontaneously within two to three weeks.
Herpes zoster infection results from reactivation of the varicella zoster virus, which lies dormant in the sensory ganglia after primary infection. While its vesicular lesions resemble those of HSV infections, their key distinguishing feature is their distribution. (5) Herpes zoster vesicles typically form a dermatomal distribution throughout the affected nerve, while HSV vesicles form at the distal ends of affected nerves.
Osler's nodes are painful, swollen, violaceous subcutaneous nodules occurring mainly in the pulp of the fingers and toes. They are one of several cutaneous manifestations of bacterial endocarditis, and are caused by septic emboli from acute bacterial endocarditis or small-vessel perivasculitis in subacute bacterial endocarditis. (6)
Paronychia, a localized infection of the perionychium, may be acute or chronic and is characterized by pain, erythema, and swelling of the posterior or lateral nail folds, and subsequent superficial abscess. Acute paronychia commonly results from nail biting or trauma and is typically a mixed infection, with Staphylococcus aureus predominating, whereas chronic paronychia likely represents a multifactorial eczematous condition or fungal infection. (7)
REFERENCES
(1.) Jones JG. Herpetic whitlow: an infectious occupational hazard. J Occup Med 1985;27:725-8.
(2.) Yeung-Yue KA, Brentjens MH, Lee PC, Tyring SK. Herpes simplex viruses 1 and 2. Dermatol Clin 2002;20:249-66.
(3.) Spruance SL, Overall JC Jr, Kern ER, Krueger GG, Pliam V, Miller W. The natural history of recurrent herpes simplex labialis: implications for antiviral therapy. N Engl J Med 1977;297:69-75.
(4.) Crosti C, Lodi A. Pompholyx: a still unresolved kind of eczema. Dermatology 1993;186:241-2.
(5.) Chen TM, George S, Woodruff CA, Hsu S. Clinical manifestations of varicella-zoster virus infection. Dermatol Clin 2002;20:267-82.
(6.) Fitzpatrick TB, Johnson RA, Wolff K, Polano MK, Suurmond D, eds. Color atlas and synopsis of clinical dermatology: common and serious diseases. 3d ed. New York: McGraw-Hill, 1997:623.
(7.) Rockwell PG. Acute and chronic paronychia. Am Fam Physician 2001;63:1113-6.
Selected Differential Diagnosis
of Inflammatory Finger Lesions
Condition Characteristics
Pompholyx Painful pruritus with vesicles on palms
and sides of fingers
Herpes zoster Vesicles along a dermatomal
distribution
Herpetic whitlow Painful, coalescing vesicles with
surrounding erythema on fingers
Endocarditis with Painful, swollen, violaceous nodules in
Osler's the pulp of fingers and toes
Paronychia Pain, erythema, and swelling of the
posterior or lateral nail folds
RAMEY WILSON, M.D.
ALEX G. TRUESDELL, M.D.
TODD C. VILLINES, M.D.
Walter Reed Army Medical Center
Washington, D.C.
COPYRIGHT 2005 American Academy of Family Physicians
COPYRIGHT 2005 Gale Group
Danazol therapy for immune thrombocytopenic purpura
Immune thrombocytopenic purpura, a fairly common condition in children, is usually benign and self-limited, resolving spontaneously within a few months. Patients with significant bleeding usually respond to steroid therapy. Many types of therapy are recommended for chronic thrombocytopenic purpura, including steroids, splenectomy, immunosuppressive agents, vincristine and high-dose intravenous gamma globulin.
Weinblatt and associates report their experience with danazol, an attenuated androgen, in ten symptomatic children with refractory immune thrombocytopenic purpura. The patients ranged in age from 30 months to 17 years. All were initially treated with prednisone and either had a poor response to therapy or became steroid-dependent, with hemorrhagic symptoms occurring when steroid doses were reduced. Other methods of treatment, including high-dose intravenous gamma globulin, azathioprine, splenectomy or plasmapheresis, had been tried in some of the children but failed to raise the platelet counts.
Danazol therapy was begun at a dosage of 20 to 30 mg per kg per day in divided doses and was increased up to a maximum of 800 mg per day in older children. Nine of the ten patients exhibited improvement in platelet counts following danazol therapy. Response times varied from one week to one month. Steroid therapy could be withdrawn in most of the patients who had been receiving concomitant steroids. No liver function abnormalities or other significant adverse effects were associated with the use of danazol. (American Journal of Diseases of Children, December 1988, vol. 142, p. 1317.)
COPYRIGHT 1989 American Academy of Family Physicians
COPYRIGHT 2004 Gale Group
Weinblatt and associates report their experience with danazol, an attenuated androgen, in ten symptomatic children with refractory immune thrombocytopenic purpura. The patients ranged in age from 30 months to 17 years. All were initially treated with prednisone and either had a poor response to therapy or became steroid-dependent, with hemorrhagic symptoms occurring when steroid doses were reduced. Other methods of treatment, including high-dose intravenous gamma globulin, azathioprine, splenectomy or plasmapheresis, had been tried in some of the children but failed to raise the platelet counts.
Danazol therapy was begun at a dosage of 20 to 30 mg per kg per day in divided doses and was increased up to a maximum of 800 mg per day in older children. Nine of the ten patients exhibited improvement in platelet counts following danazol therapy. Response times varied from one week to one month. Steroid therapy could be withdrawn in most of the patients who had been receiving concomitant steroids. No liver function abnormalities or other significant adverse effects were associated with the use of danazol. (American Journal of Diseases of Children, December 1988, vol. 142, p. 1317.)
COPYRIGHT 1989 American Academy of Family Physicians
COPYRIGHT 2004 Gale Group
Generic Wellbutrin on tap for Eon - Generics Watch - Eon Labs gets approval for generic form of antidepressant
Eon Labs received the first tentative approval to make a generic form of the antidepressant Wellbutrin (bupropion) in 100 mg and 150 mg tablet strengths. Wellbutrin SR brought in $1.2 billion in sales for GlaxoSmith Kline last year. Wellbutrin's patent protections are set to begin expiring in June 2004.
Bupropion HCl was one of four approvals Eon Labs received in January. Other Eon approvals include the generic form of the type 2 diabetes treatment Glucophage (metformin HCl) in 500 mg, 850 mg and 1,000 mg strength tablets from Bristol-Myers Squibb and Eli Lilly's antidepressant Prozac (fluoxetine) in 10 g and 20 g capsule and 10 mg tablet versions.
COPYRIGHT 2002 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2002 Gale Group
Bupropion HCl was one of four approvals Eon Labs received in January. Other Eon approvals include the generic form of the type 2 diabetes treatment Glucophage (metformin HCl) in 500 mg, 850 mg and 1,000 mg strength tablets from Bristol-Myers Squibb and Eli Lilly's antidepressant Prozac (fluoxetine) in 10 g and 20 g capsule and 10 mg tablet versions.
COPYRIGHT 2002 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2002 Gale Group
Dream weaver: former Balanchine star Allegra Kent guides Miami City Ballet dancers in "La Sonnambula"
THE STORY CONCERNS A POET WHO APPEARS AT A BARON'S LAVISH PARTY AND BECOMES ENAMORED OF A COQUETTE (APPARENTLY THE HOST'S MISTRESS) SUBSEQUENTLY (WHEN THE GUESTS HAVE RETIRED FROM SUPPER) HE MEETS THE MYSTERIOUS SLEEPWALKER (THE HOST'S WIFE), IS DISCOVERED FOLLOWING HER TO HER ROOM BY THE JEALOUS COQUETTE, AND FINALLY IS STABBED TO DEATH BY THE ENRAGED BARON.
--TAKEN FROM WAITER TERRY'S SYNOPSIS IN REPERTORY IN REVIEW BY BY NANCY REYNOLDS
Earlier this year, my friend and dancing partner of the past, Edward Villella, the founding artistic director of the Miami City Ballet, invited me to Florida to coach three of his ballerinas--Jennifer Kronenberg, Deanna Seay, and Haiyan Wu--in the role of the Sleepwalker in George Balanchine's La Sonnambula.
This ballet (originally titled Night Shadow) and I go very far back together--in fact, back into the middle of the last century. In 1949 when I saw Night Shadow with Alexandra Danilova and Frederic Franklin in a Ballet Russe de Monte Carlo production, it was a "first time ever" experience for me. Even though I'd already decided on ballet as my career and begun studying, I'd never seen a dance performance of any kind. After seeing Night Shadow, my expectations were confirmed: Dancing would be my life's work. I was 11 years old.
Eleven years later, I would dance the starring role myself when Balanchine revived the ballet for me with the great Danish dancer Erik Bruhn as the Poet. And now Eddie was giving me the honor and opportunity to share recollections of those events with his company. I was delighted.
Today because of time and money pressures, ballets are taught as quickly and as efficiently as possible. Leisure to explore a role is a luxury. Yet stories and insights from interpreters of the past are valuable. Coaching is the transmission of ideas that bring a ballet to life, particularly when the choreographer is no longer available. Studying videotapes can help, but ideas and subtle details will be lost if video is the only source.
I was to have three days in Miami working with several casts in paired sessions. All the other dancers could attend rehearsals if they wanted to. And I was excited by the talent and dedication of the entire company. We worked in the large sunny Miami City Ballet studios, which have picture windows visible from the sidewalk. Casual strollers can watch classes and rehearsals while walking by. A generous concept.
For two hours on day one, I worked with the first cast--the lithe, lovely Jennifer Kronenherg and the romantic, handsome Carlos Guerra, her real-life fiance. As an already deeply engaged couple, there was an extraordinary rapport between the two of them. Even before we began, I could feel their unspoken love and empathy for each other. Jennifer wore a red strappy leotard and dark-colored tights pulled to her waist. I requested that she put on the nightgown--the white silken fabric of a phantasmagorical premise, a sleepwalker on pointe--for this ballet of the night and of the realm of undefined shadows and dreams. Dreams that can hold danger and hopes that can shatter in an instant.
Coaching by illustration, I stopped the first rehearsal to demonstrate one of the critical sections. When the Sleepwalker first enters, she moves on pointe in an ever quickening pace, finishing the phrase in a diagonal run forward, looking as if she might step over the boundaries of the stage itself. The audience gasps. Over 40 years ago in Moscow, Mr. B had taken the candle from me to demonstrate this section by running towards the brink of the vast stage of the Kremlin's New Congress Theater. While flying forward, he called out "Step over the footlights," and did so himself. For one second, I thought Mr. B was going to die, but he didn't--instead he gave the candle back to me. Balanchine possessed the brakes of a Rolls Royce.
While tracing the same trajectory for Jennifer and nay other new Sleepwalkers, I stopped just short of crashing into the studio's mirror. I wanted to startle the dancers. Balanchine loved to create the look of choreographic danger, synchronized with the end of a musical phrase for an intense emotional impact. His heroines often ignite our anxiety--think of the girl in "The Unanswered Question" from Ivesiana who falls from a great height; she is a sister of the Sleepwalker.
I explained to the cast how a performance is enhanced by using contrasting qualities of motion and sudden stillness. I constantly reframed my phrases to see which words most effectively transmitted my ideas. I also emphasized the spontaneous quality of the choreography--his action, her reaction.
On Day Two rehearsing with Deanna and her boyfriend Mikhail Nikitine, I ran to the side of the room to watch the moment leading up to an ever-deepening penchee arabesque from a better angle. I wanted to make sure the Sleepwalker and Poet were on an exact collision course, as the audience feels their trembling anticipation of new love and clearly sees her lips moving slowly toward his. At the exact second of the expected kiss, which, in Mr. B's design, never takes place, her head moves behind his. The audience tingles with regret. In another instant, the Poet tries to embrace the Sleepwalker. With entwining arms, he circles her body and descends to the floor. She seems to be caught, but then she steps away with eerie precision. The music crests and falls, emphasizing the Poet's expectancy and despair. The effect is stunning. I remember this moment so well from 1949. Rehearsing this section, Deanna Seay created a similar atmosphere with her unblinking eyes and her musicality. Enchanting Haiyan Wu emphasized the lyrical aspects of the role.
The elegy section is different. The Sleepwalker is searching for the Poet. She knows he is dead. The music has a measured solemnity. The walking, now done entirely off pointe, is a terrifying trance-like progression forward. Balanchine didn't want this part performed on the music. The Sleepwalker's light becomes a candle of mourning.
In the Sleepwalker's action of stepping over the Poet's body, there is resolution. She walks toward her chambers. The Poet's body is lifted on high by four men and placed in her arms. She exits backwards--a spectacular and astonishing ending. The viewer questions what has transpired. As I watched Jennifer practice this moment with Carlos draped over her shoulder, I was very moved. There was a sense of sorrowful knowledge on her expressive face.
After three days in Miami Beach, I had to return home and I missed the actual performances, but I heard they were beautiful. I felt I had given my various casts enough information with which to explore the work alone, with their ballet mistresses, Roma Sosenko and Iliana Lopez, and of course with Eddie.
Information and ideas can come from unexpected places. By chance, 45 years ago, I ran into Mme. Danilova at a bus stop where she demonstrated a moment from La Sonnambula for me. All at once I understood the value of looking backward, forward, sideways, or in any direction for inspiration.
Allegra Kent, a former principal of NYCB, is the author of an autobiography, Once a Dancer.
COPYRIGHT 2005 Dance Magazine, Inc.
COPYRIGHT 2005 Gale Group
--TAKEN FROM WAITER TERRY'S SYNOPSIS IN REPERTORY IN REVIEW BY BY NANCY REYNOLDS
Earlier this year, my friend and dancing partner of the past, Edward Villella, the founding artistic director of the Miami City Ballet, invited me to Florida to coach three of his ballerinas--Jennifer Kronenberg, Deanna Seay, and Haiyan Wu--in the role of the Sleepwalker in George Balanchine's La Sonnambula.
This ballet (originally titled Night Shadow) and I go very far back together--in fact, back into the middle of the last century. In 1949 when I saw Night Shadow with Alexandra Danilova and Frederic Franklin in a Ballet Russe de Monte Carlo production, it was a "first time ever" experience for me. Even though I'd already decided on ballet as my career and begun studying, I'd never seen a dance performance of any kind. After seeing Night Shadow, my expectations were confirmed: Dancing would be my life's work. I was 11 years old.
Eleven years later, I would dance the starring role myself when Balanchine revived the ballet for me with the great Danish dancer Erik Bruhn as the Poet. And now Eddie was giving me the honor and opportunity to share recollections of those events with his company. I was delighted.
Today because of time and money pressures, ballets are taught as quickly and as efficiently as possible. Leisure to explore a role is a luxury. Yet stories and insights from interpreters of the past are valuable. Coaching is the transmission of ideas that bring a ballet to life, particularly when the choreographer is no longer available. Studying videotapes can help, but ideas and subtle details will be lost if video is the only source.
I was to have three days in Miami working with several casts in paired sessions. All the other dancers could attend rehearsals if they wanted to. And I was excited by the talent and dedication of the entire company. We worked in the large sunny Miami City Ballet studios, which have picture windows visible from the sidewalk. Casual strollers can watch classes and rehearsals while walking by. A generous concept.
For two hours on day one, I worked with the first cast--the lithe, lovely Jennifer Kronenherg and the romantic, handsome Carlos Guerra, her real-life fiance. As an already deeply engaged couple, there was an extraordinary rapport between the two of them. Even before we began, I could feel their unspoken love and empathy for each other. Jennifer wore a red strappy leotard and dark-colored tights pulled to her waist. I requested that she put on the nightgown--the white silken fabric of a phantasmagorical premise, a sleepwalker on pointe--for this ballet of the night and of the realm of undefined shadows and dreams. Dreams that can hold danger and hopes that can shatter in an instant.
Coaching by illustration, I stopped the first rehearsal to demonstrate one of the critical sections. When the Sleepwalker first enters, she moves on pointe in an ever quickening pace, finishing the phrase in a diagonal run forward, looking as if she might step over the boundaries of the stage itself. The audience gasps. Over 40 years ago in Moscow, Mr. B had taken the candle from me to demonstrate this section by running towards the brink of the vast stage of the Kremlin's New Congress Theater. While flying forward, he called out "Step over the footlights," and did so himself. For one second, I thought Mr. B was going to die, but he didn't--instead he gave the candle back to me. Balanchine possessed the brakes of a Rolls Royce.
While tracing the same trajectory for Jennifer and nay other new Sleepwalkers, I stopped just short of crashing into the studio's mirror. I wanted to startle the dancers. Balanchine loved to create the look of choreographic danger, synchronized with the end of a musical phrase for an intense emotional impact. His heroines often ignite our anxiety--think of the girl in "The Unanswered Question" from Ivesiana who falls from a great height; she is a sister of the Sleepwalker.
I explained to the cast how a performance is enhanced by using contrasting qualities of motion and sudden stillness. I constantly reframed my phrases to see which words most effectively transmitted my ideas. I also emphasized the spontaneous quality of the choreography--his action, her reaction.
On Day Two rehearsing with Deanna and her boyfriend Mikhail Nikitine, I ran to the side of the room to watch the moment leading up to an ever-deepening penchee arabesque from a better angle. I wanted to make sure the Sleepwalker and Poet were on an exact collision course, as the audience feels their trembling anticipation of new love and clearly sees her lips moving slowly toward his. At the exact second of the expected kiss, which, in Mr. B's design, never takes place, her head moves behind his. The audience tingles with regret. In another instant, the Poet tries to embrace the Sleepwalker. With entwining arms, he circles her body and descends to the floor. She seems to be caught, but then she steps away with eerie precision. The music crests and falls, emphasizing the Poet's expectancy and despair. The effect is stunning. I remember this moment so well from 1949. Rehearsing this section, Deanna Seay created a similar atmosphere with her unblinking eyes and her musicality. Enchanting Haiyan Wu emphasized the lyrical aspects of the role.
The elegy section is different. The Sleepwalker is searching for the Poet. She knows he is dead. The music has a measured solemnity. The walking, now done entirely off pointe, is a terrifying trance-like progression forward. Balanchine didn't want this part performed on the music. The Sleepwalker's light becomes a candle of mourning.
In the Sleepwalker's action of stepping over the Poet's body, there is resolution. She walks toward her chambers. The Poet's body is lifted on high by four men and placed in her arms. She exits backwards--a spectacular and astonishing ending. The viewer questions what has transpired. As I watched Jennifer practice this moment with Carlos draped over her shoulder, I was very moved. There was a sense of sorrowful knowledge on her expressive face.
After three days in Miami Beach, I had to return home and I missed the actual performances, but I heard they were beautiful. I felt I had given my various casts enough information with which to explore the work alone, with their ballet mistresses, Roma Sosenko and Iliana Lopez, and of course with Eddie.
Information and ideas can come from unexpected places. By chance, 45 years ago, I ran into Mme. Danilova at a bus stop where she demonstrated a moment from La Sonnambula for me. All at once I understood the value of looking backward, forward, sideways, or in any direction for inspiration.
Allegra Kent, a former principal of NYCB, is the author of an autobiography, Once a Dancer.
COPYRIGHT 2005 Dance Magazine, Inc.
COPYRIGHT 2005 Gale Group
Diary: from a week in practice
Monday
Competitive sports can bring out the best in people, but once in a while, athletics also bring to light something unexpected. "This is going to sound weird, but my heart's not right," Hailey disclosed in a previous visit. She began having episodes of rapid heart-pounding lasting two to three minutes while she was participating in sporting events as a senior in high school. In college, the 20-year-old no longer played softball or volleyball, but she continued to have the same symptoms during strenuous activities. Hailey's resting heart rate was in the low 90s, and her blood pressure was 116/78 mm Hg. Her electrocardiogram was unremarkable. Results of a metabolic profile, thyroid function tests, and complete blood count were normal. An event recorder documented supraventricular tachycardia and episodes of atrial flutter with a rate around 250 beats per minute. Exercise was linked to the arrhythmia. I referred Hailey to a cardiologist, and she had electrophysiologic testing, which showed uncommon atrioventricular node reentry. Hailey chose to undergo intracardiac mapping with radiofrequency catheter ablation. Since the radiofrequency ablation was performed, she has been asymptomatic. Hailey was pleased that she doesn't require long-term treatment with medication. "Isn't technology wonderful!" she exclaimed at her visit today. "I'm really thankful that everything turned out okay." Hailey's relief and gratitude were nearly as heartwarming as the procedure.
Tuesday
"It's hard to believe that I was 200 lb of pure muscle," reflected Warren at his last visit. "Nowadays, I'm just 200-plus lb of muscle aches and pains," the 52-year-old coal miner lamented. He was particularly bothered by constant soreness of the muscles in his arms and legs. In light of the more than 30 years he had logged in the mines, Warren had already formulated a diagnosis. "I think my job has ruined me." The examination I performed at that visit revealed some arthritic changes of his knees, hands, and shoulders. No muscle tenderness, atrophy, or weakness was present, so myopathy seemed unlikely. One laboratory test showed intriguing results--an abnormal creatine kinase level of 632 U per L. His MB isoenzyme of creatine kinase (1.95 ng per mL), erythrocyte sedimentation rate (11 mm per hour), and white blood cell count (6,000 cells per mm3) were normal. I asked Warren to have some additional blood work done, but I wanted him to wait until he had been off work for a day or two. The new results arrived today. Warren's creatine kinase level remained elevated--324 U per L--but it was better. The results of the aldolase (4.9 U per L) and other tests including uric acid, antinuclear antibodies, and rheumatoid factor were normal. I knew strenuous activity could cause an elevation of creatine kinase, but was that the reason for Warren's problem? If it was, then what practical remedy could I offer him? I spent so much time reviewing the literature and thinking about the case that I gave myself tired eyes and a headache. For now, the diagnosis that makes the most sense is the one he came up with himself: work hurts.
Wednesday
Mrs. Mendell loved her peas. The 71 year old relished the vegetables grown in her garden. Today, I had my doubts that the affection was mutual. Mrs. Mendell had been eating lots of tomatoes and nuts lately, and for the past few days, she had experienced lower abdominal cramping and mild constipation. On examination, I found Mrs. Mendell had left lower quadrant abdominal tenderness and a low-grade fever. Bowel sounds were normal, a stool for occult blood was negative, and the results of a urinalysis were normal, but her white blood cell count was slightly elevated.
"You have a case of diverticulitis," I informed her. The diagnosis didn't faze her. "Don't all older people have that?" she inquired. I explained to her the difference between diverticulosis and diverticulitis. "I don't want that 'itis'," Mrs. Mendell said while wagging her finger at me. Outpatient treatment seemed appropriate, so I started her on ciprofloxacin (Cipro) and metronidazole (Flagyl). I asked her to alter her diet and return in a couple of days to be reexamined. "What am I going to do with all those vegetables I can't eat?" she thought aloud. The solution suddenly surfaced. "I bet you and your staff love tomatoes. I'll have my husband drop off a shopping bag of them later today."
Thursday
Bernadette mistrusts any doctor except her own and has misgivings about prescription drugs. The 60-year-old woman is a human matchstick--tall and lean with closely cropped red hair and a temper that is easily ignited. Not long ago, Bernadette developed a deep, aching pain in her left shin. She had not injured her lower leg and denied any other bone pain. Grudgingly, she consented to an x-ray of the tibia and a blood test. The radiologist reported changes consistent with Paget's disease of the bone. Further supporting the diagnosis were an elevated alkaline phosphatase level and normal serum calcium. Not surprisingly, Bernadette refused to see an endocrinologist or orthopedist. Because she had no kidney disease or esophageal problems, I asked her to consider treatment with a bisphosphonate agent: alendronate (Fosamax) for six months or risedronate (Actonel) for two months. "No thanks," she said. "If it ain't broke, don't go trying to fix it." To no avail, I explained how the changes associated with Paget's disease make the affected bone weaker and more likely to fracture. There was no way I was going to change this woman's mind. "You don't have to decide today," I said. "I'll be happy to discuss the problem again any time you like." It's hard to light a fire under some people. In Bernadette's case, gentleness may prove to be more effective than coercion.
Friday
Seven months ago, Joe awoke from a sound sleep with an awful pain in his big toe. "Tell me this isn't gout," he entreated. I wasn't able to oblige him. The first metatarsophalangeal joint of his right foot was swollen, warm, reddened, and exquisitely tender to light touch. His uric acid was 9.4 mg per dL and serum creatinine was normal. Treatment with indomethacin (Indocin) quickly stamped out his first episode of gout. Joe failed to follow my recommendations of a low purine diet, weight reduction, and limitation of alcohol intake. Three months later, his gout was back, and so was Joe. Another round of indomethacin provided rapid relief. Today, Joe returned with his third episode of gout. After this last flare is resolved, he will begin treatment for recurrent gout with allopurinol (Zyloprim) 100 mg a day and colchicine 0.6 mg twice a day. The dose of allopurinol will be increased gradually until his uric acid level falls below 6.0 mg per dL. "Is it safe to have a beer now and then with these medicines?" he asked sheepishly. Disappointed and frustrated, I let out a sigh. "Gotcha!" he laughed. Joe had seen the light; I hoped that we had seen the end of his gout.
Saturday/Sunday
"Look in my ear," Leah instructed me. "It's been hurting off and on for the past few months." I examined her ears and found nothing wrong with them. The 36-year-old elementary school teacher vigorously rubbed the skin in front of her right ear, which tipped me off to a possible diagnosis. Mild tenderness was present over the temporo-mandibular joint (TMJ). "Open wide and say 'Aah'," I directed her. A popping noise emanated from her right jaw. "That doesn't sound too good," she remarked. I noticed Leah had a limited ability to open her mouth wide. In addition, she had a crossbite. "You can blame your earache on TMJ disorder," I informed her. She began filling in some blanks about problems at work, occasional teeth grinding, and a fondness for chewing gum. I asked Leah to take ibuprofen as needed for her pain, apply moist heat to the TMJ, and gently massage the area. She would contact her dentist about a mouth splint, and we talked about ways to reduce stress. Before Leah left the office, I gave her a final assignment, "No clenching your teeth or chewing gum at school."
Tony Miksanek, M.D., has been a family physician for more than 20 years. Most of that time has been in solo private practice in Benton, a town with a population of about 7,000 in rural southern Illinois.
Address correspondence to Tony Miksanek, M.D., 712 Old Orchard Dr., Benton, IL 62812.
To preserve patient confidentiality, the patients' names and identifying characteristics have been changed in each scenario. Any resemblance to actual persons is coincidental.
COPYRIGHT 2005 American Academy of Family Physicians
COPYRIGHT 2005 Gale Group
Competitive sports can bring out the best in people, but once in a while, athletics also bring to light something unexpected. "This is going to sound weird, but my heart's not right," Hailey disclosed in a previous visit. She began having episodes of rapid heart-pounding lasting two to three minutes while she was participating in sporting events as a senior in high school. In college, the 20-year-old no longer played softball or volleyball, but she continued to have the same symptoms during strenuous activities. Hailey's resting heart rate was in the low 90s, and her blood pressure was 116/78 mm Hg. Her electrocardiogram was unremarkable. Results of a metabolic profile, thyroid function tests, and complete blood count were normal. An event recorder documented supraventricular tachycardia and episodes of atrial flutter with a rate around 250 beats per minute. Exercise was linked to the arrhythmia. I referred Hailey to a cardiologist, and she had electrophysiologic testing, which showed uncommon atrioventricular node reentry. Hailey chose to undergo intracardiac mapping with radiofrequency catheter ablation. Since the radiofrequency ablation was performed, she has been asymptomatic. Hailey was pleased that she doesn't require long-term treatment with medication. "Isn't technology wonderful!" she exclaimed at her visit today. "I'm really thankful that everything turned out okay." Hailey's relief and gratitude were nearly as heartwarming as the procedure.
Tuesday
"It's hard to believe that I was 200 lb of pure muscle," reflected Warren at his last visit. "Nowadays, I'm just 200-plus lb of muscle aches and pains," the 52-year-old coal miner lamented. He was particularly bothered by constant soreness of the muscles in his arms and legs. In light of the more than 30 years he had logged in the mines, Warren had already formulated a diagnosis. "I think my job has ruined me." The examination I performed at that visit revealed some arthritic changes of his knees, hands, and shoulders. No muscle tenderness, atrophy, or weakness was present, so myopathy seemed unlikely. One laboratory test showed intriguing results--an abnormal creatine kinase level of 632 U per L. His MB isoenzyme of creatine kinase (1.95 ng per mL), erythrocyte sedimentation rate (11 mm per hour), and white blood cell count (6,000 cells per mm3) were normal. I asked Warren to have some additional blood work done, but I wanted him to wait until he had been off work for a day or two. The new results arrived today. Warren's creatine kinase level remained elevated--324 U per L--but it was better. The results of the aldolase (4.9 U per L) and other tests including uric acid, antinuclear antibodies, and rheumatoid factor were normal. I knew strenuous activity could cause an elevation of creatine kinase, but was that the reason for Warren's problem? If it was, then what practical remedy could I offer him? I spent so much time reviewing the literature and thinking about the case that I gave myself tired eyes and a headache. For now, the diagnosis that makes the most sense is the one he came up with himself: work hurts.
Wednesday
Mrs. Mendell loved her peas. The 71 year old relished the vegetables grown in her garden. Today, I had my doubts that the affection was mutual. Mrs. Mendell had been eating lots of tomatoes and nuts lately, and for the past few days, she had experienced lower abdominal cramping and mild constipation. On examination, I found Mrs. Mendell had left lower quadrant abdominal tenderness and a low-grade fever. Bowel sounds were normal, a stool for occult blood was negative, and the results of a urinalysis were normal, but her white blood cell count was slightly elevated.
"You have a case of diverticulitis," I informed her. The diagnosis didn't faze her. "Don't all older people have that?" she inquired. I explained to her the difference between diverticulosis and diverticulitis. "I don't want that 'itis'," Mrs. Mendell said while wagging her finger at me. Outpatient treatment seemed appropriate, so I started her on ciprofloxacin (Cipro) and metronidazole (Flagyl). I asked her to alter her diet and return in a couple of days to be reexamined. "What am I going to do with all those vegetables I can't eat?" she thought aloud. The solution suddenly surfaced. "I bet you and your staff love tomatoes. I'll have my husband drop off a shopping bag of them later today."
Thursday
Bernadette mistrusts any doctor except her own and has misgivings about prescription drugs. The 60-year-old woman is a human matchstick--tall and lean with closely cropped red hair and a temper that is easily ignited. Not long ago, Bernadette developed a deep, aching pain in her left shin. She had not injured her lower leg and denied any other bone pain. Grudgingly, she consented to an x-ray of the tibia and a blood test. The radiologist reported changes consistent with Paget's disease of the bone. Further supporting the diagnosis were an elevated alkaline phosphatase level and normal serum calcium. Not surprisingly, Bernadette refused to see an endocrinologist or orthopedist. Because she had no kidney disease or esophageal problems, I asked her to consider treatment with a bisphosphonate agent: alendronate (Fosamax) for six months or risedronate (Actonel) for two months. "No thanks," she said. "If it ain't broke, don't go trying to fix it." To no avail, I explained how the changes associated with Paget's disease make the affected bone weaker and more likely to fracture. There was no way I was going to change this woman's mind. "You don't have to decide today," I said. "I'll be happy to discuss the problem again any time you like." It's hard to light a fire under some people. In Bernadette's case, gentleness may prove to be more effective than coercion.
Friday
Seven months ago, Joe awoke from a sound sleep with an awful pain in his big toe. "Tell me this isn't gout," he entreated. I wasn't able to oblige him. The first metatarsophalangeal joint of his right foot was swollen, warm, reddened, and exquisitely tender to light touch. His uric acid was 9.4 mg per dL and serum creatinine was normal. Treatment with indomethacin (Indocin) quickly stamped out his first episode of gout. Joe failed to follow my recommendations of a low purine diet, weight reduction, and limitation of alcohol intake. Three months later, his gout was back, and so was Joe. Another round of indomethacin provided rapid relief. Today, Joe returned with his third episode of gout. After this last flare is resolved, he will begin treatment for recurrent gout with allopurinol (Zyloprim) 100 mg a day and colchicine 0.6 mg twice a day. The dose of allopurinol will be increased gradually until his uric acid level falls below 6.0 mg per dL. "Is it safe to have a beer now and then with these medicines?" he asked sheepishly. Disappointed and frustrated, I let out a sigh. "Gotcha!" he laughed. Joe had seen the light; I hoped that we had seen the end of his gout.
Saturday/Sunday
"Look in my ear," Leah instructed me. "It's been hurting off and on for the past few months." I examined her ears and found nothing wrong with them. The 36-year-old elementary school teacher vigorously rubbed the skin in front of her right ear, which tipped me off to a possible diagnosis. Mild tenderness was present over the temporo-mandibular joint (TMJ). "Open wide and say 'Aah'," I directed her. A popping noise emanated from her right jaw. "That doesn't sound too good," she remarked. I noticed Leah had a limited ability to open her mouth wide. In addition, she had a crossbite. "You can blame your earache on TMJ disorder," I informed her. She began filling in some blanks about problems at work, occasional teeth grinding, and a fondness for chewing gum. I asked Leah to take ibuprofen as needed for her pain, apply moist heat to the TMJ, and gently massage the area. She would contact her dentist about a mouth splint, and we talked about ways to reduce stress. Before Leah left the office, I gave her a final assignment, "No clenching your teeth or chewing gum at school."
Tony Miksanek, M.D., has been a family physician for more than 20 years. Most of that time has been in solo private practice in Benton, a town with a population of about 7,000 in rural southern Illinois.
Address correspondence to Tony Miksanek, M.D., 712 Old Orchard Dr., Benton, IL 62812.
To preserve patient confidentiality, the patients' names and identifying characteristics have been changed in each scenario. Any resemblance to actual persons is coincidental.
COPYRIGHT 2005 American Academy of Family Physicians
COPYRIGHT 2005 Gale Group
Atazanavir : new recommendations if combined with tenofovir —and warning on Viagra, Cialis, and Levitra
On March 19, 2004 the FDA notified the public of new prescribing information and precautions for atazanavir (brand name Reyataz), if taken in combination with tenofovir (Viread)--and warned of risks with Viagra or similar drugs.
If atazanavir is taken with tenofovir, the blood level of atazanavir is decreased. Therefore it is now recommended that a small dose of ritonavir be taken in addition, to raise the blood level of atazanavir to compensate. All three drugs are taken together once per day, with food.
Also, Reyataz increases the blood level of Viread, which could increase its side effects. As a precaution, patients combining the drugs should be monitored for tenofovir side effects.
The new Patient Information flyer also warns that if atazanavir is combined with Viagra, Cialis, or Levitra, it could increase the risk of serious side effects of those drugs. Patients are advised not to combine atazanavir with any of these drugs unless their doctor tells them it is OK.
For more information see the new prescribing information for atazanavir, which will be posted at http://www.reyataz.com (we did not find it on the site on April 14). Also see the Patient Information flyer, which may be posted at the end of the prescribing information.
COPYRIGHT 2004 John S. James
COPYRIGHT 2004 Gale Group
If atazanavir is taken with tenofovir, the blood level of atazanavir is decreased. Therefore it is now recommended that a small dose of ritonavir be taken in addition, to raise the blood level of atazanavir to compensate. All three drugs are taken together once per day, with food.
Also, Reyataz increases the blood level of Viread, which could increase its side effects. As a precaution, patients combining the drugs should be monitored for tenofovir side effects.
The new Patient Information flyer also warns that if atazanavir is combined with Viagra, Cialis, or Levitra, it could increase the risk of serious side effects of those drugs. Patients are advised not to combine atazanavir with any of these drugs unless their doctor tells them it is OK.
For more information see the new prescribing information for atazanavir, which will be posted at http://www.reyataz.com (we did not find it on the site on April 14). Also see the Patient Information flyer, which may be posted at the end of the prescribing information.
COPYRIGHT 2004 John S. James
COPYRIGHT 2004 Gale Group
Friday, June 1, 2007
Congress Should Just Say No to Drug Price Controls
Your Inside Report From Capitol Hill
"It" you put the federal government in charge of the Sahara Desert," Nobel economist Milton Friedman once quipped, "in five years there'd be a shortage of sand." Friedman's admonition is especially pertinent to the ongoing effort by Senate liberals to give federal bureaucrats a leading role in setting the price of drugs for seniors.
Their track record on this front, not surprisingly, is appalling.
Two years ago. Senate liberals, led by Majority Whip Dick Durbin (D.-I11.), sought to head off implementation of the new federal drug entitlement for seniors (not a bad idea, given that it's available to even the wealthiest seniors and adds trillions of dollars to our long-term debt). But they did this for the wrong reasons and pursued the wrong remedy.
Heavy-Handed Role
Durbin has bemoaned the absence of a heavy regulatory role for Uncle Sam. Left to negotiate freely, insurers that offer drug coverage under Medicare, he feared, would conspire with drug manufacturers to gouge seniors, and send the cost of prescription drugs under the program "through the roof."
The best way to contain those costs, Durbin argued, was a price control-mandating the price insurers could charge seniors for certain Medicare drug plans. He recently pushed legislation that would have instructed the secretary of the Department of Health and Human Services "to set a uniform national premium of $35 for the first year" and "to negotiate group-purchasing agreements" on behalf of seniors.
Happily, Durbin's legislation went nowhere. He and his colleagues quietly dropped the $35 price control on premiums. Last week, 41 Senate Republicans defeated a procedural motion to stifle debate and floor amendments on this bill, disappointing a coalition of 47 Democrats, Socialist Bernie Sanders (Vt.), six moderate Republicans, and Independent Joe lieberman (Conn.).
Raining on the liberals' parade is the fact that the competitive features of the new drug law have exceeded everyone's expectations. At $22 per month, the average premium for plans this year is more than 40% below the projected monthly cost of $37 and is actually lower than the average cost last year. To taxpayers, this translates into annual savings of $ 13 billion this year and has caused government bean counters to lower projected Medicare costs by $ 189 billion over the next decade. Satisfaction levels among seniors who have these plans, meanwhile, top 80%.
Now Durbin and his colleagues are pushing the second part of his legislation (requiring bureaucrats to interfere in negotiations between insurers and drug manufacturers). They justify the heavyhanded government role they covet by citing the drug program run by the Department of Veterans' Affairs. According to Sen. Daniel Akaka (D.-Hawaii), who chairs the Veterans' Affairs Committee, veterans get "better pharmaceutical care" than those in private or public hospitals, have access to more drugs than Medicare beneficiaries, and register higher levels of satisfaction than patients in the private health-care sector.
Not so. A comprehensive review of the drugs available to veterans by The Lewin Group, a highly respected firm that analyzes the health industry, found that the VA's drug formulary actually bars coverage for 106 of the 300 most widely prescribed drugs to seniors, including 30 of the 100 most widely used. The VA formulary also excludes many new and innovative drugs. According to a study by Columbia University Professor Frank Lichtenberg, the VA list includes only 19% of the drugs approved by the Food and Drug Administration since 2000.
Among the drugs not available: Lipitor (the most prescribed drug to seniors, rated the "best" anti-cholesterol drug by Consumer Reports), Verapamil SR (rated "best" by Consumer Reports to treat high blood pressure), and other widely prescribed drugs for conditions such as acid reflux (Nexium), enlarged prostates (FIomax), arthritis (Celebrex), osteoporosis (Evista) and bladder control (Detrol LA). The list of the 1OO most widely prescribed drugs missing from the VA formulary also includes four each to treat blood pressure, diabetes and cholesterol. Little wonder that one million veterans have voted against the VA's restricted formulary with their dollars, signing up with one of the Medicare drug plans.
This push for more government regulation recalls another prescient observation by Milton Friedman. "Many people want the government to protect the consumer," the great Nobel laureate observed, "A much more urgent problem is to protect the consumer from the government."
Mr. Franc, who has held a number of positions on Capitol Hill, is vice president of government relations at the Heritage Foundation. To send a question or comment, e-mail:
MichaelFranc@heritage.org
Copyright Human Events Publishing, Inc. Apr 23, 2007
Provided by ProQuest Information and Learning Company. All rights Reserved
"It" you put the federal government in charge of the Sahara Desert," Nobel economist Milton Friedman once quipped, "in five years there'd be a shortage of sand." Friedman's admonition is especially pertinent to the ongoing effort by Senate liberals to give federal bureaucrats a leading role in setting the price of drugs for seniors.
Their track record on this front, not surprisingly, is appalling.
Two years ago. Senate liberals, led by Majority Whip Dick Durbin (D.-I11.), sought to head off implementation of the new federal drug entitlement for seniors (not a bad idea, given that it's available to even the wealthiest seniors and adds trillions of dollars to our long-term debt). But they did this for the wrong reasons and pursued the wrong remedy.
Heavy-Handed Role
Durbin has bemoaned the absence of a heavy regulatory role for Uncle Sam. Left to negotiate freely, insurers that offer drug coverage under Medicare, he feared, would conspire with drug manufacturers to gouge seniors, and send the cost of prescription drugs under the program "through the roof."
The best way to contain those costs, Durbin argued, was a price control-mandating the price insurers could charge seniors for certain Medicare drug plans. He recently pushed legislation that would have instructed the secretary of the Department of Health and Human Services "to set a uniform national premium of $35 for the first year" and "to negotiate group-purchasing agreements" on behalf of seniors.
Happily, Durbin's legislation went nowhere. He and his colleagues quietly dropped the $35 price control on premiums. Last week, 41 Senate Republicans defeated a procedural motion to stifle debate and floor amendments on this bill, disappointing a coalition of 47 Democrats, Socialist Bernie Sanders (Vt.), six moderate Republicans, and Independent Joe lieberman (Conn.).
Raining on the liberals' parade is the fact that the competitive features of the new drug law have exceeded everyone's expectations. At $22 per month, the average premium for plans this year is more than 40% below the projected monthly cost of $37 and is actually lower than the average cost last year. To taxpayers, this translates into annual savings of $ 13 billion this year and has caused government bean counters to lower projected Medicare costs by $ 189 billion over the next decade. Satisfaction levels among seniors who have these plans, meanwhile, top 80%.
Now Durbin and his colleagues are pushing the second part of his legislation (requiring bureaucrats to interfere in negotiations between insurers and drug manufacturers). They justify the heavyhanded government role they covet by citing the drug program run by the Department of Veterans' Affairs. According to Sen. Daniel Akaka (D.-Hawaii), who chairs the Veterans' Affairs Committee, veterans get "better pharmaceutical care" than those in private or public hospitals, have access to more drugs than Medicare beneficiaries, and register higher levels of satisfaction than patients in the private health-care sector.
Not so. A comprehensive review of the drugs available to veterans by The Lewin Group, a highly respected firm that analyzes the health industry, found that the VA's drug formulary actually bars coverage for 106 of the 300 most widely prescribed drugs to seniors, including 30 of the 100 most widely used. The VA formulary also excludes many new and innovative drugs. According to a study by Columbia University Professor Frank Lichtenberg, the VA list includes only 19% of the drugs approved by the Food and Drug Administration since 2000.
Among the drugs not available: Lipitor (the most prescribed drug to seniors, rated the "best" anti-cholesterol drug by Consumer Reports), Verapamil SR (rated "best" by Consumer Reports to treat high blood pressure), and other widely prescribed drugs for conditions such as acid reflux (Nexium), enlarged prostates (FIomax), arthritis (Celebrex), osteoporosis (Evista) and bladder control (Detrol LA). The list of the 1OO most widely prescribed drugs missing from the VA formulary also includes four each to treat blood pressure, diabetes and cholesterol. Little wonder that one million veterans have voted against the VA's restricted formulary with their dollars, signing up with one of the Medicare drug plans.
This push for more government regulation recalls another prescient observation by Milton Friedman. "Many people want the government to protect the consumer," the great Nobel laureate observed, "A much more urgent problem is to protect the consumer from the government."
Mr. Franc, who has held a number of positions on Capitol Hill, is vice president of government relations at the Heritage Foundation. To send a question or comment, e-mail:
MichaelFranc@heritage.org
Copyright Human Events Publishing, Inc. Apr 23, 2007
Provided by ProQuest Information and Learning Company. All rights Reserved
From pharmacy to fish
Flushing old pills down the toilet or throwing them in the trash might clear out the bathroom cupboard, but scientists around the country are finding that these drugs are winding up in our lakes and streams - and creating problems for fish that swim in them.
The Food and Drug Administration regulates roughly 11,000 drugs on the U.S. market. Unwanted medications that are flushed into wastewater or seep into groundwater at landfills eventually expose water creatures to thousands of chemicals that interact with their bodies like medications a interact with the human body.
So what's the alternative?
Jeff Gloyd, director of the La Crosse County Household Hazardous Waste Program, thinks there is a better way to handle unwanted medications so they don't get into the water supply: by treating it as hazardous waste.
"It's all pretty new," Gloyd said. "It's a topic that has really come to a head."
Fish are used as an indicator of the ecosystem health as a whole, Gloyd said. If fish are unhealthy, human health might be affected as well.
In 1999 and 2000, the first nationwide study by the U.S. Geological Survey collected water samples from 139 streams across 30 states. Pharmaceuticals and other organic contaminants were found in 80 percent of the streams sampled.
Though most of the water samples held traces of pharmaceuticals deemed safe for wildlife and drinking water standards, many of these small amounts were mixtures of chemicals that might be more toxic than each chemical alone.
In early March, Gloyd met with about 20 representatives of water and waste treatment plants, pharmaceutical and health care industries, and city and county officials to discuss the idea of having a permanent medication collection at the Household Hazardous Waste Collection Facility.
La Crosse County residents would be able to drop off their unwanted medications during regular business hours at the facility, located adjacent to the county landfill along Hwy. 16.
The danger
The prevalence of prescription and over-the-counter drugs in the water is clear. The impact on wildlife and human health is not as clear, but aquatic scientists around the nation are scrambling to find out.
Researchers at the Great Lakes Water Institute in Milwaukee and University of Wisconsin-Milwaukee students have been trying to find answers since last summer, taking their research vessel out to Lake Michigan, where they have studied the fathead minnow - a long, silver fish native to Wisconsin.
Rebecca Klaper, the lead scientist in the study, said preliminary data show that some of the same biochemical pathways are "turned on" in the fish as in humans.
"Pharmaceuticals are designed or a very specific mode of action," Klaper said. The fish biochemical systems are responding to the chemicals the same way the human body responds.
In particular, the researchers have found in their preliminary data that lipid-regulating compounds, such as Lipitor or Zocor, are causing fish to deposit fat into their eggs, which might affect reproduction. Antidepressants, such as Prozac, appear to be affecting the nervous system of male fatheads, leading to abnormal behavior when preparing the female for nesting.
Klaper said some males are "missing a few steps" when they prepare the female for nesting. Typically, she said, the male cleans an area under a rock or stick for her nest, chases her there and performs a dance to get her to lay eggs.
As in the USGS study, the concentrations found by Klaper's team were low, but other factors might have more severe implications than what the data reveal.
"It impacts the development of the fish over time," Klaper said. "They are dosed at such an early stage and constantly, whereas humans taking these medications are much older."
Klaper said that they are still at an early stage of research.
The cure
La Crosse County might be leading the country by setting up one of the first permanent medication disposal sites.
"There are three things we want to make sure happens," Gloyd said. "One is to follow all laws, two is to do this in the most environmental way possible, and three is to make this a permanent year-round collection."
Joe Kruse, a Franciscan Skemp administrator who is spearheading the proposal with Gloyd, said "the main goal is to raise public awareness and to create some options for citizens to not just throw (medications) away, and especially not flushing them."
Medications would be collected just like other hazardous waste. People would dump their old pills straight into a 55gallon container of solvent, which dissolves the pills into a useless brown muck. The drums are then shipped away for incineration.
One hurdle to pass is making sure collection complies with strict Drug Enforcement Administration regulations of controlled substances.
Because only law enforcement officials are allowed to handle drugs in this category, like OxyContin and morphine, Gloyd and two other hazardous waste staff would have to be "deputized" - taking an oath that gives them limited deputy responsibilities such as handling controlled substances.
The Food and Drug Administration regulates roughly 11,000 drugs on the U.S. market. Unwanted medications that are flushed into wastewater or seep into groundwater at landfills eventually expose water creatures to thousands of chemicals that interact with their bodies like medications a interact with the human body.
So what's the alternative?
Jeff Gloyd, director of the La Crosse County Household Hazardous Waste Program, thinks there is a better way to handle unwanted medications so they don't get into the water supply: by treating it as hazardous waste.
"It's all pretty new," Gloyd said. "It's a topic that has really come to a head."
Fish are used as an indicator of the ecosystem health as a whole, Gloyd said. If fish are unhealthy, human health might be affected as well.
In 1999 and 2000, the first nationwide study by the U.S. Geological Survey collected water samples from 139 streams across 30 states. Pharmaceuticals and other organic contaminants were found in 80 percent of the streams sampled.
Though most of the water samples held traces of pharmaceuticals deemed safe for wildlife and drinking water standards, many of these small amounts were mixtures of chemicals that might be more toxic than each chemical alone.
In early March, Gloyd met with about 20 representatives of water and waste treatment plants, pharmaceutical and health care industries, and city and county officials to discuss the idea of having a permanent medication collection at the Household Hazardous Waste Collection Facility.
La Crosse County residents would be able to drop off their unwanted medications during regular business hours at the facility, located adjacent to the county landfill along Hwy. 16.
The danger
The prevalence of prescription and over-the-counter drugs in the water is clear. The impact on wildlife and human health is not as clear, but aquatic scientists around the nation are scrambling to find out.
Researchers at the Great Lakes Water Institute in Milwaukee and University of Wisconsin-Milwaukee students have been trying to find answers since last summer, taking their research vessel out to Lake Michigan, where they have studied the fathead minnow - a long, silver fish native to Wisconsin.
Rebecca Klaper, the lead scientist in the study, said preliminary data show that some of the same biochemical pathways are "turned on" in the fish as in humans.
"Pharmaceuticals are designed or a very specific mode of action," Klaper said. The fish biochemical systems are responding to the chemicals the same way the human body responds.
In particular, the researchers have found in their preliminary data that lipid-regulating compounds, such as Lipitor or Zocor, are causing fish to deposit fat into their eggs, which might affect reproduction. Antidepressants, such as Prozac, appear to be affecting the nervous system of male fatheads, leading to abnormal behavior when preparing the female for nesting.
Klaper said some males are "missing a few steps" when they prepare the female for nesting. Typically, she said, the male cleans an area under a rock or stick for her nest, chases her there and performs a dance to get her to lay eggs.
As in the USGS study, the concentrations found by Klaper's team were low, but other factors might have more severe implications than what the data reveal.
"It impacts the development of the fish over time," Klaper said. "They are dosed at such an early stage and constantly, whereas humans taking these medications are much older."
Klaper said that they are still at an early stage of research.
The cure
La Crosse County might be leading the country by setting up one of the first permanent medication disposal sites.
"There are three things we want to make sure happens," Gloyd said. "One is to follow all laws, two is to do this in the most environmental way possible, and three is to make this a permanent year-round collection."
Joe Kruse, a Franciscan Skemp administrator who is spearheading the proposal with Gloyd, said "the main goal is to raise public awareness and to create some options for citizens to not just throw (medications) away, and especially not flushing them."
Medications would be collected just like other hazardous waste. People would dump their old pills straight into a 55gallon container of solvent, which dissolves the pills into a useless brown muck. The drums are then shipped away for incineration.
One hurdle to pass is making sure collection complies with strict Drug Enforcement Administration regulations of controlled substances.
Because only law enforcement officials are allowed to handle drugs in this category, like OxyContin and morphine, Gloyd and two other hazardous waste staff would have to be "deputized" - taking an oath that gives them limited deputy responsibilities such as handling controlled substances.
Easing the pain of shingles
More than 40 percent of people over 70 who develop shingles suffer from unrelenting pain for months to years after their initial symptoms ease, a condition known as postherpetic neuralgia (PHN). But a new study offers some hope. Researchers at the University of Colorado Health Sciences Center in Denver gave antiviral therapy to 12 men and three women ages 53 to 82 who were suffering from moderate to severe nerve pain as a result of the shingles virus.
Each patient received 10 mg of acyclovir (Zovirax) intravenously every eight hours for two weeks and then took a 1,000-mg tablet of valacyclovir (Valtrex) three times per day for a month. Patients rated their pain after each therapy, and then a month after the treatments ended. According to researchers, 53 percent of the patients reported a noticeable difference in their pain symptoms as a result of the treatment. Because this was an open study (no controls were used), the favorable response rate could be due to the placebo effect, acknowledge researchers, but they point out that such a degree of improvement is unlikely to occur spontaneously during a three-month observation period, especially in patients with PHN. Shingles, common in people age 50 and older, occurs when the herpes zoster virus, which lies dormant after a bout of the chicken pox, reemerges years later as a result of advancing age, illness, or, possibly, stress. The virus, which affects about 500,000 people each year, is characterized by a rash and/ or blisters that last for a week or more and burning, shooting pain, tingling and/or itching, usually on one side of the body or face.
COPYRIGHT 2006 Belvoir Media Group, LLC
COPYRIGHT 2007 Gale Group
Each patient received 10 mg of acyclovir (Zovirax) intravenously every eight hours for two weeks and then took a 1,000-mg tablet of valacyclovir (Valtrex) three times per day for a month. Patients rated their pain after each therapy, and then a month after the treatments ended. According to researchers, 53 percent of the patients reported a noticeable difference in their pain symptoms as a result of the treatment. Because this was an open study (no controls were used), the favorable response rate could be due to the placebo effect, acknowledge researchers, but they point out that such a degree of improvement is unlikely to occur spontaneously during a three-month observation period, especially in patients with PHN. Shingles, common in people age 50 and older, occurs when the herpes zoster virus, which lies dormant after a bout of the chicken pox, reemerges years later as a result of advancing age, illness, or, possibly, stress. The virus, which affects about 500,000 people each year, is characterized by a rash and/ or blisters that last for a week or more and burning, shooting pain, tingling and/or itching, usually on one side of the body or face.
COPYRIGHT 2006 Belvoir Media Group, LLC
COPYRIGHT 2007 Gale Group
Plant-Derived Estrogens—Safer Than Premarin?
A drug company is trying to cash in on the public's desire to buy herbs or other products from plant sources and to avoid medications. Nothing wrong with that--if the product really is a plant. The newest estrogen product, Cenestin, is billed by its manufacturer, Duramed Pharmaceuticals, Inc., as the "only conjugated estrogens product with a mixture of nine estrogens synthesized from 100% soy and yam sources."
In the ad campaign, a fortyish woman sits on a large block of ice under the headline, "Made from plants! Isn't that cool?" Lest you miss the point, a large green leaf appears on one side of the ice block. Cenestin is competing with numerous other estrogen drugs, chief among them is Wyeth-Ayerst's Premarin, which is derived from the urine of pregnant horses. Understandably, Duramed is distancing itself from Wyeth-Ayerst's product, describing Cenestin as from "plant sources not from animal waste."
Are plant-derived synthetic conjugated estrogens any safer than Premarin? "Chemically, it makes no difference whether you synthesize a molecule, such as estradiol [the most potent naturally occurring estrogen in mammals], in the laboratory or whether you obtain it from natural sources, such as a pregnant mare's urine or plants. A chemical is the same chemical irrespective of what its sources are," answered Samuel Epstein, MD, School of Public Health, University of Illinois at Chicago and author of The Politics of Cancer--Revisited. "The problem now is that the natural product market, which has its share of scams like other markets, has an element in it that is trying to persuade women that estradiol or progesterone from plant sources is safe unlike estradiol or progesterone synthesized in the laboratory, which is unsafe. And that really is just total nonsense."
Duramed made a commendable attempt several years ago to offer women a low-cost, generic alternative to Premarin, which is also a mixture of conjugated estrogens. Premarin has dominated the estrogen market for decades because it is the drug used by women in most of the studies that have suggested (see below, Estrogen and Heart Disease) low rates of heart disease and osteoporosis. Unfortunately, Duramed lost out to Wyeth-Ayerst's well-financed campaign to convince the Food & Drug Administration (FDA) and women's groups that the generic drug should not be approved because it lacked a type of estrogen found only in horse urine.
When Duramed failed to get FDA approval as a generic equivalent to Premarin, the company had to submit its product to the type of testing required of any new drug. Thus far, Cenestin has received approval only for the short-term treatment of hot flashes and night sweats that many women experience with menopause. For the Duramed-sponsored clinical trial, 120 menopausal women were randomly assigned to take either Cenestin or a placebo (dummy pill) for 12 weeks. According to Duramed, there was an 81% reduction in hot flashes in women taking Cenestin, compared to 58% for women taking the placebo. These results have not yet been published.
Unfortunately, Cenestin is not less expensive than Premarin. Most women in the trial needed two 0.625-mg tablets daily to control symptoms, which is twice the usual dosage of other estrogens. According to The Medical Letter (7/30/99), the cost of a month's supply of each estrogen product is the same--about $l4.60. The rate of adverse effects is expected to be the same as Premarin and other estrogen regimens, according to The Medical Letter, which identified headache, breast tenderness, edema, nausea and other gastrointestinal symptoms as the most common.
Cenestin's role in preventing bone loss has yet to be proven. A Duramed spokesman told HealthFacts that the company plans to conduct the required two-year clinical trial to win FDA approval of Cenestin as a means of preventing osteoporosis. Other estrogen preparations approved for this purpose are Premarin, Estratab, Menest, Estrace, Ogen, Ortho-Est, Climara, and Estraderm.
While these drugs can stop bone loss, no long-term, randomized clinical trials have evaluated estrogen's ability to reduce the rate of fracture. Furthermore, estrogen loss is merely one of many risk factors associated with hip fracture in old age. The majority of falls among the elderly do not result in fracture, but the 5% that do are associated with risk factors, such as impaired vision, poor muscle strength, and inappropriate prescription drugs (e.g., tranquilizers, barbiturates). Taking estrogen for osteoporosis prevention means prolonged, possibly lifelong, usage. Plant-derived synthetic estrogens may be perceived as the safer course than Premarin, but there is little information about long-term effects.
For Further Consideration:
Some women may want to avoid Premarin for ethical reasons. The maltreatment of pregnant mares used in the production of this drug is described by People for the Ethical Treatment of Animals. For information, contact them at 501 Front St., Norfolk, VA 23510, (757) 622-PETA, or visit the Web site (www.peta-online.org). According to PETA, Premarin is the only estrogen drug on the market made with animal-derived estrogen.
In the ad campaign, a fortyish woman sits on a large block of ice under the headline, "Made from plants! Isn't that cool?" Lest you miss the point, a large green leaf appears on one side of the ice block. Cenestin is competing with numerous other estrogen drugs, chief among them is Wyeth-Ayerst's Premarin, which is derived from the urine of pregnant horses. Understandably, Duramed is distancing itself from Wyeth-Ayerst's product, describing Cenestin as from "plant sources not from animal waste."
Are plant-derived synthetic conjugated estrogens any safer than Premarin? "Chemically, it makes no difference whether you synthesize a molecule, such as estradiol [the most potent naturally occurring estrogen in mammals], in the laboratory or whether you obtain it from natural sources, such as a pregnant mare's urine or plants. A chemical is the same chemical irrespective of what its sources are," answered Samuel Epstein, MD, School of Public Health, University of Illinois at Chicago and author of The Politics of Cancer--Revisited. "The problem now is that the natural product market, which has its share of scams like other markets, has an element in it that is trying to persuade women that estradiol or progesterone from plant sources is safe unlike estradiol or progesterone synthesized in the laboratory, which is unsafe. And that really is just total nonsense."
Duramed made a commendable attempt several years ago to offer women a low-cost, generic alternative to Premarin, which is also a mixture of conjugated estrogens. Premarin has dominated the estrogen market for decades because it is the drug used by women in most of the studies that have suggested (see below, Estrogen and Heart Disease) low rates of heart disease and osteoporosis. Unfortunately, Duramed lost out to Wyeth-Ayerst's well-financed campaign to convince the Food & Drug Administration (FDA) and women's groups that the generic drug should not be approved because it lacked a type of estrogen found only in horse urine.
When Duramed failed to get FDA approval as a generic equivalent to Premarin, the company had to submit its product to the type of testing required of any new drug. Thus far, Cenestin has received approval only for the short-term treatment of hot flashes and night sweats that many women experience with menopause. For the Duramed-sponsored clinical trial, 120 menopausal women were randomly assigned to take either Cenestin or a placebo (dummy pill) for 12 weeks. According to Duramed, there was an 81% reduction in hot flashes in women taking Cenestin, compared to 58% for women taking the placebo. These results have not yet been published.
Unfortunately, Cenestin is not less expensive than Premarin. Most women in the trial needed two 0.625-mg tablets daily to control symptoms, which is twice the usual dosage of other estrogens. According to The Medical Letter (7/30/99), the cost of a month's supply of each estrogen product is the same--about $l4.60. The rate of adverse effects is expected to be the same as Premarin and other estrogen regimens, according to The Medical Letter, which identified headache, breast tenderness, edema, nausea and other gastrointestinal symptoms as the most common.
Cenestin's role in preventing bone loss has yet to be proven. A Duramed spokesman told HealthFacts that the company plans to conduct the required two-year clinical trial to win FDA approval of Cenestin as a means of preventing osteoporosis. Other estrogen preparations approved for this purpose are Premarin, Estratab, Menest, Estrace, Ogen, Ortho-Est, Climara, and Estraderm.
While these drugs can stop bone loss, no long-term, randomized clinical trials have evaluated estrogen's ability to reduce the rate of fracture. Furthermore, estrogen loss is merely one of many risk factors associated with hip fracture in old age. The majority of falls among the elderly do not result in fracture, but the 5% that do are associated with risk factors, such as impaired vision, poor muscle strength, and inappropriate prescription drugs (e.g., tranquilizers, barbiturates). Taking estrogen for osteoporosis prevention means prolonged, possibly lifelong, usage. Plant-derived synthetic estrogens may be perceived as the safer course than Premarin, but there is little information about long-term effects.
For Further Consideration:
Some women may want to avoid Premarin for ethical reasons. The maltreatment of pregnant mares used in the production of this drug is described by People for the Ethical Treatment of Animals. For information, contact them at 501 Front St., Norfolk, VA 23510, (757) 622-PETA, or visit the Web site (www.peta-online.org). According to PETA, Premarin is the only estrogen drug on the market made with animal-derived estrogen.
Generalized anxiety disorder: study shows Lexapro better tolerated than Paxil
MIAMI -- Escitalopram is as effective as paroxetine, but is better tolerated, for long-term treatment of generalized anxiety disorder, Dr. Robert J. Bielski said at the annual conference of the Anxiety Disorders Association of America.
Selective serotonin reuptake inhibitors (SSRIs) are increasingly being prescribed for generalized anxiety disorder, according to Dr. Bielski, a researcher at Summit Research Network in Okemos, Mich., which conducts clinical trials for pharmaceutical companies, including Forest Labs Inc., the maker of escitalopram (Lexapro).
In a rare direct comparison, he and his colleagues assessed the efficacy and tolerability of escitalopram and paroxetine (Paxil), two agents approved by the Food and Drug Administration for treating generalized anxiety disorder. (Extended-release venlafaxine is also FDA approved for this condition.)
All participants met the DSM-IV definition for generalized anxiety disorder: a baseline score on the Hamilton Anxiety Scale of 18 or more. Mean age was 37 years. There were 60 patients randomized to escitalopram and 61 to paroxetine. The study began with a week of single-blind placebo treatment, followed by 24 weeks of double-blind, flexible-dose treatment with either 10-20 mg/day of escitalopram or 20-50 mg/day of paroxetine. After an additional 2 weeks to titrate participants down, their Hamilton anxiety scores were compared for mean change from baseline.
Efficacy was similar; both agents improved anxiety symptoms. The mean baseline Hamilton anxiety score was 23.7 in the escitalopram group and 23.4 in the paroxetine group. At the end of the study, the mean reduction in scores was 15.3 in the escitalopram group and 13.3 in the paroxetine group.
"The SSRIs are a family of antidepressants that are really revolutionary. They are so much better tolerated than their predecessors," Dr. Bielski said at the meeting.
A representative of GlaxoSmithKline, the maker of paroxetine, declined to comment on the findings.
There were differences in adverse effects between the two treatment groups. The researchers noted the most frequent adverse events in 10% or more of patients. In the escitalopram group, diarrhea (21%), upper respiratory tract infection (15%), and fatigue (12%) were most common. In the paroxetine group, ejaculation disorder (30%), anorgasmia (26%), and insomnia (26%) were most common.
There was a statistically significant difference in the numbers of patients who withdrew from the study because of adverse events, Dr. Bielski said. A total of 6.6% withdrew from the escitalopram group, compared with 22.6% of the paroxetine group.
Forest Labs Inc. is considering future studies to assess these findings, he said.
Most Common Adverse Effects
ESCITALOPRAM (Lexapro) GROUP
Diarrhea 21%
Upper respiratory 15%
infection
Fatigue 12%
PAROXETINE (Paxil) GROUP
Ejaculation 30%
disorder
Anorgasmia 26%
Insomnia 26%
Note: Table made from bar graph.
BY DAMIAN MCNAMARA
Miami Bureau
COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2004 Gale Group
Selective serotonin reuptake inhibitors (SSRIs) are increasingly being prescribed for generalized anxiety disorder, according to Dr. Bielski, a researcher at Summit Research Network in Okemos, Mich., which conducts clinical trials for pharmaceutical companies, including Forest Labs Inc., the maker of escitalopram (Lexapro).
In a rare direct comparison, he and his colleagues assessed the efficacy and tolerability of escitalopram and paroxetine (Paxil), two agents approved by the Food and Drug Administration for treating generalized anxiety disorder. (Extended-release venlafaxine is also FDA approved for this condition.)
All participants met the DSM-IV definition for generalized anxiety disorder: a baseline score on the Hamilton Anxiety Scale of 18 or more. Mean age was 37 years. There were 60 patients randomized to escitalopram and 61 to paroxetine. The study began with a week of single-blind placebo treatment, followed by 24 weeks of double-blind, flexible-dose treatment with either 10-20 mg/day of escitalopram or 20-50 mg/day of paroxetine. After an additional 2 weeks to titrate participants down, their Hamilton anxiety scores were compared for mean change from baseline.
Efficacy was similar; both agents improved anxiety symptoms. The mean baseline Hamilton anxiety score was 23.7 in the escitalopram group and 23.4 in the paroxetine group. At the end of the study, the mean reduction in scores was 15.3 in the escitalopram group and 13.3 in the paroxetine group.
"The SSRIs are a family of antidepressants that are really revolutionary. They are so much better tolerated than their predecessors," Dr. Bielski said at the meeting.
A representative of GlaxoSmithKline, the maker of paroxetine, declined to comment on the findings.
There were differences in adverse effects between the two treatment groups. The researchers noted the most frequent adverse events in 10% or more of patients. In the escitalopram group, diarrhea (21%), upper respiratory tract infection (15%), and fatigue (12%) were most common. In the paroxetine group, ejaculation disorder (30%), anorgasmia (26%), and insomnia (26%) were most common.
There was a statistically significant difference in the numbers of patients who withdrew from the study because of adverse events, Dr. Bielski said. A total of 6.6% withdrew from the escitalopram group, compared with 22.6% of the paroxetine group.
Forest Labs Inc. is considering future studies to assess these findings, he said.
Most Common Adverse Effects
ESCITALOPRAM (Lexapro) GROUP
Diarrhea 21%
Upper respiratory 15%
infection
Fatigue 12%
PAROXETINE (Paxil) GROUP
Ejaculation 30%
disorder
Anorgasmia 26%
Insomnia 26%
Note: Table made from bar graph.
BY DAMIAN MCNAMARA
Miami Bureau
COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2004 Gale Group
Prednisone after emergency treatment of COPD
Randomized trials have shown that systemic corticosteroids are effective in the treatment of exacerbations of chronic obstructive pulmonary disease (COPD) that require hospitalization. However, no large, controlled trials have examined outpatient use of oral corticosteroids for milder exacerbations of COPD. Aaron and colleagues conducted a randomized controlled trial of an outpatient course of prednisone in patients who were seen at an emergency department for an exacerbation of symptoms of COPD.
The trial initially screened 1,087 patients who presented to an emergency department with an exacerbation of COPD, which was defined as the presence of at least two of the following three clinical criteria: increased dyspnea, increased sputum volume, or increased purulence of sputum. Patients included in the study were smokers who had been diagnosed with COPD for at least one year. Patients also had to be at least 35 years of age and have evidence of irreversible airflow obstruction after bronchodilator use. Exclusion criteria included being admitted to the hospital; the use of corticosteroids in the emergency department or within the previous 30 days; and a history of reversible obstructive disease, concurrent pneumonia, or congestive heart failure. The 147 subjects who met the inclusion criteria and signed consent forms were randomized to receive oral prednisone (40 mg, once daily for 10 days) or a matching placebo. Both groups received oral antibiotics (sulfamethoxazole-trimethoprim or doxycycline) and a 30-day course of inhaled albuterol (two puffs four times daily) and inhaled ipratropium (three puffs four times daily).
The rate of patient relapse, defined as an unscheduled visit to a physician's office or emergency department within 30 days of randomization, was 27 percent in those receiving prednisone and 43 percent in those receiving placebo. Spirometric measures were significantly improved by the use of prednisone. After 10 days, the forced expiratory volume in one second was improved by 34 percent in those receiving prednisone compared with 15 percent of those taking antibiotics and bronchodilators alone. Quality-of-life surveys showed decreased dyspnea-related scores with steroid use, but no significant change in life-quality status. No serious adverse effects were noted with prednisone use, but more patients in the prednisone group reported increased appetite, weight gain, insomnia, and symptoms of depression or anxiety.
The authors conclude that a 10-day course of oral prednisone in patients with exacerbations of COPD who do not require hospitalization is associated with fewer relapses in COPD symptoms after treatment and improved spirometric measures of lung function.
Aaron SD, et al. Outpatient oral prednisone after emergency treatment of chronic obstructive pulmonary disease. N Engl J Med June 26, 2003;348:2618-25.
EDITOR'S NOTE: Careful inclusion and exclusion criteria help to ensure that a proposed intervention is targeted to an appropriate population. However, when only 14 percent of the initially screened patients are enrolled in a trial, one has to wonder if too many clinical hairs have been split. The results of this study might have been generalized more easily if fewer subjects had been excluded. Most physicians treating patients with chronic obstructive pulmonary disorder have to do so in the setting of co-morbidities and would not have pre- and post-bronchodilator spirometry data readily available.--B.Z.
COPYRIGHT 2004 American Academy of Family Physicians
COPYRIGHT 2004 Gale Group
The trial initially screened 1,087 patients who presented to an emergency department with an exacerbation of COPD, which was defined as the presence of at least two of the following three clinical criteria: increased dyspnea, increased sputum volume, or increased purulence of sputum. Patients included in the study were smokers who had been diagnosed with COPD for at least one year. Patients also had to be at least 35 years of age and have evidence of irreversible airflow obstruction after bronchodilator use. Exclusion criteria included being admitted to the hospital; the use of corticosteroids in the emergency department or within the previous 30 days; and a history of reversible obstructive disease, concurrent pneumonia, or congestive heart failure. The 147 subjects who met the inclusion criteria and signed consent forms were randomized to receive oral prednisone (40 mg, once daily for 10 days) or a matching placebo. Both groups received oral antibiotics (sulfamethoxazole-trimethoprim or doxycycline) and a 30-day course of inhaled albuterol (two puffs four times daily) and inhaled ipratropium (three puffs four times daily).
The rate of patient relapse, defined as an unscheduled visit to a physician's office or emergency department within 30 days of randomization, was 27 percent in those receiving prednisone and 43 percent in those receiving placebo. Spirometric measures were significantly improved by the use of prednisone. After 10 days, the forced expiratory volume in one second was improved by 34 percent in those receiving prednisone compared with 15 percent of those taking antibiotics and bronchodilators alone. Quality-of-life surveys showed decreased dyspnea-related scores with steroid use, but no significant change in life-quality status. No serious adverse effects were noted with prednisone use, but more patients in the prednisone group reported increased appetite, weight gain, insomnia, and symptoms of depression or anxiety.
The authors conclude that a 10-day course of oral prednisone in patients with exacerbations of COPD who do not require hospitalization is associated with fewer relapses in COPD symptoms after treatment and improved spirometric measures of lung function.
Aaron SD, et al. Outpatient oral prednisone after emergency treatment of chronic obstructive pulmonary disease. N Engl J Med June 26, 2003;348:2618-25.
EDITOR'S NOTE: Careful inclusion and exclusion criteria help to ensure that a proposed intervention is targeted to an appropriate population. However, when only 14 percent of the initially screened patients are enrolled in a trial, one has to wonder if too many clinical hairs have been split. The results of this study might have been generalized more easily if fewer subjects had been excluded. Most physicians treating patients with chronic obstructive pulmonary disorder have to do so in the setting of co-morbidities and would not have pre- and post-bronchodilator spirometry data readily available.--B.Z.
COPYRIGHT 2004 American Academy of Family Physicians
COPYRIGHT 2004 Gale Group
Prilosec soon to face store-brand competition
Store-brand versions of Prilosec OTC are expected to reach drug store shelves as early as June of this year--marking the expiration of Procter & Gamble s three-year exclusivity of the popular over-the-counter proton-pump inhibitor.
Currently, five generic companies, including Mylan, have approval to market generic omeprazole as a prescription treatment for heartburn and GERD. No private label company has yet received FDA approval to market a store-brand omeprazole for the treatment of frequent heartburn, but when the P&G exclusivity expires, private label companies are expected to file for approval to market their versions of omeprazole over the counter.
In comparison, as many as seven private label suppliers, as well as Wyeth, have been approved to market another chronic over-the-counter medicine, loratadine. The market for a store-brand Prilosec OTC is expected to be at least as competitive.
The introduction of a store-brand equivalent to Prilosec OTC will help lift private label penetration in antacids, which for the 52 weeks ended Dec. 31 fell 3 percent to $143.8 million across food, drug and mass (minus WalMart), according to ACNielsen, representing a 12.6 percent share of the overall antacid market.
As for other competitive threats to Prilosec OTC, it will be another three years before a second proton-pump inhibitor is introduced to the market. Novartis late last year acquired the rights to market an OTC version of Tap Pharmaceutical's Prevacid when that drug's patent expires in 2009.
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Sales of Prevacid as a prescription-only heartburn and GERD remedy fell 2 percent in 2005 to $3.8 billion, according to pharmaceutical market research firm IMS Health.
"Our goal is to switch Prevacid upon its patent expiration and make it one of the top five OTC products in the United States, noted Larry Allgaier, chief executive officer of Novartis Consumer Health, OTC. "We have the experience and a proven track record in switching drugs from Rx to OTC. We're excited about making Prevacid a brand that people know and trust--even more accessible to patients in the future."
MICHAEL JOHNSEN
CATEGORY SPECIALIST
COPYRIGHT 2006 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2006 Gale Group
Currently, five generic companies, including Mylan, have approval to market generic omeprazole as a prescription treatment for heartburn and GERD. No private label company has yet received FDA approval to market a store-brand omeprazole for the treatment of frequent heartburn, but when the P&G exclusivity expires, private label companies are expected to file for approval to market their versions of omeprazole over the counter.
In comparison, as many as seven private label suppliers, as well as Wyeth, have been approved to market another chronic over-the-counter medicine, loratadine. The market for a store-brand Prilosec OTC is expected to be at least as competitive.
The introduction of a store-brand equivalent to Prilosec OTC will help lift private label penetration in antacids, which for the 52 weeks ended Dec. 31 fell 3 percent to $143.8 million across food, drug and mass (minus WalMart), according to ACNielsen, representing a 12.6 percent share of the overall antacid market.
As for other competitive threats to Prilosec OTC, it will be another three years before a second proton-pump inhibitor is introduced to the market. Novartis late last year acquired the rights to market an OTC version of Tap Pharmaceutical's Prevacid when that drug's patent expires in 2009.
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Sales of Prevacid as a prescription-only heartburn and GERD remedy fell 2 percent in 2005 to $3.8 billion, according to pharmaceutical market research firm IMS Health.
"Our goal is to switch Prevacid upon its patent expiration and make it one of the top five OTC products in the United States, noted Larry Allgaier, chief executive officer of Novartis Consumer Health, OTC. "We have the experience and a proven track record in switching drugs from Rx to OTC. We're excited about making Prevacid a brand that people know and trust--even more accessible to patients in the future."
MICHAEL JOHNSEN
CATEGORY SPECIALIST
COPYRIGHT 2006 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2006 Gale Group
Lilly to buy Cialis partner Icos
INDIANAPOLIS -- Eli Lilly and Co. will gain full ownership of the impotence treatment Cialis with a $2.1 billion acquisition of joint venture partner Icos Corp., the companies announced Tuesday.
Lilly will pay $32 per share in cash for each Icos share, a premium of about 18 percent over Monday's closing price.
Icos said the offer represents a 32 percent premium to its average closing price over the past 90 days.
Icos shares rose $4.38, or 16.15 percent, to close at $31.50 on the Nasdaq Stock Market. In earlier trading, the stock surpassed its previous 52-week high of $30.66. Lilly shares lost 11 cents to finish at $57.55 on the New York Stock Exchange.
Indianapolis-based Lilly and Icos, a biotech firm based in Bothell, Wash., launched Cialis in 2003, the fifth year of their partnership on the drug, whose sales rose 34 percent in the first half of the year to $456 million. The joint venture sells the drug in more than 100 countries, leading the markets in France and Brazil and holding about a 25 percent share in the U.S, the companies said.
Sidney Taurel, Lilly's chairman and chief executive officer, said the U.S. market for impotence drugs has grown 10 percent since midyear, and Cialis' market share has grown by a couple of percentage points.
"We are very encouraged by this increased growth in the U.S.," Taurel said in a conference call with stock analysts. "We expect (Cialis) to continue to make progress."
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The companies expect the deal to close late this year or early in 2007, and Lilly then will take a charge yet to be determined for acquiring research and development that's underway at Icos.
Lilly said the purchase will increase its overall sales next year and boost its profit and earnings growth rate in 2008. However, the deal will dilute Lilly's earnings next year.
Taurel said the Cialis franchise will become leaner by eliminating redundant positions at Icos in development, marketing and sales.
"We expect a significant number of jobs will be eliminated at Icos," Taurel said, without estimating how many.
The Icos board already has approved the merger, which also requires approval by Icos shareholders, antitrust clearance and other closing conditions.
Copyright C 2006 Deseret News Publishing Co.
Provided by ProQuest Information and Learning Company. All rights Reserved.
Lilly will pay $32 per share in cash for each Icos share, a premium of about 18 percent over Monday's closing price.
Icos said the offer represents a 32 percent premium to its average closing price over the past 90 days.
Icos shares rose $4.38, or 16.15 percent, to close at $31.50 on the Nasdaq Stock Market. In earlier trading, the stock surpassed its previous 52-week high of $30.66. Lilly shares lost 11 cents to finish at $57.55 on the New York Stock Exchange.
Indianapolis-based Lilly and Icos, a biotech firm based in Bothell, Wash., launched Cialis in 2003, the fifth year of their partnership on the drug, whose sales rose 34 percent in the first half of the year to $456 million. The joint venture sells the drug in more than 100 countries, leading the markets in France and Brazil and holding about a 25 percent share in the U.S, the companies said.
Sidney Taurel, Lilly's chairman and chief executive officer, said the U.S. market for impotence drugs has grown 10 percent since midyear, and Cialis' market share has grown by a couple of percentage points.
"We are very encouraged by this increased growth in the U.S.," Taurel said in a conference call with stock analysts. "We expect (Cialis) to continue to make progress."
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The companies expect the deal to close late this year or early in 2007, and Lilly then will take a charge yet to be determined for acquiring research and development that's underway at Icos.
Lilly said the purchase will increase its overall sales next year and boost its profit and earnings growth rate in 2008. However, the deal will dilute Lilly's earnings next year.
Taurel said the Cialis franchise will become leaner by eliminating redundant positions at Icos in development, marketing and sales.
"We expect a significant number of jobs will be eliminated at Icos," Taurel said, without estimating how many.
The Icos board already has approved the merger, which also requires approval by Icos shareholders, antitrust clearance and other closing conditions.
Copyright C 2006 Deseret News Publishing Co.
Provided by ProQuest Information and Learning Company. All rights Reserved.
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