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TM Vo l . 9 N o . 4 A u g u s t 2 009 Larry Kudlow Host of CNBC s The Kudlow Report and Co-host of CNBC s The Call Healthcare reform and MDs A good marriage--or sheer madness Smart investing for the short term Practice Management Forum Patients and the Internet Medical information abounds but is that good TM FROM THE PUBLISHER Welcome to this issue of EQUITY the publication dedicated to providing you--the busy physician--with top-flight advice on managing your practice as well as your financial assets. Each issue presents a dual focus timely investing insights from one of the financial world s movers and shakers and time-tested practice management strategies from a noted consultant that will help you optimize your services and practice. We re pleased to shine the spotlight in the issue on a familiar face in Washington on Wall Street and on television--Larry Kudlow host of CNBC s popular primetime show The Kudlow Report. In our interview with this well-known free market supply-side economist Kudlow candidly discusses the nation s fiscal picture and talks about what needs to be done to secure a healthy economy. He also offers readers some advice on short-term and longterm investing. Turn to this issue s Practice Management Forum for an insightful article on what you should do regarding medical information on the Internet. Many patients today are tapping into the Web for information and guidelines pertinent to their own health. This can sometimes be beneficial--but it can also present challenges to physicians. Be sure to read this article to learn what you should do to help your patients as well as protect yourself against potential malpractice claims. After reading this issue we hope you ll send us any questions or comments you may have. You may write us at 1 Office Park West 1 Pennington-Washington Crossing Road Pennington NJ 08534 fax us at 609 730-1874 or email us at frybinski fmrcommunications.com. We look forward to receiving your comments and hope you enjoy this and upcoming issues of EQUITY. Sincerely Frank Rybinski Publisher CONTENTS C O V E R F E AT U R E Volume 9 Number 4 2009 An interview with Larry Kudlow Practice Management Forum 3 11 Patients and the Web Challenges of the Internet in Clinical Practice An interview with Larry Kudlow As anchor of CNBC s primetime The Kudlow Report (7pm-8pm ET) and co-anchor of CNBC s The Call (11am-12pm ET) Larry Kudlow engages in lively dialogues with Wall Street s movers and shakers. He is also host of The Larry Kudlow Show on WABC Radio on Saturday mornings a contributing editor of National Review magazine and columnist and economics editor for National Review Online. A long-time advocate of free market supply-side economics Kudlow has advised many top decision-makers in Washington and has presented testimony at several Republican Governor s Conferences. EQUITY Volume 9 Number 4 2009 3 EQUITY Have we been in a real bull market or a fool s rally over the past few months KUDLOW That s a very hard question. I think in the short run this is a big bull market. It started in early March and my guess is it s going at least to the end of the year. I think stocks are going to rise much more than most folks think. It s all being driven by the end of the deep recession and the movement towards economic recovery. That s the big thing. The deflation and the recession are coming to a close and the stock market is playing this out. The major sectors waiting to rise are all economy-sensitive sectors such as commodities raw materials energy some consumer cyclicals industrials and perhaps the biggest is the banks. The banking crisis is over and that is the hugely positive factor. The unemployment rate will probably go up a little bit but the weekly jobless claims which is a classic leading indicator has been falling since early June. So that s extremely positive and most of this is being driven by Fed stimulus and money creation. They re pouring cash into the economy. That s cleared up the credit crunch. The credit crunch is not over but it s cleared up so bankers can loan out and make money because there s a steep upward yield curve. That s very bullish for bank profits and the banks are leading us out of this downturn. EQUITY Do you think it s time to put an end to the stimulus package and de-TARP across the board KUDLOW I do. I m very much opposed to the government Larry Kudlow has his fingers on the pulse of all the big issues facing our economy today--from de-tarping to foreign ownership of U.S. debt from the housing market to health care reform. In our interview with this highprofile CNBC host Kudlow shares his views on the nation s hot topics and offers some sage investing advice too. takeovers of General Motors and Chrysler. They own Fannie and Freddie and AIG and there has to be an end strategy--but we don t really have one. It s very good that they ve de-tarped some of the banks I d like to see that task completed as soon as possible. I agree with Senator John Thune [R-SD] who came on CNBC s The Kudlow Report to propose that we have a time limit on TARP. The government should work with these companies and if they have to go into bankruptcy let them. I think it has the most demoralizing impact to see the government take control of these big companies and interfere with the free market economy in ways we haven t used since the New Deal or even World War II. I think market forces will stop the problems. And I think it s time now for the Feds to have an exit strategy in order to prevent a burst of inflation. Right now there s a wee bit of inflation out there maybe zero to 3% and the Fed can stop that if they begin an exit strategy. I think that would really go a long way to calming fears of inflation and permitting the recovery to run its strong course. What the Fed should pay much more attention to is the dollar. We need to bring back King Dollar which we saw in the 80s and 90s. I don t want people speculating against our currency--that helps to drive up oil prices as it did last year during the Bush administration. The dollar collapsed oil went to 150 barrel and that was one of the factors behind the recession and the credit crunch. So I d like to see the Fed and the Treasury embark on an exit strategy and I d like to see some support for the dollar that would 4 EQUITY Volume 9 Number 4 2009 help the recovery. And I think the government should get out of our business and enterprise. The government can t run anything efficiently. If we don t stop this trend the landscape will be littered with new Amtraks new postal services new entitlement programs--it s absolutely insane. EQUITY So do you think that if we don t have an exit strategy and there s no support for the dollar the result would be run-away inflation KUDLOW I don t know about run away but I can tell you inflation will go up. Whenever you see this kind of big spending it sets up an inefficient economy. The government is absorbing investment resources by financing all this debt and that means that with whatever economic growth you get you re going to get a little more inflation and a little less real growth. That s what always happened in Europe when they had big spending programs and big borrowing programs. You re pulling scarce resources out of the private sector into government programs most of which are highly inefficient some of which are necessary and some of them are not. So you have an inflationary bias to this story. If however the Fed and the Treasury protect the dollar and the Fed begins a money supply exit strategy I think we can keep the inflation rate down. It won t be zero which it is now but at least it will be around 2% or 3% which is a little high but not the worst thing in the world. consumer choice and private enterprise as possible. Now we have Medicare we have Medicaid and we always will. To create a new government insurance plan is sheer madness and utter folly. It will bankrupt our whole country. And the idea that this health plan is going to save money is ridiculous. It will cost another fortune Medicare is already 80 trillion in the hole according to the actuaries. So I am completely opposed to it. I d like to see interstate competition among insurance plans and keep the government out. I don t want the government to subsidize a new program. The Obama plan is a means of crowding out the private sector--not just insurance companies but also hospital and doctor compensations-- EQUITY What about foreign ownership of U.S. debt What would happen if they start decreasing their positions KUDLOW That s an interesting question because I think you see that some of our large owners like China have some skepticism about the financial health of the United States so I think China is going to buy less debt in the future than they bought in the past. And they re worried about the long-term value of the dollar which is what s behind our debt so that complicates the picture. That s why these enormous borrowing requirements are unwise and in my opinion unnecessary. A couple of hundred billion dollars of the stimulus package is not even expected to impact the economy until after 2010 by which time we will be into recovery. Only about 5% of it is has been spent thus far. So these things are unnecessary. The Chinese know that and therefore they re looking quite skeptically at the value of the dollar and the debt behind it. That could be an issue. because this plan will have a federal board of experts that will allocate resources and set prices. This is an old sad story and I hope it s defeated. I like health savings accounts. I d like to give tax benefits to the individual consumer if that were possible. That s the way I would make a reform. But I don t want to set up a yet another government insurance plan. If you want to set up a nonprofit insurance plan fine--but do it privately. On the other hand we have profit-making insurance companies in our health care system that on the whole I think work pretty darn well. I think on the whole most people like our health care system. EQUITY What about the housing market--when do you think we ll see a rebound KUDLOW If you re looking for a condo on the west coast should be the role of government and of industry in healthcare reform KUDLOW I want as much of our health care system to EQUITY Let s turn to health care. What do you think remain in private hands period. I want as much competition of Florida now s the time to buy. No question about that. continued on page 10 EQUITY Volume 9 Number 4 2009 5 ARE YOUR RRMS PATIENTS ON A PATH TOWARD POSITIVE OUTCOMES Working together to stay on the path You choose COPAXONE for its efficacy1 The tolerability can work for your patients lives1 Together you ve got MS therapy with lasting effect2 To find out how you can partner with Shared Solutions call 1-800-887-8100 8 AM to 8 PM CT Monday through Friday. INDICATION COPAXONE is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis IMPORTANT SAFETY INFORMATION ABOUT COPAXONE Most common adverse effects were injection site reactions (including lipoatrophy and rarely skin necrosis) vasodilatation chest pain asthenia infection pain nausea arthralgia anxiety and hypertonia. Patients should be trained on proper injection technique and advised to not inject into sites with existing lipoatrophy About 10% of patients experienced an immediate postinjection reaction (flushing chest pain palpitations anxiety dyspnea throat constriction and urticaria). The symptoms were transient and self-limited and did not require specific treatment Transient chest pain was noted in 21% of COPAXONE patients (vs 11% placebo) no long-term sequelae Andrea G. started COPAXONE in 1997 Still bikes over 1000 miles each year Individual results may vary References 1. COPAXONE prescribing information. Teva Neuroscience Inc. 11 07. 2. Ford CC Johnson KP Lisak RP et al. Mult Scler. 2006 12 309-320. Please see brief summary of prescribing information on next page. COPAXONE is a registered trademark of Teva Pharmaceutical Industries Ltd. Shared Solutions is a registered trademark of Teva Neuroscience Inc. 2008 Teva Neuroscience Inc. 086215403-02 080644 www.copaxone.com D A I L Y A C T I O N COPAXONE (glatiramer acetate injection) Brief Summary of Prescribing Information INDICATIONS AND USAGE COPAXONE Injection is indicated for reduction of the frequency of relapses in patients with RelapsingRemitting Multiple Sclerosis. CONTRAINDICATIONS COPAXONE Injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. WARNINGS The only recommended route of administration of COPAXONE Injection is the subcutaneous route. COPAXONE Injection should not be administered by the intravenous route. PRECAUTIONS General Patients should be instructed in self-injection techniques to assure the safe administration of COPAXONE Injection (see PRECAUTIONS Information for Patients and the COPAXONE INJECTION PATIENT INFORMATION Leaflet). Current data indicate that no special caution is required for patients operating an automobile or using complex machinery. Considerations Regarding the Use of a Product Capable of Modifying Immune Responses Because glatiramer acetate can modify immune response it could possibly interfere with useful immune functions. For example treatment with glatiramer acetate might in theory interfere with the recognition of foreign antigens in a way that would undermine the body s tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate does this but there has as yet been no systematic evaluation of this risk. Because glatiramer acetate is an antigenic material it is possible that its use may lead to the induction of host responses that are untoward but systematic surveillance for these effects has not been undertaken. Although glatiramer acetate is intended to minimize the autoimmune response to myelin there is the possibility that continued alteration of cellular immunity due to chronic treatment with glatiramer acetate might result in untoward effects. Glatiramer acetate-reactive antibodies are formed in practically all patients exposed to daily treatment with the recommended dose. Studies in both the rat and monkey have suggested that immune complexes are deposited in the renal glomeruli. Furthermore in a controlled trial of 125 RR MS patients given glatiramer acetate 20 mg subcutaneously every day for 2 years serum IgG levels reached at least 3 times baseline values in 80% of patients by 3 months of initiation of treatment. By 12 months of treatment however 30% of patients still had IgG levels at least 3 times baseline values and 90% had levels above baseline by 12 months. The antibodies are exclusively of the IgG subtype-and predominantly of the IgG-1 subtype. No IgE type antibodies could be detected in any of the 94 sera tested nevertheless anaphylaxis can be associated with the administration of most any foreign substance and therefore this risk cannot be excluded. Information for Patients To assure safe and effective use of COPAXONE Injection the following information and instructions should be given to patients 1. Inform your physician if you are pregnant if you are planning to have a child or if you become pregnant while taking this medication. 2. Inform your physician if you are nursing. 3. Do not change the dose or dosing schedule without consulting your physician. 4. Do not stop taking the drug without consulting your physician. Patients should be instructed in the use of aseptic techniques when administering COPAXONE Injection. Appropriate instructions for the self-injection of COPAXONE Injection should be given including a careful review of the COPAXONE INJECTION PATIENT INFORMATION Leaflet. The first injection should be performed under the supervision of an appropriately qualified health care professional. Patient understanding and use of aseptic self-injection techniques and procedures should be periodically reevaluated. Patients should be cautioned against the reuse of needles or syringes and instructed in safe disposal procedures. They should use a puncture-resistant container for disposal of used needles and syringes. Patients should be instructed on the safe disposal of full containers according to local laws. Awareness of Adverse Reactions Physicians are advised to counsel patients about adverse reactions associated with the use of COPAXONE Injection (see ADVERSE REACTIONS section). In addition patients should be advised to read the COPAXONE INJECTION PATIENT INFORMATION Leaflet and resolve any questions regarding it prior to beginning COPAXONE Injection therapy. Laboratory Tests Data collected during premarketing development do not suggest the need for routine laboratory monitoring. Drug Interactions Interactions between COPAXONE Injection and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions of COPAXONE Injection with therapies commonly used in MS patients including the concurrent use of corticosteroids for up to 28 days. COPAXONE Injection has not been formally evaluated in combination with Interferon beta. Drug Laboratory Test Interactions None are known. Carcinogenesis Mutagenesis Impairment of Fertility Carcinogenesis In a two-year carcinogenicity study mice were administered up to 60 mg kg day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose on a mg m2 basis). No increase in systemic neoplasms was observed. In males of the high dose group (60 mg kg day) but not in females there was an increased incidence of fibrosarcomas at the injection sites. These sarcomas were associated with skin damage precipitated by repetitive injections of an irritant over a limited skin area. In a two-year carcinogenicity study rats were administered up to 30 mg kg day glatiramer acetate by subcutaneous injection (up to 15 times the human therapeutic dose on a mg m2 basis). No increase in systemic neoplasms was observed. Mutagenesis Glatiramer acetate was not mutagenic in four strains of Salmonella typhimurium and two strains of Escherichia coli (Ames test) or in the in vitro mouse lymphoma assay in L5178Y cells. Glatiramer acetate was clastogenic in two separate in vitro chromosomal aberration assays in cultured human lymphocytes it was not clastogenic in an in vivo mouse bone marrow micronucleus assay. Impairment of Fertility In a multigeneration reproduction and fertility study in rats glatiramer acetate at subcutaneous doses of up to 36 mg kg (18 times the human therapeutic dose on a mg m2 basis) had no adverse effects on reproductive parameters. Pregnancy Pregnancy Category B. No adverse effects on embryofetal development occurred in reproduction studies in rats and rabbits receiving subcutaneous doses of up to 37.5 mg kg of glatiramer acetate during the period of organogenesis (18 and 36 times the therapeutic human dose on a mg m2 basis respectively). In a prenatal and postnatal study in which rats received subcutaneous glatiramer acetate at doses of up to 36 mg kg from day 15 of pregnancy throughout lactation no significant effects on delivery or on offspring growth and development were observed. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response glatiramer acetate should be used during pregnancy only if clearly needed. Labor and Delivery In a prenatal and postnatal study in which rats received subcutaneous glatiramer acetate at doses of up to 36 mg kg from day 15 of pregnancy throughout lactation no significant effects on delivery were observed. The relevance of these findings to humans is unknown. Nursing Mothers It is not known whether glatiramer acetate is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when COPAXONE is administered to a nursing woman. Pediatric Use The safety and efficacy of COPAXONE Injection have not been established in individuals under 18 years of age. Use in the Elderly COPAXONE Injection has not been studied specifically in elderly patients. Use in Patients with Impaired Renal Function The pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined. ADVERSE REACTIONS During premarketing clinical trials approximately 900 individuals received at least one dose of glatiramer acetate. In controlled clinical trials the most commonly observed adverse experiences associated with the use of glatiramer acetate and not seen at an equivalent frequency among placebo-treated patients were injection site reactions vasodilatation chest pain asthenia infection pain nausea arthralgia anxiety and hypertonia. Approximately 8% of the 893 subjects receiving glatiramer acetate discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were injection site reaction (6.5%) vasodilatation unintended pregnancy depression dyspnea urticaria tachycardia dizziness and tremor. Immediate Post-Injection Reaction Approximately 10% of MS patients exposed to glatiramer acetate in premarketing studies experienced a constellation of symptoms immediately after injection that included flushing chest pain palpitations anxiety dyspnea constriction of the throat and urticaria. In clinical trials the symptoms were generally transient and self-limited and did not require specific treatment. In general these symptoms have their onset several months after the initiation of treatment although they may occur earlier and a given patient may experience one or several episodes of these symptoms. Whether or not any of these symptoms actually represent a specific syndrome is uncertain. During the postmarketing period there have been reports of patients with similar symptoms who received emergency medical care. Whether an immunologic or non-immunologic mechanism mediates these episodes or whether several similar episodes seen in a given patient have identical mechanisms is unknown. Chest Pain Approximately 21% of glatiramer acetate patients in the pre-marketing controlled studies (compared to 11% of placebo patients) experienced at least one episode of what was described as transient chest pain. While some of these episodes occurred in the context of the Immediate Post-Injection Reaction described above many did not. The temporal relationship of this chest pain to an injection of glatiramer acetate was not always known. The pain was transient (usually lasting only a few minutes) often unassociated with other symptoms and appeared to have no important clinical sequelae. There has been only one episode of chest pain during which a full EKG was performed that EKG showed no evidence of ischemia. Some patients experienced more than one such episode and episodes usually began at least 1 month after the initiation of treatment. The pathogenesis of this symptom is unknown. Incidence in Controlled Clinical Studies The following table lists treatment-emergent signs and symptoms that occurred in at least 2% of MS patients treated with glatiramer acetate in the pre-marketing placebocontrolled trials. These signs and symptoms were numerically more common in patients treated with glatiramer acetate than in patients treated with placebo. These trials include the first two controlled trials in RR MS patients and a controlled trial in patients with Chronic-Progressive MS. Adverse reactions were usually mild in intensity. The prescriber should be aware that these figures cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments uses or investigators. An inspection of these frequencies however does provide the prescriber with one basis on which to estimate the relative contribution of drug and nondrug factors to the adverse reaction incidences in the population studied. Controlled Trials in Patients with Multiple Sclerosis Incidence of Glatiramer Acetate Adverse Reactions 2% and More Frequent than Placebo Preferred Term Body as a Whole Asthenia Back Pain Bacterial Infection Chest Pain Chills Cyst Face Edema Fever Flu Syndrome Infection Injection Site Erythema Injection Site Hemorrhage Injection Site Induration Injection Site Inflammation Injection Site Mass Injection Site Pain Injection Site Pruritus Injection Site Urticaria Injection Site Welt Neck Pain Pain Cardiovascular System Migraine Palpitations Syncope Tachycardia Vasodilatation Digestive System Anorexia Diarrhea Gastroenteritis Gastrointestinal Disorder Nausea Vomiting Hemic and Lymphatic System Ecchymosis Lymphadenopathy Glatiramer Acetate (N 201) N % 83 33 11 43 8 5 12 17 38 101 132 11 26 98 54 147 80 10 22 16 56 10 35 10 11 55 17 25 6 10 44 13 16 25 41 16 5 21 4 2 6 8 19 50 66 5 13 49 27 73 40 5 11 8 28 5 17 5 5 27 8 12 3 5 22 6 8 12 Placebo (N 206) N % 78 30 9 22 2 1 2 15 35 99 40 6 1 22 21 78 12 0 5 9 52 5 16 5 8 21 15 23 2 8 34 8 13 12 38 15 4 11 1 0 1 7 17 48 19 3 0 11 10 38 6 0 2 4 25 2 8 2 4 10 7 11 1 4 17 4 6 6 Preferred Term (continued) Glatiramer Acetate (N 201) N % Placebo (N 206) N % Metabolic and Nutritional Edema 5 3 1 0 Peripheral Edema 14 7 8 4 Weight Gain 7 3 0 0 Musculoskeletal System Arthralgia 49 24 39 19 Nervous System Agitation 8 4 4 2 Anxiety 46 23 40 19 Confusion 5 2 1 0 Foot Drop 6 3 4 2 Hypertonia 44 22 37 18 Nervousness 4 2 2 1 Nystagmus 5 2 2 1 Speech Disorder 5 2 3 1 Tremor 14 7 7 3 Vertigo 12 6 11 5 Respiratory System Bronchitis 18 9 12 6 Dyspnea 38 19 15 7 Laryngismus 10 5 7 3 Rhinitis 29 14 27 13 Skin and Appendages Erythema 8 4 4 2 Herpes Simplex 8 4 6 3 Pruritus 36 18 26 13 Rash 37 18 30 15 Skin Nodule 4 2 1 0 Sweating 31 15 21 10 Urticaria 9 4 5 2 Special Senses Ear Pain 15 7 12 6 Eye Disorder 8 4 1 0 Urogenital System Dysmenorrhea 12 6 10 5 Urinary Urgency 20 10 17 8 Vaginal Moniliasis 16 8 9 4 Other events which occurred in at least 2% of glatiramer acetate patients but were present at equal or greater rates in the placebo group included Body as a Whole Headache injection site ecchymosis accidental injury abdominal pain allergic rhinitis neck rigidity and malaise. Digestive System Dyspepsia constipation dysphagia fecal incontinence flatulence nausea and vomiting gastritis gingivitis periodontal abscess and dry mouth. Musculoskeletal Myasthenia and myalgia. Nervous System Dizziness hypesthesia paresthesia insomnia depression dysesthesia incoordination somnolence abnormal gait amnesia emotional lability Lhermitte s sign abnormal thinking twitching euphoria and sleep disorder. Respiratory System Pharyngitis sinusitis increased cough and laryngitis. Skin and Appendages Acne alopecia and nail disorder. Special Senses Abnormal vision diplopia amblyopia eye pain conjunctivitis tinnitus taste perversion and deafness. Urogenital System Urinary tract infection urinary frequency urinary incontinence urinary retention dysuria cystitis metrorrhagia breast pain and vaginitis. Data on adverse reactions occurring in the controlled clinical trials were analyzed to evaluate differences based on sex. No clinically significant differences were identified. Ninety-two percent of patients in these clinical trials were Caucasian. This percentage reflects the racial composition of the MS population. In addition the vast majority of patients treated with COPAXONE were between the ages of 18 and 45. Consequently data are inadequate to perform an analysis of the adverse reaction incidence related to clinically relevant age subgroups. Laboratory analyses were performed on all patients participating in the clinical program for glatiramer acetate. Clinically significant laboratory values for hematology chemistry and urinalysis were similar for both glatiramer acetate and placebo groups in blinded clinical trials. No patient receiving glatiramer acetate withdrew from any trial because of abnormal laboratory findings. Other Adverse Events Observed During Clinical Trials Glatiramer acetate was administered to 979 individuals during premarketing clinical trials only some of which were placebo-controlled. During these trials all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events similar types of events were grouped into standardized categories using COSTART dictionary terminology. All reported events occurring at least twice and potentially important events occurring once are listed below except those already listed in the previous table those too general to be informative trivial events and other reactions which occurred in at least 2% of treated patients and were present at equal or greater rates in the placebo group. Additional adverse reactions reported during the post-marketing period are included. Events are further classified within body system categories and listed in order of decreasing frequency using the following definitions Frequent adverse events are defined as those occurring in at least 1 100 patients Infrequent adverse events are those occurring in 1 100 to 1 1000 patients Rare adverse events are those occurring in less than 1 1000 patients. Body as a Whole N Frequent Injection site edema injection site atrophy abscess injection site hypersensitivity. N Infrequent Injection site hematoma injection site fibrosis moon face cellulitis generalized edema hernia injection site abscess serum sickness suicide attempt injection site hypertrophy injection site melanosis lipoma and photosensitivity reaction. Cardiovascular N Frequent Hypertension. N Infrequent Hypotension midsystolic click systolic murmur atrial fibrillation bradycardia fourth heart sound postural hypotension and varicose veins. Digestive N Infrequent Dry mouth stomatitis burning sensation on tongue cholecystitis colitis esophageal ulcer esophagitis gastrointestinal carcinoma gum hemorrhage hepatomegaly increased appetite melena mouth ulceration pancreas disorder pancreatitis rectal hemorrhage tenesmus tongue discoloration and duodenal ulcer. Endocrine N Infrequent Goiter hyperthyroidism and hypothyroidism. Gastrointestinal N Frequent Bowel urgency oral moniliasis salivary gland enlargement tooth caries and ulcerative stomatitis. Hemic and Lymphatic N Infrequent Leukopenia anemia cyanosis eosinophilia hematemesis lymphedema pancytopenia and splenomegaly. Metabolic and Nutritional N Infrequent Weight loss alcohol intolerance Cushing s syndrome gout abnormal healing and xanthoma. Musculoskeletal N Infrequent Arthritis muscle atrophy bone pain bursitis kidney pain muscle disorder myopathy osteomyelitis tendon pain and tenosynovitis. Nervous N Frequent Abnormal dreams emotional lability and stupor. N Infrequent Aphasia ataxia convulsion circumoral paresthesia depersonalization hallucinations hostility hypokinesia coma concentration disorder facial paralysis decreased libido manic reaction memory impairment myoclonus neuralgia paranoid reaction paraplegia psychotic depression and transient stupor. Respiratory N Frequent Hyperventilation hay-fever. N Infrequent Asthma pneumonia epistaxis hypoventilation and voice alteration. Skin and Appendages N Frequent Eczema herpes zoster pustular rash skin atrophy and warts. N Infrequent Dry skin skin hypertrophy dermatitis furunculosis psoriasis angioedema contact dermatitis erythema nodosum fungal dermatitis maculopapular rash pigmentation benign skin neoplasm skin carcinoma skin striae and vesiculobullous rash. Special Senses N Frequent Visual field defect. N Infrequent Dry eyes otitis externa ptosis cataract corneal ulcer mydriasis optic neuritis photophobia and taste loss. Urogenital N Frequent Amenorrhea hematuria impotence menorrhagia suspicious papanicolaou smear urinary frequency and vaginal hemorrhage. N Infrequent Vaginitis flank pain (kidney) abortion breast engorgement breast enlargement carcinoma in situ cervix fibrocystic breast kidney calculus nocturia ovarian cyst priapism pyelonephritis abnormal sexual function and urethritis. Postmarketing Clinical Experience Postmarketing experience has shown an adverse event profile similar to that presented above. Reports of adverse reactions occurring under treatment with COPAXONE (glatiramer acetate for injection) not mentioned above that have been received since market introduction and that may have or not have causal relationship to the drug include the following Body as a Whole sepsis LE syndrome hydrocephalus enlarged abdomen injection site hypersensitivity allergic reaction anaphylactoid reaction Cardiovascular System thrombosis peripheral vascular disease pericardial effusion myocardial infarct deep thrombophlebitis coronary occlusion congestive heart failure cardiomyopathy cardiomegaly arrhythmia angina pectoris Digestive System tongue edema stomach ulcer hemorrhage liver function abnormality liver damage hepatitis eructation cirrhosis of the liver cholelithiasis Hemic and Lymphatic System thrombocytopenia lymphoma-like reaction acute leukemia Metabolic and Nutritional Disorders hypercholesterolemia Musculoskeletal System rheumatoid arthritis generalized spasm Nervous System myelitis meningitis CNS neoplasm cerebrovascular accident brain edema abnormal dreams aphasia convulsion neuralgia Respiratory System pulmonary embolus pleural effusion carcinoma of lung hay fever Special Senses glaucoma blindness visual field defect Urogenital System urogenital neoplasm urine abnormality ovarian carcinoma nephrosis kidney failure breast carcinoma bladder carcinoma urinary frequency Adverse Reactions Associated with Subcutaneous Use At injection sites localized lipoatrophy and rarely injection site skin necrosis have been reported during the postmarketing experience. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy. To assist in possibly minimizing these events the patient should be advised to follow proper injection technique and to rotate injection areas and sites on a daily basis. (See PATIENT INFORMATION) only. Manufactured in Israel by TEVA Pharmaceutical Industries Ltd. Kfar Saba 44102 Israel Manufactured by Baxter Pharmaceutical Solutions LLC Bloomington IN 47403 Manufactured For TEVA Neuroscience Inc. Kansas City MO 64131 Copp1107BP Rev 11 2007 Larry Kudlow continued from page 5 Home sales the key indicator are stabilizing. We ve been bottoming pretty much all year long. We ve had a big drop in prices in about four states California Arizona Nevada and Florida. That s where most (but not all) of the damage was really done. That s where building halted and where a lot of the mortgage speculation took place. Hopefully we ve learned a thing or two about giving mortgages to people with no down payment and no documentation for income. I think the housing sector will no longer be a negative for the economy. That s one of the reasons I think we ll see a pop in the gross domestic product (GDP) in the third quarter--maybe as much as 5%. And as I said housing affordability is at an all-time high. The market is correcting. Government programs have had hardly any impact at all. Instead the market is correcting on its own. We ve got a lot of auctions of foreclosed properties--that s how the White House has a different model. They have more of a central planning model. They think experts can direct the economy. I do not. And I think the most efficient market comes from the free and open market. The incentive system should be strengthened and that will create the kind of risk taking and investment that could get us booming again. Keep the regulations to a minimum keep the taxes to a minimum keep the spending to a minimum protect the currency and that will help the upper class help the middle class and create a lot of jobs and income. That s my basic point Incentive drives the economy not government planners. EQUITY What advice would you give investors today who KUDLOW In the shorter term (The next 6 to 12 months) want to do something with their money but don t know what I d say basically own the S&P 500 index and the Wilshire 5000 index. You should also probably own an emerging countries index. You re going to see a lot of economic growth in Asia for example and in at least parts of South America. And you should always own some bonds depending on how old you are. If you re over 60 you probably want to have about half of your money in bonds and half in stock. In terms of a stock strategy I ve shied away from a long-term prediction because of what s coming out of Washington. I think we ll see a shift in next year s mid-term elections to more traditional free enterprise policies. But I also acknowledge there are political threats for bad policies in the next year or so that we have to be leery of. You have to keep your eyes open for an inflation threat. EQUITY Are there any specific sectors that you like marketplace works--and a lot of younger people are now going to have an opportunity to buy a nice house at a much KUDLOW In an economic sense the sectors that are lower price. That s good and I m all for it. going to do the best are industrials probably raw materials and probably energy. Banks and financial companies EQUITY What would you advise the administration to do are having a big comeback. Technology looks good but at this point it s had the habit in the past 10 years of breaking your heart. I m a little leery of the energy companies because of KUDLOW We should do everything we can to promote the regulatory threats. I like the global consumer compaentrepreneurship and risk taking in this economy. For nies such as Procter and Gamble those are usually good two years the animal spirits have been dead and dormant. long-run plays. If you want to be a little risky you can look Vibrant recovery can only come by a private free enterprise at housing home builders and Home Depot. economy--from business from entrepreneurs from invesHowever to me the best way to play is through the tors. What we want to do is get people to start reinvesting index. I always think the S&P 500 and Wilshire 5000 are and we want them to start financing new businesses that a good strategy. But you ve got to keep your eyes open. I will create jobs and income. think that s one of the things we learned You just got to I d like to see more optimism and nurturing. It s silly keep your eyes open. And be diverse. I also like corporate to raise tax rates on capital gains or dividends or corpo- bonds which you can also own through a bond index rations or oil and gas companies. The economy is driven fund. They re doing very well and they will continue to by incentive and rewards for extra hard work extra do well they sort of move with stocks. investments and extra risk taking. That s the key but the continued on page 12 10 EQUITY Volume 9 Number 4 2009 PRACTICE MANAGEMENT FORUM Patients and the Web Challenges of the Internet in Clinical Practice In pre-Internet days it was difficult if not impossible for consumers to directly access medical research. But all that has changed and many physicians are finding that today s transfer of health information to patients via the Internet is a double-edged sword. Consumers direct access to medical information is causing a shift in traditional roles for patients and physicians. Patients are less likely to be the passive recipients of advice from the wise and all-knowing physician. Rather they are increasingly likely to use the Internet to supplement what their doctors tell them or to verify the accuracy of their doctors advice. Inevitably physicians will encounter patients who are armed with an arsenal of material gathered from the Internet and ask the physician to respond. From a risk management perspective a physician should have concerns about the possibility that the patient may identify a body of valuable research unfamiliar to the physician. To prevail in a medical malpractice claim a patient must show the following 1 The provider is responsible for conforming to a standard of care necessary to avoid unreasonable risk. The provider s conduct did not meet that standard. The deviation from the standard was causally related to the claimant s injury. The claimant actually suffered an injury. By Robert Falk lines to address the applicable standard of care in medical malpractice litigation.2 While it is highly unlikely that such guidelines will determine exclusively a particular standard of care it is conceivable that future guidelines could reference Internet-based standards and or include a requirement that physicians familiarize themselves with online resources. Accordingly physicians facing medical malpractice litigation could be held to a more stringent standard of care and therefore have a more difficult time mounting a successful defense that their conduct was consistent with that standard. More appropriately a physician should recognize the inevitability of patient use of the Internet and emphasize to the patient the importance of maintaining communication and a dialogue with the physician in addition to using online resources. This point might be illustrated by describing scenarios in which Internet research and self-diagnoses could have adverse results for the health of the patient. For physicians who are familiar with the research presented feel free to explain why you did not choose the therapeutic option highlighted in the material. For physicians who are not familiar with this research saying I don t know but I will review the information and get back to you is always an acceptable answer and does not indicate ineptitude or inability. To the contrary such a frank admission will likely have more positive effects on the physician-patient relationship as compared with a physician response feigning familiarity. Best Practices Today it is increasingly possi- The following best practices can help physicians handle patient ble that a physician could be use of the Internet held liable for not meeting a Become familiar with the online resources available to assist you in your clinical practice. This need not be an overly standard of care that could time-consuming endeavor but rather a regular (ie weekly be identified through the or monthly) look at resources available to clinicians and Internet. Courts are beginresources likely to be viewed by patients. ning to use practice guide Be prepared to mentor patients who wish to use the Internet to research their condition. Mentorship and education about accurate and useful online resources are much better approaches than simply discouraging patient Internet use and or needlessly dramatizing the dangers of Internet use in this context. Be familiar with the existence of What Your Patients Are Reading resources such as that on MD Consult. This service not only alerts physicians to medical items in the popular press but also provides informative peer-reviewed material on each topic to help physicians give accurate and complete responses to patient questions. Recognize that the ability to use email and online resources varies from continued on page 12 EQUITY Volume 9 Number 4 2009 11 EQUITY Editor Annette Lenzi Martin Creative Director David Zwierz Account Executive Howard Good Publisher Frank Rybinski Copyright 2009 FMR Communications 1 Office Park West Pennington-Washington Crossing Road Pennington NJ 08534. All rights reserved. The publisher reserves the copyright and renewal on all published material and such material may not be reproduced in any form without the written permission of the publisher. The opinions expressed in the articles are those of the authors and are not to be construed as the opinions or recommendations of the advertiser or publisher. The publication is designed to provide accurate information with regard to the subject matter included herein however the publication and its advertisers are not engaged in rendering legal accounting tax or other professional advice. For specific advice regarding the information contained herein the services of a professional advisor should be sought. FMR Communications is neither associated with or endorsed by FMR Corp. Fidelity Investments or any of their affiliated companies. Financial and Practice Strategies for Today s Physician Provided as a service by TM PRESORTED STANDARD U.S. POSTAGE ST. CROIX PRESS PAID An Interview With Larry Kudlow continued from page 10 Patients and the Web continued from page 11 thing else you d like our readers to know add that this is a real turning point in the medical profession. Physicians are under assault like never seen before. The only thing I can say to them is fight back politically. If they find candidates that agree with their views help them in the election. A government-run system will do great damage not only to doctors but also to their patients to the development of new breakthroughs in all the areas of drugs technologies and procedures. Risk taking will dry up in the medical profession if it is run by the government but this is a political issue and providers must fight back. They can t stand aside and be a victim. EQUITY Thanks so much for your great input. KUDLOW I d like to EQUITY Is there any- patient to patient. Compile lists of frequently asked questions. Also consider recommending to patients those Web sites you know contain reliable scientifically accurate information. Periodically survey patient use of Internet resources as a means of staying current with available resources and of ensuring prompt intervention should you discover that your patients are regularly visiting Web sites that physicians know to be misleading and or inaccurate. Keep in mind that patients will frequently find references to articles that describe experimental treatments. They may bombard clinicians with information about these options without realizing their experimental nature and the need to win approval from a hospital s internal review board. Patients and their advocates should be apprised of these constraints and should be given the option of contacting the researchers to determine their eligibility for an experimental treatment. Patients who do extensive research on the Internet may be more likely to contact their providers by email often creating a burden of repeated Internet communication. Providers should determine whether the patient s insurer may offer reimbursement for such exchanges that could be deemed consultative. Increasingly carriers are providing modest reimbursement for a limited number of such Internet contacts per year as a means of limiting office visits. Robert Falk is counsel in the Washington DC office of Powell Goldstein LLP. This article was adapted from A Patient an Internet and Thou Challenges of the Internet in Clinical Practice Greenbranch Publishing. References 1. Tyler BJ. Ind L Rev. 1998 31 259 2. Shuman DW. Cal W L Rev. 1997 34 99-100 12 EQUITY Volume 9 Number 4 2009