Consumer Alert: What You Should Know About OTC and Prescription Drug Marketing. Gerald DeVries, Ph.D. November 8, 2013

Transcription

1 Consumer Alert: What You Should Know About OTC and Prescription Drug Marketing Gerald DeVries, Ph.D. November 8, 2013

2 Course Goal These presentations are intended to provide additional insight into the effects of various OTC and prescription drugs and how they are marketed to consumers. They are not intended to provide medical advice or disease diagnosis.

3 Course Outline Week 1 Basic principles of drug actions Common OTC drugs for heartburn, pain, allergy & flu FDA regulation of OTC drugs Week 2 Direct to consumer advertising Classes of drugs most frequently advertised Drug type and FDA regulation

4 Requirements of Effective OTC Drug Use Self-diagnosis of a condition. Self-selection of treatment. Self-management of therapy. Failure at any step may lead to unsafe and/or ineffective use of a drug.

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6 Heartburn, GERD Absorption, Efficacy

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13 Product Al(OH) Mg(OH) CaCO3 Maalox Mylanta Rolaids Tums EX Maalox TC Mylanta Milk of Magnesia

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16 H2 Receptor Antagonists Tagamet: cimetidine Zantac: ranitidine Pepcid: famotidine Axid: nizatidine

17 Drug Interactions with H2 Antagonists Tagamet: inhibits liver metabolic enzymes, can increase levels of other drugs. Zantac: also inhibits liver enzymes but at much reduced levels. Pepcid & Axid: even safer in this regard

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24 Goodman & Gilman, 2011

25 Pain, Analgesics Duration of action, toxicity

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36 Aspirin Pain/fever relief: mg every 4-6 hours. Irreversible inhibition of COX. Anti-platelet activity: repeated dosing of 80 mg/day. Takes 8-10 days to reverse effect.

37 NSAID Toxicity Most common side effects are GI: nausea, abdominal pain, diarrhea, gastric or intestinal ulcers. Ulcers estimated to occur in 15-30% of regular users. Age generally correlated with increased probability of serious adverse reactions.

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39 Poisons Associated with largest number of fatalities Sedatives/hypnotics/antipsychotics Acetaminophen Opiods Antidepressants Cardiovascular drugs Stimulants and street drugs Alcohols Bronstein et al., 2008

40 Flu, Allergy Drug Distribution in the Body

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47 Anti-Histamines: 1 st Generation Benadryl Chlor-Trimeton Tavist diphenhydramine chlorpheniramine clemastine fumarate Adverse effects: Sedation, dry mouth & respiratory tract, urinary retention

48 Anti-Histamines: 2 nd Generation Claritin Zyrtec Allegra loratadine cetirizine fexofenadine Adverse effects: no sedation, no anti-cholinergic effects. Drugs of choice for common allergic disorders.

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51 Combination OTC Therapies

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53 Nasal Decongestants Pseudoephedrine (Sudafed): decreases volume of the nasal mucosa (blood vessel constriction). Loss of effect, rebound hyperemia, damage to nasal mucosa. Avoid in pts. with hypertension, ischemic heart disease, men with BPH.

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57 Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg

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59 Famotidine 10 mg CaCO3 800 mg Mg(OH) 165 mg

60 Acetaminophen 650 mg Dextromethorphan 30 mg Doxylamine 12.5 mg

61 FDA Regulation of OTC Drugs Currently, >300,000 marketed nonprescription drug products. (U.S. FDA, 2012) Many drugs have switched from prescription to nonprescription. Increased the range of nonprescription drugs, e.g. antihistamines, nasal decongestants, analgesics, acid reducers.

62 Background for New FDA Initiative on OTC Drugs Undertreatment of common diseases contributes to critical gaps in public health. Lack of regular access to medical and pharmacological care. Poor medical adherence to therapy - 20% to 30% of prescriptions not filled - 50% of medications not taken as prescribed.

63 FDA Initiative on OTC Drugs (cont.) FDA exploring a regulatory expansion of the nonprescription drug class. Nonprescription Safe Use Regulatory Expansion (NSURE) Public meeting March, 2012 Pharmacists, Physicians, Pharma Industry, Nurse Practioners, Academics, Patient Support Groups

64 FDA Initiative (cont.) Drugs that may become available OTC without a prescription include cholesterol, asthma, migraine and blood-pressure medications.

65 Requirements of Effective OTC Drug Use Self-diagnosis of a condition. Self-selection of treatment. Self-management of therapy. Failure at any step may lead to unsafe and/or ineffective use of a drug.

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68 Thank You

69 Consumer Alert: What You Should Know About OTC and Prescription Drug Marketing Gerald DeVries, Ph.D. November 15, 2013

70 Course Outline Week 1 Basic principles of drug actions Common OTC drugs for heartburn, pain, allergy & flu FDA regulation of OTC drugs Week 2 Direct to consumer advertising Classes of drugs most frequently advertised Drug type and FDA regulation

71 Prescription Drugs Total sales in $307 billion 12% of all health care spending Private health insurance - $117 billion (45%) Public programs - $93 billion (36%) -Medicare -Medicaid Consumers - $49 billion (19%)

72 History of DTC Marketing United States and New Zealand are the only developed countries that permit DTC advertising (DTCA) of prescription drugs FDA granted authority to regulate presecription drug advertisement Merck publishes first print ad in Reader s Digest Boots Pharm. first TV DTC ad.

73 History of DTCA (cont.) Ads primarily focused in print media, because of brief summary req FDA releases new guidelines: no longer mandated brief summary. Replaced with adequate provision clause. Only major risks and most common adverse events disclosed DTCA $791 million 2005 DTCA $4.2 billion

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75 Top Selling Drugs 2011 Lipitor Pfizer $7.668 billion Plavix Bristol-Myers $6.771 Nexium AstraZeneca $6.155 Abilify Otsuka $5.194 AdvairDiskus GSK $4.636 Seroquel AstraZeneca $4.636 Singulair Merk $4.592 Crestor AstraZeneca $4.403

76 Top Selling Drugs 2011 (cont.) Cymbalta Lilly $3.666 billion Humira Abbott $3.531 Enbrel Amgen $3.506 Remicade Centocor $3.474 Actos Takeda $3.437 Neulasta Amgen $3.316 Rituxan Genentech $3,004 Zyprexa Lilly $2.964

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81 Types of DTC Ads Product claim ad: names a drug and the indications -risks must be included in major statement and adequate provision for access to a brief summary is required. - telephone number, website, reference to print ad, ask health care provider.

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88 Types of DTC Ads Reminder ad: names a drug, dosage form, but not its uses. - no product claims are made, so fair balance does not apply - mention of risks in brief summary, major statement or adequate provision is not required.

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93 Types of DTC Ads Help-seeking ad: describes a disease or condition but does not mention a specific drug. - no product is mentioned, nor are any claims made, so fair balance does not apply.

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96 Content Analysis of DTCA Appeals: - positive emotional 95% - negative emotional 68% Lifestyle portrayals: - Condition interferes with healthy activities 26% - Product enables healthy activity 56% Frosch et al., Annals Family Medicine, 2007

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101 Content Analysis (what s not there) Factual claims: - Any factual information 82% - Risk factors or cause of condition 25% - Prevalence of condition 24% Lifestyle portrayals: - lifestyle change as alternative 0% - lifestyle change is insufficient 21%

102 DTC Target Audiences

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113 On balance, do you think prescription drug advertising is mostly a good thing, or mostly a bad thing?

114 Do you agree or disagree with this statement? Prescription drug ads educate people about Available treatment and encourage them to get help for medical conditions they might not have been aware of.

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118 Effect of DCTA on Physician/Patient Interaction Encourages patients to contact a clinician. Promotes patient dialogue with clinicians. Encourages patient compliance. Manufactures disease and encourages drug over-utilization. Leads to inappropriate prescribing. Strains relationships with clinicians. Ventola CL, P&T, 2011

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120 Influence of Patients Requests for Advertised Antidepressants Study of physicians prescribing practices in major depression, or adjustment disorder. Major depression: rates of prescribing when pts. ask for brand names, 53%; general drugs, 76%; no requests, 31%. Adjustment disorder: brand name, 55%; general, 39%; no request, 10%. Kravitz et al.; JAMA, 2005

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122 Biologics vs Conventional Drugs

123 Biologics Drugs made in or isolated from living systems. Increasingly use recombinant DNA technology. First recombinant product for human use, human insulin (Humulin) approved in the US in 1982.

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125 Some Current Biologic Drugs Remicade: monoclonal antibody (rheumatoid arthritis; Crohn s disease) Humira: monoclonal antibody (rheumatoid arthritis; psoriatic arthritis) Enbrel: fusion protein (rheumatoid arthritis) Erbitux: monoclonal antibody (cancer) Herceptin: monoclonal antibody (cancer)

126 Cost of Biologic Therapies Herceptin (breast cancer): $54 K/yr Kadcyla (breast cancer): $117 K/yr Lucentis (macular degeneration): $23 K/yr Humira (rheumatoid/crohns): $50 K / yr Avastin (cancer): $100 K / yr Cerezyme ( Gaucher ) : $200 K / yr

127 Cost of Biologics (cont.) Often used for chronic, on-going conditions Top 6 biologics currently consume 43% of the drug budget for Medicare Part B

128 Sloan-Kettering Says No Zaltrap receives FDA approval for colorectal cancer August, 2012 Sanofi sets price at $11K / month Sloan-Kettering refuses to use Zaltrap for cost reasons Sanofi announces reduction in cost by 50% in November, 2012

129 Biologics Growth Approximately 30% of pharmaceutical R&D pipeline composed of biologics. Anticipated by of the 20 top-selling drugs will be biologics. Seven of these (Humira, Avastin, Rituxan, Herceptin, Remicade, Prolia and Lucentis) are monoclonal antibodies. Global sales in 2009 were $93 billion.

130 Samsung Biologics Samsung and Biogen Idec announce joint venture One of our goals is to help patients by increasing accessibility to existing medicines. Making high quality biosimilars is critical to that goal A number of biologics come off patent in the next decade.

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132 Pathway for Small Molecule Generics Abbreviated New Drug Application process established by the 1984 Hatch-Waxman Amendments to the FDCA, creating a generic drug program for small molecule drugs. Act facilitated earlier, less costly market entry.

133 Requirements for Generic Drug Approval Same active ingredient Same route of administration Same strength Same intended use Same rate and extent of absorption into the body Do NOT need to provide independent evidence of safety and efficacy in clinical trials

134 Impact of Generics on Health Care Costs Retail price of generics on average is 75% lower than brand name drugs. Generics make up about 78% of drugs dispensed in retail settings. Estimated savings to US health care system through use of generics ( ) is more than $1 trillion. [GAO Jan. 2012]

135 What is Bioequivalence? For simple chemical molecules, the mechanism to establish comparability is streamlined through the concept of bioequivalence 1 Two medicinal products are bioequivalent if they have the same pharmacokinetics, i.e., Their time to maximal plasma concentration [C max ], and area under the plasma concentration-time curve (AUC) falls in the same prespecified confidence interval 2 For complex biological molecules, the concept of bioequivalence has yet to be established, because pharmacokinetic criteria are not relevant or measurable 3 1. European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Proprietary Medicinal products (CPMP) Note For Guidance on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/1401/98 2. Food Drug administration (FDA). Guidance for Industry Statistical Approaches to Establishing Bioequivalence. Available at: Accessed January Schellekens H and Ryff JC. Biogenerics: the off-patent biotech products. Trends Pharmacol Sci 2002;23:

136 Regulation of Biologics Science-Based Regulatory Concept of Comparability Supported by industry, e.g. Pharmaceutical Research and Manufacturers of America In Europe, per 2003 EMA guideline, comparable extended to products from different sponsors.

137 Regulation of Biologics (cont.) In 2010, Biologics Price Competition and Innovation Act (BPCIA) allows FDA to approve biosimilars and to lead on the formal designation of interchangeability. However, it is not clear if the FDA will waive pre-clinical and clinical studies for biosimilars in the near future.

138 State Bills to Limit Biosimilars Amgen and Genentech are proposing bills to restrict pharmacists substituting generic biologics for brand name products. North Dakota: State Senator said Genentech was the one that brought the bill to me. Indiana: PH Comm. Chairman said bill had been brought to him by Genentech and supported by Eli Lilly.

139 State Bills (cont.) California bill SB 598 would have allowed biosimilars deemed interchangeable with brand name product by FDA to be substituted by pharmacists. However, pharmacists would have to notify patient s doctor and patient. Gov. Jerry Brown vetoed the bill.

140 Thank You