Doses of nicotine and lung carcinogens delivered to cigarette smokers.
(1/10)
BACKGROUND: Cigarette smoke yields of tar and nicotine obtained under the Federal Trade Commission (FTC)-specified machine-smoking protocol (35-mL puff volume drawn for 2 seconds once per minute) may not accurately reflect the delivery of toxins and carcinogens to the smoker. We conducted this study to obtain more realistic estimates of exposure to components of cigarette smoke that affect lung cancer risk. METHODS: We used a pressure transducer system to evaluate puffing characteristics for 133 smokers of cigarettes rated by the FTC at 1.2 mg of nicotine or less (56 smokers of low-yield cigarettes [+info)
Smoke yields of tobacco-specific nitrosamines in relation to FTC tar level and cigarette manufacturer: analysis of the Massachusetts Benchmark Study.
(2/10)
OBJECTIVES: This research assessed the relationship between the deliveries of carcinogenic tobacco-specific nitrosamines (TSNAs) and the Federal Trade Commission (FTC) "tar" ratings of US commercial cigarettes. METHODS: Analysis of covariance (ANCOVA) was used to assess the explanatory power of FTC tar, the particular manufacturer, and other cigarette characteristics to predict the yields of four TSNAs (N'-nitrosonornicotine [NNN], 4-(N-methyl-N-nitrosamino)-1-(3-pyridyl)-1-butanone [NNK], N'-nitrosoanatabine [NAT], and N'-nitrosoanabasine [NAB]) in 26 US commercial brands tested in the 1999 Massachusetts Benchmark Study. RESULTS: When FTC tar alone was used to predict TSNA yield, the squared correlation coefficient (R(2)) was only 38% for NNN, 76% for NNK, 46% for NAT, and 49% for NAB. Inclusion of manufacturer-specific variables significantly (p < 0.001) increased the estimated R(2) for three of the four species of nitrosamine to: 78% for NNN, 88% for NNK, and 81% for NAT. Inclusion of other cigarette characteristics (filter type, paper permeability, tobacco weight, tip dilution) did not reduce the significance of the manufacturer-specific effects. Federal Trade Commission nicotine and carbon monoxide (CO) yields were no better at predicting TSNA levels. CONCLUSIONS: FTC ratings for tar, nicotine, and carbon monoxide do not tell the entire story about the comparative yields of toxic agents in marketed cigarette brands. The significant manufacturer-specific effects suggest that proprietary blending and processing of tobacco matter as well. Public, brand-by-brand disclosure of the yields of TSNA and possibly other smoke constituents appears to be warranted. (+info)
Relevance of federal antitrust statutes to clinical practice.
(3/10)
With the advent of Medicare prospective payment systems, health care entities and physicians were forced to decrease expenses by sharing services and to increase revenue by attempting to jointly negotiate better reimbursement from third- party payers. Both activities have raised the specter of prosecution under antitrust laws that have been with us for more than a century but are poorly understood by practicing physicians. Recent monopolistic activities in the health care arena have prompted the Federal Trade Commission to file actions under specific acts of Congress, eg, the Sherman Anti-Trust Act, Clayton Act, Federal Trade Commission Act, Robinson-Patman Act, and Celler-Kefauver Act. Inasmuch as it is likely that specialties such as vascular surgery as a business will undergo substantial transformation, physicians need to be aware of the severe civil and criminal sanctions imposed if they are found guilty; fines that are several times actual damages; activities that raise antitrust issues including utilization review, medical staff privileges for competing specialties, participating provider agreements, and predatory pricing; and affirmative defenses and relief available in terms of specific exemptions. As health care providers react, innovate, and adjust to stay solvent, their business strategies will surely continue to be scrutinized for antitrust behavior by federal and state officials. The physician must have a basic understanding of the groundrules that govern any contemplated business strategy so that common pitfalls may be averted. (+info)
Protecting competition and consumers: a conversation with Timothy J. Muris. Interview by William Sage.
(4/10)
In this interview with William Sage of Columbia University, Federal Trade Commission (FTC) chair Timothy Muris discusses his commission's role in the health care arena. He details the FTC's antitrust and consumer protection activities in a variety of sectors, including hospitals, physicians, and pharmaceuticals. Muris affirms the commission's belief that markets benefit consumers and that markets need basic rules to operate. The FTC's role is to enforce those rules, based on empirical evidence, in as much of the economy as possible, including health care. (+info)
Ignoring puff counts: another shortcoming of the Federal Trade Commission cigarette testing programme.
(5/10)
Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.
(7/10)
BACKGROUND: Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. OBJECTIVES: To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). METHODS: Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR(4)) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions regarding what the average generic lorazepam price would have been in the absence of the alleged conspiracy. To find counterfactual prices, the average per-claim reimbursement for lorazepam for the 4 quarters prior to the alleged conspiracy, $6.80, was inflated using (a) the quarterly change in the average per-claim reimbursement for generic alprazolam and (b) the Consumer Price Index (CPI) for all urban consumers, all goods. Potential impact of the alleged conspiracy on the branded lorazepam and generic alprazolam markets was investigated. RESULTS: The average pre-rebate reimbursements per claim for generic lorazepam were $10.25, $23.12, and $8.48 in 1991, 1998, and 2009, respectively. For the same 3 years, CR(4) = 52.80, 76.02, and 86.74, while HHI = 905.71, 2,166.25, and 2,233.36. Medicaid's excess payments from 1998-2009 were estimated at approximately $625-$657 million. The data also suggest the possibility of small impacts on the utilization of branded lorazepam and the price of generic alprazolam. CONCLUSIONS: Prior to the alleged conspiracy in 1997, average pre-rebate reimbursement per claim for generic lorazepam was declining, while seller concentration was rising. After a jump in average payment per claim in the years immediately following the alleged conspiracy, prices have gradually returned to their pre-1998 levels. However, the generic lorazepam market was more concentrated in 2009 than prior to the alleged conspiracy. (+info)
Quality and provider choice: a multinomial logit-least-squares model with selectivity.
(8/10)
A Federal Trade Commission survey of contact lens wearers is used to estimate a multinomial logit-least-squares model of the joint determination of provider choice and quality of care in the contact lens industry. The effect of personal and industry characteristics on a consumer's choice among three types of providers--opticians, ophthalmologists, and optometrists--is estimated via multinomial logit. The regression model of the quality of care has two features that distinguish it from previous work in the area. First, it uses an outcome rather than a structural or process measure of quality. Quality is measured as an index of the presence of seven potentially pathological eye conditions caused by poorly fitted lenses. Second, the model controls for possible selection bias that may arise from the fact that the sample observations on quality are generated by consumers' nonrandom choices of providers. The multinomial logit estimates of provider choice indicate that professional regulations limiting the commercial practices of optometrists shift demand for contact lens services away from optometrists toward ophthalmologists. Further, consumers are more likely to have their lenses fitted by opticians in states that require the licensing of opticians. The regression analysis of variations in quality across provider types shows a strong positive selection bias in the estimate of the quality of care received by consumers of ophthalmologists' services. Failure to control for this selection bias results in an overestimate of the quality of care provided by ophthalmologists. (+info)