fined $3 billion for marketing violations. (#12-23 July 5, 2012)
GlaxoSmithKline LLC (GSK) has agreed to plead guilty and to pay $3 billion to resolve liabilities arising from (a) the company's unlawful promotion of certain prescription drugs for uses not approved by the FDA, (b) its failure to report certain safety data, and (c) its civil liability for alleged false price reporting practices. [GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data. US Department of Justice news release, July 2, 2012] http://www.justice.gov/opa/pr/2012/July/12-civ-842.html
The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company. GSK agreed to plead guilty to two counts of introducing misbranded drugs (Paxil and Wellbutrin) into interstate commerce and one count of failing to report safety data about the drug Avandia to the FDA. Under the plea agreement, GSK will pay a criminal fine of $956,814,400 and forfeiture of $43,185,600. The company will also pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states. The civil settlement resolves claims relating to Paxil, Wellbutrin, Avandia, and several other drugs, and also resolves pricing fraud allegations and alleged kickbacks to physicians who prescribed the drugs. The Associated Press has reported that the improper marketing to doctors included expensive resort vacations, European hunting trips, high-paid speaking tours, and even tickets to a Madonna concert. [Holland J. GlaxoSmithKline to pay 3 billion for health fraud. Bloomberg/Business Week News, July 2, 2012] http://www.businessweek.com/ap/2012-07-02/glaxosmithkline-to-pay-3-billion-for-health-fraud.
common arguments against flu vaccine. (#13-04, January 24, 2013)
A recent article in the Journal of the American Medical Association has explained why five common arguments about influenza vaccine are unfounded:
"The vaccine does not work."
"The vaccine causes the flu"
"I have an allergy to eggs."
"I cannot get the vaccine because I am pregnant or have an underlying medical condition or because I live with an immunocompromised person."
"I never get the flu/I am healthy."
The authors also advocate basic preventive measures such as hand hygiene, cough control, and exposure reduction. The full article, Influenza prevention update: Examining common arguments against influenza vaccination, can be viewed online free of charge (link).
plan B emergency contraception restrictions. (#13-31, August 22, 2013)
The FDA has approved Plan B One-Step emergency contraceptives for use without a prescription for all women of child-bearing potential. This action complies with the April 5, 2013 order of the U.S. District Court in New York to make levonorgestrel-containing emergency contraceptives available over-the-counter without age or point-of-sale restrictions. Plan B One Step is a single-dose pill that can decrease the chance of pregnancy by stopping ovulation. It can be taken up to 120 hours after unprotected sex, but the earlier it is used, the more effective it is. If taken within 12 hours, the pregnancy rate is 0.4%. If taken within 1 to 3 days, the rate is 2.7%. The court case was spearheaded by the Center for Reproductive Rights.
cigarette warnings appear to be effective (#14-22 June 15, 2014)
Household consumption of tobacco products in Australia fell 4.9% in the year that ended in March. [Innis M.Australia's graphic cigarette pack warnings appear to work. The New York Times, June 11, 2014]. The drop appears to be due to rising prices and the packaging regulations that took effect in December 2012. Australian cigarette packages must now be plain except for large, graphic warnings about heart disease, lung disease, and other serious illnesses. The Supplier Guide, which provides full details, can be viewed online.
December 6, 2015)
The American College of Physicians has issued a position statement calling for wider prescription of generic drugs. [Choudrey NK and others. Improving adherence to therapy and clinical outcomes while containing costs: Opportunities from the greater use of generic medications: Best practice advice from the Clinical Guidelines Committee of the American College of Physicians. Annals of Internal Medicine. Published online, Nov 24, 2015] The advice is based on a literature review which concluded:
- Research shows that generic medicines are just as effective as brand-name medicines.
- Many brand-name medicines are being used when equally effective and less expensive generic options are available.
- By using more generic medicines, patients can save a lot of money without having any impact on their health care or outcomes. In addition, billions of dollars in health care spending could be saved.
- Generic medicines decrease out-of-pocket costs for patients. Some research shows that less expensive generic medicines could help patients stay on their treatment plans. This is especially helpful for patients with chronic conditions that require long-term drug treatment.
- Some patients and physicians wrongly assume that lower costs mean lower effectiveness, even when research shows the opposite.
- Clinicians should prescribe generic medicines, when possible, in place of more expensive brand-name medicines.
lampoons drug company marketing (#16-12
- April 3, 2016)
Comedian John Oliver has examined how drug companies spend billions of dollars to influence doctors to prescribe their products. The extent to which the marketing strategies work is difficult to measure, but the companies themselves believe that they are effective. Oliver's 17-minute video has had more than 6 million views since it was posted on YouTube two months ago.
concern about the use of "smart drugs" (#16-27 - July 17, 2016)
The American Medical Association House of Delegates has voted to discourage the prescribing and use of prescription drugs for cognitive enhancement in healthy individuals. These products, referred to as nootropics or "smart drugs," include prescription drugs, dietary supplements, or other substances that are claimed to improve brain functions such as executive function, memory, learning, and/or intelligence. [AMA confronts the rise of nootropics. AMA news release, June 14, 2016] The new policy statement noted:
- Prescription drugs that are FDA-approved to treat attention-deficit hyperactivity disorder or narcolepsy are commonly used by students and others seeking to boost memory, learning or other aspects of cognition.
- While prescription stimulants carry real risks, they do not make people smarter. The available evidence suggests the cognitive effects of prescription stimulants appear to be highly variable among individuals, are dose-dependent, and limited or modest at best in healthy individuals.
- More than 100 substances from amino acids to botanical preparations are claimed on Web sites to improve cognitive performance, but their safety and efficacy have not been systematically examined. The AMA will urge the FTC to examine advertisements for these products to ensure that they are not misleading.
sale of marijuana derivative as cancer cures (#17-41 - November 5, 2017)
The FDA has ordered four companies - Greenroads Health, Natural Alchemist, That's Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC -to stop selling cannabidiol (CBD) products with unproven claims that they are effective against cancer. The products include oil drops, capsules, syrups, teas, and topical lotions and creams. Some were also marketed as an alternative or additional treatment for Alzheimer's and other serious diseases. CBD is a component of the marijuana plant that is not FDA approved in any drug product for any indication. [FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer. FDA news release, Nov 1, 2017].
promoters warned (#19-14
April 8, 2019)
The Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) have jointly sent warning letters to Nutra Pure LLC, PotNetwork Holdings, Inc., and Advanced Spine and Pain, LLC (d/b/a Relievus) because they believe the companies are illegally marketing products containing cannabidiol (CBD) to treat a variety of serious diseases and conditions. [FTC joins FDA in sending warning letters to companies advertising and selling products containing cannabidiol (CBD) claiming to treat Alzheimer's, cancer, and other diseases. FTC Press Release. April 2, 2019] CBD is a chemical compound found in marijuana and hemp that does not produce a high. In 2018, the FDA approved a cannabidiol preparation (brand name Epidiolex) to treat two rare, severe forms of epilepsy. But since 2015, the FDA has ordered many companies to stop making unapproved claims. The market for unapproved CBD products is nevertheless burgeoning, as consumer protection is lacking. The FDA and others have found that some CBD products have not contained dosages claimed by marketers. Dangerous chemicals have been found in popular CBD vaping liquids. Although there is great interest in potential medical uses for CBD, the evidence for its safety and effectiveness falls far short of the marketing hype for available products.