Some Lung Cancer Patients May Breathe Easier With Newly Approved Drug

On December 12, 2014, the FDA approved a new use for Cyramza® (ramucirumab), a cancer drug made by Eli Lilly Co. specifically for the treatment of metastatic nonsmall cell lung cancer (NSCLC). NSCLC is the most common form of lung cancer, occurring when cancer cells develop in lung tissue. Lung cancer is expected to kill about 159,000 people in the United States in 2014.

How it Works

Cyramza works by stopping blood flow to the tumor. It is intended to be used in conjunction with another drug, docetaxel, to treat patients whose tumors have continued to grow during or after treatment with a platinum-based chemotherapy.

Supporting Study

Cyramza was approved under the FDA’s priority review program based on a study of about 1,300 patients. Half the patients received docetaxel plus a placebo, while the other half received docetaxel plus Cyramza. The treatment continued until “disease progression” or the development of intolerable side effects. The study measured the length of time the patients survived after beginning treatment. The patients who received Cyramza lived an average of 10.5 weeks, while those who received the placebo survived an average of 9.1 weeks.

Prior Approvals

The FDA first approved Cyramza on April 21, 2014, as a single line treatment for advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, which occurs in the region where the esophagus joins the stomach. On November 5, 2014, the FDA approved Cyramza for use with paclitaxel to treat advanced gastric cancer or GEJ adenocarcinoma.

E-Cigarettes Are Within Reach of 16 Million Children

E-cigarettes can be lawfully purchased by minors in ten states and the District of Columbia, according to a report published by the Centers for Disease Control and Prevention (CDC) in the Morbidity and Mortality Weekly Report (MMWR). Although 40 states have enacted laws to prevent the sale of electronic nicotine delivery systems (ENDS), the products are still readily available to more than 16 million children ages 17 and under.  

ENDS

In the words of Tim McAfee, M.D., M.P.H., Director of CDC’s Office on Smoking and Health, “e-cigarettes are not safe for youth.” The danger stems from the fact that the aerosol byproduct of the ENDS is, contrary to widespread belief, not harmless water vapor. According to a CDC press release, Brian King, Ph.D., senior scientific advisor in CDC’s Office on Smoking and Health, said that the aerosol contains nicotine and toxins. Additionally, King said “exposure to nicotine can harm adolescent brain development and can be toxic to fetuses. The standard for protecting the health of children and bystanders should be clean air, free of toxic secondhand smoke as well as ENDS aerosol.” A CDC infographic corroborates King’s position. While ENDS are regularly promoted as aids to help smokers quit smoking, the CDC says that there is no credible scientific support for that claim.  The CDC reminds smokers that there are FDA approved methods to help smokers quit and ENDS are not one of them.

Adults

The issue presented by ENDS and their use is broader than child access. According to the CDC, there is a problematic disparity between smoke-free laws and ENDS prohibitions. For example, in 26 states and the District of Columbia, smoking is prohibited in restaurants, worksites, and bars; however, only three states, New Jersey, North Dakota, and Utah have prohibited the use of ENDS indoors. The result, according to the CDC, is that 300 million Americans, including 70 million children, stand to be involuntarily exposed to either second-hand smoke from smoked tobacco products or ENDS aerosol.   

Minor Laws

Laws restricting the sale of ENDS to minors have increased in recent years. For example, of the 40 states with minor sale restrictions, 12 of the laws took effect in 2013 and 16 of the laws took effect in 2014. However, there is some concern that the prohibitions of ENDS sales to minors is due in large part to efforts from the tobacco industry. The push from the tobacco industry is potentially problematic, according to the CDC, because the 2012 Surgeon General’s Report found that bills sponsored by the tobacco industry, while effective in restricting ENDS sales, tend to undermine efforts to prevent youth from using tobacco products as an alternative.

The CVS Co-Payment: The Next Step in the Anti-Tobacco Initiative or an Anti-Competitive Practice?

By Sydney Mayer, DePaul University College of Law-

In September 2014, CVS and Caremark, CVS Health’s pharmacy benefits manager, became the first major pharmaceutical chain to ban tobacco sales in all of its 7,700 stores. The company is moving forward with a plan to “improve public health and generate goodwill” among its customers. However, while their commitment to remove tobacco products from its shelves is admirable and a step in the right direction against cigarettes and other addictive products, CVS sacrificed a reported $2 billion in annual tobacco sales for this initiative. In an attempt to compensate for their financial damages, beginning in 2015, Caremark will require certain customers to pay an extra co-payment on any prescription filled at a pharmacy that sells tobacco products. The co-payment could be as high as $15 for some customers. Caremark currently works with Walgreens, Rite Aid, Target, Kroger, and CVS as a pharmaceutical benefits manager, responsible for processing and paying prescription drug claims. Of those, only CVS and Target are tobacco-free. With a start date of January 1, 2015, employers and Caremark-managed pharmacies would have the option of joining the tobacco-free network, and any of its customers that fill at a pharmacy not in the network would have to pay the additional co-payment. This action is meant to encourage other pharmacies in the Caremark network to join the tobacco-free network and ban tobacco sales in their store. Furthermore, CVS hopes that this initiative will drive business in their direction; individuals who do not want to pay an extra co-payment will leave their tobacco-selling pharmacy and come to CVS. The additional co-payment appears to be the answer to CVS’s financial losses since pulling tobacco-products from its shelves.

While CVS and Caremark are optimistic about the tobacco-free network, independent pharmacy groups and management companies have expressed concern and criticism over the plan and its implications. John Norton, a spokesperson for the National Community of Pharmacists, believes that Caremark must make consumers aware of smaller pharmacies that have not sold tobacco products for decades, so that consumers can make an informed decision when choosing a pharmacy. From the perspective of the smaller pharmacies, this seems to be a fair request. Smaller pharmacies already face numerous obstacles in being noticed over the bigger pharmacies like CVS and Walgreens. The new initiative will drive away even more clientele of the small business owner as consumers try to avoid the potential co-payment. Some are going further and calling the tobacco-free network “unfair competition” between big pharmaceuticals and the smaller companies that are struggling to survive in their shadow. Essentially, CVS and Caremark are driving customers away from other pharmacies and straight through their doors.

John Giampolo, President of the Independent Pharmacy Alliance of America, believes CVS’s actions will lead to “independent pharmac[ies]… scrambl[ing] to do their own marketing,” which will still not compare to the money and resources available to larger, corporate pharmacies. CVS has faced similar controversy in the past. Since acquiring Caremark in 2007, the Federal Trade Commission (“FTC”) has investigated CVS for using Caremark to push customers away from its competitors and to its own stores. The FTC investigated CVS and Caremark for antitrust violations, unfair business practices, and unfair competition allegations. However, in 2012, the investigation was closed, and no charges were filed. Nonetheless, CVS is stirring up controversy again with its new initiative. It can be argued that the company took a historic step in the promotion of public health and safety through its tobacco-sales ban. CVS and Caremark, however, may have diminished the goodwill it developed through its plan to enforce an additional co-payment on customers who use tobacco-selling pharmacies.

 

Sydney Mayer attended the University of Illinois at Chicago(UIC) for her undergraduate degree, double majoring in Political Science and French with Honors in both areas of study. Sydney hosted her own radio show at UIC, and was the Vice-President and Editor for the Honors College publication, OneWorld. She currently attends DePaul University College of Law. She is a Co-Vice Chair of Programming for the Health Law Institute (HLI), writer for the HLI newsletter, E-Pulse, and is a writer for the Journal of Healthcare Law. 

Misleading “Sprinkle, Eat, and Lose Weight” Claims Result in $26M Refund

The Federal Trade Commission (FTC) has announced that Epiq Systems, Inc., a redress administrator, will be mailing 477,083 refund checks totaling $26,023,329 to consumers who bought the sprinkle-on weight-loss supplement Sensa. The average refund each consumer will receive is $54, but that amount may differ based on how much he or she actually lost. The checks must be cashed within 60 days of their issuance date.

The refund announcement is the result of a January 2014 settlement with the national marketers of Sensa, who deceived consumers by claiming they could “sprinkle, eat, and lose weight” by using the supplement and by making misleading endorsements. The settlement imposed a $46.5 million judgment against the marketers, and required them to pay $26.5 million, with the rest suspended due to their inability to pay. However, if it is later determined that the financial information the marketers gave the FTC is untrue, the full amount of their judgment will become due.

FTC Complaint

The FTC charged that California-based Sensa Products, LLC, its parent company, Sensa, Inc., formerly Intelligent Beauty, Inc., Adam Goldberg, chief executive officer of Sensa, Inc., and Dr. Alan R. Hirsch, the creator of Sensa and a 10 percent owner of Sensa Products, LLC, deceptively advertised that the powdered food additive enhances food’s smell and taste, making users feel full faster, so they eat less and lose weight, without dieting, and without changing their exercise regime.

According to the FTC complaint: (1) the defendants typically charged $59 plus shipping and handling for a one-month supply of Sensa; (2) the powder was provided in twelve flavors, and marketed through radio and print advertisements, retail chains such as Costco and GNC, a promotional book, television ads and infomercials, the Home Shopping Network, ShopNBC, telemarketing, and the Internet; and (3) U.S. sales of Sensa totaled more than $364 million between 2008 and 2012.

The complaint further alleged that:

  • The defendants failed to disclose that some consumers were compensated for their endorsements of Sensa. In some instances, compensation included payments of $1,000 or $5,000, and trips to Los Angeles.
  • Hirsch, who conducted two of the studies cited in the ads and wrote a promotional book about Sensa, gave expert endorsements that were not supported by scientific evidence, and provided the means for the other defendants to deceive consumers.
  • The defendants falsely cited Dr. Hirsch’s studies as clinical proof that consumers could lose substantial weight without dieting or exercise.

Settlement

Under the January 2014 settlement, the defendants are barred from: (1) making weight-loss claims about dietary supplements, foods, or drugs, unless they have two adequate and well-controlled human clinical studies supporting the claims; (2) making any other health-related claim unless it is supported by competent and reliable scientific tests, analyses, research, or studies; and (3) misrepresenting any scientific evidence.

Dr. Hirsch is specifically barred from: (1) providing expert endorsements unless he relies on both competent and reliable scientific evidence and his own expertise; and (2) providing to others studies, promotional materials, endorsements, or other means for deceiving consumers.

The defendants also must disclose any material connections with the endorsers of a product or program, as well as with anyone conducting or participating in a study of the product or program.

Insolvency Reported

While consumers who purchased Sensa may still file a complaint with the FTC, no additional funds are presently available. Sensa, Inc. and Sensa Products, LLC have ceased operations. Sensa, Inc. and Sensa Products, LLC entered into Assignments for the Benefit of the Creditors under California state law on October 17, 2014. An Assignment for the Benefit of the Creditors is a form of insolvency under state law.