Articles Tagged with #Pfizer

Harmful drugs are commonly found in dietary supplements people take for weight loss, or muscle building, sexual enhancement or general health according to a new analysis. When California health department researchers took a closer look at more than 700 supplements subject to warnings from the FDA over a 10-year span, they often found drugs like sildenafil (Viagra), the heart drug sibutramine, and synthetic steroids, all of which could be harmful.

50% of adults in the U.S.  consume dietary supplements, which is now a $35 billion industry. These supplements include vitamins, minerals, botanicals, amino acids, and enzymes that according to the US Food and Drug Administration (FDA) are not intended to treat or prevent disease.  In the recent study, c ertain drug ingredients were commonly detected across products marketed for the same purposes . Overall, 287 of 353 adulterated sexual enhancement supplements (81.3%) contained sildenafil (166 of 353 [47.0%]) and/or at least 1 of its structural analogues (134 of 353 [38.0%]). Sildenafil is the active pharmaceutical ingredient in Viagra, which is a prescription medication manufactured by Pfizer Inc for erectile dysfunction. Analogues are metabolized in the body into active pharmaceutical ingredients. In the beginning of the 10-year period from 2007 through 2016, analogues of sildenafil were detected in a majority of adulterated sexual enhancement supplements (Figure 2). In 2012, however, the proportion of products containing sildenafil began to increase.

Harvard’s Dr. Pieter Cohen — who penned a commentary that accompanies the study — says the FDA’s “dereliction of duty” is to blame for tainted supplements still on the market. He says that the FDA plays an essential role in ensuring the safety of vitamins.  He also suggests that there are major deficiencies in the FDA’s regulation of supplements.

 Pfizer, Inc. has agreed to pay $23.85 million to settle charges that it used a foundation as a conduit to pay the copays of Medicare patients taking three Pfizer drugs, in violation of the False Claims Act, the Justice Department announced today.  The government alleged that Pfizer used a foundation as a mechanism to pay the copay obligations of Medicare patients taking three Pfizer drugs:  Sutent and Inlyta, which both treat renal cell carcinoma, and Tikosyn, which treats arrhythmia in patients with atrial flutter.  The government said that to generate revenue, and instead of giving Sutent and Inlyta to Medicare patients who met the financial qualifications of Pfizer’s existing free drug program, Pfizer allowed certain patients to use the foundation to cover the patients’ Medicare copays.  Pfizer allegedly made donations to the foundation to enable it to cover the copays of these patients.

The government’s resolution of this matter illustrates the government’s emphasis on combating health care fraud.  One of the most powerful tools in this effort is the False Claims Act.  The investigation was conducted by the Justice Department’s Civil Division and the U.S. Attorney’s Office for the District of Massachusetts, in conjunction with the Department of Health and Human Services, Office of Inspector General; the Federal Bureau of Investigation: the Department of Veterans Affairs, Office of Inspector General; and the United States Postal Inspection Service.

Jeffrey Newman represents whistleblowers