Life Science Compliance Update

May 25, 2015

Media Outlets Using 2013 Open Payments Data To Imply Misconduct

Open Payments CMS

Open Payments, a public list of the transfers of value made from pharmaceutical and device manufacturers to physicians and teaching hospitals, has yet to be the basis for a government enforcement action. The Justice Department has not, for example, explicitly used the Centers for Medicare and Medicaid Services’ database as the foundation for bringing kickback allegations against a company. That day may be a ways off—after all the database currently lists only five months of payment data covering September through December of 2013, and a large portion of that data is aggregated, meaning it doesn't list the physician recipients by name. Furthermore, there have been multiple reports that payment data has been matched to the incorrect physician.

While the government has been patient in its enforcement, the media has not.

After 13 years of wariness, FDA approves five potentially harmful new diet drugs

Most recently, MedPage Today paired with reporters from Milwaukee Journal Sentinel to create a series “Watchdog Report” targeting diet drugs. The article’s premise centers on the idea that history provides an important lesson. Bolstering this notion is the article’s use of a timeline starting in 1890, which states simply: “Early treatments for obesity fail.”

“In recent years, seven U.S. drug companies – Orexigen, Takeda, Eisai, Arena, Vivus, Novo Nordisk and Shire Pharmaceuticals – have been at the center of efforts to get the U.S. Food and Drug Administration to allow new diet drugs on the market,” states the article. “Critics worry the new products will repeat the diet-drug mistakes of the past, which have led to decades of injuries, deaths and, in the end, products forced off the market.”

The authors take issue with the fact that the drugs are approved specifically for obesity, with “no proof the drugs improve the main health concern posed by obesity: heart attacks and other cardiovascular problems.” The article also focuses on a number of potential risks associated with previous diet therapies--such as pancreatic cancer--that should have made FDA reconsider whether to approve these new drugs. 

The article suggests that the risks inherent in the five diet drug products outweigh the benefits, though the article glosses over any benefits associated with weight-loss, and lumps all five drugs together when discussing risks. To bolster this risk/reward analysis, the authors then turn to drug company expenditures that they suggest forced FDA's hand. 

"Diet drug companies spent $60 million since 2010 amid push to win FDA approval for new products"

In a connected article, MedPage Today and the Milwaukee Sentinel put together an outline of the money that drug companies spent promoting their diet drugs. "The latest diet drug push was propelled with a fusion of public health, private enterprise and politics — and plenty of drug company money," note the authors.

The article indicates that the seven companies connected to the new drugs spent:

  • $51 million lobbying the FDA and Congress on a host of issues, including obesity.
  • At least $4 million since 2013 on sponsorships of medical societies that encouraged use of drugs to treat obesity.
  • At least $5 million on travel, food and speaking fees paid directly to physicians. The number is likely much higher, but publicly-reported data covers just the last five months of 2013.

The authors reveal that they used the Open Payments database to gather the information on physician payments. "According to the federal Open Payments database, the manufacturers of Belviq spent at least $4.1 million on travel, food and speaking fees to doctors on behalf of the drug in the last five months of 2013, [and] Qsymia makers spent $1 million in that same period." the article states. "The publicly-available data only covers that period, which is before the other three drugs were approved."

In addition, the article hones in on particular recipients involved in the Endocrine Society's clinical practice guidelines, which recommend certain drugs for treating obesity as a disease. For example, the authors state that guideline author Caroline Apovian "is listed in the disclosure section of the society's obesity guidelines as having a 'significant financial interest or leadership position' in four obesity drug companies: Eisai, Vivus, Orexigen and Takeda." The authors used Open Payments data to show that she received at least $31,000 in travel, food and speaking fees from diet drug-makers in the last five months of 2013. Three other members of the group that issued the Endocrine Society guidelines received at least $50,000 combined from diet drug-makers for the same type of work during that time period, according to the Open Payments website, note the authors.

"Apovian has leadership positions with two different organizations that get funding from diet drug companies," including being chairwoman of the Endocrine Society and a board member of the Obesity Society, states the article.

When asked about the payments, Apovian said because of her expertise in the field, she is often sought out by drug-makers to serve on scientific advisory boards, which compensate her for her time and expenses. "Despite the growing problem of obesity in this country," Apovian said, "there are still very few qualified experts in the field today."

The authors also uncovered via Open Payments that one of the guidelines panel members had not disclosed his payments. 

 ---

As this article shows, when journalists have a government database to point to that shows physician payments, they are more emboldened to make claims about drug efficacy. While the MedPage today article is one of the first in-depth stories to rely heavily on Open Payments, the article could signify a new trend, especially as data from 2014 comes out in the next few months. 

 

May 22, 2015

Open Payments Data Correction Period: May 21 - June 5

Open Payments CMS

Today, May 21, the Open Payments 15-day data correction period begins for applicable manufactures and group purchasing organizations. The correction period will end June 5. During this time, applicable manufacturers and GPOs should acknowledge and resolve disputes initiated by physicians and teaching hospitals during the review and dispute period conducted between April 6 and May 20, 2015. The 2014 Open Payments data will become public on June 30, 2015. 

The data correction period follows the 45-day dispute process, where physicians and teaching hospitals could inspect manufacturer or GPO submitted data before it is published on the Open Payments website. 

Understand the impact of dispute timing at CMS's resource, Review and Dispute Timing and Data Publication Quick Reference Guide, which provides information on how data is published based on when a dispute is initiated and its dispute resolution status.

"It is important that applicable manufacturers or GPOs work directly with the physician or teaching hospital to resolve any disputes in accordance with the Final Rule, states the Centers for Medicare and Medicaid Services (CMS). The agency notes that it "is not responsible for mediating disputes."

Instructions for the Data Correction Process 

  • Step-by-step instructions regarding the data correction process are available below and on the Resources page of the Open Payments website. 

For Applicable Manufacturers and GPOs

For Physicians and Teaching Hospitals

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